%0 Journal Article %@ 1929-0748 %I JMIR Publications %V 14 %N %P e66335 %T Resource-Oriented Case Management to Implement Recommendations for Patients With Chronic Pain and Frequent Use of Analgesics in General Practices (Project RELIEF): Protocol for a Single-Arm Exploratory Feasibility Study %A Poß-Doering,Regina %A Brinkmöller,Sabrina %A Balzer,Alexandra %A Wurmbach,Viktoria Sophie %A Paul,Cinara %A Stolz,Regina %A Zugaj,Marco Richard %A Tesarz,Jonas %A Wensing,Michel %A Straßner,Cornelia %+ Department of Primary Care and Health Services Research, Medical Faculty, Heidelberg University, University Hospital Heidelberg, Im Neuenheimer Feld 130.3, Heidelberg, 69120, Germany, 49 622156 ext 38643, regina.poss-doering@med.uni-heidelberg.de %K chronic noncancer pain %K case management %K primary care %K general practice resource-oriented %K chronic pain %K analgesics %K pharmacological treatment %K pain medications %K holistic approach %K feasibility %K single-arm %K exploratory %K pilot study %K screening %K questionnaire %K survey %K protocol %D 2025 %7 15.4.2025 %9 Protocol %J JMIR Res Protoc %G English %X Background: Chronic noncancer pain (CNCP) is a frequent reason for counseling in general practice. Current German guidelines emphasize its biopsychosocial etiology and the importance of self-care and nonpharmacological treatment strategies such as education, physical and social activity, and psychological approaches. Comprehensive assessments are necessary to individualize treatment maximally and monitor appropriate use of pain medication. General practitioners face many challenges in implementing holistic pain management, which considers biological, psychological, and social aspects. In project RELIEF (resource-oriented case management to implement recommendations for patients with chronic pain and frequent use of analgesics in general practices), a case management program was developed to facilitate implementation of guideline recommendations on pain management regarding medical assessment and monitoring, patient and practice team education, promotion of self-care strategies, and rational pharmacotherapy. Objective: We evaluated the feasibility of the intervention and study procedures before applying them in a larger cluster randomized controlled trial. Our secondary objective is to estimate potential effects of the complex intervention. Methods: A single-arm trial with general practices and patients with CNCP and analgesics use will be conducted, accompanied by a mixed methods process evaluation. The intervention comprises 5 components, including software-supported medical pain history, 3 scheduled structured appointments, e-learning on CNCP for general practitioners and medical assistants, educational material for patients, toolbox with information on (regional) resources for patients and practice teams. Participating practices will be located in the federal state of Baden-Württemberg, Germany, and will recruit eligible patients (adults with CNCP for more than 3 months, with at least moderate pain-related disability, permanent or on-demand use of analgesics or co-analgesics in the previous 4 weeks, and practice team assessed ability to participate actively in the trial). A questionnaire given to the first 150 adult patients entering the practice in February 2025 will help screen eligible patients. The primary objective will be measured by a set of predefined indicators. The key secondary outcome is pain-related disability measured by the Pain Disability Index German version. All participants will be asked to participate in the process evaluation. Outcome evaluation data will be gathered by paper-based and digitally provided questionnaires to be completed by participants. Process evaluation data will be gathered in surveys and a qualitative study. Descriptive analyses will be performed. Results: Recruitment occurred between October and December 2024. Targeted sample size was 6 practices and 50 patients. The intervention period will be February-June 2025. It is expected that eligible patients will benefit from the intervention and that improved medication management and intensified use of nonpharmacological treatment strategies will reduce pain-related disabilities and other patient-reported outcomes. Conclusions: This study will provide valuable information regarding feasibility and potential effects before testing the intervention in a confirmatory cluster randomized controlled trial. Trial Registration: German Clinical Trials Register DRKS00034831; https://www.drks.de/search/de/trial/DRKS00034831 International Registered Report Identifier (IRRID): PRR1-10.2196/66335 %M 40233357 %R 10.2196/66335 %U https://www.researchprotocols.org/2025/1/e66335 %U https://doi.org/10.2196/66335 %U http://www.ncbi.nlm.nih.gov/pubmed/40233357 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 14 %N %P e67248 %T Effectiveness of The Umbrella Collaboration Versus Traditional Umbrella Reviews for Evidence Synthesis in Health Care: Protocol for a Validation Study %A Carrillo,Beltran %A Rubinos-Cuadrado,Marta %A Parellada-Martin,Jazmin %A Palacios-López,Alejandra %A Carrillo-Rubinos,Beltran %A Canillas-Del Rey,Fernando %A Baztán-Cortes,Juan Jose %A Gómez-Pavon,Javier %+ The Umbrella Collaboration, C/ Ferraz, 49 - 1º izq, Madrid, 28008, Spain, 34 915422945, bcm@theumbrellacollaboration.org %K tertiary evidence synthesis %K The Umbrella Collaboration %K umbrella reviews %K health research methodology %K AI-assisted synthesis %K AI-assisted %K evidence-based decision making %K machine learning %K ML %K artificial intelligence %K AI %K algorithms %K models %K analytics %K digital health %K digital technology %K digital interventions %D 2025 %7 14.4.2025 %9 Original Paper %J JMIR Res Protoc %G English %X Background: The synthesis of evidence in health care is essential for informed decision-making and policy development. This study aims to validate The Umbrella Collaboration (TU), an innovative, semiautomatic tertiary evidence synthesis methodology, by comparing it with Traditional Umbrella Reviews (TUR), which are currently the gold standard. Objective: This study aimed to evaluate whether TU, an artificial intelligence—assisted, software-driven system for tertiary evidence synthesis, can achieve comparable effectiveness to TURs, while offering a more timely, efficient, and comprehensive approach. In addition, as a secondary objective, the study aims to assess the accessibility and comprehensibility of TU’s outputs to ensure its usability and practical applicability for health care professionals. Methods: This protocol outlines a comparative study divided into 2 main parts. The first part involves a quantitative comparison of results obtained using TU and TURs in geriatrics. We will evaluate the identification, size effect, direction, statistical significance, and certainty of outcomes, as well as the time and resources required for each methodology. Data for TURs will be sourced from Medline (via PubMed), while TU will use artificial intelligence—assisted informatics to replicate the research questions of the selected TURs. The second part of the study assesses the ease of use and comprehension of TU through an online survey directed at health professionals, using interactive features and detailed data access. Results: Expected results include the assessment of concordance in identifying outcomes, the size effect, direction and significance of these outcomes, and the certainty of evidence. In addition, we will measure the operational efficiency of each methodology by evaluating the time taken to complete projects. User perceptions of the ease of use and comprehension of TU will be gathered through detailed surveys. The implementation of new methodologies in evidence synthesis requires validation. This study will determine whether TU can match the accuracy and comprehensiveness of TURs while offering benefits in terms of efficiency and user accessibility. The comparative study is designed to address the inherent challenges in validating a new methodology against established standards. Conclusions: If TU proves as effective as TURs but more time-efficient, accessible, and easily updatable, it could significantly enhance the process of evidence synthesis, facilitating informed decision-making and improving health care. This study represents a step toward integrating innovative technologies into routine evidence synthesis practice, potentially transforming health research. International Registered Report Identifier (IRRID): PRR1-10.2196/67248 %M 40057944 %R 10.2196/67248 %U https://www.researchprotocols.org/2025/1/e67248 %U https://doi.org/10.2196/67248 %U http://www.ncbi.nlm.nih.gov/pubmed/40057944 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 14 %N %P e70575 %T Early Detection of Type 1 Diabetes in First-Degree Relatives in Saudi Arabia (VISION-T1D): Protocol for a Pilot Implementation Study %A Algadi,Iman S %A AlRuthia,Yazed %A Mujammami,Muhammad H %A Aburisheh,Khaled Hani %A Alotaibi,Metib %A Al Issa,Sharifah %A Al-Saif,Amal A %A Seftel,David %A Tsai,Cheng-Ting %A Al Khalifah,Reem A %+ Department of Pediatrics, College of Medicine, King Saud University, PO Box 800, Riyadh, 11421, Saudi Arabia, 966 0557100303, reem_ah@yahoo.com %K islet autoimmunity %K type 1 diabetes mellitus %K T1D %K screening program %K antibody detection by agglutination–polymerase chain reaction %K PCR %K ADAP %K human leukocyte antigen %K genetic risk score %D 2025 %7 14.4.2025 %9 Protocol %J JMIR Res Protoc %G English %X Background: Type 1 diabetes (T1D) is a growing global health concern, with a notable rise in incidence in Saudi Arabia. Despite the potential benefits of early detection through screening programs, such initiatives are currently lacking in Saudi Arabia and other Arab countries. Objective: This study aims to evaluate the feasibility, acceptability, and cost-effectiveness of a T1D-screening program targeting high-risk individuals, specifically children with a first-degree relative diagnosed with T1D. Methods: The VISION-T1D program is a prospective cohort study focused on the early detection of presymptomatic T1D by screening children aged 2-18 years. The primary screening method involves testing for islet autoantibodies, including insulin autoantibodies, glutamic acid decarboxylase autoantibodies, insulinoma associated-2 autoantibodies, and zinc transporter-8 autoantibodies. Optional genetic testing, including human leukocyte antigen phenotyping and the genetic risk score, is offered. Outcomes include the feasibility of the screening process, prevalence of early-stage T1D, psychological impacts, educational intervention effectiveness, progression rates to stage-3 T1D, and economic viability. Results: The VISION-T1D program began in May 2024. As of December 2024, a total of 176 families have been enrolled. Data collection will continue until April 2025, with final data analysis projected for mid-2025. Conclusions: The VISION-T1D study provides a practical approach to T1D screening tailored to the health care landscape of Saudi Arabia. The insights gained from this pilot program will inform the development of a national, population-based screening initiative designed to reduce diabetic ketoacidosis at diagnosis, improve long-term outcomes, and alleviate the economic burden of T1D. The VISION-T1D initiative could also serve as a scalable and sustainable model that can be adopted internationally, contributing to global efforts to manage and prevent T1D. Trial Registration: ClinicalTrials.gov NCT06513247; https://clinicaltrials.gov/study/NCT06513247 International Registered Report Identifier (IRRID): DERR1-10.2196/70575 %M 39930327 %R 10.2196/70575 %U https://www.researchprotocols.org/2025/1/e70575 %U https://doi.org/10.2196/70575 %U http://www.ncbi.nlm.nih.gov/pubmed/39930327 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 14 %N %P e66579 %T Feasibility of a Progesterone-Modified Natural Protocol for Frozen Embryo Transfer: Protocol for a Pilot Cohort Study %A Churchill,Alexandra %A Georgiou,Ektoras %A Abruzzo,Veronica %A Polyakov,Alex %A Teh,Wan Tinn %+ Reproductive Services Unit, The Royal Women's Hospital, 20 Flemington Rd, Parkville, Melbourne, VIC 3050, Australia, 61 (03) 8345 2000, Wan.Teh@thewomens.org.au %K frozen embryo transfer %K fertility care %K reproductive health %K infertility %K progesterone-modified natural cycle protocol %K in vitro fertilization %D 2025 %7 11.4.2025 %9 Protocol %J JMIR Res Protoc %G English %X Background: With the existence of various frozen embryo transfer (FET) methods currently used in the field of assisted reproductive technologies, the debate surrounding which of these is superior remains. All FET protocols aim to prime the endometrium and time embryo transfer during the window of implantation. Current methods include the true natural cycle FET (tNFET), modified natural cycle FET, artificial cycle FET, and ovulation induction. Each of these harbors, distinct advantages and disadvantages, namely, surrounding the timing of transfer and flexibility conferred through this process. More recently, a newer approach has been used whereby the need to monitor or trigger ovulation is circumvented, with luteal phase support commenced once a certain follicle diameter and endometrial thickness criteria are met but before ovulation. However, the research into this protocol has certain important limitations that our study seeks to address. Objective: This study aims to assess the feasibility of a progesterone-modified natural cycle protocol for FET. The primary outcome will be the presence of a corpus luteum on ultrasound scans on the day of embryo transfer. The secondary outcomes will include the number of clinic visits required per patient undergoing the protocol, biochemical pregnancy rate, and clinical pregnancy rate. Methods: We will conduct a prospective cohort study, recruiting 20 women undertaking FET at the Public Fertility Care of The Royal Women’s Hospital in Melbourne, Australia. These women will be matched to a control group who have undergone the tNFET protocol within the preceding 12 months of the study start date. Results: This project received ethics approval on July 17, 2024, with commencement of the study in September 2024, aiming for a duration of completion of 9 months. The completion of the follow-up and submission of the study for publication are anticipated for September 2025. Conclusions: After this preliminary study, the aim would be to progress to a noninferiority randomized controlled trial to compare the progesterone-modified natural cycle protocol for FET to the tNFET. International Registered Report Identifier (IRRID): PRR1-10.2196/66579 %M 40215104 %R 10.2196/66579 %U https://www.researchprotocols.org/2025/1/e66579 %U https://doi.org/10.2196/66579 %U http://www.ncbi.nlm.nih.gov/pubmed/40215104 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 14 %N %P e51434 %T Effect of Continuous Positive Airway Pressure or Positional Therapy Compared to Control for Treatment of Obstructive Sleep Apnea on the Development of Gestational Diabetes Mellitus in Pregnancy: Protocol for Feasibility Randomized Controlled Trial %A Clements,Frances %A Vedam,Hima %A Chung,Yewon %A Smoleniec,John %A Sullivan,Colin %A Shanmugalingam,Renuka %A Hennessy,Annemarie %A Makris,Angela %+ Department of Respiratory and Sleep Medicine, Liverpool Hospital, South Western Sydney Local Health District, 13 Elizabeth St, Sydney, 2170, Australia, 61 287384101, frances.clements@health.nsw.gov.au %K obstructive sleep apnoea %K OSA %K sleep disordered breathing %K pregnancy %K CPAP %K positional therapy %K gestational diabetes %K GDM %K preeclampsia %K fetomaternal %K maternal %K pregnant %K fetus %K fetal %K breathing %K apnoea %K sleep %K respiratory %K eclampsia %K pregnant women %K pregnancy complications %K hypertension %D 2025 %7 11.4.2025 %9 Protocol %J JMIR Res Protoc %G English %X Background: Obstructive sleep apnea (OSA) is a common sleep disorder, and in pregnancy, it is associated with an increased risk of complications, including gestational diabetes mellitus and preeclampsia. Supine sleep may worsen OSA, and in pregnancy, it is associated with an increased risk of stillbirth due to effects on fetomaternal blood flow. Continuous positive airway pressure (CPAP) therapy is considered the gold-standard treatment for moderate to severe OSA, although compliance is frequently poor; positional therapy (PT) is generally less effective than CPAP in nonpregnant patients but may be better tolerated and more accessible during pregnancy. There is limited data on whether widespread, early screening for sleep disorders in pregnant women with symptoms of sleep-disordered breathing or at high risk of metabolic complications and subsequent early intervention with CPAP or PT attenuates fetomaternal risks. Objective: This study aims to determine the feasibility of conducting a randomized controlled trial to assess improved fetomaternal outcomes in a high-risk pregnant population with OSA, using CPAP or PT, initiated by the 16th week of gestation. Methods: This study is a randomized, controlled, open-label feasibility study in which pregnant women with an apnea-hypopnea index (AHI) or respiratory disturbance index (RDI) ≥5 are treated with CPAP (auto-titrating and fixed pressure) or positional therapy from early gestation (by 16 weeks) until delivery. The primary outcome is the feasibility of the study protocol and the development of gestational diabetes mellitus by the 28-week gestation period. Secondary outcomes include the development of hypertensive disorders of pregnancy (HDP), maternal weight gain, uterine artery blood flow, glycemic control during pregnancy (in participants who develop gestational diabetes), changes in maternal circulating biomarkers, and neonatal birthweight complications. Polysomnography at 28- to 32-week gestation period, postpartum polysomnography, therapy compliance, and patient acceptability are also assessed. Results: The trial commenced on September 30, 2019. The trial is ongoing as of August 6, 2024. Conclusions: The trial intends to contribute to the growing evidence base to support the need for the identification and treatment of OSA occurring during pregnancy and to assess the feasibility of the study protocol. This will be the first trial to compare the early initiation of CPAP (auto-titrating and fixed pressure) and positional therapy in pregnant women from early gestation, providing alternative therapies for the treatment of OSA in this important population. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12619001530112; https://tinyurl.com/yctdzs4u International Registered Report Identifier (IRRID): DERR1-10.2196/51434 %M 40215099 %R 10.2196/51434 %U https://www.researchprotocols.org/2025/1/e51434 %U https://doi.org/10.2196/51434 %U http://www.ncbi.nlm.nih.gov/pubmed/40215099 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 14 %N %P e52121 %T Tailoring a Skills-Based Serostatus Disclosure Intervention for Transgender Women in South Africa: Protocol for a Usability and Feasibility Study %A Daniels,Joseph %A van der Merwe,Leonashia Leigh-Ann %A Portle,Sarah %A Bongo,Cikizwa %A Nadkarni,Shiv %A Petrus Peters,Remco %+ Edson College of Nursing and Health Innovation, Arizona State University, 500 N 3rd Street, Phoenix, AZ, 85004, United States, daniels.joseph@gmail.com %K transgender women %K intervention development %K relationships %K HIV treatment %K South Africa %K mobile phones, smartphones %K skills-based %K serostatus disclosure %K HIV %K HIV prevention %K transgender %K treatment outcomes %K transmission %K HIV-discordant partnerships %K behavioral intervention %K safe sex %K human-centered design %K viral suppression %K Speaking Out and Allying Relationships %K LGBTQ2S %K LGBTQ %K 2SILGBTQ %D 2025 %7 26.3.2025 %9 Protocol %J JMIR Res Protoc %G English %X Background: Transgender women have few interventions to support their HIV prevention and treatment outcomes in South Africa. Further, increased focus should be on intervention development that will reduce HIV transmission within HIV-discordant partnerships, especially for transgender women who navigate gender, sexuality, and relationship stigma. The Speaking Out and Allying Relationships (SOAR) intervention has been developed for sexual minority men to address these outcomes in South Africa. It is a behavioral intervention that is delivered in groups via videoconference to develop coping skills to manage HIV-related stress, assist with disclosure to partners, and establish and maintain safer sex practices with partners. Tailoring SOAR may be feasible for transgender women to support their HIV care while reducing transmission within their relationships. Objective: This study aims to (1) adapt SOAR for transgender women and test its usability, then (2) assess its feasibility. Methods: To achieve aim 1, we will use a human-centered design approach to tailor the existing SOAR intervention for transgender women. Interviews and a survey will be administered to transgender women (N=15) to assess intervention preferences. Findings will be used to tailor content like roleplays, scenarios, and media to align with transgender women’s lived experiences navigating HIV and relationships. Afterward, we will conduct a usability test with 7 (47%) of the 15 participants to determine intervention understanding and satisfaction. Participants will be transgender women living with HIV and in a relationship with a man who has unknown HIV status or is HIV-negative. All participants will be recruited using community-based approaches. In aim 2, we will examine SOAR feasibility using a 1-arm pilot study. Transgender women (N=20) will be recruited using aim 1 methods and eligibility criteria, with participants completing feasibility surveys and interviews, as well as behavioral and biomedical assessments. Results: Intervention adaptation began in May 2023 with interviews. Feasibility pilot testing was conducted with 14 transgender women, with study completion in January 2025. Conclusions: Transgender women need more intervention options that engage their relationships since these can present barriers to HIV treatment outcomes like hindering viral suppression in South Africa. Delivering an existing yet tailored intervention via videoconference expands its reach to transgender women and allows them to engage with others and learn new skills in a secure setting like their homes. SOAR has the potential to improve relationship dynamics and reduce violence, which will in turn enhance HIV treatment and prevention engagement. International Registered Report Identifier (IRRID): PRR1-10.2196/52121 %M 40138676 %R 10.2196/52121 %U https://www.researchprotocols.org/2025/1/e52121 %U https://doi.org/10.2196/52121 %U http://www.ncbi.nlm.nih.gov/pubmed/40138676 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 14 %N %P e67128 %T Exploring Climate Change’s Impact on the Cardiopulmonary Health of Adults Living in the Canton of Valais, Switzerland: Protocol for a Development and Usability Pilot Study %A Portela Dos Santos,Omar %A Alves,Paulo Jorge Pereira %A Verloo,Henk %+ Department of Nursing Sciences, School of Health Sciences, HES-SO Valais/Wallis, Chemin de l'Agasse 5, Sion, 1950, Switzerland, 41 786680125, omar.porteladossantos@hevs.ch %K climate change %K global warming %K emergency department %K emergency nursing %K sustainable care %K ecological medicine %K cardiopulmonary %K cardio health %K Valais %K Switzerland %K pilot study %K study protocol %K humanity %K air pollution %K impact %K comorbidities %K adults %K mixed methods design %K feasibility %K health promotion %K disease prevention %K acceptability %D 2025 %7 25.3.2025 %9 Protocol %J JMIR Res Protoc %G English %X Background: Climate change is affecting public health and well-being. In 2016, Swiss emergency departments (EDs) treated 1,722,000 cases, with 4718 daily admissions. In 2023, the ED of Sion Regional Hospital recorded 75,000 consultations. The links between climate change and health are complex, necessitating urgent research on its impact on cardiopulmonary health in Valais, Switzerland. Raising awareness among frontline professionals is crucial for developing health promotion and disease prevention strategies. Objective: This study explores the preliminary effects of climate change on cardiopulmonary health in Valais and assesses adult patients’ knowledge of its health consequences. Findings will inform adaptations in patient care, health promotion, and disease prevention at Sion Hospital’s ED. The feasibility of patient selection and data collection will also be evaluated. Methods: Using a convergent, parallel, mixed methods design, data will be collected from September 21, 2024, to September 20, 2025, with a target sample of 60 patients. The quantitative phase will examine patient recruitment feasibility, consultation reasons, and triage levels, correlating them with climate variables (temperature, nitrogen dioxide, particulate matter, sulfur dioxide, and ozone). It will also analyze sociodemographic profiles. The qualitative phase will explore patients’ knowledge of climate change and its potential links to their ED visits. The feasibility and acceptability of the study process will be assessed. The protocol follows the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) Extension for Pilot and Feasibility Trials. Results: Data collection started on September 21, 2024, following the approval by the ethical commission. Data collection will take place over 1 year, until September 20, 2025. Conclusions: This study will test the feasibility of a larger investigation and examine potential associations between Valais’ changing microclimate and population health. Findings will establish patient profiles and explore their perceptions and knowledge of climate change, informing future health interventions. International Registered Report Identifier (IRRID): DERR1-10.2196/67128 %M 40132196 %R 10.2196/67128 %U https://www.researchprotocols.org/2025/1/e67128 %U https://doi.org/10.2196/67128 %U http://www.ncbi.nlm.nih.gov/pubmed/40132196 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 14 %N %P e59326 %T Student Acceptance of Digital Entrustable Professional Activities: Protocol for a Cohort Study %A Domann,Maximilian %A Richters,Constanze %A Stadler,Matthias %+ Institute of Medical Education, LMU University Hospital, Ludwig Maximilians University Munich, Pettenkoferstraße 8a, Munich, 80336, Germany, 49 15789310545, domann.maximilian@gmail.com %K medical education %K entrustable professional activities %K EPAs %K digital EPAs %K technology acceptance model %D 2025 %7 25.3.2025 %9 Protocol %J JMIR Res Protoc %G English %X Background: Integrating digital entrustable professional activities (EPAs) and simulations in medical education represents a substantial shift toward competency-based learning. This approach focuses on developing specific skills through manageable units and enhancing proficiency in high-stakes environments. The technology acceptance model provides a framework to evaluate the adoption of these educational technologies, emphasizing the roles of perceived usefulness and ease of use. Objective: This cohort study aims to investigate the acceptance of digital EPAs among medical students within simulated training environments. It seeks to understand how perceived usefulness and ease of use influence this acceptance, guided by the principles of the technology acceptance model. Methods: The cohort study will involve medical students in the clinical phase of their education at Ludwig Maximilians University Munich. The survey, distributed through the Module-6 distributor, will capture their perceptions of digital EPAs. The data will be analyzed using regression analysis. Results: Data collection is anticipated to be complete by April 2025, with analysis concluded by May 2025. The results will provide insights into students’ attitudes toward digital EPAs and their willingness to integrate these tools into their learning. Conclusions: This study will contribute to the understanding of digital EPAs’ role in medical education, potentially guiding future design and implementation of these tools. While highlighting the importance of perceived usefulness and ease of use, the study also acknowledges limitations in sample size and recruitment methodology, indicating the need for further research with more diverse and larger groups. This research is poised to shape future medical training programs, aligning with the evolving landscape of medical education. International Registered Report Identifier (IRRID): PRR1-10.2196/59326 %M 40132182 %R 10.2196/59326 %U https://www.researchprotocols.org/2025/1/e59326 %U https://doi.org/10.2196/59326 %U http://www.ncbi.nlm.nih.gov/pubmed/40132182 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 9 %N %P e62935 %T Assessment of Digital Capabilities by 9 Countries in the Alliance for Healthy Cities Using AI: Cross-Sectional Analysis %A Lee, Hocheol %K digital capabilities %K digital health cities %K digital transformation %K Asian Forum of Healthy Cities %K assessment %K digital health %K artificial intelligence %K AI %K World Health Organization %K WHO %K healthy city %K data %K health management %K digital era %K qualitative analysis %K cross-sectional survey %K database %K digital health database %K effectiveness %K digital literacy %D 2025 %7 7.2.2025 %9 %J JMIR Form Res %G English %X Background: The Alma-Ata Declaration of 1978 initiated a global focus on universal health, supported by the World Health Organization (WHO) through healthy cities policies. The concept emerged at the 1984 Toronto “Beyond Health Care” conference, leading to WHO’s first pilot project in Lisbon in 1986. The WHO continues to support regional healthy city networks, emphasizing digital transformation and data-driven health management in the digital era. Objective: This study explored the capabilities of digital healthy cities within the framework of digital transformation, focusing on member countries of the Asian Forum of Healthy Cities. It examined the cities’ preparedness and policy needs for transitioning to digital health. Methods: A cross-sectional survey was conducted of 9 countries—Australia, Cambodia, China, Japan, South Korea, Malaysia, Mongolia, the Philippines, and Vietnam—from August 1 to September 21, 2023. The 6-section SPIRIT (setting approach and sustainability; political commitment, policy, and community participation; information and innovation; resources and research; infrastructure and intersectoral; and training) checklist was modified to assess healthy cities’ digital capabilities. With input from 3 healthy city experts, the checklist was revised for digital capabilities, renaming “healthy city” to “digital healthy city.” The revised tool comprises 8 sections with 33 items. The survey leveraged ChatGPT (version 4.0; OpenAI, Microsoft), accessed via Python (Python Software Foundation) application programming interface. The openai library was installed, and an application programming interface key was entered to use ChatGPT (version 4.0). The “GPT-4 Turbo” model command was applied. A qualitative analysis of the collected data was conducted by 5 healthy city experts through group deep-discussions. Results: The results indicate that these countries should establish networks and committees for sustainable digital healthy cities. Cambodia showed the lowest access to electricity (70%) and significant digital infrastructure disparities. Efforts to sustain digital health initiatives varied, with countries such as Korea focusing on telemedicine, while China aimed to build a comprehensive digital health database, highlighting the need for tailored strategies in promoting digital healthy cities. Life expectancy was the highest in the Republic of Korea and Japan (both 84 y). Access to electricity was the lowest in Cambodia (70%) with the remaining countries having had 95% or higher access. The internet use rate was the highest in Malaysia (97.4%), followed by the Republic of Korea (97.2%), Australia (96.2%), and Japan (82.9%). Conclusions: This study highlights the importance of big data-driven policies and personal information protection systems. Collaborative efforts across sectors for effective implementation of digital healthy cities. The findings suggest that the effectiveness of digital healthy cities is diminished without adequate digital literacy among managers and users, suggesting the need for policies to improve digital literacy. %R 10.2196/62935 %U https://formative.jmir.org/2025/1/e62935 %U https://doi.org/10.2196/62935 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 14 %N %P e64970 %T Evaluation of the Transition-to-Practice Arrangements for Novice Perioperative Nurses: Protocol for a Mixed Methods Study %A Nijkamp,Nick %A Calleja,Pauline %A Sahay,Ashlyn %A Jack,Leanne %+ School of Nursing, Midwifery, and Social Sciences, CQUniversity, 6 University Dr, Bundaberg, 4670, Australia, 61 4150 7701, n.nijkamp@cqu.edu.au %K transition to practice %K perioperative nursing %K novice nurses %K nurse educators %K mixed methods research %K protocol %K document analysis %K semistructured interviews %K pedagogy %D 2025 %7 23.1.2025 %9 Protocol %J JMIR Res Protoc %G English %X Background: Transitioning into the first year of clinical practice as a nurse or changing specialties in the nursing career presents a critical phase for novice nurses characterized by excitement, apprehension, and the phenomenon of “transition shock.” Within perioperative nursing, this transition phase takes on distinctive challenges. However, there is a lack of empirical evidence on transition programs and arrangements. Objective: This study aimed to evaluate the current transition-to-practice (TTP) arrangements available to new graduate and novice nurses within Australian perioperative nursing settings. Methods: This study uses an exploratory mixed-method, multilevel triangulation with a sequential phase design to address 4 research questions. Phases 1 to 3 will use document analysis, surveys, and semistructured interviews to establish the findings of the research questions. Phase 4 will use meta-inference and triangulation to aggregate and analyze the data from all preceding phases. These findings will be the foundation for developing a framework to inform future TTP arrangements. This robust framework will embed empirical evidence, existing literature, and sound learning and teaching pedagogy. Results emerging from this study will be reported using the Good Reporting of Mixed Methods Study guidelines. Results: This project received approval in June 2023. Following this, Human Research Ethics Committee approval was sought for phases 1 and 2, and recruitment began. As of August 2024, phase 1 has collected 50 responses and phase 2 has collected 69 responses. Data collection for phase 3 is projected to commence in May 2025 once data from phases 1 and 2 have been analyzed. Phase 4 is projected to occur in 2026. Each phase is anticipated to have a results manuscript submitted for publication once data are analyzed and written up. Conclusions: The findings of this study will provide an in-depth exploration of TTP arrangements within perioperative nursing in Australia and provide a framework to guide the future development of TTP arrangements. Trial Registration: OSF Registries osf.io/zm432; https://osf.io/54s36 International Registered Report Identifier (IRRID): DERR1-10.2196/64970 %M 39847424 %R 10.2196/64970 %U https://www.researchprotocols.org/2025/1/e64970 %U https://doi.org/10.2196/64970 %U http://www.ncbi.nlm.nih.gov/pubmed/39847424 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e51493 %T Strengthening Cause of Death Statistics in Selected Districts of 3 States in India: Protocol for an Uncontrolled, Before-After, Mixed Method Study %A Grover,Ashoo %A Nair,Saritha %A Sharma,Saurabh %A Gupta,Shefali %A Shrivastava,Suyesh %A Singh,Pushpendra %A Kanungo,Srikanta %A Ovung,Senthanro %A Singh,Charan %A Khan,Abdul Mabood %A Sharma,Sandeep %A Palo,Subrata Kumar %A Chakma,Tapas %A Bajaj,Anjali %+ Indian Council of Medical Research, PO Box 491, Ansari Nagar, New Delhi, 110029, India, 91 9871087189, nairs@icmr.gov.in %K cause of death %K Medical Certification of Cause of Death %K capacity building %K Civil Registration and Vital Statistics %K training %D 2024 %7 20.12.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: Mortality statistics are vital for health policy development, epidemiological research, and health care service planning. A robust surveillance system is essential for obtaining vital information such as cause of death (CoD) information. Objective: This study aims to develop a comprehensive model to strengthen the CoD information in the selected study sites. The specific objectives are (1) to identify the best practices and challenges in the functioning of the Civil Registration and Vital Statistics (CRVS) system with respect to mortality statistics and CoD information; (2) to develop and implement interventions to strengthen the CoD information; (3) to evaluate the quality improvement of the Medical Certification of Cause of Death (MCCD); and (4) to improve the CoD information at the population level through verbal autopsy for noninstitutional deaths in the selected study sites. Methods: An uncontrolled, before-after, mixed method study will be conducted in 3 blocks located in the districts of 3 states (Madhya Pradesh, Uttar Pradesh, and Odisha) in India. A baseline assessment to identify the best practices and challenges in the functioning of the CRVS system, along with a quality assessment of the MCCD, will be conducted. An intervention informed by existing literature and the baseline assessment will be developed and implemented in the study sites. The major components of intervention will include a Training of Trainers workshop, orientation of stakeholders in the functioning of the CRVS system, training of physicians and medical officers in the MCCD, and training of community health workers in World Health Organization Verbal Autopsy 2022 instrument. Postintervention evaluation will be carried out to assess the impact made by the intervention on the availability and quality improvement of CoD information in the selected study sites. The outcome will be measured in terms of the quality improvement of the MCCD and the availability of CoD information at population level through verbal autopsy in the selected study sites. Results: The project has been funded, and regulatory approval has been obtained from the Institutional Ethics Committee. The data collection process began in May 2023. The duration of the study will be for 24 months. Conclusions: Our study is expected to provide a valuable contribution toward strengthening CoD information, which could be helpful for policy making and further research. The intervention model will be developed in collaboration with the existing functionaries of the health and CRVS systems in the selected study sites that are engaged in reporting and recording CoD information; this will ensure sustainability and provide lessons for upscaling, with the aim to improve the reporting of CoD information in the country. International Registered Report Identifier (IRRID): DERR1-10.2196/51493 %M 39705697 %R 10.2196/51493 %U https://www.researchprotocols.org/2024/1/e51493 %U https://doi.org/10.2196/51493 %U http://www.ncbi.nlm.nih.gov/pubmed/39705697 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e60677 %T A Gender-Informed Smoking Cessation App for Women: Protocol for an Acceptability and Feasibility Study %A Melamed,Osnat C %A Mehra,Kamna %A Panda,Roshni %A Minian,Nadia %A Veldhuizen,Scott %A Zawertailo,Laurie %A Buckley,Leslie %A Maslej,Marta %A Greaves,Lorraine %A Brabete,Andreea C %A Rose,Jonathan %A Ratto,Matt %A Selby,Peter %+ INTREPID Lab, Centre for Addiction and Mental Health, 1025 Queen Street West, Toronto, ON, M6J1H4, Canada, 1 4165358501 ext 36019, osnat.melamed@camh.ca %K smoking cessation %K mHealth %K co-development %K feasibility %K smoking %K mobile app %K cigarette smoking %K tobacco cessation %K gender-informed design %K app design %K women's health %K behavior change %K health behavior change %K mobile phone %D 2024 %7 10.12.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: Tobacco smoking remains the leading preventable cause of death and disease among women. Quitting smoking offers numerous health benefits; however, women tend to have less success than men when attempting to quit. This discrepancy is partly due to sex- and gender-related factors, including the lower effectiveness of smoking cessation medication and the presence of unique motives for smoking and barriers to quitting among women. Despite the gendered nature of smoking, most smoking cessation apps are gender-neutral and fail to address women’s specific needs. Objective: This study aims to test the acceptability and feasibility of a smartphone app that delivers gender-informed content to support women in quitting smoking. Methods: We co-developed a smoking cessation app specifically tailored for women, named My Change Plan-Women (MCP-W). This app builds upon our previous gender-neutral app, MCP, by retaining its content grounded in behavioral change techniques aimed at supporting tobacco reduction and cessation. This includes goal setting for quitting, identifying triggers to smoking, creating coping strategies, tracking cigarettes and cravings, and assessing financial savings from quitting smoking. The MCP-W app contains additional gender-informed content that acknowledges barriers to quitting, such as coping with stress, having smokers in one’s social circle, and managing unpleasant emotions. This content is delivered through testimonials and animated videos. This study is a prospective, single-group, mixed methods investigation in which 30 women smokers will trial the app for a period of 28 days. Once participants provide informed consent, they will complete a baseline survey and download the app on their smartphones. After 28 days, participants will complete follow-up surveys. Acceptability will be assessed using the Theoretical Framework of Acceptability, which evaluates whether participants perceive the app as helpful in changing their smoking. The app will be deemed acceptable if the majority of participants rate it as such, and feasible if the majority of the participants use it for at least 7 days. Furthermore, after the 28-day trial period, participants will complete a semistructured interview regarding their experience with the app and suggestions for improvement. Results: Development of the MCP-W app was completed in September 2023. Participant recruitment for testing of the app commenced in February 2024 and was completed in July 2024. We will analyze the data upon completion of data collection from all 30 participants. We expect to share the results of this acceptability trial in the middle of 2025. Conclusions: Offering smoking cessation support tailored specifically to address the unique needs of women through a smartphone app represents a novel approach. This study will test whether women who smoke perceive this approach to be acceptable and feasible in their journey toward smoking cessation. International Registered Report Identifier (IRRID): DERR1-10.2196/60677 %M 39433391 %R 10.2196/60677 %U https://www.researchprotocols.org/2024/1/e60677 %U https://doi.org/10.2196/60677 %U http://www.ncbi.nlm.nih.gov/pubmed/39433391 %0 Journal Article %@ 2561-7605 %I JMIR Publications %V 7 %N %P e63907 %T Internet-Based Social Activities and Cognitive Functioning 2 Years Later Among Middle-Aged and Older Adults: Prospective Cohort Study %A Jeon,Sangha %A Charles,Susan Turk %K online social interaction %K cognitive health %K age differences %K Health and Retirement Study %K social activity %K internet use %K isolation %D 2024 %7 10.12.2024 %9 %J JMIR Aging %G English %X Background: A number of studies document the benefits of face-to-face social interactions for cognitive functioning among middle-aged and older adults. Social activities in virtual worlds may confer similar if not enhanced cognitive benefits as face-to-face social activities, given that virtual interactions require the additional cognitive tasks of learning and navigating communicative tools and technology platforms. Yet, few studies have examined whether social activities in internet-based settings may have synergistic effects on cognitive functioning beyond those of face-to-face interactions. Objective: This study examined whether internet-based social activity participation is associated with concurrent and later cognitive functioning, after adjusting for face-to-face social activity participation and sociodemographic covariates. Methods: For cross-sectional analyses, we included 3650 adults aged 50 years and older who completed questions in the 2020 Health and Retirement Study about social activity participation, including specific internet-based social activities such as emailing or accessing social networks. Cognitive functioning was measured using the standardized cognitive tasks assessing working memory, episodic memory, and attention and processing speed. The longitudinal analyses included the 2034 participants who also completed follow-up cognitive assessments in 2022. Results: Our results revealed that those with higher levels of internet-based social activity participation had higher levels of concurrent cognitive functioning than those with low levels of internet-based social activity participation, after adjusting for demographic and health-related factors and face-to-face social activity participation (b=0.44, SE 0.07; P<.001). More internet-based social activity participation also predicted better cognitive functioning 2 years later, even when adjusting for baseline cognitive functioning and other covariates (b=0.35, SE 0.09; P<.001). Conclusions: Our findings suggest that greater engagement in internet-based social activities is associated with higher levels of concurrent cognitive functioning and slower cognitive decline in middle-aged and older adults. %R 10.2196/63907 %U https://aging.jmir.org/2024/1/e63907 %U https://doi.org/10.2196/63907 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e64547 %T A Web-Based Mind-Body Intervention to Improve Resilience Among Patients With Nontraumatic Painful Upper-Extremity Conditions and Comorbid Risky Substance Use: Protocol for a Mixed Methods Study %A Levey,Nadine %A Chen,Neal %A Ditre,Joseph %A Sylvia,Louisa %A Mudgal,Chaitanya %A Bhashyam,Abhiram %A Garg,Rohit %A Ring,David %A Vranceanu,Ana-Maria %A Bakhshaie,Jafar %+ Center for Health Outcomes and Interdisciplinary Research, Department of Psychiatry, Massachusetts General Hospital, 1 Bowdoin Square, 1st Floor, Suite 100, Boston, MA, 02114, United States, 1 8325388333, jbakhshaie@mgh.harvard.edu %K chronic pain %K upper-extremity conditions %K psychiatry %K mindfulness %K mind-body %K substance use %K web-based intervention development %D 2024 %7 9.12.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: Nontraumatic painful upper-extremity conditions (NPUCs) are largely age-related degenerations that affect the majority of adults. Most patients with NPUCs do not seek medical care and adjust on their own. Among those who do seek care, approximately 20% report risky substance use, defined as a consumption pattern that increases the risk of harm to physical or psychosocial health. In the context of NPUC, risky substance use is associated with more intense pain, emotional distress, disability, and opioid or other substance misuse (ie, cross-tolerance). Consequently, risky substance use is a significant modifiable risk factor for the progression and maintenance of chronic pain-related disability and comorbid psychopathology among patients with NPUCs. Objective: This study aims to develop, adapt, and test the feasibility of the Web-Based Toolkit for Resilient Life Beyond Pain and Substance Use (Web-TIRELESS), a novel, asynchronous, and web-based mind-body intervention aimed at modifying maladaptive pain-coping behaviors in patients with NPUC and comorbid risky substance use. This study illustrates the proposed study design, methodology, and intervention content. Methods: In aim 1, we will conduct live video qualitative interviews (n=20) with care-seeking adult patients with NPUC and comorbid risky substance use to inform the development and refinement of Web-TIRELESS and study procedures. In aim 2, we propose an open pilot study (n=12) of Web-TIRELESS with exit interviews and pre- and postintervention assessments to evaluate the feasibility, credibility, and acceptability of Web-TIRELESS and refine study procedures. Aim 3 consists of a pilot feasibility randomized controlled trial of Web-TIRELESS versus minimally enhanced usual care (n=50), both of which follow a web-based modality, to demonstrate the feasibility of recruitment procedures and data collection, as well as the feasibility, credibility, and acceptability of Web-TIRELESS and the control condition (adherence, retention, fidelity, and satisfaction), following prespecified benchmarks. Results: Patient interviews (aim 1) concluded in May 2024 and qualitative analysis is expected to be completed in September 2024. Completion of aim 2 (data collection and analysis) is expected by June 2025. The completion of aim 3 and other study-related operations is anticipated by June 2027. Conclusions: We will develop and test Web-TIRELESS, the first asynchronous mind-body intervention specifically adapted to enhance resilience in response to chronic pain among individuals with NPUCs and comorbid risky substance use. Results from this 3-aim study (feasibility, acceptability, and satisfaction of Web-TIRELESS) will be leveraged to inform a future efficacy randomized controlled trial of Web-TIRELESS versus the minimally enhanced usual care. Trial Registration: ClinicalTrials.gov NCT06366633; https://clinicaltrials.gov/study/NCT06366633 International Registered Report Identifier (IRRID): DERR1-10.2196/64547 %M 39652859 %R 10.2196/64547 %U https://www.researchprotocols.org/2024/1/e64547 %U https://doi.org/10.2196/64547 %U http://www.ncbi.nlm.nih.gov/pubmed/39652859 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e56999 %T Presenting and Evaluating a Smartwatch-Based Intervention for Smoking Relapse (StopWatch): Feasibility and Acceptability Study %A Stone,Chris %A Essery,Rosie %A Matthews,Joe %A Naughton,Felix %A Munafo,Marcus %A Attwood,Angela %A Skinner,Andy %+ School of Psychological Science, University of Bristol, 12a Priory Road, Bristol, BS8 1TU, United Kingdom, 44 01174555910, chris.stone@bristol.ac.uk %K smoking %K smoking cessation %K passive detection %K just-in-time intervention %K JITAI %K relapse prevention %K relapse %K smartwatch %K wearable technology %K wearable %K mobile health %K mHealth %K mobile phone %D 2024 %7 21.11.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Despite the benefits of smoking cessation, maintaining abstinence during a quit attempt is difficult, and most attempts result in relapse. Innovative, evidence-based methods of preventing relapse are needed. We present a smartwatch-based relapse prevention system that uses passive detection of smoking to trigger just-in-time smoking cessation support. Objective: This study aims to evaluate the feasibility of hosting just-in-time smoking cessation support on a smartwatch and the acceptability of the “StopWatch” intervention on this platform. Methods: The person-based approach for intervention development was used to design the StopWatch smoking relapse prevention intervention. Intervention delivery was triggered by an algorithm identifying hand movements characteristic of smoking from the smartwatch’s motion sensors, and the system-generated intervention messages (co-designed by smokers) were delivered on the smartwatch screen. A total of 18 smokers tested the intervention over a 2-week period, and at the end of this period, they provided qualitative feedback on the acceptability of both the intervention and the smartwatch platform. Results: Participants reported that the smartwatch intervention increased their awareness of smoking and motivated them to quit. System-generated intervention messages were generally felt to be relevant and timely. There were some challenges with battery life that had implications for intervention adherence, and the bulkiness of the device and the notification style reduced some participants’ acceptability of the smartwatch platform. Conclusions: Our findings indicate our smoking relapse prevention intervention and the use of a smartwatch as a platform to host a just-in-time behavior change intervention are both feasible and acceptable to most (12/18, 66%) participants as a relapse prevention intervention, but we identify some concerns around the physical limitations of the smartwatch device. In particular, the bulkiness of the device and the battery capacity present risks to adherence to the intervention and the potential for missed detections. We recommend that a longer-term efficacy trial be carried out as the next step. %M 39570656 %R 10.2196/56999 %U https://formative.jmir.org/2024/1/e56999 %U https://doi.org/10.2196/56999 %U http://www.ncbi.nlm.nih.gov/pubmed/39570656 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e63562 %T Methodology for Biological Sample Collection, Processing, and Storage in the Newcastle 1000 Pregnancy Cohort: Protocol for a Longitudinal, Prospective Population-Based Study in Australia %A Fisher,Joshua J %A Grace,Tegan %A Castles,Nathan A %A Jones,Elizabeth A %A Delforce,Sarah J %A Peters,Alexandra E %A Crombie,Gabrielle K %A Hoedt,Emily C %A Warren,Kirby E %A Kahl,Richard GS %A Hirst,Jonathan J %A Pringle,Kirsty G %A Pennell,Craig E %+ School of Medicine and Public Health, College and Health, Medicine and Wellbeing, The University of Newcastle, University Drive, Callaghan, 2308, Australia, 61 02 4042 0345, tegan.grace@newcastle.edu.au %K pregnancy cohort study %K biobanking protocol %K toenails %K blood %K microbiome %K urine %K hair %K pregnancy %K cohort study %D 2024 %7 15.11.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: Research in the developmental origins of health and disease provides compelling evidence that adverse events during the first 1000 days of life from conception can impact life course health. Despite many decades of research, we still lack a complete understanding of the mechanisms underlying some of these associations. The Newcastle 1000 Study (NEW1000) is a comprehensive, prospective population-based pregnancy cohort study based in Newcastle, New South Wales, Australia, that will recruit pregnant women and their partners at 11-14 weeks’ gestation, with assessments at 20, 28, and 36 weeks; birth; 6 weeks; and 6 months, in order to provide detailed data about the first 1000 days of life to investigate the developmental origins of noncommunicable diseases. Objective: The study aims to provide a longitudinal multisystem approach to phenotyping, supported by robust clinical data and collection of biological samples in NEW1000. Methods: This manuscript describes in detail the large variety of samples collected in the study and the method of collection, storage, and utility of the samples in the biobank, with a particular focus on incorporation of the samples into emerging and novel large-scale “-omics” platforms, including the genome, microbiome, epigenome, transcriptome, fragmentome, metabolome, proteome, exposome, and cell-free DNA and RNA. Specifically, this manuscript details the methods used to collect, process, and store biological samples, including maternal, paternal, and fetal blood, microbiome (stool, skin, vaginal, oral), urine, saliva, hair, toenail, placenta, colostrum, and breastmilk. Results: Recruitment for the study began in March 2021. As of July 2024, 1040 women and 684 partners were enrolled, with 922 infants born. The NEW1000 biobank contains 24,357 plasma aliquots from ethylenediaminetetraacetic acid (EDTA) tubes, 5284 buffy coat aliquots, 4000 plasma aliquots from lithium heparin tubes, 15,884 blood serum aliquots, 2977 PAX RNA tubes, 26,595 urine sample aliquots, 2280 fecal swabs, 17,687 microbiome swabs, 2356 saliva sample aliquots, 1195 breastmilk sample aliquots, 4007 placental tissue aliquots, 2680 hair samples, and 2193 nail samples. Conclusions: NEW1000 will generate a multigenerational, deeply phenotyped cohort with a comprehensive biobank of samples relevant to a large variety of analyses, including multiple -omics platforms. International Registered Report Identifier (IRRID): DERR1-10.2196/63562 %M 39546349 %R 10.2196/63562 %U https://www.researchprotocols.org/2024/1/e63562 %U https://doi.org/10.2196/63562 %U http://www.ncbi.nlm.nih.gov/pubmed/39546349 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e53447 %T Using a Device-Free Wi-Fi Sensing System to Assess Daily Activities and Mobility in Low-Income Older Adults: Protocol for a Feasibility Study %A Chung,Jane %A Pretzer-Aboff,Ingrid %A Parsons,Pamela %A Falls,Katherine %A Bulut,Eyuphan %+ Nell Hodgson Woodruff School of Nursing, Emory University, 1520 Clifton Road NE, Atlanta, GA, 30322, United States, 1 4047277980, jane.chung@emory.edu %K Wi-Fi sensing %K dementia %K mild cognitive impairment %K older adults %K health disparities %K in-home activities %K mobility %K machine learning %D 2024 %7 12.11.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: Older adults belonging to racial or ethnic minorities with low socioeconomic status are at an elevated risk of developing dementia, but resources for assessing functional decline and detecting cognitive impairment are limited. Cognitive impairment affects the ability to perform daily activities and mobility behaviors. Traditional assessment methods have drawbacks, so smart home technologies (SmHT) have emerged to offer objective, high-frequency, and remote monitoring. However, these technologies usually rely on motion sensors that cannot identify specific activity types. This group often lacks access to these technologies due to limited resources and technology experience. There is a need to develop new sensing technology that is discreet, affordable, and requires minimal user engagement to characterize and quantify various in-home activities. Furthermore, it is essential to explore the feasibility of developing machine learning (ML) algorithms for SmHT through collaborations between clinical researchers and engineers and involving minority, low-income older adults for novel sensor development. Objective: This study aims to examine the feasibility of developing a novel channel state information–based device-free, low-cost Wi-Fi sensing system, and associated ML algorithms for localizing and recognizing different patterns of in-home activities and mobility in residents of low-income senior housing with and without mild cognitive impairment. Methods: This feasibility study was conducted in collaboration with a wellness care group, which serves the healthy aging needs of low-income housing residents. Prior to this feasibility study, we conducted a pilot study to collect channel state information data from several activity scenarios (eg, sitting, walking, and preparing meals) using the proposed Wi-Fi sensing system continuously over a week in apartments of low-income housing residents. These activities were videotaped to generate ground truth annotations to test the accuracy of the ML algorithms derived from the proposed system. Using qualitative individual interviews, we explored the acceptability of the Wi-Fi sensing system and implementation barriers in the low-income housing setting. We use the same study protocol for the proposed feasibility study. Results: The Wi-Fi sensing system deployment began in November 2022, with participant recruitment starting in July 2023. Preliminary results will be available in the summer of 2025. Preliminary results are focused on the feasibility of developing ML models for Wi-Fi sensing–based activity and mobility assessment, community-based recruitment and data collection, ground truth, and older adults’ Wi-Fi sensing technology acceptance. Conclusions: This feasibility study can make a contribution to SmHT science and ML capabilities for early detection of cognitive decline among socially vulnerable older adults. Currently, sensing devices are not readily available to this population due to cost and information barriers. Our sensing device has the potential to identify individuals at risk for cognitive decline by assessing their level of physical function by tracking their in-home activities and mobility behaviors, at a low cost. International Registered Report Identifier (IRRID): DERR1-10.2196/53447 %M 39531268 %R 10.2196/53447 %U https://www.researchprotocols.org/2024/1/e53447 %U https://doi.org/10.2196/53447 %U http://www.ncbi.nlm.nih.gov/pubmed/39531268 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e57165 %T Insights From the Development of a Dynamic Consent Platform for the Australians Together Health Initiative (ATHENA) Program: Interview and Survey Study %A Xiong,Eddy %A Bonner,Carissa %A King,Amanda %A Bourne,Zoltan Maxwell %A Morgan,Mark %A Tolosa,Ximena %A Stanton,Tony %A Greaves,Kim %+ The Australians Together Health Initiative Program (The ATHENA Program), Sunshine Coast University Hospital, Queensland Health, 6 Doherty Street, Birtinya, Queensland, 4575, Australia, 61 0427389900, kim.greaves@health.qld.gov.au %K dynamic consent %K research %K clinical trials %K consumer engagement %K digital consent %K development %K decision making %K decision %K feedback %K user platform %K users %K communication %D 2024 %7 6.11.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Dynamic consent has the potential to address many of the issues facing traditional paper-based or electronic consent, including enrolling informed and engaged participants in the decision-making process. The Australians Together Health Initiative (ATHENA) program aims to connect participants across Queensland, Australia, with new research opportunities. At its core is dynamic consent, an interactive and participant-centric digital platform that enables users to view ongoing research activities, update consent preferences, and have ongoing engagement with researchers. Objective: This study aimed to describe the development of the ATHENA dynamic consent platform within the framework of the ATHENA program, including how the platform was designed, its utilization by participants, and the insights gained. Methods: One-on-one interviews were undertaken with consumers, followed by a workshop with health care staff to gain insights into the dynamic consent concept. Five problem statements were developed, and solutions were posed, from which a dynamic consent platform was constructed, tested, and used for implementation in a clinical trial. Potential users were randomly recruited from a pre-existing pool of 615 participants in the ATHENA program. Feedback on user platform experience was gained from a survey hosted on the platform. Results: In the 13 consumer interviews undertaken, participants were positive about dynamic consent, valuing privacy, ease of use, and adequate communication. Motivators for registration were feedback on data usage and its broader community benefits. Problem statements were security, trust and governance, ease of use, communication, control, and need for a scalable platform. Using the newly constructed dynamic consent platform, 99 potential participants were selected, of whom 67 (68%) were successfully recontacted. Of these, 59 (88%) agreed to be sent the platform, 44 (74%) logged on (indicating use), and 22 (57%) registered for the clinical trial. Survey feedback was favorable, with an average positive rating of 78% across all questions, reflecting satisfaction with the clarity, brevity, and flexibility of the platform. Barriers to implementation included technological and health literacy. Conclusions: This study describes the successful development and testing of a dynamic consent platform that was well-accepted, with users recognizing its advantages over traditional methods of consent regarding flexibility, ease of communication, and participant satisfaction. This information may be useful to other researchers who plan to use dynamic consent in health care research. %M 39504120 %R 10.2196/57165 %U https://formative.jmir.org/2024/1/e57165 %U https://doi.org/10.2196/57165 %U http://www.ncbi.nlm.nih.gov/pubmed/39504120 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e56387 %T Family-Centered Treatment Program for Problematic Gaming and Excessive Screen Use in a Clinical Child and Youth Population (FAME): Protocol for a Feasibility Pilot Mixed Method Study %A Werner,Marie %A Kapetanovic,Sabina %A Claesdotter-Knutsson,Emma %+ Department of Clinical Sciences Lund, Faculty of Medicine, Lund University, BOX 117, Lund, 22100, Sweden, 46 724685697, marie.werner@skane.se %K gaming %K family program %K family intervention %K pilot study, %K adolescent %K problematic gaming %K excessive screen time %K children %K screen use %K child-parent relationship %K motivational interviewing %D 2024 %7 8.10.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: Screen time among children and adolescents has increased dramatically, raising concerns about its impact on development and mental health. While research highlights both potential benefits and risks, excessive use has been linked to issues like anxiety, depression, and gaming addiction. Despite growing concern, effective interventions are scarce. Recognizing the importance of family dynamics in child development, we propose a family-centered program to address problematic gaming and excessive screen use in a clinical population. By involving both children and parents, we aim to create a more comprehensive approach to prevention and treatment. Objective: This study aims to determine the possibility of distributing and evaluating a family-centered group program for problematic gaming and excessive screen use (FAME) in a clinical child and adolescent psychiatry (CAP) population. We will monitor the recruitment rate; track the retention and attendance rates of both parents and children; and assess whether each session’s objectives are met, the content is delivered within the allotted time, and the necessary resources (eg, facilitators and materials) are available. Additionally, we will gather qualitative and quantitative feedback from participants through postprogram surveys and individual interviews with both children and parents. Methods: A total of 10 families with ongoing contact with CAP in Skåne, Sweden, will be recruited and offered participation in a family-centered group program targeting children aged 10-18 years with reported difficulties regarding screen gaming or screen use. The intervention to be tested is a newly developed, family-centered, psychoeducational, cognitive behavioral therapy–based intervention addressing both positive and negative aspects of screen use; setting boundaries; the connection between thoughts, feelings, and behaviors; conflict triggers; and sleep hygiene. The primary goal of the pilot study is to test the feasibility of the program, as well as recruitment and the analysis of participants’ experiences with the program. Results: A total of 11 children and their parents were enrolled during first quarter of 2024. A 4-session pilot was delivered in first quarter of 2024, and the first results are expected in the third quarter of 2024. Conclusions: The overarching goal of this pilot study is to determine the possibility of distributing and evaluating a family-centered group program for problematic gaming and excessive screen use (FAME) in a clinical CAP population. The insights gained from this study will guide our future research, which will focus on conducting a larger-scale evaluation of the intervention’s impact on family screen time conflicts and inform future strategies for the implementation of family-centered interventions in child and youth clinics. Trial Registration: ClinicalTrials.gov NCT06098807; https://clinicaltrials.gov/study/NCT06098807 International Registered Report Identifier (IRRID): DERR1-10.2196/56387 %M 39378066 %R 10.2196/56387 %U https://www.researchprotocols.org/2024/1/e56387 %U https://doi.org/10.2196/56387 %U http://www.ncbi.nlm.nih.gov/pubmed/39378066 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e55511 %T Predicting the Transition From Depression to Suicidal Ideation Using Facebook Data Among Indian-Bangladeshi Individuals: Protocol for a Cohort Study %A Turjo,Manoshi Das %A Mundada,Khushboo Suchit %A Haque,Nuzhat Jabeen %A Ahmed,Nova %+ North South University, Bashundhara, Dhaka, 1219, Bangladesh, 880 1701754745, manoshi.turjo@northsouth.edu %K human-computer interaction %K depression %K suicidal ideation %K mental health %K India %K Bangladesh %K Facebook %K major depressive disorder %K MDD %K 9-item Patient Health Questionnaire %K PHQ-9 %K natural language processing %K NLP %K machine learning %K ML %D 2024 %7 7.10.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: Suicide stands as a global public health concern with a pronounced impact, especially in low- and middle-income countries, where it remains largely unnoticed as a significant health concern, leading to delays in diagnosis and intervention. South Asia, in particular, has seen limited development in this area of research, and applying existing models from other regions is challenging due to cost constraints and the region’s distinct linguistics and behavior. Social media analysis, notably on platforms such as Facebook (Meta Platforms Inc), offers the potential for detecting major depressive disorder and aiding individuals at risk of suicidal ideation. Objective: This study primarily focuses on India and Bangladesh, both South Asian countries. It aims to construct a predictive model for suicidal ideation by incorporating unique, unexplored features along with masked content from both public and private Facebook profiles. Moreover, the research aims to fill the existing research gap by addressing the distinct challenges posed by South Asia’s unique behavioral patterns, socioeconomic conditions, and linguistic nuances. Ultimately, this research strives to enhance suicide prevention efforts in the region by offering a cost-effective solution. Methods: This quantitative research study will gather data through a web-based platform. Initially, participants will be asked a few demographic questions and to complete the 9-item Patient Health Questionnaire assessment. Eligible participants who provide consent will receive an email requesting them to upload a ZIP file of their Facebook data. The study will begin by determining whether Facebook is the primary application for the participants based on their active hours and Facebook use duration. Subsequently, the predictive model will incorporate a wide range of previously unexplored variables, including anonymous postings, and textual analysis features, such as captions, biographic information, group membership, preferred pages, interactions with advertisement content, and search history. The model will also analyze the use of emojis and the types of games participants engage with on Facebook. Results: The study obtained approval from the scientific review committee on October 2, 2023, and subsequently received institutional review committee ethical clearance on December 8, 2023. Our system is anticipated to automatically detect posts related to depression by analyzing the text and use pattern of the individual with the best accuracy possible. Ultimately, our research aims to have practical utility in identifying individuals who may be at risk of depression or in need of mental health support. Conclusions: This initiative aims to enhance engagement in suicidal ideation medical care in South Asia to improve health outcomes. It is set to be the first study to consider predicting participants’ primary social application use before analyzing their content to forecast behavior and mental states. The study holds the potential to revolutionize strategies and offer insights for scalable, accessible interventions while maintaining quality through comprehensive Facebook feature analysis. International Registered Report Identifier (IRRID): DERR1-10.2196/55511 %M 39374059 %R 10.2196/55511 %U https://www.researchprotocols.org/2024/1/e55511 %U https://doi.org/10.2196/55511 %U http://www.ncbi.nlm.nih.gov/pubmed/39374059 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e54914 %T Parent Education and Counseling (PairEd-C) Intervention to Improve Family-Centered Care: Protocol for a Prospective Acceptability Study Using the Theoretical Framework of Acceptability %A Deribe,Leul %A Girma,Eshetu %A Lindström,Nataliya %A Gidey,Abdulkadir %A Teferra,Solomon %A Addissie,Adamu %+ Department of Applied Information Technology, University of Gothenburg, Universitetsplatsen 1, Forskningsgången, Göteborg, 405 30, Sweden, 46 733268716, nataliya.berbyuk.lindstrom@ait.gu.se %K family-centered care %K child cancer %K theoretical framework of acceptability %K education and counseling %K acceptability %K parent education %K family centered %K care service %K theoretical framework %K study protocol %K family %K health care %K well-being %K children %K implementation %K design intervention %D 2024 %7 4.10.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: Family-centered care (FCC) is an intervention approach based on a respectful relationship between family and health care providers (HCPs) to ensure the health and well-being of children and their families. Although HCPs have a better perception of FCC, the level of its implementation is low. Reasons for low implementation include limited understanding, lack of training, and lack of implementation guidelines and tools to support implementation. Thus, we developed the Parent Education and Counseling (PairEd-C) intervention to improve FCC in pediatric oncology settings and assess its acceptability. Objective: The objective of this study is to assess the prospective acceptability of the PairEd-C intervention using the theoretical framework of acceptability (TFA) in the pediatric oncology department in a tertiary hospital in Ethiopia. Methods: The study was conducted using an exploratory qualitative study design. We aimed to recruit 10 to 15 participants for the in-depth interview. The study participants were health service leaders working in child cancer, HCPs, social workers, and parents of children with cancer. The intervention was developed using the integration of the first phase of the Medical Research Council (MRC) framework for developing and testing complex interventions and the behavior change wheel (BCW) framework. The main PairEd-C intervention components align with the intervention functions of education, persuasion, training, environmental restructuring, modeling, and enablement, which were intended to improve FCC in the pediatric oncology unit by providing structured and comprehensive education and counseling of parents of children with cancer. The intervention was implemented by providing training for the health care team, facilitating discussion among HCPs and setting a shared plan, improving the commitment of the health care team, providing education for parents, improving parents’ capacity to attend the intervention sessions, arranging discussion among parents of children with cancer, and provision of education and counseling on distress. The HCPs working in the unit received training on the designed intervention. The trained educators and the health care provider delivered the intervention. Data will be analyzed using deductive thematic coding with a framework analysis technique based on the 7 TFA constructs. Atlas ti. version 9 will be used for data analysis. Results: Funding was acquired in 2017, and ethical clearance for conducting the study was obtained. We conducted the interviews with the study participants from December 2023 to January 2024. As of the acceptance of this protocol (June 2024), 12 study participants were interviewed. The data analysis process was started subsequently, and the manuscript will be completed and submitted for publication in early 2025. Conclusions: This acceptability study is expected to show that the designed intervention is acceptable to study participants, and the findings will be used to improve the intervention before progressing to the next step of our project. International Registered Report Identifier (IRRID): DERR1-10.2196/54914 %M 39365661 %R 10.2196/54914 %U https://www.researchprotocols.org/2024/1/e54914 %U https://doi.org/10.2196/54914 %U http://www.ncbi.nlm.nih.gov/pubmed/39365661 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e60361 %T Neural Conversational Agent for Weight Loss Counseling: Protocol for an Implementation and Feasibility Study %A Kotov,Alexander %A Idalski Carcone,April %A Towner,Elizabeth %+ Department of Computer Science, College of Engineering, Wayne State University, Suite 14001.6, 5057 Woodward Ave, Detroit, MI, 48202, United States, 1 3135779307, kotov@wayne.edu %K conversational agents %K artificial intelligence %K behavior change %K weight loss %K obesity %K motivational interviewing %K web-based application %K deep learning %K transformers %K large language models %K feasibility study %D 2024 %7 20.9.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: Obesity is a common, serious and costly chronic disease. Current clinical practice guidelines recommend that providers augment the longitudinal care of people living with obesity with consistent support for the development of self-efficacy and motivation to modify their lifestyle behaviors. Lifestyle behavior change aligns with the goals of motivational interviewing (MI), a client-centered yet directive counseling modality. However, training health care providers to be proficient in MI is expensive and time-consuming, resulting in a lack of trained counselors and limiting the widespread adoption of MI in clinical practice. Artificial intelligence (AI) counselors accessible via the internet can help circumvent these barriers. Objective: The primary objective is to explore the feasibility of conducting unscripted MI-consistent counseling using Neural Agent for Obesity Motivational Interviewing (NAOMI), a large language model (LLM)–based web app for weight loss counseling. The secondary objectives are to test the acceptability and usability of NAOMI’s counseling and examine its ability to shift motivational precursors in a sample of patients with overweight and obesity recruited from primary care clinics. Methods: NAOMI will be developed based on recent advances in deep learning in four stages. In stages 1 and 2, NAOMI will be implemented using an open-source foundation LLM and (1) few-shot learning based on a prompt with task-specific instructions and (2) domain adaptation strategy based on fine-tuning LLM using a large corpus of general psychotherapy and MI treatment transcripts. In stages 3 and 4, we will refine the best of these 2 approaches. Each NAOMI version will be evaluated using a mixed methods approach in which 10 adults (18-65 years) meeting the criteria for overweight or obesity (25.0≥BMI≤39.9) interact with NAOMI and provide feedback. NAOMI’s fidelity to the MI framework will be assessed using the Motivational Interviewing Treatment Integrity scale. Participants’ general perceptions of AI conversational agents and NAOMI specifically will be assessed via Pre- and Post-Interaction Questionnaires. Motivational precursors, such as participants’ confidence, importance, and readiness for changing lifestyle behaviors (eg, diet and activity), will be measured before and after the interaction, and 1 week later. A qualitative analysis of changes in the measures of perceptions of AI agents and counselors and motivational precursors will be performed. Participants will rate NAOMI’s usability and empathic skills post interaction via questionnaire-based assessments along with providing feedback about their experience with NAOMI via a qualitative interview. Results: NAOMI (version 1.0) has been developed. Participant recruitment will commence in September 2024. Data collection activities are expected to conclude in May 2025. Conclusions: If proven effective, LLM-based counseling agents can become a cost-effective approach for addressing the obesity epidemic at a public health level. They can also have a broad, transformative impact on the delivery of MI and other psychotherapeutic treatment modalities extending their reach and broadening access. International Registered Report Identifier (IRRID): PRR1-10.2196/60361 %M 39303273 %R 10.2196/60361 %U https://www.researchprotocols.org/2024/1/e60361 %U https://doi.org/10.2196/60361 %U http://www.ncbi.nlm.nih.gov/pubmed/39303273 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 11 %N %P e54859 %T Integrating Health and Disability Data Into Academic Information Systems: Workflow Optimization Study %A Jabour,Abdulrahman %K disability %K health data %K student health %K health measures %K disability data %K university setting %K university system %K student system %K academic system %K health informatics %K health-related %K health information %K support %K well-being %K user-centered %K data collection %K analysis %K development %K privacy %K confidentiality %K timely communication %K task automation %K resources %K quality of life %K wellness %K advisor %K advisors %K support system %K interview %K interviews %K administrative staff %K admin staff %K physician %K physicians %K faculty %K student %K students %K thematic analysis %K focus group %D 2024 %7 4.9.2024 %9 %J JMIR Hum Factors %G English %X Background: Integrating health information into university information systems holds significant potential for enhancing student support and well-being. Despite the growing body of research highlighting issues faced by university students, including stress, depression, and disability, little has been done in the informatics field to incorporate health technologies at the institutional level. Objective: This study aims to investigate the current state of health information integration within university systems and provide design recommendations to address existing gaps and opportunities. Methods: We used a user-centered approach to conduct interviews and focus group sessions with stakeholders to gather comprehensive insights and requirements for the system. The methodology involved data collection, analysis, and the development of a suggested workflow. Results: The findings of this study revealed the shortcomings in the current process of handling health and disability data within university information systems. In our results, we discuss some requirements identified for integrating health-related information into student information systems, such as privacy and confidentiality, timely communication, task automation, and disability resources. We propose a workflow that separates the process into 2 distinct components: a health and disability system and measures of quality of life and wellness. The proposed workflow highlights the vital role of academic advisors in facilitating support and enhancing coordination among stakeholders. Conclusions: To streamline the workflow, it is vital to have effective coordination among stakeholders and redesign the university information system. However, implementing the new system will require significant capital and resources. We strongly emphasize the importance of increased standardization and regulation to support the information system requirements for health and disability. Through the adoption of standardized practices and regulations, we can ensure the smooth and effective implementation of the required support system. %R 10.2196/54859 %U https://humanfactors.jmir.org/2024/1/e54859 %U https://doi.org/10.2196/54859 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e56957 %T Feasibility and Acceptability Study of a Culturally Adapted Web-Based Intervention to Reduce Suicidal Ideation for Syrian Asylum Seekers and Refugees in the United Kingdom: Protocol for a Mixed Methods Study %A Beuthin,Oliver %A Shahid,Sadiya %A Yu,Ly-Mee %A Bhui,Kamaldeep %+ Department of Psychiatry, University of Oxford, Linacre College, St Cross Road, Oxford, OX1 3JA, United Kingdom, 44 1865 618200, oliver.beuthin@linacre.ox.ac.uk %K cultural adaptation %K digital mental health %K suicidal ideation %K refugee mental health %K Syrian refugee %K experience-based co-design %K mental health %K suicide %K suicidal %K refugee %K immigrant %K ethnic minority %K asylum %K user experience %K cultural %K Syria %K Syrian %K refugees %K feasibility %K acceptability %K depression %K anxiety %K posttraumatic stress disorder %K United Kingdom %K Arabic-speaking %D 2024 %7 2.9.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: The war in Syria has displaced over 6.8 million people, more than any other conflict since the Second World War. As a result, Syrian asylum seekers and refugees have experienced several life-changing events, resulting in high rates of anxiety, depression, posttraumatic stress disorder, and suicidal ideation (SI). To address the treatment gap and reduce the burden of help-seeking, a web-based intervention to reduce SI developed for general populations was culturally adapted for and with Syrian asylum seekers and refugees in the United Kingdom. The study revealed the importance of understanding their lived experience with migration and the acculturative process in providing treatment for SI. This study will now assess the feasibility and acceptability of the culturally adapted intervention for this population. Objective: The first phase of the study will include recruiting participants and delivering the web-based intervention (1) to assess the feasibility of meeting recruitment goals and recruitment rates and (2) to assess the feasibility of outcome measures. The second phase of the study will include one-to-one semistructured interviews (1) to assess the suitability of the culturally adapted intervention in terms of recruitment and adherence rates and barriers and facilitators to engagement and (2) to assess the acceptability of the intervention in terms of its cultural relevance and appropriateness. Methods: This is a protocol for a single-group, noncontrolled, mixed methods feasibility and acceptability study of a culturally adapted web-based intervention to reduce SI for Syrian asylum seekers and refugees in the United Kingdom. The study will assess the feasibility of recruitment goals, recruitment rates, adherence rates, and outcome measures using individual participant tracking forms, which will be analyzed quantitatively. The suitability and acceptability of the intervention will be assessed using one-to-one semistructured interviews with 12 participants who completed the intervention, which will be analyzed qualitatively. Results: Recruitment began in February 2024 and will run until 30 participants are recruited to the study or until the end of July 2024. Thus far, 19 participants have provided informed consent, 16 were eligible and enrolled, and 12 have completed a postintervention interview. No data have been analyzed. The study, including the write-up period, is expected to end in December 2024. Conclusions: Despite experiencing several stressors related to forced displacement and high rates of mental health issues, access to treatment is still limited for Syrian asylum seekers and refugees in the United Kingdom. To address the treatment gap and reduce the burden of help-seeking, a web-based intervention to reduce SI was culturally adapted in collaboration with Syrian asylum seekers and refugees in the United Kingdom. This study will now assess the feasibility and acceptability of the intervention and culturally appropriate recruitment strategies. Trial Registration: ISRCTN ISRCTN11417025; https://www.isrctn.com/ISRCTN11417025 International Registered Report Identifier (IRRID): PRR1-10.2196/56957 %M 39222345 %R 10.2196/56957 %U https://www.researchprotocols.org/2024/1/e56957 %U https://doi.org/10.2196/56957 %U http://www.ncbi.nlm.nih.gov/pubmed/39222345 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e56170 %T Optimizing Response Rates to Examine Health IT Maturity and Nurse Practitioner Care Environments in US Nursing Homes: Mixed Mode Survey Recruitment Protocol %A Alexander,Gregory L %A Poghosyan,Lusine %A Zhao,Yihong %A Hobensack,Mollie %A Kisselev,Sergey %A Norful,Allison A %A McHugh,John %A Wise,Keely %A Schrimpf,M Brooke %A Kolanowski,Ann %A Bhatia,Tamanna %A Tasnova,Sabrina %+ School of Nursing, Columbia University, 560 W. 168 Room 628, New York, NY, 10032, United States, 1 5733013131, ga2545@cumc.columbia.edu %K surveys and questionnaires %K survey methods %K health care surveys %K survey %K survey design %K mixed-mMode survey %K nursing homes %K nursing home %K clinical informatics research %K electronic health records %K electronic health record %K clinicians %K HIT Maturity %K Care Environments %K United States %D 2024 %7 29.8.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: Survey-driven research is a reliable method for large-scale data collection. Investigators incorporating mixed-mode survey designs report benefits for survey research including greater engagement, improved survey access, and higher response rate. Mix-mode survey designs combine 2 or more modes for data collection including web, phone, face-to-face, and mail. Types of mixed-mode survey designs include simultaneous (ie, concurrent), sequential, delayed concurrent, and adaptive. This paper describes a research protocol using mixed-mode survey designs to explore health IT (HIT) maturity and care environments reported by administrators and nurse practitioners (NPs), respectively, in US nursing homes (NHs). Objective: The aim of this study is to describe a research protocol using mixed-mode survey designs in research using 2 survey tools to explore HIT maturity and NP care environments in US NHs. Methods: We are conducting a national survey of 1400 NH administrators and NPs. Two data sets (ie, Care Compare and IQVIA) were used to identify eligible facilities at random. The protocol incorporates 2 surveys to explore how HIT maturity (survey 1 collected by administrators) impacts care environments where NPs work (survey 2 collected by NPs). Higher HIT maturity collected by administrators indicates greater IT capabilities, use, and integration in resident care, clinical support, and administrative activities. The NP care environment survey measures relationships, independent practice, resource availability, and visibility. The research team conducted 3 iterative focus groups, including 14 clinicians (NP and NH experts) and recruiters from 2 national survey teams experienced with these populations to achieve consensus on which mixed-mode designs to use. During focus groups we identified the pros and cons of using mixed-mode designs in these settings. We determined that 2 mixed-mode designs with regular follow-up calls (Delayed Concurrent Mode and Sequential Mode) is effective for recruiting NH administrators while a concurrent mixed-mode design is best to recruit NPs. Results: Participant recruitment for the project began in June 2023. As of April 22, 2024, a total of 98 HIT maturity surveys and 81 NP surveys have been returned. Recruitment of NH administrators and NPs is anticipated through July 2025. About 71% of the HIT maturity surveys have been submitted using the electronic link and 23% were submitted after a QR code was sent to the administrator. Approximately 95% of the NP surveys were returned with electronic survey links. Conclusions: Pros of mixed-mode designs for NH research identified by the team were that delayed concurrent, concurrent, and sequential mixed-mode methods of delivering surveys to potential participants save on recruitment time compared to single mode delivery methods. One disadvantage of single-mode strategies is decreased versatility and adaptability to different organizational capabilities (eg, access to email and firewalls), which could reduce response rates. International Registered Report Identifier (IRRID): DERR1-10.2196/56170 %M 39207828 %R 10.2196/56170 %U https://www.researchprotocols.org/2024/1/e56170 %U https://doi.org/10.2196/56170 %U http://www.ncbi.nlm.nih.gov/pubmed/39207828 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e54272 %T Technology-Assisted Mental Health Intervention Delivered by Frontline Workers at Community Doorsteps for Reducing Anxiety and Depression in Rural Pakistan: Protocol for the mPareshan Mixed Methods Implementation Trial %A Rabbani,Fauziah %A Nafis,Javeria %A Akhtar,Samina %A Khan,Muhammad Shahid %A Sayani,Saleem %A Siddiqui,Amna %A Siddiqi,Sameen %A Merali,Zul %+ Department of Community Health Sciences, Aga Khan University, Stadium Road, Karachi, 3500, Pakistan, 92 2134864864, fauziah.Rabbani@aku.edu %K anxiety %K depression %K feasibility %K mental health %K health workers %K mPareshan app %K implementation research %D 2024 %7 23.7.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: There is a dearth of specialized mental health workforce in low- and middle-income countries. Use of mobile technology by frontline community health workers (CHWs) is gaining momentum in Pakistan and needs to be explored as an alternate strategy to improve mental well-being. Objective: The aim of this study is to assess the feasibility, acceptability, and usefulness of an app-based counseling intervention delivered by government lady health workers (LHWs) to reduce anxiety and depression in rural Pakistan. Methods: Project mPareshan is a single-arm, pre- and posttest implementation research trial in Badin District, Sindh, using mixed methods of data collection executed in 3 phases (preintervention, intervention, and postintervention). In the preintervention phase, formative qualitative assessments through focus group discussions and in-depth interviews assess the acceptability and appropriateness of intervention through perceptions of all concerned stakeholders using a specific interview guide. A REDCap (Research Electronic Data Capture)-based baseline survey using Patient Health Questionnaire-9 (PHQ-9) and Generalized Anxiety Disorder-7 Scale (GAD-7) determines the point prevalence of depression and anxiety among consenting men and women older than 18 years. Individuals with mild and moderate anxiety and depression are identified as screen positives (SPs) and are eligible for mPareshan app–based intervention. Mental health literacy of health workers is improved through customized training adapting the World Health Organization’s Mental Health Gap Action Programme guide 2.0. The intervention (mPareshan app) consists of tracking, counseling, and referral segments. The tracking segment facilitates participant consent and enrollment while the referral segment is used by LHWs to transfer severe cases to the next level of specialist care. Through the counseling segment, identified SPs are engaged during LHWs’ routine home visits in 6 face-to-face 20-minute counseling sessions over 6 months. Each session imparts psychoeducation through audiovisual aids, breathing exercises, and coping skills to reduce stress. Clinical and implementation outcomes include change in mean anxiety and depression scores and identification of facilitators and barriers in intervention uptake and rollout. Results: At the time of this submission (April 2024), we are analyzing the results of 366 individuals who participated in the baseline prevalence survey, the change in knowledge and skills of 72 health workers who took the mPareshan training, change in anxiety and depression scores of 98 SPs recruited for app-based counseling intervention, and perceptions of stakeholders pre- and postintervention gathered through 8 focus group discussions and 18 in-depth interviews. Conclusions: This trial will assess the feasibility of early home-based mental health screening, counseling, and prompt referrals by frontline health workers to reduce anxiety and depression in the community. The study findings will set the stage for integrating mental health into primary health care. Trial Registration: Australian New Zealand Clinical Trial Registry ACTRN12622000989741; https://tinyurl.com/5n844c8z International Registered Report Identifier (IRRID): DERR1-10.2196/54272 %M 39042878 %R 10.2196/54272 %U https://www.researchprotocols.org/2024/1/e54272 %U https://doi.org/10.2196/54272 %U http://www.ncbi.nlm.nih.gov/pubmed/39042878 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e54407 %T A Simple and Systematic Approach to Qualitative Data Extraction From Social Media for Novice Health Care Researchers: Tutorial %A Pretorius,Kelly %+ School of Health Sciences, St. Edward's University, 3001 South Congress Avenue, Austin, TX, 78704, United States, 1 (512) 448 8500, kpretori@stedwards.edu %K social media analysis %K data extraction %K health care research %K extraction tutorial %K Facebook extraction %K Facebook analysis %K safe sleep %K sudden unexpected infant death %K social media %K analysis %K systematic approach %K qualitative data %K data extraction %K Facebook %K health-related %K maternal perspective %K maternal perspectives %K sudden infant death syndrome %K mother %K mothers %K women %K United States %K SIDS %K SUID %K post %K posts %D 2024 %7 9.7.2024 %9 Tutorial %J JMIR Form Res %G English %X Social media analyses have become increasingly popular among health care researchers. Social media continues to grow its user base and, when analyzed, offers unique insight into health problems. The process of obtaining data for social media analyses varies greatly and involves ethical considerations. Data extraction is often facilitated by software tools, some of which are open source, while others are costly and therefore not accessible to all researchers. The use of software for data extraction is accompanied by additional challenges related to the uniqueness of social media data. Thus, this paper serves as a tutorial for a simple method of extracting social media data that is accessible to novice health care researchers and public health professionals who are interested in pursuing social media research. The discussed methods were used to extract data from Facebook for a study of maternal perspectives on sudden unexpected infant death. %M 38980712 %R 10.2196/54407 %U https://formative.jmir.org/2024/1/e54407 %U https://doi.org/10.2196/54407 %U http://www.ncbi.nlm.nih.gov/pubmed/38980712 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e52361 %T Quality of Life in Patients and Their Spouses and Cohabitating Partners in the Year Following a Cancer Biopsy (the Couples Cope Study): Protocol for a Prospective Observational Study %A Moreno,Patricia I %A Worch,Sarah M %A Thomas,Jessica L %A Nguyen,Rebecca L %A Medina,Heidy N %A Penedo,Frank J %A Moskowitz,Judith T %A Yanez,Betina %A Kircher,Sheetal M %A Kundu,Shilajit D %A Flury,Sarah C %A Cheung,Elaine O %+ Department of Public Health Sciences, University of Miami Miller School of Medicine, 1120 NW 14th St, Miami, FL, 33136, United States, 1 3052439844, patricia.moreno@miami.edu %K quality of life %K cancer %K biopsy %K couples %K dyads %K caregiver %K patients %K patient %K cancer biopsy %K spouse %K spouses %K partner %K partners %K diagnostic %K diagnostic procedure %K feasibility of recruitment %K recruitment %K prostate biopsy %K breast biopsy %K screening %K electronic health record %K survey %K surveys %D 2024 %7 18.6.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: Receiving a diagnosis of cancer is a profound and often very stressful experience. Few studies have prospectively recruited patients prior to receiving a new diagnosis of cancer and included spouses or partners. Objective: The aim of the Couples Cope Study is to understand the impact of undergoing a diagnostic biopsy and receiving a new cancer diagnosis on quality of life (QoL) in both patients and their spouses or partners, as well as on the quality of their relationship. This protocol paper describes the study design and assesses the feasibility of recruitment and retention. Methods: Study staff reviewed the schedules of collaborating physicians using specific encounter codes to identify patients scheduled for breast or prostate biopsies. Potential participants were prescreened via the electronic health record and sent a recruitment letter at least 2 to 3 weeks prior to their biopsy procedure. Patients subsequently underwent a phone screening to determine eligibility. Patients who enrolled provided study staff with contact information for their spouses or partners. All consent forms were completed online. Surveys were completed online prior to receiving the biopsy results (baseline), and at 1, 3, 6, and 9 months after the biopsy. Study staff engaged in ongoing, personalized contact with participants and sent assessment completion reminders via phone and email. Results: A total of 2294 patients undergoing a breast or prostate biopsy were identified and 69% (n=1582) were eligible for phone screening following electronic health record prescreening. Of the 431 patients who underwent phone screening, 75% (n=321) were eligible to participate. Of the eligible patients, 72% (n=231) enrolled and 82% (n=190) of enrolled patients had an accompanying partner or spouse who also enrolled. A total of 77% (34/44) of patients who received a cancer diagnosis and 72% (26/36) of their spouses or partners were retained through 9 months, while 80% (53/66) of patients who received a benign diagnosis and 68% (42/62) of their partners were retained. Conclusions: Prospective recruitment of patients undergoing diagnostic biopsy and their partners is feasible and requires both strategic collaboration with providers and concerted prescreening and recruitment efforts by study staff. Importantly, this study was able to conduct all study activities online without disrupting clinical workflow and without requiring patients and their spouses or partners to come into the laboratory. Consideration should be given to the ratio of biopsies to cancer diagnoses, which can vary significantly by cancer type. Prospective studies are needed and can inform our ability to provide effective support earlier to couples facing a possible cancer diagnosis. Future studies should examine other tumor types that have received less attention in QoL studies, include behavioral and neurobiological assessments beyond self-report measures, and follow couples beyond 9 months in order to examine long-term effects on QoL. International Registered Report Identifier (IRRID): DERR1-10.2196/52361 %M 38889402 %R 10.2196/52361 %U https://www.researchprotocols.org/2024/1/e52361 %U https://doi.org/10.2196/52361 %U http://www.ncbi.nlm.nih.gov/pubmed/38889402 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e53454 %T A Community Mental Health Integrated Disaster Preparedness Intervention for Bushfire Recovery in Rural Australian Communities: Protocol for a Multimethods Feasibility and Acceptability Pilot Study %A Pike,Caitlin E %A Dohnt,Henriette C %A Tully,Phillip J %A Bartik,Warren %A Welton-Mitchell,Courtney %A Murray,Clara V %A Rice,Kylie %A Cosh,Suzanne M %A Lykins,Amy D %+ School of Psychology, University of New England, Elm Avenue, NSW, Armidale, 2350, Australia, 61 267735014, alykins@une.edu.au %K bushfires %K wildfires %K rural mental health %K natural disasters %K mental health %K disaster preparedness %K natural hazards resilience %K community interventions %K mixed-methods %K pilot study %K disaster %K preparedness %K preparation %K natural hazard %K psychological distress %K resilience %K help-seeking %D 2024 %7 4.6.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: Natural hazards are increasing in frequency and intensity due to climate change. Many of these natural disasters cannot be prevented; what may be reduced is the extent of the risk and negative impact on people and property. Research indicates that the 2019-2020 bushfires in Australia (also known as the “Black Summer Bushfires”) resulted in significant psychological distress among Australians both directly and indirectly exposed to the fires. Previous intervention research suggests that communities impacted by natural hazards (eg, earthquakes, hurricanes, and floods) can benefit from interventions that integrate mental health and social support components within disaster preparedness frameworks. Research suggests that disaster-affected communities often prefer the support of community leaders, local services, and preexisting relationships over external supports, highlighting that community-based interventions, where knowledge stays within the local community, are highly beneficial. The Community-Based Disaster Mental Health Intervention (CBDMHI) is an evidence-based approach that aims to increase disaster preparedness, resilience, social cohesion, and social support (disaster-related help-seeking), and decrease mental health symptoms, such as depression and anxiety. Objective: This research aims to gain insight into rural Australian’s recovery needs post natural hazards, and to enhance community resilience in advance of future fires. Specifically, this research aims to adapt the CBDMHI for the rural Australian context and for bushfires and second, to assess the acceptability and feasibility of the adapted CBDMHI in a rural Australian community. Methods: Phase 1 consists of qualitative interviews (individual or dyads) with members of the target bushfire-affected rural community. Analysis of these data will include identifying themes related to disaster preparedness, social cohesion, and mental health, which will inform the adaptation. An initial consultation phase is a key component of the adaptation process and, therefore, phase 2 will involve additional discussion with key stakeholders and members of the community to further guide adaptation of the CBDMHI to specific community needs, building on phase 1 inputs. Phase 3 includes identifying and training local community leaders in the adapted intervention. Following this, leaders will co-deliver the intervention. The acceptability and feasibility of the adapted CBDMHI within the community will be evaluated by questionnaires and semistructured interviews. Effectiveness will be evaluated by quantifying psychological distress, resilience, community cohesion, psychological preparedness, and help-seeking intentions. Results: This study has received institutional review board approval and commenced phase 1 recruitment in October 2022. Conclusions: The study will identify if the adapted CBDMHI is viable and acceptable within a village in the Northern Tablelands of New South Wales, Australia. These findings will inform future scale-up in the broader rural Australian context. If this intervention is well received, the CBDMHI may be valuable for future disaster recovery and preparedness efforts in rural Australia. These findings may inform future scale-up in the broader rural Australian context. International Registered Report Identifier (IRRID): DERR1-10.2196/53454 %M 38833279 %R 10.2196/53454 %U https://www.researchprotocols.org/2024/1/e53454 %U https://doi.org/10.2196/53454 %U http://www.ncbi.nlm.nih.gov/pubmed/38833279 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e53646 %T Lack of Diversity in Research on Females with Ehlers-Danlos Syndromes: Recruitment Protocol for a Quantitative Online Survey %A Glayzer,Jennifer E %A Bray,Bethany C %A Kobak,William H %A Steffen,Alana D %A Schlaeger,Judith M %+ Department of Human Development Nursing Science, College of Nursing, University of Illinois Chicago, 845 S. Damen Ave, Chicago, IL, 60622, United States, 1 2487629576, jglayzer@iu.edu %K Ehlers-Danlos syndrome %K hypermobility %K social media %K recruitment %K Facebook %K hereditary disease %K connective tissue disorders %K racial %K ethnic %K diversity %K challenges %K strategies %K strategy %K online %K information seeking %K cross-sectional survey %K dyspareunia %K painful sex %K United States %D 2024 %7 2.5.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: Ehlers-Danlos syndromes (EDS) are a group of connective tissue disorders caused by fragile lax collagen. Current EDS research lacks racial and ethnic diversity. The lack of diversity may be associated with the complexities of conducting a large international study on an underdiagnosed condition and a lack of EDS health care providers who diagnose and conduct research outside of the United States and Europe. Social media may be the key to recruiting a large diverse EDS sample. However, studies that have used social media to recruit have not been able to recruit diverse samples. Objective: This study aims to discuss challenges, strategies, outcomes, and lessons learned from using social media to recruit a large sample of females with EDS. Methods: Recruitment on social media for a cross-sectional survey examining dyspareunia (painful sexual intercourse) in females was examined. Inclusion criteria were (1) older than 18 years of age, (2) assigned female at birth, and (3) diagnosed with EDS. Recruitment took place on Facebook and Twitter (now X), from June 1 to June 25, 2019. Results: A total of 1178 females with EDS were recruited from Facebook (n=1174) and X (n=4). On Facebook, participants were recruited via support groups. A total of 166 EDS support groups were identified, 104 permitted the principal investigator to join, 90 approved posting, and the survey was posted in 54 groups. Among them, 30 of the support groups posted in were globally focused and not tied to any specific country or region, 21 were for people in the United States, and 3 were for people outside of the United States. Recruitment materials were posted on X with the hashtag #EDS. A total of 1599 people accessed the survey and 1178 people were eligible and consented. The average age of participants was 38.6 (SD 11.7) years. Participants were predominantly White (n=1063, 93%) and non-Hispanic (n=1046, 92%). Participants were recruited from 29 countries, with 900 (79%) from the United States and 124 (11%) from Great Britain. Conclusions: Our recruitment method was successful at recruiting a large sample. The sample was predominantly White and from North America and Europe. More research needs to be conducted on how to recruit a diverse sample. Areas to investigate may include connecting with more support groups from outside the United States and Europe, researching which platforms are popular in different countries, and translating study materials into different languages. A larger obstacle to recruiting diverse samples may be the lack of health care providers that diagnose EDS outside the United States and Europe, making the pool of potential participants small. There needs to be more health care providers that diagnose and treat EDS in countries that are predominantly made up of people of color as well as research that specifically focuses on these populations. International Registered Report Identifier (IRRID): RR1-10.2196/53646 %M 38696252 %R 10.2196/53646 %U https://www.researchprotocols.org/2024/1/e53646 %U https://doi.org/10.2196/53646 %U http://www.ncbi.nlm.nih.gov/pubmed/38696252 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e51540 %T Investigating Rhythmicity in App Usage to Predict Depressive Symptoms: Protocol for Personalized Framework Development and Validation Through a Countrywide Study %A Ahmed,Md Sabbir %A Hasan,Tanvir %A Islam,Salekul %A Ahmed,Nova %+ Design Inclusion and Access Lab, North South University, Plot # 15, Block B, Bashundhara R/A, Dhaka, 1229, Bangladesh, 880 1781920068, msg2sabbir@gmail.com %K depressive symptoms %K app usage rhythm %K behavioral markers %K personalization %K multitask learning framework %D 2024 %7 24.4.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: Understanding a student’s depressive symptoms could facilitate significantly more precise diagnosis and treatment. However, few studies have focused on depressive symptom prediction through unobtrusive systems, and these studies are limited by small sample sizes, low performance, and the requirement for higher resources. In addition, research has not explored whether statistically significant rhythms based on different app usage behavioral markers (eg, app usage sessions) exist that could be useful in finding subtle differences to predict with higher accuracy like the models based on rhythms of physiological data. Objective: The main objective of this study is to explore whether there exist statistically significant rhythms in resource-insensitive app usage behavioral markers and predict depressive symptoms through these marker-based rhythmic features. Another objective of this study is to understand whether there is a potential link between rhythmic features and depressive symptoms. Methods: Through a countrywide study, we collected 2952 students’ raw app usage behavioral data and responses to the 9 depressive symptoms in the 9-item Patient Health Questionnaire (PHQ-9). The behavioral data were retrieved through our developed app, which was previously used in our pilot studies in Bangladesh on different research problems. To explore whether there is a rhythm based on app usage data, we will conduct a zero-amplitude test. In addition, we will develop a cosinor model for each participant to extract rhythmic parameters (eg, acrophase). In addition, to obtain a comprehensive picture of the rhythms, we will explore nonparametric rhythmic features (eg, interdaily stability). Furthermore, we will conduct regression analysis to understand the association of rhythmic features with depressive symptoms. Finally, we will develop a personalized multitask learning (MTL) framework to predict symptoms through rhythmic features. Results: After applying inclusion criteria (eg, having app usage data of at least 2 days to explore rhythmicity), we kept the data of 2902 (98.31%) students for analysis, with 24.48 million app usage events, and 7 days’ app usage of 2849 (98.17%) students. The students are from all 8 divisions of Bangladesh, both public and private universities (19 different universities and 52 different departments). We are analyzing the data and will publish the findings in a peer-reviewed publication. Conclusions: Having an in-depth understanding of app usage rhythms and their connection with depressive symptoms through a countrywide study can significantly help health care professionals and researchers better understand depressed students and may create possibilities for using app usage–based rhythms for intervention. In addition, the MTL framework based on app usage rhythmic features may more accurately predict depressive symptoms due to the rhythms’ capability to find subtle differences. International Registered Report Identifier (IRRID): DERR1-10.2196/51540 %M 38657238 %R 10.2196/51540 %U https://www.researchprotocols.org/2024/1/e51540 %U https://doi.org/10.2196/51540 %U http://www.ncbi.nlm.nih.gov/pubmed/38657238 %0 Journal Article %@ 2561-7605 %I %V 7 %N %P e47229 %T Home-Based Cognitive Intervention for Healthy Older Adults Through Asking Robots Questions: Randomized Controlled Trial %A Tokunaga,Seiki %A Sekiguchi,Takuya %A Watanabe Miura,Kumi %A Sugimoto,Hikaru %A S Abe,Masato %A Tamura,Kazuhiro %A Kishimoto,Taishiro %A Kudo,Takashi %A Otake-Matsuura,Mihoko %K cognitive intervention %K home-based experiment %K robots %K older adults %K technology adoption %K digital health %D 2024 %7 22.4.2024 %9 %J JMIR Aging %G English %X Background: Asking questions is common in conversations, and while asking questions, we need to listen carefully to what others say and consider the perspective our questions adopt. However, difficulties persist in verifying the effect of asking questions on older adults’ cognitive function due to the lack of a standardized system for conducting experiments at participants’ homes. Objective: This study examined the intervention effect of cognitive training moderated by robots on healthy older adults. A focus on the feasibility of the intervention at participants’ homes was also maintained. Feasibility was evaluated by considering both the dropout rate during the intervention and the number of questions posed to each participant during the experiment. Methods: We conducted a randomized controlled trial with 81 adults older than 65 years. Participants were recruited through postal invitations and then randomized into 2 groups. The intervention group (n=40) received sessions where participants listened to photo-integrated stories and posed questions to the robots. The control group (n=41) received sessions where participants listened to photo-integrated stories and only thanked the robots for confirming participation. The participants participated in 12 dialogue sessions for 2-3 weeks. Scores of global cognitive functioning tests, recall tests, and verbal fluency tasks measured before and after the intervention were compared between the 2 groups. Results: There was no significant intervention effect on the Telephone Interview for Cognitive Status-Japanese scores, recall tests, and verbal fluency tasks. Additionally, our study successfully concluded with no participant dropouts at follow-up, confirming the feasibility of our approach. Conclusions: There was no statistically significant evidence indicating intervention benefits for cognitive functioning. Although the feasibility of home-based interventions was demonstrated, we identified areas for improvement in the future, such as setting up more efficient session themes. Further research is required to identify the effectiveness of an improved cognitive intervention involving the act of asking questions. Trial Registration: University Hospital Medical Information Network Center UMIN000039489; https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045027 %R 10.2196/47229 %U https://aging.jmir.org/2024/1/e47229 %U https://doi.org/10.2196/47229 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e52616 %T Assessing and Improving the Care of Patients With Heart Failure in Ghana: Protocol for a Prospective Observational Study and the Ghana Heart Initiative-Heart Failure Registry %A Awindaogo,Felix %A Acheamfour-Akowuah,Emmanuel %A Doku,Alfred %A Kokuro,Collins %A Agyekum,Francis %A Owusu,Isaac Kofi %+ Department of Medicine and Therapeutics, University of Ghana Medical School, University of Ghana, 22nd Guggisberg Avenue, Korle-Bu, PO Box GP 4236, Accra, Ghana, 233 244273573, dokukavin@gmail.com %K clinical %K cross-sectional %K epidemiology %K Ghana %K heart failure %K heart %K management %K medium-term %K monitoring %K mortality %K outcome %K patient data %K prevention %K protocol %K teaching %K treatment %D 2024 %7 8.4.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: Heart failure (HF) is a leading cause of morbidity and mortality globally, with a high disease burden. The prevalence of HF in Ghana is increasing rapidly, but epidemiological profiles, treatment patterns, and survival data are scarce. The national capacity to diagnose and manage HF appropriately is also limited. To address the growing epidemic of HF, it is crucial to recognize the epidemiological characteristics and medium-term outcomes of HF in Ghana and improve the capability to identify and manage HF promptly and effectively at all levels of care. Objective: This study aims to determine the epidemiological characteristics and medium-term HF outcomes in Ghana. Methods: We conducted a prospective, multicenter, multilevel cross-sectional observational study of patients with HF from January to December 2023. Approximately 5000 patients presenting with HF to 9 hospitals, including teaching, regional, and municipal hospitals, will be recruited and evaluated according to a standardized protocol, including the use of an echocardiogram and an N-terminal pro-brain natriuretic peptide (NT-proBNP) test. Guideline-directed medical treatment of HF will be initiated for 6 months, and the medium-term outcomes of interventions, including rehospitalization and mortality, will be assessed. Patient data will be collated into a HF registry for continuous assessment and monitoring. Results: This intervention will generate the necessary information on the etiology of HF, clinical presentations, the diagnostic yield of various tools, and management outcomes. In addition, it will build the necessary capacity and support for HF management in Ghana. As of July 30, 2023, the training and onboarding of all 9 centers had been completed. Preliminary analyses will be conducted by the end of the second quarter of 2024, and results are expected to be publicly available by the middle of 2024. Conclusions: This study will provide the necessary data on HF, which will inform decisions on the prevention and management of HF and form the basis for future research. Trial Registration: ISRCTN Registry (United Kingdom) ISRCTN18216214; https:www.isrctn.com/ISRCTN18216214 International Registered Report Identifier (IRRID): DERR1-10.2196/52616 %M 38588528 %R 10.2196/52616 %U https://www.researchprotocols.org/2024/1/e52616 %U https://doi.org/10.2196/52616 %U http://www.ncbi.nlm.nih.gov/pubmed/38588528 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e53301 %T Evaluating a Remotely Delivered Cardio-Oncology Rehabilitation Intervention for Patients With Breast Cancer (REMOTE-COR-B): Protocol for a Single-Arm Feasibility Trial %A Short,Camille E %A Rawstorn,Jonathan C %A Jones,Tamara L %A Edbrooke,Lara %A Hayes,Sandra C %A Maddison,Ralph %A Nightingale,Sophie %A Ismail,Hilmy %A De Boer,Richard %A Hegi-Johnson,Fiona %A Sverdlov,Aaron L %A Bell,Robyn %A Halligan,Irene %A Denehy,Linda %+ Melbourne Centre for Behaviour Change, Melbourne School of Psychological Sciences, The University of Melbourne, Tin Alley, Melbourne, 3010, Australia, 61 0408 288 786, camille.short@unimelb.edu.au %K breast cancer survivor %K breast cancer %K cancer survivor %K cancer %K cardiac rehabilitation %K cardiac %K cardiotoxicity %K cardiovascular disease %K digital health %K efficacy %K exercise %K exercise %K feasibility %K fitness %K rehabilitation intervention %K rehabilitation %K safety %D 2024 %7 5.4.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: Exercise rehabilitation is a promising strategy for reducing cardiovascular disease risk among patients with breast cancer. However, the evidence is primarily derived from programs based at exercise centers with in-person supervised delivery. Conversely, most patients report a preference for home-based rehabilitation. As such, there is a clear need to explore strategies that can provide real-time supervision and coaching while addressing consumer preferences. Evidence from cardiac rehabilitation has demonstrated the noninferiority of a smartphone-based telerehabilitation approach (REMOTE-CR) to improve cardiorespiratory fitness in people with cardiovascular disease compared to a center-based program. Objective: This study aims to assess the feasibility, safety, and preliminary efficacy of the REMOTE-CR program adapted for patients with breast cancer at risk of cardiotoxicity (REMOTE-COR-B). We will also assess the satisfaction and usability of REMOTE-COR-B. Methods: We will conduct a single-arm feasibility study of the REMOTE-COR-B program among patients with stage I-III breast cancer who are at risk of cardiotoxicity (taking treatment type and dose, as well as other common cardiovascular disease risk factors into account) and who are within 24 months of completing primary definitive treatment. Participants (target sample size of 40) will receive an 8-week smartphone-based telerehabilitation exercise program involving remotely delivered real-time supervision and behavior change support. The platform comprises a smartphone and wearable heart rate monitor, as well as a custom-built smartphone app and web application. Participants will be able to attend remotely monitored exercise sessions during set operating hours each week, scheduled in both the morning and evening. Adherence is the primary outcome of the trial, assessed through the number of remotely monitored exercise sessions attended compared to the trial target (ie, 3 sessions per week). Secondary outcomes include additional trial feasibility indicators (eg, recruitment and retention), safety, satisfaction, and usability, and objective and patient-reported efficacy outcomes (cardiovascular fitness, quality of life, fatigue, self-reported exercise, self-efficacy, habit strength, and motivation). Adherence, feasibility, and safety outcomes will be assessed during the intervention period; intervention satisfaction and usability will be assessed post intervention; and objective and patient-reported efficacy outcomes will be assessed at baseline, post intervention (2-month postbaseline assessment), and at follow-up (5-month postbaseline assessment). Results: Recruitment for this trial commenced in March 2023, and 7 participants had been recruited as of the submission of the manuscript. The estimated completion date for the project is October 2024, with results expected to be published in mid-2025. Conclusions: The REMOTE-COR-B intervention is a novel and promising approach to providing exercise therapy to patients with breast cancer at risk of cardiotoxicity who have unique needs and heightened safety risks. This project will provide important information on the extent to which this approach is satisfactory to patients with breast cancer, safe, and potentially effective, which is necessary before larger-scale research or clinical projects. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12621001557820; www.anzctr.org.au/ACTRN12621001557820.aspx International Registered Report Identifier (IRRID): DERR1-10.2196/53301 %M 38578682 %R 10.2196/53301 %U https://www.researchprotocols.org/2024/1/e53301 %U https://doi.org/10.2196/53301 %U http://www.ncbi.nlm.nih.gov/pubmed/38578682 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 12 %N %P e48027 %T The Effectiveness of a Cell Phone eHealth App in Changing Knowledge, Stigmatizing Attitudes, and Intention to Seek Help Associated With Obsessive-Compulsive Disorder: Pilot Questionnaire Study %A Chaves,Antonio %A Arnáez,Sandra %A García-Soriano,Gemma %+ Departamento de Personalidad, Evaluación y Tratamientos Psicológicos, Universitat de València, Avda Blasco Ibáñez, 21, Valencia, 46010, Spain, 34 963983389, gemma.garcia@uv.es %K obsessive-compulsive disorder %K OCD %K mental health literacy %K stigma %K app %K help-seeking intention %K seek help %K mobile phone %D 2024 %7 29.3.2024 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Obsessive-compulsive disorder (OCD) is a disabling disorder associated with high interference in people’s lives. However, patients with OCD either do not seek help or delay seeking help. Research suggests that this could be explained by poor mental health literacy about the disorder and the associated stigma. Objective: This study aims to evaluate the feasibility, acceptability, and preliminary effectiveness of a mental health mobile app, esTOCma, developed to improve knowledge about OCD and its treatment, increase help-seeking intention, and reduce stigmatizing attitudes and social distance associated with OCD. Methods: We used preintervention, postintervention, and 3-month follow-up assessments in this single-arm pilot intervention. Overall, 90 participants were recruited from the community using the snowball sampling method. We used esTOCma to defeat the “stigma monster” over the course of 10 missions. The participants completed the sociodemographic information and Obsessive-Compulsive Inventory–Revised at preassessment and an acceptability questionnaire at postassessment. All other measures were completed at the preassessment, postassessment, and 3-month follow-up (ie, the Spanish Mental Illness Stigma Attribution Questionnaire–27, the General Help-Seeking Questionnaire, the Social Distance Scale, and the Mental Health Literacy Questionnaire). Results: Of the 90 participants from the community that were assessed for eligibility, 86% (n=78) were allocated to intervention. Of these 78 participants, 79% (n=62) completed the game and answered the postintervention assessment (completer group). Overall, 69% (43/62) of the participants also completed the 3-month follow-up assessment. The participants completing the study were older (P=.003) and had a higher baseline knowledge of OCD (P=.05). The participants took an average of 13.64 (SD 10.50) days to complete the intervention, including the pre- and postassessments. The participants spent an average of 4.56 (SD 3.33) days completing the 10 missions included in the app. Each mission took a mean of between 2 (SD 3.01) and 9.35 (SD 3.06) minutes. The app was rated as useful or very useful by the vast majority of participants 90% (56/62). Moreover, 90% (56/62) of the participants reported that they had learned or learned a lot, and 98% (61/62) of the participants reported that they would recommend the app to a friend. Repeated measures ANOVA (43/62, 69%) showed that after the intervention participants showed an increased knowledge of mental health and intention to seek help as well as fewer stigmatizing attitudes and less social distance. Conclusions: Preliminary data show that esTOCma is a feasible and acceptable app, and after completing its 10 missions, there is an increase in the understanding of OCD and help-seeking intention along with a decrease in the social stigma and social distance associated with OCD that lasts for at least 3 months. The results support the potential of technology-based interventions to increase the intention to seek help and reduce the stigma associated with OCD. A larger, community-controlled study is also recommended. %M 38551629 %R 10.2196/48027 %U https://mhealth.jmir.org/2024/1/e48027 %U https://doi.org/10.2196/48027 %U http://www.ncbi.nlm.nih.gov/pubmed/38551629 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e55701 %T Comparison of Spontaneous Pushing and Directed Pushing During the Second Stage of Labor Among Chinese Women Without Epidural Analgesia: Protocol for a Noninferior Feasibility Study %A Yao,Jiasi %A Roth,Heike %A Anderson,Debra %A Lu,Hong %A Rong,Huijuan %A Baird,Kathleen %+ Faculty of Health, University of Technology Sydney, 235 Jones Street, Ultimo, Sydney, 2007, Australia, 61 0415 786 708, jiasi.yao@student.uts.edu.au %K spontaneous pushing %K directed pushing %K labour stage, labour %K labor %K obstetric %K obstetrics %K child %K birth %K delivery %K second %K feasibility study %K China %K Chinese %K women %K protocol %K maternal-neonatal outcomes %K maternal %K healthcare %K labouring women %K cohort %K effectiveness %K Midwives %K midwife %K midwifery %K childbirth %D 2024 %7 26.3.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: Maternal pushing during the second stage of labor could influence labor progress and maternal-neonatal outcomes. Although the image of health care providers directing the laboring women to push during the second stage of labor could be commonly observed globally, this practice is not sufficiently researched and is questioned regarding its effectiveness and outcomes on the mother and baby. Meanwhile, a strategy referred to as “spontaneous pushing,” which supports women to push by following their bodily urges, has been evaluated in several trials. However, in China, spontaneous pushing is not common practice. Notwithstanding the evaluation of spontaneous pushing, there is a lack of high-quality evidence to support either strategies of directed pushing or spontaneous pushing. Objective: This study aims to test the feasibility of a future randomized controlled trial to compare the effects of spontaneous pushing and directed pushing during the second stage of labor for maternal and neonatal outcomes in China. Methods: A nonrandomized, single-group, noninferiority feasibility study will be conducted in a public hospital in Hebei Province, China. In total, 105 women meeting the selection criteria will be recruited to receive the intervention (spontaneous pushing), while 105 sets of medical notes from women who received routine care (directed pushing) will be identified and reviewed to compare outcomes for both cohorts. A mixed methods approach will be used to assess primary outcomes (feasibility and acceptability) and secondary outcomes (effectiveness). Results: Data collection took place between May and October 2023. A total of 110 women were invited to participate in the intervention of spontaneous pushing. Midwives’ interviews were conducted and will be transcribed for analysis in March 2024. The data analysis is planned to be completed by May 2024. Conclusions: This feasibility study will provide important information by conducting a full-scale clinical trial in the future as well as the potential facilitators and barriers of it. A future randomized controlled trial is likely to have considerable policy and funding impacts regarding pushing management during the second stage of labor and improvement in women’s childbirth experience. Trial Registration: Chinese Clinical Trial Register ChiCTR2300071178; https://tinyurl.com/mudtnbft International Registered Report Identifier (IRRID): DERR1-10.2196/55701 %M 38530330 %R 10.2196/55701 %U https://www.researchprotocols.org/2024/1/e55701 %U https://doi.org/10.2196/55701 %U http://www.ncbi.nlm.nih.gov/pubmed/38530330 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e55999 %T Examining Passively Collected Smartphone-Based Data in the Days Prior to Psychiatric Hospitalization for a Suicidal Crisis: Comparative Case Analysis %A Jacobucci,Ross %A Ammerman,Brooke %A Ram,Nilam %+ Department of Psychology, University of Notre Dame, 390 Corbett Family Hall, Notre Dame, IN, 46556, United States, 1 574 631 6650, rjacobuc@nd.edu %K screenomics %K digital phenotyping %K passive assessment %K intensive time sampling %K suicide risk %K suicidal behaviors %K risk detection %K Comparative Analysis %K suicide %K suicidal %K risk %K risks %K behavior %K behaviors %K detection %K prediction %K Smartphone-Based %K screenomic %K case review %K participant %K participants %K smartphone %K smartphones %K suicidal ideation %D 2024 %7 20.3.2024 %9 Case Report %J JMIR Form Res %G English %X Background: Digital phenotyping has seen a broad increase in application across clinical research; however, little research has implemented passive assessment approaches for suicide risk detection. There is a significant potential for a novel form of digital phenotyping, termed screenomics, which captures smartphone activity via screenshots. Objective: This paper focuses on a comprehensive case review of 2 participants who reported past 1-month active suicidal ideation, detailing their passive (ie, obtained via screenomics screenshot capture) and active (ie, obtained via ecological momentary assessment [EMA]) risk profiles that culminated in suicidal crises and subsequent psychiatric hospitalizations. Through this analysis, we shed light on the timescale of risk processes as they unfold before hospitalization, as well as introduce the novel application of screenomics within the field of suicide research. Methods: To underscore the potential benefits of screenomics in comprehending suicide risk, the analysis concentrates on a specific type of data gleaned from screenshots—text—captured prior to hospitalization, alongside self-reported EMA responses. Following a comprehensive baseline assessment, participants completed an intensive time sampling period. During this period, screenshots were collected every 5 seconds while one’s phone was in use for 35 days, and EMA data were collected 6 times a day for 28 days. In our analysis, we focus on the following: suicide-related content (obtained via screenshots and EMA), risk factors theoretically and empirically relevant to suicide risk (obtained via screenshots and EMA), and social content (obtained via screenshots). Results: Our analysis revealed several key findings. First, there was a notable decrease in EMA compliance during suicidal crises, with both participants completing fewer EMAs in the days prior to hospitalization. This contrasted with an overall increase in phone usage leading up to hospitalization, which was particularly marked by heightened social use. Screenomics also captured prominent precipitating factors in each instance of suicidal crisis that were not well detected via self-report, specifically physical pain and loneliness. Conclusions: Our preliminary findings underscore the potential of passively collected data in understanding and predicting suicidal crises. The vast number of screenshots from each participant offers a granular look into their daily digital interactions, shedding light on novel risks not captured via self-report alone. When combined with EMA assessments, screenomics provides a more comprehensive view of an individual’s psychological processes in the time leading up to a suicidal crisis. %M 38506916 %R 10.2196/55999 %U https://formative.jmir.org/2024/1/e55999 %U https://doi.org/10.2196/55999 %U http://www.ncbi.nlm.nih.gov/pubmed/38506916 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e49857 %T An Ecological Mobile Momentary Intervention to Support Dynamic Goal Pursuit: Feasibility and Acceptability Study %A O'Driscoll,Ciarán %A Singh,Aneesha %A Chichua,Iya %A Clodic,Joachim %A Desai,Anjali %A Nikolova,Dara %A Yap,Alex Jie %A Zhou,Irene %A Pilling,Stephen %+ CORE Data Lab, Centre for Outcomes Research and Effectiveness, University College London, Gower Street, London, WC1E 6BT, United Kingdom, 44 207679 1897, c.odriscoll@ucl.ac.uk %K goal pursuit %K ecological momentary intervention %K ecological momentary assessment %K mood %K dynamics %K network analysis %K MCII %K COM-B %K support %K pilot study %K training %K feasibility %K acceptability %K self-monitoring %K implementation %K psychological %K effectiveness %D 2024 %7 20.3.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Individuals can experience difficulties pursuing their goals amid multiple competing priorities in their environment. Effective goal dynamics require flexible and generalizable pursuit skills. Supporting successful goal pursuit requires a perpetually adapting intervention responsive to internal states. Objective: The purpose of this study was to (1) develop a flexible intervention that can adapt to an individual’s changing short to medium-term goals and be applied to their daily life and (2) examine the feasibility and acceptability of the just-in-time adaptive intervention for goal pursuit. Methods: This study involved 3 iterations to test and systematically enhance all aspects of the intervention. During the pilot phase, 73 participants engaged in an ecological momentary assessment (EMA) over 1 month. After week 1, they attended an intervention training session and received just-in-time intervention prompts during the following 3 weeks. The training employed the Capability, Opportunity, Motivation, and Behavior (COM-B) framework for goal setting, along with mental contrasting with implementation intentions (MCII). Subsequent prompts, triggered by variability in goal pursuit, guided the participants to engage in MCII in relation to their current goal. We evaluated feasibility and acceptability, efficacy, and individual change processes by combining intensive (single-case experimental design) and extensive methods. Results: The results suggest that the digital intervention was feasible and acceptable to participants. Compliance with the intervention was high (n=63, 86%). The participants endorsed high acceptability ratings relating to both the study procedures and the intervention. All participants (N=73, 100%) demonstrated significant improvements in goal pursuit with an average difference of 0.495 units in the outcome (P<.001). The results of the dynamic network modeling suggest that self-monitoring behavior (EMA) and implementing the MCII strategy may aid in goal reprioritization, where goal pursuit itself is a driver of further goal pursuit. Conclusions: This pilot study demonstrated the feasibility and acceptability of a just-in-time adaptive intervention among a nonclinical adult sample. This intervention used self-monitoring of behavior, the COM-B framework, and MCII strategies to improve dynamic goal pursuit. It was delivered via an Ecological Momentary Intervention (EMI) procedure. Future research should consider the utility of this approach as an additional intervention element within psychological interventions to improve goal pursuit. Sustaining goal pursuit throughout interventions is central to their effectiveness and warrants further evaluation. %M 38506904 %R 10.2196/49857 %U https://formative.jmir.org/2024/1/e49857 %U https://doi.org/10.2196/49857 %U http://www.ncbi.nlm.nih.gov/pubmed/38506904 %0 Journal Article %@ 2561-1011 %I JMIR Publications %V 8 %N %P e54823 %T Cardiac Rehabilitation During the COVID-19 Pandemic and the Potential for Digital Technology to Support Physical Activity Maintenance: Qualitative Study %A Park,Linda G %A Chi,Serena %A Pitsenbarger,Susan %A Johnson,Julene K %A Shah,Amit J %A Elnaggar,Abdelaziz %A von Oppenfeld,Julia %A Cho,Evan %A Harzand,Arash %A Whooley,Mary A %+ Department of Community Health Systems, University of California San Francisco, 2 Koret Way, Room 531A, San Francisco, CA, 94143-0610, United States, 1 415 502 6616, linda.park@ucsf.edu %K cardiac rehabilitation %K cardiac rehab %K COVID-19 %K digital health %K digital technology %K physical activity %K physical activity maintenance %K social media %K older adults %K pandemic %K social distancing %K technology %K wearables %K CR %K exercise %K cardiovascular disease %K gerontology %K geriatric %K geriatrics %K hospital %K medical facility %K California %K interview %K thematic analysis %K anxiety %D 2024 %7 14.3.2024 %9 Original Paper %J JMIR Cardio %G English %X Background: Social distancing from the COVID-19 pandemic may have decreased engagement in cardiac rehabilitation (CR) and may have had possible consequences on post-CR exercise maintenance. The increased use of technology as an adaptation may benefit post-CR participants via wearables and social media. Thus, we sought to explore the possible relationships of both the pandemic and technology on post-CR exercise maintenance. Objective: This study aimed to (1) understand CR participation during the COVID-19 pandemic, (2) identify perceived barriers and facilitators to physical activity after CR completion, and (3) assess willingness to use technology and social media to support physical activity needs among older adults with cardiovascular disease. Methods: We recruited participants aged 55 years and older in 3 different CR programs offered at both public and private hospitals in Northern California. We conducted individual interviews on CR experiences, physical activity, and potential for using technology. We used thematic analysis to synthesize the data. Results: In total, 22 participants (n=9, 41% female participants; mean age 73, SD 8 years) completed in-depth interviews. Themes from participants’ feedback included the following: (1) anxiety and frustration about the wait for CR caused by COVID-19 conditions, (2) positive and safe participant experience once in CR during the pandemic, (3) greater attention needed to patients after completion of CR, (4) notable demand for technology during the pandemic and after completion of CR, and (5) social media networking during the CR program considered valuable if training is provided. Conclusions: Individuals who completed CR identified shared concerns about continuing physical activity despite having positive experiences during the CR program. There were significant challenges during the pandemic and heightened concerns for safety and health. The idea of providing support by leveraging digital technology (wearable devices and social media for social support) resonated as a potential solution to help bridge the gap from CR to more independent physical activity. More attention is needed to help individuals experience a tailored and safe transition to home to maintain physical activity among those who complete CR. %M 38483450 %R 10.2196/54823 %U https://cardio.jmir.org/2024/1/e54823 %U https://doi.org/10.2196/54823 %U http://www.ncbi.nlm.nih.gov/pubmed/38483450 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e54251 %T Navigating Social Cognitive Impairments in Schizophrenia Spectrum Disorders: Protocol for a Pilot Pre-Post Quasi-Experimental Study for Remote Avatar-Assisted Cognitive Remediation Therapy %A Thibaudeau,Elisabeth %A Peyroux,Elodie %A Franck,Nicolas %A Carling,Hannah %A Lepage,Martin %+ Douglas Research Center, 6875 Boulevard LaSalle, Montreal, QC, H4H 1R3, Canada, 1 514 761 6131 ext 4393, elisabeth.thibaudeau@mail.mcgill.ca %K social cognition %K schizophrenia spectrum disorder %K psychosis %K cognitive remediation therapy %K social cognitive training %K digital relational simulation %K cultural adaptation %K feasibility %K acceptability %K mobile phone %D 2024 %7 13.3.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: Social cognitive impairments are prevalent in schizophrenia spectrum disorder (SSD) and have detrimental effects on functioning. Cognitive remediation (CR) has shown its efficacy in improving social cognitive impairments, although the transfer of these skills to daily life and the personalization of these interventions remain challenging. RC2S (Remédiation Cognitive de la Cognition Sociale dans la Schizophrénie; Cognitive remediation of social cognition in Schizophrenia) is a French CR that combines the learning of strategies and practice using paper-and-pencil exercises and digital relational simulations. This French program was designed as an in-person intervention. Objective: This project aims to culturally adapt the RC2S program, in French-Canadian and North American English and to assess the feasibility, acceptability, safety, and implementation of a remote version in people with SSD. An exploratory objective is to assess the preliminary effect of remote RC2S on goal attainment, social cognition, and psychosocial outcomes. Methods: We will use a pre-post quasi-experimental design. First, the translation and cultural adaptation in North American English and French-Canadian of RC2S is presented. Then, 20 participants aged ≥18 years with a diagnosis of SSD, presenting with a subjective or an objective impairment in social cognition, will be included to receive RC2S. In addition, 5 therapists will be included as research participants to assess their perspective on RC2S. Participants with SSD will undergo a baseline remote assessment of their social cognition, clinical symptoms, and functioning. They will then start remote RC2S for 24 biweekly individual 1-hour sessions with a therapist. Following the case formulation and goal setting, participants will complete personalized paper-and-pencil exercises to develop strategies and integrative digital relational simulations, during which they will help an avatar navigate through a variety of social contexts and relationships. The last 2 sessions are dedicated to the transfer to daily life. All participants will complete in-session questionnaires assessing therapeutic alliance, motivation, acceptability, feasibility, and implementation. Following RC2S, the participants with SSD will repeat the same assessment as the baseline. Descriptive statistics will be used to summarize the data about acceptability, feasibility, safety, and implementation. To assess the preliminary effect of RC2S, an intention-to-treat approach will be used with linear mixed models for repeated measures with fixed effects of time. Results: So far, 45% (9/20) of participants with SSD (mean age 37.9, SD 9.3 years) have completed the project. They received a mean of 20.5 out of 24 (SD 3.5) sessions of RC2S. A total of 5 therapists also completed the project. Conclusions: Improving social cognitive impairments is an important target in SSD to promote functional recovery. Using digital technologies to address these impairments and deliver the intervention is a promising approach to increase the ecological validity of CR and access to the intervention. Trial Registration: ClinicalTrials.gov NCT05017532; https://classic.clinicaltrials.gov/ct2/show/NCT05017532 International Registered Report Identifier (IRRID): DERR1-10.2196/54251 %M 38477975 %R 10.2196/54251 %U https://www.researchprotocols.org/2024/1/e54251 %U https://doi.org/10.2196/54251 %U http://www.ncbi.nlm.nih.gov/pubmed/38477975 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e49492 %T Using mHealth to Improve Communication in Adult Day Services Around the Needs of People With Dementia: Mixed Methods Assessment of Acceptability and Feasibility %A Zheng,Amy %A Bergh,Marissa %A Patel Murali,Komal %A Sadarangani,Tina %+ New York University Rory Meyers College of Nursing, 433 First Avenue, 6th Floor, New York, NY, 10010, United States, 1 212 998 5300, msb7677@nyu.edu %K adult day services %K primary health care %K health communication %K dementia %K mobile health %K mHealth %K community-based %K health care %K older adults %K older adult %K chronic condition %K health information %K feasibility %K acceptability %K CareMOBI %K mixed methods design %K caregivers %K caregiver %K care workers %K nurses %K social workers %D 2024 %7 1.3.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Adult day services (ADS) provide community-based health care for older adults with complex chronic conditions but rely on outdated methods for communicating users’ health information with providers. CareMOBI, a novel mobile health (mHealth) app, was developed to address the need for a technological platform to improve bidirectional information exchange and communication between the ADS setting and providers. Objective: This study aims to examine the feasibility and acceptability of CareMOBI in the ADS setting. Methods: A concurrent-triangulation mixed methods design was used, and participants were client-facing ADS staff members, including direct care workers (paid caregivers), nurses, and social workers. Interviews were conducted to describe barriers and facilitators to the adoption of the CareMOBI app. The acceptability of the app was measured using an adapted version of the Technology Acceptance Model questionnaire. Data were integrated into 4 themes as anchors of an informational matrix: ease of use, clinical value, fit within workflow, and likelihood of adoption. Results: A mix of ADS staff (N=22) participated in the study. Participants reported high levels of acceptability across the 4 domains. Qualitative findings corroborated the questionnaire results; participants viewed the app as useful and were likely to implement CareMOBI in their practice. However, participants expressed a need for proper training and technical support throughout the implementation process. Conclusions: The CareMOBI app has the potential to improve care management in the ADS setting by promoting effective communication through an easy-to-use and portable method. While the integration of CareMOBI is acceptable and feasible, developing role-specific training modules and technical assistance programs is imperative for successful implementation within the ADS setting. %M 38427418 %R 10.2196/49492 %U https://formative.jmir.org/2024/1/e49492 %U https://doi.org/10.2196/49492 %U http://www.ncbi.nlm.nih.gov/pubmed/38427418 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e53659 %T Feasibility of Guided Internet-Based Cognitive Behavioral Therapy for Panic Disorder and Social Anxiety Disorder in Japan: Pilot Single-Arm Trial %A Shinno,Seina %A Matsumoto,Kazuki %A Hamatani,Sayo %A Inaba,Yosuke %A Ozawa,Yoshihito %A Kawasaki,Yohei %A Ikai,Tomoki %A Sutoh,Chihiro %A Hayashi,Hiroyuki %A Shimizu,Eiji %+ Division of Clinical Psychology, Kagoshima University Medical and Dental Hospital, 1-35-8 Sakuragaoka, Kagoshima, 8908520, Japan, 81 099 275 5707, k2782199@kadai.jp %K cognitive behavioral therapy %K internet intervention %K panic disorder %K social anxiety %K feasibility trail %K adult %K adults %K anxiety disorder %K internet-based %K e-learning %K Japan %K statistical analyses %K therapist %K therapists %K intervention %K severity %K symptoms %K therapeutic alliance %K mobile phone %D 2024 %7 29.2.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Cognitive behavioral therapy (CBT) is effective in treating anxiety disorders. Accessibility to CBT has been limited in Japan due to the shortage of therapists. While an open-source e-learning system can be used to create a simple internet-based cognitive behavioral therapy (ICBT) program, the safety and outpatient acceptance of this treatment approach have not been explored in Japan. Objective: The aim of this study was to investigate whether outpatients with anxiety disorders could accept and successfully complete the ICBT program with guidance by CBT therapists when implementing therapeutic modules and CBT tasks. Due to being in the initial phase of a novel treatment in Japan, this study was intended for verification with a small sample size. Methods: In total, 6 adults, including 4 male participants and 2 female participants, were enrolled in a single-arm trial. The intervention involved guided ICBT comprising 12 sessions, including CBT text, comprehension confirmation tests, and explanatory videos about cognitive behavioral models, accessible through a website. The therapist guided the participants in accessing the ICBT program and answering their questions using a chat tool. The primary outcome was anxiety severity assessed using the State-Trait Anxiety Inventory-Trait. Secondary outcomes included the Panic Disorder Severity Scale, Liebowitz Social Anxiety Scale (LSAS), Beck Anxiety Inventory (BAI), Patient Health Questionnaire–9, Generalized Anxiety Disorder–7, and Working Alliance Inventory–Short Form (WAI-SF). Statistical analyses were performed using paired 2-tailed t tests to assess the changes in clinical symptoms. The total WAI-SF score at the final session was used to evaluate the therapeutic alliance. For statistical analyses, mean changes for total State-Trait Anxiety Inventory-Trait, BAI, Panic Disorder Severity Scale, LSAS, Patient Health Questionnaire–9, and Generalized Anxiety Disorder–7 scores were analyzed using the paired 2-tailed t test. The 2-sided significance level for hypothesis testing was set at 5%, and 2-sided 95% CIs were calculated. Results: Most participants diligently engaged with the ICBT program. No adverse events were reported. The mean total scores for the primary outcome decreased by 11.0 (SD 9.6) points (95% CI –22.2 to 0.20; Hedges g=0.95), but it was not statistically significant. The mean total scores for the secondary outcomes that assess clinical symptoms decreased, with a significant reduction observed in the BAI of 15.7 (SD 12.1) points (95% CI –28.4 to –3.0; P=.03; Hedges g=1.24). The mean total scores for PDSS and LSAS decreased significantly, by 12.0 (SD 4.24) points (95% CI –50.1 to 26.1; P=.16; Hedges g=1.79) and 32.4 (SD 11.1) points (95% CI –59.7 to –4.3; P=.04; Hedges g=1.38), respectively. Of the participants, 67% (n=4) showed treatment response, and 50% (n=3) achieved remission after the intervention. The therapeutic alliance, measured using the WAI-SF, was moderate. Conclusions: Guided ICBT may be feasible for the treatment of outpatients with panic disorder and social anxiety disorder in Japan. Trial Registration: University Hospital Medical Information Network Clinical Trials Registry UMIN0000038118; https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000043439 %M 38421717 %R 10.2196/53659 %U https://formative.jmir.org/2024/1/e53659 %U https://doi.org/10.2196/53659 %U http://www.ncbi.nlm.nih.gov/pubmed/38421717 %0 Journal Article %@ 2561-7605 %I JMIR Publications %V 7 %N %P e46522 %T Barriers to and Facilitators of Older People’s Engagement With Web-Based Services: Qualitative Study of Adults Aged >75 Years %A Money,Annemarie %A Hall,Alex %A Harris,Danielle %A Eost-Telling,Charlotte %A McDermott,Jane %A Todd,Chris %+ School of Health Sciences, University of Manchester, 5th Floor, Jean McFarlane Building, Manchester, M13 9PL, United Kingdom, 44 0161 306 7777, annemarie.money@manchester.ac.uk %K digital exclusion %K digital inclusion %K older people %K technology %K aged %K web-based %K internet %D 2024 %7 28.2.2024 %9 Original Paper %J JMIR Aging %G English %X Background: The COVID-19 pandemic has accelerated the shift toward the digital provision of many public services, including health and social care, public administration, and financial and leisure services. COVID-19 services including test appointments, results, vaccination appointments and more were primarily delivered through digital channels to the public. Many social, cultural, and economic activities (appointments, ticket bookings, tax and utility payments, shopping, etc) have transitioned to web-based platforms. To use web-based public services, individuals must be digitally included. This is influenced by 3 main factors: access (whether individuals have access to the internet), ability (having the requisite skills and confidence to participate over the web), and affordability (ability to pay for infrastructure [equipment] and data packages). Many older adults, especially those aged >75 years, are still digitally excluded. Objective: This study aims to explore the views of adults aged >75 years on accessing public services digitally. Methods: We conducted semistructured qualitative interviews with a variety of adults aged ≥75 years residing in Greater Manchester, United Kingdom. We also interviewed community support workers. Thematic analysis was used to identify the key themes from the data. Results: Overall, 24 older adults (mean age 81, SD 4.54 y; 14/24, 58% female; 23/24, 96% White British; and 18/24, 75% digitally engaged to some extent) and 2 support workers participated. A total of five themes were identified as key in understanding issues around motivation, engagement, and participation: (1) “initial motivation to participate digitally”—for example, maintaining social connections and gaining skills to be able to connect with family and friends; (2) “narrow use and restricted activity on the web”—undertaking limited tasks on the web and in a modified manner, for example, limited use of web-based public services and selected use of specific services, such as checking but never transferring funds during web-based banking; (3) “impact of digital participation on well-being”—choosing to go to the shops or general practitioner’s surgery to get out of the house and get some exercise; (4) “the last generation?”—respondents feeling that there were generational barriers to adapting to new technology and change; and (5) “making digital accessible”—understanding the support needed to keep those engaged on the web. Conclusions: As we transition toward greater digitalization of public services, it is crucial to incorporate the perspectives of older people. Failing to do so risks excluding them from accessing services they greatly rely on and need. %M 38416543 %R 10.2196/46522 %U https://aging.jmir.org/2024/1/e46522 %U https://doi.org/10.2196/46522 %U http://www.ncbi.nlm.nih.gov/pubmed/38416543 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e47570 %T How to Identify e-Cigarette Brands Available in the United States During 2020-2022: Development and Usability Study %A Ma,Shaoying %A Kaareen,Aadeeba %A Park,Hojin %A He,Yanyun %A Jiang,Shuning %A Qiu,Zefeng %A Xie,Zidian %A Li,Dongmei %A Chen,Jian %A O’Connor,Richard J %A Fong,Geoffrey T %A Shang,Ce %+ Center for Tobacco Research, The Ohio State University Wexner Medical Center, 3650 Olentangy River Road, 1st Floor, Suite 110, Columbus, OH, 43214, United States, 1 6148976063, shaoying.ma@osumc.edu %K tobacco %K electronic cigarette %K e-cigarette %K electronic nicotine delivery systems %K electronic nicotine delivery system %K vaping %K market surveillance %K tobacco marketing %D 2024 %7 28.2.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Prior studies have demonstrated that the e-cigarette market contains a large number of brands. Identifying these existing e-cigarette brands is a key element of market surveillance, which will further assist in policy making and compliance checks. Objective: To facilitate the surveillance of the diverse product landscape in the e-cigarette market, we constructed a semantic database of e-cigarette brands that have appeared in the US market as of 2020-2022. Methods: In order to build the brand database, we searched and compiled e-cigarette brands from a comprehensive list of retail channels and sources, including (1) e-liquid and disposable brands sold in web-based stores, (2) e-cigarette brands sold in brick-and-mortar stores and collected by the Nielsen Retail Scanner Data, (3) e-cigarette brands compiled by Wikipedia, (4) self-reported e-cigarette brands from the 2020 International Tobacco Control Four-Country Smoking and Vaping (ITC 4CV) US survey, and (5) e-cigarette brands on Twitter. We also estimated the top 5 e-cigarette brands by sales volume in brick-and-mortar stores, by the frequency and variety of offerings in web-based shops, and by the frequency of self-reported brands from the 2020 ITC 4CV US survey. Results: As of 2020-2022, a total of 912 e-cigarette brands have been sold by various retail channels. During 2020-2022, the top 5 brands are JUUL, vuse, njoy, blu, and logic in brick-and-mortar stores; blu, king, monster, twist, and air factory for e-liquids in web-based stores; hyde, pod mesh, suorin, vaporlax, and xtra for disposables sold in web-based stores; and smok, aspire, vaporesso, innokin, and eleaf based on self-reported survey data. Conclusions: As the US Food and Drug Administration enforces the premarket tobacco market authorization, many e-cigarette brands may become illegal in the US market. In this context, how e-cigarette brands evolve and consolidate in different retail channels will be critical for understanding the regulatory impacts on product availability. Our semantic database of e-cigarette brands can serve as a useful tool to monitor product and marketplace development, conduct compliance checks, assess manufacturers’ marketing behaviors, and identify regulatory impacts. %M 38416562 %R 10.2196/47570 %U https://formative.jmir.org/2024/1/e47570 %U https://doi.org/10.2196/47570 %U http://www.ncbi.nlm.nih.gov/pubmed/38416562 %0 Journal Article %@ 2561-1011 %I JMIR Publications %V 8 %N %P e54530 %T Feasibility of Using Text Messaging to Identify and Assist Patients With Hypertension With Health-Related Social Needs: Cross-Sectional Study %A Kormanis,Aryn %A Quinones,Selina %A Obermiller,Corey %A Denizard-Thompson,Nancy %A Palakshappa,Deepak %+ Department of Internal Medicine, Wake Forest University School of Medicine, Medical Center Blvd, Winston Salem, NC, 27157, United States, 1 3367161795, dpalaksh@wakehealth.edu %K social determinants of health %K health-related social needs %K mobile health %K health information technology %K feasibility %K mobile phone %K SMS text messaging %K message %K pilot study %K patients %K patient %K hypertension %K screening %D 2024 %7 13.2.2024 %9 Original Paper %J JMIR Cardio %G English %X Background: Health-related social needs are associated with poor health outcomes, increased acute health care use, and impaired chronic disease management. Given these negative outcomes, an increasing number of national health care organizations have recommended that the health system screen and address unmet health-related social needs as a routine part of clinical care, but there are limited data on how to implement social needs screening in clinical settings to improve the management of chronic diseases such as hypertension. SMS text messaging could be an effective and efficient approach to screen patients; however, there are limited data on the feasibility of using it. Objective: We conducted a cross-sectional study of patients with hypertension to determine the feasibility of using SMS text messaging to screen patients for unmet health-related social needs. Methods: We randomly selected 200 patients (≥18 years) from 1 academic health system. Patients were included if they were seen at one of 17 primary care clinics that were part of the academic health system and located in Forsyth County, North Carolina. We limited the sample to patients seen in one of these clinics to provide tailored information about local community-based resources. To ensure that the participants were still patients within the clinic, we only included those who had a visit in the previous 3 months. The SMS text message included a link to 6 questions regarding food, housing, and transportation. Patients who screened positive and were interested received a subsequent message with information about local resources. We assessed the proportion of patients who completed the questions. We also evaluated for the differences in the demographics between patients who completed the questions and those who did not using bivariate analyses. Results: Of the 200 patients, the majority were female (n=109, 54.5%), non-Hispanic White (n=114, 57.0%), and received commercial insurance (n=105, 52.5%). There were no significant differences in demographics between the 4446 patients who were eligible and the 200 randomly selected patients. Of the 200 patients included, the SMS text message was unable to be delivered to 9 (4.5%) patients and 17 (8.5%) completed the social needs questionnaire. We did not observe a significant difference in the demographic characteristics of patients who did versus did not complete the questionnaire. Of the 17, a total of 5 (29.4%) reported at least 1 unmet need, but only 2 chose to receive resource information. Conclusions: We found that only 8.5% (n=17) of patients completed a SMS text message–based health-related social needs questionnaire. SMS text messaging may not be feasible as a single modality to screen patients in this population. Future research should evaluate if SMS text message–based social needs screening is feasible in other populations or effective when paired with other screening modalities. %M 38349714 %R 10.2196/54530 %U https://cardio.jmir.org/2024/1/e54530 %U https://doi.org/10.2196/54530 %U http://www.ncbi.nlm.nih.gov/pubmed/38349714 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e50735 %T Evaluating the Appropriateness of Podcasts to Improve the Knowledge and Awareness of Selected Health Topics Among Undergraduate General Nursing Students: Protocol for an International Feasibility Study %A Denny,Alanna %A Curtin,Brian %A Taylor-Robinson,Simon %A Chirambo,Griphin Baxter %A Cilliers,Liezel %A Wu,Tsung-Shu Joseph %A O'Meara,Ciara %A Booth,Richard %A O'Donoghue,John %+ Imperial College London, Electrical Engineering, South Kensington Campus, London, SW7 2AZ, United Kingdom, 44 203 312 6199, s.taylor-robinson@imperial.ac.uk %K podcasting %K podcast %K nursing student %K gestational diabetes %K mental health %K health %K knowledge %D 2024 %7 6.2.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: Podcasts have proven to be a successful alternative source of educational material for students. Given the ability to listen to podcasts 24/7 and while on the go, this technology has the potential to provide informative and educational material to a large number of people at any given time. Podcasts are usually freely available on commonly used mobile devices, such as smartphones, laptops, and tablets. Objective: This paper describes the impact of health-related podcasts as an intervention tool to support the knowledge and awareness of nursing students on a given topic. Methods: Pre- and postpodcast questionnaires will gather data regarding the participants’ knowledge and awareness of two topics—gestational diabetes and mental health. This intervention will be tested on general nursing undergraduate students. The total number of students (N=2395) from the participating universities are broken down as follows: (1) University College Cork (n=850) and the University of Galway (n=450) in Ireland, (2) Mzuzu University in Malawi (n=719), and (3) University of Fort Hare in South Africa (n=376). Results: The study received ethical approval from the University College Cork Ethics Committee (2022-027A1). The approval obtained from University College Cork sufficed as ethics coverage for the University of Galway in Ireland. Ethics approval was also received from the Mzuzu University Research Ethics Committee (ID MZUNIREC/DOR/23/28) and the Inter-Faculty Research Ethics Committee of the University of Fort Hare (ID CIL002-21). Data collection is currently underway and will continue until the end of February 2024. The quantitative and qualitative data are expected to be analyzed in March 2024. Conclusions: Results from this study will allow for an investigation into the impact of podcasts in different settings: a high-income country (Ireland), an upper-middle–income country (South Africa), and a low-to-middle–income country (Malawi). The data gathered from this feasibility study will provide more clarity on the potential utility of podcasts as an intervention tool. We will gather data regarding listener demographics (eg, country of residence, age, gender, and year of study). International Registered Report Identifier (IRRID): DERR1-10.2196/50735 %M 38319702 %R 10.2196/50735 %U https://www.researchprotocols.org/2024/1/e50735 %U https://doi.org/10.2196/50735 %U http://www.ncbi.nlm.nih.gov/pubmed/38319702 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e52560 %T Mental Health and Well-Being in Racial or Ethnic Minority Individuals After Using a Faith and Prayer Mobile App (Pray.com): Feasibility and Preliminary Efficacy Trial %A Laird,Breanne %A Zuniga,Sabrina %A Hook,Joshua N %A Van Tongeren,Daryl R %A Joeman,Lynda %A Huberty,Jennifer %+ Pray, Inc, 4607 Lakeview Canyon Rd #456, Westlack Village, CA, 91361, United States, 1 9095574002, breanne.laird@pray.com %K religion %K spirituality %K mobile apps %K mental health %K well-being %K app %K ethnic %K technology %K engagement %K stress %K depression %K anxiety %K quality of life %K spiritual well-being %K racial %K spiritual practices %K spiritual practice %K mobile phone %K mobile health %K mHealth %D 2024 %7 2.2.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Research is needed on how faith and prayer apps fit within the values of racial and ethnic minority (REM) groups, as well as whether such apps are effective in promoting mental health and well-being. Objective: This study aims to determine the feasibility and preliminary effectiveness of using the mobile app Pray.com on mental health and well-being among REM participants. Methods: This study was a single-group (N=77), 4-week feasibility trial in REM groups (65/77, 84% Black or African American). Participants were asked to use the Pray.com app at no cost for at least 5 times per week for 5 minutes per day. Participants completed questionnaires at the baseline and postintervention time points. Feasibility questionnaires were only completed at the postintervention time point, including qualitative interviews (n=15). The feasibility questions included acceptability (ie, satisfaction, intent to continue use, perceived appropriateness, and fit within culture), demand (ie, self-reported app use, expressed interest, and perceived demand), and practicality (ie, ease or difficulty of use, ability to use the app, and cost-effectiveness). Frequency and descriptive statistics were used to analyze feasibility outcomes. Changes in dependent variables were analyzed using paired-sample 2-tailed t tests. Partial correlations were conducted to explore the association between app use and outcomes, controlling for baseline scores. Results: Participants reported (54/72, 75% responded with “very likely” or “likely” to the feasibility questions) that they perceived the Pray.com app as acceptable. These findings were supported by qualitative interviews (n=15). Most participants (62/72, 86%) did not meet the app use prescription but expressed interest in using the app in the future and perceived demand for it in their communities. In addition, participants reported that the app was easy to use and perceived it to be inexpensive (US $7.99). Participants reported improved mental health (ie, stress and depressive and anxiety symptoms) and well-being (ie, satisfaction with life, spiritual well-being, religious commitment, and racial or ethnic identity development) at postintervention despite relatively low average levels and high variability of app use (average total of 45.83, SD 111.90 min over the course of the study). Greater app use was significantly associated with improvements in mental health and spiritual well-being. However, app use and study methodology limitations suggest that the study results may not accurately capture the full impact of Pray.com use. Conclusions: This is the first study to assess the feasibility of a faith and prayer app for mental health and well-being in a sample of REM individuals. Our findings suggest that the use of a faith and prayer app (ie, Pray.com) could be feasible and significantly impactful for the improvement of mental health symptoms and well-being in REM individuals and their communities, especially Black and African American individuals with a Christian affiliation. Further research is warranted. %M 38306173 %R 10.2196/52560 %U https://formative.jmir.org/2024/1/e52560 %U https://doi.org/10.2196/52560 %U http://www.ncbi.nlm.nih.gov/pubmed/38306173 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e45506 %T Telephone-Based Training Intervention for Using Digital Communication Technologies for Social Housing Residents During the COVID-19 Pandemic: Mixed Methods Feasibility and Acceptability Evaluation %A Walker,Tim %A Buckingham,Sarah Ann %A Poole,Ria %A Elliott,Lewis Roland %A Menneer,Tamaryn %A Tu,Gengyang %A Morrissey,Karyn %+ European Centre for Environment and Human Health, University of Exeter Medical School, Knowledge Spa, Truro, TR1 3HD, United Kingdom, 44 (0) 1872 258131, t.w.walker@exeter.ac.uk %K digital training %K telephone-based %K social housing %K feasibility %K acceptability %K communication technologies %K sociodigital inequalities %K mobile phone %D 2024 %7 26.1.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: In an era in which digital communication technologies play a pivotal role in everyday life, social housing residents remain highly susceptible to digital exclusion. Objective: This study aims to evaluate the feasibility and acceptability of a telephone-based training intervention designed to empower people to confidently use digital communication technologies (ie, video calls and web-based messaging). Methods: Conducted in collaboration with a UK social housing association, the intervention was facilitated by a unitary authority’s Digital Inclusion Team during the COVID-19 pandemic. A mixed methods approach was used, encompassing quantitative and qualitative data collection on demand, reach, implementation, and potential outcomes. Demographic and qualitative data on the reasons for undertaking or not undertaking the training were collected via telephone interviews during the recruitment process. Digital competency and well-being data were collected via a self-reported survey before and after the intervention. Results: Among the 4485 residents who were offered training, 67 (1.49%) expressed interest, of whom 12 (18%) of the 67 completed the training. The findings indicate a demand for basic digital training among social housing residents. The key findings revolve around the substantial dropout rate among those who were interested in undertaking the training. Barriers were strongly influenced by socioeconomic and health circumstances, reflecting the sociodigital inequalities commonly found in this group. For the training participants, the intervention was acceptable and achieved its goals, demonstrating the potential of tailored, persistent training efforts in overcoming barriers. There were no changes in self-reported well-being or digital competency outcomes (but this was limited by the small sample size). Conclusions: Sociodigital inequalities impact the reach, implementation, and acceptability of telephone-based digital training for social housing residents. Barriers to reaching and training digitally excluded groups can be overcome through the use of trusted intermediaries, personalized recruitment approaches, the minimization of administrative barriers, and tailored and agile training programs. Recognizing the resource-intensive nature of such initiatives, this study calls for enhanced recognition of intermediary efforts in national digital inclusion policies. %M 38277209 %R 10.2196/45506 %U https://formative.jmir.org/2024/1/e45506 %U https://doi.org/10.2196/45506 %U http://www.ncbi.nlm.nih.gov/pubmed/38277209 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e47157 %T A Bluetooth-Enabled Device for Real-Time Detection of Sitting, Standing, and Walking: Cross-Sectional Validation Study %A Daryabeygi-Khotbehsara,Reza %A Rawstorn,Jonathan C %A Dunstan,David W %A Shariful Islam,Sheikh Mohammed %A Abdelrazek,Mohamed %A Kouzani,Abbas Z %A Thummala,Poojith %A McVicar,Jenna %A Maddison,Ralph %+ Institute for Physical Activity and Nutrition, School of Exercise and Nutrition Sciences, Deakin University, 221 Burwood Hw, Melbourne Burwood, 3125, Australia, 61 3 924 45936, reza.d@deakin.edu.au %K activity tracker %K algorithms %K deep neural network %K machine learning %K real-time data %K Sedentary behaviOR Detector %K sedentary behavior %K SORD %K standing %K validation %K walking %K wearables %D 2024 %7 24.1.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: This study assesses the accuracy of a Bluetooth-enabled prototype activity tracker called the Sedentary behaviOR Detector (SORD) device in identifying sedentary, standing, and walking behaviors in a group of adult participants. Objective: The primary objective of this study was to determine the criterion and convergent validity of SORD against direct observation and activPAL. Methods: A total of 15 healthy adults wore SORD and activPAL devices on their thighs while engaging in activities (lying, reclining, sitting, standing, and walking). Direct observation was facilitated with cameras. Algorithms were developed using the Python programming language. The Bland-Altman method was used to assess the level of agreement. Results: Overall, 1 model generated a low level of bias and high precision for SORD. In this model, accuracy, sensitivity, and specificity were all above 0.95 for detecting sitting, reclining, standing, and walking. Bland-Altman results showed that mean biases between SORD and direct observation were 0.3% for sitting and reclining (limits of agreement [LoA]=–0.3% to 0.9%), 1.19% for standing (LoA=–1.5% to 3.42%), and –4.71% for walking (LoA=–9.26% to –0.16%). The mean biases between SORD and activPAL were –3.45% for sitting and reclining (LoA=–11.59% to 4.68%), 7.45% for standing (LoA=–5.04% to 19.95%), and –5.40% for walking (LoA=–11.44% to 0.64%). Conclusions: Results suggest that SORD is a valid device for detecting sitting, standing, and walking, which was demonstrated by excellent accuracy compared to direct observation. SORD offers promise for future inclusion in theory-based, real-time, and adaptive interventions to encourage physical activity and reduce sedentary behavior. %M 38265864 %R 10.2196/47157 %U https://formative.jmir.org/2024/1/e47157 %U https://doi.org/10.2196/47157 %U http://www.ncbi.nlm.nih.gov/pubmed/38265864 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e48992 %T Acceptability and Feasibility of a Smartphone-Based Real-Time Assessment of Suicide Among Black Men: Mixed Methods Pilot Study %A Adams,Leslie B %A Watts,Thomasina %A DeVinney,Aubrey %A Haroz,Emily E %A Thrul,Johannes %A Stephens,Jasmin Brooks %A Campbell,Mia N %A Antoine,Denis %A Lê Cook,Benjamin %A Joe,Sean %A Thorpe Jr,Roland J %+ Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, 624 N. Broadway, Baltimore, MD, 21205, United States, 1 410 955 1906, ladams36@jhu.edu %K Black men %K suicide %K ecological momentary assessment %K feasibility %K acceptability %K mixed methods %K smartphone %K real-time assessment %K suicide prevention %K user experience %K behavior %K implementation %K intervention %K mobile phone %D 2024 %7 22.1.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Suicide rates in the United States have increased recently among Black men. To address this public health crisis, smartphone-based ecological momentary assessment (EMA) platforms are a promising way to collect dynamic, real-time data that can help improve suicide prevention efforts. Despite the promise of this methodology, little is known about its suitability in detecting experiences related to suicidal thoughts and behavior (STB) among Black men. Objective: This study aims to clarify the acceptability and feasibility of using smartphone-based EMA through a pilot study that assesses the user experience among Black men. Methods: We recruited Black men aged 18 years and older using the MyChart patient portal messaging (the patient-facing side of the Epic electronic medical record system) or outpatient provider referrals. Eligible participants self-identified as Black men with a previous history of STB and ownership of an Android or iOS smartphone. Eligible participants completed a 7-day smartphone-based EMA study. They received a prompt 4 times per day to complete a brief survey detailing their STB, as well as proximal risk factors, such as depression, social isolation, and feeling like a burden to others. At the conclusion of each day, participants also received a daily diary survey detailing their sleep quality and their daily experiences of everyday discrimination. Participants completed a semistructured exit interview of 60-90 minutes at the study’s conclusion. Results: In total, 10 participants completed 166 EMA surveys and 39 daily diary entries. A total of 4 of the 10 participants completed 75% (21/28) or more of the EMA surveys, while 9 (90%) out of 10 completed 25% (7/28) or more. The average completion rate of all surveys was 58% (20.3/35), with a minimum of 17% (6/35) and maximum of 100% (35/35). A total of 4 (40%) out of 10 participants completed daily diary entries for the full pilot study. No safety-related incidents were reported. On average, participants took 2.08 minutes to complete EMA prompts and 2.72 minutes for daily diary surveys. Our qualitative results generally affirm the acceptability and feasibility of the study procedures, but the participants noted difficulties with the technology and the redundancy of the survey questions. Emerging themes also addressed issues such as reduced EMA survey compliance and diminished mood related to deficit-framed questions related to suicide. Conclusions: Findings from this study will be used to clarify the suitability of EMA for Black men. Overall, our EMA pilot study demonstrated mixed feasibility and acceptability when delivered through smartphone-based apps to Black men. Specific recommendations are provided for managing safety within these study designs and for refinements in future intervention and implementation science research. International Registered Report Identifier (IRRID): RR2-10.2196/31241 %M 38252475 %R 10.2196/48992 %U https://formative.jmir.org/2024/1/e48992 %U https://doi.org/10.2196/48992 %U http://www.ncbi.nlm.nih.gov/pubmed/38252475 %0 Journal Article %@ 2291-9694 %I JMIR Publications %V 12 %N %P e51925 %T Predicting Depression Risk in Patients With Cancer Using Multimodal Data: Algorithm Development Study %A de Hond,Anne %A van Buchem,Marieke %A Fanconi,Claudio %A Roy,Mohana %A Blayney,Douglas %A Kant,Ilse %A Steyerberg,Ewout %A Hernandez-Boussard,Tina %+ Department of Medicine (Biomedical Informatics), Stanford Medicine, Stanford University, 1265 Welch Road, Stanford, CA, 94305, United States, 1 650 725 5507, boussard@stanford.edu %K natural language processing %K machine learning %K artificial intelligence %K oncology %K depression %K clinical decision support %K decision support %K cancer %K patients with cancer %K chemotherapy %K mental health %K prediction model %K depression risk %K cancer treatment %K radiotherapy %K diagnosis %K validation %K cancer care %K care %D 2024 %7 18.1.2024 %9 Original Paper %J JMIR Med Inform %G English %X Background: Patients with cancer starting systemic treatment programs, such as chemotherapy, often develop depression. A prediction model may assist physicians and health care workers in the early identification of these vulnerable patients. Objective: This study aimed to develop a prediction model for depression risk within the first month of cancer treatment. Methods: We included 16,159 patients diagnosed with cancer starting chemo- or radiotherapy treatment between 2008 and 2021. Machine learning models (eg, least absolute shrinkage and selection operator [LASSO] logistic regression) and natural language processing models (Bidirectional Encoder Representations from Transformers [BERT]) were used to develop multimodal prediction models using both electronic health record data and unstructured text (patient emails and clinician notes). Model performance was assessed in an independent test set (n=5387, 33%) using area under the receiver operating characteristic curve (AUROC), calibration curves, and decision curve analysis to assess initial clinical impact use. Results: Among 16,159 patients, 437 (2.7%) received a depression diagnosis within the first month of treatment. The LASSO logistic regression models based on the structured data (AUROC 0.74, 95% CI 0.71-0.78) and structured data with email classification scores (AUROC 0.74, 95% CI 0.71-0.78) had the best discriminative performance. The BERT models based on clinician notes and structured data with email classification scores had AUROCs around 0.71. The logistic regression model based on email classification scores alone performed poorly (AUROC 0.54, 95% CI 0.52-0.56), and the model based solely on clinician notes had the worst performance (AUROC 0.50, 95% CI 0.49-0.52). Calibration was good for the logistic regression models, whereas the BERT models produced overly extreme risk estimates even after recalibration. There was a small range of decision thresholds for which the best-performing model showed promising clinical effectiveness use. The risks were underestimated for female and Black patients. Conclusions: The results demonstrated the potential and limitations of machine learning and multimodal models for predicting depression risk in patients with cancer. Future research is needed to further validate these models, refine the outcome label and predictors related to mental health, and address biases across subgroups. %M 38236635 %R 10.2196/51925 %U https://medinform.jmir.org/2024/1/e51925 %U https://doi.org/10.2196/51925 %U http://www.ncbi.nlm.nih.gov/pubmed/38236635 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e46367 %T Preoperative Virtual Reality to Expose Patients With Breast Cancer to the Operating Room Environment: Feasibility and Pilot Case Series Study %A Sommer,Jordana L %A Reynolds,Kristin %A Hebbard,Pamela %A Smith,Michael S D %A Mota,Natalie %A Mutch,W Alan C %A Maples-Keller,Jessica %A Roos,Leslie %A El-Gabalawy,Renée %+ Department of Anesthesiology, Perioperative and Pain Medicine, University of Manitoba, AE207 Harry Medovy House, 671 William Avenue, Winnipeg, MB, R3E 0Z2, Canada, 1 204 787 4713, sommerj@myumanitoba.ca %K virtual reality %K preoperative anxiety and distress %K breast cancer surgery %K anesthesia %K feasibility %K pilot %D 2024 %7 17.1.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Clinically elevated preoperative distress and anxiety are common among patients undergoing cancer surgery. Preoperative interventions have been developed to mitigate this distress and anxiety but are inconsistent in efficacy and feasibility for broad implementation. Objective: This preliminary pilot study aims to assess the feasibility and utility of a newly developed virtual reality (VR) intervention to expose patients awaiting breast cancer surgery to the operating room environment and a simulation of anesthetic induction. Methods: Patients undergoing breast cancer surgery (N=7) were assigned to the VR intervention or control (treatment as usual) group and completed self-report measures of distress and anxiety before surgery, on the day of surgery, and after surgery (5 and 30 d postoperatively). Those in the intervention group trialed the VR simulation 1 to 2 weeks preoperatively and provided qualitative and quantitative feedback. We assessed the feasibility of recruitment capability and study design and evaluated participants’ impressions of the intervention using self-report rating scales and open-ended questions. We also descriptively examined distress and anxiety levels throughout the duration of the study. Results: Recruitment occurred between December 2021 and December 2022 and progressed slowly (rate: 1 participant/7 wk on average; some hesitancy because of stress and being overwhelmed). All participants who consented to participate completed the entire study. All participants were female and aged 56 (SD 10.56) years on average. In total, 57% (4/7) of the participants were assigned to the intervention group. On average, intervention participants spent 12 minutes engaged in the VR simulation. In general, the intervention was rated favorably (eg, clear information, enjoyable, and attractive presentation; mean% agreement 95.00-96.25, SD 4.79-10.00) and as helpful (mean% agreement 87.50, SD 25.00). Participants described the intervention as realistic (eg, “It was realistic to my past surgical experiences”), impacting their degree of preparedness and expectations for surgery (eg, “The sounds and sights and procedures give you a test run; they prepare you for the actual day”), and having a calming or relaxing effect (eg, “You feel more relaxed for the surgery”). Conclusions: This preoperative VR intervention demonstrated preliminary feasibility among a sample of patients undergoing breast cancer surgery. Results and participant feedback will inform modifications to the VR intervention and the study design of a large-scale randomized controlled trial to examine the efficacy of this intervention. Trial Registration: ClinicalTrials.gov NCT04544618; https://clinicaltrials.gov/study/NCT04544618 %M 38231570 %R 10.2196/46367 %U https://formative.jmir.org/2024/1/e46367 %U https://doi.org/10.2196/46367 %U http://www.ncbi.nlm.nih.gov/pubmed/38231570 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e46284 %T Feasibility and Acceptability of a Mobile Technology Intervention to Support Postabortion Care After Surgical Abortion (the FACTS Study Phase 3): Mixed Methods Prospective Pilot Study %A Gill,Roopan %A Ogilvie,Gina %A Norman,Wendy V %A Fitzsimmons,Brian %A Maher,Ciana %A Renner,Regina %+ Department of Obstetrics and Gynecology, University of Toronto, 123 Edward Street, Suite 1200, Toronto, ON, M5G1E2, Canada, 1 4169782216, roopan.gill@gmail.com %K mobile health %K mHealth %K digital health %K abortion %K human-centered design %K sexual and reproductive health %K qualitative research %K mixed methods %D 2024 %7 9.1.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: In Canada, 1 in 3 women and people of gestational age undergo an abortion in their lifetime. Despite the liberal legal context, barriers continue to exist for women and people who can become pregnant to access this service. Objective: This study aims to (1) conduct a pilot study to demonstrate the feasibility and acceptability of myPostCare to support follow-up care after a procedural abortion; (2) use the findings to understand whether myPostCare has the potential to improve contraceptive behavior and knowledge, emotional well-being, and sexual health knowledge; and (3) develop a better understanding of how innovative mobile solutions can support integrative health programs in British Columbia with the goal of expanding to other sites across Canada. Methods: People of gestational age (aged 14-45 y) who underwent a procedural abortion were recruited from 2 urban abortion facilities in British Columbia. The participants completed a baseline quantitative survey and were provided access to myPostCare for up to 30 days. A follow-up quantitative survey was sent via email on day 30. Qualitative interviews were conducted to explore user satisfaction and usability of myPostCare. Responses to the survey questions were summarized using descriptive statistics, and the system usability scale (SUS) was scored according to the instructions. A secure analytics platform was implemented to obtain data on the overall use of the website by users. Qualitative analysis was conducted with NVivo using a thematic analysis approach. This study was approved by the Women’s and Children’s Research Ethics Board. Results: Overall, 62 participants were recruited (average age 30 y); 40% (25/62) of the participants completed the exit surveys, and 24% (6/25) consented to participate in the semistructured interviews; 40 participants had undergone an immediate postabortion intrauterine device (IUD) insertion, and 22 did not have an IUD inserted. Participants were satisfied with myPostCare. The SUS average score was 81.5 (SD 9.7; median 82.5, IQR 77.5-87.5), indicating high usability of the tool. Overall, 88% (22/25) of the participants changed their contraceptive method to an IUD. Web-based analytics demonstrated that there were 61 unique visitors to the site, and the top pages visited were Postprocedure Care, Emotional Well-Being, and Contraception Explorer. The longest time spent on the website was 56 minutes. The overall email open rate was 80%, with a click rate of 36%. Conclusions: This study demonstrates that communities and individuals are important collaborators in developing a mobile innovation that facilitates access to high-quality patient-centered abortion care. Through the cocreation process, a digital platform such as myPostCare highlighted a gap in abortion care in Canada, particularly around follow-up support after a procedural abortion. %M 38194252 %R 10.2196/46284 %U https://formative.jmir.org/2024/1/e46284 %U https://doi.org/10.2196/46284 %U http://www.ncbi.nlm.nih.gov/pubmed/38194252 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e46413 %T Identification of Hypertension in Electronic Health Records Through Computable Phenotype Development and Validation for Use in Public Health Surveillance: Retrospective Study %A Valvi,Nimish %A McFarlane,Timothy %A Allen,Katie S %A Gibson,P Joseph %A Dixon,Brian Edward %+ Department of Health Policy & Management, Fairbanks School of Public Health, Indiana University, 1050 Wishard Blvd, RG 5000, Indianapolis, IN, 46202, United States, 1 317 278 3072, bedixon@regenstrief.org %K computable phenotypes %K electronic health records %K health information exchange %K hypertension %K population surveillance %K public health informatics %D 2023 %7 27.12.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Electronic health record (EHR) systems are widely used in the United States to document care delivery and outcomes. Health information exchange (HIE) networks, which integrate EHR data from the various health care providers treating patients, are increasingly used to analyze population-level data. Existing methods for population health surveillance of essential hypertension by public health authorities may be complemented using EHR data from HIE networks to characterize disease burden at the community level. Objective: We aimed to derive and validate computable phenotypes (CPs) to estimate hypertension prevalence for population-based surveillance using an HIE network. Methods: Using existing data available from an HIE network, we developed 6 candidate CPs for essential (primary) hypertension in an adult population from a medium-sized Midwestern metropolitan area in the United States. A total of 2 independent clinician reviewers validated the phenotypes through a manual chart review of 150 randomly selected patient records. We assessed the precision of CPs by calculating sensitivity, specificity, positive predictive value (PPV), F1-score, and validity of chart reviews using prevalence-adjusted bias-adjusted κ. We further used the most balanced CP to estimate the prevalence of hypertension in the population. Results: Among a cohort of 548,232 adults, 6 CPs produced PPVs ranging from 71% (95% CI 64.3%-76.9%) to 95.7% (95% CI 84.9%-98.9%). The F1-score ranged from 0.40 to 0.91. The prevalence-adjusted bias-adjusted κ revealed a high percentage agreement of 0.88 for hypertension. Similarly, interrater agreement for individual phenotype determination demonstrated substantial agreement (range 0.70-0.88) for all 6 phenotypes examined. A phenotype based solely on diagnostic codes possessed reasonable performance (F1-score=0.63; PPV=95.1%) but was imbalanced with low sensitivity (47.6%). The most balanced phenotype (F1-score=0.91; PPV=83.5%) included diagnosis, blood pressure measurements, and medications and identified 210,764 (38.4%) individuals with hypertension during the study period (2014-2015). Conclusions: We identified several high-performing phenotypes to identify essential hypertension prevalence for local public health surveillance using EHR data. Given the increasing availability of EHR systems in the United States and other nations, leveraging EHR data has the potential to enhance surveillance of chronic disease in health systems and communities. Yet given variability in performance, public health authorities will need to decide whether to seek optimal balance or declare a preference for algorithms that lean toward sensitivity or specificity to estimate population prevalence of disease. %M 38150296 %R 10.2196/46413 %U https://formative.jmir.org/2023/1/e46413 %U https://doi.org/10.2196/46413 %U http://www.ncbi.nlm.nih.gov/pubmed/38150296 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e47222 %T Minimally Invasive Posterior Spinal Nonfusion Surgery in Patients With Adolescent Idiopathic Scoliosis Using a Bipolar One-Way Self-Expanding Rod System: Protocol for a Single-Center Clinical Cohort Study %A Post,Anne Mareille %A Berends,Hanneke I %A van Royen,Barend J %+ Department of Orthopedic Surgery and Sports Medicine, University Medical Center Amsterdam, room K1-207, Meibergdreef 9, Amsterdam, 1105 AZ, Netherlands, 31 205662672, a.m.post@amsterdamumc.nl %K adolescent idiopathic scoliosis %K minimally invasive %K nonfusion %K posterior spinal surgery %K protocol %K one-way self-expanding rod %K scoliosis %K idiopathic scoliosis %K spinal fusion %K spinal deformity surgery %K nonfusion techniques %K surgery %K intraoperative %K surgical technique %K operation %K musculoskeletal %K orthopedic %D 2023 %7 25.12.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: The current surgical treatment for patients diagnosed with progressive and severe adolescent idiopathic scoliosis (AIS) consists of the correction of the spinal curvature, followed by posterior spinal fusion (PSF). However, research has uncovered short- and long-term complications of posterior spinal fusion in patients with AIS. Minimally invasive growing rod techniques have successfully been used to treat patients with early-onset scoliosis and neuromuscular scoliosis. It may be questioned if minimally invasive posterior spinal nonfusion (PSnF) surgery with bipolar instrumentation can be used for the treatment of AIS. Objective: This study will be performed to monitor the efficacy and safety of PSnF surgery by using a commercially available Conformité Européenne-certified spinal implant consisting of bilateral bipolar one-way self-expanding rods (OWSER) for the treatment of patients diagnosed with AIS. Methods: In 14 selected patients with AIS with Lenke 1-6 curves, minimally invasive PSnF surgery with the OWSER system is performed after the failure of conservative treatment (curve progression of >5° within 1 year). The patients are over 7 years of age, with a major Cobb angle of ≥30°, sufficient flexibility, and a Risser stage of ≤2. Patients will be followed over time, according to the standard medical care. Efficacy will be measured using radiological and patient satisfaction assessments and safety will be determined by the amount of perioperative complications. Results: Patient inclusion started on November 17, 2021 and we hope to finalize patient inclusion by the beginning of 2025. The first results will be expected by the beginning of 2024. Conclusions: Minimally invasive PSnF in patients with AIS is presented as a less invasive surgical technique that prevents the progression of the scoliotic curve and that allows minor posture correction of coronal imbalance. This will be the first study to examine whether the PSnF bipolar OWSER instrumentation will be the next generation of surgical instrumentation in AIS. Trial Registration: ClinicalTrials.gov NCT04441411; https://clinicaltrials.gov/study/NCT04441411 International Registered Report Identifier (IRRID): DERR1-10.2196/47222 %M 38145474 %R 10.2196/47222 %U https://www.researchprotocols.org/2023/1/e47222 %U https://doi.org/10.2196/47222 %U http://www.ncbi.nlm.nih.gov/pubmed/38145474 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e51202 %T Assessing Facilitator Fidelity to Principles of Public Deliberation: Tutorial %A Draucker,Claire %A Carrión,Andrés %A Ott,Mary A %A Knopf,Amelia %+ School of Nursing, Indiana University, 600 Barnhill Drive, Indianapolis, IN, 46201, United States, 1 317 274 2285, asknopf@iu.edu %K public deliberation %K deliberative democracy %K bioethics %K engagement %K theory %K process %K ethical conflict %K ethical %K ethics %K coding %K evaluation %K tutorial %K biomedical %K HIV %K HIV prevention %K HIV research %D 2023 %7 13.12.2023 %9 Tutorial %J JMIR Form Res %G English %X Public deliberation, or deliberative democracy, is a method used to elicit informed perspectives and justifiable solutions to ethically fraught or contentious issues that affect multiple stakeholder groups with conflicting interests. Deliberative events bring together stakeholders (deliberants) who are provided with empirical evidence on the central issue or concern and then asked to discuss the evidence, consider the issue from a societal perspective, and collectively work toward a justifiable resolution. There is increasing interest in this method, which warrants clear guidance for evaluating the quality of its use in research. Most of the existing literature on measuring deliberation quality emphasizes the quality of deliberants’ inputs (eg, engagement and evidence of compromise) during deliberative sessions. Fewer researchers have framed quality in terms of facilitator inputs, and these researchers tend to examine inputs that are consistent with generic group processes. The theory, process, and purpose of public deliberation, however, are distinct from those of focus groups or other group-based discussions and warrant a mechanism for measuring quality in terms of facilitator fidelity to the principles and processes of deliberative democracy. In our public deliberation on ethical conflicts in minor consent for biomedical HIV prevention research, we assessed facilitator fidelity to these principles and processes because we believe that such assessments serve as a component of a comprehensive evaluation of overall deliberation quality. We examined verbatim facilitator remarks in the deliberation transcripts and determined whether they aligned with the 6 principles of public deliberation: equal participation, respect for the opinions of others, adoption of a societal perspective, reasoned justification of ideas, expression of diverse opinions, and compromise or movement toward consensus. In this tutorial, we describe the development of a blueprint to guide researchers in assessing facilitator fidelity, share 3 templates that will assist them in the task, and describe the results of our assessment of facilitator fidelity in 1 of the 4 sites in which we conducted deliberations. %M 38090788 %R 10.2196/51202 %U https://formative.jmir.org/2023/1/e51202 %U https://doi.org/10.2196/51202 %U http://www.ncbi.nlm.nih.gov/pubmed/38090788 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e50797 %T Transformation and Articulation of Clinical Data to Understand Students’ and Health Professionals’ Clinical Reasoning: Protocol for a Scoping Review %A Deschênes,Marie-France %A Fernandez,Nicolas %A Lechasseur,Kathleen %A Caty,Marie-Ève %A Azimzadeh,Dina %A Mai,Tue-Chieu %A Lavoie,Patrick %+ Faculté des sciences infirmières, Université de Montréal, C. P. 6128, succ. Centre-Ville, Montréal, QC, H3C 3J7, Canada, 1 514 343 6111 ext 6879, marie-france.deschenes@umontreal.ca %K clinical reasoning %K semantic qualifiers %K discourse %K linguistics %K education %K natural language processing %K scoping review %K clinical data %K educational strategy %K student %K health care professional %K semantic transformation %D 2023 %7 13.12.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: There are still unanswered questions regarding effective educational strategies to promote the transformation and articulation of clinical data while teaching and learning clinical reasoning. Additionally, understanding how this process can be analyzed and assessed is crucial, particularly considering the rapid growth of natural language processing in artificial intelligence. Objective: The aim of this study is to map educational strategies to promote the transformation and articulation of clinical data among students and health care professionals and to explore the methods used to assess these individuals’ transformation and articulation of clinical data. Methods: This scoping review follows the Joanna Briggs Institute framework for scoping reviews and the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews) checklist for the analysis. A literature search was performed in November 2022 using 5 databases: CINAHL (EBSCOhost), MEDLINE (Ovid), Embase (Ovid), PsycINFO (Ovid), and Web of Science (Clarivate). The protocol was registered on the Open Science Framework in November 2023. The scoping review will follow the 9-step framework proposed by Peters and colleagues of the Joanna Briggs Institute. A data extraction form has been developed using key themes from the research questions. Results: After removing duplicates, the initial search yielded 6656 results, and study selection is underway. The extracted data will be qualitatively analyzed and presented in a diagrammatic or tabular form alongside a narrative summary. The review will be completed by February 2024. Conclusions: By synthesizing the evidence on semantic transformation and articulation of clinical data during clinical reasoning education, this review aims to contribute to the refinement of educational strategies and assessment methods used in academic and continuing education programs. The insights gained from this review will help educators develop more effective semantic approaches for teaching or learning clinical reasoning, as opposed to fragmented, purely symptom-based or probabilistic approaches. Besides, the results may suggest some ways to address challenges related to the assessment of clinical reasoning and ensure that the assessment tasks accurately reflect learners’ developing competencies and educational progress. International Registered Report Identifier (IRRID): DERR1-10.2196/50797 %M 38090795 %R 10.2196/50797 %U https://www.researchprotocols.org/2023/1/e50797 %U https://doi.org/10.2196/50797 %U http://www.ncbi.nlm.nih.gov/pubmed/38090795 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 11 %N %P e49135 %T Using Mobile Ecological Momentary Assessment to Understand Consumption and Context Around Online Food Delivery Use: Pilot Feasibility and Acceptability Study %A Jia,Si Si %A Allman-Farinelli,Margaret %A Roy,Rajshri %A Phongsavan,Philayrath %A Hyun,Karice %A Gibson,Alice Anne %A Partridge,Stephanie Ruth %+ School of Health Sciences, Faculty of Medicine and Health, The University of Sydney, Camperdown NSW 2006, Sydney, 2006, Australia, 61 2 8627 1697, sisi.jia@sydney.edu.au %K ecological momentary assessment %K mobile applications %K mobile apps %K feasibility studies %K online food delivery %K smartphone %K young adult %K adolescent %K food environment %K consumer behavior %K mobile phone %D 2023 %7 29.11.2023 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Mobile ecological momentary assessment (EMA) is a powerful tool for collecting real-time and contextual data from individuals. As our reliance on online technologies to increase convenience accelerates, the way we access food is changing. Online food delivery (OFD) services may further encourage unhealthy food consumption habits, given the high availability of energy-dense, nutrient-poor foods. We used EMA to understand the real-time effects of OFD on individuals’ food choices and consumption behaviors. Objective: The primary aims of this pilot study were to assess the feasibility and acceptability of using EMA in young users of OFD and compare 2 different EMA sampling methods. The secondary aims were to gather data on OFD events and their context and examine any correlations between demographics, lifestyle chronic disease risk factors, and OFD use. Methods: This study used EMA methods via a mobile app (mEMASense, ilumivu Inc). Existing users of OFD services aged 16 to 35 years in Australia who had access to a smartphone were recruited. Participants were randomly assigned to 1 of 2 groups: signal-contingent or event-contingent. The signal-contingent group was monitored over 3 days between 7 AM and 10 PM. They received 5 prompts each day to complete EMA surveys via the smartphone app. In contrast, the event-contingent group was monitored over 7 days and was asked to self-report any instance of OFD. Results: A total of 102 participants were analyzed, with 53 participants in the signal-contingent group and 49 participants in the event-contingent group. Compliance rates, indicating the feasibility of signal-contingent and event-contingent protocols, were similar at 72.5% (574/792) and 73.2% (251/343), respectively. Feedback from the participants suggested that the EMA app was not easy to use, which affected their acceptability of the study. Participants in the event-contingent group were 3.53 (95% CI 1.52-8.17) times more likely to have had an OFD event captured during the study. Pizza (23/124, 18.5%) and fried chicken (18/124, 14.5%) comprised a bulk of the 124 OFD orders captured. Most orders were placed at home (98/124, 79%) for 1 person (68/124, 54.8%). Age (incidence rate ratio 0.95, 95% CI 0.91-0.99; P=.03) and dependents (incidence rate ratio 2.01, 95% CI 1.16-3.49; P=.01) were significantly associated with the number of OFD events in a week after adjusting for gender, socioeconomic status, diet quality score, and perceived stress levels. Conclusions: This pilot study showed that EMA using an event-contingent sampling approach may be a better method to capture OFD events and context than signal-contingent sampling. The compliance rates showed that both sampling methods were feasible and acceptable. Although the findings from this study have gathered some insight on the consumption and context of OFD in young people, further studies are required to develop targeted interventions. %M 38019563 %R 10.2196/49135 %U https://mhealth.jmir.org/2023/1/e49135 %U https://doi.org/10.2196/49135 %U http://www.ncbi.nlm.nih.gov/pubmed/38019563 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e46835 %T Exploring Current Practices, Needs, and Barriers for Expanding Distributed Medical Education and Scholarship in Psychiatry: Protocol for an Environmental Scan Using a Formal Information Search Approach and Explanatory Design %A Hazelton,Lara %A da Luz Dias,Raquel %A Esliger,Mandy %A Tibbo,Philip %A Sinha,Nachiketa %A Njoku,Anthony %A Satyanarayana,Satyendra %A Siddhartha,Sanjay %A Alexiadis-Brown,Peggy %A Rahman,Faisal %A Maguire,Hugh %A Gray,Gerald %A Bosma,Mark %A Parker,Deborah %A Connolly,Owen %A Raji,Adewale %A Manning,Alexandra %A Bagnell,Alexa %A Israel Opoku Agyapong,Vincent %+ Department of Psychiatry, Faculty of Medicine, Dalhousie University, 5909 Veterans' Memorial Lane, 8th Floor Abbie J. Lane Memorial Building QEII Health Sciences Centre, Halifax, NS, B3H 2E2, Canada, 1 902 473 6214, vn602367@dal.ca %K distributed learning sites %K medical education %K psychiatry %K environmental scan %K needs assessment %K strategic plan %K distributed medical education %K rural area %K physician %K mixed methods approach %K education program %D 2023 %7 27.11.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Distributed medical education (DME) offers manifold benefits, such as increased training capacity, enhanced clinical learning, and enhanced rural physician recruitment. Engaged faculty are pivotal to DME's success, necessitating efforts from the academic department to promote integration into scholarly and research activities. Environmental scanning has been used to gather, analyze, and apply information for strategic planning purposes. It helps organizations identify current practices, assess needs and barriers, and respond to emerging risks and opportunities. There are process models and conceptual frameworks developed for environmental scanning in the business and educational sectors. However, the literature lacks methodological direction on how to go about designing and implementing this strategy to guide research and practice in DME, especially in the psychiatry field. Objective: This paper presents a protocol for an environmental scanning that aims to understand current practices and identify needs and barriers that must be addressed to facilitate the integration of psychiatrists from the Dalhousie University Faculty of Medicine’s distributed education sites in Nova Scotia and New Brunswick into the Department of Psychiatry, contributing for the expansion of DME in both provinces and informing strategic planning and decision-making within the organization. Methods: This protocol adopts an innovative approach combining a formal information search and an explanatory design that includes quantitative and qualitative data. About 120 psychiatrists from 8 administrative health zones of both provinces will be invited to complete an anonymous web-based survey with questions about demographics, participants' experience and interest in undergraduate, postgraduate, and continuing medical education, research and scholarly activities, quality improvement, and knowledge translation. Focus group sessions will be conducted with a purposive sample of psychiatrists to collect qualitative data on their perspectives on the expansion of DME. Results: Results are expected within 6 months of data collection and will inform policy options for expanding Dalhousie University’s psychiatry residency and fellowship programs using the infrastructure and human resources at distributed learning sites, leveraging opportunities regionally, especially in rural areas. Conclusions: This paper proposes a comprehensive environmental scan procedure adapted from existing approaches. It does this by collecting important characteristics that affect psychiatrists' desire to be involved with research and scholarly activities, which is crucial for the DME expansion. Furthermore, its concordance with the literature facilitates interpretation and comparison. The protocol's new method also fills DME information gaps, allowing one to identify insights and patterns that may shape psychiatric education. This environmental scan's results will answer essential questions about how training programs could involve therapists outside the academic core and make the most of training experiences in semiurban and rural areas. This could help other psychiatry and medical units outside tertiary care establish residency and fellowship programs. International Registered Report Identifier (IRRID): DERR1-10.2196/46835 %M 38010790 %R 10.2196/46835 %U https://www.researchprotocols.org/2023/1/e46835 %U https://doi.org/10.2196/46835 %U http://www.ncbi.nlm.nih.gov/pubmed/38010790 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e52336 %T Investigating the Feasibility, Acceptability, and Appropriation of a Socially Assistive Robot Among Minority Youth at Risk of Self-Harm: Results of 2 Mixed Methods Pilot Studies %A Williams,A Jess %A Townsend,Ellen %A Naeche,Nkem %A Chapman-Nisar,Amelia %A Hollis,Chris %A Slovak,Petr %A , %+ Department of Informatics, King's College London, 30 Aldwych, Bush House, Strand Campus, London, WC2B 4BG, United Kingdom, 44 020 7848 1988, amy_jess.williams@kcl.ac.uk %K digital intervention %K self-harm %K young people %K emotion regulation %K experience sampling %K interviews %D 2023 %7 22.11.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Minority youth are at an increased risk of experiencing self-harmful thoughts and behaviors. However, there is limited evidence of successful interventions to support young people in the moment of their distress. Digital interventions are considered a potential solution for providing in-the-moment support for those at risk of adverse mental health and self-harm. Objective: These pilot studies aim to investigate the feasibility and acceptability of a new in situ intervention tool, Purrble, among two broad groups of minority youth: (1) lesbian, gay, bisexual, transgender, queer, and similar minority (LGBTQ+) youth and (2) racial and ethnic minority youth. Purrble was designed to support in-situ emotion regulation (ER) support when individuals are facing emotionally challenging situations. Methods: This study consisted of 2 mixed methods pilot studies that followed the same mixed methods design, including 3 weeks of daily and weekly surveys and optional follow-up interviews. Inclusion criteria were (1) aged between 16 and 25 years, (2) part of a minority group, (3) had experiences of self-harmful thoughts or behaviors or elevated symptoms of depression or anxiety, and (4) living in the United Kingdom at the time of the study. The primary outcomes were (1) the feasibility of Purrble as an intervention among pilot samples (analyzed by consent rate, retention rate, adherence to surveys, and engagement with the device) and (2) the acceptability and appropriation of Purrble across pilot studies as a tool to support ER in situ (thematically analyzed qualitative open-ended questions and interview data). The secondary outcomes were descriptive pilot data concerning the mental health outcomes in each sample. Results: In total, 21 LGBTQ+ young people participated in pilot study 1, with 86% (n=18) completing the baseline and 3 weeks of daily surveys. These young people maintained engagement with Purrble across deployment, across which period there was a decrease in self-harmful thoughts and anxiety symptoms. A total of 19 ethnic and racial minority youths participated in pilot study 2, and 84% (n=16) completed the study. Although pilot study 2 participants also maintained engagement with Purrble across deployment, this was to a lesser degree than participants of pilot study 1, and perceived mental health outcomes did not indicate potential change associated with the device. The thematic analysis indicated three superordinate themes: (1) stopping the self-harm cycle, (2) adopting ER strategies, and (3) stages of change. Conclusions: These were the first pilot studies of a novel intervention that aimed to provide in situ ER support for young people at risk of self-harm. Both quantitative and qualitative findings indicate that young people found Purrble to be a feasible and acceptable intervention, as they effectively incorporated the device into their ER practices. These engagements with Purrble were described as interrupting the cycle of self-harmful ideation and behavior. %M 37991838 %R 10.2196/52336 %U https://formative.jmir.org/2023/1/e52336 %U https://doi.org/10.2196/52336 %U http://www.ncbi.nlm.nih.gov/pubmed/37991838 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e52036 %T Empowering Foot Care Literacy Among People Living With Diabetes and Their Carers With an mHealth App: Protocol for a Feasibility Study %A Liew,Huiling %A Pienkowska,Anita %A Ang,Chin-Siang %A Mahadzir,Muhammad Daniel Azlan %A Goh,Kelley Fann Ing %A Lodh,Nandika %A Bojic,Iva %A Lawate,Ashwini %A Ong,Qi Chwen %A Venkataraman,Kavita %A Car,Josip %A Ho,Andy Hau Yan %+ Department of Endocrinology, Tan Tock Seng Hospital, 11 Jln Tan Tock Seng, Singapore, 308433, Singapore, 65 62566011, huiling_liew@ttsh.com.sg %K digital therapeutics %K mHealth %K diabetes mellitus %K diabetes foot ulcer %K feasibility study %K mobile phone %D 2023 %7 21.11.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Diabetic foot ulcers (DFUs) cause significant morbidity affecting 19% to 34% of people living with diabetes mellitus. DFUs not only impair quality of life but may also result in limb loss and mortality. Patient education has been advocated to raise awareness of proper foot self-care and the necessity of seeking assistance when a foot wound occurs. Modern technologies, including mobile health (mHealth) interventions such as health apps, bring the potential for more cost-effective and scalable interventions. Objective: This study aims to examine the feasibility and usability of a newly developed mHealth app called Well Feet, which is a diabetes and foot care education app for individuals at risk of developing DFU. Methods: Well Feet was developed using an evidence-based and expert panel cocreation approach to deliver educational content available in 3 languages (ie, English, Chinese, and Malay) via animation videos and a range of additional features, including adaptive learning. A nonrandomized, single-arm feasibility study using a mixed methods approach with a series of validated questionnaires and focus group discussions will be conducted. In total, 40 patients and carers will be recruited from a tertiary hospital diabetes clinic to receive a 1-month mHealth intervention. The primary outcomes are the usability of the app and a qualitative perspective on user experience. Secondary outcomes include changes in foot care knowledge, self-management behaviors, and quality of life. Results: Patient recruitment began in July 2023, and the intervention and data collection will be completed by the end of September 2023. This study has been approved by National Healthcare Group Domain Specific Review Board (2022/00614) on February 10, 2023. The expected results will be published in spring 2024. Conclusions: Through this feasibility study, the Well Feet DFU education app will undergo a comprehensive quantitative and qualitative evaluation of its usability and acceptance for future improvement in its design. With local contextualization, cultural adaptation, and its multilingual functionality, the app addresses a critical aspect of DFU health education and self-management in a multiethnic population. Findings from this study will refine and enhance the features of the app based on user feedback and shape the procedural framework for a subsequent randomized controlled trial to assess the effectiveness of Well Feet. Trial Registration: ClinicalTrials.gov NCT05564728; https://clinicaltrials.gov/study/NCT05564728 International Registered Report Identifier (IRRID): DERR1-10.2196/52036 %M 37988150 %R 10.2196/52036 %U https://www.researchprotocols.org/2023/1/e52036 %U https://doi.org/10.2196/52036 %U http://www.ncbi.nlm.nih.gov/pubmed/37988150 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e42916 %T Feasibility of Using Research Electronic Data Capture (REDCap) to Collect Daily Experiences of Parent-Child Dyads: Ecological Momentary Assessment Study %A El Dahr,Yola %A Perquier,Florence %A Moloney,Madison %A Woo,Guyyunge %A Dobrin-De Grace,Roksana %A Carvalho,Daniela %A Addario,Nicole %A Cameron,Emily E %A Roos,Leslie E %A Szatmari,Peter %A Aitken,Madison %+ Cundill Centre for Child and Youth Depression, Centre for Addiction and Mental Health, 80 Workman Way, Toronto, ON, M6J 1H4, Canada, 1 416 535 8501 ext 34091, madison.aitken@camh.ca %K ambulatory assessment %K children %K ecological momentary assessment %K longitudinal %K parents %K survey %D 2023 %7 9.11.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Intensive longitudinal data collection, including ecological momentary assessment (EMA), has the potential to reduce recall biases, collect more ecologically valid data, and increase our understanding of dynamic associations between variables. EMA is typically administered using an application that is downloaded on participants’ devices, which presents cost and privacy concerns that may limit its use. Research Electronic Data Capture (REDCap), a web-based survey application freely available to nonprofit organizations, may allow researchers to overcome these barriers; however, at present, little guidance is available to researchers regarding the setup of EMA in REDCap, especially for those who are new to using REDCap or lack advanced programming expertise. Objective: We provide an example of a simplified EMA setup in REDCap. This study aims to demonstrate the feasibility of this approach. We provide information on survey completion and user behavior in a sample of parents and children recruited across Canada. Methods: We recruited 66 parents and their children (aged 9-13 years old) from an existing longitudinal cohort study to participate in a study on risk and protective factors for children’s mental health. Parents received survey prompts (morning and evening) by email or SMS text message for 14 days, twice daily. Each survey prompt contained 2 sections, one for parents and one for children to complete. Results: The completion rates were good (mean 82%, SD 8%) and significantly higher on weekdays than weekends and in dyads with girls than dyads with boys. Children were available to respond to their own survey questions most of the time (in 1134/1498, 75.7% of surveys submitted). The number of assessments submitted was significantly higher, and response times were significantly faster among participants who selected SMS text message survey notifications compared to email survey notifications. The average response time was 47.0 minutes after the initial survey notification, and the use of reminder messages increased survey completion. Conclusions: Our results support the feasibility of using REDCap for EMA studies with parents and children. REDCap also has features that can accommodate EMA studies by recruiting participants across multiple time zones and providing different survey delivery methods. Offering the option of SMS text message survey notifications and reminders may be an important way to increase completion rates and the timeliness of responses. REDCap is a potentially useful tool for researchers wishing to implement EMA in settings in which cost or privacy are current barriers. Researchers should weigh these benefits with the potential limitations of REDCap and this design, including staff time to set up, monitor, and clean the data outputs of the project. %M 37943593 %R 10.2196/42916 %U https://formative.jmir.org/2023/1/e42916 %U https://doi.org/10.2196/42916 %U http://www.ncbi.nlm.nih.gov/pubmed/37943593 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e51884 %T Developing Health Management Competency for Digital Health Transformation: Protocol for a Qualitative Study %A Brommeyer,Mark %A Liang,Zhanming %A Whittaker,Maxine %A Mackay,Mark %+ College of Public Health, Medical and Veterinary Science, James Cook University, James Cook Drive, Townsville, 4810, Australia, 61 400825555, mark.brommeyer@flinders.edu.au %K health care management %K health service manager %K digital health %K health informatics %K competency %K workforce development %K innovation %K research protocol %K informatics %K manager %K managers %K service %K services %K delivery %K organization %K organizational %K workforce %K management %K managerial %K qualification %K qualifications %K focus group %K focus groups %K interview %K interviews %K scoping %K review methods %K review methodology %D 2023 %7 3.11.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Globally, the health care system is experiencing a period of rapid and radical change. In response, innovative service models have been adopted for the delivery of high-quality care that require a health workforce with skills to support transformation and new ways of working. Objective: The aim of this research protocol is to describe research that will contribute to developing the capability of health service managers in the digital health era and enabling digital transformation within the Australian health care environment. It also explains the process of preparing and finalizing the research design and methodologies by seeking answers to the following three research questions: (1) To what extent can the existing health service management and digital health competency frameworks guide the development of competence for health service managers in understanding and managing in the digital health space? (2) What are the competencies that are necessary for health service managers to acquire in order to effectively work with and manage in the digital health context? (3) What are the key factors that enable and inhibit health service managers to develop and demonstrate digital health competence in the workplace? Methods: The study has adopted a qualitative approach, guided by the empirically validated management competency identification process, using four steps: (1) health management and digital health competency mapping, (2) scoping review of literature and policy analysis, (3) focus group discussions with health service managers, and (4) semistructured interviews with digital health leaders. The first 2 steps were to confirm the need for updating the current health service management curriculum to address changing competency requirements of health service managers in the digital health context. Results: Two initial steps have been completed confirming the significance of the study and study design. Step 1, competency mapping, found that nearly half of the digital competencies were only partially or not addressed at all by the health management competency framework. The scoping review articulated the competencies health service managers need to effectively demonstrate digital health competence in the workplace. The findings effectively support the importance of the current research and also the appropriateness of the proposed steps 3 and 4 in answering the research questions and achieving the research aim. Conclusions: This study will provide insights into the health service management workforce performance and development needs for digital health and inform credentialing and professional development requirements. This will guide health service managers in leading and managing the adoption and implementation of digital health as a contemporary tool for health care delivery. The study will develop an in-depth understanding of Australian health service managers’ experiences and views. This research process could be applied in other contexts, noting that the results need contextualization to individual country jurisdictions and environments. International Registered Report Identifier (IRRID): DERR1-10.2196/51884 %M 37921855 %R 10.2196/51884 %U https://www.researchprotocols.org/2023/1/e51884 %U https://doi.org/10.2196/51884 %U http://www.ncbi.nlm.nih.gov/pubmed/37921855 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e47167 %T Continuous Assessment of Function and Disability via Mobile Sensing: Real-World Data-Driven Feasibility Study %A Sükei,Emese %A Romero-Medrano,Lorena %A de Leon-Martinez,Santiago %A Herrera López,Jesús %A Campaña-Montes,Juan José %A Olmos,Pablo M %A Baca-Garcia,Enrique %A Artés,Antonio %+ Department of Signal Theory and Communications, Universidad Carlos III de Madrid, Ed. Torres Quevedo, 3rd Fl., Av. de la Universidad, 30, Leganés, 28911, Spain, 34 916 248 741, esukei@tsc.uc3m.es %K WHODAS %K functional limitations %K mobile sensing %K passive ecological momentary assessment %K predictive modeling %K interpretable machine learning %K machine learning %K disability %K clinical outcome %D 2023 %7 30.10.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Functional limitations are associated with poor clinical outcomes, higher mortality, and disability rates, especially in older adults. Continuous assessment of patients’ functionality is important for clinical practice; however, traditional questionnaire-based assessment methods are very time-consuming and infrequently used. Mobile sensing offers a great range of sources that can assess function and disability daily. Objective: This work aims to prove the feasibility of an interpretable machine learning pipeline for predicting function and disability based on the World Health Organization Disability Assessment Schedule (WHODAS) 2.0 outcomes of clinical outpatients, using passively collected digital biomarkers. Methods: One-month-long behavioral time-series data consisting of physical and digital activity descriptor variables were summarized using statistical measures (minimum, maximum, mean, median, SD, and IQR), creating 64 features that were used for prediction. We then applied a sequential feature selection to each WHODAS 2.0 domain (cognition, mobility, self-care, getting along, life activities, and participation) in order to find the most descriptive features for each domain. Finally, we predicted the WHODAS 2.0 functional domain scores using linear regression using the best feature subsets. We reported the mean absolute errors and the mean absolute percentage errors over 4 folds as goodness-of-fit statistics to evaluate the model and allow for between-domain performance comparison. Results: Our machine learning–based models for predicting patients’ WHODAS functionality scores per domain achieved an average (across the 6 domains) mean absolute percentage error of 19.5%, varying between 14.86% (self-care domain) and 27.21% (life activities domain). We found that 5-19 features were sufficient for each domain, and the most relevant being the distance traveled, time spent at home, time spent walking, exercise time, and vehicle time. Conclusions: Our findings show the feasibility of using machine learning–based methods to assess functional health solely from passively sensed mobile data. The feature selection step provides a set of interpretable features for each domain, ensuring better explainability to the models’ decisions—an important aspect in clinical practice. %M 37902823 %R 10.2196/47167 %U https://formative.jmir.org/2023/1/e47167 %U https://doi.org/10.2196/47167 %U http://www.ncbi.nlm.nih.gov/pubmed/37902823 %0 Journal Article %@ 2561-7605 %I JMIR Publications %V 6 %N %P e49319 %T Exploring the Needs and Requirements of Informal Caregivers of Older Adults With Cognitive Impairment From Sensor-Based Care Solutions: Multimethod Study %A Sharma,Nikita %A Braakman-Jansen,Louise M A %A Oinas-Kukkonen,Harri %A Croockewit,Jan Hendrik %A Gemert-Pijnen,JEWC van %+ Faculty of Behavioural, Management and Social Sciences, University of Twente, Enschede, Zilverling, Hallenweg 19,, Enschede, 7522 NH, Netherlands, 31 53 489 9111, n.sharma@utwente.nl %K informal caregiving %K cognitive impairment %K unobtrusive sensing solutions %K in-home care %K aging in place %K assistive technologies %D 2023 %7 25.10.2023 %9 Original Paper %J JMIR Aging %G English %X Background: With the increase in the older adult population, sensor-based care solutions that can monitor the deviations in physical, emotional, and physiological activities in real-time from a distance are demanded for prolonging the stay of community-dwelling older adults with cognitive impairment. To effectively develop and implement these care solutions, it is important to understand the current experiences, future expectations, perceived usefulness (PU), and communication needs of the informal caregivers of older adults with cognitive impairment regarding such solutions. Objective: This comprehensive study with informal caregivers of older adults with cognitive impairment aims to (1) highlight current experiences with (if any) and future expectations from general sensor-based care solutions, (2) explore PU specifically toward unobtrusive sensing solutions (USSs), (3) determine the information communication (IC) needs and requirements for communicating the information obtained through USSs in different care scenarios (fall, nocturnal unrest, agitation, and normal daily life), and (4) elicit the design features for designing the interaction platform in accordance with the persuasive system design (PSD) model. Methods: A multimethod research approach encompassing a survey (N=464) and in-depth interviews (10/464, 2.2%) with informal caregivers of older adults with cognitive impairment was used. The insights into past experiences with and future expectations from the sensor-based care solutions were obtained through inductive thematic analysis of the interviews. A convergent mixed methods approach was used to explore PU and gather the IC needs from USSs by using scenario-specific questions in both survey and interviews. Finally, the design features were elicited by using the PSD model on the obtained IC needs and requirements. Results: Informal caregivers expect care infrastructure to consider centralized and empathetic care approaches. Specifically, sensor-based care solutions should be adaptable to care needs, demonstrate trust and reliability, and ensure privacy and safety. Most informal caregivers found USSs to be useful for emergencies (mean 4.09, SD 0.04) rather than for monitoring normal daily life activities (mean 3.50, SD 0.04). Moreover, they display variations in information needs including mode, content, time, and stakeholders involved based on the care scenario at hand. Finally, PSD features, namely, reduction, tailoring, personalization, reminders, suggestions, trustworthiness, and social learning, were identified for various care scenarios. Conclusions: From the obtained results, it can be concluded that the care scenario at hand drives PU and IC design needs and requirements toward USSs. Therefore, future technology developers are recommended to develop technology that can be easily adapted to diverse care scenarios, whereas designers of such sensor-driven platforms are encouraged to go beyond tailoring and strive for strong personalization while maintaining the privacy of the users. %M 37878353 %R 10.2196/49319 %U https://aging.jmir.org/2023/1/e49319 %U https://doi.org/10.2196/49319 %U http://www.ncbi.nlm.nih.gov/pubmed/37878353 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e45715 %T Facilitators and Barriers in the Implementation of a Digital Surveillance and Outbreak Response System in Ghana Before and During the COVID-19 Pandemic: Qualitative Analysis of Stakeholder Interviews %A Kaburi,Basil Benduri %A Wyss,Kaspar %A Kenu,Ernest %A Asiedu-Bekoe,Franklin %A Hauri,Anja M %A Laryea,Dennis Odai %A Klett-Tammen,Carolina J %A Leone,Frédéric %A Walter,Christin %A Krause,Gérard %+ Department of Epidemiology, Helmholtz Centre for Infection Research, Inhoffenstrasse 7, Braunschweig, 38124, Germany, 49 5316181 ext 3147, BasilBenduri.Kaburi@helmholtz-hzi.de %K implementation %K Surveillance Outbreak Response Management and Analysis System %K SORMAS %K barriers %K facilitators %K digital disease surveillance %K outbreak response %K COVID-19 %K pandemic %K Ghana %K mobile phone %D 2023 %7 20.10.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: In the past 2 decades, many countries have recognized the use of electronic systems for disease surveillance and outbreak response as an important strategy for disease control and prevention. In low- and middle-income countries, the adoption of these electronic systems remains a priority and has attracted the support of global health players. However, the successful implementation and institutionalization of electronic systems in low- and middle-income countries have been challenged by the local capacity to absorb technologies, decisiveness and strength of leadership, implementation costs, workforce attitudes toward innovation, and organizational factors. In November 2019, Ghana piloted the Surveillance Outbreak Response Management and Analysis System (SORMAS) for routine surveillance and subsequently used it for the national COVID-19 response. Objective: This study aims to identify the facilitators of and barriers to the sustainable implementation and operation of SORMAS in Ghana. Methods: Between November 2021 and March 2022, we conducted a qualitative study among 22 resource persons representing different stakeholders involved in the implementation of SORMAS in Ghana. We interviewed study participants via telephone using in-depth interview guides developed consistent with the model of diffusion of innovations in health service organizations. We transcribed the interviews verbatim and performed independent validation of transcripts and pseudonymization. We performed deductive coding using 7 a priori categories: innovation, adopting health system, adoption and assimilation, diffusion and dissemination, outer context, institutionalization, and linkages among the aspects of implementation. We used MAXQDA Analytics Pro for transcription, coding, and analysis. Results: The facilitators of SORMAS implementation included its coherent design consistent with the Integrated Disease Surveillance and Response system, adaptability to evolving local needs, relative advantages for task performance (eg, real-time reporting, generation of case-base data, improved data quality, mobile offline capability, and integration of laboratory procedures), intrinsic motivation of users, and a smartphone-savvy workforce. Other facilitators were its alignment with health system goals, dedicated national leadership, political endorsement, availability of in-country IT capacities, and financial and technical support from inventors and international development partners. The main barriers were unstable technical interoperability between SORMAS and existing health information systems, reliance on a private IT company for data hosting, unreliable internet connectivity, unstable national power supply, inadequate numbers and poor quality of data collection devices, and substantial dependence on external funding. Conclusions: The facilitators of and barriers to SORMAS implementation are multiple and interdependent. Important success conditions for implementation include enhanced scope and efficiency of task performance, strong technical and political stewardship, and a self-motivated workforce. Inadequate funding, limited IT infrastructure, and lack of software development expertise are mutually reinforcing barriers to implementation and progress to country ownership. Some barriers are external, relate to the overall national infrastructural development, and are not amenable even to unlimited project funding. %M 37862105 %R 10.2196/45715 %U https://formative.jmir.org/2023/1/e45715 %U https://doi.org/10.2196/45715 %U http://www.ncbi.nlm.nih.gov/pubmed/37862105 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e48641 %T Twitch Data in Health Promotion Research: Protocol for a Case Study Exploring COVID-19 Vaccination Views Among Young People %A Chau,Brian %A Taba,Melody %A Dodd,Rachael %A McCaffery,Kirsten %A Bonner,Carissa %+ Sydney Health Literacy Lab, School of Public Health, Faculty of Medicine and Health, University of Sydney, Edward Ford Building, A27, Sydney, NSW 2006, Australia, 61 2 9351 7125, brianychau@gmail.com %K twitch %K social media %K COVID-19 %K vaccination communication %K video gaming %K gaming %K health promotion %K streaming %D 2023 %7 18.10.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Social media platforms have emerged as a useful channel for health promotion communication, offering different channels to reach targeted populations. For example, social media has recently been used to disseminate information about COVID-19 vaccination across various demographics. Traditional modes of health communication such as television, health events, and newsletters may not reach all groups within a community. Health communications for younger generations are increasingly disseminated through social media to reflect key information sources. This paper explores a social media gaming platform as an alternative way to reach young people in health promotion research. Objective: This protocol study aimed to pilot-test the potential of Twitch, a live streaming platform initially designed for video gaming, to conduct health promotion research with young people. We used COVID-19 vaccination as a topical case study that was recommended by Australian health authorities at the time of the research. Methods: The research team worked with a Twitch Account Manager to design and test a case study within the guidelines and ethics protocols required by Twitch, identify suitable streamers to approach and establish a protocol for conducting research on the platform. This involved conducting a poll to initiate discussion about COVID-19 vaccination, monitoring the chat in 3 live Twitch sessions with 2 streamers to pilot the protocol, and briefly analyze Twitch chat logs to observe the range of response types that may be acquired from this methodology. Results: The Twitch streams provided logs and videos on demand that were derived from the live session. These included demographics of viewers, chat logs, and polling results. The results of the poll showed a range of engagement in health promotion for the case study topic: the majority of participants had received their vaccination by the time of the poll; however, there was still a proportion that had not received their vaccination yet or had decided to not be vaccinated. Analysis of the Twitch chat logs demonstrated a range of both positive and negative themes regarding health promotion for the case study topic. This included irrelevant comments, misinformation (compared to health authority information at the time of this study), comedic and conspiracy responses, as well as vaccine status, provaccine comments, and vaccine-hesitant comments. Conclusions: This study developed and tested a protocol for using Twitch data for health promotion research with young people. With live polling, open text discussion between participants and immediate responses to questions, Twitch can be used to collect both quantitative and qualitative research data from demographics that use social media. The platform also presents some challenges when engaging with independent streamers and sensitive health topics. This study provides an initial protocol for future researchers to use and build on. International Registered Report Identifier (IRRID): RR1-10.2196/48641 %M 37851494 %R 10.2196/48641 %U https://www.researchprotocols.org/2023/1/e48641 %U https://doi.org/10.2196/48641 %U http://www.ncbi.nlm.nih.gov/pubmed/37851494 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e46765 %T Prehabilitation in an Integrative Medicine Day Clinic for Patients Undergoing Neoadjuvant Treatment: Single-Center Feasibility Pilot Study %A Raff,Christian %A Dörr-Harim,Colette %A Otto,Stephanie %A Thiele,Johanna %A Mihaljevic,Andre %A Kramer,Klaus %+ Department of General and Visceral Surgery, Working Group of Integrative Medicine, University Hospital Ulm, Albert-Einstein-Allee 23, Ulm, 89081, Germany, 49 73150053538, christian.raff@uniklinik-ulm.de %K supportive care %K prehabilitation %K neoadjuvant treatment %K integrative medicine %K multimodal prehabilitation %K cancer %K oncology %K surgery %K preoperative %K feasibility %K integrative %K naturopathy %K naturopathic %K diet %K nutrition %D 2023 %7 18.10.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Patients with cancer receiving neoadjuvant treatment prior to surgery are in a very stressful situation. Chemotherapy and radiation therapy put a strain on the quality of life and the pending surgery poses a relevant burden for many patients. Preparation of these patients for the intervention in terms of prehabilitation has great potential to reduce the burden of postoperative complications and may improve the clinical outcome. A prehabilitation approach also yields the possibility to address unmet patients’ needs and to help them modify their lifestyle in a maintainable way. Therefore, a multimodal approach is mandatory during this critical period. Objective: The aim of this study is to assess the feasibility of prehabilitation in an integrative medicine day clinic (PRIME-DC) prior to cancer surgery at a major university clinic. PRIME-DC is considered feasible if 80% of enrolled patients are willing and able to complete at least 6 out of the 8 weekly meetings, each lasting 6.5 hours, at such a clinic. Secondary end points aim to evaluate this multimodal program. Methods: The PRIME-DC intervention combines mind-body medicine, exercise therapy, nutrition therapy, naturopathic counseling, and the application of a yarrow liver compress. Adult patients with cancer, with a primary tumor in the abdomen (including intraperitoneal cancer, stomach cancer, and extraperitoneal cancers such as pancreatic, bladder, rectal, esophageal, endometrial, ovarian, and cervical cancer) or the breast requiring a neoadjuvant oncological treatment setting are eligible to participate. The addressed cancer entities imply either an extensive surgical intervention with an expected need for prehabilitation (eg, abdominal surgery) or a neoadjuvant treatment of several months with a high burden of treatment-associated side effects (breast cancer). Adherence to the day clinic program is the primary end point being defined as presence during the day clinic session. Secondary end points are physical assessment and quality of life, together with a structured assessment of neoadjuvant treatment-associated side effects. Furthermore, to collect qualitative data voluntary participants of the day clinic will be interviewed in a semistructured way after completion of the day clinic program on each component of the study (mind-body intervention, exercise, nutrition, naturopathic counseling, and a yarrow liver compress). Results: The procedures used in this study adhere to the tenets of the Declaration of Helsinki. As of February 2023, we enrolled 23 patients; the dominant cancer entity is breast cancer (18 enrolled patients). Conclusions: The presented protocol combines prehabilitation, lifestyle modification, naturopathic counseling, dietary assistance, and naturopathic treatment in an innovative and integrative way. Trial Registration: Deutsches Register Klinischer Studien German Clinical Trials Register DRKS00028126; https://drks.de/search/de/trial/DRKS00028126 International Registered Report Identifier (IRRID): DERR1-10.2196/46765 %M 37851493 %R 10.2196/46765 %U https://www.researchprotocols.org/2023/1/e46765 %U https://doi.org/10.2196/46765 %U http://www.ncbi.nlm.nih.gov/pubmed/37851493 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e46209 %T Virtual Reality Meditation for Fatigue in Persons With Rheumatoid Arthritis: Mixed Methods Pilot Study %A Dreesmann,Nathan J %A Buchanan,Diana %A Tang,Hsin-Yi Jean %A Furness III,Thomas %A Thompson,Hilaire %+ Virtual Therapeutics, 13905 NE 128th St, Suite 200, Kirkland, WA, 98034, United States, 1 (425) 821 8001, nathan.dreesmann@vthera.com %K anxiety %K chronic pain %K depression %K fatigue %K feasibility study %K feasibility %K head-mounted display %K meditation %K mixed method %K mood %K pain %K rheumatoid arthritis %K symptom %K virtual reality %K VR %D 2023 %7 17.10.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Effective symptom management is crucial to enhancing the quality of life for individuals with chronic diseases. Health care has changed markedly over the past decade as immersive, stand-alone, and wearable technologies including virtual reality have become available. One chronic pain population that could benefit from such an intervention is individuals with rheumatoid arthritis (RA). Recent pharmacologic advances in the management of RA have led to a decrease in inflammatory symptoms (eg, chronic pain) or even disease remission, yet up to 70% of patients with RA still suffer from fatigue. While VR-delivered behavior, meditation, and biofeedback programs show promise for pain and anxiety management, there is little information on the use of virtual reality meditation (VRM) for fatigue management among individuals with RA. Objective: This study aims to (1) examine the feasibility of implementing a study protocol that uses VRM, (2) determine the acceptability of using VRM for fatigue management in an outpatient population, and (3) identify barriers and contextual factors that might impact VRM use for fatigue management in outpatients with RA. Methods: We used a convergent, mixed methods design and enrolled adults aged 18 years or older with a clinical diagnosis of RA. Patient-Reported Outcome Measure Information System (PROMIS) measures of fatigue, depression, anxiety, pain behavior, and physical function were assessed alongside the brief mood introspection scale at baseline and weekly for 4 weeks. VRM use across the 4-week study period was automatically stored on headsets and later extracted for analysis. Semistructured interview questions focused on feedback regarding the participant’s experience with RA, previous experience of fatigue, strategies participants use for fatigue management, and the participant’s experience using VRM and recommendations for future use. Results: A total of 13 participants completed this study. Most participants completed all study surveys and measures (11/13, 84% and 13/13, 100%, respectively) and were active participants in interviews at the beginning and end of the program. Participants used VRM an average of 8.9 (SD 8.5) times over the course of the 4-week program. Most participants enjoyed VRM, found it relaxing, or recommended its use (12/13, 92%), but 8 (62%) noted barriers and conceptual factors that impacted VRM use. On average, participants saw decreases in PROMIS fatigue (–6.4, SD 5.1), depression (–5.6, SD 5.7), anxiety (–4.5, SD 6), and pain behavior (–3.9, SD 5.3), and improvements in PROMIS physical function (1.5, SD 2.7) and Brief Mood Introspection Scale mood (5.3, SD 6.7) over the course of this 4-week study. Conclusions: While this study’s implementation was feasible, VRM’s acceptability as an adjunctive modality for symptom management in RA is contingent on effectively overcoming barriers to use and thoughtfully addressing the contextual factors of those with RA to ensure successful intervention deployment. Trial Registration: ClinicalTrials.gov NCT04804462; https://classic.clinicaltrials.gov/ct2/show/NCT04804462 %M 37847542 %R 10.2196/46209 %U https://formative.jmir.org/2023/1/e46209 %U https://doi.org/10.2196/46209 %U http://www.ncbi.nlm.nih.gov/pubmed/37847542 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e44887 %T Acceptability and Feasibility of Online Support Groups for Mental Health Promotion in Brazilian Graduate Students During the COVID-19 Pandemic: Longitudinal Observational Study %A Prado,Aneliana da Silva %A Kohls,Elisabeth %A Baldofski,Sabrina %A Rummel-Kluge,Christine %A Freitas,Joanneliese de Lucas %+ Department of Psychiatry and Psychotherapy, Medical Faculty, Leipzig University, Semmelweisstraße 10, Haus 13, Leipzig, 04103, Germany, 49 3419724464, Aneliana.daSilvaPrado@medizin.uni-leipzig.de %K support group %K online group %K COVID-19 pandemic %K higher education %K graduate students %K university students %K mental health %K online intervention %K internet intervention %K e–mental health %K mental health promotion %K feasibility %K students %K acceptability %D 2023 %7 13.10.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: The outbreak of the COVID-19 pandemic in 2020 aggravated already existing difficulties and added new challenges for students. Owing to the gap between needed and available psychological services, group interventions may offer a helpful strategy for student mental health promotion. Objective: This study aimed to investigate the acceptability and feasibility of a 4-week online support group program designed for mental health promotion tailored to graduate students at a Brazilian public university in the context of the COVID-19 pandemic (May 2022 to June 2022). Methods: Participants in the program took part in online support groups based on a pilot group facilitated by a trained clinical psychologist. Self-administered, standardized web-based questionnaires were assessed at the baseline (T0; before the intervention), postintervention (T2), and follow-up (T3; after 4-6 weeks) time points. We measured sociodemographic variables, treatment credibility and expectancy (Credibility and Expectancy Questionnaire), satisfaction (Client Satisfaction Questionnaire), negative effects of the intervention (Negative Effects Questionnaire), depressive symptoms (Patient Health Questionnaire–9 [PHQ-9]), and participants’ quality of life (abbreviated World Health Organization Quality of Life assessment). A 9–answer option questionnaire and open-ended questions also assessed the group’s perceived positive and negative outcomes. Results: The total sample comprised 32 participants. Most (23/32, 72%) were doctoral students. Credibility and expectancy scores were high. Participants’ satisfaction (Client Satisfaction Questionnaire) with the program was high at the postintervention (T2) and follow-up (T3) evaluations (T2: mean 28.66, SD 3.02; T3: mean 27.91, SD 3.02). Most participants reported that they could learn from other participants’ experiences (T2: 29/32, 91%; T3: 27/32, 84%) and felt encouraged to take better care of themselves (T2: 22/32, 69%; T3: 24/32, 75%). None of the participants reported that they had no benefits from the program. The PHQ-9 scores showed mild to moderate depressive symptoms (mean 9.59, SD 6.34), whereas the answers of 9% (3/32) of the participants to the PHQ-9 item 9 indicated suicidality at baseline (T0). Finally, the 4 domains of quality of life (physical: P=.01; psychological: P=.004; social: P=.02; and environmental: P<.001) showed a slight and statistically significant improvement at the postintervention evaluation (T0: mean 57.03, SD 15.39 to 59.64, SD 17.21; T2: mean 64.32, SD 11.97 to 68.75, SD 8.87). Conclusions: Online support groups for the mental health promotion of graduate students are feasible and can be especially useful for universities with students allocated to different cities. They are also satisfactory and may positively influence participants’ quality of life. Therefore, they can be considered a helpful mental health promotion strategy in the educational context. Further studies could evaluate these (or similar) programs under nonpandemic circumstances. %M 37831483 %R 10.2196/44887 %U https://formative.jmir.org/2023/1/e44887 %U https://doi.org/10.2196/44887 %U http://www.ncbi.nlm.nih.gov/pubmed/37831483 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e49096 %T Digital Phenotyping for Monitoring and Disease Trajectory Prediction of Patients With Cancer: Protocol for a Prospective Observational Cohort Study %A Jenciūtė,Gabrielė %A Kasputytė,Gabrielė %A Bunevičienė,Inesa %A Korobeinikova,Erika %A Vaitiekus,Domas %A Inčiūra,Arturas %A Jaruševičius,Laimonas %A Bunevičius,Romas %A Krikštolaitis,Ričardas %A Krilavičius,Tomas %A Juozaitytė,Elona %A Bunevičius,Adomas %+ Department of Neurology, Columbia University Vagelos College of Physicians and Surgeons, 710 W 168th St, New York, NY, 10032, United States, 1 617 417 7174, a.bunevicius@yahoo.com %K cancer %K digital phenotyping %K biomarkers %K oncology %K digital phenotype %K biomarker %K data collection %K data generation %K monitor %K monitoring %K data collection %K predict %K prediction %K model %K models %K mobile phone %D 2023 %7 10.10.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Timely recognition of cancer progression and treatment complications is important for treatment guidance. Digital phenotyping is a promising method for precise and remote monitoring of patients in their natural environments by using passively generated data from sensors of personal wearable devices. Further studies are needed to better understand the potential clinical benefits of digital phenotyping approaches to optimize care of patients with cancer. Objective: We aim to evaluate whether passively generated data from smartphone sensors are feasible for remote monitoring of patients with cancer to predict their disease trajectories and patient-centered health outcomes. Methods: We will recruit 200 patients undergoing treatment for cancer. Patients will be followed up for 6 months. Passively generated data by sensors of personal smartphone devices (eg, accelerometer, gyroscope, GPS) will be continuously collected using the developed LAIMA smartphone app during follow-up. We will evaluate (1) mobility data by using an accelerometer (mean time of active period, mean time of exertional physical activity, distance covered per day, duration of inactive period), GPS (places of interest visited daily, hospital visits), and gyroscope sensors and (2) sociability indices (frequency of duration of phone calls, frequency and length of text messages, and internet browsing time). Every 2 weeks, patients will be asked to complete questionnaires pertaining to quality of life (European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire [EORTC QLQ-C30]), depression symptoms (Patient Health Questionnaire-9 [PHQ-9]), and anxiety symptoms (General Anxiety Disorder-7 [GAD-7]) that will be deployed via the LAIMA app. Clinic visits will take place at 1-3 months and 3-6 months of the study. Patients will be evaluated for disease progression, cancer and treatment complications, and functional status (Eastern Cooperative Oncology Group) by the study oncologist and will complete the questionnaire for evaluating quality of life (EORTC QLQ-C30), depression symptoms (PHQ-9), and anxiety symptoms (GAD-7). We will examine the associations among digital, clinical, and patient-reported health outcomes to develop prediction models with clinically meaningful outcomes. Results: As of July 2023, we have reached the planned recruitment target, and patients are undergoing follow-up. Data collection is expected to be completed by September 2023. The final results should be available within 6 months after study completion. Conclusions: This study will provide in-depth insight into temporally and spatially precise trajectories of patients with cancer that will provide a novel digital health approach and will inform the design of future interventional clinical trials in oncology. Our findings will allow a better understanding of the potential clinical value of passively generated smartphone sensor data (digital phenotyping) for continuous and real-time monitoring of patients with cancer for treatment side effects, cancer complications, functional status, and patient-reported outcomes as well as prediction of disease progression or trajectories. International Registered Report Identifier (IRRID): PRR1-10.2196/49096 %M 37815850 %R 10.2196/49096 %U https://www.researchprotocols.org/2023/1/e49096 %U https://doi.org/10.2196/49096 %U http://www.ncbi.nlm.nih.gov/pubmed/37815850 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e45161 %T Digital Application of Clinical Staging to Support Stratification in Youth Mental Health Services: Validity and Reliability Study %A Chong,Min K %A Hickie,Ian B %A Cross,Shane P %A McKenna,Sarah %A Varidel,Mathew %A Capon,William %A Davenport,Tracey A %A LaMonica,Haley M %A Sawrikar,Vilas %A Guastella,Adam %A Naismith,Sharon L %A Scott,Elizabeth M %A Iorfino,Frank %+ Brain and Mind Centre, University of Sydney, 94 Mallett Street, Camperdown, 2050, Australia, 61 291142199, min.chong@sydney.edu.au %K clinical staging %K digital health solution %K online diagnosis %K service transformation %K staged care %K stratified care %K youth mental health %D 2023 %7 8.9.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: As the demand for youth mental health care continues to rise, managing wait times and reducing treatment delays are key challenges to delivering timely and quality care. Clinical staging is a heuristic model for youth mental health that can stratify care allocation according to individuals’ risk of illness progression. The application of staging has been traditionally limited to trained clinicians yet leveraging digital technologies to apply clinical staging could increase the scalability and usability of this model in services. Objective: The aim of this study was to validate a digital algorithm to accurately differentiate young people at lower and higher risk of developing mental disorders. Methods: We conducted a study with a cohort comprising 131 young people, aged between 16 and 25 years, who presented to youth mental health services in Australia between November 2018 and March 2021. Expert psychiatrists independently assigned clinical stages (either stage 1a or stage 1b+), which were then compared to the digital algorithm’s allocation based on a multidimensional self-report questionnaire. Results: Of the 131 participants, the mean age was 20.3 (SD 2.4) years, and 72% (94/131) of them were female. Ninety-one percent of clinical stage ratings were concordant between the digital algorithm and the experts’ ratings, with a substantial interrater agreement (κ=0.67; P<.001). The algorithm demonstrated an accuracy of 91% (95% CI 86%-95%; P=.03), a sensitivity of 80%, a specificity of 93%, and an F1-score of 73%. Of the concordant ratings, 16 young people were allocated to stage 1a, while 103 were assigned to stage 1b+. Among the 12 discordant cases, the digital algorithm allocated a lower stage (stage 1a) to 8 participants compared to the experts. These individuals had significantly milder symptoms of depression (P<.001) and anxiety (P<.001) compared to those with concordant stage 1b+ ratings. Conclusions: This novel digital algorithm is sufficiently robust to be used as an adjunctive decision support tool to stratify care and assist with demand management in youth mental health services. This work could transform care pathways and expedite care allocation for those in the early stages of common anxiety and depressive disorders. Between 11% and 27% of young people seeking care may benefit from low-intensity, self-directed, or brief interventions. Findings from this study suggest the possibility of redirecting clinical capacity to focus on individuals in stage 1b+ for further assessment and intervention. %M 37682588 %R 10.2196/45161 %U https://formative.jmir.org/2023/1/e45161 %U https://doi.org/10.2196/45161 %U http://www.ncbi.nlm.nih.gov/pubmed/37682588 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e46526 %T Supervised Home-Based Exercise Prehabilitation in Unfit Patients Scheduled for Pancreatic Surgery: Protocol for a Multicenter Feasibility Study %A Hildebrand,Nicole D %A Wijma,Allard G %A Bongers,Bart C %A Rensen,Sander S %A den Dulk,Marcel %A Klaase,Joost M %A Olde Damink,Steven W M %+ Department of Surgery, Maastricht University Medical Center+, P. Debyelaan 25, Maastricht, 6229 HX, Netherlands, 31 (0)43 3875492, nicole.hildebrand@mumc.nl %K preoperative care %K prehabilitation %K preoperative training %K high-intensity interval training %K pancreatic resection %K cardiorespiratory fitness %D 2023 %7 7.9.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Morbidity rates in pancreatic surgery are high, and frail patients with low aerobic capacity are especially at risk of complications and require prophylactic interventions. Previous studies of small patient cohorts receiving intra-abdominal surgery have shown that an exercise prehabilitation program increases aerobic capacity, leading to better treatment outcomes. Objective: In this study, we aim to assess the feasibility of a home-based exercise prehabilitation program in unfit patients scheduled for pancreatic surgery on a larger scale. Methods: In this multicenter study, adult patients scheduled for elective pancreatic surgery with a preoperative oxygen uptake (VO2) at the ventilatory anaerobic threshold ≤13 mL/kg/min or a VO2 at peak exercise ≤18 mL/kg/min will be recruited. A total of 30 patients will be included in the 4-week, home-based, partly supervised exercise prehabilitation program. The program comprises 25-minute high-intensity interval training on an advanced cycle ergometer 3 times a week. Training intensity will be based on steep ramp test performance (ie, a short-term maximal exercise test on a cycle ergometer), aiming to improve aerobic capacity. Twice a week, patients will perform functional task exercises to improve muscle function and functional mobility. A steep ramp test will be repeated weekly, and training intensity will be adjusted accordingly. Next to assessing the feasibility (participation rate, reasons for nonparticipation, adherence, dropout rate, reasons for dropout, adverse events, and patient and therapist appreciation) of this program, individual patients’ responses to prehabilitation on aerobic capacity, functional mobility, body composition, quality of life, and immune system factors will be evaluated. Results: Recruitment for this study began in January 2022 and is expected to be completed in the summer of 2023. Conclusions: Results of this study will provide important clinical and scientific knowledge on the feasibility of a partly supervised home-based exercise prehabilitation program in a vulnerable patient population. This might ease the path to implementing prehabilitation programs in unfit patients undergoing complex abdominal surgery, such as pancreatic surgery. Trial Registration: ClinicalTrials.gov NCT05496777; https://classic.clinicaltrials.gov/ct2/show/NCT05496777 International Registered Report Identifier (IRRID): DERR1-10.2196/46526 %M 37676715 %R 10.2196/46526 %U https://www.researchprotocols.org/2023/1/e46526 %U https://doi.org/10.2196/46526 %U http://www.ncbi.nlm.nih.gov/pubmed/37676715 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 10 %N %P e46508 %T Evaluating a Smartphone App (MeT4VeT) to Support the Mental Health of UK Armed Forces Veterans: Feasibility Randomized Controlled Trial %A Parkes,Steven %A Croak,Bethany %A Brooks,Samantha K %A Stevelink,Sharon A M %A Leightley,Daniel %A Fear,Nicola T %A Rafferty,Laura %A Greenberg,Neil %+ King’s Centre for Military Health Research, Institute of Psychiatry, Psychology & Neuroscience, King’s College London, 10 Cutcombe Road, London, SE5 9RJ, United Kingdom, 44 0207848 ext 5335, steven.j.parkes@kcl.ac.uk %K military %K veteran %K mental health %K military to civilian transition %K digital health %K mobile apps %K smartphone %K mobile phone %K mobile health %K mHealth %K digital intervention %K support %K app %K feasibility %K acceptability %K engagement %K usability %D 2023 %7 28.8.2023 %9 Original Paper %J JMIR Ment Health %G English %X Background: Previous research demonstrates that less than 50% of military veterans experiencing mental health difficulties seek formal support. Veterans often struggle to identify problems as mental health difficulties. In addition, they may fail to recognize the need for support before reaching a crisis point and face difficulties navigating care pathways to access support. Objective: A feasibility trial was conducted to assess a novel digital smartphone app (Mental Health Toolkit for Veterans Project [MeT4VeT]) for UK Armed Forces (UKAF) veterans experiencing mental health difficulties. The trial aimed to explore the feasibility and acceptability of trial procedures for a later randomized controlled trial (RCT) and to assess the acceptability of the MeT4VeT app. Methods: Participants were recruited at UK military medical centers, by advertising on social media, and through veteran third-sector organizations between February and November 2021, and assessed for eligibility (male, owned a smartphone, served at least 2 years in the UKAF, left the UKAF within the last 2 years, not undertaking formal mental health treatment). Eligible participants were assigned, on a 1:1 ratio, to either the intervention group (full app) or a control group (noninteractive app with signposting information). Three key objectives were determined a priori to assess the practicality of running an RCT including an assessment of recruitment and retention, evaluation of the technical app delivery and measurement processes, and acceptability and usability of the intervention. Results: In total, 791 individuals completed the participant information sheet, of which 261 (33%) were ineligible, 377 (48%) declined or were unable to be contacted for consent, and 103 (13%) did not download the app or complete the baseline measures. Of this, 50 participants completed baseline measures and were randomly assigned to the intervention group (n=24) or the control group (n=26). The trial was effective at enabling both the technical delivery of the intervention and collection of outcome measures, with improvements in mental health demonstrated for the intervention group from baseline to the 3-month follow-up. Recruitment and retention challenges were highlighted with only 50 out of the 530 eligible participants enrolled in the trial. The acceptability and usability of the MeT4VeT app were generally supported, and it was reported to be a useful, accessible way for veterans to monitor and manage their mental health. Conclusions: The results highlighted that further work is needed to refine recruitment processes and maintain engagement with the app. Following this, an RCT can be considered to robustly assess the ability of the app to positively affect mental health outcomes indicated within this trial. Trial Registration: ClinicalTrials.gov NCT05993676; https://clinicaltrials.gov/ct2/show/NCT05993676 %M 37639295 %R 10.2196/46508 %U https://mental.jmir.org/2023/1/e46508 %U https://doi.org/10.2196/46508 %U http://www.ncbi.nlm.nih.gov/pubmed/37639295 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e49284 %T A Digital Music-Based Mindfulness Intervention for Black Americans With Elevated Race-Based Anxiety: A Multiple-Baseline Pilot Study %A Jones,Grant %A Herrmann,Felipe %A Nock,Matthew K %+ Harvard University, 33 Kirkland Street, Cambridge, MA, 02138, United States, gmj005@g.harvard.edu %K Black music %K mindfulness %K meditation %K single-case experiment %K race %K anxiety %K mindfulness %K digital health intervention %K low income %K Black community %K racial disparity %D 2023 %7 16.8.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Race-based anxiety is a substantial health issue for the Black community. Although mindfulness interventions have demonstrated efficacy for alleviating anxiety, three central barriers prevent Black Americans from accessing existing mindfulness treatments: high costs, excessive time commitments, and limited cultural relevance. There is a need for novel mindfulness interventions for the Black community that can overcome these barriers. Objective: The goal of this web-based study was to examine the preliminary efficacy, feasibility, and acceptability of a novel digital music-based mindfulness intervention for middle-to-low-income Black Americans with elevated race-based anxiety. Methods: This study used a nonconcurrent multiple-baseline design (n=5). The intervention featured contributions from Lama Rod Owens (a world-renowned meditation teacher and LA Times best-selling author) and Terry Edmonds (the former chief speechwriter for President Bill Clinton). We examined the effect of the intervention on state anxiety and assessed its feasibility and acceptability using quantitative and qualitative measures. Results: Results revealed that administration of the intervention led to significant decreases in state anxiety (Tau-U range –0.75 to –0.38; P values<.001). Virtually all feasibility and acceptability metrics were high (ie, the average likelihood of recommending the intervention was 98 out of 100). Conclusions: This study offers preliminary evidence that a digital music-based mindfulness intervention can decrease race-based anxiety in Black Americans. Future research is needed to replicate these results, test whether the intervention can elicit lasting changes in anxiety, assess mechanisms of change, and explore the efficacy of the intervention in real-world contexts. %M 37585252 %R 10.2196/49284 %U https://formative.jmir.org/2023/1/e49284 %U https://doi.org/10.2196/49284 %U http://www.ncbi.nlm.nih.gov/pubmed/37585252 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e45438 %T A Clinical Model for the Differentiation of Suicidality: Protocol for a Usability Study of the Proposed Model %A de Winter,Remco F P %A Meijer,Connie M %A Enterman,John H %A Kool-Goudzwaard,Nienke %A Gemen,Manuela %A van den Bos,Anne T %A Steentjes,Danielle %A van Son,Gabrielle E %A Hazewinkel,Mirjam C %A de Beurs,Derek P %A de Groot,Marieke H %+ Mental Health Institute Rivierduinen, Sandifortdreef 19, 2333 ZZ Leiden Postbox 405, Leiden, 2333 ZZ, Netherlands, 31 71 890 8888, bgd@rivierduinen.nl %K differentiation %K suicidality %K suicidal behavior %K subtype %K subcategory %K category %K categories %K categorize %K subcategories %K validation study %K mental health %K suicide %K suicidal %K differentiation %K classification %K psychiatry %K classify %K psychiatric %K suicide prevention %K suicidal ideation %K mental illness %K suicidal thought %K dying %K perceptual disintegration %K PD %K primary depressive cognition %K PDC %K psychosocial turmoil %K inadequate communication %K intraclass correlation coefficients %K ICC %D 2023 %7 11.8.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Even though various types of suicidality are observed in clinical practice, suicidality is still considered a uniform concept. To distinguish different types of suicidality and consequently improve detection and management of suicidality, we developed a clinical differentiation model for suicidality. We believe that the model allows for a more targeted assessment of suicidal conditions and improves the use of evidence-based treatment strategies. The differentiation model is based on the experience with suicidality that we have encountered in clinical practice. This model distinguishes 4 subtypes of entrapment leading to suicidality. The earliest description of this model and a proposal for usability research has been previously presented in a book chapter. Objective: In this study, we present the most recent version of the 4-type differentiation model of suicidality and a protocol for a study into the usability of the proposed model. Methods: The 4-type differentiation model of suicidality distinguishes the following subtypes: (1) perceptual disintegration, (2) primary depressive cognition, (3) psychosocial turmoil, and (4) inadequate coping or communication. We plan to test the usability of the 4 subtypes in a pilot study of 25 cases, and subsequently, we will include 75 cases in a follow-up study. We looked at the case notes of 100 anonymized patients with suicidality who presented to mental health care emergency service in The Hague International Center. The summary and conclusions of the letters sent to the patients’ general practitioners after suicide risk assessment will be independently rated by 3 psychiatrists and 3 nurse-scientists for absolute and dimensional scores. The Suicidality Differentiation version 2 (SUICIDI-II) instrument, developed for this study, is used for rating all the cases. Intraclass correlation coefficients for absolute and dimensional scores will be calculated to examine type agreement between raters to examine the usability of the model and the feasibility of the SUICIDI-II instrument. Results: We consider the model tentatively valid if the intraclass correlation coefficients are ≥0.70. Subsequently, if the model turns out to be valid, we plan to rate 75 other cases in a follow-up study, according to a similar or adjusted procedure. Study results are expected to be published by the end of 2023. Conclusions: The theoretical roots of the differentiation model stem from classic and contemporary theoretical models of suicidality and from our clinical practice experiences with suicidal behaviors. We believe that this model can be used to adjust the diagnosis, management, treatment, and research of suicidality, in addition to distinguishing different dynamics between practitioners and patients with suicidality and their families. International Registered Report Identifier (IRRID): DERR1-10.2196/45438 %M 37566444 %R 10.2196/45438 %U https://www.researchprotocols.org/2023/1/e45438 %U https://doi.org/10.2196/45438 %U http://www.ncbi.nlm.nih.gov/pubmed/37566444 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e45666 %T Referring Adolescent Primary Care Patients to Single-Session Interventions for Anxiety and Depression: Protocol for a Feasibility Study %A Eyllon,Mara %A Dalal,Michelle %A Jans,Laura %A Sotomayor,Ian %A Peloquin,Gabrielle %A Yon,James %A Fritz,Rochelle %A Schleider,Jessica %+ Practice Research Network, Reliant Medical Group, 5 Neponset Street, Worcester, MA, 01606, United States, 1 6178754554, mara.eyllon@reliantmedicalgroup.org %K adolescents %K behavioral health care %K mental health %K primary care %K single-session interventions %D 2023 %7 9.8.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Despite the growing prevalence of depression and anxiety among adolescents, fewer than half access appropriate mental health care. Single-session interventions (SSIs) for depression and anxiety offered in primary care are a promising approach to bridging the treatment gap. Objective: We aimed to implement a clinical workflow for primary care and behavioral health providers to refer patients aged 13 to 17 years with mild to moderate depression and anxiety symptoms to Project YES (Youth Empowerment and Support), an open-access SSI platform, in a large group medical practice with an integrated behavioral health department. Methods: Pediatric primary care and integrated behavioral health providers will be educated on the benefits of Project YES for adolescent anxiety and depression and trained in a workflow integrated within the electronic health record system, Epic, to refer patients during well-child visits and pediatric behavioral health visits. Patients with mild to moderate internalizing symptoms based on the 17-item Pediatric Symptom Checklist or youth Pediatric Symptom Checklist will be invited to try an SSI through Project YES. We will examine provider uptake and perceptions of acceptability, feasibility, and appropriateness over time. Results: The rollout will take place between November 2022 and May 2023, when outcomes will be evaluated. Data analysis and manuscript writing are anticipated to be completed during the summer of 2023. Conclusions: SSIs such as those available through Project YES have the potential to provide low-cost, evidence-based mental health treatment to adolescents with mild to moderate depression and anxiety. If deemed feasible and acceptable, providing SSIs in primary care settings could significantly improve access to mental health care without taxing pediatric primary care and behavioral health providers. International Registered Report Identifier (IRRID): DERR1-10.2196/45666 %M 37556202 %R 10.2196/45666 %U https://www.researchprotocols.org/2023/1/e45666 %U https://doi.org/10.2196/45666 %U http://www.ncbi.nlm.nih.gov/pubmed/37556202 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e40277 %T Expressive Interviewing Agents to Support Health-Related Behavior Change: Randomized Controlled Study of COVID-19 Behaviors %A Stewart,Ian %A Welch,Charles %A An,Lawrence %A Resnicow,Ken %A Pennebaker,James %A Mihalcea,Rada %+ School of Computer Science and Engineering, University of Michigan, 2260 Hayward Street, Ann Arbor, MI, 48109, United States, 1 7347648504, ianbstew@umich.edu %K expressive writing %K motivational interviewing %K dialogue systems %K counseling %K behavior change %K text analysis %K COVID-19 %K mental health %K automated writing %K writing system %K stress %K psychological health %D 2023 %7 1.8.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Expressive writing and motivational interviewing are well-known approaches to help patients cope with stressful life events. Although these methods are often applied by human counselors, it is less well understood if an automated artificial intelligence approach can benefit patients. Providing an automated method would help expose a wider range of people to the possible benefits of motivational interviewing, with lower cost and more adaptability to sudden events like the COVID-19 pandemic. Objective: This study presents an automated writing system and evaluates possible outcomes among participants with respect to behavior related to the COVID-19 pandemic. Methods: We developed a rule-based dialogue system for “Expressive Interviewing” to elicit writing from participants on the subject of how COVID-19 has impacted their lives. The system prompts participants to describe their life experiences and emotions and provides topic-specific prompts in response to participants’ use of topical keywords. In May 2021 and June 2021, we recruited participants (N=151) via Prolific to complete either the Expressive Interviewing task or a control task. We surveyed participants immediately before the intervention, immediately after the intervention, and again 2 weeks after the intervention. We measured participants’ self-reported stress, general mental health, COVID-19–related health behavior, and social behavior. Results: Participants generally wrote long responses during the task (53.3 words per response). In aggregate, task participants experienced a significant decrease in stress in the short term (~23% decrease, P<.001) and a slight difference in social activity compared with the control group (P=.03). No significant differences in short-term or long-term outcomes were detected between participant subgroups (eg, male versus female participants) except for some within-condition differences by ethnicity (eg, higher social activity among African American people participating in Expressive Interviewing vs participants of other ethnicities). For short-term effects, participants showed different outcomes based on their writing. Using more anxiety-related words was correlated with a greater short-term decrease in stress (r=–0.264, P<.001), and using more positive emotion words was correlated with a more meaningful experience (r=0.243, P=.001). As for long-term effects, writing with more lexical diversity was correlated with an increase in social activity (r=0.266, P<.001). Conclusions: Expressive Interviewing participants exhibited short-term, but not long-term, positive changes in mental health, and some linguistic metrics of writing style were correlated with positive change in behavior. Although there were no significant long-term effects observed, the positive short-term effects suggest that the Expressive Interviewing intervention could be used in cases in which a patient lacks access to traditional therapy and needs a short-term solution. Trial Registration: Clincaltrials.gov NCT05949840; https://www.clinicaltrials.gov/study/NCT05949840 %M 37074948 %R 10.2196/40277 %U https://formative.jmir.org/2023/1/e40277 %U https://doi.org/10.2196/40277 %U http://www.ncbi.nlm.nih.gov/pubmed/37074948 %0 Journal Article %@ 2561-6722 %I JMIR Publications %V 6 %N %P e44701 %T Comparing the Effectiveness of a Web-Based Application With a Digital Live Seminar to Improve Safe Communication for Pregnant Women: 3-Group Partially Randomized Controlled Trial %A Kötting,Lukas %A Derksen,Christina %A Keller,Franziska Maria %A Lippke,Sonia %+ Psychology & Methods, Constructor University, Campus Ring 1, Bremen, 28759, Germany, 49 421 200 4721, l.koetting@jacobs-university.de %K Health Action Process Approach %K HAPA %K intention %K safe communication behavior %K patient safety %K obstetric patients %K digital intervention %K web-based app %D 2023 %7 24.7.2023 %9 Original Paper %J JMIR Pediatr Parent %G English %X Background: Medical internet interventions such as asynchronous apps and synchronous digital live seminars can be effective behavior change interventions. The research question of this study was whether digital interventions based on the Health Action Process Approach can improve pregnant women’s safe communication and patient safety in obstetric care. Objective: This study aims to compare a digital live seminar with a web-based application intervention and a passive control group and to identify which social cognitive variables determine safe communication behavior and patient safety. Methods: In total, 657 pregnant women were recruited, and hereof, 367 expectant mothers from 2 German university hospitals participated in the pre-post study (live seminar: n=142; web-based app: n=81; passive control group: n=144). All interventions targeted intention, planning, self-efficacy, and communication of personal preferences. The 2.5-hour midwife-assisted live seminar included exercises on empathy and clear communication. The fully automated web-based application consisted of 9 consecutive training lessons with the same content as that of the live seminar. Results: Controlled for sociodemographic characteristics, repeated measures analyses of covariance revealed that pregnant women significantly improved their self-reported communication behavior in all groups. The improvement was more pronounced after the digital live seminar than after the web-based application (P<.001; ηp2=0.043). Perceived patient safety improved more for pregnant women participating in the live seminar than for those participating in the web-based application group (P=.03 ηp2=0.015). A regression analysis revealed that social cognitive variables predicted safe communication behavior. Conclusions: Overall, the web-based application intervention appeared to be less effective than the digital live training in terms of communication behavior. Application interventions addressing communication behaviors might require more face-to-face elements. Improving intention, coping planning, and coping self-efficacy appeared to be key drivers in developing safe communication behavior in pregnant women. Future research should include social learning aspects and focus on the practical application of medical internet interventions when aiming to improve pregnant women’s communication and patient safety in obstetrics. Trial Registration: ClinicalTrials.gov NCT03855735; https://clinicaltrials.gov/ct2/show/NCT03855735 %M 37486755 %R 10.2196/44701 %U https://pediatrics.jmir.org/2023/1/e44701 %U https://doi.org/10.2196/44701 %U http://www.ncbi.nlm.nih.gov/pubmed/37486755 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e47025 %T Ultrasound-Assisted Continence Care Support in an Inpatient Care Setting: Protocol for a Pilot Implementation Study %A Hofstetter,Sebastian %A Ritter-Herschbach,Madeleine %A Behr,Dominik %A Jahn,Patrick %+ AG-Versorgungsforschung/Pflege im Krankenhaus, Departement of Internel Medicine, Martin-Luther-University Halle-Wittenberg, Ernst-Grube-Str. 40, Halle (Saale), 06120, Germany, 49 +345557 ext 4244, sebastian.hofstetter@medizin.uni-halle.de %K bladder control %K bladder dysfunction %K continence care %K digitization %K incontinence %K nursing %K selfmanagement %K ultrasound %K urology %K user requirements %D 2023 %7 13.7.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: This nonrandomized exploratory intervention and feasibility study examines how digital assistive technology (DAT), comprising a DFree ultrasound sensor, affects nursing care for continence support and evaluates nurses’ willingness to incorporate DAT into the planning and practical implementation of care processes. Objective: The relief provided by DFree in the clinical care setting and the extent to which it supports nursing care for activities of daily living pertaining to “micturition” is unclear. DAT DFree is expected to reduce nurses’ workload in clinical continence-care settings and was designed as a human-technology interaction that ensures a high level of usability for the subjects (ie, the nurses) and increases user acceptance by at least one level (eg, from average to slightly above average) during the study. Methods: Approximately 45 nurses from neurology, neurosurgery, and geriatric medicine clinics and polyclinics at the University Medicine Halle will be included in the 90-day (3-month) intervention on-site in the respective wards. After the wards are equipped with digital technologies, the participating nurses will be trained to use DFree and will be able to select DFree as a possible patient-care resource if the anamnesis includes bladder dysfunction among only patients who are willing to participate. The willingness of nurse participants to use DFree in planning their care process will be assessed using the Technology Usage Inventory at 3 measurement points. The primary target values include the results of the multidimensional Technology Usage Inventory assessment that will be processed using descriptive statistics. Ten participating nurses will be invited to conduct extensive guided interviews that are intended to provide information about the device’s usefulness and feasibility in the specific field of continence care and possible improvements. Results: It is expected that the intention to use will be confirmed by nurses, and the number of nursing problems, such as bladder dysfunction-induced bedwetting, will be reduced with a high rating of DAT usability. Conclusions: First, this study aims to produce multilevel innovative impacts, including practical, scientific, and societal effects. The results will provide practical solutions for workload reduction in the field of nursing support for continence care, where digital assistive technologies are becoming increasingly important. The DFree ultrasonic sensor is a new technical tool for the treatment of bladder dysfunction. Generating feedback to improve technical applications can increase the user-friendliness and usefulness of the device. Trial Registration: Deutsches Register Klinischer Studien DRKS00031483; https://drks.de/search/en/trial/DRKS00031483 International Registered Report Identifier (IRRID): PRR1-10.2196/47025 %M 37317590 %R 10.2196/47025 %U https://www.researchprotocols.org/2023/1/e47025 %U https://doi.org/10.2196/47025 %U http://www.ncbi.nlm.nih.gov/pubmed/37317590 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e47516 %T Feasibility, Engagement, and Usability of a Remote, Smartphone-Based Contingency Management Program as a Treatment Add-On for Patients Who Use Methamphetamine: Single-Arm Pilot Study %A Hallgren,Kevin A %A Duncan,Mark H %A Iles-Shih,Matthew D %A Cohn,Eliza B %A McCabe,Connor J %A Chang,Yanni M %A Saxon,Andrew J %+ Department of Psychiatry and Behavioral Sciences, University of Washington, Box 356560, 1959 NE Pacific St., Seattle, WA, 98195, United States, 1 206 616 2906, khallgre@uw.edu %K contingency management %K methamphetamine use disorder %K mobile health %K mHealth %K mobile phone %D 2023 %7 6.7.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: In the United States, methamphetamine-related overdoses have tripled from 2015 to 2020 and continue to rise. However, efficacious treatments such as contingency management (CM) are often unavailable in health systems. Objective: We conducted a single-arm pilot study to evaluate the feasibility, engagement, and usability of a fully remotely delivered mobile health CM program offered to adult outpatients who used methamphetamine and were receiving health care within a large university health system. Methods: Participants were referred by primary care or behavioral health clinicians between September 2021 and July 2022. Eligibility criteria screening was conducted by telephone and included self-reported methamphetamine use on ≥5 out of the past 30 days and a goal of reducing or abstaining from methamphetamine use. Eligible participants who agreed to take part then completed an initial welcome phase that included 2 videoconference calls to register for and learn about the CM program and 2 “practice” saliva-based substance tests prompted by a smartphone app. Participants who completed these welcome phase activities could then receive the remotely delivered CM intervention for 12 consecutive weeks. The intervention included approximately 24 randomly scheduled smartphone alerts requesting a video recording of themselves taking a saliva-based substance test to verify recent methamphetamine abstinence, 12 weekly calls with a CM guide, 35 self-paced cognitive behavioral therapy modules, and multiple surveys. Financial incentives were disbursed via reloadable debit cards. An intervention usability questionnaire was completed at the midpoint. Results: Overall, 37 patients completed telephone screenings, with 28 (76%) meeting the eligibility criteria and consenting to participate. Most participants who completed a baseline questionnaire (21/24, 88%) self-reported symptoms consistent with severe methamphetamine use disorder, and most had other co-occurring non-methamphetamine substance use disorders (22/28, 79%) and co-occurring mental health disorders (25/28, 89%) according to existing electronic health records. Overall, 54% (15/28) of participants successfully completed the welcome phase and were able to receive the CM intervention. Among these participants, engagement with substance testing, calls with CM guides, and cognitive behavioral therapy modules varied. Rates of verified methamphetamine abstinence in substance testing were generally low but varied considerably across participants. Participants reported positive opinions about the intervention’s ease of use and satisfaction with the intervention. Conclusions: Fully remote CM can be feasibly delivered within health care settings lacking existing CM programs. Although remote delivery may help reduce barriers to treatment access, many patients who use methamphetamine may struggle to engage with initial onboarding. High rates of co-occurring psychiatric conditions in the patient population may also contribute to uptake and engagement challenges. Future efforts could leverage greater human-to-human connection, more streamlined onboarding procedures, larger incentives, longer durations, and the incentivization of non–abstinence-based recovery goals to increase uptake and engagement with fully remote mobile health–based CM. %M 37410529 %R 10.2196/47516 %U https://formative.jmir.org/2023/1/e47516 %U https://doi.org/10.2196/47516 %U http://www.ncbi.nlm.nih.gov/pubmed/37410529 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e45477 %T Internet of Things and New Technologies for Tracking Perioperative Patients With an Innovative Model for Operating Room Scheduling: Protocol for a Development and Feasibility Study %A Bottani,Eleonora %A Bellini,Valentina %A Mordonini,Monica %A Pellegrino,Mattia %A Lombardo,Gianfranco %A Franchi,Beatrice %A Craca,Michelangelo %A Bignami,Elena %+ Anesthesiology, Critical Care and Pain Medicine Division, Department of Medicine and Surgery, University of Parma, Viale Gramsci 14, Parma, 43126, Italy, 39 0521 033609, elenagiovanna.bignami@unipr.it %K internet of things %K artificial intelligence %K machine learning %K perioperative organization %K operating rooms %D 2023 %7 5.7.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Management of operating rooms is a critical point in health care organizations because surgical departments represent a significant cost in hospital budgets. Therefore, it is increasingly important that there is effective planning of elective, emergency, and day surgery and optimization of both the human and physical resources available, always maintaining a high level of care and health treatment. This would lead to a reduction in patient waiting lists and better performance not only of surgical departments but also of the entire hospital. Objective: This study aims to automatically collect data from a real surgical scenario to develop an integrated technological-organizational model that optimizes operating block resources. Methods: Each patient is tracked and located in real time by wearing a bracelet sensor with a unique identifier. Exploiting the indoor location, the software architecture is able to collect the time spent for every step inside the surgical block. This method does not in any way affect the level of assistance that the patient receives and always protects their privacy; in fact, after expressing informed consent, each patient will be associated with an anonymous identification number. Results: The preliminary results are promising, making the study feasible and functional. Times automatically recorded are much more precise than those collected by humans and reported in the organization’s information system. In addition, machine learning can exploit the historical data collection to predict the surgery time required for each patient according to the patient’s specific profile. Simulation can also be applied to reproduce the system’s functioning, evaluate current performance, and identify strategies to improve the efficiency of the operating block. Conclusions: This functional approach improves short- and long-term surgical planning, facilitating interaction between the various professionals involved in the operating block, optimizing the management of available resources, and guaranteeing a high level of patient care in an increasingly efficient health care system. Trial Registration: ClinicalTrials.gov NCT05106621; https://clinicaltrials.gov/ct2/show/NCT05106621 International Registered Report Identifier (IRRID): DERR1-10.2196/45477 %M 37405821 %R 10.2196/45477 %U https://www.researchprotocols.org/2023/1/e45477 %U https://doi.org/10.2196/45477 %U http://www.ncbi.nlm.nih.gov/pubmed/37405821 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e46659 %T Automated Diet Capture Using Voice Alerts and Speech Recognition on Smartphones: Pilot Usability and Acceptability Study %A Chikwetu,Lucy %A Daily,Shaundra %A Mortazavi,Bobak J %A Dunn,Jessilyn %+ Department of Biomedical Engineering, Duke University, 1427 FCIEMAS, Durham, NC, 27708, United States, 1 9196605131, jessilyn.dunn@duke.edu %K automatic dietary monitoring %K ADM %K food logging %K diet logging %K voice technologies %K voice alert %K speech recognition %K natural language processing %K NLP %D 2023 %7 16.5.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Effective monitoring of dietary habits is critical for promoting healthy lifestyles and preventing or delaying the onset and progression of diet-related diseases, such as type 2 diabetes. Recent advances in speech recognition technologies and natural language processing present new possibilities for automated diet capture; however, further exploration is necessary to assess the usability and acceptability of such technologies for diet logging. Objective: This study explores the usability and acceptability of speech recognition technologies and natural language processing for automated diet logging. Methods: We designed and developed base2Diet—an iOS smartphone application that prompts users to log their food intake using voice or text. To compare the effectiveness of the 2 diet logging modes, we conducted a 28-day pilot study with 2 arms and 2 phases. A total of 18 participants were included in the study, with 9 participants in each arm (text: n=9, voice: n=9). During phase I of the study, all 18 participants received reminders for breakfast, lunch, and dinner at preselected times. At the beginning of phase II, all participants were given the option to choose 3 times during the day to receive 3 times daily reminders to log their food intake for the remainder of the phase, with the ability to modify the selected times at any point before the end of the study. Results: The total number of distinct diet logging events per participant was 1.7 times higher in the voice arm than in the text arm (P=.03, unpaired t test). Similarly, the total number of active days per participant was 1.5 times higher in the voice arm than in the text arm (P=.04, unpaired t test). Furthermore, the text arm had a higher attrition rate than the voice arm, with only 1 participant dropping out of the study in the voice arm, while 5 participants dropped out in the text arm. Conclusions: The results of this pilot study demonstrate the potential of voice technologies in automated diet capturing using smartphones. Our findings suggest that voice-based diet logging is more effective and better received by users compared to traditional text-based methods, underscoring the need for further research in this area. These insights carry significant implications for the development of more effective and accessible tools for monitoring dietary habits and promoting healthy lifestyle choices. %M 37191989 %R 10.2196/46659 %U https://formative.jmir.org/2023/1/e46659 %U https://doi.org/10.2196/46659 %U http://www.ncbi.nlm.nih.gov/pubmed/37191989 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e44385 %T Exploring Access as a Process of Adaptation in a Self-Monitoring Perinatal eHealth System: Mixed Methods Study From a Sociomaterial Perspective %A Auxier,Jennifer %A Savolainen,Kaisu T %A Bender,Miriam %A Rahmani,Amir M %A Sarhaddi,Fatemeh %A Azimi,Iman %A Axelin,Anna M %+ Donald Bren School of Information and Computer Sciences, University of California, Irvine, 123 street, Irvine, CA, 123 431, United States, 1 4516819876, a.rahmani@uci.edu %K patient engagement %K eHealth %K pregnancy %K motivation %K pregnant %K maternal %K cocreation %K participatory %K codesign %K use pattern %K usage %K self-monitor %K sociomaterial %D 2023 %7 15.5.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: The development and quality assurance of perinatal eHealth self-monitoring systems is an upcoming area of inquiry in health science. Building patient engagement into eHealth development as a core component has potential to guide process evaluation. Access, 1 attribute of patient engagement, is the focus of study here. Access to eHealth self-monitoring programs has the potential to influence pregnancy health and wellness outcomes. Little is known about how pregnant users’ ability to obtain resources is influenced by their own adaptive activities and the mediating activities of eHealth systems during the process of real-world testing of these systems. Objective: Here, we examine the patient engagement process of access occurring during the adaptation of eHealth self-monitoring use from a sociomaterial perspective. Methods: In this mixed methods convergent evaluation design, we interviewed women about perceptions of the adaptation process of using an eHealth self-monitoring system. Deductive analysis was conducted guided by the definition of access as an attribute of patient engagement. After initial qualitative and quantitative data collection and analysis, participants were spilt based on their level of use of the eHealth system (physical wear time of self-monitoring device). Content analysis was then conducted according to user group, using a conceptual matrix developed from ontological perspectives of sociomateriality. Results: Pregnant users’ adaptive activities and the mediation activities of the eHealth system represent a cocreation process that resulted in user group–specific characteristics of accessing and using the system. The high- and low-use groups experienced different personal adaptation and eHealth mediation during this process of cocreation. Differences were noted between high- and low-use groups, with the high-use group giving attention to developing skills in recording and interpreting data and the low-use group discussing the manual adding of activities to the system and how the system worked best for them when they used it in their mother tongue. Conclusions: A cocreation process between pregnant users and the eHealth system was identified, illustrating access as a useful core component of perinatal eHealth self-monitoring systems. Researchers and clinicians can observe reasons for why pregnant users access eHealth systems in unique ways based on their personal preferences, habits, and values. Mediation activities of the eHealth system and the different user adaptive activities represent a cocreation process between the users and the eHealth system that is necessary for the personalization of perinatal eHealth systems. %M 37184929 %R 10.2196/44385 %U https://formative.jmir.org/2023/1/e44385 %U https://doi.org/10.2196/44385 %U http://www.ncbi.nlm.nih.gov/pubmed/37184929 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e44632 %T Evaluating the Feasibility of Emotion Expressions in Avatars Created From Real Person Photos: Pilot Web-Based Survey of Virtual Reality Software %A Dechsling,Anders %A Cogo-Moreira,Hugo %A Gangestad,Jonathan Spydevold %A Johannessen,Sandra Nettum %A Nordahl-Hansen,Anders %+ Department of Education, ICT and Learning, Faculty of Teacher Education and Languages, Østfold University College, B R A veien 4, Halden, NO-1757, Norway, 47 69608000, anders.dechsling@hiof.no %K avatar %K emotion recognition %K emotion %K face %K facial expression %K facial %K images %K real images %K software %K virtual reality %D 2023 %7 11.5.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: The availability and potential of virtual reality (VR) has led to an increase of its application. VR is suggested to be helpful in training elements of social competence but with an emphasis on interventions being tailored. Recognizing facial expressions is an important social skill and thus a target for training. Using VR in training these skills could have advantages over desktop alternatives. Children with autism, for instance, appear to prefer avatars over real images when assessing facial expressions. Available software provides the opportunity to transform profile pictures into avatars, thereby giving the possibility of tailoring according to an individual’s own environment. However, the emotions provided by such software should be validated before application. Objective: Our aim was to investigate whether available software is a quick, easy, and viable way of providing emotion expressions in avatars transformed from real images. Methods: A total of 401 participants from a general population completed a survey on the web containing 27 different images of avatars transformed, using a software, from real images. We calculated the reliability of each image and their level of difficulty using a structural equation modeling approach. We used Bayesian confirmatory factor analysis testing under a multidimensional first-order correlated factor structure where faces showing the same emotions represented a latent variable. Results: Few emotions were correctly perceived and rated as higher than other emotions. The factor loadings indicating the discrimination of the image were around 0.7, which means 49% shared variance with the latent factor that the face is linked with. The standardized thresholds indicating the difficulty level of the images are mostly around average, and the highest correlation is between faces showing happiness and anger. Conclusions: Only using a software to transform profile pictures to avatars is not sufficient to provide valid emotion expressions. Adjustments are needed to increase faces’ discrimination (eg, increasing reliabilities). The faces showed average levels of difficulty, meaning that they are neither very difficult nor very easy to perceive, which fits a general population. Adjustments should be made for specific populations and when applying this technology in clinical practice. %M 37166970 %R 10.2196/44632 %U https://formative.jmir.org/2023/1/e44632 %U https://doi.org/10.2196/44632 %U http://www.ncbi.nlm.nih.gov/pubmed/37166970 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e40437 %T Patient Feedback on a Mobile Medication Adherence App for Buprenorphine and Naloxone: Closed and Open-Ended Survey on Feasibility and Acceptability %A Smith,Crystal L %A Keever,Abigail %A Bowden,Theresa %A Olson,Katie %A Rodin,Nicole %A McDonell,Michael G %A Roll,John M %A Smoody,Gillian %A LeBrun,Jeff %A Miguel,Andre QC %A McPherson,Sterling M %+ Department of Community and Behavioral Health, Elson S Floyd College of Medicine, Washington State University, 412 E Spokane Falls Blvd, Spokane, WA, 99202-2131, United States, 1 509 368 6876, crystal.lederhos@wsu.edu %K opioids %K mobile technology %K medication adherence %K buprenorphine %K naloxone %K opioid use disorder %K opioid agonist therapy %K medication-assisted treatment %K medications for opioid use disorder %K opioid %K opioid use %K well-being %K quality of life %K clinic %K technology %K medication %K remote %K coaching %K tracking %K stress %K incentive %K tool %K mobile phone %D 2023 %7 19.4.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Opioid use disorders impact the health and well-being of millions of Americans. Buprenorphine and naloxone (BUP and NAL) can reduce opioid overdose deaths, decrease misuse, and improve quality of life. Unfortunately, poor medication adherence is a primary barrier to the long-term efficacy of BUP and NAL. Objective: We aimed to examine patient feedback on current and potential features of a Bluetooth-enabled pill bottle cap and associated mobile app for patients prescribed BUP and NAL for an opioid use disorder, and to solicit recommendations for improvement to effectively and appropriately tailor the technology for people in treatment for opioid use disorder. Methods: A convenience sample of patients at an opioid use disorder outpatient clinic were asked about medication adherence, opioid cravings, experience with technology, motivation for treatment, and their existent support system through a brief e-survey. Patients also provided detailed feedback on current features and features being considered for inclusion in a technology designed to increase medication adherence (eg, inclusion of a personal motivational factor, craving and stress tracking, incentives, and web-based coaching). Participants were asked to provide suggestions for improvement and considerations specifically applicable to people in treatment for opioid use disorder with BUP and NAL. Results: Twenty people with an opioid use disorder who were prescribed BUP and NAL participated (mean age 34, SD 8.67 years; 65% female; 80% White). Participants selected the most useful, second-most useful, and least useful features presented; 42.1% of them indicated that motivational reminders would be most useful, followed by craving and stress tracking (26.3%) and web-based support forums (21.1%). Every participant indicated that they had at least 1 strong motivating factor for staying in treatment, and half (n=10) indicated children as that factor. All participants indicated that they had, at some point in their lives, the most extreme craving a person could have; however, 42.1% indicated that they had no cravings in the last month. Most respondents (73.7%) stated that tracking cravings would be helpful. Most respondents (84.2%) also indicated that they believed reinforcers or prizes would help them achieve their treatment goals. Additionally, 94.7% of respondents approved of adherence tracking to accommodate this feature using smart packaging, and 78.9% of them approved of selfie videos of them taking their medication. Conclusions: Engaging patients taking treatment for opioid use disorder with BUP and NAL allowed us to identify preferences and considerations that are unique to this treatment area. As the technology developer of the pill cap and associated mobile app is able to take into consideration or integrate these preferences and suggestions, the smart cap and associated mobile app will become tailored to this population and more useful for them, which may encourage patient use of the smart cap and associated mobile app. %M 37074780 %R 10.2196/40437 %U https://formative.jmir.org/2023/1/e40437 %U https://doi.org/10.2196/40437 %U http://www.ncbi.nlm.nih.gov/pubmed/37074780 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e43512 %T Examining Visual Attention to Tobacco Marketing Materials Among Young Adult Smokers: Protocol for a Remote Webcam-Based Eye-Tracking Experiment %A Chen-Sankey,Julia %A Elhabashy,Maryam %A Gratale,Stefanie %A Geller,Jason %A Mercincavage,Melissa %A Strasser,Andrew A %A Delnevo,Cristine D %A Jeong,Michelle %A Wackowski,Olivia A %+ Center for Tobacco Studies, School of Public Health, Rutgers Biomedical and Health Sciences, 303 George St. Room 525, New Brunswick, NJ, 08901, United States, 1 838 932 1855, jc.sankey@rutgers.edu %K eye tracking %K remote eye tracking %K e-cigarette marketing %K young adults %K mobile phone %D 2023 %7 13.4.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Eye tracking provides an objective way to measure attention, which can advance researchers’ and policy makers’ understanding of tobacco marketing influences. The development of remote webcam-based eye-tracking technology, integrated with web-based crowdsourcing studies, may be a cost-effective and time-efficient alternative to laboratory-based eye-tracking methods. However, research is needed to evaluate the utility of remote eye-tracking methods. Objective: This study aimed to detail the process of designing a remote webcam-based eye-tracking experiment and provide data on associations between participant characteristics and the outcomes of experiment completion. Methods: A total of 2023 young adult (aged 18-34 years) cigarette smokers in the United States were recruited to complete a web-based survey that included a 90-second remote eye-tracking experiment that examined attention to e-cigarette marketing materials. Primary outcome measures assessed the completion of the remote eye-tracking experiment—specifically, experiment initiated versus not initiated, experiment completed versus not completed, and usable versus nonusable eye-tracking data generated. Multivariable logistic regressions examined the associations between outcome measures and participants’ sociodemographic backgrounds, tobacco use history, and electronic devices (mobile vs desktop) used during the experiment. Results: Study recruitment began on April 14, 2022, and ended on May 3, 2022. Of the 2023 survey participants, 1887 (93.28%) initiated the experiment, and 777 (38.41%) completed the experiment. Of the 777 participants who completed the experiment, 381 (49%) generated usable data. Results from the full regression models show that non-Hispanic Black participants (adjusted odds ratio [AOR] 0.64, 95% CI 0.45-0.91) were less likely to complete the eye-tracking experiment than non-Hispanic White participants. In addition, female (vs male) participants (AOR 1.46, 95% CI 1.01-2.11), those currently using (vs not using) e-cigarettes (AOR 2.08, 95% CI 1.13-3.82), and those who used mobile (vs desktop) devices (AOR 5.10, 95% CI 3.05-8.52) were more likely to generate usable eye-tracking data. Conclusions: Young adult participants were willing to try remote eye-tracking technology, and nearly half of those who completed the experiment generated usable eye-tracking data (381/777, 49%). Thus, we believe that the use of remote eye-tracking tools, integrated with crowdsourcing recruitment, can be a useful approach for the tobacco regulatory science research community to collect high-quality, large-scale eye-tracking data in a timely fashion and thereby address research questions related to the ever-evolving tobacco marketing landscape. It would be useful to investigate techniques to enhance completion rates and data usability. International Registered Report Identifier (IRRID): RR1-10.2196/43512 %M 37052989 %R 10.2196/43512 %U https://www.researchprotocols.org/2023/1/e43512 %U https://doi.org/10.2196/43512 %U http://www.ncbi.nlm.nih.gov/pubmed/37052989 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e43503 %T German Health Update Fokus (GEDA Fokus) among Residents with Croatian, Italian, Polish, Syrian, or Turkish Citizenship in Germany: Protocol for a Multilingual Mixed-Mode Interview Survey %A Koschollek,Carmen %A Zeisler,Marie-Luise %A Houben,Robin A %A Geerlings,Julia %A Kajikhina,Katja %A Bug,Marleen %A Blume,Miriam %A Hoffmann,Robert %A Hintze,Marcel %A Kuhnert,Ronny %A Gößwald,Antje %A Schmich,Patrick %A Hövener,Claudia %+ Department for Epidemiology and Health Monitoring, Robert Koch Institute, General-Pape-Straße 62-66, Berlin, 12101, Germany, 49 30187543142, KoschollekC@rki.de %K migration %K interview survey %K hard-to-survey %K health inequalities %K mixed-mode %K multilingual %D 2023 %7 12.4.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Germany has a long history of migration. In 2020, more than 1 person in every 4 people had a statistically defined, so-called migration background in Germany, meaning that the person or at least one of their parents was born with a citizenship other than German citizenship. People with a history of migration are not represented proportionately to the population within public health monitoring at the Robert Koch Institute, thus impeding differentiated analyses of migration and health. To develop strategies for improving the inclusion of people with a history of migration in health surveys, we conducted a feasibility study in 2018. The lessons learned were implemented in the health interview survey German Health Update (Gesundheit in Deutschland aktuell [GEDA]) Fokus, which was conducted among people with selected citizenships representing the major migrant groups in Germany. Objective: GEDA Fokus aimed to collect comprehensive data on the health status and social, migration-related, and structural factors among people with selected citizenships to enable differentiated explanations of the associations between migration-related aspects and their impact on migrant health. Methods: GEDA Fokus is an interview survey among people with Croatian, Italian, Polish, Syrian, or Turkish citizenship living in Germany aged 18-79 years, with a targeted sample size of 1200 participants per group. The gross sample of 33,436 people was drawn from the residents’ registration offices of 99 German municipalities based on citizenship. Sequentially, multiple modes of administration were offered. The questionnaire was available for self-administration (web-based and paper-based); in larger municipalities, personal or phone interviews were possible later on. Study documents and the questionnaire were bilingual—in German and the respective translation language depending on the citizenship. Data were collected from November 2021 to May 2022. Results: Overall, 6038 respondents participated in the survey, of whom 2983 (49.4%) were female. The median age was 39 years; the median duration of residence in Germany was 10 years, with 19.69% (1189/6038) of the sample being born in Germany. The overall response rate was 18.4% (American Association for Public Opinion Research [AAPOR] response rate 1) and was 6.8% higher in the municipalities where personal interviews were offered (19.3% vs 12.5%). Overall, 78.12% (4717/6038) of the participants self-administered the questionnaire, whereas 21.88% (1321/6038) took part in personal interviews. In total, 41.85% (2527/6038) of the participants answered the questionnaire in the German language only, 16.69% (1008/6038) exclusively used the translation. Conclusions: Offering different modes of administration, as well as multiple study languages, enabled us to recruit a heterogeneous sample of people with a history of migration. The data collected will allow differentiated analyses of the role and interplay of migration-related and social determinants of health and their impact on the health status of people with selected citizenships. International Registered Report Identifier (IRRID): DERR1-10.2196/43503 %M 36790192 %R 10.2196/43503 %U https://www.researchprotocols.org/2023/1/e43503 %U https://doi.org/10.2196/43503 %U http://www.ncbi.nlm.nih.gov/pubmed/36790192 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e38042 %T Examining a Resilience Mental Health App in Adolescents: Acceptability and Feasibility Study %A Elledge,Daniel K %A Lee,Simon Craddock %A Stewart,Sunita M %A Pop,Radu %A Trivedi,Madhukar H %A Hughes,Jennifer L %+ Center for Depression Research and Clinical Care, Department of Psychiatry, University of Texas Southwestern Medical Center, 5323 Harry Hines Boulevard, Dallas, TX, 75390-9119, United States, 1 214 648 0188, madhukar.trivedi@utsouthwestern.edu %K youth %K prevention %K resilience %K mental health app %K mobile phone %D 2023 %7 22.3.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Resilience is defined as the ability to rely on internal characteristics and external strengths to adapt to adverse events. Although universal resilience-enhancing programs are effective for adolescents, there is a need for interventions that are more easily accessible and can be customized for individual teens. Phone apps are easy to use, can be tailored to individuals, and have demonstrated positive effects for mental health outcomes. Objective: This study aimed to examine the feasibility and acceptability of a resilience app for adolescents. This app aimed to enhance resilience through modules focused on depression prevention, stress management, and healthy lifestyle approaches containing videos, measures, and practice suggestions. Furthermore, the study aimed to evaluate the effect of short-term app use on changes in resilience. Methods: In study 1, individual interviews and focus groups were conducted with adolescents, parents, teachers, and clinicians to discuss possible incentives for using a mental health app, the benefits of app use, and concerns associated with app use. Feedback from study 1 led to ideas for the prototype. In study 2, individual interviews and focus groups were conducted with adolescents, parents, teachers, and clinicians to gather feedback about the resilience app prototype. Feedback from study 2 led to changes in the prototype, although not all suggestions could be implemented. In study 3, 40 adolescents used the app for 30 days to determine feasibility and acceptability. Additionally, resilience and secondary mental health outcomes were measured before and after app use. Dependent samples 2-tailed t tests were conducted to determine whether there were changes in resilience and secondary mental health outcomes among the adolescents before and after app use. Results: Multiple themes were identified through study 1 individual interviews and focus groups, including app content, features, engagement, benefits, concerns, and improvement. Specifically, the adolescents provided helpful suggestions for making the prototype more appealing and functional for teen users. Study 2 adolescents and adults reported that the prototype was feasible and acceptable through the Computer System Usability Questionnaire (mean 6.30, SD 1.03) and Mobile App Rating Scale (mean 4.08, SD 0.61). In study 2, there were no significant differences in resilience and mental health outcomes after using the app for 30 days. There was variation between the participants in the extent to which they used the app, which may have led to variation in the results. The users appeared to prefer the depression module and survey sections, which provided mental health feedback. Conclusions: Qualitative and quantitative data provide evidence that youth are interested in a resilience mental health app and that the current prototype is feasible. Although there were no significant mental health changes in study 3 users, practical implications and future directions are discussed for mental health app research. %M 36947113 %R 10.2196/38042 %U https://formative.jmir.org/2023/1/e38042 %U https://doi.org/10.2196/38042 %U http://www.ncbi.nlm.nih.gov/pubmed/36947113 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e40675 %T Design and Implementation of the Surveys of Women: Protocol for an Address-Based Sampling Multimodal Study %A Poland,Stephanie %A Stern,Michael %A English,Ned %A Pedlow,Steven %A Archambeau,Katherine %A Carris,Kari %+ National Opinion Research Center at the University of Chicago, 55 E Monroe, Ste 3000, Chicago, IL, 60603, United States, 1 3127594261, poland-stephanie@norc.org %K multimode %K web survey %K cross-sectional %K women’s health %K reproductive health %K methods %K data collection %K implementation %K survey %K contraceptive health %K contraception %K survey methods %K data collection %K data processing %D 2023 %7 15.3.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Studies conducted in the United States such as the National Survey of Family Growth (NSFG) and the Pregnancy Risk Assessment Monitoring System (PRAMS) collect data on pregnancy intentions to aid in improving health education, services, and programs. PRAMS collects data from specific sites, and NSFG is a national household-based survey. Like NSFG, the Surveys of Women was designed to survey participants residing in households using an address-based sample and a multimode data collection approach. The Surveys of Women collects data from eligible participants in 9 states within the United States on contraception use, reproductive health, and pregnancy intentions. In this paper, we focus on the baseline data collection protocol, including sample design, data collection procedures, and data processing. We also include a brief discussion on the follow-up and endline survey methodologies. Our goal is to inform other researchers on methods to consider when fielding a household-level reproductive health survey. Objective: The Surveys of Women was developed to support state-specific research and evaluation projects, with an overall goal of understanding contraceptive health practices among women aged 18-44 years. The project collects data from respondents in 9 different states (Arizona, Alabama, Delaware, Iowa, Maryland, New Jersey, Ohio, South Carolina, and Wisconsin) over multiple rounds. Methods: Households were selected at random using address-based sampling methods. This project includes a cross-sectional baseline survey, 2 or 3 follow-up surveys with an opt-in panel of respondents, and a cross-sectional endline survey. Each round of data collection uses a multimode design through the use of a programmed web survey and a formatted hard copy questionnaire. Participants from the randomly selected households access their personalized surveys through a web survey or mail in a hard copy questionnaire. To maximize responses, these surveys follow a rigorous schedule of various prompts bolstering the survey implementation design, and the participants received a modest monetary incentive. Results: This is an ongoing project with results published separately by the evaluation teams involved with data analysis. Conclusions: The methods used in the first baseline survey informed modifications to the methods used in subsequent statewide surveys. Data collected from this project will provide insight into women’s reproductive health, contraceptive use, and abortion attitudes in the 9 selected states. The long-term goal of the project is to use a data collection methodology that collects data from a representative sample of participants to assess changes in reproductive health behaviors over time. International Registered Report Identifier (IRRID): DERR1-10.2196/40675 %M 36920469 %R 10.2196/40675 %U https://www.researchprotocols.org/2023/1/e40675 %U https://doi.org/10.2196/40675 %U http://www.ncbi.nlm.nih.gov/pubmed/36920469 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e45887 %T An Online Acceptance and Mindfulness Intervention for Chronic Pain in Veterans: Development and Protocol for a Pilot Feasibility Randomized Controlled Trial %A Reilly,Erin D %A Kathawalla,Ummul-Kiram %A Robins,Hannah E %A Heapy,Alicia A %A Hogan,Timothy P %A Waring,Molly E %A Quigley,Karen S %A Drebing,Charles E %A Bickmore,Timothy %A Volonte,Matias %A Kelly,Megan M %+ Mental Illness Research, Education, and Clinical Center, Veteran Affairs Bedford Healthcare System, Department of Veteran Affairs, 200 Springs Road, Bedford, MA, 01730, United States, 1 781 687 4191, erin.reilly@va.gov %K chronic pain %K randomized controlled trial %K usability %K acceptance and commitment therapy %K embodied conversational agent %D 2023 %7 7.3.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: In the veteran community, chronic pain is particularly prevalent and often debilitating. Until recently, veterans with chronic pain were offered primarily pharmacological intervention options, which rarely suffice and can also have negative health consequences. To better address chronic pain in veterans, the Veterans Health Administration has invested in novel, nonpharmacological behavior interventions that target both pain management and chronic pain–related functional issues. One approach, acceptance and commitment therapy (ACT) for chronic pain, is supported by decades of efficacy evidence for improving pain outcomes; however, ACT can be difficult to obtain owing to issues such as a lack of trained therapists or veterans having difficulty committing to the time and resources needed for the full clinician-led ACT protocol. Given the strong ACT evidence base combined with access limitations, we set out to develop and evaluate Veteran ACT for Chronic Pain (VACT-CP), an online program guided by an embodied conversational agent to improve pain management and functioning. Objective: The aims of this study are to develop, iteratively refine, and then conduct a pilot feasibility randomized controlled trial (RCT) of a VACT-CP group (n=20) versus a waitlist and treatment-as-usual control group (n=20). Methods: This research project includes 3 phases. In phase 1, our research team consulted with pain and virtual care experts, developed the preliminary VACT-CP online program, and conducted interviews with providers to obtain their feedback on the intervention. In phase 2, we incorporated feedback from phase 1 into the VACT-CP program and completed initial usability testing with veterans with chronic pain. In phase 3, we are conducting a small pilot feasibility RCT, with the primary outcome being assessment of usability of the VACT-CP system. Results: This study is currently in phase 3; recruitment for the RCT began in April 2022 and is expected to continue through April 2023. Data collection is expected to be completed by October 2023, with full data analysis completed by late 2023. Conclusions: The findings from this research project will provide information on the usability of the VACT-CP intervention, as well as secondary outcomes related to treatment satisfaction, pain outcomes (pain-related daily functioning and pain severity), ACT processes (pain acceptance, behavioral avoidance, and valued living), and mental and physical functioning. Trial Registration: ClinicalTrials.gov NCT03655132; https://clinicaltrials.gov/ct2/show/NCT03655132 International Registered Report Identifier (IRRID): DERR1-10.2196/45887 %M 36881446 %R 10.2196/45887 %U https://www.researchprotocols.org/2023/1/e45887 %U https://doi.org/10.2196/45887 %U http://www.ncbi.nlm.nih.gov/pubmed/36881446 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e40536 %T Feasibility and Acceptability of Wearable Cameras to Assess Self-care in People With Heart Failure: Pilot Study %A Askman,Sanna %A Löf,Marie %A Maddison,Ralph %A Nourse,Rebecca %+ Department of Health, Medicine and Caring Sciences, Linköping University, Norra Skolgatan 18, Malmö, 21152, Sweden, 46 0730773773, sanna.askman@hotmail.se %K heart failure %K HF %K life logging %K self-management %K cardiovascular disease %K wearable devices %K self management %K self-care %D 2023 %7 17.2.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Heart failure (HF) is a common chronic condition that affects over 26 million people worldwide. It is a progressive and debilitating disease with a broad symptom profile, intermittently marked by periods of acute decompensation. People with HF generally do not self-manage their condition well (eg, monitoring symptoms, taking medications regularly, physical activity, etc). A better understanding of self-care activities and what factors may indicate deterioration is warranted. Objective: The aim of this study was to determine the feasibility and acceptability of using wearable cameras to assess self-care activities in people with HF. The study objectives were to (1) explore whether changes in self-care activities could be identified prior to hospitalization and (2) determine the acceptability of wearable cameras to people with HF. Methods: A total of 30 people recently diagnosed with HF wore a camera for a maximum of 30 days; the camera took a photo every 30 seconds in the forward-facing direction. At the end of the study, all 30 participants were presented with 8 statements of acceptability, scored on a 5-point Likert scale. To determine whether camera images could identify changes in self-care activities and lifestyle risk factors before hospitalization, we analyzed images from participants (n=8) who were hospitalized during the 30-day study period. Images from the period immediately prior to hospitalization and a comparison were selected for each participant. Images were manually coded according to 9 different event categories relating to self-care and lifestyle risk factors, and events were compared between the 2 periods. Results: The participants reported high acceptability for wearing the cameras, as most strongly agreed or agreed that they were comfortable to wear (28/30, 93%) and easy to use (30/30, 100%). The results of the camera image analysis showed that participants undertook fewer activities of daily living (P=.008) and were more sedentary (P=.02) prior to being hospitalized, compared to a period nonadjacent to hospitalization. Conclusions: Adults with HF were accepting of using a wearable camera for periods within a 30-day time frame. Wearable cameras were a feasible approach for providing data on selected self-care activities and lifestyle risk factors for HF and offer the potential to be a valuable tool for improving our understanding of self-care. %M 36800215 %R 10.2196/40536 %U https://formative.jmir.org/2023/1/e40536 %U https://doi.org/10.2196/40536 %U http://www.ncbi.nlm.nih.gov/pubmed/36800215 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e40867 %T Testing the Outcomes of a Smoking Cessation Smartphone App for Nondaily Smokers: Protocol for a Proof-of-concept Randomized Controlled Trial %A Hoeppner,Bettina B %A Siegel,Kaitlyn R %A Dickerman,Sarah R %A Todi,Akshiti A %A Kahler,Christopher W %A Park,Elyse R %A Hoeppner,Susanne S %+ Recovery Research Institute, Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, 151 Merrimac Street, 6th Floor, Boston, MA, 02114, United States, 1 617 643 1988, bhoeppner@mgh.harvard.edu %K mobile health %K mHealth %K smartphone %K smartphone app %K smoking %K smoking cessation %K nondaily smoking %K positive psychology %K happiness %K positive affect %K clinical trial %K feasibility %K acceptability %K app use %K mobile phone %D 2023 %7 14.2.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Nondaily smoking is a widespread, increasingly prevalent pattern of smoking, particularly in ethnic minority and vulnerable populations. To date, no effective treatment approach for this type of smokers has been identified. Objective: This study aims to use a randomized controlled trial to evaluate proof-of-concept markers of the Smiling instead of Smoking (SiS) app, a smoking cessation smartphone app designed specifically for nondaily smokers. This app was developed iteratively and is now in its third version. Previous studies have demonstrated acceptability and feasibility when participants were onboarded in person (study 1) and remotely (study 2) and showed within-person changes in line with hypothesized mechanisms of change. This is the first randomized test of this app. Methods: In total, 225 adult nondaily smokers will be asked to undertake a quit attempt while using smoking cessation support materials for a period of 7 weeks. Participants will be randomized to use the SiS smartphone app, the National Cancer Institute smartphone app QuitGuide, or the National Cancer Institute smoking cessation brochure “Clearing the Air.” Participants will take part in a 15-minute scripted onboarding phone call during which study staff will introduce participants to their support materials. Survey links will be sent 2, 6, 12, and 24 weeks after the participants’ initially chosen quit date. The primary outcome is self-efficacy to remain abstinent from smoking at treatment end, measured using the Smoking Self-Efficacy Questionnaire. Secondary outcomes cover several domains relevant to treatment development and implementation: treatment acceptability (eg, satisfaction with smoking cessation support, measured using the Client Satisfaction Questionnaire, and app usability, measured using the System Usability Scale); treatment feasibility (eg, measured using the number of days participants used the SiS or QuitGuide app during the prescribed treatment period); and, in an exploratory way, treatment efficacy assessed using self-reported 30-day point prevalence abstinence. Results: Recruitment began in January 2021 and ended June 2022. The final 24-week follow-up was completed in January 2023. This trial is funded by the American Cancer Society. Conclusions: This study is designed to test whether the prescribed use of the SiS app results in greater self-efficacy to abstain from smoking in nondaily smokers than commonly recommended alternative treatments and whether the SiS app treatment is acceptable and feasible. Positive results will mean that the SiS app warrants testing in a large-scale randomized controlled trial to test its effectiveness in supporting smoking cessation in nondaily smokers. The design of this study also provides insights into issues pertinent to smoking cessation smartphone app treatment development and implementation by measuring, in a randomized design, markers of treatment satisfaction, engagement with the technology and content of the treatment, and adherence to the treatment plan. Trial Registration: ClinicalTrials.gov NCT04672239; https://clinicaltrials.gov/ct2/show/NCT04672239 International Registered Report Identifier (IRRID): DERR1-10.2196/40867 %M 36787172 %R 10.2196/40867 %U https://www.researchprotocols.org/2023/1/e40867 %U https://doi.org/10.2196/40867 %U http://www.ncbi.nlm.nih.gov/pubmed/36787172 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e42390 %T Comparing the Feasibility and Acceptability of a Virtual Human, Teletherapy, and an e-Manual in Delivering a Stress Management Intervention to Distressed Adult Women: Pilot Study %A Loveys,Kate %A Antoni,Michael %A Donkin,Liesje %A Sagar,Mark %A Broadbent,Elizabeth %+ Department of Psychological Medicine, The University of Auckland, Level 3, Building 507, 22-30 Park Avenue, Grafton, Auckland, 1023, New Zealand, 64 93737599 ext 86756, e.broadbent@auckland.ac.nz %K stress %K cognitive behavioral stress management %K telehealth %K conversational agent %K virtual human %K e-manual %K pilot randomized controlled trial %D 2023 %7 9.2.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Virtual humans (VHs), teletherapy, and self-guided e-manuals may increase the accessibility of psychological interventions. However, there is limited research on how these technologies compare in terms of their feasibility and acceptability in delivering stress management interventions. Objective: We conducted a preliminary comparison of the feasibility and acceptability of a VH, teletherapy, and an e-manual at delivering 1 module of cognitive behavioral stress management (CBSM) to evaluate the feasibility of the trial methodology in preparation for a future randomized controlled trial (RCT). Methods: A pilot RCT was conducted with a parallel, mixed design. A community sample of distressed adult women were randomly allocated to receive 1 session of CBSM involving training in cognitive and behavioral techniques by a VH, teletherapy, or an e-manual plus homework over 2 weeks. Data were collected on the feasibility of the intervention technologies (technical support and homework access), trial methods (recruitment methods, questionnaire completion, and methodological difficulty observations), intervention acceptability (intervention completion, self-report ratings, therapist rapport, and trust), and acceptability of the trial methods (self-report ratings and observations). Qualitative data in the form of written responses to open-ended questions were collected to enrich and clarify the findings on intervention acceptability. Results: Overall, 38 participants’ data were analyzed. A VH (n=12), teletherapy (n=12), and an e-manual (n=14) were found to be feasible and acceptable for delivering 1 session of CBSM to distressed adult women based on the overall quantitative and qualitative findings. Technical difficulties were minimal and did not affect intervention completion, and no significant differences were found between the conditions (P=.31). The methodology was feasible, although improvements were identified for a future trial. All conditions achieved good satisfaction and perceived engagement ratings, and no significant group differences were found (P>.40). Participants had similar willingness to recommend each technology (P=.64). There was a nonsignificant trend toward participants feeling more open to using the VH and e-manual from home than teletherapy (P=.10). Rapport (P<.001) and trust (P=.048) were greater with the human teletherapist than with the VH. The qualitative findings enriched the quantitative results by revealing the unique strengths and limitations of each technology that may have influenced acceptability. Conclusions: A VH, teletherapy, and a self-guided e-manual were found to be feasible and acceptable methods of delivering 1 session of a stress management intervention to a community sample of adult women. The technologies were found to have unique strengths and limitations that may affect which works best for whom and in what circumstances. Future research should test additional CBSM modules for delivery by these technologies and conduct a larger RCT to compare their feasibility, acceptability, and effectiveness when delivering a longer home-based stress management program. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12620000859987; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=380114&isReview=true %M 36757790 %R 10.2196/42390 %U https://formative.jmir.org/2023/1/e42390 %U https://doi.org/10.2196/42390 %U http://www.ncbi.nlm.nih.gov/pubmed/36757790 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e41416 %T A Communication Partner Training Program Delivered via Telehealth for People Living With Parkinson's (Better Conversations With Parkinson's): Protocol for a Feasibility Study %A Clay,Philippa %A Beeke,Suzanne %A Volkmer,Anna %A Dangerfield,Lynn %A Bloch,Steven %+ Division of Psychology and Language Sciences, University College London, Chandler House, 2 Wakefield Street, London, WC1N 1PF, United Kingdom, 44 020 7679 2000, philippa.clay@ucl.ac.uk %K Parkinson’s %K conversation %K speech and language therapy %K communication partner training %K speech therapy %K language therapy %K communication difficulty %K conversation skills %D 2023 %7 3.2.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Parkinson’s can impact people’s speech, cognition, pragmatics, and language, significantly affecting their conversations with others. The speech and language therapy approach called communication partner training (CPT) is effective for a range of communication difficulties. However, speech and language therapy interventions for people with Parkinson’s predominantly focus on impairments, with little provision of CPT for this population. Better Conversations is a CPT approach that involves working with a dyad (the person with the communication difficulty and a conversation partner [CP]) to build conversation skills. It is effective at reducing barriers to conversation, and for some, it significantly increases targeted facilitatory strategies. Some approaches to CPT have been adapted to be delivered via telehealth. This can maximize ecological validity and convenience. Furthermore, telehealth is widely accepted as a delivery method for other interventions for Parkinson’s. This study presents the protocol for a pilot feasibility study of a Better Conversations CPT delivered via telehealth to people living with Parkinson’s and their CPs, called Better Conversations with Parkinson’s (BCP). Objective: The primary aim is to evaluate the feasibility of the BCP program delivered via telehealth with a treatment group from a collaborating National Health Service (NHS) site to establish for a main trial whether BCP can be delivered as intended in an NHS setting. The aim is to establish: (1) the acceptability of the program for people living with Parkinson’s, family members, and speech and language therapists (SLTs); (2) the feasibility of delivering the BCP program; (3) the recruitment and retention rates; (4) a sample size calculation; and (5) the most appropriate primary outcome measure. Methods: Ethical approval for this study was obtained from London-Central Research Ethics Committee (reference: 22/LO/0332). This case-series feasibility pilot study will recruit 10-12 dyads to ensure 10 complete data sets. Participants will be recruited by a collaborating NHS site located in England. Participants will be involved for 16 weeks (weeks 1-2 preintervention measures, weeks 3-8 intervention, weeks 10-12 postintervention measures, week 16 follow-up interview). Quantitative and qualitative methods will be used to analyze the study data. Speech, communication, and quality of life assessment data will be analyzed statistically to determine a suitably sensitive outcome measure. Descriptive statistics will be used to report on recruitment, attendance, and attrition. Finally, acceptability and feasibility will be evaluated using participant feedback, interviews, and the reflective diary and feedback of the SLT administering the therapy (by the research assistant who is the first author). This data will be analyzed using descriptive statistics and reflexive thematic analysis. Results: This study was approved for funding from Parkinson’s UK. Study recruitment commenced in July 2022. The results of the data analysis are expected to be available by September 2024. Conclusions: Insights from this study will provide valuable information about the acceptability and feasibility of a remotely delivered Better Conversations CPT approach for people living with Parkinson’s and their CPs. An outcome of this study will be a manualized BCP program coproduced by people living with Parkinson’s, their families, and a group of expert SLTs. The study results will guide the next stages of intervention development. International Registered Report Identifier (IRRID): PRR1-10.2196/41416 %M 36735301 %R 10.2196/41416 %U https://www.researchprotocols.org/2023/1/e41416 %U https://doi.org/10.2196/41416 %U http://www.ncbi.nlm.nih.gov/pubmed/36735301 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e43557 %T A Digital Health Intervention for Concussion: Development and Clinical Feasibility Study %A d'Offay,Christine %A Ng,Xin Yi %A Alexander,Laura %A Grant,Alison %A Grahamslaw,Julia %A Pagliari,Claudia %A Reed,Matthew J %A Carson,Alan %A Gillespie,David C %A Jamjoom,Aimun A B %+ Centre for Clinical Brain Sciences, The University of Edinburgh, Chancellors Building, Edinburgh, EH16 4SA, United Kingdom, 44 131 650 1000, v1ajamjo@ed.ac.uk %K concussion %K digital intervention %K behavior change %K feasibility study %D 2023 %7 1.2.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: Concussion is a common condition that can lead to a constellation of symptoms that affect quality of life, social integration, and return to work. There are several evidence-based behavioral and psychological interventions that have been found to improve postconcussion symptom burden. However, these are not routinely delivered, and individuals receive limited support during their concussion recovery. Objective: This study aimed to develop and test the feasibility of a digital health intervention using a systematic evidence-, theory-, and person-based approach. Methods: This was a mixed methodology study involving a scoping review (n=21), behavioral analysis, and logic model to inform the intervention design and content. During development, the intervention was optimized with feedback from individuals who had experienced concussions (n=12) and health care professionals (n=11). The intervention was then offered to patients presenting to the emergency department with a concussion (n=50). Participants used the intervention freely and input symptom data as part of the program. A number of outcome measures were obtained, including participant engagement with the intervention, postconcussion symptom burden, and attitudes toward the intervention. A selection of participants (n=15) took part in in-depth qualitative interviews to understand their attitudes toward the intervention and how to improve it. Results: Engagement with the intervention functionality was 90% (45/50) for the symptom diary, 62% (31/50) for sleep time setting, 56% (28/50) for the alcohol tracker, 48% (24/50) for exercise day setting, 34% (17/50) for the thought diary, and 32% (16/50) for the goal setter. Metrics indicated high levels of early engagement that trailed off throughout the course of the intervention, with an average daily completion rate of the symptom diary of 28.23% (494/1750). A quarter of the study participants (13/50, 26%) were classified as high engagers who interacted with all the functionalities within the intervention. Quantitative and qualitative feedback indicated a high level of usability and positive perception of the intervention. Daily symptom diaries (n=494) demonstrated a wide variation in individual participant symptom burden but a decline in average burden over time. For participants with Rivermead scores on completion of HeadOn, there was a strong positive correlation (r=0.86; P<.001) between their average daily HeadOn symptom diary score and their end-of-program Rivermead score. Insights from the interviews were then fed back into development to optimize the intervention and facilitate engagement. Conclusions: Using this systematic approach, we developed a digital health intervention for individuals who have experienced a concussion that is designed to facilitate positive behavior change. Symptom data input as part of the intervention provided insights into postconcussion symptom burden and recovery trajectories. Trial Registration: ClinicalTrials.gov NCT05069948; https://clinicaltrials.gov/ct2/show/NCT05069948 %M 36724010 %R 10.2196/43557 %U https://formative.jmir.org/2023/1/e43557 %U https://doi.org/10.2196/43557 %U http://www.ncbi.nlm.nih.gov/pubmed/36724010 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 7 %N %P e40145 %T Web-Based Mind-Body Tactical Resilience Training Program for First Responders: Pre-Post Study Assessing Feasibility, Acceptability, and Usability %A Tan,Leona %A Deady,Mark %A Mead,Olivia %A Foright,Rebecca M %A Brenneman,Eric M %A Yeager,Jamie R %A Bryant,Richard A %A Harvey,Samuel B %+ Black Dog Institute, University of New South Wales, Hospital Road, Randwick, 2031, Australia, 61 290659135, leona.tan@unsw.edu.au %K resilience training %K first responders %K web-based intervention %K mental health %K mind-body %K posttraumatic stress disorder %K PTSD %K prevention %D 2023 %7 1.2.2023 %9 Original Paper %J JMIR Form Res %G English %X Background: First responders report elevated rates of mental disorders, including posttraumatic stress disorder (PTSD), yet many are reluctant to seek care. Preventative resilience training programs attempt to proactively address this issue, and there is evidence showing promise for programs targeting cognitive processes. However, these programs rarely address the physical health conditions associated with PTSD. There is emerging evidence of mind-body exercise training improving PTSD symptoms as well as its associated physical health symptoms. However, the feasibility and acceptability of delivering a web-based mind-body resilience training among first responders are not yet known. Objective: This study aimed to evaluate the feasibility, usability, and acceptability of a web-based mind-body tactical resilience training program designed for first responders. In addition, we explored the preliminary effectiveness of the training program on mental health outcomes, adaptive cognitive strategies, and work productivity. Methods: A total of 42 first responders based in the United States enrolled in the web-based training program. Participants were administered web-based surveys before enrolling in the 6-week web-based program and at the end of the program. The primary outcomes of feasibility were measured using the number of training hours, program adherence rates, and self-reported data on frequency of practice. Acceptability and usability were measured using self-reported data. Secondary outcomes were symptoms of PTSD, psychological distress, emotion regulation, stress mindset, psychological preparedness, and work performance. Results: Overall, the training program was feasible based on the median number of training hours spent on the web-based program (7.57 hours out of an expected total of 6 to 9 hours), and 55% (23/42) of the enrolled participants completed more than half of the program. Although acceptability, usability, and frequency of practice were rated as high, this was based on only 29% (12/42) of the respondents who provided follow-up data. Secondary outcomes showed a significant improvement in the adaptive cognitive strategy of the stress mindset, with a mean difference of –5.42 (SD 4.81; 95% CI −8.475 to −2.358; t11=−3.898; P=.002). All other secondary outcomes were not significant. However, the secondary outcomes were exploratory only, and this study was neither designed nor powered to adequately assess efficacy. Conclusions: These findings suggest that a mind-body tactical resilience training program delivered in a web-based format is feasible and acceptable among first responders; however, further refinements may be required to improve adherence rates. Further research using a larger, more rigorous trial design is warranted to examine the effectiveness of this type of training as a possible prevention or treatment strategy for this population. %M 36724011 %R 10.2196/40145 %U https://formative.jmir.org/2023/1/e40145 %U https://doi.org/10.2196/40145 %U http://www.ncbi.nlm.nih.gov/pubmed/36724011 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e39724 %T Technology-Enabled Collaborative Care for Concurrent Diabetes and Distress Management During the COVID-19 Pandemic: Protocol for a Mixed Methods Feasibility Study %A Vojtila,Lenka %A Sherifali,Diana %A Dragonetti,Rosa %A Ashfaq,Iqra %A Veldhuizen,Scott %A Naeem,Farooq %A Agarwal,Sri Mahavir %A Melamed,Osnat C %A Crawford,Allison %A Gerretsen,Philip %A Hahn,Margaret %A Hill,Sean %A Kidd,Sean %A Mulsant,Benoit %A Serhal,Eva %A Tackaberry-Giddens,Leah %A Whitmore,Carly %A Marttila,Jennifer %A Tang,Frank %A Ramdass,Seeta %A Lourido,Gloria %A Sockalingam,Sanjeev %A Selby,Peter %+ Nicotine Dependence Service, Addictions Program, Centre for Addiction and Mental Health, 1025 Queen Street West, Toronto, ON, M6J 1H1, Canada, 1 416 535 8501 ext 36859, peter.selby@camh.ca %K collaborative care %K type 2 diabetes mellitus %K technology %K mental health %K diabetes %K diabetic %K feasibility %K coaching %K patient education %K satisfaction %K qualitative %K nursing %K nurse %K virtual care %K eHealth %K digital health %K health outcome %K substance use %D 2023 %7 17.1.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: The COVID-19 pandemic disrupted the delivery of diabetes care and worsened mental health among many patients with type 2 diabetes (T2D). This disruption puts patients with T2D at risk for poor diabetes outcomes, especially those who experience social disadvantage due to socioeconomic class, rurality, or ethnicity. The appropriate use of communication technology could reduce these gaps in diabetes care created by the pandemic and also provide support for psychological distress. Objective: The purpose of this study is to test the feasibility of an innovative co-designed Technology-Enabled Collaborative Care (TECC) model for diabetes management and mental health support among adults with T2D. Methods: We will recruit 30 adults with T2D residing in Ontario, Canada, to participate in our sequential explanatory mixed methods study. They will participate in 8 weekly web-based health coaching sessions with a registered nurse, who is a certified diabetes educator, who will be supported by a digital care team (ie, a peer mentor, an addictions specialist, a dietitian, a psychiatrist, and a psychotherapist). Assessments will be completed at baseline, 4 weeks, and 8 weeks, with a 12-week follow-up. Our primary outcome is the feasibility and acceptability of the intervention, as evident by the participant recruitment and retention rates. Key secondary outcomes include assessment completion and delivery of the intervention. Exploratory outcomes consist of changes in mental health, substance use, and physical health behaviors. Stakeholder experience and satisfaction will be explored through a qualitative descriptive study using one-on-one interviews. Results: This paper describes the protocol of the study. The recruitment commenced in June 2021. This study was registered on October 29, 2020, on ClinicalTrials.gov (Registry ID: NCT04607915). As of June 2022, all participants have been recruited. It is anticipated that data analysis will be complete by the end of 2022, with study findings available by the end of 2023. Conclusions: The development of an innovative, technology-enabled model will provide necessary support for individuals living with T2D and mental health challenges. This TECC program will determine the feasibility of TECC for patients with T2D and mental health issues. Trial Registration: ClinicalTrials.gov NCT04607915; https://clinicaltrials.gov/ct2/show/NCT04607915 International Registered Report Identifier (IRRID): DERR1-10.2196/39724 %M 36649068 %R 10.2196/39724 %U https://www.researchprotocols.org/2023/1/e39724 %U https://doi.org/10.2196/39724 %U http://www.ncbi.nlm.nih.gov/pubmed/36649068 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 11 %N 12 %P e42754 %T Clinical Source Data Production and Quality Control in Real-world Studies: Proposal for Development of the eSource Record System %A Wang,Bin %A Lai,Junkai %A Jin,Feifei %A Liao,Xiwen %A Zhu,Huan %A Yao,Chen %+ Peking University Clinical Research Institute, Peking University First Hospital, No. 8, Xishiku Street, Xicheng District, Beijing, 100034, China, 86 01083325822, yaochen@hsc.pku.edu.cn %K electronic medical record %K electronic health record %K eSource %K real-world data %K eSource record %K clinical research %K data collection %K data transcription %K data quality %K interoperability %D 2022 %7 23.12.2022 %9 Proposal %J JMIR Res Protoc %G English %X Background: An eSource generally includes the direct capture, collection, and storage of electronic data to simplify clinical research. It can improve data quality and patient safety and reduce clinical trial costs. There has been some eSource-related research progress in relatively large projects. However, most of these studies focused on technical explorations to improve interoperability among systems to reuse retrospective data for research. Few studies have explored source data collection and quality control during prospective data collection from a methodological perspective. Objective: This study aimed to design a clinical source data collection method that is suitable for real-world studies and meets the data quality standards for clinical research and to improve efficiency when writing electronic medical records (EMRs). Methods: On the basis of our group’s previous research experience, TransCelerate BioPharm Inc eSource logical architecture, and relevant regulations and guidelines, we designed a source data collection method and invited relevant stakeholders to optimize it. On the basis of this method, we proposed the eSource record (ESR) system as a solution and invited experts with different roles in the contract research organization company to discuss and design a flowchart for data connection between the ESR and electronic data capture (EDC). Results: The ESR method included 5 steps: research project preparation, initial survey collection, in-hospital medical record writing, out-of-hospital follow-up, and electronic case report form (eCRF) traceability. The data connection between the ESR and EDC covered the clinical research process from creating the eCRF to collecting data for the analysis. The intelligent data acquisition function of the ESR will automatically complete the empty eCRF to create an eCRF with values. When the clinical research associate and data manager conduct data verification, they can query the certified copy database through interface traceability and send data queries. The data queries are transmitted to the ESR through the EDC interface. The EDC and EMR systems interoperate through the ESR. The EMR and EDC systems transmit data to the ESR system through the data standards of the Health Level Seven Clinical Document Architecture and the Clinical Data Interchange Standards Consortium operational data model, respectively. When the implemented data standards for a given system are not consistent, the ESR will approach the problem by first automating mappings between standards and then handling extensions or corrections to a given data format through human evaluation. Conclusions: The source data collection method proposed in this study will help to realize eSource’s new strategy. The ESR solution is standardized and sustainable. It aims to ensure that research data meet the attributable, legible, contemporaneous, original, accurate, complete, consistent, enduring, and available standards for clinical research data quality and to provide a new model for prospective data collection in real-world studies. %M 36563036 %R 10.2196/42754 %U https://www.researchprotocols.org/2022/12/e42754 %U https://doi.org/10.2196/42754 %U http://www.ncbi.nlm.nih.gov/pubmed/36563036 %0 Journal Article %@ 2561-9128 %I JMIR Publications %V 5 %N 1 %P e40352 %T Personal Devices to Monitor Physical Activity and Nutritional Intake After Colorectal Cancer Surgery: Feasibility Study %A van der Linden,Manouk J W %A Nahar van Venrooij,Lenny M W %A Verdaasdonk,Emiel G G %+ Department of Dietetics, Jeroen Bosch Hospital, Henri Dunantstraat 1, ’s-Hertogenbosch, 5223 GZ, Netherlands, 31 735532019, manouk.v.d.linden@jbz.nl %K eHealth %K fitness trackers %K diet records %K colorectal neoplasm %K colorectal cancer %K surgery %K self management %K patient care %K physical activity %K tracking %K activity tracking %K self-monitoring %K feasibility %K usability %D 2022 %7 13.12.2022 %9 Original Paper %J JMIR Perioper Med %G English %X Background: The use of self-monitoring devices is promising for improving perioperative physical activity and nutritional intake. Objective: This study aimed to assess the feasibility, usability, and acceptability of a physical activity tracker and digital food record in persons scheduled for colorectal cancer (CRC) surgery. Methods: This observational cohort study was conducted at a large training hospital between November 2019 and November 2020. The study population consisted of persons with CRC between 18- and 75 years of age who were able to use a smartphone or tablet and scheduled for elective surgery with curative intent. Excluded were persons not proficient in Dutch or following a protein-restricted diet. Participants used an activity tracker (Fitbit Charge 3) from 4 weeks before until 6 weeks after surgery. In the week before surgery (preoperative) and the fifth week after surgery (postoperative), participants also used a food record for 1 week. They shared their experience regarding usability (system usability scale, range 0-100) and acceptability (net promoter score, range –100 to +100). Results: In total, 28 persons were included (n=16, 57% male, mean age 61, SD 8 years), and 27 shared their experiences. Scores regarding the activity tracker were as follows: preoperative median system usability score, 85 (IQR 73-90); net promoter score, +65; postoperative median system usability score, 78 (IQR 68-85); net promotor score, +67. The net promoter scores regarding the food record were +37 (preoperative) and–7 (postoperative). Conclusions: The perioperative use of a physical activity tracker is considered feasible, usable, and acceptable by persons with CRC in this study. Preoperatively, the use of a digital food record was acceptable, and postoperatively, the acceptability decreased. %M 36512385 %R 10.2196/40352 %U https://periop.jmir.org/2022/1/e40352 %U https://doi.org/10.2196/40352 %U http://www.ncbi.nlm.nih.gov/pubmed/36512385 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 12 %P e38496 %T Use of an Interactive Obesity Treatment Approach in Individuals With Severe Mental Illness: Feasibility, Acceptability, and Proposed Engagement Criteria %A Nicol,Ginger %A Jansen,Madeline %A Haddad,Rita %A Ricchio,Amanda %A Yingling,Michael D %A Schweiger,Julia A %A Keenoy,Katie %A Evanoff,Bradley A %A Newcomer,John W %+ Department of Psychiatry, Washington University School of Medicine, 600 S. Taylor Ave., Suite 121, St. Louis, MO, 63110, United States, 1 13143625939, nicolg@wustl.edu %K obesity %K mentally ill people/persons %K health services %K mobile health %D 2022 %7 13.12.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: Digital and mobile health interventions are increasingly being used to support healthy lifestyle change, including in certain high-risk populations such as those with severe mental illnesses (SMIs). Life expectancy in this population lags 15 years behind counterparts in the general population, primarily due to obesity-related health conditions. Objective: We tested the feasibility and usability of a 12-week interactive obesity treatment approach (iOTA) to adults with chronic SMIs (depression, bipolar disorder and schizophrenia spectrum disorder) receiving treatment in community settings. The iOTA incorporates short message service (SMS) text messages to supplement monthly in-person health coaching. Methods: Factors hypothesized to be associated with weight change were illness severity and treatment engagement. Severe psychiatric symptoms were defined as baseline Clinical Global Impression severity score of >5. Criterion engagement was defined as a text messaging response rate >80% during the first 4 weeks of treatment. Disordered eating, assessed with the Loss of Control Over Eating Scores, was also evaluated. Participants provided qualitative data, further informing assessment of intervention feasibility, usability, and acceptability. Results: A total of 26 participants were enrolled. The mean age was 48.5 (SD 15.67) years; 40% (10/26) were Black and 60% (15/26) female. Participants with lower symptom severity and adequate engagement demonstrated significantly decreased weight (F1,16=22.54, P<.001). Conversely, high symptom severity and lower text message response rates were associated with trend-level increases in weight (F1,7=4.33, P=.08). Loss-of-control eating was not observed to impact treatment outcome. Participants voiced preference for combination of live health coaching and text messaging, expressing desire for personalized message content. Conclusions: These results demonstrate the feasibility of delivering an adapted iOTA to SMI patients receiving care in community settings and suggest testable criteria for defining sufficient treatment engagement and psychiatric symptom severity, two factors known to impact weight loss outcomes. These important findings suggest specific adaptations may be needed for optimal treatment outcomes in individuals with SMI. %M 36512399 %R 10.2196/38496 %U https://formative.jmir.org/2022/12/e38496 %U https://doi.org/10.2196/38496 %U http://www.ncbi.nlm.nih.gov/pubmed/36512399 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 11 %N 12 %P e39238 %T Collective Action for Wellness in the Malaysian Workplace: Protocol for a Feasibility Study %A Thai,Janus Y %A McCaffrey,Tracy %A Ramadas,Amutha %A Chandrasekara,Dharshani %A Koh,Sharon G M %A Choi,Tammie Suet Ting %A Malini,Hema %A Xie,Jue %A Olivier,Patrick %A Md Zain,Anuar Zaini %A Watterson,Jessica %+ Jeffrey Cheah School of Medicine and Health Sciences, Monash University Malaysia, Jalan Lagoon Selatan, Bandar Sunway, 47500 Subang Jaya, Selangor, Subang Jaya, 47500, Malaysia, 60 355146000, jessica.watterson@monash.edu %K workplace wellness %K healthy behaviours %K chronic diseases %K digital health %K Malaysia %K wellness %K workplace %K disease %K digital wellness %K digital %K promote %K health knowledge %K diet %K employee %K mobile device %K intervention %K social %K social group %D 2022 %7 5.12.2022 %9 Protocol %J JMIR Res Protoc %G English %X Background: Chronic diseases and the associated risk factors are preventable with lifestyle changes such as eating a healthier diet and being more physically active. In Malaysia, the prevalence of chronic diseases, including diabetes, hypertension, and heart diseases, has risen. In the present study, we explore the potential of co-designing and implementing a digital wellness intervention to promote socially-driven health knowledge and practices in the workplace in Malaysia, drawing on social cognitive theory, social impact theory, and social influence theory. Objective: This study aims to co-design and assess the feasibility of a socially-driven digital health intervention to promote healthy behavior and prevent chronic diseases in a workplace in Malaysia. Methods: This study involves two phases: (i) identifying the barriers and facilitators to healthy behaviors at work and co-designing the intervention activities with the employees, (ii) implementing and evaluating the intervention’s feasibility. Phase 1 will involve qualitative data collection and analysis through semi-structured, in-depth interviews and co-design workshops with the employees, while Phase 2 will consist of a feasibility study employing quantitative measurements of health behaviors through accelerometers and questionnaires. Results: This study was funded in June 2021 and ethics approval for Phase 1 was obtained from the Monash University Human Research Ethics Committee in January 2022. As of August 2022, qualitative interviews with 12 employees have been completed and the data has been transcribed and analyzed. These results will be published in a future paper with results from all Phase 1 activities. Conclusions: The study will help us to better understand the mechanisms through which digital technologies can promote socially-driven health knowledge and behaviors. This research will also result in a scalable wellness intervention that could be further tailored and expanded to other employers and social groups across the region. International Registered Report Identifier (IRRID): PRR1-10.2196/39238 %M 36469407 %R 10.2196/39238 %U https://www.researchprotocols.org/2022/12/e39238/ %U https://doi.org/10.2196/39238 %U http://www.ncbi.nlm.nih.gov/pubmed/36469407 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 12 %P e37609 %T Using Social Media to Engage Justice-Involved Young Adults in Digital Health Interventions for Substance Use: Pilot Feasibility Survey Study %A Harrison,Anna %A Folk,Johanna %A Rodriguez,Christopher %A Wallace,Amanda %A Tolou-Shams,Marina %+ Mental Health Service, San Francisco Veterans Affairs Health Care System, 4150 Clement Street, San Francisco, CA, 94121, United States, 1 415 221 4810, anna.harrison@ucsf.edu %K substance use %K young adult %K social media %K digital health technology %K mobile phone %D 2022 %7 2.12.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: Young adults involved in the justice system have high rates of substance use disorders and low rates of treatment engagement. Most justice-involved young adults are supervised in the community—not incarcerated in jail or prison—where they have ongoing access to substances and experience significant barriers to care. When they do engage in treatment, they tend to have worse outcomes than justice-involved adolescents and older adults. Despite the need to develop targeted treatments, there are unique challenges in recruiting this population into clinical research. Digital health technology offers many novel avenues for recruiting justice-involved young adults into clinical research studies and disseminating substance use disorder treatments to justice-involved young adults. Because the vast majority of young adults regularly use one or more social media platforms, social media may offer a cost-effective and efficient way to achieve these goals. Objective: This study aimed to describe the process and feasibility of using social media platforms (Facebook and Reddit) to recruit justice-involved young adults into clinical research. Justice-involved young adults recruited from these platforms completed a survey assessing the acceptability of digital health interventions to address substance use in this population. Methods: Justice-involved young adults (aged 18-24 years) were recruited through paid advertisements placed on Facebook and Reddit. Participants responded to a web-based survey focused on their substance use, treatment use history, and acceptability of various digital health interventions focused on substance use. Results: A national sample of justice-involved young adults were successfully enrolled and completed the survey (N=131). Participants were racially diverse (8/131, 6.1% American Indian individuals; 27/131, 20.6% Asian individuals; 23/131, 17.6% Black individuals; 26/131, 19.8% Latinx individuals; 8/131, 6.1% Pacific Islander individuals; 49/131, 37.4% White individuals; and 2/131, 1.5% individuals who identified as “other” race and ethnicity). Advertisements were cost-effective (US $0.66 per click on Facebook and US $0.47 per click on Reddit). More than half (72/131, 54.9%) of the participants were on probation or parole in the past year and reported hazardous alcohol (54/131, 51.9%) or drug (66/131, 57.4%) use. Most of the participants (103/131, 78.6%) were not currently participating in substance use treatment. Nearly two-third (82/131, 62.6%) of the participants were willing to participate in one or more hypothetical digital health interventions. Conclusions: Social media is a feasible and cost-effective method for reaching justice-involved young adults to participate in substance use research trials. With limited budgets, researchers can reach a broad audience, many of whom could benefit from treatment but are not currently engaged in care. Proposed digital health interventions focusing on reducing substance use, such as private Facebook groups, SMS text message–based appointment reminders, and coaching, had high acceptability. Future work will build on these findings to develop substance use treatment interventions for this population. %M 36459404 %R 10.2196/37609 %U https://formative.jmir.org/2022/12/e37609 %U https://doi.org/10.2196/37609 %U http://www.ncbi.nlm.nih.gov/pubmed/36459404 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 11 %P e33952 %T Fitbits for Monitoring Depressive Symptoms in Older Aged Persons: Qualitative Feasibility Study %A Mughal,Fiza %A Raffe,William %A Stubbs,Peter %A Kneebone,Ian %A Garcia,Jaime %+ Faculty of Engineering and IT, University of Technology Sydney, 15 Broadway, Ultimo, Sydney, 2007, Australia, 61 4 5262 7824, fiza.mughal@uts.edu.au %K digital mental health %K Fitbit %K smartwatch %K smart wearable %K geriatric %K aging %K health informatics %K feasibility %K usability %K older aged %D 2022 %7 29.11.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: In 2022, an estimated 1.105 billion people used smart wearables and 31 million used Fitbit devices worldwide. Although there is growing evidence for the use of smart wearables to benefit physical health, more research is required on the feasibility of using these devices for mental health and well-being. In studies focusing on emotion recognition, emotions are often inferred and dependent on external cues, which may not be representative of true emotional states. Objective: The aim of this study was to evaluate the feasibility and acceptability of using consumer-grade activity trackers for apps in the remote mental health monitoring of older aged people. Methods: Older adults were recruited using criterion sampling. Participants were provided an activity tracker (Fitbit Alta HR) and completed weekly online questionnaires, including the Geriatric Depression Scale, for 4 weeks. Before and after the study period, semistructured qualitative interviews were conducted to provide insight into the acceptance and feasibility of performing the protocol over a 4-week period. Interview transcripts were analyzed using a hybrid inductive-deductive thematic analysis. Results: In total, 12 participants enrolled in the study, and 9 returned for interviews after the study period. Participants had positive attitudes toward being remotely monitored, with 78% (7/9) of participants experiencing no inconvenience throughout the study period. Moreover, 67% (6/9) were interested in trialing our prototype when it is implemented. Participants stated they would feel more comfortable if mental well-being was being monitored by carers remotely. Conclusions: Fitbit-like devices were an unobtrusive and convenient tool to collect physiological user data. Future research should integrate physiological user inputs to differentiate and predict depressive tendencies in users. %M 36268552 %R 10.2196/33952 %U https://formative.jmir.org/2022/11/e33952 %U https://doi.org/10.2196/33952 %U http://www.ncbi.nlm.nih.gov/pubmed/36268552 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 10 %P e36782 %T The First Asynchronous Online Evidence-Based Medicine Course for Syrian Health Workforce: Effectiveness and Feasibility Pilot Study %A Kenjrawi,Yazan %A Dashash,Mayssoon %+ Medical Education Program, Syrian Virtual University, Omar Bin Abdulaziz Street, Damascus, Syrian Arab Republic, 963 948379097, yazankenjrawi@gmail.com %K evidence-based medicine %K continuous medical education %K web-based learning %K Syria %K medical graduates %K medical education %K web-based course %D 2022 %7 25.10.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: Evidence-based medicine (EBM) is critical for providing the best scientifically proven patient health care, and it is implemented worldwide in order to improve the quality of the delivered health care. However, not all Syrian health professionals are knowledgeable about the importance, methodology, and implementation of EBM. Providing web-based learning courses on EBM might be effective in improving the EBM knowledge of health care professionals. Objective: This study was performed to test the effectiveness and the feasibility of an asynchronous web-based course on EBM in improving the competencies of Syrian health care professionals in terms of EBM. Methods: A web-based course on EBM was developed in Arabic and uploaded onto the Syrian Virtual University platform. An electronic registration form was designed and distributed to medical groups on social media for registration to this web-based course. Both the pretest and posttest had the same 3 sections to measure the impact of this web-based EBM program on the knowledge, skills, and attitudes of the Syrian health care professionals. The posttest had an additional section for measuring the efficacy and ease of use of this program. Student paired 1-tailed t test was used to analyze the differences in the different assessment sections among the participants. Results: Nineteen participants filled the electronic registration form, but 8 participants did not meet the inclusion criteria. Therefore, the pretest was sent to the remaining 11 participants (7 men and 4 women) who graduated from Syrian universities. Ten of them completed the pretest, while 7 of them completed the posttest. The web-based course was found to be effective in improving the participants’ EBM knowledge, skills, and attitudes at P>.05. Further, the web-based EBM course was feasible and easy-to-use. Conclusions: In order for EBM to be implemented in Syria, continuous medical education training programs should be designed for clinical practitioners. Our study shows that asynchronous web-based medical education is an effective and a feasible means for introducing the concept of EBM, improving practitioners’ skills, and promoting the positive attitudes of Syrian clinical practitioners toward EBM. %M 36282556 %R 10.2196/36782 %U https://formative.jmir.org/2022/10/e36782 %U https://doi.org/10.2196/36782 %U http://www.ncbi.nlm.nih.gov/pubmed/36282556 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 11 %N 10 %P e41445 %T Feasibility of Digital Cognitive Behavioral Therapy for Depressed Older Adults With the Moodbuster Platform: Protocol for 2 Pilot Feasibility Studies %A Amarti,Khadicha %A Schulte,Mieke H J %A Kleiboer,Annet %A Van Genugten,Claire Rosalie %A Oudega,Mardien %A Sonnenberg,Caroline %A Gonçalves,Gonçalo C %A Rocha,Artur %A Riper,Heleen %+ Clinical Psychology Section, Department of Clinical, Neuro- and Developmental Psychology, Vrije Universiteit, De Boelelaan 1117, Amsterdam, 1081 HV, Netherlands, 31 020 59 83 348, k.amarti@vu.nl %K iCBT %K study protocol %K feasibility study %K acceptance %K satisfaction %K usability %K engagement %K depression severity %K older adults %D 2022 %7 25.10.2022 %9 Protocol %J JMIR Res Protoc %G English %X Background: Internet-based interventions can be effective in the treatment of depression. However, internet-based interventions for older adults with depression are scarce, and little is known about their feasibility and effectiveness. Objective: To present the design of 2 studies aiming to assess the feasibility of internet-based cognitive behavioral treatment for older adults with depression. We will assess the feasibility of an online, guided version of the Moodbuster platform among depressed older adults from the general population as well as the feasibility of a blended format (combining integrated face-to-face sessions and internet-based modules) in a specialized mental health care outpatient clinic. Methods: A single-group, pretest-posttest design will be applied in both settings. The primary outcome of the studies will be feasibility in terms of (1) acceptance and satisfaction (measured with the Client Satisfaction Questionnaire-8), (2) usability (measured with the System Usability Scale), and (3) engagement (measured with the Twente Engagement with eHealth Technologies Scale). Secondary outcomes include (1) the severity of depressive symptoms (measured with the 8-item Patient Health Questionnaire depression scale), (2) participant and therapist experience with the digital technology (measured with qualitative interviews), (3) the working alliance between patients and practitioners (from both perspectives; measured with the Working Alliance Inventory–Short Revised questionnaire), (4) the technical alliance between patients and the platform (measured with the Working Alliance Inventory for Online Interventions–Short Form questionnaire), and (5) uptake, in terms of attempted and completed modules. A total of 30 older adults with mild to moderate depressive symptoms (Geriatric Depression Scale 15 score between 5 and 11) will be recruited from the general population. A total of 15 older adults with moderate to severe depressive symptoms (Geriatric Depression Scale 15 score between 8 and 15) will be recruited from a specialized mental health care outpatient clinic. A mixed methods approach combining quantitative and qualitative analyses will be adopted. Both the primary and secondary outcomes will be further explored with individual semistructured interviews and synthesized descriptively. Descriptive statistics (reported as means and SDs) will be used to examine the primary and secondary outcome measures. Within-group depression severity will be analyzed using a 2-tailed, paired-sample t test to investigate differences between time points. The interviews will be recorded and analyzed using thematic analysis. Results: The studies were funded in October 2019. Recruitment started in September 2022. Conclusions: The results of these pilot studies will show whether this platform is feasible for use by the older adult population in a blended, guided format in the 2 settings and will represent the first exploration of the size of the effect of Moodbuster in terms of decreased depressive symptoms. International Registered Report Identifier (IRRID): PRR1-10.2196/41445 %M 36282565 %R 10.2196/41445 %U https://www.researchprotocols.org/2022/10/e41445 %U https://doi.org/10.2196/41445 %U http://www.ncbi.nlm.nih.gov/pubmed/36282565 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 10 %P e34055 %T An Accessible Communication System for Population-Based Genetic Testing: Development and Usability Study %A Coffin,Tara %A Bowen,Deborah %A Swisher,Elizabeth %A Lu,Karen %A Rayes,Nadine %A Norquist,Barbara %A Blank,Stephanie %A Levine,Douglas %A Bakkum-Gamez,Jamie %A Fleming,Gini %A Olopade,Olufunmilayo %A D’Andrea,Alan %A Nebgen,Denise %A Peterson,Christine %A Munsell,Mark %A Gavin,Kathleen %A Lechner,Rebecca %A Crase,Jamie %A Polinsky,Deborah %A Romero,Iris %+ University of Washington, 1400 NE Campus Parkway, Seattle, WA, 98195-4550, United States, 1 206 543 2100, tbcoffin@uw.edu %K genetic testing %K internet %K social media %K accessibility %D 2022 %7 17.10.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: Genetic testing uptake is low, despite the well-established connection between pathogenic variants in certain cancer-linked susceptibility genes and ovarian cancer risk. Given that most major insurers cover genetic testing for those with a family history suggestive of hereditary cancer, the issue may lie in access to genetic testing. Remotely accessible web-based communication systems may improve awareness, and uptake, of genetic testing services. Objective: This study aims to present the development and formative evaluation of the multistep web-based communication system required to support the implementation of, and access to, genetic testing. Methods: While designing the multistep web-based communication system, we considered various barriers and facilitators to genetic testing, guided by dimensions of accessibility. In addition to conducting usability testing, we performed ongoing assessments focusing on the function of the web-based system and participant response rates, with the goal of continuing to make modifications to the web-based communication system as it is in use. Results: The combined approach of usability testing and expert user experience consultation resulted in several modifications to the multistep web-based communication system, including changes that related to imagery and content, web accessibility, and general organization of the web-based system. All recommendations were made with the goal of improving the overall accessibility of the web-based communication system. Conclusions: A multistep web-based communication system appears to be an effective way to address many potential barriers to access, which may otherwise make genetic testing difficult for at-risk individuals to participate in. Importantly, some dimensions of access were easy to assess before study recruitment, but other aspects of the communication system required ongoing assessment during the implementation process of the Making Genetic Testing Accessible study. %M 36251350 %R 10.2196/34055 %U https://formative.jmir.org/2022/10/e34055 %U https://doi.org/10.2196/34055 %U http://www.ncbi.nlm.nih.gov/pubmed/36251350 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 11 %N 10 %P e39017 %T Objective Assessment of the Nature and Extent of Children’s Internet-Based World: Protocol for the Kids Online Aotearoa Study %A Gurtner,Marcus %A Smith,Moira %A Gage,Ryan %A Howey-Brown,Anna %A Wang,Xinyi %A Latavao,Tevita %A D Deng,Jeremiah %A P Zwanenburg,Sander %A Stanley,James %A Signal,Louise %+ Department of Public Health, University of Otago, 23 Mein Street Newtown, Wellington, 6021, New Zealand, 64 210541869, marcus.gurtner@otago.ac.nz %K public health %K child health %K internet %K policy %K methods %K child %K youth %K methodology %K student %K human-computer interaction %K digital health %K eHealth %K technology use %K computer use %K user experience %K perception %K attitude %K internet use %K screen time %K perceived behavior %K phone use %K social media %D 2022 %7 11.10.2022 %9 Protocol %J JMIR Res Protoc %G English %X Background: Children under 18 years of age account for approximately 1 in 3 internet users worldwide. Largely unregulated, the internet-based world is evolving rapidly and becoming increasingly intrusive. There is a dearth of objective research globally on children’s real-time experiences of the internet-based world. Objective: This paper reports an objective methodology to study the nature and extent of children’s internet-based world, their engagement with it, and how this impacts their health and well-being. Methods: A total of 180 year 8 students from 12 schools will be recruited into the study within the Wellington region of Aotearoa, New Zealand. Children use Zoom video teleconferencing software to record real-time, screen-shared internet-based content, for 4 consecutive days. Data on demographics, health and well-being, and attitudes and perceived behaviors in relation to the internet-based world are collected. Phone screen-time balances are retrieved. Data collection commenced in June 2021 and is anticipated to be completed in 2023. Results: Recordings show children exploring diverse web-based settings and content, including personalized content curated by algorithms on platforms such as TikTok, YouTube, and Instagram. Preliminary analysis shows that the data can be used to study a wide range of topics. Behavioral Observation Research Interaction Software is being used to manually code recordings. Artificial Intelligence techniques are also being applied, including hashtag extraction, optical character recognition, as well as object, pattern, speech, and lyric recognition. Conclusions: This novel methodology reveals the unique internet-based experiences of children. It is underpinned by a commitment to ensuring that their rights are protected. It seeks to provide concrete evidence on internet usage in this group and to facilitate appropriate political and societal action to effectively regulate the internet-based world to prevent harm to children. International Registered Report Identifier (IRRID): DERR1-10.2196/39017 %M 36129809 %R 10.2196/39017 %U https://www.researchprotocols.org/2022/10/e39017 %U https://doi.org/10.2196/39017 %U http://www.ncbi.nlm.nih.gov/pubmed/36129809 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 11 %N 10 %P e37316 %T A Tailored SMS Text Message–Based Intervention to Facilitate Patient Access to Referred Community-Based Social Needs Resources: Protocol for a Pilot Feasibility and Acceptability Study %A Lian,Tyler %A Reid,Hadley %A Rader,Abigail %A Dewitt-Feldman,Sarah %A Hezarkhani,Elmira %A Gu,Elizabeth %A Scott,Malik %A Kutzer,Kate %A Sandhu,Sahil %A Crowder,Carolyn %A Ito,Kristin %A Eisenson,Howard %A Bettger,Janet Prvu %A Shaw,Ryan J %A Lewinski,Allison A %A Ming,David Y %A Bosworth,Hayden B %A Zullig,Leah L %A Batch,Bryan C %A Drake,Connor %+ Department of Population Health Science, Duke University School of Medicine, 215 Morris St, Durham, NC, 27701, United States, 1 (919) 681 6801, connor.drake@duke.edu %K text messaging %K primary health care %K social determinants of health %K needs assessment %K community health centers %K vulnerable populations %D 2022 %7 11.10.2022 %9 Protocol %J JMIR Res Protoc %G English %X Background: Health care providers are increasingly screening patients for unmet social needs (eg, food, housing, transportation, and social isolation) and referring patients to relevant community-based resources and social services. Patients’ connection to referred services is often low, however, suggesting the need for additional support to facilitate engagement with resources. SMS text messaging presents an opportunity to address barriers related to contacting resources in an accessible, scalable, and low-cost manner. Objective: In this multi-methods pilot study, we aim to develop an automated SMS text message–based intervention to promote patient connection to referred social needs resources within 2 weeks of the initial referral and to evaluate its feasibility and patient acceptability. This protocol describes the intervention, conceptual underpinnings, study design, and evaluation plan to provide a detailed illustration of how SMS technology can complement current social needs screening and referral practice patterns without disrupting care. Methods: For this pilot prospective cohort study, this SMS text message–based intervention augments an existing social needs screening, referral, and navigation program at a federally qualified health center. Patients who received at least one referral for any identified unmet social need are sent 2 rounds of SMS messages over 2 weeks. The first round consists of 5-10 messages that deliver descriptions of and contact information for the referred resources. The second round consists of 2 messages that offer a brief reminder to contact the resources. Participants will evaluate the intervention via a survey and a semistructured interview, informed by an adapted technology acceptance model. Rapid qualitative and thematic analysis will be used to extract themes from the responses. Primary outcomes are implementation feasibility and patient acceptability. Secondary outcomes relate to intervention effectiveness: self-reported attempt to connect and successful connection to referred resources 2 weeks after the initial referral encounter. Results: The study received regulatory approval in May 2021, and we anticipate enrolling 15-20 participants for this initial pilot. Conclusions: This protocol presents detailed implementation methods about a novel automated SMS intervention for social care integration within primary care. By sharing the study protocol early, we intend to facilitate the development and adoption of similar tools across different clinical settings, as more health care providers seek to address the unmet social needs of patients. Study findings will provide practical insights into the design and implementation of SMS text message–based interventions to improve social and medical care coordination. International Registered Report Identifier (IRRID): DERR1-10.2196/37316 %M 36222790 %R 10.2196/37316 %U https://www.researchprotocols.org/2022/10/e37316 %U https://doi.org/10.2196/37316 %U http://www.ncbi.nlm.nih.gov/pubmed/36222790 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 11 %N 10 %P e39140 %T Developing an Immersive Virtual Reality Training System for Novel Pediatric Power Wheelchair Users: Protocol for a Feasibility Study %A Drisdelle,Sara %A Power,Liam %A Thieu,Scott %A Sheriko,Jordan %+ Department of Pediatrics, Izaak Walton Killam Health Centre, 5850/5980 University Avenue, Halifax, NS, B3K 6R8, Canada, 1 902 470 8719, Sara.Drisdelle@iwk.nshealth.ca %K immersive virtual reality %K power wheelchair %K training %K pediatric rehabilitation %K feasibility %D 2022 %7 6.10.2022 %9 Protocol %J JMIR Res Protoc %G English %X Background: Power wheelchairs can empower children with physical limitations to gain independence in their everyday lives; however, traditional methods of power wheelchair training are often limited by poor accessibility and safety concerns. Immersive virtual reality technology (IVRT) uses advanced display technology to place users in a fully immersive web-based environment that can support real-time skills training, often requiring less resources and fewer safety concerns than real-world methods. IVRT interventions have shown to be a feasible training option among adult power wheelchair users; however, there is still a need to understand the technical and clinical feasibility of developing an IVRT power wheelchair training tool for the pediatric population. Objective: This proposed study aims to use expert feedback and an iterative design process to develop an IVRT training intervention for pediatric power wheelchair skill development. Methods: This 3-phase feasibility study will be conducted within the assistive technology unit of a public pediatric hospital. Separate participant groups will be recruited for each phase, consisting of approximately 10 to 15 clinicians (phase 1), 10 pediatric power wheelchair users (phase 2), and 15 to 20 additional pediatric power wheelchair users (phase 3). Phase 1 will be conducted to gather feedback on the baseline IVRT training intervention. Clinicians will test the intervention and assess its usability and acceptability using qualitative and quantitative methods. Phase 1 participants will also be invited back for a subsequent session to reassess a revised version of the training intervention that has been updated based on their previous feedback. Phase 2 and phase 3 will also use mixed methods to gather feedback on the usability, acceptability, and user experience of the IVRT training intervention from current pediatric power wheelchair users. In addition, phase 3 participants will perform a skills transfer assessment to compare power mobility skill performance between the virtual reality and real-life environments. Data gathered in phase 2 will be used to further refine the IVRT intervention, whereas phase 3 data will be used to statistically evaluate the final version. Results: This study was approved by the Izaak Walton Killam Health Centre research ethics board in August 2021. Phase 1 testing began in February 2022. The entire study is expected to be completed by 2023. Conclusions: The results of this study will be used to create an IVRT training intervention for pediatric power wheelchair skill development through an iterative and collaborative design process. Results may also assist in directing future studies in this area. International Registered Report Identifier (IRRID): DERR1-10.2196/39140 %M 36201405 %R 10.2196/39140 %U https://www.researchprotocols.org/2022/10/e39140 %U https://doi.org/10.2196/39140 %U http://www.ncbi.nlm.nih.gov/pubmed/36201405 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 10 %P e36275 %T Using Personalized Avatars as an Adjunct to an Adult Weight Loss Management Program: Randomized Controlled Feasibility Study %A Horne,Maria %A Hardy,Maryann %A Murrells,Trevor %A Ugail,Hassan %A Hill,Andrew John %+ Faculty of Medicine and Health, School of Healthcare, University of Leeds, Baines Wing, Leeds, LS2 9JT, United Kingdom, 44 113 343 ext 1230, M.Horne@leeds.ac.uk %K avatar %K feasibility %K obesity %K weight loss %K weight management %D 2022 %7 5.10.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: Obesity is a global public health concern. Interventions rely predominantly on managing dietary intake and increasing physical activity; however, sustained adherence to behavioral regimens is often poor. The lack of sustained motivation, self-efficacy, and poor adherence to behavioral regimens are recognized barriers to successful weight loss. Avatar-based interventions achieve better patient outcomes in the management of chronic conditions by promoting more active engagement. Virtual representations of self can affect real-world behavior, acting as a catalyst for sustained weight loss behavior. Objective: We evaluated whether a personalized avatar, offered as an adjunct to an established weight loss program, can increase participant motivation, sustain engagement, optimize service delivery, and improve participant health outcomes. Methods: A feasibility randomized design was used to determine the case for future development and evaluation of avatar-based technology in a randomized controlled trial. Participants were recruited from general practitioner referrals to a 12-week National Health Service weight improvement program. The main outcome measure was weight loss. Secondary outcome measures were quality-of-life and self-efficacy. Quantitative data were subjected to descriptive statistical tests and exploratory comparison between intervention and control arms. Feasibility and acceptability were assessed through interviews and analyzed using framework approach. Health Research Authority ethics approval was granted. Results: Overall, 10 men (n=7, 70% for routine care and avatar and n=3, 30% for routine care) and 33 women (n=23, 70% for intervention and n=10, 30% for routine care) were recruited. Participants’ initial mean weight was greater in the intervention arm than in the routine care arm (126.3 kg vs 122.9 kg); pattern of weight loss was similar across both arms of the study in T0 to T1 period but accelerated in T1 to T2 period for intervention participants, suggesting that access to the self-resembling avatar may promote greater engagement with weight loss initiatives in the short-to-medium term. Mean change in participants’ weight from T0 to T2 was 4.5 kg (95% CI 2.7-6.3) in the routine care arm and 5.3 kg (95% CI 3.9-6.8) in the intervention arm. Quality-of-life and self-efficacy measures demonstrated greater improvement in the intervention arm at both T1 (105.5 for routine care arm and 99.7 for intervention arm) and T2 (100.1 for routine care arm and 81.2 for intervention arm). Overall, 13 participants (n=11, 85% women and n=2, 15% men) and two health care professionals were interviewed about their experience of using the avatar program. Conclusions: Participants found using the personalized avatar acceptable, and feedback reiterated that seeing a future self helped to reinforce motivation to change behavior. This feasibility study demonstrated that avatar-based technology may successfully promote engagement and motivation in weight loss programs, enabling participants to achieve greater weight loss gains and build self-confidence. Trial Registration: ISRCTN Registry 17953876; https://doi.org/10.1186/ISRCTN17953876 %M 36197703 %R 10.2196/36275 %U https://formative.jmir.org/2022/10/e36275 %U https://doi.org/10.2196/36275 %U http://www.ncbi.nlm.nih.gov/pubmed/36197703 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 11 %N 10 %P e37626 %T Feasibility of Monitoring Patients Who Have Cancer With a Smart T-shirt: Protocol for the OncoSmartShirt Study %A Steen-Olsen,Emma Balch %A Pappot,Helle %A Green,Allan %A Langberg,Henning %A Holländer-Mieritz,Cecilie %+ Department of Oncology, Rigshospitalet, University Hospital of Copenhagen, Blegdamsvej 9, Copenhagen Ø, 2100, Denmark, 45 35453545, emma.balch.steen-olsen@regionh.dk %K biometric sensor technology %K cancer %K home monitoring %K patient-generated health data %K sensor %K smart t-shirt %K remote monitoring %K adolescent %K protocol %K patient %K youth %K health care professional %K cancer treatment %D 2022 %7 3.10.2022 %9 Protocol %J JMIR Res Protoc %G English %X Background: Studies have shown that there may be dissimilar perceptions on symptoms or side effects between patients with cancer and health care professionals. This may lead to symptomatic patients notifying the clinic irregularly or not telling the clinic at all. Wearables could help identify symptoms earlier. Patients with low socioeconomic status and less self-awareness of their health may benefit from this. A new design of wearables is a smart t-shirt that, with embedded sensors, provides measurement flows such as electrocardiogram, thoracic and abdominal respiration, and temperature. Objective: This study evaluates the feasibility of using a smart t-shirt for home monitoring of biometric sensor data in adolescent and young adult and elderly patients during cancer treatment. Methods: The OncoSmartShirt study is an explorative study investigating the feasibility of using the Chronolife smart t-shirt during cancer treatment. This smart t-shirt is designed with multiple fully embedded sensors and electrodes that engender 6 different measurement flows continuously. A total of 20 Danish patients with cancer ≥18 years old in antineoplastic treatment at Department of Oncology Rigshospitalet Denmark will be recruited from all cancer wards, whether patients are in curative or palliative care. Of these 20 patients, 10 (50%) will be <39 years old, defined as adolescent and young adult, and 10 (50%) will be patients >65 years old, defined as elderly. Consenting patients will be asked to wear a smart t-shirt daily for 2 weeks during their treatment course. Results: The primary outcome is to determine if it is feasible to wear a smart t-shirt throughout the day (preferably 8 hours per day) for 2 weeks. Inclusion of patients started in March 2022. Conclusions: The study will assess the feasibility of using the Chronolife smart t-shirt for home monitoring of vital parameters in patients with cancer during their treatment and bring new insights into how wearables and biometric data can be used as part of symptom or side-effect recognition in patients with cancer during treatment, with the aim to increase patients’ quality of life. Trial Registration: ClinicalTrials.gov NCT05235594; https://beta.clinicaltrials.gov/study/NCT05235594 International Registered Report Identifier (IRRID): PRR1-10.2196/37626 %M 36190744 %R 10.2196/37626 %U https://www.researchprotocols.org/2022/10/e37626 %U https://doi.org/10.2196/37626 %U http://www.ncbi.nlm.nih.gov/pubmed/36190744 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 9 %P e40572 %T Feasibility of Measuring Screen Time, Activity, and Context Among Families With Preschoolers: Intensive Longitudinal Pilot Study %A Parker,Hannah %A Burkart,Sarah %A Reesor-Oyer,Layton %A Smith,Michal T %A Dugger,Roddrick %A von Klinggraeff,Lauren %A Weaver,R Glenn %A Beets,Michael W %A Armstrong,Bridget %+ Department of Exercise Science, Arnold School of Public Health, University of South Carolina, 921 Assembly St, Columbia, SC, 29208-3904, United States, 1 803 576 8418, ba12@mailbox.sc.edu %K ecological momentary assessment %K accelerometry %K objective digital media use %K screen time %K sleep %K activity %K preschool %K dyads %K mobile phone %D 2022 %7 29.9.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: Digital media has made screen time more available across multiple contexts, but our understanding of the ways children and families use digital media has lagged behind the rapid adoption of this technology. Objective: This study evaluated the feasibility of an intensive longitudinal data collection protocol to objectively measure digital media use, physical activity, sleep, sedentary behavior, and socioemotional context among caregiver-child dyads. This paper also describes preliminary convergent validity of ecological momentary assessment (EMA) measures and preliminary agreement between caregiver self-reported phone use and phone use collected from passive mobile sensing. Methods: Caregivers and their preschool-aged child (3-5 years) were recruited to complete a 30-day assessment protocol. Within 30-days, caregivers completed 7 days of EMA to measure child behavior problems and caregiver stress. Caregivers and children wore an Axivity AX3 (Newcastle Upon Tyne) accelerometer to assess physical activity, sedentary behavior, and sleep. Phone use was assessed via passive mobile sensing; we used Chronicle for Android users and screenshots of iOS screen time metrics for iOS users. Participants were invited to complete a second 14-day protocol approximately 3-12 months after their first assessment. We used Pearson correlations to examine preliminary convergent validity between validated questionnaire measures of caregiver psychological functioning, child behavior, and EMA items. Root mean square errors were computed to examine the preliminary agreement between caregiver self-reported phone use and objective phone use. Results: Of 110 consenting participants, 105 completed all protocols (105/110, 95.5% retention rate). Compliance was defined a priori as completing ≥70%-75% of each protocol task. There were high compliance rates for passive mobile sensing for both Android (38/40, 95%) and iOS (64/65, 98%). EMA compliance was high (105/105, 100%), but fewer caregivers and children were compliant with accelerometry (62/99, 63% and 40/100, 40%, respectively). Average daily phone use was 383.4 (SD 157.0) minutes for Android users and 354.7 (SD 137.6) minutes for iOS users. There was poor agreement between objective and caregiver self-reported phone use; root mean square errors were 157.1 and 81.4 for Android and iOS users, respectively. Among families who completed the first assessment, 91 re-enrolled to complete the protocol a second time, approximately 7 months later (91/105, 86.7% retention rate). Conclusions: It is feasible to collect intensive longitudinal data on objective digital media use simultaneously with accelerometry and EMA from an economically and racially diverse sample of families with preschool-aged children. The high compliance and retention of the study sample are encouraging signs that these methods of intensive longitudinal data collection can be completed in a longitudinal cohort study. The lack of agreement between self-reported and objectively measured mobile phone use highlights the need for additional research using objective methods to measure digital media use. International Registered Report Identifier (IRRID): RR2-36240 %M 36173677 %R 10.2196/40572 %U https://formative.jmir.org/2022/9/e40572 %U https://doi.org/10.2196/40572 %U http://www.ncbi.nlm.nih.gov/pubmed/36173677 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 9 %P e38262 %T A Method to Deliver Automated and Tailored Intervention Content: 24-month Clinical Trial %A Miller,Hailey N %A Voils,Corrine I %A Cronin,Kate A %A Jeanes,Elizabeth %A Hawley,Jeffrey %A Porter,Laura S %A Adler,Rachel R %A Sharp,Whitney %A Pabich,Samantha %A Gavin,Kara L %A Lewis,Megan A %A Johnson,Heather M %A Yancy Jr,William S %A Gray,Kristen E %A Shaw,Ryan J %+ School of Nursing, Duke University, 307 Trent Drive, North Carolina, NC, 27710, United States, 1 919 684 9434, ryan.shaw@duke.edu %K text message %K weight management %K automation %K clinical trial %K engagement %K digital technology %K electronic data capture %K REDCap %K automated text message %K digital health intervention %K health intervention %K health database %K digital health %D 2022 %7 6.9.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: The use of digital technologies and software allows for new opportunities to communicate and engage with research participants over time. When software is coupled with automation, we can engage with research participants in a reliable and affordable manner. Research Electronic Data Capture (REDCap), a browser-based software, has the capability to send automated text messages. This feature can be used to automate delivery of tailored intervention content to research participants in interventions, offering the potential to reduce costs and improve accessibility and scalability. Objective: This study aimed to describe the development and use of 2 REDCap databases to deliver automated intervention content and communication to index participants and their partners (dyads) in a 2-arm, 24-month weight management trial, Partner2Lose. Methods: Partner2Lose randomized individuals with overweight or obesity and cohabitating with a partner to a weight management intervention alone or with their partner. Two databases were developed to correspond to 2 study phases: one for weight loss initiation and one for weight loss maintenance and reminders. The weight loss initiation database was programmed to send participants (in both arms) and their partners (partner-assisted arm) tailored text messages during months 1-6 of the intervention to reinforce class content and support goal achievement. The weight maintenance and reminder database was programmed to send maintenance-related text messages to each participant (both arms) and their partners (partner-assisted arm) during months 7-18. It was also programmed to send text messages to all participants and partners over the course of the 24-month trial to remind them of group classes, dietary recall and physical activity tracking for assessments, and measurement visits. All text messages were delivered via Twilio and were unidirectional. Results: Five cohorts, comprising 231 couples, were consented and randomized in the Partner2Lose trial. The databases will send 53,518 automated, tailored text messages during the trial, significantly reducing the need for staff to send and manage intervention content over 24 months. The cost of text messaging will be approximately US $450. Thus far, there is a 0.004% known error rate in text message delivery. Conclusions: Our trial automated the delivery of tailored intervention content and communication using REDCap. The approach described provides a framework that can be used in future behavioral health interventions to create an accessible, reliable, and affordable method for intervention delivery and engagement that requires minimal trial-specific resources and personnel time. Trial Registration: ClinicalTrials.gov NCT03801174; https://clinicaltrials.gov/ct2/show/NCT03801174?term=NCT03801174 %M 36066936 %R 10.2196/38262 %U https://formative.jmir.org/2022/9/e38262 %U https://doi.org/10.2196/38262 %U http://www.ncbi.nlm.nih.gov/pubmed/36066936 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 8 %P e37856 %T Assessing the Feasibility of Studying Awareness of a Digital Health Campaign on Facebook: Pilot Study Comparing Young Adult Subsamples %A Tulsiani,Shreya %A Ichimiya,Megumi %A Gerard,Raquel %A Mills,Sarah %A Bingenheimer,Jeffrey B %A Hair,Elizabeth C %A Vallone,Donna %A Evans,W Douglas %+ Schroeder Institute, Truth Initiative, 900 G St NW, 4th Fl, Washington, DC, 20001, United States, 1 202 454 5765, stulsiani@truthinitiative.org %K campaign evaluation %K outcome evaluation %K young adults %K social marketing %K health communications %K tobacco control and policy %K health campaign %K youth %K Facebook %K digital media %D 2022 %7 29.8.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: Mass media campaigns for preventive health messaging have been shown to be effective through years of research. However, few studies have assessed the effectiveness of campaigns on digital media, which is currently how youths and young adults are primarily consuming media. In particular, a platform that can accurately assess exposure to digital messaging in a real-life setting has yet to be developed. Objective: This study examines the feasibility of a unique survey platform, Virtual Lab, to conduct a study on exposure to a media campaign within Facebook using a chatbot-style survey administration technique. Methods: Virtual Lab is a survey platform that was used to recruit and survey participants within Facebook and Facebook Messenger, respectively. We created a Facebook business account with 2 Facebook pages: one for recruitment and disseminating the survey and the other one for serving the target advertisements. Pre- and postexposure surveys were administered via Facebook Messenger using a chatbot-style questionnaire 1 week apart. During this time, the target advertisements were shown to participants who completed the pre-exposure survey. The total time from recruitment to completion of the postexposure survey was 13 days, and incentive costs were US $10 per participant. Survey data were compared between those who completed both pre- and postexposure surveys and those who only completed the pre-exposure survey; that is, those who were lost to follow-up. The demographics of the complete cases were also compared to the US census data. Results: A total of 375 Facebook users aged between 18 and 24 years met eligibility requirements and consented to the study, which consisted of complete cases (n=234) and participants lost to follow-up (n=141). A few differences between complete cases and participants lost to follow-up were observed. Regarding gender, complete cases comprised 40.2% males and 59.4% females, and among participants lost to follow-up, 44.0% were male and 50.4% were female (P=.003). Differences were also observed for e-cigarette use status, where a greater number of current users and fewer past and never users were lost to follow-up than complete cases (P=.01). Conclusions: The use of Virtual Lab yielded a diverse sample quickly and cost-effectively. Demographic characteristics of participants who completed the study and those who were lost to follow-up were similar, indicating that no biases were caused by the platform during recruitment or testing. This study suggests the feasibility of the Virtual Lab survey platform for studies of media campaign exposure within Facebook. This platform can advance health campaign research by providing more accurate data to inform digital messaging. %M 36036974 %R 10.2196/37856 %U https://formative.jmir.org/2022/8/e37856 %U https://doi.org/10.2196/37856 %U http://www.ncbi.nlm.nih.gov/pubmed/36036974 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 11 %N 8 %P e36741 %T Continuous Remote Patient Monitoring in Patients With Heart Failure (Cascade Study): Protocol for a Mixed Methods Feasibility Study %A Reamer,Courtney %A Chi,Wei Ning %A Gordon,Robert %A Sarswat,Nitasha %A Gupta,Charu %A Gaznabi,Safwan %A White VanGompel,Emily %A Szum,Izabella %A Morton-Jost,Melissa %A Vaughn,Jorma %A Larimer,Karen %A Victorson,David %A Erwin,John %A Halasyamani,Lakshmi %A Solomonides,Anthony %A Padman,Rema %A Shah,Nirav S %+ Department of Medicine, NorthShore University HealthSystem, 2650 Ridge Avenue, Evanston, IL, United States, 1 847 570 2000, CReamer@northshore.org %K continuous remote patient monitoring %K remote patient monitoring %K feasibility %K heart failure %K wearable biosensor %K preliminary efficacy %K mobile phone %D 2022 %7 25.8.2022 %9 Protocol %J JMIR Res Protoc %G English %X Background: Heart failure (HF) is a prevalent chronic disease and is associated with increases in mortality and morbidity. HF is a leading cause of hospitalizations and readmissions in the United States. A potentially promising area for preventing HF readmissions is continuous remote patient monitoring (CRPM). Objective: The primary aim of this study is to determine the feasibility and preliminary efficacy of a CRPM solution in patients with HF at NorthShore University HealthSystem. Methods: This study is a feasibility study and uses a wearable biosensor to continuously remotely monitor patients with HF for 30 days after discharge. Eligible patients admitted with an HF exacerbation at NorthShore University HealthSystem are being recruited, and the wearable biosensor is placed before discharge. The biosensor collects physiological ambulatory data, which are analyzed for signs of patient deterioration. Participants are also completing a daily survey through a dedicated study smartphone. If prespecified criteria from the physiological data and survey results are met, a notification is triggered, and a predetermined electronic health record–based pathway of telephonic management is completed. In phase 1, which has already been completed, 5 patients were enrolled and monitored for 30 days after discharge. The results of phase 1 were analyzed, and modifications to the program were made to optimize it. After analysis of the phase 1 results, 15 patients are being enrolled for phase 2, which is a calibration and testing period to enable further adjustments to be made. After phase 2, we will enroll 45 patients for phase 3. The combined results of phases 1, 2, and 3 will be analyzed to determine the feasibility of a CRPM program in patients with HF. Semistructured interviews are being conducted with key stakeholders, including patients, and these results will be analyzed using the affective adaptation of the technology acceptance model. Results: During phase 1, of the 5 patients, 2 (40%) were readmitted during the study period. The study completion rate for phase 1 was 80% (4/5), and the study attrition rate was 20% (1/5). There were 57 protocol deviations out of 150 patient days in phase 1 of the study. The results of phase 1 were analyzed, and the study protocol was adjusted to optimize it for phases 2 and 3. Phase 2 and phase 3 results will be available by the end of 2022. Conclusions: A CRPM program may offer a low-risk solution to improve care of patients with HF after hospital discharge and may help to decrease readmission of patients with HF to the hospital. This protocol may also lay the groundwork for the use of CRPM solutions in other groups of patients considered to be at high risk. International Registered Report Identifier (IRRID): DERR1-10.2196/36741 %M 36006689 %R 10.2196/36741 %U https://www.researchprotocols.org/2022/8/e36741 %U https://doi.org/10.2196/36741 %U http://www.ncbi.nlm.nih.gov/pubmed/36006689 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 11 %N 8 %P e35442 %T Description of the Method for Evaluating Digital Endpoints in Alzheimer Disease Study: Protocol for an Exploratory, Cross-sectional Study %A Curcic,Jelena %A Vallejo,Vanessa %A Sorinas,Jennifer %A Sverdlov,Oleksandr %A Praestgaard,Jens %A Piksa,Mateusz %A Deurinck,Mark %A Erdemli,Gul %A Bügler,Maximilian %A Tarnanas,Ioannis %A Taptiklis,Nick %A Cormack,Francesca %A Anker,Rebekka %A Massé,Fabien %A Souillard-Mandar,William %A Intrator,Nathan %A Molcho,Lior %A Madero,Erica %A Bott,Nicholas %A Chambers,Mieko %A Tamory,Josef %A Shulz,Matias %A Fernandez,Gerardo %A Simpson,William %A Robin,Jessica %A Snædal,Jón G %A Cha,Jang-Ho %A Hannesdottir,Kristin %+ Novartis Institutes for Biomedical Research, Fabrikstrasse 2 Novartis Campus, Basel, 4056, Switzerland, 41 795003648, jelena.curcic@novartis.com %K digital endpoints %K cognition %K Alzheimer disease %K brain amyloid %K methodology study %K clinical trial design %K mobile phone %D 2022 %7 10.8.2022 %9 Protocol %J JMIR Res Protoc %G English %X Background: More sensitive and less burdensome efficacy end points are urgently needed to improve the effectiveness of clinical drug development for Alzheimer disease (AD). Although conventional end points lack sensitivity, digital technologies hold promise for amplifying the detection of treatment signals and capturing cognitive anomalies at earlier disease stages. Using digital technologies and combining several test modalities allow for the collection of richer information about cognitive and functional status, which is not ascertainable via conventional paper-and-pencil tests. Objective: This study aimed to assess the psychometric properties, operational feasibility, and patient acceptance of 10 promising technologies that are to be used as efficacy end points to measure cognition in future clinical drug trials. Methods: The Method for Evaluating Digital Endpoints in Alzheimer Disease study is an exploratory, cross-sectional, noninterventional study that will evaluate 10 digital technologies’ ability to accurately classify participants into 4 cohorts according to the severity of cognitive impairment and dementia. Moreover, this study will assess the psychometric properties of each of the tested digital technologies, including the acceptable range to assess ceiling and floor effects, concurrent validity to correlate digital outcome measures to traditional paper-and-pencil tests in AD, reliability to compare test and retest, and responsiveness to evaluate the sensitivity to change in a mild cognitive challenge model. This study included 50 eligible male and female participants (aged between 60 and 80 years), of whom 13 (26%) were amyloid-negative, cognitively healthy participants (controls); 12 (24%) were amyloid-positive, cognitively healthy participants (presymptomatic); 13 (26%) had mild cognitive impairment (predementia); and 12 (24%) had mild AD (mild dementia). This study involved 4 in-clinic visits. During the initial visit, all participants completed all conventional paper-and-pencil assessments. During the following 3 visits, the participants underwent a series of novel digital assessments. Results: Participant recruitment and data collection began in June 2020 and continued until June 2021. Hence, the data collection occurred during the COVID-19 pandemic (SARS-CoV-2 virus pandemic). Data were successfully collected from all digital technologies to evaluate statistical and operational performance and patient acceptance. This paper reports the baseline demographics and characteristics of the population studied as well as the study's progress during the pandemic. Conclusions: This study was designed to generate feasibility insights and validation data to help advance novel digital technologies in clinical drug development. The learnings from this study will help guide future methods for assessing novel digital technologies and inform clinical drug trials in early AD, aiming to enhance clinical end point strategies with digital technologies. International Registered Report Identifier (IRRID): DERR1-10.2196/35442 %M 35947423 %R 10.2196/35442 %U https://www.researchprotocols.org/2022/8/e35442 %U https://doi.org/10.2196/35442 %U http://www.ncbi.nlm.nih.gov/pubmed/35947423 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 11 %N 8 %P e36213 %T Supporting Self-management and Quality of Life in Bipolar Disorder With the PolarUs App (Alpha): Protocol for a Mixed Methods Study %A Michalak,Erin E %A Barnes,Steven J %A Morton,Emma %A O'Brien,Heather L %A Murray,Greg %A Hole,Rachelle %A Meyer,Denny %+ Department of Psychiatry, University of British Columbia, 420-5950 University Blvd, Vancouver, BC, V6T1Z3, Canada, 1 604 827 3393, erin.michalak@ubc.ca %K eHealth %K mobile health %K mHealth %K bipolar disorder %K self-management %K engagement %K mobile phone %D 2022 %7 4.8.2022 %9 Protocol %J JMIR Res Protoc %G English %X Background: Quality of life (QoL) is increasingly being recognized as a key outcome of interventions for bipolar disorder (BD). Mobile phone apps can increase access to evidence-based self-management strategies and provide real-time support. However, although individuals with lived experiences desire support with monitoring and improving broader health domains, existing BD apps largely target mood symptoms only. Further, evidence from the broader mobile health (mHealth) literature has shown that the desires and goals of end users are not adequately considered during app development, and as a result, engagement with mental health apps is suboptimal. To capitalize on the potential of apps to optimize wellness in BD, there is a need for interventions developed in consultation with real-world users designed to support QoL self-monitoring and self-management. Objective: This mixed methods pilot study was designed to evaluate the alpha version of the newly developed PolarUs app, developed to support QoL self-monitoring and self-management in people with BD. Co-designed using a community-based participatory research framework, the PolarUs app builds on the web-based adaptation of a BD-specific QoL self-assessment measure and integrates material from a web-based portal providing information on evidence-informed self-management strategies in BD. The primary objectives of this project were to evaluate PolarUs app feasibility (via behavioral use metrics), the impact of PolarUs (via the Brief Quality of Life in Bipolar Disorder scale, our primary outcome measure), and explore engagement with the PolarUs app (via quantitative and qualitative methods). Methods: Participants will be residents of North America (N=150), aged >18 years, with a Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision diagnosis of BD type 1, BD type 2, or BD not otherwise specified as assessed by structured diagnostic interview. An embedded mixed methods research design will be adopted; qualitative interviews with a purposefully selected subsample (approximately, n=30) of participants will be conducted to explore in more depth feasibility, impact, and engagement with the PolarUs app over the 12-week study period. Results: At the time of publication of this protocol, the development of the alpha version of the PolarUs app was complete. Participant enrollment has begun in June 2022. Data collection is expected to be completed by December 2022. Conclusions: Beyond contributing knowledge on the feasibility and impact of a novel app to support QoL and self-management in BD, this study will also provide new insights related to engagement with mHealth apps. Furthermore, it will function as a case study of successful co-design between people with BD, health care providers, and BD researchers, providing a template for the future use of community-based participatory research frameworks in mHealth intervention development. The results will be used to further refine the PolarUs app and inform the design of a larger clinical trial. International Registered Report Identifier (IRRID): PRR1-10.2196/36213 %M 35925666 %R 10.2196/36213 %U https://www.researchprotocols.org/2022/8/e36213 %U https://doi.org/10.2196/36213 %U http://www.ncbi.nlm.nih.gov/pubmed/35925666 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 11 %N 7 %P e37929 %T Pediatric Research Observing Trends and Exposures in COVID-19 Timelines (PROTECT): Protocol for a Multisite Longitudinal Cohort Study %A Burns,Joy %A Rivers,Patrick %A LeClair,Lindsay B %A Jovel,Krystal S %A Rai,Ramona P %A Lowe,Ashley A %A Edwards,Laura J %A Khan,Sana M %A Mathenge,Clare %A Ferraris,Maria %A Kuntz,Jennifer L %A Lamberte,Julie Mayo %A Hegmann,Kurt T %A Odean,Marilyn J %A McLeland-Wieser,Hilary %A Beitel,Shawn %A Odame-Bamfo,Leah %A Schaefer Solle,Natasha %A Mak,Josephine %A Phillips,Andrew L %A Sokol,Brian E %A Hollister,James %A Ochoa,Jezahel S %A Grant,Lauren %A Thiese,Matthew S %A Jacoby,Keya B %A Lutrick,Karen %A Pubillones,Felipe A %A Yoo,Young M %A Rentz Hunt,Danielle %A Ellingson,Katherine %A Berry,Mark C %A Gerald,Joe K %A Lopez,Joanna %A Gerald,Lynn B %A Wesley,Meredith G %A Krupp,Karl %A Herring,Meghan K %A Madhivanan,Purnima %A Caban-Martinez,Alberto J %A Tyner,Harmony L %A Meece,Jennifer K %A Yoon,Sarang K %A Fowlkes,Ashley L %A Naleway,Allison L %A Gwynn,Lisa %A Burgess,Jefferey L %A Thompson,Mark G %A Olsho,Lauren EW %A Gaglani,Manjusha %+ COVID-19 Response Team, Centers for Disease Control and Prevention, 1600 Clifton Rd NE, H24-7, Atlanta, GA, 30333, United States, 1 404 822 1999, ahl4@cdc.gov %K COVID-19 %K SARS-CoV-2 %K vaccine effectiveness %K vaccine %K efficacy %K effectiveness %K cohort study %K pediatric %K child %K inoculation %K vaccination %K public health %K children %K health care professional %K health care %K caregiver %K health data %K online survey %K incidence %D 2022 %7 28.7.2022 %9 Protocol %J JMIR Res Protoc %G English %X Background: Assessing the real-world effectiveness of COVID-19 vaccines and understanding the incidence and severity of SARS-CoV-2 illness in children are essential to inform policy and guide health care professionals in advising parents and caregivers of children who test positive for SARS-CoV-2. Objective: This report describes the objectives and methods for conducting the Pediatric Research Observing Trends and Exposures in COVID-19 Timelines (PROTECT) study. PROTECT is a longitudinal prospective pediatric cohort study designed to estimate SARS-CoV-2 incidence and COVID-19 vaccine effectiveness (VE) against infection among children aged 6 months to 17 years, as well as differences in SARS-CoV-2 infection and vaccine response between children and adolescents. Methods: The PROTECT multisite network was initiated in July 2021, which aims to enroll approximately 2305 children across four US locations and collect data over a 2-year surveillance period. The enrollment target was based on prospective power calculations and accounts for expected attrition and nonresponse. Study sites recruit parents and legal guardians of age-eligible children participating in the existing Arizona Healthcare, Emergency Response, and Other Essential Workers Surveillance (HEROES)-Research on the Epidemiology of SARS-CoV-2 in Essential Response Personnel (RECOVER) network as well as from surrounding communities. Child demographics, medical history, COVID-19 exposure, vaccination history, and parents/legal guardians’ knowledge and attitudes about COVID-19 are collected at baseline and throughout the study. Mid-turbinate nasal specimens are self-collected or collected by parents/legal guardians weekly, regardless of symptoms, for SARS-CoV-2 and influenza testing via reverse transcription-polymerase chain reaction (RT-PCR) assay, and the presence of COVID-like illness (CLI) is reported. Children who test positive for SARS-CoV-2 or influenza, or report CLI are monitored weekly by online surveys to report exposure and medical utilization until no longer ill. Children, with permission of their parents/legal guardians, may elect to contribute blood at enrollment, following SARS-CoV-2 infection, following COVID-19 vaccination, and at the end of the study period. PROTECT uses electronic medical record (EMR) linkages where available, and verifies COVID-19 and influenza vaccinations through EMR or state vaccine registries. Results: Data collection began in July 2021 and is expected to continue through the spring of 2023. As of April 13, 2022, 2371 children are enrolled in PROTECT. Enrollment is ongoing at all study sites. Conclusions: As COVID-19 vaccine products are authorized for use in pediatric populations, PROTECT study data will provide real-world estimates of VE in preventing infection. In addition, this prospective cohort provides a unique opportunity to further understand SARS-CoV-2 incidence, clinical course, and key knowledge gaps that may inform public health. International Registered Report Identifier (IRRID): RR1-10.2196/37929 %M 35635842 %R 10.2196/37929 %U https://www.researchprotocols.org/2022/7/e37929 %U https://doi.org/10.2196/37929 %U http://www.ncbi.nlm.nih.gov/pubmed/35635842 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 7 %P e39004 %T Single-Session Interventions Embedded Within Tumblr: Acceptability, Feasibility, and Utility Study %A Dobias,Mallory L %A Morris,Robert R %A Schleider,Jessica L %+ Department of Psychology, Stony Brook University, Psychology Building B-363, Stony Brook, NY, 11794-2500, United States, 1 512 818 9040, mallory.dobias@stonybrook.edu %K web-based intervention %K internet intervention %K digital intervention %K single-session intervention %K mental health %D 2022 %7 25.7.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: Existing mental health treatments are insufficient for addressing mental health needs at scale, particularly for teenagers, who now seek mental health information and support on the web. Single-session interventions (SSIs) may be particularly well suited for dissemination as embedded web-based support options that are easily accessible on popular social platforms. Objective: We aimed to evaluate the acceptability and effectiveness of three SSIs, each with a duration of 5 to 8 minutes (Project Action Brings Change, Project Stop Adolescent Violence Everywhere, and REFRAME)—embedded as Koko minicourses on Tumblr—to improve three key mental health outcomes: hopelessness, self-hate, and the desire to stop self-harm behavior. Methods: We used quantitative data (ie, star ratings and SSI completion rates) to evaluate acceptability and short-term utility of all 3 SSIs. Paired 2-tailed t tests were used to assess changes in hopelessness, self-hate, and the desire to stop future self-harm from before to after the SSI. Where demographic information was available, the analyses were restricted to teenagers (13-19 years). Examples of positive and negative qualitative user feedback (ie, written text responses) were provided for each program. Results: The SSIs were completed 6179 times between March 2021 and February 2022. All 3 SSIs generated high star ratings (>4 out of 5 stars), with high completion rates (approximately 25%-57%) relative to real-world completion rates among other digital self-help interventions. Paired 2-tailed t tests detected significant pre-post reductions in hopelessness for those who completed Project Action Brings Change (P<.001, Cohen dz=−0.81, 95% CI −0.85 to −0.77) and REFRAME (P<.001, Cohen dz=−0.88, 95% CI −0.96 to −0.80). Self-hate significantly decreased (P<.001, Cohen dz=−0.67, 95% CI −0.74 to −0.60), and the desire to stop self-harm significantly increased (P<.001, Cohen dz=0.40, 95% CI 0.33 to 0.47]) from before to after the completion of Project Stop Adolescent Violence Everywhere. The results remained consistent across sensitivity analyses and after correcting for multiple tests. Examples of positive and negative qualitative user feedback point toward future directions for SSI research. Conclusions: Very brief SSIs, when embedded within popular social platforms, are one promising and acceptable method for providing free, scalable, and potentially helpful mental health support on the web. Considering the unique barriers to mental health treatment access that many teenagers face, this approach may be especially useful for teenagers without access to other mental health supports. %M 35877163 %R 10.2196/39004 %U https://formative.jmir.org/2022/7/e39004 %U https://doi.org/10.2196/39004 %U http://www.ncbi.nlm.nih.gov/pubmed/35877163 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 11 %N 7 %P e33717 %T Developing, Implementing, and Evaluating an Artificial Intelligence–Guided Mental Health Resource Navigation Chatbot for Health Care Workers and Their Families During and Following the COVID-19 Pandemic: Protocol for a Cross-sectional Study %A Noble,Jasmine M %A Zamani,Ali %A Gharaat,MohamadAli %A Merrick,Dylan %A Maeda,Nathanial %A Lambe Foster,Alex %A Nikolaidis,Isabella %A Goud,Rachel %A Stroulia,Eleni %A Agyapong,Vincent I O %A Greenshaw,Andrew J %A Lambert,Simon %A Gallson,Dave %A Porter,Ken %A Turner,Debbie %A Zaiane,Osmar %+ Department of Computing Science, University of Alberta, ATH 443 (Athabasca Hall), Edmonton, AB, T6G 2E8, Canada, 1 780 492 2860, zaiane@ualberta.ca %K eHealth %K chatbot %K conversational agent %K health system navigation %K electronic health care %K mobile phone %D 2022 %7 25.7.2022 %9 Protocol %J JMIR Res Protoc %G English %X Background: Approximately 1 in 3 Canadians will experience an addiction or mental health challenge at some point in their lifetime. Unfortunately, there are multiple barriers to accessing mental health care, including system fragmentation, episodic care, long wait times, and insufficient support for health system navigation. In addition, stigma may further reduce an individual’s likelihood of seeking support. Digital technologies present new and exciting opportunities to bridge significant gaps in mental health care service provision, reduce barriers pertaining to stigma, and improve health outcomes for patients and mental health system integration and efficiency. Chatbots (ie, software systems that use artificial intelligence to carry out conversations with people) may be explored to support those in need of information or access to services and present the opportunity to address gaps in traditional, fragmented, or episodic mental health system structures on demand with personalized attention. The recent COVID-19 pandemic has exacerbated even further the need for mental health support among Canadians and called attention to the inefficiencies of our system. As health care workers and their families are at an even greater risk of mental illness and psychological distress during the COVID-19 pandemic, this technology will be first piloted with the goal of supporting this vulnerable group. Objective: This pilot study seeks to evaluate the effectiveness of the Mental Health Intelligent Information Resource Assistant in supporting health care workers and their families in the Canadian provinces of Alberta and Nova Scotia with the provision of appropriate information on mental health issues, services, and programs based on personalized needs. Methods: The effectiveness of the technology will be assessed via voluntary follow-up surveys and an analysis of client interactions and engagement with the chatbot. Client satisfaction with the chatbot will also be assessed. Results: This project was initiated on April 1, 2021. Ethics approval was granted on August 12, 2021, by the University of Alberta Health Research Board (PRO00109148) and on April 21, 2022, by the Nova Scotia Health Authority Research Ethics Board (1027474). Data collection is anticipated to take place from May 2, 2022, to May 2, 2023. Publication of preliminary results will be sought in spring or summer 2022, with a more comprehensive evaluation completed by spring 2023 following the collection of a larger data set. Conclusions: Our findings can be incorporated into public policy and planning around mental health system navigation by Canadian mental health care providers—from large public health authorities to small community-based, not-for-profit organizations. This may serve to support the development of an additional touch point, or point of entry, for individuals to access the appropriate services or care when they need them, wherever they are. International Registered Report Identifier (IRRID): PRR1-10.2196/33717 %M 35877158 %R 10.2196/33717 %U https://www.researchprotocols.org/2022/7/e33717 %U https://doi.org/10.2196/33717 %U http://www.ncbi.nlm.nih.gov/pubmed/35877158 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 11 %N 7 %P e21994 %T An Integrated Care Platform System (C3-Cloud) for Care Planning, Decision Support, and Empowerment of Patients With Multimorbidity: Protocol for a Technology Trial %A von Tottleben,Malte %A Grinyer,Katie %A Arfa,Ali %A Traore,Lamine %A Verdoy,Dolores %A Lim Choi Keung,Sarah N %A Larranaga,Igor %A Jaulent,Marie-Christine %A De Manuel Keenoy,Esteban %A Lilja,Mikael %A Beach,Marie %A Marguerie,Christopher %A Yuksel,Mustafa %A Laleci Erturkmen,Gokce Banu %A Klein,Gunnar O %A Lindman,Pontus %A Mar,Javier %A Kalra,Dipak %A , %A Arvanitis,Theodoros N %+ Institute of Digital Healthcare (IDH), Warwick Manufacturing Group, University of Warwick, International Digital Laboratory, Lord Bhattacharyya Way, Coventry, CV4 7AL, United Kingdom, 44 (0)7796 707955, t.arvanitis@warwick.ac.uk %K multimorbidity %K polypharmacy %K guidelines reconciliation %K clinical decision support %K personalized care plans %K diabetes mellitus type 2 %K heart failure %K depression %K renal failure %K acceptability %K usability %K evaluation %K cost-benefit evaluation %K predictive modeling %D 2022 %7 13.7.2022 %9 Original Paper %J JMIR Res Protoc %G English %X Background: There is an increasing need to organize the care around the patient and not the disease, while considering the complex realities of multiple physical and psychosocial conditions, and polypharmacy. Integrated patient-centered care delivery platforms have been developed for both patients and clinicians. These platforms could provide a promising way to achieve a collaborative environment that improves the provision of integrated care for patients via enhanced information and communication technology solutions for semiautomated clinical decision support. Objective: The Collaborative Care and Cure Cloud project (C3-Cloud) has developed 2 collaborative computer platforms for patients and members of the multidisciplinary team (MDT) and deployed these in 3 different European settings. The objective of this study is to pilot test the platforms and evaluate their impact on patients with 2 or more chronic conditions (diabetes mellitus type 2, heart failure, kidney failure, depression), their informal caregivers, health care professionals, and, to some extent, health care systems. Methods: This paper describes the protocol for conducting an evaluation of user experience, acceptability, and usefulness of the platforms. For this, 2 “testing and evaluation” phases have been defined, involving multiple qualitative methods (focus groups and surveys) and advanced impact modeling (predictive modeling and cost-benefit analysis). Patients and health care professionals were identified and recruited from 3 partnering regions in Spain, Sweden, and the United Kingdom via electronic health record screening. Results: The technology trial in this 4-year funded project (2016-2020) concluded in April 2020. The pilot technology trial for evaluation phases 3 and 4 was launched in November 2019 and carried out until April 2020. Data collection for these phases is completed with promising results on platform acceptance and socioeconomic impact. We believe that the phased, iterative approach taken is useful as it involves relevant stakeholders at crucial stages in the platform development and allows for a sound user acceptance assessment of the final product. Conclusions: Patients with multiple chronic conditions often experience shortcomings in the care they receive. It is hoped that personalized care plan platforms for patients and collaboration platforms for members of MDTs can help tackle the specific challenges of clinical guideline reconciliation for patients with multimorbidity and improve the management of polypharmacy. The initial evaluative phases have indicated promising results of platform usability. Results of phases 3 and 4 were methodologically useful, yet limited due to the COVID-19 pandemic. Trial Registration: ClinicalTrials.gov NCT03834207; https://clinicaltrials.gov/ct2/show/NCT03834207 International Registered Report Identifier (IRRID): RR1-10.2196/21994 %M 35830239 %R 10.2196/21994 %U https://www.researchprotocols.org/2022/7/e21994 %U https://doi.org/10.2196/21994 %U http://www.ncbi.nlm.nih.gov/pubmed/35830239 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 11 %N 7 %P e32288 %T Physical Activity and Fall Prevention in Geriatric Inpatients in an Acute Care Unit (AGIR Study): Protocol for a Usability Study %A Noublanche,Frédéric %A Simon,Romain %A Ben-Sadoun,Grégory %A Annweiler,Cédric %+ Department of Geriatric Medicine and Memory Clinic, Research Center on Autonomy and Longevity, University Hospital of Angers, 4, rue Larrey, Angers, 49 933 Angers Cedex 9, France, 33 2 41 35 36 37, gregory.ben-sadoun@unicaen.fr %K fall prevention %K physical activity %K older patients %K geriatric acute care unit %D 2022 %7 11.7.2022 %9 Original Paper %J JMIR Res Protoc %G English %X Background: Falls are one of the world’s top 10 risks associated with disability in people older than 60 years. They also represent more than two-thirds of adverse events in hospitals, mainly affecting patients older than 65 years. Physical activity is a central intervention in fall prevention for older people. Whatever the details of the prevention strategy that is adopted (ie, how a mono- or multifactorial intervention is evaluated, the category of person the intervention targets, and where it is used), it is important to ensure that the proposed intervention is feasible and usable for the patient and the health care team. Objective: The primary objective is to study the usability of carrying out a physical activity intervention, including 3 types of exercises, in older patients hospitalized in a geriatric acute care unit and categorized according to 3 fall risk levels: low, moderate, and high. The secondary objectives are to determine the difficulty of the physical exercise for patients with different fall risk levels, to study the health care team’s perceptions of the intervention’s feasibility, and to study the benefits for patients. Methods: This is an open-label, unicenter, nonrandomized, usability prospective clinical trial. The intervention tested is a daily physical activity program. It consists of 3 types of physical exercise: staying out of bed for at least 3 hours, performing balance exercises while standing for 2 minutes, and the Five Times Sit to Stand transfer exercise. These exercises are carried out under the supervision of the health care team. Fall risk in the patients is classified with the Brief Geriatric Assessment tool. The exercise program starts on the second day of hospitalization after inclusion in the study. Patient assessment continues until the last day of hospitalization or the 20th day of hospitalization, whichever is earlier. For each fall-risk group and each type of exercise, the intervention will be defined as usable if at least 80% of the participants complete 75% or more of the exercises (ie, the ratio between the number of days when the patient completes a type of exercise and the total number of hospitalization days). The perceived feasibility by the health care team is measured with 2 scales, measuring perceived difficulty and time spent with the patient. The intervention benefit is evaluated using the performance of the Five Times Sit to Stand test before and after the intervention. Results: The first patient was recruited on March 16, 2015. The study enrolled 266 patients, including 75 with low fall risk, 105 with moderate risk, and 85 with high risk. Conclusions: We have not yet analyzed the results, but our observations suggest that the usability of each type of exercise for a given patient will depend on their fall risk level. Trial Registration: ClinicalTrials.gov NCT02393014; https://clinicaltrials.gov/ct2/show/NCT02393014 International Registered Report Identifier (IRRID): DERR1-10.2196/32288 %M 35816381 %R 10.2196/32288 %U https://www.researchprotocols.org/2022/7/e32288 %U https://doi.org/10.2196/32288 %U http://www.ncbi.nlm.nih.gov/pubmed/35816381 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 6 %P e34424 %T Feasibility and Acceptability of a Ugandan Telehealth Engagement Platform for Informational Messaging on Modern Contraception: Pilot Cross-sectional Study %A Kamulegeya,Louis Henry %A Bwanika,JohnMark %A Banonya,Joy %A Atuhaire,Joan %A Musinguzi,Davis %A Nakate,Vivian %A Kyenkya,Joshua %A Namatende,Lydia %A Horvath,Keith J %A Kiragga,Agnes %+ The Medical Concierge Group, Projects and Research Department, Lugogo Bypass, Mirembe Business Center, Kampala, 256, Uganda, 256 783216066, louis@tmcg.co.ug %K telehealth %K mHealth %K digital health %K family planning %K contraception %K messaging %K male involvement %K health education %K Uganda %D 2022 %7 28.6.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: With the region’s highest population growth rate (30%), Uganda is on the brink of a population explosion, yet access to and utilization of public health control measures like modern contraception is a challenge. This is due to remotely located health facilities, noncustomized health content, and poor or nonfunctional post-facility follow-up. Objective: The aim of our study was to evaluate the feasibility and acceptability of a telehealth engagement platform primarily targeting men; the platform provided behavioral and informational messaging on modern contraception (ie, family planning) and its impact on shaping sexual and reproductive health and knowledge and uptake of family planning services. Methods: A longitudinal cohort of men aged 18 years and older gave consent to receive mobile phone messages on family planning; follow-up was performed at months 1, 4, and 6 to assess key study-related outcomes on knowledge transfer and acquisition on modern contraception, partner communication, and spousal uptake of family planning. Qualitative interviews with the study participants’ spouses were also performed. Results: The study included 551 study participants, 450 of whom were men, the primary study participants, who received the family planning mobile messages and 101 of whom were their spouses. Of the 450 primary participants, 426 (95%) successfully received the messages and only 24 (5%) reported not receiving them. The average response (ie, participation) rate in weekly quizzes was 23%. There was a noted 18.1% increase in couple communication attributed to the intervention; couples opened up more to each other on matters concerning family planning. Conclusions: Using digital channels to address the concerns and inquiries of participants in real time or as fast as possible helped to increase the likelihood that couples adopted family planning. %M 35763336 %R 10.2196/34424 %U https://formative.jmir.org/2022/6/e34424 %U https://doi.org/10.2196/34424 %U http://www.ncbi.nlm.nih.gov/pubmed/35763336 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 6 %P e37414 %T Remotely Delivered Behavioral Weight Loss Intervention Using an Ad Libitum Plant-Based Diet: Pilot Acceptability, Feasibility, and Preliminary Results %A Chwyl,Christina %A Wright,Nicholas %A M Turner-McGrievy,Gabrielle %A L Butryn,Meghan %A M Forman,Evan %+ Center for Weight, Eating, and Lifestyle Sciences, Drexel University, 3141 Chestnut Street, Philadelphia, PA, 19104, United States, 1 267 606 0414, cmc646@drexel.edu %K vegetarian diet %K vegan diet %K overweight %K eHealth %K behavioral intervention %D 2022 %7 23.6.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: Many traditional lifestyle interventions use calorie prescriptions, but most individuals have difficulty sustaining calorie tracking and thus weight loss. In contrast, whole food plant-based diets (WFPBDs) have previously shown significant weight loss without this issue. However, most WFPBD interventions are face-to-face and time-intensive, and do not leverage gold standard behavioral strategies for health behavior change. Objective: This open pilot trial was the first to evaluate the feasibility of a fully featured, remotely delivered behavioral weight loss intervention using an ad libitum WFPBD. Methods: Over 12 weeks, participants (N=15) with overweight or obesity received a newly designed program that integrated behavioral weight loss and a WFPBD prescription via weekly web-based modules and brief phone coaching calls. Assessments were performed at baseline, midtreatment (6 weeks), and after treatment (12 weeks). Results: The intervention was rated as highly acceptable (mean 4.40 out of 5, SE 0.18), and attrition was low (6.7%). In all, intention-to-treat analyses revealed that 69% (10.4/15) of the participants lost 5% of their weight (mean –5.89, SE 0.68 kg). Predefined benchmarks for quality of life were met. Conclusions: A pilot digital behavioral weight loss intervention with a non–energy-restricted WFPBD was feasible, and the mean acceptability was high. Minimal contact time (80-150 minutes of study interventionist time per participant over 12 weeks) led to clinically relevant weight loss and dietary adherence for most participants (10.4/15, 69% and 11.8/15, 79%, respectively), and quality of life improvements (reliable change indices >1.53). We hope that this work will serve as a springboard for future larger scale randomized controlled studies evaluating the efficacy of such programs for weight loss, dietary change, and quality of life. Trial Registration: ClinicalTrials.gov NCT04892030; https://clinicaltrials.gov/ct2/show/NCT04892030 %M 35737443 %R 10.2196/37414 %U https://formative.jmir.org/2022/6/e37414 %U https://doi.org/10.2196/37414 %U http://www.ncbi.nlm.nih.gov/pubmed/35737443 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 6 %P e38162 %T Digital Screening and Automated Resource Identification System to Address COVID-19–Related Behavioral Health Disparities: Feasibility Study %A Stiles-Shields,Colleen %A Batts,Kathryn R %A Reyes,Karen M %A Archer,Joseph %A Crosby,Sharad %A Draxler,Janel M %A Lennan,Nia %A Held,Philip %+ Section of Community Behavioral Health, Department of Psychiatry and Behavioral Sciences, Rush University Medical Center, 1645 W Jackson Blvd, Suite 302, Chicago, IL, 60612, United States, 1 312 942 9998, colleen_stiles-shields@rush.edu %K digital mental health %K underserved %K health disparities %K COVID-19 %K screening %K referral %K mental health %K digital health %K feasibility study %K mobile app %K mHealth %K mobile health %K emotional need %K digital health tool %K health resource %K health care cost %D 2022 %7 22.6.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: Digital mental health (DMH) tools use technology (eg, websites and mobile apps) to conveniently deliver mental health resources to users in real time, reducing access barriers. Underserved communities facing health care provider shortages and limited mental health resources may benefit from DMH tools, as these tools can help improve access to resources. Objective: This study described the development and feasibility evaluation of the Emotional Needs Evaluation and Resource Guide for You (ENERGY) System, a DMH tool to meet the mental health and resource needs of youth and their families developed in the context of the COVID-19 pandemic. The ENERGY System offers a brief assessment of resource needs; problem-solving capabilities; and symptoms of depression, anxiety, trauma, and alcohol and substance use followed by automated, personalized feedback based on the participant’s responses. Methods: Individuals aged ≥15 years were recruited through community partners, community events, targeted electronic health record messages, and social media. Participants completed screening questions to establish eligibility, entered demographic information, and completed the ENERGY System assessment. Based on the participant’s responses, the ENERGY System immediately delivered digital resources tailored to their identified areas of need (eg, relaxation). A subset of participants also voluntarily completed the following: COVID-19 Exposure and Family Impact Survey (CEFIS) or COVID-19 Exposure and Family Impact Survey Adolescent and Young Adult Version (CEFIS-AYA); resource needs assessment; and feedback on their experience using the ENERGY System. If resource needs (eg, housing and food insecurity) were endorsed, lists of local resources were provided. Results: A total of 212 individuals accessed the ENERGY System link, of which 96 (45.3%) completed the screening tool and 86 (40.6%) received resources. Participant responses on the mental health screening questions triggered on average 2.04 (SD 1.94) intervention domains. Behavioral Activation/Increasing Activities was the most frequently launched intervention domain (56%, 54/96), and domains related to alcohol or substance use were the least frequent (4%, 4/96). The most frequently requested support areas were finances (33%, 32/96), transportation (26%, 25/96), and food (24%, 23/96). The CEFIS and CEFIS-AYA indicated higher than average impacts from the pandemic (ie, average scores >2.5). Participants were satisfied with the ENERGY System overall (65%, 39/60) as well as the length of time it took to answer the questions (90%, 54/60), which they found easy to answer (87%, 52/60). Conclusions: This study provided initial support for the feasibility of the ENERGY System, a DMH tool capable of screening for resource and mental health needs and providing automated, personalized, and free resources and techniques to meet the identified needs. Future studies should seek direct feedback from community members to further improve the ENERGY System and its dissemination to encourage use. %M 35696607 %R 10.2196/38162 %U https://formative.jmir.org/2022/6/e38162 %U https://doi.org/10.2196/38162 %U http://www.ncbi.nlm.nih.gov/pubmed/35696607 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 6 %P e35365 %T Perspectives on Participation in a Feasibility Study on Exercise-Based Cardiac Telerehabilitation After Transcatheter Aortic Valve Implantation: Qualitative Interview Study Among Patients and Health Professionals %A Thorup,Charlotte Brun %A Villadsen,Anne %A Andreasen,Jan Jesper %A Aarøe,Jens %A Andreasen,Jane %A Brocki,Barbara Cristina %+ Department of Cardiothoracic Surgery, Aalborg University Hospital, Hoborvej 18-22, Aalborg, 9000, Denmark, 45 30739950, cbt@rn.dk %K transcatheter aortic valve implantation %K aortic valve %K implant %K TAVI %K telerehabilitation %K rehabilitation %K aortic stenosis %K patients’ perspective %K older people %K elder %K aged %K geriatric %K gerontology %K patient experience %K user experience %K health professional experience %K physician experience %K telehealth %K older adult %K telemedicine %K cardiac %K cardiology %K heart %K perspective %K home-based %K exercise %K activity tracker %K physical activity %K mHealth %K mobile health %K fitness %D 2022 %7 20.6.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: Aortic valve stenosis affects approximately half of people aged ≥85 years, and the recommended surgical treatment for older patients is transcatheter aortic valve implantation (TAVI). Despite strong evidence for its advantages, low attendance rate in cardiac rehabilitation is observed among patients after TAVI. Cardiac telerehabilitation (CTR) has proven comparable with center-based rehabilitation; however, no study has investigated CTR targeting patients after TAVI. On the basis of participatory design, an exercise-based CTR program (TeleTAVI) was developed, which included a web-based session with a cardiac nurse, a tablet containing an informative website, an activity tracker, and supervised home-based exercise sessions that follow the national recommendations for cardiac rehabilitation. Objective: This study aims to explore patients’ and health professionals’ experiences with using health technologies and participating in the exercise-based CTR program, TeleTAVI. Methods: This study is a part of a feasibility study and will only report patients’ and health professionals’ experiences of being a part of TeleTAVI. A total of 11 qualitative interviews were conducted using a semistructured interview guide (n=7, 64% patients and n=4, 36% health professionals). Patient interviews were conducted after 8 weeks of participation in TeleTAVI, and interviews with health professionals were conducted after the end of the program. The analysis was conducted as inductive content analysis to create a condensed meaning presented as themes. Results: Reticence toward using the website was evident with reduced curiosity to explore it, and reduced benefit from using the activity tracker was observed, as the patients’ technical competencies were challenged. This was also found when using the tablet for web-based training sessions, leading to patients feeling worried before the training, as they anticipated technical problems. Disadvantages of the TeleTAVI program were technical problems and inability to use hands-on guidance with the patients. However, both physiotherapists and patients reported a feeling of improvement in patients’ physical fitness. The home training created a feeling of safety, supported adherence, and made individualization possible, which the patients valued. A good relationship and continuity in the contact with health professionals seemed very important for the patients and affected their positive attitude toward the program. Conclusions: The home-based nature of the TeleTAVI program seems to provide the opportunity to support individualization, autonomy, independence, and adherence to physical training in addition to improvement in physical capability in older patients. Despite technological challenges, basing the relationship between the health professionals and patients on continuity may be beneficial for patients. Prehabilitation may also be considered, as it may create familiarity toward technology and adherence to the training. %M 35723925 %R 10.2196/35365 %U https://formative.jmir.org/2022/6/e35365 %U https://doi.org/10.2196/35365 %U http://www.ncbi.nlm.nih.gov/pubmed/35723925 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 6 %P e38283 %T Assessing the Initial Validity of the PortionSize App to Estimate Dietary Intake Among Adults: Pilot and Feasibility App Validation Study %A Saha,Sanjoy %A Lozano,Chloe Panizza %A Broyles,Stephanie %A Martin,Corby K %A Apolzan,John W %+ Pennington Biomedical Research Center, Louisiana State University System, 6400 Perkins Road, Baton Rouge, LA, 70808, United States, 1 2257632827, john.apolzan@pbrc.edu %K dietary assessment %K eating %K food intake %K energy intake %K portion size %K mHealth %K digital health %K eHealth %K nutrition %K food groups %D 2022 %7 15.6.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: Accurately assessing dietary intake can promote improved nutrition. The PortionSize app (Pennington Biomedical Research Center) was designed to quantify and provide real-time feedback on the intake of energy, food groups, saturated fat, and added sugar. Objective: This study aimed to assess the preliminary feasibility and validity of estimating food intake via the PortionSize app among adults. Methods: A total of 15 adults (aged 18-65 years) were recruited and trained to quantify the food intake from a simulated meal by using PortionSize. Trained personnel prepared 15 simulated meals and covertly weighed (weigh back) the amount of food provided to participants as well as food waste. Equivalence tests (±25% bounds) were performed to compare PortionSize to the weigh back method. Results: Participants were aged a mean of 28 (SD 12) years, and 11 were female. The mean energy intake estimated with PortionSize was 742.9 (SD 328.2) kcal, and that estimated via weigh back was 659.3 (SD 190.7) kcal (energy intake difference: mean 83.5, SD 287.5 kcal). The methods were not equivalent in estimating energy intake (P=.18), and PortionSize overestimated energy intake by 83.5 kcal (12.7%) at the meal level. Estimates of portion sizes (gram weight; P=.01), total sugar (P=.049), fruit servings (P=.01), and dairy servings (P=.047) from PortionSize were equivalent to those estimated via weigh back. PortionSize was not equivalent to weigh back with regard to estimates for carbohydrate (P=.10), fat (P=.32), vegetable (P=.37), grain (P=.31), and protein servings (P=.87). Conclusions: Due to power limitations, the equivalence tests had large equivalence bounds. Though preliminary, the results of this small pilot study warrant the further adaptation, development, and validation of PortionSize as a means to estimate energy intake and provide users with real-time and actionable dietary feedback. %M 35704355 %R 10.2196/38283 %U https://formative.jmir.org/2022/6/e38283 %U https://doi.org/10.2196/38283 %U http://www.ncbi.nlm.nih.gov/pubmed/35704355 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 11 %N 6 %P e32955 %T Immersive Virtual Reality Exergames to Promote the Well-being of Community-Dwelling Older Adults: Protocol for a Mixed Methods Pilot Study %A Mehrabi,Samira %A Muñoz,John E %A Basharat,Aysha %A Boger,Jennifer %A Cao,Shi %A Barnett-Cowan,Michael %A Middleton,Laura E %+ Department of Kinesiology, University of Waterloo, 200 University Ave W, Waterloo, ON, N2L 3G1, Canada, 1 (519) 888 4567, samira.mehrabi@uwaterloo.ca %K virtual reality %K exergames %K community-dwelling older adults %K pilot protocol %K feasibility %K well-being %K physical activity %K cognition %K perception %K mood %K COVID-19 %D 2022 %7 13.6.2022 %9 Protocol %J JMIR Res Protoc %G English %X Background: Despite the proven benefits of exercise in older adults, challenges such as access and motivation can deter their engagement. Interactive virtual reality (VR) games combined with exercise (exergames) are a plausible strategy to encourage physical activity among this population. However, there has been little research on the feasibility, acceptability, and potential benefits of deploying at-home VR exergames among community-dwelling older adults. Objective: The objectives of this study are to estimate the feasibility, usability, and acceptability of a co-designed VR exergame in community-dwelling older adults; examine intervention feasibility and assessment protocols for a future large-scale trial; and provide pilot data on outcomes of interest (physical activity, exercise self-efficacy, mood, cognition, perception, and gameplay metrics). Methods: The study will be a remote, 6-week intervention comprising an experimental and a control group. A sample of at least 12 community-dwelling older adults (with no or mild cognitive impairment) will be recruited for each group. Both groups will follow the same study procedures and assessment methods. However, the experimental group will engage with a co-designed VR exergame (Seas The Day) thrice weekly for approximately 20 minutes using the Oculus Quest 2 (Facebook Reality Labs) VR headset. The control group will read (instead of playing Seas The Day) thrice weekly for approximately 20 minutes over the 6-week period. A mixed methods evaluation will be used. Changes in physical activity, exercise self-efficacy, mood, cognition, and perception will be compared before and after acute data as well as before and after the 6 weeks between the experimental (exergaming) and control (reading) groups. Qualitative data from postintervention focus groups or interviews and informal notes and reports from all participants will be analyzed to assess the feasibility of the study protocol. Qualitative data from the experimental group will also be analyzed to assess the feasibility, usability, and acceptability of at-home VR exergames and explore perceived facilitators of and barriers to uptaking VR systems among community-dwelling older adults. Results: The screening and recruitment process for the experimental group started in May 2021, and the data collection process will be completed by September 2021. The timeline of the recruitment process for the control group is September 2021 to December 2021. We anticipate an estimated adherence rate of ≥80%. Challenges associated with VR technology and the complexity of remote assessments are expected. Conclusions: This pilot study will provide important information on the feasibility, acceptability, and usability of a custom-made VR exergaming intervention to promote older adults’ well-being. Findings from this study will be useful to inform the methodology, design, study procedures, and assessment protocol for future large-scale trials of VR exergames with older adults as well as deepen the understanding of remote deployment and at-home use of VR for exercise in older adults. International Registered Report Identifier (IRRID): DERR1-10.2196/32955 %M 35700014 %R 10.2196/32955 %U https://www.researchprotocols.org/2022/6/e32955 %U https://doi.org/10.2196/32955 %U http://www.ncbi.nlm.nih.gov/pubmed/35700014 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 11 %N 6 %P e37084 %T The First National Remote Emergency System for Malignant Hyperthermia (MH-NRES) in China: Protocol for the Design, Development, and Evaluation of a WeChat Applet %A Yu,Hong %A Tan,Lingcan %A Teng,Yi %A Xu,Zhao %A Xiao,Kun %A Yin,Jin %A Zuo,Yunxia %A Zhu,Tao %A Deng,Xiaoqian %+ Department of Anesthesiology, Sichuan University West China Hospital, No 37 Guoxue Alley, Chengdu, 610041, China, 86 13880408185, d_xiaoqian@163.com %K malignant hyperthermia %K hyperthermia %K anesthetic %K anesthesia %K anesthesiology %K anesthesiologist %K mHealth %K mobile health %K health app %K evaluation %K user experience %K perception %K development %K uni-app %K digital health %K national remote emergency system %K WeChat %K emergency %K WeChat applet %K dantrolene %K China %K Chinese %K applet %K messaging app %K calling app %K diagnosis %K diagnostic service %D 2022 %7 10.6.2022 %9 Protocol %J JMIR Res Protoc %G English %X Background: Malignant hyperthermia (MH) is a rare life-threatening anesthetic emergency. With respect to the high fatality rate, difficulty in early recognition, and the lack of disease-specific drug (ie, dantrolene) in China, more effort is needed to strengthen early diagnosis and effective treatment of MH emergencies. Nowadays, mobile health (mHealth) apps are changing the way of medical practice; they can serve as an accessible tool to help anesthesiologists deal with MH crises. However, no related mHealth-based emergency system is available currently. Objective: The aim of this study is to outline the protocol for the development of a WeChat applet used to design a National Remote Emergency System for Malignant Hyperthermia (MH-NRES) in China, as well as the protocol for the evaluation of the user experience and perception of the system. Methods: The system adopts the client-server architecture, with a custom user interface operating as clients and the back-end system operating as the server. The client-side software was developed using uni-app technology with Vue.js-based framework, which consists of 6 modules: Quick Diagnosis, Dantrolene Mobilization, Instruction on Dantrolene Use, MH Treatment, Recovery Period Treatment, and DNA Test and Biopsy. The back-end system was developed based on the Spring framework. The system will be evaluated by administrating a modified user version of the Mobile App Rating Scale. Pilot testing will be conducted in Sichuan Province, China, and a subsequent evaluation on a national scale is planned. Results: The theoretical framework design of this system was completed in August 2021. The development of the system was completed in February 2022, and the refinement is currently ongoing. Pilot testing after the implementation of the system in Sichuan Province is planned to take 2 months, and the subsequent evaluation on a national scale is planned to take 2 months. Conclusions: We have described a novel approach using the WeChat applet to develop the MH-NRES. Findings from the usability testing process in the current study may lead to refinements and is expected to suggest that this system is both feasible and welcomed by anesthesiologists. Depending on the availability of research funding, this system will be extended nationally across China. International Registered Report Identifier (IRRID): PRR1-10.2196/37084 %M 35687418 %R 10.2196/37084 %U https://www.researchprotocols.org/2022/6/e37084 %U https://doi.org/10.2196/37084 %U http://www.ncbi.nlm.nih.gov/pubmed/35687418 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 6 %P e34951 %T Feasibility, Acceptability, and Preliminary Efficacy of an App-Based Meditation Intervention to Decrease Firefighter Psychological Distress and Burnout: A One-Group Pilot Study %A Pace,Thaddeus W W %A Zeiders,Katharine H %A Cook,Stephanie H %A Sarsar,Evelyn D %A Hoyt,Lindsay T %A Mirin,Nicholas L %A Wood,Erica P %A Tatar,Raquel %A Davidson,Richard J %+ Division of Biobehavioral Health Science, College of Nursing, University of Arizona, 1305 N Martin Ave, Tucson, AZ, 85721, United States, 1 520 626 3520, twwpace@arizona.edu %K firefighter %K meditation %K smartphone app %K anxiety %K cortisol %K digital health %K mobile health %K mHealth %K mental health %K burnout %K stress management %D 2022 %7 8.6.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: Firefighters are often exposed to occupational stressors that can result in psychological distress (ie, anxiety and depression) and burnout. These occupational stressors have only intensified with the onset of the COVID-19 pandemic and will likely persist in the postpandemic world. Objective: To address occupational stressors confronting firefighters, we pilot tested a novel, cost-effective, smartphone app–based meditation intervention created by Healthy Minds Innovations that focused on mindfulness (awareness) training along with practices designed to cultivate positive relationships (connection), insight into the nature of the self (insight), and a sense of purpose in the context of challenge (purpose) with a sample of professional firefighters from a large metropolitan area in southwestern United States. Methods: A total of 35 participants were recruited from a closed online group listserv and completed the self-guided 10-unit meditation app over the course of 10 days, at 1 unit per day. We assessed anxiety symptoms, depression symptoms, burnout, and negative affect as well as saliva diurnal cortisol rhythm, an objective indicator of stress-related biology, before and after use of the meditation app. Results: This study demonstrated the meditation app was both feasible and acceptable for use by the majority of firefighters. We also found significant reductions in firefighters’ anxiety (P=.01), burnout (P=.05), and negative affect (P=.04), as well as changes in cortisol diurnal rhythm, such as waking cortisol (P=.02), from before to after use of the meditation app. Conclusions: Our study findings call for future research to demonstrate the efficacy of this meditation app to reduce psychological distress and burnout in firefighters. %M 35675115 %R 10.2196/34951 %U https://formative.jmir.org/2022/6/e34951 %U https://doi.org/10.2196/34951 %U http://www.ncbi.nlm.nih.gov/pubmed/35675115 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 11 %N 5 %P e37975 %T Exploring the Use of Wearable Sensors and Natural Language Processing Technology to Improve Patient-Clinician Communication: Protocol for a Feasibility Study %A LeBaron,Virginia %A Boukhechba,Mehdi %A Edwards,James %A Flickinger,Tabor %A Ling,David %A Barnes,Laura E %+ School of Nursing, University of Virginia, 225 Jeannette Lancaster Way, Charlottesville, VA, 22908, United States, 1 520 4883649, vtl6k@virginia.edu %K communication %K technology %K ubiquitous computing, natural language processing %K cancer %K palliative care %D 2022 %7 20.5.2022 %9 Protocol %J JMIR Res Protoc %G English %X Background: Effective communication is the bedrock of quality health care, but it continues to be a major problem for patients, family caregivers, health care providers, and organizations. Although progress related to communication skills training for health care providers has been made, clinical practice and research gaps persist, particularly regarding how to best monitor, measure, and evaluate the implementation of communication skills in the actual clinical setting and provide timely feedback about communication effectiveness and quality. Objective: Our interdisciplinary team of investigators aims to develop, and pilot test, a novel sensing system and associated natural language processing algorithms (CommSense) that can (1) be used on mobile devices, such as smartwatches; (2) reliably capture patient-clinician interactions in a clinical setting; and (3) process these communications to extract key markers of communication effectiveness and quality. The long-term goal of this research is to use CommSense in a variety of health care contexts to provide real-time feedback to end users to improve communication and patient health outcomes. Methods: This is a 1-year pilot study. During Phase I (Aim 1), we will identify feasible metrics of communication to extract from conversations using CommSense. To achieve this, clinical investigators will conduct a thorough review of the recent health care communication and palliative care literature to develop an evidence-based “ideal and optimal” list of communication metrics. This list will be discussed collaboratively within the study team and consensus will be reached regarding the included items. In Phase II (Aim 2), we will develop the CommSense software by sharing the “ideal and optimal” list of communication metrics with engineering investigators to gauge technical feasibility. CommSense will build upon prior work using an existing Android smartwatch platform (SWear) and will include sensing modules that can collect (1) physiological metrics via embedded sensors to measure markers of stress (eg, heart rate variability), (2) gesture data via embedded accelerometer and gyroscope sensors, and (3) voice and ultimately textual features via the embedded microphone. In Phase III (Aim 3), we will pilot test the ability of CommSense to accurately extract identified communication metrics using simulated clinical scenarios with nurse and physician participants. Results: Development of the CommSense platform began in November 2021, with participant recruitment expected to begin in summer 2022. We anticipate that preliminary results will be available in fall 2022. Conclusions: CommSense is poised to make a valuable contribution to communication science, ubiquitous computing technologies, and natural language processing. We are particularly eager to explore the ability of CommSense to support effective virtual and remote health care interactions and reduce disparities related to patient-clinician communication in the context of serious illness. International Registered Report Identifier (IRRID): PRR1-10.2196/37975 %M 35594139 %R 10.2196/37975 %U https://www.researchprotocols.org/2022/5/e37975 %U https://doi.org/10.2196/37975 %U http://www.ncbi.nlm.nih.gov/pubmed/35594139 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 5 %P e35674 %T Using Mixed Reality Headsets to Deliver Remote Bedside Teaching During the COVID-19 Pandemic: Feasibility Trial of HoloLens 2 %A Sivananthan,Arun %A Gueroult,Aurelien %A Zijlstra,Geiske %A Martin,Guy %A Baheerathan,Aravindhan %A Pratt,Philip %A Darzi,Ara %A Patel,Nisha %A Kinross,James %+ Institute of Global Health Innovation, Imperial College London, Praed Street, London, W2 1NY, United Kingdom, 44 020 3312 6666, arun.sivananthan@nhs.net %K mixed reality %K remote learning %K HoloLens %K bedside teaching %K COVID-19 %K personal protective equipment %K digital education %K medical education %K e-learning %K protection %K feasibility %K medical student %K virtual reality %D 2022 %7 17.5.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: COVID-19 has had a catastrophic impact in terms of human lives lost. Medical education has also been impacted as appropriately stringent infection control policies precluded medical trainees from attending clinical teaching. Lecture-based education has been easily transferred to a digital platform, but bedside teaching has not. Objective: This study aims to assess the feasibility of using a mixed reality (MR) headset to deliver remote bedside teaching. Methods: Two MR sessions were led by senior doctors wearing the HoloLens headset. The trainers selected patients requiring their specialist input. The headset allowed bidirectional audiovisual communication between the trainer and trainee doctors. Trainee doctor conceptions of bedside teaching, impact of the COVID-19 pandemic on bedside teaching, and the MR sessions were evaluated using pre- and postround questionnaires, using Likert scales. Data related to clinician exposure to at-risk patients and use of personal protective equipment (PPE) were collected. Results: Prequestionnaire respondents (n=24) strongly agreed that bedside teaching is key to educating clinicians (median 7, IQR 6-7). Postsession questionnaires showed that, overall, users subjectively agreed the MR session was helpful to their learning (median 6, IQR 5.25-7) and that it was worthwhile (median 6, IQR 5.25-7). Mixed reality versus in-person teaching led to a 79.5% reduction in cumulative clinician exposure time and 83.3% reduction in PPE use. Conclusions: This study is proof of principle that HoloLens can be used effectively to deliver clinical bedside teaching. This novel format confers significant advantages in terms of minimizing exposure of trainees to COVID-19, reducing PPE use, enabling larger attendance, and delivering convenient and accessible real-time clinical training. %M 35389347 %R 10.2196/35674 %U https://formative.jmir.org/2022/5/e35674 %U https://doi.org/10.2196/35674 %U http://www.ncbi.nlm.nih.gov/pubmed/35389347 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 11 %N 5 %P e36845 %T A Skills-Based HIV Serostatus Disclosure Intervention for Sexual Minority Men in South Africa: Protocol for Intervention Adaptation and a Pilot Randomized Controlled Trial %A Daniels,Joseph %A Peters,Remco P H %A Medina-Marino,Andrew %A Bongo,Cikizwa %A Stephenson,Rob %+ Edson College of Nursing and Health Innovation, Arizona State University, 550 N 3rd St, Phoenix, AZ, 85004, United States, 1 602 496 2644, daniels.joseph@gmail.com %K gay %K bisexual %K men who have sex with men %K HIV intervention adaptation %K videoconference delivery %K HIV %K public health %K mobile phone %D 2022 %7 16.5.2022 %9 Protocol %J JMIR Res Protoc %G English %X Background: Gay, bisexual, and other men who have sex with men (GBMSM) living with HIV have low antiretroviral treatment adherence in South Africa due to limited skills in managing disclosure and prevention behaviors with sexual and romantic partners. As a result, there is a high HIV transmission risk within HIV-discordant partnerships, but an existing intervention may address these outcomes, if adapted effectively. Healthy Relationships (HR) is a behavioral intervention that was originally delivered in groups and in person over 5 sessions to develop coping skills for managing HIV-related stress and sexually risky situations, enhance decision-making skills for HIV disclosure to partners, and establish and maintain safer sex practices with partners. HR effectively improves prevention behaviors but has yet to be tailored to a non-US context. Objective: We aim to adapt HR into a new culturally grounded intervention entitled Speaking Out & Allying Relationships for GBMSM and then assess its feasibility in Eastern Cape, South Africa. Methods: The study will have 2 aims. For aim 1—adaptation—we will use a human-centered design approach. Initial intervention tailoring will involve integrating Undetectable=Untransmittable and pre-exposure prophylaxis education, developing intervention content for a videoconference format, and designing role-plays and movies for skill building based on preliminary data. Afterward, interviews and surveys will be administered to GBMSM to assess intervention preferences, and a focus group will be conducted with health care providers and information technology experts to assess the intervention’s design. Finally, a usability test will be performed to determine functionality and content understanding. Participants will be GBMSM living with HIV (n=15) who are in a relationship and health care providers and information technology (n=7) experts working in HIV care and programming with this population. For aim 2, we will examine the feasibility of the adapted intervention by using a pilot randomized control design. There will be 60 individuals per arm. Feasibility surveys and interviews will be conducted with the intervention arm, and behavioral and biomedical assessments for relationship and treatment adherence outcomes will be collected for both arms. All participants will be GBMSM living with HIV who are in a relationship with an HIV-negative or unknown status partner. Results: Intervention adaptation began in August 2021. Initial tailoring and the refining of GBMSM intervention preferences were completed in December 2021. Usability and feasibility assessments are due to be completed by March 2022 and February 2024, respectively. Conclusions: GBMSM need efficacious interventions that tackle partnership dynamics, HIV prevention, and treatment outcomes for antiretroviral treatment adherence and viral suppression in South Africa. Harnessing everyday technology use for social networking (eg, videoconferences), Undetectable=Untransmittable education, and pre-exposure prophylaxis to update an existing intervention for South African GBMSM has the potential to strengthen relationship communication about HIV treatment and prevention and, in turn, improve outcomes. International Registered Report Identifier (IRRID): DERR1-10.2196/36845 %M 35576574 %R 10.2196/36845 %U https://www.researchprotocols.org/2022/5/e36845 %U https://doi.org/10.2196/36845 %U http://www.ncbi.nlm.nih.gov/pubmed/35576574 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 11 %N 5 %P e36673 %T Long COVID Optimal Health Program (LC-OHP) to Enhance Psychological and Physical Health: Protocol for a Feasibility Randomized Controlled Trial %A Al-Jabr,Hiyam %A Windle,Karen %A Thompson,David R %A Jenkins,Zoe M %A Castle,David J %A Ski,Chantal F %+ Integrated Care Academy, University of Suffolk, Waterfront Building, 19 Neptune Quay, Ipswich, IP4 1QJ, United Kingdom, 44 01473 338845, h.al-jabr@uos.ac.uk %K long COVID %K COVID-19 %K optimal health program %K telemedicine %K integrated care %K telehealth %K patient care %K health intervention %K mental health %K physical health %K psychological health %K pandemic %K patient support %D 2022 %7 12.5.2022 %9 Protocol %J JMIR Res Protoc %G English %X Background: Long COVID is a collection of symptoms that develop during or following a confirmed or suspected case of COVID-19, which continue for more than 12 weeks. Despite the negative impact of long COVID on people’s lives and functioning, there is no validated treatment or even rehabilitation guidance. What has been recommended thus far is the adoption of holistic management approaches. The Optimal Health Program (OHP) is a brief 5-session, plus booster, psychosocial program designed to support mental and physical well-being that has been used effectively for a range of chronic conditions. Objective: This study examines the feasibility and acceptability of employing an especially customized version of OHP (long COVID OHP [LC-OHP]) to improve psychological and physical health of people with long COVID. Methods: This is a feasibility randomized controlled trial that will be running from November 2021 to February 2023. Eligible participants aged 18 years or older who are experiencing symptoms of long COVID will be identified through their secondary practitioners with recruitment to be undertaken by the research team. A total of 60 participants will be randomized into a control (usual care) or an intervention (LC-OHP) group. Outcomes will be feasibility and acceptability of the program (primary); and efficacy of the LC-OHP in improving anxiety, depression, fatigue, self-efficacy, and quality of life (secondary). Up to 20 participants will be interviewed at the end of the trial to explore their experience with the program. Quantitative data will be analyzed using SPSS, and differences between groups will be compared using inferential tests where appropriate. Qualitative data will be transcribed and thematically analyzed to identify common emerging themes. Results: This is an ongoing study, which began in November 2021. Conclusions: Long COVID has a significant impact on an individual’s mental and physical functioning. The LC-OHP has a potential to provide people living with long COVID with additional support and to improve self-efficacy. The findings of this study would identify the feasibility of delivering this program to this population and will provide an indication for the program’s effectiveness. Trial Registration: ISRCTN Registry ISRCTN38746119; https://www.isrctn.com/ISRCTN38746119 International Registered Report Identifier (IRRID): DERR1-10.2196/36673 %M 35468586 %R 10.2196/36673 %U https://www.researchprotocols.org/2022/5/e36673 %U https://doi.org/10.2196/36673 %U http://www.ncbi.nlm.nih.gov/pubmed/35468586 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 9 %N 2 %P e35325 %T Audio Recording Patient-Nurse Verbal Communications in Home Health Care Settings: Pilot Feasibility and Usability Study %A Zolnoori,Maryam %A Vergez,Sasha %A Kostic,Zoran %A Jonnalagadda,Siddhartha Reddy %A V McDonald,Margaret %A Bowles,Kathryn K H %A Topaz,Maxim %+ School of Nursing, Columbia University, 390 Fort Washington Avenue, New York, NY, 10033, United States, 1 317 515 1950, mz2825@cumc.columbia.edu %K patients %K HHC %K communications %K nurse %K audio recording %K device %D 2022 %7 11.5.2022 %9 Original Paper %J JMIR Hum Factors %G English %X Background: Patients’ spontaneous speech can act as a biomarker for identifying pathological entities, such as mental illness. Despite this potential, audio recording patients’ spontaneous speech is not part of clinical workflows, and health care organizations often do not have dedicated policies regarding the audio recording of clinical encounters. No previous studies have investigated the best practical approach for integrating audio recording of patient-clinician encounters into clinical workflows, particularly in the home health care (HHC) setting. Objective: This study aimed to evaluate the functionality and usability of several audio-recording devices for the audio recording of patient-nurse verbal communications in the HHC settings and elicit HHC stakeholder (patients and nurses) perspectives about the facilitators of and barriers to integrating audio recordings into clinical workflows. Methods: This study was conducted at a large urban HHC agency located in New York, United States. We evaluated the usability and functionality of 7 audio-recording devices in a laboratory (controlled) setting. A total of 3 devices—Saramonic Blink500, Sony ICD-TX6, and Black Vox 365—were further evaluated in a clinical setting (patients’ homes) by HHC nurses who completed the System Usability Scale questionnaire and participated in a short, structured interview to elicit feedback about each device. We also evaluated the accuracy of the automatic transcription of audio-recorded encounters for the 3 devices using the Amazon Web Service Transcribe. Word error rate was used to measure the accuracy of automated speech transcription. To understand the facilitators of and barriers to integrating audio recording of encounters into clinical workflows, we conducted semistructured interviews with 3 HHC nurses and 10 HHC patients. Thematic analysis was used to analyze the transcribed interviews. Results: Saramonic Blink500 received the best overall evaluation score. The System Usability Scale score and word error rate for Saramonic Blink500 were 65% and 26%, respectively, and nurses found it easier to approach patients using this device than with the other 2 devices. Overall, patients found the process of audio recording to be satisfactory and convenient, with minimal impact on their communication with nurses. Although, in general, nurses also found the process easy to learn and satisfactory, they suggested that the audio recording of HHC encounters can affect their communication patterns. In addition, nurses were not aware of the potential to use audio-recorded encounters to improve health care services. Nurses also indicated that they would need to involve their managers to determine how audio recordings could be integrated into their clinical workflows and for any ongoing use of audio recordings during patient care management. Conclusions: This study established the feasibility of audio recording HHC patient-nurse encounters. Training HHC nurses about the importance of the audio-recording process and the support of clinical managers are essential factors for successful implementation. %M 35544296 %R 10.2196/35325 %U https://humanfactors.jmir.org/2022/2/e35325 %U https://doi.org/10.2196/35325 %U http://www.ncbi.nlm.nih.gov/pubmed/35544296 %0 Journal Article %@ 2561-7605 %I JMIR Publications %V 5 %N 2 %P e33498 %T Using Smart Speaker Technology for Health and Well-being in an Older Adult Population: Pre-Post Feasibility Study %A McCloud,Rachel %A Perez,Carly %A Bekalu,Mesfin Awoke %A Viswanath,K %+ Dana-Farber Cancer Institute, 450 Brookline Ave, Boston, MA, 02215, United States, 1 706 224 8893, rachel_faulkenberry@dfci.harvard.edu %K technology %K older adults %K communication inequalities %K digital health %K elderly population %K smart technology %K smart speaker %K well-being %K health technology %K mobile phone %D 2022 %7 9.5.2022 %9 Original Paper %J JMIR Aging %G English %X Background: Although smart speaker technology is poised to help improve the health and well-being of older adults by offering services such as music, medication reminders, and connection to others, more research is needed to determine how older adults from lower socioeconomic position (SEP) accept and use this technology. Objective: This study aimed to investigate the feasibility of using smart speakers to improve the health and well-being of low-SEP older adults. Methods: A total of 39 adults aged between 65 and 85 years who lived in a subsidized housing community were recruited to participate in a 3-month study. The participants had a smart speaker at their home and were given a brief orientation on its use. Over the course of the study, participants were given weekly check-in calls to help assist with any problems and newsletters with tips on how to use the speaker. Participants received a pretest and posttest to gauge comfort with technology, well-being, and perceptions and use of the speaker. The study staff also maintained detailed process notes of interactions with the participants over the course of the study, including a log of all issues reported. Results: At the end of the study period, 38% (15/39) of the participants indicated using the speaker daily, and 38% (15/39) of the participants reported using it several times per week. In addition, 72% (28/39) of the participants indicated that they wanted to continue using the speaker after the end of the study. Most participants (24/39, 62%) indicated that the speaker was useful, and approximately half of the participants felt that the speaker gave them another voice to talk to (19/39, 49%) and connected them with the outside world (18/39, 46%). Although common uses were using the speaker for weather, music, and news, fewer participants reported using it for health-related questions. Despite the initial challenges participants experienced with framing questions to the speaker, additional explanations by the study staff addressed these issues in the early weeks of the study. Conclusions: The results of this study indicate that there is promise for smart speaker technology for low-SEP older adults, particularly to connect them to music, news, and reminders. Future studies will need to provide more upfront training on query formation as well as develop and promote more specific options for older adults, particularly in the area of health and well-being. %M 35532979 %R 10.2196/33498 %U https://aging.jmir.org/2022/2/e33498 %U https://doi.org/10.2196/33498 %U http://www.ncbi.nlm.nih.gov/pubmed/35532979 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 11 %N 5 %P e35277 %T Development of an Internet of Things Technology Platform (the NEX System) to Support Older Adults to Live Independently: Protocol for a Development and Usability Study %A Timon,Claire M %A Heffernan,Emma %A Kilcullen,Sophia M %A Lee,Hyowon %A Hopper,Louise %A Quinn,Joe %A McDonald,David %A Gallagher,Pamela %A Smeaton,Alan F %A Moran,Kieran %A Hussey,Pamela %A Murphy,Catriona %+ Centre for eIntegrated Care, School of Nursing, Psychotherapy and Community Health, Dublin City University, Glasnevin, Dublin, D09 NR58, Ireland, 353 17006811, claire.timon@dcu.ie %K independent living %K older adults %K Internet of Things %K wearable electronic devices %K activities of daily living %K mobile phone %D 2022 %7 5.5.2022 %9 Protocol %J JMIR Res Protoc %G English %X Background: In a rapidly aging population, new and efficient ways of providing health and social support to older adults are required that not only preserve independence but also maintain quality of life and safety. Objective: The NEX project aims to develop an integrated Internet of Things system coupled with artificial intelligence to offer unobtrusive health and wellness monitoring to support older adults living independently in their home environment. The primary objective of this study is to develop and evaluate the technical performance and user acceptability of the NEX system. The secondary objective is to apply machine learning algorithms to the data collected via the NEX system to identify and eventually predict changes in the routines of older adults in their own home environment. Methods: The NEX project commenced in December 2019 and is expected to be completed by August 2022. Mixed methods research (web-based surveys and focus groups) was conducted with 426 participants, including older adults (aged ≥60 years), family caregivers, health care professionals, and home care workers, to inform the development of the NEX system (phase 1). The primary outcome will be evaluated in 2 successive trials (the Friendly trial [phase 2] and the Action Research Cycle trial [phase 3]). The secondary objective will be explored in the Action Research Cycle trial (phase 3). For the Friendly trial, 7 older adult participants aged ≥60 years and living alone in their own homes for a 10-week period were enrolled. A total of 30 older adult participants aged ≥60 years and living alone in their own homes will be recruited for a 10-week data collection period (phase 3). Results: Phase 1 of the project (n=426) was completed in December 2020, and phase 2 (n=7 participants for a 10-week pilot study) was completed in September 2021. The expected completion date for the third project phase (30 participants for the 10-week usability study) is June 2022. Conclusions: The NEX project has considered the specific everyday needs of older adults and other stakeholders, which have contributed to the design of the integrated system. The innovation of the NEX system lies in the use of Internet of Things technologies and artificial intelligence to identify and predict changes in the routines of older adults. The findings of this project will contribute to the eHealth research agenda, focusing on the improvement of health care provision and patient support in home and community environments. International Registered Report Identifier (IRRID): DERR1-10.2196/35277 %M 35511224 %R 10.2196/35277 %U https://www.researchprotocols.org/2022/5/e35277 %U https://doi.org/10.2196/35277 %U http://www.ncbi.nlm.nih.gov/pubmed/35511224 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 11 %N 4 %P e31003 %T Buccal Mucosal Grafts as a Novel Treatment for the Repair of Rectovaginal Fistulas: Protocol for an Upcoming Prospective Single-Surgeon Case Series %A Cahill,Caitlin %A Kruger,Natalia %A Heine,John %+ Cumming School of Medicine, University of Calgary, 1403 29 Street NW, Calgary, AB, T2N 2T9, Canada, 1 403 880 1775, natalia.kruger@ucalgary.ca %K surgical protocol %K colorectal surgery, rectovaginal fistulas %K fistula %K surgery %K gynecology %K grafts %K perioperative medicine %D 2022 %7 29.4.2022 %9 Original Paper %J JMIR Res Protoc %G English %X Background: Rectovaginal fistulas (RVFs) are abnormal communications between the rectum/anus and the vagina. They are most frequently formed a result of obstetric injury and have deleterious effects on patients’ quality of life. Despite several treatment modalities, RVFs remain difficult problems to manage, and many patients fail multiple attempts at surgical repair. Buccal mucosal grafts (BMGs) may be a solution to this problem. A BMG is an oral mucosal tissue harvested from the inner cheek. There are 2 case reports that describe the successful use of BMGs in the repair of RVFs. Objective: Our objective is to validate these findings with a prospective case series while also addressing the key issues of indication, technical details, procedure safety, and short-term outcomes. Methods: A prospective single-surgeon case series will be undertaken at a university-affiliated academic tertiary care hospital in Calgary, Alberta (Canada). The estimated recruitment is between 3 and 5 patients. Patients will undergo surgical repair of their RVFs with an autologous BMG. Data on patient characteristics, fistula characteristics, and surgical variables will be collected and analyzed prospectively. The primary outcome is fistula closure. This study has been approved by the Conjoint Health Research Ethics Board at the University of Calgary (REB20-1123). Results: Two previous case reports have described the successful use of BMGs in the repair of RVFs. We have received ethics approval to attempt to validate these findings through a prospective case series. Conclusions: RVFs cause significant patient morbidity and are difficult problems to manage. Bolstered by the successful use of BMGs in urologic surgery and the previously published case reports demonstrating success in RVFs, we believe that BMGs may be a solution to RVFs. International Registered Report Identifier (IRRID): PRR1-10.2196/31003 %M 35486431 %R 10.2196/31003 %U https://www.researchprotocols.org/2022/4/e31003 %U https://doi.org/10.2196/31003 %U http://www.ncbi.nlm.nih.gov/pubmed/35486431 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 4 %P e31835 %T Computerized Cognitive Behavioral Therapy Intervention for Depression Among Veterans: Acceptability and Feasibility Study %A Stearns-Yoder,Kelly A %A Ryan,Arthur T %A Smith,Alexandra A %A Forster,Jeri E %A Barnes,Sean M %A Brenner,Lisa A %+ Veterans Affairs Rocky Mountain Mental Illness Research Education and Clinical Center, Rocky Mountain Regional Veterans Affairs Medical Center, 1700 N Wheeling Street, Aurora, CO, 80045, United States, 1 7204151717, kelly.stearns@va.gov %K computerized cognitive behavioral therapy %K depression %K veterans %K acceptability %K feasibility %D 2022 %7 25.4.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: Computerized cognitive behavioral therapies (cCBTs) have been developed to deliver efficient, evidence-based treatment for depression and other mental health conditions. Beating the Blues (BtB) is one of the most empirically supported cCBTs for depression. The previous trial of BtB with veterans included regular guidance by health care personnel, which increased the complexity and cost of the intervention. Objective: This study, conducted by researchers at a Veterans Affairs Medical Center, aims to test the acceptability and feasibility of unguided cCBT for depression among US military veterans. Methods: To examine the acceptability of BtB delivered without additional peer or other mental health care provider support, a before-and-after trial was conducted among United States (US) military veterans experiencing mild to moderate depressive symptoms. The feasibility of the study design for a future efficacy trial was also evaluated. Results: In total, 49 veterans completed preintervention assessments and received access to BtB, and 29 participants completed all postintervention assessments. The predetermined acceptability criterion for the intervention was met. Although the predetermined feasibility criteria regarding screening eligibility rate, number of BtB modules completed, and completion of a posttreatment assessment were not met, the results were comparable with those of other cCBT studies. Conclusions: This is the first study among US military veterans to demonstrate support for the implementation of cCBT for depression without the assistance of a mental health professional or a peer support specialist, suggesting that stand-alone computer-aided interventions may be viable. Ideas for improving feasibility in future trials based on this study are discussed. %M 35468088 %R 10.2196/31835 %U https://formative.jmir.org/2022/4/e31835 %U https://doi.org/10.2196/31835 %U http://www.ncbi.nlm.nih.gov/pubmed/35468088 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 11 %N 4 %P e37009 %T Acceptability and Feasibility of a Return-to-Work Intervention for Posttreatment Breast Cancer Survivors: Protocol for a Co-design and Development Study %A Bilodeau,Karine %A Gouin,Marie-Michelle %A Lecours,Alexandra %A Lederer,Valérie %A Durand,Marie-José %A Kilpatrick,Kelley %A Lepage,David %A Ladouceur-Deslauriers,Lauriane %A Dorta,Tomas %+ Faculty of Nursing, University of Montreal, PO Box 6128, Station Centre-ville, Montreal, QC, H3C 3J7, Canada, 1 514 343 6111 ext 43254, karine.bilodeau.2@umontreal.ca %K co-design %K breast cancer %K intervention %K return-to-work %K primary care %K qualitative %D 2022 %7 22.4.2022 %9 Protocol %J JMIR Res Protoc %G English %X Background: The mortality rate from breast cancer has been declining for many years, and the population size of working-age survivors is steadily increasing. However, the recurrent side effects of cancer and its treatment can result in multiple disabilities and disruptions to day-to-day life, including work disruptions. Despite the existing knowledge of best practices regarding return to work (RTW) for breast cancer survivors, only a few interdisciplinary interventions have been developed to address the individualized needs and multiple challenges of breast cancer survivors, health care professionals, and employer and insurer representatives. Thus, it seems appropriate to develop RTW interventions collaboratively by using a co-design approach with these specific stakeholders. Objective: This paper presents a protocol for developing and testing an innovative, interdisciplinary pilot intervention based on a co-design approach to better support RTW and job retention after breast cancer treatment. Methods: First, a participatory research approach will be used to develop the intervention in a co-design workshop with 12 to 20 participants, including people affected by cancer, employer and insurer representatives, and health care professionals. Next, a pilot intervention will be tested in a primary care setting with 6 to 8 women affected by breast cancer. The acceptability and feasibility of the pilot intervention will be pretested through semistructured interviews with participants, health care professionals, and involved patient partners. The transcribed data will undergo an iterative content analysis. Results: The first phase of the project—the co-design workshop—was completed in June 2021. The pilot test of the intervention will begin in spring 2022. The results from the test will be available in late 2022. Conclusions: The project will offer novel data regarding the use of the co-design approach for the development of innovative, co-designed interventions. In addition, it will be possible to document the acceptability and feasibility of the pilot intervention with a primary care team. Depending on the results obtained, the intervention could be implemented on a larger scale. International Registered Report Identifier (IRRID): DERR1-10.2196/37009 %M 35451972 %R 10.2196/37009 %U https://www.researchprotocols.org/2022/4/e37009 %U https://doi.org/10.2196/37009 %U http://www.ncbi.nlm.nih.gov/pubmed/35451972 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 4 %P e34827 %T Assessment of a Mobile Health iPhone App for Semiautomated Self-management of Chronic Recurrent Medical Conditions Using an N-of-1 Trial Framework: Feasibility Pilot Study %A Mande,Archana %A Moore,Susan L %A Banaei-Kashani,Farnoush %A Echalier,Benjamin %A Bull,Sheana %A Rosenberg,Michael A %+ Division of Personalized Medicine and Biomedical Informatics, University of Colorado Anschutz Medical Campus, 13001 E 17th Avenue, Aurora, CO, 80045, United States, 1 303 724 8391, michael.a.rosenberg@cuanschutz.edu %K mHealth %K patient-specific modeling %K chronic disease %K smartphone %K implementation and deployment %K facilitators and barriers %D 2022 %7 12.4.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: Management of chronic recurrent medical conditions (CRMCs), such as migraine headaches, chronic pain, and anxiety/depression, remains a major challenge for modern providers. Our team has developed an edge-based, semiautomated mobile health (mHealth) technology called iMTracker that employs the N-of-1 trial approach to allow self-management of CRMCs. Objective: This study examines the patterns of adoption, identifies CRMCs that users selected for self-application, and explores barriers to use of the iMTracker app. Methods: This is a feasibility pilot study with internet-based recruitment that ran from May 15, 2019, to December 23, 2020. We recruited 180 patients to pilot test the iMTracker app for user-selected CRMCs for a 3-month period. Patients were administered surveys before and after the study. Results: We found reasonable usage rates: a total of 73/103 (70.9%) patients who were not lost to follow-up reported the full 3-month use of the app. Most users chose to use the iMTracker app to self-manage chronic pain (other than headaches; 80/212, 37.7%), followed by headaches in 36/212 (17.0%) and mental health (anxiety and depression) in 27/212 (12.8%). The recurrence rate of CRMCs was at least weekly in over 93% (169/180) of patients, with 36.1% (65/180) of CRMCs recurring multiple times in a day, 41.7% (75/180) daily, and 16.1% (29/180) weekly. We found that the main barriers to use were the design and technical function of the app, but that use of the app resulted in an improvement in confidence in the efficiency and safety/privacy of this approach. Conclusions: The iMTracker app provides a feasible platform for the N-of-1 trial approach to self-management of CRMCs, although internet-based recruitment provided limited follow-up, suggesting that in-person evaluation may be needed. The rate of CRMC recurrence was high enough to allow the N-of-1 trial assessment for most traits. %M 35412460 %R 10.2196/34827 %U https://formative.jmir.org/2022/4/e34827 %U https://doi.org/10.2196/34827 %U http://www.ncbi.nlm.nih.gov/pubmed/35412460 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 11 %N 4 %P e34297 %T A Study on Prevalence and Determinants of Ototoxicity During Treatment of Childhood Cancer (SOUND): Protocol for a Prospective Study %A Diepstraten,Franciscus A %A Meijer,Annelot JM %A van Grotel,Martine %A Plasschaert,Sabine LA %A Hoetink,Alexander E %A Fiocco,Marta %A Janssens,Geert O %A Stokroos,Robert J %A van den Heuvel-Eibrink,Marry M %+ Princess Máxima Center for Pediatric Oncology, Heidelberglaan 25, Utrecht, 3584 CS, The Netherlands, 31 625710488, f.a.diepstraten@prinsesmaximacentrum.nl %K pediatrics %K ototoxicity %K audiometry %K antibiotics %K diuretics %K radiotherapy %K solid tumors %K neuro-oncology %K audiology %K cancer %K children %D 2022 %7 7.4.2022 %9 Protocol %J JMIR Res Protoc %G English %X Background: Some children with central nervous system (CNS) and solid tumors are at risk to develop ototoxicity during treatment. Up to now, several risk factors have been identified that may contribute to ototoxicity, such as platinum derivates, cranial irradiation, and brain surgery. Comedication, like antibiotics and diuretics, is known to enhance ototoxicity, but their independent influence has not been investigated in childhood cancer patients. Recommendations for hearing loss screening are missing or vary highly across treatment protocols. Additionally, adherence to existing screening guidelines is not always optimal. Currently, knowledge is lacking on the prevalence of ototoxicity. Objective: The aim of the Study on Prevalence and Determinants of Ototoxicity During Treatment of Childhood Cancer (SOUND) is to determine the feasibility of audiological testing and to determine the prevalence and determinants of ototoxicity during treatment for childhood cancer in a national cohort of patients with solid and CNS tumors. Methods: The SOUND study is a prospective cohort study in the national childhood cancer center in the Netherlands. The study aims to include all children aged 0 to 19 years with a newly diagnosed CNS or solid tumor. Part of these patients will get audiological examination as part of their standard of care (stratum 1). Patients in which audiological examination is not the standard of care will be invited for inclusion in stratum 2. Age-dependent audiological assessments will be pursued before the start of treatment and within 3 months after the end of treatment. Apart from hearing loss, we will investigate the feasibility to screen patients for tinnitus and vertigo prevalence after cancer treatment. This study will also determine the independent contribution of antibiotics and diuretics on ototoxicity. Results: This study was approved by the Medical Research Ethics Committee Utrecht (Identifier 20-417/M). Currently, we are in the process of recruitment for this study. Conclusions: The SOUND study will raise awareness about the presence of ototoxicity during the treatment of children with CNS or solid tumors. It will give insight into the prevalence and independent clinical and cotreatment-related determinants of ototoxicity. This is important for the identification of future high-risk patients. Thereby, the study will provide a basis for the selection of patients who will benefit from innovative otoprotective intervention trials during childhood cancer treatment that are currently being prepared. Trial Registration: Netherlands Trial Register NL8881; https://www.trialregister.nl/trial/8881 International Registered Report Identifier (IRRID): DERR1-10.2196/34297 %M 35389352 %R 10.2196/34297 %U https://www.researchprotocols.org/2022/4/e34297 %U https://doi.org/10.2196/34297 %U http://www.ncbi.nlm.nih.gov/pubmed/35389352 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 4 %P e32423 %T Linking Individual-Level Facebook Posts With Psychological and Health Data in an Epidemiological Cohort: Feasibility Study %A James,Peter %A Trudel-Fitzgerald,Claudia %A Lee,Harold H %A Koga,Hayami K %A Kubzansky,Laura D %A Grodstein,Francine %+ Division of Chronic Disease Research Across the Lifecourse, Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, 401 Park Drive, Suite 401, Boston, MA, 02215, United States, 1 617 867 4850, pjames@hsph.harvard.edu %K social media %K cohort %K psychological factors %K recruitment %K feasibility %K middle-aged and older adults %K women %D 2022 %7 7.4.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: Psychological factors (eg, depression) and related biological and behavioral responses are associated with numerous physical health outcomes. Most research in this area relies on self-reported assessments of psychological factors, which are difficult to scale because they may be expensive and time-consuming. Investigators are increasingly interested in using social media as a novel and convenient platform for obtaining information rapidly in large populations. Objective: We evaluated the feasibility of obtaining Facebook data from a large ongoing cohort study of midlife and older women, which may be used to assess psychological functioning efficiently with low cost. Methods: This study was conducted with participants in the Nurses’ Health Study II (NHSII), which was initiated in 1989 with biennial follow-ups. Facebook does not share data readily; therefore, we developed procedures to enable women to download and transfer their Facebook data to cohort servers (for linkage with other study data they have provided). Since privacy is a critical concern when collecting individual-level data, we partnered with a third-party software developer, Digi.me, to enable participants to obtain their own Facebook data and to send it securely to our research team. In 2020, we invited a subset of the 18,519 NHSII participants (aged 56-73 years) via email to participate. Women were selected if they reported on the 2017-2018 questionnaire that they regularly posted on Facebook and were still active cohort participants. We included an exit survey for those who chose not to participate in order to gauge the reasons for nonparticipation. Results: We invited 309 women to participate. Few women signed the consent form (n=52), and only 3 used the Digi.me app to download and transfer their Facebook data. This low participation rate was observed despite modifying our protocol between waves of recruitment, including by (1) excluding active health care workers, who might be less available to participate due to the pandemic, (2) developing a Frequently Asked Questions factsheet to provide more information regarding the protocol, and (3) simplifying the instructions for using the Digi.me app. On our exit survey, the reasons most commonly reported for not participating were concerns regarding data privacy and hesitation sharing personal Facebook posts. The low participation rate suggests that obtaining individual-level Facebook data in a cohort of middle-aged and older women may be challenging. Conclusions: In this cohort of midlife and older women who were actively participating for over three decades, we were largely unable to obtain permission to access individual-level data from participants’ Facebook accounts. Despite working with a third-party developer to customize an app to implement safeguards for privacy, data privacy remained a key concern in these women. Future studies aiming to leverage individual-level social media data should explore alternate populations or means of sharing social media data. %M 35389368 %R 10.2196/32423 %U https://formative.jmir.org/2022/4/e32423 %U https://doi.org/10.2196/32423 %U http://www.ncbi.nlm.nih.gov/pubmed/35389368 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 3 %P e33581 %T Mobile App Intervention on Reducing the Myeloproliferative Neoplasm Symptom Burden: Pilot Feasibility and Acceptability Study %A Win,Hninyee %A Russell,Samantha %A Wertheim,Betsy C %A Maizes,Victoria %A Crocker,Robert %A Brooks,Audrey J %A Mesa,Ruben %A Huberty,Jennifer %A Geyer,Holly %A Eckert,Ryan %A Larsen,Ashley %A Gowin,Krisstina %+ Department of Hematology, University of Arizona, 1501 N Campbell, Tucson, AZ, 85724, United States, 1 5206260662, gowink@email.arizona.edu %K myeloproliferative neoplasm %K mobile application %K symptom burden %K wellness %K self-management %K mobile phone %D 2022 %7 31.3.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: Myeloproliferative neoplasms (MPNs) are a group of myeloid malignancies associated with significant symptom burden. Despite pharmacological advances in therapies, inadequate management of MPN symptoms results in reduced quality of life. Objective: This study aims to determine the feasibility of a 12-week global wellness mobile app intervention in decreasing MPN symptom burden. The University of Arizona Andrew Weil Center for Integrative Medicine’s global wellness mobile app, My Wellness Coach (MWC), guides patients to improve their health and well-being through facilitating behavior changes. Methods: Of the 30 patients enrolled in a 12-week intervention, 16 (53%) were retained through the final assessment. Feasibility was assessed by the ease of recruitment, participant adherence, and mobile app acceptability. App acceptability was measured using the user version of the Mobile Application Rating Scale. MPN symptom burden was measured at baseline and 12 weeks after the intervention. Results: Recruitment was efficient, with the participant goal reached within a 60-day period, suggestive of a demand for such an intervention. Adherence was less than the target within study design (75%), although similar to mobile device app use in other studies (53%). The app was deemed acceptable based on the mean user version of the Mobile Application Rating Scale 3-star rating by participants. Finally, there were statistically significant improvements in several MPN symptoms, quality of life, and total score on the Myeloproliferative Neoplasm Symptom Assessment Form surveys. Conclusions: Our 12-week intervention with the MWC app was feasible and was associated with a decrease in MPN symptom burden. Further investigation of the MWC app for use as a self-management strategy to reduce the symptom burden in patients with MPN is warranted. %M 35357315 %R 10.2196/33581 %U https://formative.jmir.org/2022/3/e33581 %U https://doi.org/10.2196/33581 %U http://www.ncbi.nlm.nih.gov/pubmed/35357315 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 11 %N 3 %P e34201 %T Leveraging Large-Scale Electronic Health Records and Interpretable Machine Learning for Clinical Decision Making at the Emergency Department: Protocol for System Development and Validation %A Liu,Nan %A Xie,Feng %A Siddiqui,Fahad Javaid %A Ho,Andrew Fu Wah %A Chakraborty,Bibhas %A Nadarajan,Gayathri Devi %A Tan,Kenneth Boon Kiat %A Ong,Marcus Eng Hock %+ Programme in Health Services and Systems Research, Duke-NUS Medical School, 8 College Road, Singapore, 169857, Singapore, 65 66016503, liu.nan@duke-nus.edu.sg %K electronic health records %K machine learning %K clinical decision making %K emergency department %D 2022 %7 25.3.2022 %9 Protocol %J JMIR Res Protoc %G English %X Background: There is a growing demand globally for emergency department (ED) services. An increase in ED visits has resulted in overcrowding and longer waiting times. The triage process plays a crucial role in assessing and stratifying patients’ risks and ensuring that the critically ill promptly receive appropriate priority and emergency treatment. A substantial amount of research has been conducted on the use of machine learning tools to construct triage and risk prediction models; however, the black box nature of these models has limited their clinical application and interpretation. Objective: In this study, we plan to develop an innovative, dynamic, and interpretable System for Emergency Risk Triage (SERT) for risk stratification in the ED by leveraging large-scale electronic health records (EHRs) and machine learning. Methods: To achieve this objective, we will conduct a retrospective, single-center study based on a large, longitudinal data set obtained from the EHRs of the largest tertiary hospital in Singapore. Study outcomes include adverse events experienced by patients, such as the need for an intensive care unit and inpatient death. With preidentified candidate variables drawn from expert opinions and relevant literature, we will apply an interpretable machine learning–based AutoScore to develop 3 SERT scores. These 3 scores can be used at different times in the ED, that is, on arrival, during ED stay, and at admission. Furthermore, we will compare our novel SERT scores with established clinical scores and previously described black box machine learning models as baselines. Receiver operating characteristic analysis will be conducted on the testing cohorts for performance evaluation. Results: The study is currently being conducted. The extracted data indicate approximately 1.8 million ED visits by over 810,000 unique patients. Modelling results are expected to be published in 2022. Conclusions: The SERT scoring system proposed in this study will be unique and innovative because of its dynamic nature and modelling transparency. If successfully validated, our proposed solution will establish a standard for data processing and modelling by taking advantage of large-scale EHRs and interpretable machine learning tools. International Registered Report Identifier (IRRID): DERR1-10.2196/34201 %M 35333179 %R 10.2196/34201 %U https://www.researchprotocols.org/2022/3/e34201 %U https://doi.org/10.2196/34201 %U http://www.ncbi.nlm.nih.gov/pubmed/35333179 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 3 %P e29943 %T A Novel Diagnostic Decision Support System for Medical Professionals: Prospective Feasibility Study %A Timiliotis,Joanna %A Blümke,Bibiana %A Serfözö,Peter Daniel %A Gilbert,Stephen %A Ondrésik,Marta %A Türk,Ewelina %A Hirsch,Martin Christian %A Eckstein,Jens %+ CMIO Research Group, Digitalization & ICT Department, University Hospital Basel, Hebelstrasse, 10, Basel, 4031, Switzerland, 41 0613285489, joanna.timiliotis@usb.ch %K diagnostic decision support system %K DDSS %K probabilistic reasoning %K artificial intelligence %K dyspnea %K emergency department %K internal medicine %K symptom checker %D 2022 %7 24.3.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: Continuously growing medical knowledge and the increasing amount of data make it difficult for medical professionals to keep track of all new information and to place it in the context of existing information. A variety of digital technologies and artificial intelligence–based methods are currently available as persuasive tools to empower physicians in clinical decision-making and improve health care quality. A novel diagnostic decision support system (DDSS) prototype developed by Ada Health GmbH with a focus on traceability, transparency, and usability will be examined more closely in this study. Objective: The aim of this study is to test the feasibility and functionality of a novel DDSS prototype, exploring its potential and performance in identifying the underlying cause of acute dyspnea in patients at the University Hospital Basel. Methods: A prospective, observational feasibility study was conducted at the emergency department (ED) and internal medicine ward of the University Hospital Basel, Switzerland. A convenience sample of 20 adult patients admitted to the ED with dyspnea as the chief complaint and a high probability of inpatient admission was selected. A study physician followed the patients admitted to the ED throughout the hospitalization without interfering with the routine clinical work. Routinely collected health-related personal data from these patients were entered into the DDSS prototype. The DDSS prototype’s resulting disease probability list was compared with the gold-standard main diagnosis provided by the treating physician. Results: The DDSS presented information with high clarity and had a user-friendly, novel, and transparent interface. The DDSS prototype was not perfectly suited for the ED as case entry was time-consuming (1.5-2 hours per case). It provided accurate decision support in the clinical inpatient setting (average of cases in which the correct diagnosis was the first diagnosis listed: 6/20, 30%, SD 2.10%; average of cases in which the correct diagnosis was listed as one of the top 3: 11/20, 55%, SD 2.39%; average of cases in which the correct diagnosis was listed as one of the top 5: 14/20, 70%, SD 2.26%) in patients with dyspnea as the main presenting complaint. Conclusions: The study of the feasibility and functionality of the tool was successful, with some limitations. Used in the right place, the DDSS has the potential to support physicians in their decision-making process by showing new pathways and unintentionally ignored diagnoses. The DDSS prototype had some limitations regarding the process of data input, diagnostic accuracy, and completeness of the integrated medical knowledge. The results of this study provide a basis for the tool’s further development. In addition, future studies should be conducted with the aim to overcome the current limitations of the tool and study design. Trial Registration: ClinicalTrials.gov NCT04827342; https://clinicaltrials.gov/ct2/show/NCT04827342 %M 35323125 %R 10.2196/29943 %U https://formative.jmir.org/2022/3/e29943 %U https://doi.org/10.2196/29943 %U http://www.ncbi.nlm.nih.gov/pubmed/35323125 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 11 %N 3 %P e16430 %T Development of a Digital Health Intervention for Rheumatoid Arthritis Symptom Management in a Biotechnology Industry Context: Protocol for the Application of a Human-Centered Design Framework %A Nugent,Lisa %A Anthony Kouyate,Robin %A Jackson,Shawna %A Smith,Meredith Y %+ Amgen, 1224 Paseo Rancho Serrano, Thousand Oaks, CA, 91362, United States, 1 4102413997, rakouyate@gmail.com %K human-centered design %K patient-reported outcomes %K rheumatoid arthritis %K digital journal %K patient diaries %K data visualization %K mobile phone %D 2022 %7 22.3.2022 %9 Protocol %J JMIR Res Protoc %G English %X Background: Involving chronically ill patients in the management of their health is widely recognized as a vital component of high-quality health care. However, to assume the role of informed participants, patients need both access to their health information and assistance in interpreting such data. Smartphone technology with SMS text messaging functionality offers a convenient and minimally demanding mechanism for providing such dual capabilities to patients. To date, a number of similar digital tools have been developed for use in various chronic and progressive disease conditions, including rheumatoid arthritis. Objective: This paper aims to describe the development of a research protocol that applies a human-centered design (HCD) approach to develop a mobile health (mHealth) intervention to support symptom management and treatment adherence for rheumatoid arthritis. Methods: To guide the development of the mHealth intervention for use within a commercial biotechnology context, we selected and applied an HCD framework consisting of three phases: understanding, ideation, and implementation. Results: Leveraging the framework, we mapped the key objectives and research questions to each phase and identified the HCD techniques and methods most suitable for addressing them. In addition, we identified the need to include a fourth phase, one that referred to postimplementation assessment, which would enable evaluation of patient engagement and intervention impact on symptom self-management. Conclusions: This paper presents a research protocol that applied an HCD framework to guide the development of an mHealth intervention within a commercial biotechnology context. This type of guidance is salient because commercial entities are becoming one of the leading producers of this type of intervention. However, the methodologies used and challenges faced from a research and development perspective are not well-represented in the published research literature to date. Our application of the HCD framework yielded important findings. Each phase of the HCD framework provided important guidance for increasing the likelihood that the final product would be understandable, acceptable, feasible, and engaging to use. Consistent with other researchers in the field of mHealth interventions, we identified the need to add a fourth phase to the HCD framework, one that focused on a postimplementation assessment to guide further improvements to support adoption in real-world settings. International Registered Report Identifier (IRRID): RR1-10.2196/16430 %M 35315784 %R 10.2196/16430 %U https://www.researchprotocols.org/2022/3/e16430 %U https://doi.org/10.2196/16430 %U http://www.ncbi.nlm.nih.gov/pubmed/35315784 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 3 %P e30606 %T Digital Prompts to Increase Engagement With the Headspace App and for Stress Regulation Among Parents: Feasibility Study %A Militello,Lisa %A Sobolev,Michael %A Okeke,Fabian %A Adler,Daniel A %A Nahum-Shani,Inbal %+ College of Nursing, The Ohio State University, 1585 Neil Ave, Columbus, OH, 43210, United States, 1 614 688 4248, militello.14@osu.edu %K Headspace %K engagement %K mHealth %K mindfulness %K mental health %K mobile phone %D 2022 %7 21.3.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: Given the interrelated health of children and parents, strategies to promote stress regulation are critically important in the family context. However, the uptake of preventive mental health is limited among parents owing to competing family demands. Objective: In this study, we aim to determine whether it is feasible and acceptable to randomize digital prompts designed to engage parents in real-time brief mindfulness activities guided by a commercially available app. Methods: We conducted a 30-day pilot microrandomized trial among a sample of parents who used Android smartphones. Each day during a parent-specified time frame, participants had a 50% probability of receiving a prompt with a message encouraging them to engage in a mindfulness activity using a commercial app, Headspace. In the 24 hours following randomization, ecological momentary assessments and passively collected smartphone data were used to assess proximal engagement (yes or no) with the app and any mindfulness activity (with or without the app). These data were combined with baseline and exit surveys to determine feasibility and acceptability. Results: Over 4 months, 83 interested parents were screened, 48 were eligible, 16 were enrolled, and 10 were successfully onboarded. Reasons for nonparticipation included technology barriers, privacy concerns, time constraints, or change of mind. In total, 80% (8/10) of parents who onboarded successfully completed all aspects of the intervention. While it is feasible to randomize prompt delivery, only 60% (6/10) of parents reported that the timing of prompts was helpful despite having control over the delivery window. Across the study period, we observed higher self-reported engagement with Headspace on days with prompts (31/62, 50% of days), as opposed to days without prompts (33/103, 32% of days). This pattern was consistent for most participants in this study (7/8, 87%). The time spent using the app on days with prompts (mean 566, SD 378 seconds) was descriptively higher than on days without prompts (mean 225, SD 276 seconds). App usage was highest during the first week and declined over each of the remaining 3 weeks. However, self-reported engagement in mindfulness activities without the app increased over time. Self-reported engagement with any mindfulness activity was similar on days with (40/62, 65% of days) and without (65/103, 63% of days) prompts. Participants found the Headspace app helpful (10/10, 100%) and would recommend the program to others (9/10, 90%). Conclusions: Preliminary findings suggest that parents are receptive to using mindfulness apps to support stress management, and prompts are likely to increase engagement with the app. However, we identified several implementation challenges in the current trial, specifically a need to optimize prompt timing and frequency as a strategy to engage users in preventive digital mental health. %M 35311675 %R 10.2196/30606 %U https://formative.jmir.org/2022/3/e30606 %U https://doi.org/10.2196/30606 %U http://www.ncbi.nlm.nih.gov/pubmed/35311675 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 3 %P e33329 %T Improving Outcomes Through Personalized Recommendations in a Remote Diabetes Monitoring Program: Observational Study %A Kamath,Sowmya %A Kappaganthu,Karthik %A Painter,Stefanie %A Madan,Anmol %+ Teladoc Health, 2 Manhattanville Rd, Purchase, NY, 10577, United States, 1 3123307236, spainter@teladoc.com %K personalization %K type 2 diabetes %K recommendation %K causal %K observational %K mobile health %K machine learning %K engagement %K glycemic control %K mHealth %K recommender systems %D 2022 %7 21.3.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: Diabetes management is complex, and program personalization has been identified to enhance engagement and clinical outcomes in diabetes management programs. However, 50% of individuals living with diabetes are unable to achieve glycemic control, presenting a gap in the delivery of self-management education and behavior change. Machine learning and recommender systems, which have been used within the health care setting, could be a feasible application for diabetes management programs to provide a personalized user experience and improve user engagement and outcomes. Objective: This study aims to evaluate machine learning models using member-level engagements to predict improvement in estimated A1c and develop personalized action recommendations within a remote diabetes monitoring program to improve clinical outcomes. Methods: A retrospective study of Livongo for Diabetes member engagement data was analyzed within five action categories (interacting with a coach, reading education content, self-monitoring blood glucose level, tracking physical activity, and monitoring nutrition) to build a member-level model to predict if a specific type and level of engagement could lead to improved estimated A1c for members with type 2 diabetes. Engagement and improvement in estimated A1c can be correlated; therefore, the doubly robust learning method was used to model the heterogeneous treatment effect of action engagement on improvements in estimated A1c. Results: The treatment effect was successfully computed within the five action categories on estimated A1c reduction for each member. Results show interaction with coaches and self-monitoring blood glucose levels were the actions that resulted in the highest average decrease in estimated A1c (1.7% and 1.4%, respectively) and were the most recommended actions for 54% of the population. However, these were found to not be the optimal interventions for all members; 46% of members were predicted to have better outcomes with one of the other three interventions. Members who engaged with their recommended actions had on average a 0.8% larger reduction in estimated A1c than those who did not engage in recommended actions within the first 3 months of the program. Conclusions: Personalized action recommendations using heterogeneous treatment effects to compute the impact of member actions can reduce estimated A1c and be a valuable tool for diabetes management programs in encouraging members toward actions to improve clinical outcomes. %M 35311691 %R 10.2196/33329 %U https://formative.jmir.org/2022/3/e33329 %U https://doi.org/10.2196/33329 %U http://www.ncbi.nlm.nih.gov/pubmed/35311691 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 3 %P e34029 %T A Lifestyle Intervention to Delay Early Chronic Kidney Disease in African Americans With Diabetic Kidney Disease: Pre-Post Pilot Study %A Ozieh,Mukoso N %A Egede,Leonard E %+ Department of Medicine, Division of Nephrology, Medical College of Wisconsin, 8701 Watertown Plank Road, Milwaukee, WI, 53226, United States, 1 4149558839, mozieh@mcw.edu %K type 2 diabetes mellitus %K chronic kidney insufficiency %K healthy lifestyle %K outcomes research %K African Americans %K quasiexperimental study %D 2022 %7 15.3.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: Behavioral factors, such as lifestyle, have been shown to explain approximately 24% of the excess risk of chronic kidney disease (CKD) among African Americans. However, there are limited intervention studies culturally tailored to African Americans with type 2 diabetes mellitus and CKD. Objective: The main objective of this study was to examine the feasibility and preliminary efficacy of a culturally tailored lifestyle intervention among African Americans with type 2 diabetes mellitus and CKD. Methods: A pre-post design was used to test the feasibility of a lifestyle intervention in 30 African American adults recruited from the Medical University of South Carolina between January 2017 and February 2017. A research nurse delivered the manualized study intervention weekly for 6 weeks. Clinical outcomes (hemoglobin A1c, blood pressure, and estimated glomerular filtration rate [eGFR]) were measured at baseline and postintervention. Disease knowledge, self-care, and behavior outcomes were also measured using validated structured questionnaires at baseline and postintervention. Descriptive statistics and effect sizes were calculated to determine clinically important changes from baseline. Results: Significant pre-post mean differences and decreases were observed for hemoglobin A1c (mean 0.75%, 95% CI 0.16-1.34; P=.01), total cholesterol (mean 16.38 mg/dL, 95% CI 5.82-26.94; P=.004), low-density lipoprotein (mean 13.73 mg/dL, 95% CI 3.91-23.54; P=.008), and eGFR (mean 6.73 mL/min/1.73m2, 95% CI 0.97-12.48; P=.02). Significant pre-post mean differences and increases were observed for CKD self-efficacy (mean −11.15, 95% CI −21.55 to −0.75; P=.03), CKD knowledge (mean −2.62, 95% CI −3.98 to −1.25; P<.001), exercise behavior (mean −1.21, 95% CI −1.96 to −0.46; P=.003), and blood sugar testing (mean −2.15, 95% CI −3.47 to −0.83; P=.003). Conclusions: This study provides preliminary data for a large-scale appropriately powered randomized controlled trial to examine a culturally tailored lifestyle intervention in African Americans with type 2 diabetes mellitus and CKD in order to improve clinical, knowledge, self-care, and behavior outcomes in this population. %M 35289751 %R 10.2196/34029 %U https://formative.jmir.org/2022/3/e34029 %U https://doi.org/10.2196/34029 %U http://www.ncbi.nlm.nih.gov/pubmed/35289751 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 11 %N 3 %P e27921 %T Lessons From a Rapid Project Management Exercise in the Time of Pandemic: Methodology for a Global COVID-19 VIRUS Registry Database %A Turek,Janice R %A Bansal,Vikas %A Tekin,Aysun %A Singh,Shuchita %A Deo,Neha %A Sharma,Mayank %A Bogojevic,Marija %A Qamar,Shahraz %A Singh,Romil %A Kumar,Vishakha %A Kashyap,Rahul %+ Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, 1216 2nd St SW, Rochester, MN, 55902, United States, 1 507 255 7196, kashyap.rahul@mayo.edu %K COVID-19 %K critical care %K global %K program management %K registry %D 2022 %7 15.3.2022 %9 Protocol %J JMIR Res Protoc %G English %X Background: The rapid emergence of the COVID-19 pandemic globally collapsed health care organizations worldwide. Incomplete knowledge of best practices, progression of disease, and its impact could result in fallible care. Data on symptoms and advancement of the SARS-CoV-2 virus leading to critical care admission have not been captured or communicated well between international organizations experiencing the same impact from the virus. This led to the expedited need for establishing international communication and data collection on the critical care patients admitted with COVID-19. Objective: Developing a global registry to collect patient data in the critical care setting was imperative with the goal of analyzing and ameliorating outcomes. Methods: A prospective, observational global registry database was put together to record extensive deidentified clinical information for patients hospitalized with COVID-19. Results: Project management was crucial for prompt implementation of the registry for synchronization, improving efficiency, increasing innovation, and fostering global collaboration for valuable data collection. The Society of Critical Care Medicine Discovery VIRUS (Viral Infection and Respiratory Illness Universal Study): COVID-19 Registry would compile data for crucial longitudinal outcomes for disease, treatment, and research. The agile project management approach expedited establishing the registry in 15 days and submission of institutional review board agreement for 250 participating sites. There has been enrollment of sites every month with a total of 306 sites from 28 countries and 64,114 patients enrolled (as of June 7, 2021). Conclusions: This protocol addresses project management lessons in a time of crises which can be a precept for rapid project management for a large-scale health care data registry. We aim to discuss the approach and methodology for establishing the registry, the challenges faced, and the factors contributing to successful outcomes. Trial Registration: ClinicalTrials.gov NCT04323787; https://clinicaltrials.gov/ct2/show/NCT04323787 %M 34762062 %R 10.2196/27921 %U https://www.researchprotocols.org/2022/3/e27921 %U https://doi.org/10.2196/27921 %U http://www.ncbi.nlm.nih.gov/pubmed/34762062 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 3 %P e23589 %T CoGNIT Automated Tablet Computer Cognitive Testing in Patients With Mild Cognitive Impairment: Feasibility Study %A Behrens,Anders %A Berglund,Johan Sanmartin %A Anderberg,Peter %+ Department of Health, Blekinge Institute of Technology, Valhallavägen 1, Karlskrona, 37141, Sweden, 46 734223736, pan@bth.se %K internet %K cognitive testing %K software %K testing %K impairment %K cognition %K feasibility %K diagnosis %K app %K assessment %K cognitive impairment %D 2022 %7 11.3.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: Early diagnosis of cognitive disorders is becoming increasingly important. Limited resources for specialist assessment and an increasing demographical challenge warrants the need for efficient methods of evaluation. In response, CoGNIT, a tablet app for automatic, standardized, and efficient assessment of cognitive function, was developed. Included tests span the cognitive domains regarded as important for assessment in a general memory clinic (memory, language, psychomotor speed, executive function, attention, visuospatial ability, manual dexterity, and symptoms of depression). Objective: The aim of this study was to assess the feasibility of automatic cognitive testing with CoGNIT in older patients with symptoms of mild cognitive impairment (MCI). Methods: Patients older than 55 years with symptoms of MCI (n=36) were recruited at the research clinic at the Blekinge Institute of Technology (BTH), Karlskrona, Sweden. A research nurse administered the Mini-Mental State Exam (MMSE) and the CoGNIT app on a tablet computer. Technical and testing issues were documented. Results: The test battery was completed by all 36 patients. One test, the four-finger–tapping test, was performed incorrectly by 42% of the patients. Issues regarding clarity of instructions were found in 2 tests (block design test and the one finger-tapping test). Minor software bugs were identified. Conclusions: The overall feasibility of automatic cognitive testing with the CoGNIT app in patients with symptoms of MCI was good. The study highlighted tests that did not function optimally. The four-finger–tapping test will be discarded, and minor improvements to the software will be added before further studies and deployment in the clinic. %M 35275064 %R 10.2196/23589 %U https://formative.jmir.org/2022/3/e23589 %U https://doi.org/10.2196/23589 %U http://www.ncbi.nlm.nih.gov/pubmed/35275064 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 11 %N 3 %P e32338 %T Feasibility and Acceptability of an Online WhatsApp Support Group on Breastfeeding: Protocol for a Randomized Controlled Trial %A Lok,Kris YW %A Ko,Rachel WT %A Fan,Heidi SL %A Chau,PH %A Wong,Janet YH %A Wang,MP %A Tsang,Vicky %+ School of Nursing, Li Ka Shing Faculty of Medicine, University of Hong Kong, 4/F, William MW Mong Block, 21 Sassoon Road, Pokfulam, Hong Kong, 852 39176690, krislok@hku.hk %K mHealth %K breastfeeding %K peer support %K mobile health %K parenting %K instant messaging %K online support %K women's health %K postpartum health %K postpartum support %D 2022 %7 9.3.2022 %9 Original Paper %J JMIR Res Protoc %G English %X Background: Mobile health, the use of mobile technology in delivering health care, has been found to be effective in changing health behaviors, including improving breastfeeding practices in postpartum women. With the widespread use of smartphones and instant messaging apps in Hong Kong, instant messaging groups could be a useful channel for delivering breastfeeding peer support. Objective: The aim of this paper is to study the feasibility and acceptability of an online instant messaging peer support group by trained peer counselors on improving breastfeeding outcome in primiparous women in Hong Kong. Methods: A two-arm, assessor-blind, randomized controlled feasibility study will be conducted on 40 primiparous women with the intention to breastfeed. Participants are recruited from the antenatal obstetrics and gynecology clinic of a public hospital in Hong Kong and randomly assigned at a 1:1 ratio to either intervention or control group. The intervention group receives peer support in an online instant messaging group with trained peer counselors on top of standard care, whereas the control group receives standard care. Breastfeeding outcome will be assessed for 6 months post partum or until weaned. The breastfeeding status, the proportion and duration of exclusive and any breastfeeding in each group, and the self-efficacy and attitude of participants will be assessed. The feasibility and acceptability of the study would also be assessed in preparation for a full randomized controlled trial. Results: This study (protocol version 1 dated January 5, 2021) has been reviewed and approved by the institutional review board of the University of Hong Kong, Hospital Authority Hong Kong West Cluster (reference UW 21-039), on January 26, 2021. Data collection is ongoing and expected to be completed in December 2021. The findings will be updated on clinical trial registry and disseminated in peer-reviewed journals. Conclusions: This study aims to assess the feasibility and effectiveness of an online instant messaging peer support group in improving the breastfeeding outcome of primiparous women in Hong Kong. Its findings could inform the feasibility of a full-scale trial with this intervention design. Trial Registration: ClinicalTrials.gov NCT04826796; https://clinicaltrials.gov/ct2/show/NCT04826796 International Registered Report Identifier (IRRID): DERR1-10.2196/32338 %M 35262504 %R 10.2196/32338 %U https://www.researchprotocols.org/2022/3/e32338 %U https://doi.org/10.2196/32338 %U http://www.ncbi.nlm.nih.gov/pubmed/35262504 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 3 %P e28877 %T Token Economy–Based Hospital Bed Allocation to Mitigate Information Asymmetry: Proof-of-Concept Study Through Simulation Implementation %A Hiragi,Shusuke %A Hatanaka,Jun %A Sugiyama,Osamu %A Saito,Kenichi %A Nambu,Masayuki %A Kuroda,Tomohiro %+ Division of Health Science, Tazuke Kofukai Medical Research Institute, 2-4-10 Ohgimachi Kita-ku, Osaka, 5308480, Japan, 81 6 6312 1221, shiragi@kuhp.kyoto-u.ac.jp %K hospital administration %K resource allocation %K token economy %K bed occupancy %K hospital management %K simulation %K decision-making %K organization %D 2022 %7 4.3.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: Hospital bed management is an important resource allocation task in hospital management, but currently, it is a challenging task. However, acquiring an optimal solution is also difficult because intraorganizational information asymmetry exists. Signaling, as defined in the fields of economics, can be used to mitigate this problem. Objective: We aimed to develop an assignment process that is based on a token economy as signaling intermediary. Methods: We implemented a game-like simulation, representing token economy–based bed assignments, in which 3 players act as ward managers of 3 inpatient wards (1 each). As a preliminary evaluation, we recruited 9 nurse managers to play and then participate in a survey about qualitative perceptions for current and proposed methods (7-point Likert scale). We also asked them about preferred rewards for collected tokens. In addition, we quantitatively recorded participant pricing behavior. Results: Participants scored the token economy–method positively in staff satisfaction (3.89 points vs 2.67 points) and patient safety (4.38 points vs 3.50 points) compared to the current method, but they scored the proposed method negatively for managerial rivalry, staff employee development, and benefit for patients. The majority of participants (7 out of 9) listed human resources as the preferred reward for tokens. There were slight associations between workload information and pricing. Conclusions: Survey results indicate that the proposed method can improve staff satisfaction and patient safety by increasing the decision-making autonomy of staff but may also increase managerial rivalry, as expected from existing criticism for decentralized decision-making. Participant behavior indicated that token-based pricing can act as a signaling intermediary. Given responses related to rewards, a token system that is designed to incorporate human resource allocation is a promising method. Based on aforementioned discussion, we concluded that a token economy–based bed allocation system has the potential to be an optimal method by mitigating information asymmetry. %M 35254264 %R 10.2196/28877 %U https://formative.jmir.org/2022/3/e28877 %U https://doi.org/10.2196/28877 %U http://www.ncbi.nlm.nih.gov/pubmed/35254264 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 3 %P e33701 %T Digital Life Coaching During Stem Cell Transplantation: Development and Usability Study %A Banerjee,Rahul %A Huang,Chiung-Yu %A Dunn,Lisa %A Knoche,Jennifer %A Ryan,Chloe %A Brassil,Kelly %A Jackson,Lindsey %A Patel,Dhiren %A Lo,Mimi %A Arora,Shagun %A Wong,Sandy W %A Wolf,Jeffrey %A Martin III,Thomas %A Dhruva,Anand %A Shah,Nina %+ Division of Hematology/Oncology, Department of Medicine, University of California San Francisco, 400 Parnassus Avenue, San Francisco, CA, 94158, United States, 1 415 353 8000, rahul.banerjee.md@gmail.com %K digital health %K life coaching %K multiple myeloma %K stem cell transplantation %K stem cell therapy %K cancer %K high-dose chemotherapy %K patient engagement %K feasibility %K digital life coaching %K mobile phone %D 2022 %7 4.3.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: For patients with multiple myeloma receiving high-dose chemotherapy followed by autologous stem cell transplantation (SCT), acute life disruptions and symptom burden may lead to worsened quality of life (QOL) and increased emotional distress. Digital life coaching (DLC), whereby trained coaches deliver personalized well-being–related support via phone calls and SMS text messaging, has been shown to improve QOL among SCT survivors. However, DLC has not been investigated during the acute peri-SCT period, which is generally characterized by symptomatic exacerbations and 2-week hospitalizations. Objective: We launched a single-arm pilot study to investigate the feasibility of patient engagement with DLC during this intensive period. Methods: We approached English-speaking adult patients with multiple myeloma undergoing autologous SCT at our center. Enrolled patients received 16 weeks of virtual access to a life coach beginning on day −5 before SCT. Coaches used structured frameworks to help patients identify and overcome personal barriers to well-being. Patients chose the coaching topics and preferred communication styles. Our primary endpoint was ongoing DLC engagement, defined as bidirectional conversations occurring at least once every 4 weeks during the study period. Secondary endpoints were electronic patient-reported outcome assessments of QOL, distress, and sleep disturbances. Results: Of the 20 patients who were screened, 17 (85%) chose to enroll and 15 (75%) underwent SCT as planned. Of these 15 patients (median age 65 years, range 50-81 years), 11 (73%) demonstrated ongoing DLC engagement. The median frequency of bidirectional conversations during the 3-month study period was once every 6.2 days (range 3.9-28 days). During index hospitalizations with median lengths of stay of 16 days (range 14-31 days), the median frequency of conversations was once every 5.3 days (range 2.7-15 days). Electronic patient-reported outcome assessments (94% adherence) demonstrated an expected QOL nadir during the second week after SCT. The prevalence of elevated distress was highest immediately before and after SCT, with 69% of patients exhibiting elevated distress on day −5 and on day +2. Conclusions: DLC may be feasible for older patients during intensive hospital-based cancer treatments such as autologous SCT for multiple myeloma. The limitations of our study include small sample size, selection bias among enrolled patients, and heterogeneity in DLC use. Based on the positive results of this pilot study, a larger phase 2 randomized study of DLC during SCT is underway to investigate the efficacy of DLC with regard to patient well-being. Trial Registration: ClinicalTrials.gov NCT04432818; https://clinicaltrials.gov/ct2/show/NCT04432818. %M 35039279 %R 10.2196/33701 %U https://formative.jmir.org/2022/3/e33701 %U https://doi.org/10.2196/33701 %U http://www.ncbi.nlm.nih.gov/pubmed/35039279 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 3 %P e34032 %T Feasibility and Preliminary Efficacy of Web-Based and Mobile Interventions for Common Mental Health Problems in Working Adults: Multi-Arm Randomized Pilot Trial %A Economides,Marcos %A Bolton,Heather %A Male,Rhian %A Cavanagh,Kate %+ Unmind Ltd, 180 Borough High St, London, SE1 1LB, United Kingdom, 44 2078664050, marcos.economides@unmind.com %K mHealth %K workplace %K CBT %K ACT %K feasibility %K stress %K anxiety %K depression %K resilience %K mobile phone %D 2022 %7 3.3.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: There is growing interest in digital platforms as a means of implementing scalable, accessible, and cost-effective mental health interventions in the workplace. However, little is known about the efficacy of such interventions when delivered to employee groups. Objective: This study aims to evaluate the feasibility and preliminary efficacy of a digital mental health platform for the workplace, which incorporates evidence-based practices such as cognitive behavioral therapy and acceptance and commitment therapy. A total of 3 brief, unguided interventions designed to address stress, anxiety, and resilience, respectively, are evaluated. The primary aim is to determine the feasibility of the study methods and interventions in preparation for a definitive randomized controlled trial. Methods: The study used a fully remote, parallel, multi-arm, external pilot randomized controlled trial, with 3 intervention arms and a no-intervention control group. Participants were working adults representative of the general UK population with respect to age, sex, and ethnicity who were recruited from a web-based participant platform. Primary outcomes included objective and self-report measures of feasibility, acceptability, engagement, transferability, relevance, and negative effects. Secondary outcomes included 4 self-report measures of mental health and well-being, completed at baseline (time point 0 [t0]), postintervention (time point 1 [t1]), and the 1-month follow-up (time point 2 [t2]). Secondary outcomes were analyzed via linear mixed-effects models using intention-to-treat principles. Preregistered criteria for progression to a definitive trial were evaluated. Results: Data were collected between January and March of 2021. A total of 383 working adult participants meeting trial eligibility were randomized, of whom 356 (93%) were retained at t2. Objective engagement data showed that 67.8% (196/289) of participants randomized to an intervention arm completed their intervention. Overall, 87.1% (203/233) of participants reported being satisfied or very satisfied with their intervention and rated the quality of their intervention as good or excellent. All intervention groups reported significantly greater improvements than the control group on at least one secondary outcome at t1, with between-group Hedges g effect sizes for the pooled interventions ranging from 0.25 (95% CI 0.05-0.46) to 0.43 (95% CI 0.23-0.64). All the improvements were maintained at t2. Conclusions: The study methods were feasible, and all preregistered criteria for progression to a definitive trial were met. Several minor protocol amendments were noted. Preliminary efficacy findings suggest that the study interventions may result in improved mental health outcomes when offered to working adults. Trial Registration: ISRCTN Registry 80309011; http://www.isrctn.com/ISRCTN80309011 %M 35238794 %R 10.2196/34032 %U https://formative.jmir.org/2022/3/e34032 %U https://doi.org/10.2196/34032 %U http://www.ncbi.nlm.nih.gov/pubmed/35238794 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 3 %P e30052 %T eDOL mHealth App and Web Platform for Self-monitoring and Medical Follow-up of Patients With Chronic Pain: Observational Feasibility Study %A Kerckhove,Nicolas %A Delage,Noémie %A Cambier,Sébastien %A Cantagrel,Nathalie %A Serra,Eric %A Marcaillou,Fabienne %A Maindet,Caroline %A Picard,Pascale %A Martiné,Gaelle %A Deleens,Rodrigue %A Trouvin,Anne-Priscille %A Fourel,Lauriane %A Espagne-Dubreuilh,Gaelle %A Douay,Ludovic %A Foulon,Stéphane %A Dufraisse,Bénédicte %A Gov,Christian %A Viel,Eric %A Jedryka,François %A Pouplin,Sophie %A Lestrade,Cécile %A Combe,Emmanuel %A Perrot,Serge %A Perocheau,Dominique %A De Brisson,Valentine %A Vergne-Salle,Pascale %A Mertens,Patrick %A Pereira,Bruno %A Djiberou Mahamadou,Abdoul Jalil %A Antoine,Violaine %A Corteval,Alice %A Eschalier,Alain %A Dualé,Christian %A Attal,Nadine %A Authier,Nicolas %+ Service de Pharmacologie médicale, Centre Hospitalier Universitaire de Clermont-Ferrand, 29 boulevard Joseph Girod, Clermont-Ferrand, 63000, France, 33 0473178414, nkerckhove@chu-clermontferrand.fr %K mHealth %K chronic pain %K feasibility study %K eHealth %K self-monitoring %D 2022 %7 2.3.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: Chronic pain affects approximately 30% of the general population, severely degrades quality of life (especially in older adults) and professional life (inability or reduction in the ability to work and loss of employment), and leads to billions in additional health care costs. Moreover, available painkillers are old, with limited efficacy and can cause significant adverse effects. Thus, there is a need for innovation in the management of chronic pain. Better characterization of patients could help to identify the predictors of successful treatments, and thus, guide physicians in the initial choice of treatment and in the follow-up of their patients. Nevertheless, current assessments of patients with chronic pain provide only fragmentary data on painful daily experiences. Real-life monitoring of subjective and objective markers of chronic pain using mobile health (mHealth) programs can address this issue. Objective: We hypothesized that regular patient self-monitoring using an mHealth app would lead physicians to obtain deeper understanding and new insight into patients with chronic pain and that, for patients, regular self-monitoring using an mHealth app would play a positive therapeutic role and improve adherence to treatment. We aimed to evaluate the feasibility and acceptability of a new mHealth app called eDOL. Methods: We conducted an observational study to assess the feasibility and acceptability of the eDOL tool. Patients completed several questionnaires using the tool over a period of 2 weeks and repeated assessments weekly over a period of 3 months. Physicians saw their patients at a follow-up visit that took place at least 3 months after the inclusion visit. A composite criterion of the acceptability and feasibility of the eDOL tool was calculated after the completion of study using satisfaction surveys from both patients and physicians. Results: Data from 105 patients (of 133 who were included) were analyzed. The rate of adherence was 61.9% (65/105) after 3 months. The median acceptability score was 7 (out of 10) for both patients and physicians. There was a high rate of completion of the baseline questionnaires and assessments (mean 89.3%), and a low rate of completion of the follow-up questionnaires and assessments (63.8% (67/105) and 61.9% (65/105) respectively). We were also able to characterize subgroups of patients and determine a profile of those who adhered to eDOL. We obtained 4 clusters that differ from each other in their biopsychosocial characteristics. Cluster 4 corresponds to patients with more disabling chronic pain (daily impact and comorbidities) and vice versa for cluster 1. Conclusions: This work demonstrates that eDOL is highly feasible and acceptable for both patients with chronic pain and their physicians. It also shows that such a tool can integrate many parameters to ensure the detailed characterization of patients for future research works and pain management. Trial Registration: ClinicalTrial.gov NCT03931694; http://clinicaltrials.gov/ct2/show/NCT03931694 %M 35234654 %R 10.2196/30052 %U https://formative.jmir.org/2022/3/e30052 %U https://doi.org/10.2196/30052 %U http://www.ncbi.nlm.nih.gov/pubmed/35234654 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 2 %P e33636 %T A Smartphone-Based Information Communication Technology Solution for Primary Modifiable Risk Factors for Noncommunicable Diseases: Pilot and Feasibility Study in Norway %A Gram,Inger Torhild %A Skeie,Guri %A Oyeyemi,Sunday Oluwafemi %A Borch,Kristin Benjaminsen %A Hopstock,Laila Arnesdatter %A Løchen,Maja-Lisa %+ Norwegian Centre for E-health Research, University Hospital of North Norway, Forskningsparken i Breivika, 3rd floor, Sykehusvn. 23, Tromsø, 9019, Norway, 47 92401177, inger.gram@ehealthresearch.no %K eHealth %K feasibility study %K modifiable risk factor %K noncommunicable disease %K pilot study %K smartphone-based information communication technology solution %K short text message service %K feasibility %K risk %K factor %K information communication technology %K smartphone %K development %K monitoring %D 2022 %7 25.2.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: Cardiovascular diseases, cancers, chronic respiratory diseases, and diabetes are the 4 main noncommunicable diseases. These noncommunicable diseases share 4 modifiable risk factors (tobacco use, harmful use of alcohol, physical inactivity, and unhealthy diet). Short smartphone surveys have the potential to identify modifiable risk factors for individuals to monitor trends. Objective: We aimed to pilot a smartphone-based information communication technology solution to collect nationally representative data, annually, on 4 modifiable risk factors. Methods: We developed an information communication technology solution with functionalities for capturing sensitive data from smartphones, receiving, and handling data in accordance with general data protection regulations. The main survey comprised 26 questions: 8 on socioeconomic factors, 17 on the 4 risk factors, and 1 about current or previous noncommunicable diseases. For answers to the continuous questions, a keyboard was displayed for entering numbers; there were preset upper and lower limits for acceptable response values. For categorical questions, pull-down menus with response options were displayed. The second survey comprised 9 yes-or-no questions. For both surveys, we used SMS text messaging. For the main survey, we invited 11,000 individuals, aged 16 to 69 years, selected randomly from the Norwegian National Population Registry (1000 from each of the 11 counties). For the second survey, we invited a random sample of 100 individuals from each county who had not responded to the main survey. All data, except county of residence, were self-reported. We calculated the distribution for socioeconomic background, tobacco use, diet, physical activity, and health condition factors overall and by sex. Results: The response rate was 21.9% (2303/11,000; women: 1397/2263; 61.7%, men: 866/2263, 38.3%; missing: 40/2303, 1.7%). The median age for men was 52 years (IQR 40-61); the median age for women was 48 years (IQR 35-58). The main reported reason for nonparticipation in the main survey was that the sender of the initial SMS was unknown. Conclusions: We successfully developed and piloted a smartphone-based information communication technology solution for collecting data on the 4 modifiable risk factors for the 4 main noncommunicable diseases. Approximately 1 in 5 invitees responded; thus, these data may not be nationally representative. The smartphone-based information communication technology solution should be further developed with the long-term goal to reduce premature mortality from the 4 main noncommunicable diseases. %M 35212636 %R 10.2196/33636 %U https://formative.jmir.org/2022/2/e33636 %U https://doi.org/10.2196/33636 %U http://www.ncbi.nlm.nih.gov/pubmed/35212636 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 11 %N 2 %P e31595 %T Examining a Continuous Glucose Monitoring Plus Online Peer Support Community Intervention to Support Hispanic Adults With Type 2 Diabetes: Protocol for a Mixed Methods Feasibility Study %A Ng,Ashley H %A Greenwood,Deborah A %A Iacob,Eli %A Allen,Nancy A %A Ferrer,Mila %A Rodriguez,Bruno %A Litchman,Michelle L %+ Department of Dietetics, Human Nutrition and Sport, La Trobe University, Plenty Road and Kingsbury Drive, Bundoora, 3086, Australia, 61 394793249, a.ng@latrobe.edu.au %K type 2 diabetes %K hispanic %K social support %K online community %K technology %K peer support %K diabetes %K T2D %K continuous glucose monitoring %K behavior change %K patient education %D 2022 %7 24.2.2022 %9 Protocol %J JMIR Res Protoc %G English %X Background: Type 2 diabetes is twice as likely to affect Hispanic people than their White counterparts. Technology and social support may be an important part of behavior change. In this study, we address gaps in diabetes care for Hispanic Spanish-speaking people with diabetes through an online peer support community (OPSC) pilot intervention using Hispanic Spanish-speaking peer facilitators with diabetes to enhance the use of continuous glucose monitoring (CGM) for diabetes management. Objective: This study aims to address gaps in diabetes care for Hispanic Spanish-speaking people with diabetes through an OPSC pilot intervention using Hispanic Spanish-speaking peer facilitators with diabetes to enhance the use of CGM for diabetes management. Methods: A mixed-methods, pre-post test design will be used in this feasibility study. A total of 50 Hispanic participants with type 2 diabetes willing to wear a continuous glucose monitor for 13 weeks will be recruited. Hispanic Spanish-speaking peer facilitators with diabetes and experience wearing a continuous glucose monitor will be employed and undergo training. Peer facilitators will help participants learn how CGM data can inform behavior changes via an OPSC. Participants will interact with the private OPSC at least three times a week. Weekly questions and prompts derived from the Association of Diabetes Care and Education Specialists, previously American Association of Diabetes Educators, and seven self-care behaviors will be delivered by peer facilitators to engage participants. Measures of feasibility and acceptability will be determined by the percentage of participants who enroll, complete the study, and use CGM (number of scans) and objective metrics from the OPSC. Efficacy potential outcomes include change in time in range of 70 to 180 mg/dL from baseline to 12 weeks, A1c, diabetes online community engagement, self-efficacy, and quality of life. Additionally, semistructured exit interviews will be conducted. Results: Funding for this project was secured in November 2018 and approved by the institutional review board in April 2019. Peer facilitator recruitment and training were undertaken in the second half of 2019, with participant recruitment and data collection conducted in January and April 2020. The study has now concluded. Conclusions: This study will generate new evidence about the use of an OPSC for Hispanic Spanish-speaking patients with diabetes to make behavior changes incorporating feedback from CGM. Trial Registration: ClinicalTrials.gov NCT03799796; https://clinicaltrials.gov/ct2/show/NCT03799796 International Registered Report Identifier (IRRID): RR1-10.2196/31595 %M 35200153 %R 10.2196/31595 %U https://www.researchprotocols.org/2022/2/e31595 %U https://doi.org/10.2196/31595 %U http://www.ncbi.nlm.nih.gov/pubmed/35200153 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 11 %N 2 %P e32240 %T Digital Interventions to Reduce Distress Among Health Care Providers at the Frontline: Protocol for a Feasibility Trial %A Nguyen,Binh %A Torres,Andrei %A Sim,Walter %A Kenny,Deborah %A Campbell,Douglas M %A Beavers,Lindsay %A Lou,Wendy %A Kapralos,Bill %A Peter,Elizabeth %A Dubrowski,Adam %A Krishnan,Sridhar %A Bhat,Venkat %+ Interventional Psychiatry Program, St Michael’s Hospital, Unity Health Toronto, 193 Yonge Street, Suite 6-013, Toronto, ON, M5B 1M8, Canada, 1 416 360 4000 ext 76404, venkat.bhat@utoronto.ca %K virtual reality %K mobile app %K moral distress %K simulation %K moral injury %K COVID-19 %D 2022 %7 16.2.2022 %9 Protocol %J JMIR Res Protoc %G English %X Background: Stress, anxiety, distress, and depression are high among health care workers during the COVID-19 pandemic, and they have reported acting in ways that are contrary to their moral values and professional commitments that degrade their integrity. This creates moral distress and injury due to constraints they have encountered, such as limited resources. Objective: The purpose of this study is to develop and show the feasibility of digital platforms (a virtual reality and a mobile platform) to understand the causes and ultimately reduce the moral distress of health care providers during the COVID-19 pandemic. Methods: This will be a prospective, single cohort, pre- and posttest study examining the effect of a brief informative video describing moral distress on perceptual, psychological, and physiological indicators of stress and decision-making during a scenario known to potentially elicit moral distress. To accomplish this, we have developed a virtual reality simulation that will be used before and after the digital intervention for monitoring short-term impacts. The simulation involves an intensive care unit setting during the COVID-19 pandemic, and participants will be placed in morally challenging situations. The participants will be engaged in an educational intervention at the individual, team, and organizational levels. During each test, data will be collected for (1) physiological measures of stress and after each test, data will be collected regarding (2) thoughts, feelings and behaviors during a morally challenging situation, and (3) perceptual estimates of psychological stress. In addition, participants will continue to be monitored for moral distress and other psychological stresses for 8 weeks through our Digital intervention/intelligence Group mobile platform. Finally, a comparison will be conducted using machine learning and biostatistical techniques to analyze the short- and long-term impacts of the virtual reality intervention. Results: The study was funded in November 2020 and received research ethics board approval in March 2021. The study is ongoing. Conclusions: This project is a proof-of-concept integration to demonstrate viability over 6 months and guide future studies to develop these state-of-the-art technologies to help frontline health care workers work in complex moral contexts. In addition, the project will develop innovations that can be used for future pandemics and in other contexts prone to producing moral distress and injury. This project aims to demonstrate the feasibility of using digital platforms to understand the continuum of moral distress that can lead to moral injury. Demonstration of feasibility will lead to future studies to examine the efficacy of digital platforms to reduce moral distress. Trial Registration: ClinicalTrials.gov NCT05001542; https://clinicaltrials.gov/ct2/show/NCT05001542 International Registered Report Identifier (IRRID): DERR1-10.2196/32240 %M 34871178 %R 10.2196/32240 %U https://www.researchprotocols.org/2022/2/e32240 %U https://doi.org/10.2196/32240 %U http://www.ncbi.nlm.nih.gov/pubmed/34871178 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 2 %P e27500 %T Early Development of a Virtual Coach for Healthy Coping Interventions in Type 2 Diabetes Mellitus: Validation Study %A Bassi,Giulia %A Donadello,Ivan %A Gabrielli,Silvia %A Salcuni,Silvia %A Giuliano,Claudio %A Forti,Stefano %+ Department of Developmental and Socialization Psychology, University of Padova, Via Venezia 8, Padova, 35131, Italy, 39 3477334405, giulia.bassi@phd.unipd.it %K virtual coach %K early development %K type 2 diabetes mellitus %K healthy coping %K Wizard of Oz %K ORBIT model %K pilot study %K mobile phone %D 2022 %7 11.2.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: Mobile health solutions aimed at monitoring tasks among people with diabetes mellitus (DM) have been broadly applied. However, virtual coaches (VCs), embedded or not in mobile health, are considered valuable means of improving patients’ health-related quality of life and ensuring adherence to self-care recommendations in diabetes management. Despite the growing need for effective, healthy coping digital interventions to support patients’ self-care and self-management, the design of psychological digital interventions that are acceptable, usable, and engaging for the target users still represents the main challenge, especially from a psychosocial perspective. Objective: This study primarily aims to test VC interventions based on psychoeducational and counseling approaches to support and promote healthy coping behaviors in adults with DM. As a preliminary study, university students have participated in it and have played the standardized patients’ (SPs) role with the aim of improving the quality of the intervention protocol in terms of user acceptability, experience, and engagement. The accuracy of users’ role-playing is further analyzed. Methods: This preliminary study is based on the Obesity-Related Behavioral Intervention Trial model, with a specific focus on its early phases. The healthy coping intervention protocol was initially designed together with a team of psychologists following the main guidelines and recommendations for psychoeducational interventions for healthy coping in the context of DM. The protocol was refined with the support of 3 experts in the design of behavioral intervention technologies for mental health and well-being, who role-played 3 SPs’ profiles receiving the virtual coaching intervention in a Wizard of Oz setting via WhatsApp. A refined version of the healthy coping protocol was then iteratively tested with a sample of 18 university students (mean age 23.61, SD 1.975 years) in a slightly different Wizard of Oz evaluation setting. Participants provided quantitative and qualitative postintervention feedback by reporting their experiences with the VC. Clustering techniques on the logged interactions and dialogs between the VC and users were collected and analyzed to identify additional refinements for future VC development. Results: Both quantitative and qualitative analyses showed that the digital healthy coping intervention was perceived as supportive, motivating, and able to trigger self-reflection on coping strategies. Analyses of the logged dialogs showed that most of the participants accurately played the SPs’ profile assigned, confirming the validity and usefulness of this testing approach in preliminary assessments of behavioral digital interventions and protocols. Conclusions: This study outlined an original approach to the early development and iterative testing of digital healthy coping interventions for type 2 DM. Indeed, the intervention was well-accepted and proved its effectiveness in the definition and refinement of the initial protocol and of the user experience with a VC before directly involving real patients in its subsequent use and testing. %M 35147505 %R 10.2196/27500 %U https://formative.jmir.org/2022/2/e27500 %U https://doi.org/10.2196/27500 %U http://www.ncbi.nlm.nih.gov/pubmed/35147505 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 10 %N 2 %P e30782 %T Evaluation of myCOPD Digital Self-management Technology in a Remote and Rural Population: Real-world Feasibility Study %A Cooper,Rowena %A Giangreco,Adam %A Duffy,Michelle %A Finlayson,Elaine %A Hamilton,Shellie %A Swanson,Mahri %A Colligan,Judith %A Gilliatt,Joanna %A McIvor,Mairi %A Sage,Elizabeth Kathryn %+ Department of Respiratory Medicine, National Health Service Highland, Raigmore Hospital, Old Perth Road, Inverness, IV2 3UJ, United Kingdom, 44 463 706294 ext 8823, beth.sage@nhs.scot %K digital self-management %K COPD %K remote and rural %K mobile health %K application %K chronic pulmonary obstructive disease %K rural communities %D 2022 %7 7.2.2022 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Chronic obstructive pulmonary disease (COPD) is a common, costly, and incurable respiratory disease affecting 1.2 million people in the United Kingdom alone. Acute COPD exacerbations requiring hospitalization place significant demands on health services, and the incidence of COPD in poor, remote, and rural populations is up to twice that of cities. Objective: myCOPD is a commercial, digital health, self-management technology designed to improve COPD outcomes and mitigate demands on health services. In this pragmatic real-world feasibility study, we aimed to evaluate myCOPD use and its clinical effectiveness at reducing hospitalizations, inpatient bed days, and other National Health Service (NHS) resource use. Methods: myCOPD engagement and NHS resource use was monitored for up to 1 year after myCOPD activation and was compared against health service use in the year prior to activation. A total of 113 participants from predominantly remote and rural communities were recruited via community-based care settings, including scheduled home visits, outpatient appointments, pulmonary rehabilitation, and phone or group appointments. There were no predetermined age, disease severity, geographical, or socioeconomic inclusion or exclusion criteria. Results: Out of 113 participants, 89 activated myCOPD (78.8%), with 56% (50/89) of those participants doing so on the day of enrollment and 90% (80/89) doing so within 1 month. There was no correlation between participant enrollment, activation, or myCOPD engagement and either age, socioeconomics, rurality, or COPD severity. Most active participants used at least one myCOPD module and entered their symptom scores at least once (79/89, 89%). A subgroup (15/89, 17%) recorded their symptom scores very frequently (>1 time every 5 days), 14 of whom (93%) also used four or five myCOPD modules. Overall, there were no differences in hospital admissions, inpatient bed days, or other health service use before or after myCOPD activation, apart from a modest increase in home visits. Subgroup analysis did, however, identify a trend toward reduced inpatient bed days and hospital admissions for those participants with very high myCOPD usage. Conclusions: Our results suggest that neither age, wealth, nor geographical location represent significant barriers to using myCOPD. This finding may help mitigate perceived risks of increased health inequalities associated with the use of digital health technologies as part of routine care provision. Despite high levels of activation, myCOPD did not reduce overall demands on health services, such as hospital admissions or inpatient bed days. Subgroup analysis did, however, suggest that very high myCOPD usage was associated with a moderate reduction in NHS resource use. Thus, although our study does not support implementation of myCOPD to reduce health service demands on a population-wide basis, our results do indicate that highly engaged patients may derive benefits. %M 35129453 %R 10.2196/30782 %U https://mhealth.jmir.org/2022/2/e30782 %U https://doi.org/10.2196/30782 %U http://www.ncbi.nlm.nih.gov/pubmed/35129453 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 1 %P e33449 %T An Acceptance and Commitment Therapy Prototype Mobile Program for Individuals With a Visible Difference: Mixed Methods Feasibility Study %A Zucchelli,Fabio %A Donnelly,Olivia %A Rush,Emma %A White,Paul %A Gwyther,Holly %A Williamson,Heidi %A , %+ Health and Applied Sciences, University of the West of England, Frenchay Campus, Bristol, BS16 1QY, United Kingdom, 44 7816449143, fabio.zucchelli@uwe.ac.uk %K mobile health %K acceptance and commitment therapy %K appearance %K mixed methods %K mobile phone %D 2022 %7 21.1.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: Mobile apps may offer a valuable platform for delivering evidence-based psychological interventions for individuals with atypical appearances, or visible differences, who experience psychosocial appearance concerns such as appearance-based social anxiety and body dissatisfaction. Before this study, researchers and stakeholders collaboratively designed an app prototype based on acceptance and commitment therapy (ACT), an evidence-based form of cognitive behavioral therapy that uses strategies such as mindfulness, clarification of personal values, and value-based goal setting. The intervention also included social skills training, an established approach for increasing individuals’ confidence in managing social interactions, which evoke appearance-based anxiety for many. Objective: In this study, the authors aim to evaluate the feasibility of an ACT-based app prototype via the primary objectives of user engagement and acceptability and the secondary feasibility objective of clinical safety and preliminary effectiveness. Methods: To address the feasibility objectives, the authors used a single-group intervention design with mixed methods in a group of 36 participants who have a range of visible differences. The authors collected quantitative data via measures of program use, satisfaction ratings, and changes over 3 time points spanning 12 weeks in outcomes, including selected ACT process measures (experiential avoidance, cognitive defusion, and valued action), scales of appearance concerns (appearance-based life disengagement, appearance-fixing behaviors, appearance self-evaluation, and fear of negative appearance evaluation), and clinical well-being (depression and anxiety). Semistructured exit interviews with a subsample of 12 participants provided qualitative data to give a more in-depth understanding of participants’ views and experiences of the program. Results: In terms of user engagement, adherence rates over 6 sessions aligned with the upper boundary of those reported across mobile mental health apps, with over one-third of participants completing all sessions over 12 weeks, during which a steady decline in adherence was observed. Time spent on sessions matched design intentions, and engagement frequencies highlighted semiregular mindfulness practice, mixed use of value-based goal setting, and high engagement with social skills training. The findings indicate a good overall level of program acceptability via satisfaction ratings, and qualitative interview findings offer positive feedback as well as valuable directions for revisions. Overall, testing for clinical safety and potential effectiveness showed encouraging changes over time, including favorable changes in appearance-related life disengagement, appearance-fixing behaviors, and selected ACT measures. No iatrogenic effects were indicated for depression or anxiety. Conclusions: An ACT-based mobile program for individuals struggling with visible differences shows promising proof of concept in addressing appearance concerns, although further revisions and development are required before further development and more rigorous evaluation. %M 35060908 %R 10.2196/33449 %U https://formative.jmir.org/2022/1/e33449 %U https://doi.org/10.2196/33449 %U http://www.ncbi.nlm.nih.gov/pubmed/35060908 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 11 %N 1 %P e33776 %T Effectiveness of Mindfulness-Based Cognitive Therapy With Follow-Up Sessions for Pharmacotherapy-Refractory Anxiety Disorders: Protocol for a Feasibility Randomized Controlled Trial %A Sado,Mitsuhiro %A Ninomiya,Akira %A Nagaoka,Maki %A Koreki,Akihiro %A Goto,Naho %A Sasaki,Yohei %A Takamori,Chie %A Kosugi,Teppei %A Yamada,Masashi %A Park,Sunre %A Sato,Yasunori %A Fujisawa,Daisuke %A Nakagawa,Atsuo %A Mimura,Masaru %+ Department of Neuropsychiatry, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan, 1 0333531211 ext 62454, mitsusado@keio.jp %K mindfulness-based cognitive therapy %K anxiety disorders %K long-term effects %K randomized controlled trial %K cost-effectiveness %D 2022 %7 21.1.2022 %9 Protocol %J JMIR Res Protoc %G English %X Background: Augmented mindfulness-based cognitive therapy (MBCT) with treatment as usual (mainly pharmacotherapy) is reported to be effective after treatment for anxiety disorders. However, whether its effectiveness persists in the long term is unclear. Objective: This study aims to examine the feasibility, acceptability, and effectiveness of a follow-up program by conducting a feasibility randomized controlled trial (RCT) that compares augmented MBCT with follow-up sessions and that without follow-up sessions in preparation for a definitive RCT. Methods: The study involves an 8-week MBCT with a 10-month follow-up. Patients aged 20 to 65 years who meet the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) criteria for panic disorder, agoraphobia, or social anxiety disorder, which is not remitted with usual treatment for at least 4 weeks, will be included in the study and randomly allocated to receive augmented MBCT with follow-up sessions or augmented MBCT without follow-up sessions. For this feasibility RCT, the primary outcomes are (1) study inclusion rate, (2) dropout rate, (3) attendance rate, and (4) mean and standard deviation of several clinical measures at 8 weeks and 5, 8, and 12 months. Results: We started recruiting participants in January 2020, and 43 participants have been enrolled up to January 2021. The study is ongoing, and data collection will be completed by May 2022. Conclusions: This study is novel in terms of its design, which compares augmented MBCT with and without follow-up sessions. The limitations of the trial are as follows: (1) mixed participants in terms of the delivery mode of the intervention, and (2) lack of a pharmacotherapy-alone arm. Owing to its novelty and significance, this study will provide fruitful knowledge for future definitive RCTs. Trial Registration: UMIN Clinical Trials Registry UMIN000038626; https://tinyurl.com/2p9dtxzh International Registered Report Identifier (IRRID): DERR1-10.2196/33776 %M 34787573 %R 10.2196/33776 %U https://www.researchprotocols.org/2022/1/e33776 %U https://doi.org/10.2196/33776 %U http://www.ncbi.nlm.nih.gov/pubmed/34787573 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 1 %P e31989 %T A Remote Health Coaching, Text-Based Walking Program in Ethnic Minority Primary Care Patients With Overweight and Obesity: Feasibility and Acceptability Pilot Study %A Smart,Mary H %A Nabulsi,Nadia A %A Gerber,Ben S %A Gupta,Itika %A Di Eugenio,Barbara %A Ziebart,Brian %A Sharp,Lisa K %+ Department of Pharmacy Systems, Outcomes and Policy, College of Pharmacy, University of Illinois Chicago, 833 South Wood St, Chicago, IL, 60612, United States, 1 312 355 3569, sharpl@uic.edu %K mHealth %K Fitbit %K SMART goals %K texting %K health coach %K mobile phone %D 2022 %7 19.1.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: Over half of US adults have at least one chronic disease, including obesity. Although physical activity is an important component of chronic disease self-management, few reach the recommended physical activity goals. Individuals who identify as racial and ethnic minorities are disproportionally affected by chronic diseases and physical inactivity. Interventions using consumer-based wearable devices have shown promise for increasing physical activity among patients with chronic diseases; however, populations with the most to gain, such as minorities, have been poorly represented to date. Objective: This study aims to assess the feasibility, acceptability, and preliminary outcomes of an 8-week text-based coaching and Fitbit program aimed at increasing the number of steps in a predominantly overweight ethnic minority population. Methods: Overweight patients (BMI >25 kg/m2) were recruited from an internal medicine clinic located in an inner-city academic medical center. Fitbit devices were provided. Using 2-way SMS text messaging, health coaches (HCs) guided patients to establish weekly step goals that were specific, measurable, attainable, realistic, and time-bound. SMS text messaging and Fitbit activities were managed using a custom-designed app. Program feasibility was assessed via the recruitment rate, retention rate (the proportion of eligible participants completing the 8-week program), and patient engagement (based on the number of weekly text message goals set with the HC across the 8-week period). Acceptability was assessed using a qualitative, summative evaluation. Exploratory statistical analysis included evaluating the average weekly steps in week 1 compared with week 8 using a paired t test (2-tailed) and modeling daily steps over time using a linear mixed model. Results: Of the 33 patients initially screened; 30 (91%) patients were enrolled in the study. At baseline, the average BMI was 39.3 (SD 9.3) kg/m2, with 70% (23/33) of participants presenting as obese. A total of 30% (9/30) of participants self-rated their health as either fair or poor, and 73% (22/30) of participants set up ≥6 weekly goals across the 8-week program. In total, 93% (28/30) of participants completed a qualitative summative evaluation, and 10 themes emerged from the evaluation: patient motivation, convenient SMS text messaging experience, social support, supportive accountability, technology support, self-determined goals, achievable goals, feedback from Fitbit, challenges, and habit formation. There was no significant group change in the average weekly steps for week 1 compared with week 8 (mean difference 7.26, SD 6209.3; P=.99). However, 17% (5/30) of participants showed a significant increase in their daily steps. Conclusions: Overall, the results demonstrate the feasibility and acceptability of a remotely delivered walking study that included an HC; SMS text messaging; a wearable device (Fitbit); and specific, measurable, attainable, realistic, and time-bound goals within an ethnic minority patient population. Results support further development and testing in larger samples to explore efficacy. %M 35044308 %R 10.2196/31989 %U https://formative.jmir.org/2022/1/e31989 %U https://doi.org/10.2196/31989 %U http://www.ncbi.nlm.nih.gov/pubmed/35044308 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 11 %N 1 %P e34573 %T Digital Biomarkers for Supporting Transitional Care Decisions: Protocol for a Transnational Feasibility Study %A Petsani,Despoina %A Ahmed,Sara %A Petronikolou,Vasileia %A Kehayia,Eva %A Alastalo,Mika %A Santonen,Teemu %A Merino-Barbancho,Beatriz %A Cea,Gloria %A Segkouli,Sofia %A Stavropoulos,Thanos G %A Billis,Antonis %A Doumas,Michael %A Almeida,Rosa %A Nagy,Enikő %A Broeckx,Leen %A Bamidis,Panagiotis %A Konstantinidis,Evdokimos %+ Medical Physics and Digital Innovation Laboratory, School of Medicine, Aristotle University of Thessaloniki, University Campus, Thessaloniki, 54124, Greece, 30 6986177524, despoinapets@gmail.com %K Living Lab %K cocreation %K transitional care %K technology %K feasibility study %D 2022 %7 19.1.2022 %9 Protocol %J JMIR Res Protoc %G English %X Background: Virtual Health and Wellbeing Living Lab Infrastructure is a Horizon 2020 project that aims to harmonize Living Lab procedures and facilitate access to European health and well-being research infrastructures. In this context, this study presents a joint research activity that will be conducted within Virtual Health and Wellbeing Living Lab Infrastructure in the transitional care domain to test and validate the harmonized Living Lab procedures and infrastructures. The collection of data from various sources (information and communications technology and clinical and patient-reported outcome measures) demonstrated the capacity to assess risk and support decisions during care transitions, but there is no harmonized way of combining this information. Objective: This study primarily aims to evaluate the feasibility and benefit of collecting multichannel data across Living Labs on the topic of transitional care and to harmonize data processes and collection. In addition, the authors aim to investigate the collection and use of digital biomarkers and explore initial patterns in the data that demonstrate the potential to predict transition outcomes, such as readmissions and adverse events. Methods: The current research protocol presents a multicenter, prospective, observational cohort study that will consist of three phases, running consecutively in multiple sites: a cocreation phase, a testing and simulation phase, and a transnational pilot phase. The cocreation phase aims to build a common understanding among different sites, investigate the differences in hospitalization discharge management among countries, and the willingness of different stakeholders to use technological solutions in the transitional care process. The testing and simulation phase aims to explore ways of integrating observation of a patient’s clinical condition, patient involvement, and discharge education in transitional care. The objective of the simulation phase is to evaluate the feasibility and the barriers faced by health care professionals in assessing transition readiness. Results: The cocreation phase will be completed by April 2022. The testing and simulation phase will begin in September 2022 and will partially overlap with the deployment of the transnational pilot phase that will start in the same month. The data collection of the transnational pilots will be finalized by the end of June 2023. Data processing is expected to be completed by March 2024. The results will consist of guidelines and implementation pathways for large-scale studies and an analysis for identifying initial patterns in the acquired data. Conclusions: The knowledge acquired through this research will lead to harmonized procedures and data collection for Living Labs that support transitions in care. International Registered Report Identifier (IRRID): PRR1-10.2196/34573 %M 35044303 %R 10.2196/34573 %U https://www.researchprotocols.org/2022/1/e34573 %U https://doi.org/10.2196/34573 %U http://www.ncbi.nlm.nih.gov/pubmed/35044303 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 6 %N 1 %P e32627 %T Expert-Moderated Peer-to-Peer Online Support Group for People With Knee Osteoarthritis: Mixed Methods Randomized Controlled Pilot and Feasibility Study %A Egerton,Thorlene %A Lawford,Belinda J %A Campbell,Penny K %A Plinsinga,Melanie L %A Spiers,Libby %A Mackenzie,David A %A Graham,Bridget %A Mills,Kathryn %A Eyles,Jillian %A Knox,Gabrielle %A Metcalf,Ben %A Maclachlan,Liam R %A Besomi,Manuela %A Dickson,Chris %A Abraham,Charles %A Vicenzino,Bill %A Hodges,Paul W %A Hunter,David J %A Bennell,Kim L %+ Centre for Health, Exercise & Sports Medicine, The University of Melbourne, Level 7, Alan Gilbert Building, Melbourne, VIC 3010, Australia, 61 3 83441233, thorlene.egerton@unimelb.edu.au %K support group %K online support group %K knee %K osteoarthritis %K arthritis %K online forums %K patient education %K self-efficacy %K health literacy %K self-management %K qualitative %D 2022 %7 17.1.2022 %9 Original Paper %J JMIR Form Res %G English %X Background: Osteoarthritis (OA) is a major problem globally. First-line management comprises education and self-management strategies. Online support groups may be a low-cost method of facilitating self-management. Objective: The aim of this randomized controlled pilot study is to evaluate the feasibility of the study design and implementation of an evidence-informed, expert-moderated, peer-to-peer online support group (My Knee Community) for people with knee OA. The impacts on psychological determinants of self-management, selected self-management behaviors, and health outcomes were secondary investigations. Methods: This mixed methods study evaluated study feasibility (participant recruitment, retention, and costs), experimental intervention feasibility (acceptability and fidelity to the proposed design, including perceived benefit, satisfaction, and member engagement), psychological determinants (eg, self-efficacy and social support), behavioral measures, health outcomes, and harms. Of a total of 186, 63 (33.9%) participants (41/63, 65% experimental and 22/63, 35% control) with self-reported knee OA were recruited from 186 volunteers. Experimental group participants were provided membership to My Knee Community, which already had existing nonstudy members, and were recommended a web-based education resource (My Joint Pain). The control group received the My Joint Pain website recommendation only. Participants were not blinded to their group allocation or the study interventions. Participant-reported data were collected remotely using web-based questionnaires. A total of 10 experimental group participants also participated in semistructured interviews. The transcribed interview data and all forum posts by the study participants were thematically analyzed. Results: Study feasibility was supported by acceptable levels of retention; however, there were low levels of engagement with the support group by participants: 15% (6/41) of participants did not log in at all; the median number of times visited was 4 times per participant; only 29% (12/41) of participants posted, and there were relatively low levels of activity overall on the forum. This affected the results for satisfaction (overall mean 5.9/10, SD 2.7) and perceived benefit (17/31, 55%: yes). There were no differences among groups for quantitative outcomes. The themes discussed in the interviews were connections and support, information and advice, and barriers and facilitators. Qualitative data suggest that there is potential for people to derive benefit from connecting with others with knee OA by receiving support and assisting with unmet informational needs. Conclusions: Although a large-scale study is feasible, the intervention implementation was considered unsatisfactory because of low levels of activity and engagement by members. We recommend that expectations about the support group need to be made clear from the outset. Additionally, the platform design needs to be more engaging and rewarding, and membership should only be offered to people willing to share their personal stories and who are interested in learning from the experiences of others. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12619001230145; http://anzctr.org.au/Trial/Registration/TrialReview.aspx?id=377958 %M 35037880 %R 10.2196/32627 %U https://formative.jmir.org/2022/1/e32627 %U https://doi.org/10.2196/32627 %U http://www.ncbi.nlm.nih.gov/pubmed/35037880 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 1 %P e29559 %T Web-Based Problem-solving Training With and Without Peer Support in Veterans With Unmet Mental Health Needs: Pilot Study of Feasibility, User Acceptability, and Participant Engagement %A Possemato,Kyle %A Wu,Justina %A Greene,Carolyn %A MacQueen,Rex %A Blonigen,Daniel %A Wade,Michael %A Owen,Jason %A Keane,Terence %A Brief,Deborah %A Lindley,Steven %A Prins,Annabel %A Mackintosh,Margaret-Anne %A Carlson,Eve %+ National Center for Post Traumatic Stress Disorder, Veterans Affairs Palo Alto Health Care System, 3801 Miranda Avenue, Palo Alto, CA, 94304, United States, 1 6507143064, eve.carlson@va.gov %K problem-solving training %K mHealth %K peer specialists %K veterans %D 2022 %7 13.1.2022 %9 Original Paper %J J Med Internet Res %G English %X Background: eHealth tools have the potential to meet the mental health needs of individuals who experience barriers to accessing in-person treatment. However, most users have less than optimal engagement with eHealth tools. Coaching from peer specialists may increase their engagement with eHealth. Objective: This pilot study aims to test the feasibility and acceptability of a novel, completely automated web-based system to recruit, screen, enroll, assess, randomize, and then deliver an intervention to a national sample of military veterans with unmet mental health needs; investigate whether phone-based peer support increases the use of web-based problem-solving training compared with self-directed use; and generate hypotheses about potential mechanisms of action for problem-solving and peer support for future full-scale research. Methods: Veterans (N=81) with unmet mental health needs were recruited via social media advertising and enrolled and randomized to the self-directed use of a web-based problem-solving training called Moving Forward (28/81, 35%), peer-supported Moving Forward (27/81, 33%), or waitlist control (26/81, 32%). The objective use of Moving Forward was measured with the number of log-ins. Participants completed pre- and poststudy measures of mental health symptoms and problem-solving confidence. Satisfaction was also assessed post treatment. Results: Automated recruitment, enrollment, and initial assessment methods were feasible and resulted in a diverse sample of veterans with unmet mental health needs from 38 states. Automated follow-up methods resulted in 46% (37/81) of participants completing follow-up assessments. Peer support was delivered with high fidelity and was associated with favorable participant satisfaction. Participants randomized to receive peer support had significantly more Moving Forward log-ins than those of self-directed Moving Forward participants, and those who received peer support had a greater decrease in depression. Problem-solving confidence was associated with greater Moving Forward use and improvements in mental health symptoms among participants both with and without peer support. Conclusions: Enrolling and assessing individuals in eHealth studies without human contact is feasible; however, different methods or designs are necessary to achieve acceptable participant engagement and follow-up rates. Peer support shows potential for increasing engagement in web-based interventions and reducing symptoms. Future research should investigate when and for whom peer support for eHealth is helpful. Problem-solving confidence should be further investigated as a mechanism of action for web-based problem-solving training. Trial Registration: ClinicalTrials.gov NCT03555435; http://clinicaltrials.gov/ct2/show/NCT03555435 %M 35023846 %R 10.2196/29559 %U https://www.jmir.org/2022/1/e29559 %U https://doi.org/10.2196/29559 %U http://www.ncbi.nlm.nih.gov/pubmed/35023846 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 11 %N 1 %P e32550 %T A Text Messaging–Enhanced Intervention for African American Patients With Heart Failure, Depression, and Anxiety (TXT COPE-HF): Protocol for a Pilot Feasibility Study %A Cornelius,Judith %A Whitaker-Brown,Charlene %A Smoot,Jaleesa %A Hart,Sonia %A Lewis,Zandria %A Smith,Olivia %+ School of Nursing, University of North Carolina at Charlotte, 9201 University City Blvd, Charlotte, NC, 28223, United States, 1 7046877978, jbcornel@uncc.edu %K African American %K heart failure %K depression %K anxiety %K assessment %K decision %K administration %K production %K topical expert %K integration %K training and testing model %K text messaging %K SMS %K minorities %K behavior therapy %D 2022 %7 7.1.2022 %9 Protocol %J JMIR Res Protoc %G English %X Background: African Americans have a higher incidence rate of heart failure (HF) and an earlier age of HF onset compared to those of other racial and ethnic groups. Scientific literature suggests that by 2030, African Americans will have a 30% increased prevalence rate of HF coupled with depression. In addition to depression, anxiety is a predictor of worsening functional capacity, decreased quality of life, and increased hospital readmission rates. There is no consensus on the best way to treat patients with HF, depression, and anxiety. One promising type of treatment—cognitive behavioral therapy (CBT)—has been shown to significantly improve patients’ quality of life and treatment compliance, but CBT has not been used with SMS text messaging reminders to enhance the effect of reducing symptoms of depression and anxiety in racial and ethnic minority patients with HF. Objective: The objectives of our study are to (1) adapt and modify the Creating Opportunities for Personal Empowerment (COPE) curriculum for delivery to patients with HF by using an SMS text messaging component to improve depression and anxiety symptoms, (2) administer the adapted intervention to 10 patients to examine the feasibility and acceptability of the approach and modify it as needed, and (3) examine trends in depression and anxiety symptoms postintervention. We hypothesize that patients will show an improvement in depression scores and anxiety symptoms postintervention. Methods: The study will comprise a mixed methods approach. We will use the eight steps of the ADAPT-ITT (assessment, decision, administration, production, topical expert, integration, training, and testing) model to adapt the intervention. The first step in this feasibility study will involve assembling individuals from the target population (n=10) to discuss questions on a specific topic. In phase 2, we will examine the feasibility and acceptability of the enhanced SMS text messaging intervention (TXT COPE-HF [Texting With COPE for Patients With HF]) and its preliminary effects with 10 participants. The Beck Depression Inventory will be used to assess depression, the State-Trait Anxiety Inventory will be used to assess anxiety, and the Healthy Beliefs and Lifestyle Behavior surveys will be used to assess participants’ lifestyle beliefs and behavior changes. Changes will be compared from baseline to end point by using paired 2-tailed t tests. An exit focus group (n=10) will be held to examine facilitators and barriers to the SMS text messaging protocol. Results: The pilot feasibility study was funded by the Academy for Clinical Research and Scholarship. Institutional review board approval was obtained in April 2021. Data collection and analysis are expected to conclude by November 2021 and April 2022, respectively. Conclusions: The study results will add to the literature on the effectiveness of an SMS text messaging CBT-enhanced intervention in reducing depression and anxiety among African American patients with HF. International Registered Report Identifier (IRRID): PRR1-10.2196/32550 %M 34994709 %R 10.2196/32550 %U https://www.researchprotocols.org/2022/1/e32550 %U https://doi.org/10.2196/32550 %U http://www.ncbi.nlm.nih.gov/pubmed/34994709 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 12 %P e31545 %T The Use of Multimode Data Collection in Random Digit Dialing Cell Phone Surveys for Young Adults: Feasibility Study %A Gundersen,Daniel Alexander %A Wivagg,Jonathan %A Young,William J %A Yan,Ting %A Delnevo,Cristine D %+ Survey and Qualitative Methods Core, Division of Population Sciences, Dana-Farber Cancer Institute, 450 Brookline Avenue, LW 686, Boston, MA, 02215, United States, 1 6176325827, DanielA_Gundersen@dfci.harvard.edu %K web mode %K web survey %K random digit dialing %K mixed mode surveys %K survey methodology %K data capture %K research methods %K recruitment %K survey %K feasibility %K smoking %D 2021 %7 20.12.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: Young adults’ early adoption of new cell phone technologies have created challenges to survey recruitment but offer opportunities to combine random digit dialing (RDD) sampling with web mode data collection. The National Young Adult Health Survey was designed to test the feasibility of this methodology. Objective: In this study, we compared response rates across the telephone mode and web mode, assessed sample representativeness, examined design effects (DEFFs), and compared cigarette smoking prevalence to a gold standard national survey. Methods: We conducted a survey experiment where the sampling frame was randomized to single-mode telephone interviews, telephone-to-web sequential mixed mode, and single-mode web survey. A total of 831 respondents aged 18 to 34 years were recruited via RDD at baseline. A soft launch was conducted prior to main launch. We compared the web mode to the telephone modes (ie, single-mode and mixed mode) at wave 1 based on the American Association for Public Opinion Research response rate 3 for screening and extended surveys. Base-weighted demographic distributions were compared to the American Community Survey. The sample was calibrated to the US Census Bureau's American Community Survey to calculate DEFFs and to compare cigarette smoking prevalence to the National Health Interview Survey. Prevalence estimates are estimated with sampling weights and are presented with unweighted sample sizes. Consistency of estimates was judged by 95% CI. Results: The American Association for Public Opinion Research response rate 3 was higher in the telephone mode than in the web mode (24% and 30% vs 6.1% and 12.5%, for soft launch and main launch, respectively), which was reflected in response rate 3 for screening and extended surveys. During the soft launch, the extended survey and eligibility rate were low for respondents pushed to the web mode. To boost productivity and survey completes for the web condition, the main launch used cell phone numbers from the sampling frame where the sample vendor matched the number to auxiliary data, which suggested that the number likely belonged to an adult in the target age range. This increased the eligibility rate, but the screener response rate was lower. Compared to population distribution from the US Census Bureau, the telephone mode overrepresented men (57.1% [unweighted n=412] vs 50.9%) and those enrolled in college (40.3% [unweighted n=269] vs 23.8%); it also underrepresented those with a Bachelor of Arts or Science (34.4% [unweighted n=239] vs 55%). The web mode overrepresented White, non-Latinos (70.7% [unweighted n=90] vs 54.4%) and those with some college education (30.4% [unweighted n=40] vs 7.6%); it also underrepresented Latinos (13.6% [unweighted n=20] vs 20.7%) and those with a high school or General Education Development diploma (15.3% [unweighted n=20] vs 29.3%). The DEFF measure was 1.28 (subpopulation range 0.96-1.93). The National Young Adult Health Survey cigarette smoking prevalence was consistent with the National Health Interview Survey overall (15%, CI 12.4%-18% [unweighted 149/831] vs 13.5%, CI 12.3%-14.7% [unweighted 823/5552]), with notable deviation among 18- to 24-year-olds (15.6%, CI 11.3%-22.2% [unweighted 51/337] vs 8.7%, CI 7.1%-10.6% [unweighted 167/1647]), and those with education levels lower than Bachelor of Arts or Science (24%, CI 19.3%-29.4% [unweighted 123/524] vs 17.1%, CI 15.6%-18.7% [unweighted 690/3493]). Conclusions: RDD sampling for a web survey is not feasible for young adults due to its low response rate. However, combining this methodology with RDD telephone surveys may have a great potential for including media and collecting autophotographic data in population surveys. %M 34932017 %R 10.2196/31545 %U https://www.jmir.org/2021/12/e31545 %U https://doi.org/10.2196/31545 %U http://www.ncbi.nlm.nih.gov/pubmed/34932017 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 12 %P e31541 %T Validation of a Musculoskeletal Digital Assessment Routing Tool: Protocol for a Pilot Randomized Crossover Noninferiority Trial %A Lowe,Cabella %A Hanuman Sing,Harry %A Marsh,William %A Morrissey,Dylan %+ Centre for Sports & Exercise Medicine, William Harvey Research Institute, Queen Mary University of London, Mile End Hospital, Bancroft Road, London, E1 4DG, United Kingdom, 44 07976315105, c.lowe@qmul.ac.uk %K mHealth %K mobile health %K eHealth %K digital health %K digital technology %K musculoskeletal %K triage %K physiotherapy triage %K validation %K mobile phone %D 2021 %7 13.12.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: Musculoskeletal conditions account for 16% of global disability, resulting in a negative effect on millions of patients and an increasing demand for health care use. Digital technologies to improve health care outcomes and efficiency are considered a priority; however, innovations are rarely tested with sufficient rigor in clinical trials, which is the gold standard for clinical proof of safety and efficacy. We have developed a new musculoskeletal digital assessment routing tool (DART) that allows users to self-assess and be directed to the right care. DART requires validation in a real-world setting before implementation. Objective: This pilot study aims to assess the feasibility of a future trial by exploring the key aspects of trial methodology, assessing the procedures, and collecting exploratory data to inform the design of a definitive randomized crossover noninferiority trial to assess DART safety and effectiveness. Methods: We will collect data from 76 adults with a musculoskeletal condition presenting to general practitioners within a National Health Service (NHS) in England. Participants will complete both a DART assessment and a physiotherapist-led triage, with the order determined by randomization. The primary analysis will involve an absolute agreement intraclass correlation (A,1) estimate with 95% CI between DART and the clinician for assessment outcomes signposting to condition management pathways. Data will be collected to allow the analysis of participant recruitment and retention, randomization, allocation concealment, blinding, data collection process, and bias. In addition, the impact of trial burden and potential barriers to intervention delivery will be considered. The DART user satisfaction will be measured using the system usability scale. Results: A UK NHS ethics submission was done during June 2021 and is pending approval; recruitment will commence in early 2022, with data collection anticipated to last for 3 months. The results will be reported in a follow-up paper in 2022. Conclusions: This study will inform the design of a randomized controlled crossover noninferiority study that will provide evidence concerning mobile health DART system clinical signposting in an NHS setting before real-world implementation. Success should produce evidence of a safe, effective system with good usability, potentially facilitating quicker and easier patient access to appropriate care while reducing the burden on primary and secondary care musculoskeletal services. This rigorous approach to mobile health system testing could be used as a guide for other developers of similar applications. Trial Registration: ClinicalTrials.gov NCT04904029; http://clinicaltrials.gov/ct2/show/NCT04904029 International Registered Report Identifier (IRRID): PRR1-10.2196/31541 %M 34898461 %R 10.2196/31541 %U https://www.researchprotocols.org/2021/12/e31541 %U https://doi.org/10.2196/31541 %U http://www.ncbi.nlm.nih.gov/pubmed/34898461 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 12 %P e28307 %T Conjugation of Silver Nanoparticles With De Novo–Engineered Cationic Antimicrobial Peptides: Exploratory Proposal %A Hu,Alvin %+ Internal Medicine Residency, Indiana University Health Ball Memorial Hospital, 2401 W University Ave, Muncie, IN, 47303, United States, 1 4087754272, alvin863h@gmail.com %K antimicrobial peptides %K silver nanoparticles %K ESKAPE pathogens %K research proposal %D 2021 %7 8.12.2021 %9 Proposal %J JMIR Res Protoc %G English %X Background: Cationic antimicrobial peptides have broad antimicrobial activity and provide a novel way of targeting multidrug-resistant bacteria in the era of increasing antimicrobial resistance. Current developments show positive prospects for antimicrobial peptides and silver nanoparticles (AgNPs) individually. Objective: The primary objective is to propose another method for enhancing antimicrobial activity by conjugating AgNPs with cationic antimicrobial peptides, with a subsequent preliminary assessment of the minimum inhibitory concentration of multidrug-resistant bacteria. The secondary objective is to evaluate the safety of the conjugated compound and assess its viability for in vivo use. Methods: The proposal involves 3 stages. First, WLBU2C, a modified version of the antimicrobial peptide WLBU2 with an added cysteine group, needs to be synthesized using a standard Fmoc procedure. It can then be stably conjugated with AgNPs ideally through photochemical means. Second, the WLBU2C-AgNP conjugate should be tested for antimicrobial activity according to the Clinical & Laboratory Standards Institute manual on standard minimum inhibitory concentration testing. Third, the cytotoxicity of the conjugate should be tested using cell lysis assays if the above stages are completed. Results: I-TASSER (iterative threading assembly refinement) simulation revealed that the modified peptide WLBU2C has a secondary structure similar to that of the original WLBU2 peptide. No other results have been obtained at this time. Conclusions: The addition of AgNPs to already developed de novo–engineered antimicrobial peptides provides an opportunity for the development of potent antimicrobials. Future prospects include emergency last-line therapy and treatment for current difficult-to-eradicate bacterial colonization, such as in cystic fibrosis, implantable medical devices, cancer, and immunotherapy. As I do not anticipate funding at this time, I hope this proposal provides inspiration to other researchers. International Registered Report Identifier (IRRID): PRR1-10.2196/28307 %M 34780345 %R 10.2196/28307 %U https://www.researchprotocols.org/2021/12/e28307 %U https://doi.org/10.2196/28307 %U http://www.ncbi.nlm.nih.gov/pubmed/34780345 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 5 %N 12 %P e27956 %T Conversational Agent for Healthy Lifestyle Behavior Change: Web-Based Feasibility Study %A Dhinagaran,Dhakshenya Ardhithy %A Sathish,Thirunavukkarasu %A Soong,AiJia %A Theng,Yin-Leng %A Best,James %A Tudor Car,Lorainne %+ Lee Kong Chian School of Medicine, Nanyang Technological University, Singapore, Clinical Sciences Building, 11 Mandalay Road, Singapore, 308232, Singapore, 65 69041258, lorainne.tudor.car@ntu.edu.sg %K chatbot %K conversational agents %K behavior change %K healthy lifestyle behavior change %K pilot study %K feasibility trial %K usability %K acceptability %K preliminary efficacy %K mobile phone %D 2021 %7 3.12.2021 %9 Original Paper %J JMIR Form Res %G English %X Background: The rising incidence of chronic diseases is a growing concern, especially in Singapore, which is one of the high-income countries with the highest prevalence of diabetes. Interventions that promote healthy lifestyle behavior changes have been proven to be effective in reducing the progression of prediabetes to diabetes, but their in-person delivery may not be feasible on a large scale. Novel technologies such as conversational agents are a potential alternative for delivering behavioral interventions that promote healthy lifestyle behavior changes to the public. Objective: The aim of this study is to assess the feasibility and acceptability of using a conversational agent promoting healthy lifestyle behavior changes in the general population in Singapore. Methods: We performed a web-based, single-arm feasibility study. The participants were recruited through Facebook over 4 weeks. The Facebook Messenger conversational agent was used to deliver the intervention. The conversations focused on diet, exercise, sleep, and stress and aimed to promote healthy lifestyle behavior changes and improve the participants’ knowledge of diabetes. Messages were sent to the participants four times a week (once for each of the 4 topics of focus) for 4 weeks. We assessed the feasibility of recruitment, defined as at least 75% (150/200) of our target sample of 200 participants in 4 weeks, as well as retention, defined as 33% (66/200) of the recruited sample completing the study. We also assessed the participants’ satisfaction with, and usability of, the conversational agent. In addition, we performed baseline and follow-up assessments of quality of life, diabetes knowledge and risk perception, diet, exercise, sleep, and stress. Results: We recruited 37.5% (75/200) of the target sample size in 1 month. Of the 75 eligible participants, 60 (80%) provided digital informed consent and completed baseline assessments. Of these 60 participants, 56 (93%) followed the study through till completion. Retention was high at 93% (56/60), along with engagement, denoted by 50% (30/60) of the participants communicating with the conversational agent at each interaction. Acceptability, usability, and satisfaction were generally high. Preliminary efficacy of the intervention showed no definitive improvements in health-related behavior. Conclusions: The delivery of a conversational agent for healthy lifestyle behavior change through Facebook Messenger was feasible and acceptable. We were unable to recruit our planned sample solely using the free options in Facebook. However, participant retention and conversational agent engagement rates were high. Our findings provide important insights to inform the design of a future randomized controlled trial. %M 34870611 %R 10.2196/27956 %U https://formative.jmir.org/2021/12/e27956 %U https://doi.org/10.2196/27956 %U http://www.ncbi.nlm.nih.gov/pubmed/34870611 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 5 %N 12 %P e24840 %T Development of a Web-Based School Support System Within the AVATAR Project for Psychosocial Well-being in Adolescents: Pilot Feasibility Study %A Mastorci,Francesca %A Piaggi,Paolo %A Trivellini,Gabriele %A Doveri,Cristina %A Casu,Anselmo %A Bastiani,Luca %A Marinaro,Irene %A Vassalle,Cristina %A Pingitore,Alessandro %+ Clinical Physiology Institute, Consiglio Nazionale delle Ricerche Area della Ricerca di Pisa (CNR), Via Moruzzi 1, Pisa, 56124, Italy, 39 050312605, pingi@ifc.cnr.it %K adolescent %K well-being management %K schools %K web tool %K health promotion %D 2021 %7 2.12.2021 %9 Original Paper %J JMIR Form Res %G English %X Background: Health and well-being promotions are key points of educational programs for adolescents within schools. There are several health education programs mainly based on lifestyle habit changes; however, social and emotional dimensions should be considered within these educational strategies. Objective: This study aimed to (1) develop a new web-based school support system to assess and analyze individual, classroom, and scholastic institute data on lifestyle habits, social context, emotional status, and scholastic performance; (2) create a web tool for managing the well-being of adolescents through a dynamic and personalized interface that provides immediate feedback that allows the school to monitor progress; and (3) evaluate, in a pilot study, the feasibility of this web-based school support system in order to build health programs that are specific to the needs of the studied population. Methods: The AVATAR (a new purpose for the promotion and evaluation of health and well-being among healthy teenagers) method consists of integrating the information coming from different questionnaires. In particular, to allow planning didactic and educational actions based on the results obtained, the AVATAR approach allows subdivision of the results of the different observed variables and the 4 components into the following 3 percentile categories: modify, improve, and maintain. The AVATAR web platform was designed to collect data on lifestyle, emotional status, and social context from junior high schools in terms of the fundamental aspects of adolescent daily life, with free use by the scholastic community (scholars, teachers, and parents). In this pilot/feasibility study, data from 331 students were acquired between 2018 and 2019 at the beginning of the scholastic year (pre) and at the end following the school-based program (post). Results: Preliminary results showed that after school planning and specific program implementation, defined after AVATAR feedback, students reported better well-being perception characterized by higher perception in psychological well-being (P=.001), mood (P=.001), self-perception (P=.006), and autonomy (P=.001), and an increase in the perception of financial resources (P=.001), which helped in developing healthy lifestyle habits (P=.007). In the social context assessment, students reported stronger relationships with family (P=.02) and peers (P=.001), and a lower perception of bullying (P=.001). Conclusions: The AVATAR web-based platform is a feasible and flexible tool for the health and well-being management of adolescents from epidemiological, preventive, and educational points of view. In particular, it can be used to (1) promote information campaigns aimed at modifying risk behaviors in the student population, (2) sensitize students and put them at the center of their growth path, (3) inform institutions about the health and well-being of the school population, (4) ensure health programs are acceptable and feasible to users before launching on a large scale, and (5) improve the relationship of users (school) and educational agencies with research groups. %M 34860668 %R 10.2196/24840 %U https://formative.jmir.org/2021/12/e24840 %U https://doi.org/10.2196/24840 %U http://www.ncbi.nlm.nih.gov/pubmed/34860668 %0 Journal Article %@ 2561-7605 %I JMIR Publications %V 4 %N 4 %P e28652 %T An App-Based Mindfulness-Based Self-compassion Program to Support Caregivers of People With Dementia: Participatory Feasibility Study %A Goodridge,Donna %A Reis,Nathan %A Neiser,Jenna %A Haubrich,Tim %A Westberg,Bev %A Erickson-Lumb,Laura %A Storozinski,Jo %A Gonzales,Cesar %A Michael,Joanne %A Cammer,Allison %A Osgood,Nathaniel %+ Department of Medicine, University of Saskatchewan, Room E1216, Health Sciences Building, 107 Wiggins Road, Saskatoon, SK, S7N 2Z4, Canada, 1 3069664209, donna.goodridge@usask.ca %K virtual support programs %K caregivers %K dementia %K mindfulness %K self-compassion %K mobile health %K mobile applications %K elderly %K older adults %K usability %K feasibility %K smartphone app %K mobile phone %D 2021 %7 26.11.2021 %9 Original Paper %J JMIR Aging %G English %X Background: The number of persons with dementia is steadily growing, as is the number of individuals supporting persons with dementia. Primary caregivers of persons with dementia are most often family members or spouses of the persons with dementia, and they are more likely to experience increased stress and other negative effects than individuals who are not primary caregivers. Although in-person support groups have been shown to help buffer the negative impacts of caregiving, some caregivers live in isolated or rural communities and are unable to make the burdensome commitment of traveling to cities. Using an interdisciplinary approach, we developed a mobile smartphone support app designed for primary caregivers of persons with dementia, with the goal of reducing caregiver burden and easing stress. The app features a 12-week intervention, largely rooted in mindfulness-based self-compassion (MBSC), because MBSC has been linked to minimizing stress, depression, and anxiety. Objective: The primary objectives of our program are twofold: to explore the feasibility of a 12-week mobile support program and to conduct an initial efficacy evaluation of changes in perceived caregiver burden, coping styles, and emotional well-being of caregivers before and after the program. Methods: Our feasibility study used a 2-phase participatory pretest and posttest design, focusing on acceptability, demand, practicality, implementation, and efficacy. At phase I, we recruited 57 primary caregivers of persons with dementia (mean age 76.3, SD 12.9 years), comprising spouses (21/57, 37%), children (21/57, 37%), and friends or relatives (15/57, 26%) of persons with dementia, of whom 29 (51%) completed all measures at both pre- and postprogram. The content of the program featured a series of MBSC podcasts. Our primary outcome measure was caregiver burden, with secondary outcome measures including coping styles and emotional well-being. Daily ecological momentary assessments enabled us to ask participants, “How are you feeling today?” Phase II of our study involved semistructured follow-up interviews with most participants (n=21) who completed phase I. Results: Our findings suggest that our app or program meets the feasibility criteria examined. Notably, participants generally accepted the program and believed it could be a useful resource. Emotional well-being increased significantly (P=.04), and emotion-based coping significantly decreased (P=.01). Participants generally considered the app or program to be a helpful resource. Conclusions: Although there were no significant changes in caregiver burden, we were encouraged by the increased emotional well-being of our participants following the completion of our program. We also conclude that our app or program demonstrated feasibility (ie, acceptability, practicality, implementation, and efficacy) and can provide a much-needed resource for primary caregivers of persons with dementia. In the subsequent version of the program, we will respond to participant feedback by incorporating web-based weekly sessions and incorporating an outcome measure of self-compassion. %M 34842530 %R 10.2196/28652 %U https://aging.jmir.org/2021/4/e28652 %U https://doi.org/10.2196/28652 %U http://www.ncbi.nlm.nih.gov/pubmed/34842530 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 8 %N 4 %P e26964 %T Clinician Preimplementation Perspectives of a Decision-Support Tool for the Prediction of Cardiac Arrhythmia Based on Machine Learning: Near-Live Feasibility and Qualitative Study %A Matthiesen,Stina %A Diederichsen,Søren Zöga %A Hansen,Mikkel Klitzing Hartmann %A Villumsen,Christina %A Lassen,Mats Christian Højbjerg %A Jacobsen,Peter Karl %A Risum,Niels %A Winkel,Bo Gregers %A Philbert,Berit T %A Svendsen,Jesper Hastrup %A Andersen,Tariq Osman %+ Department of Computer Science, Faculty of Science, University of Copenhagen, Universitetsparken 5, Copenhagen, 2100, Denmark, 45 21231008, matthiesen@di.ku.dk %K cardiac arrhythmia %K short-term prediction %K clinical decision support systems %K machine learning %K artificial intelligence %K preimplementation %K qualitative study %K implantable cardioverter defibrillator %K remote follow-up %K sociotechnical %D 2021 %7 26.11.2021 %9 Original Paper %J JMIR Hum Factors %G English %X Background: Artificial intelligence (AI), such as machine learning (ML), shows great promise for improving clinical decision-making in cardiac diseases by outperforming statistical-based models. However, few AI-based tools have been implemented in cardiology clinics because of the sociotechnical challenges during transitioning from algorithm development to real-world implementation. Objective: This study explored how an ML-based tool for predicting ventricular tachycardia and ventricular fibrillation (VT/VF) could support clinical decision-making in the remote monitoring of patients with an implantable cardioverter defibrillator (ICD). Methods: Seven experienced electrophysiologists participated in a near-live feasibility and qualitative study, which included walkthroughs of 5 blinded retrospective patient cases, use of the prediction tool, and questionnaires and interview questions. All sessions were video recorded, and sessions evaluating the prediction tool were transcribed verbatim. Data were analyzed through an inductive qualitative approach based on grounded theory. Results: The prediction tool was found to have potential for supporting decision-making in ICD remote monitoring by providing reassurance, increasing confidence, acting as a second opinion, reducing information search time, and enabling delegation of decisions to nurses and technicians. However, the prediction tool did not lead to changes in clinical action and was found less useful in cases where the quality of data was poor or when VT/VF predictions were found to be irrelevant for evaluating the patient. Conclusions: When transitioning from AI development to testing its feasibility for clinical implementation, we need to consider the following: expectations must be aligned with the intended use of AI; trust in the prediction tool is likely to emerge from real-world use; and AI accuracy is relational and dependent on available information and local workflows. Addressing the sociotechnical gap between the development and implementation of clinical decision-support tools based on ML in cardiac care is essential for succeeding with adoption. It is suggested to include clinical end-users, clinical contexts, and workflows throughout the overall iterative approach to design, development, and implementation. %M 34842528 %R 10.2196/26964 %U https://humanfactors.jmir.org/2021/4/e26964 %U https://doi.org/10.2196/26964 %U http://www.ncbi.nlm.nih.gov/pubmed/34842528 %0 Journal Article %@ 2291-9279 %I JMIR Publications %V 9 %N 4 %P e29330 %T Effects of an Immersive Virtual Reality Exergame on University Students’ Anxiety, Depression, and Perceived Stress: Pilot Feasibility and Usability Study %A Xu,Wenge %A Liang,Hai-Ning %A Baghaei,Nilufar %A Ma,Xiaoyue %A Yu,Kangyou %A Meng,Xuanru %A Wen,Shaoyue %+ Department of Computing, School of Advanced Technology, Xi'an Jiaotong-Liverpool University, 111 Renai Road, Suzhou Industrial Park, Suzhou, 215123, China, 86 51288161516, haining.liang@xjtlu.edu.cn %K university students %K depression %K anxiety %K stress %K immersive virtual reality %K exergame %D 2021 %7 22.11.2021 %9 Original Paper %J JMIR Serious Games %G English %X Background: In recent years, there has been an increase in the number of students with depression, anxiety, and perceived stress. A solution that has been increasingly used for improving health and well-being is exergaming. The effects and acceptability of exergames have been studied widely but mostly with older adults. The feasibility and usability of exergames among university students, especially those of immersive virtual reality (iVR) exergames, remain unexplored. Objective: This study aimed to explore the feasibility of a 6-week iVR exergame–based intervention in reducing anxiety, depression, and perceived stress among university students and to examine the usability and acceptability of such games. Methods: A total of 31 university students were recruited to participate in a 6-week study in which they needed to play a boxing-style iVR exergame called FitXR (FitXR Limited) twice per week (30 minutes per session). Their anxiety (Beck Anxiety Inventory), depression (Beck Depression Inventory-II), and perceived stress (Perceived Stress Scale) levels were measured before and after intervention. Results: A total of 15 participants completed the 6-week study. Our results suggested that participants’ mean depression scores decreased significantly from 8.33 (SD 5.98) to 5.40 (SD 5.14) after the intervention (P=.01). In addition, most participants (14/15, 93%) believed that the iVR exergame has good usability. Furthermore, most participants (14/15, 93%) were satisfied with the iVR gameplay experience and would play the iVR exergame again in the future. Of the 15 participants, 11 (73%) would recommend the iVR exergame to their friends. Conclusions: The results gained from this study show that the iVR exergame has good usability, is highly acceptable, and has the potential to reduce depression levels among university students. %M 34813487 %R 10.2196/29330 %U https://games.jmir.org/2021/4/e29330 %U https://doi.org/10.2196/29330 %U http://www.ncbi.nlm.nih.gov/pubmed/34813487 %0 Journal Article %@ 2561-7605 %I JMIR Publications %V 4 %N 4 %P e16824 %T Developing a Management Guide (the DemPower App) for Couples Where One Partner Has Dementia: Nonrandomized Feasibility Study %A Lasrado,Reena %A Bielsten,Therese %A Hann,Mark %A Schumm,James %A Reilly,Siobhan Theresa %A Davies,Linda %A Swarbrick,Caroline %A Dowlen,Robyn %A Keady,John %A Hellström,Ingrid %+ Social Care & Society, The University of Manchester, Oxford Road, Manchester, M13 9PL, United Kingdom, 44 1613067884, reena.lasrado@manchester.ac.uk %K dementia guide %K self-management for couples with dementia %K dementia self-help %K dementia app %K dementia resource %K feasibility study %K nonrandomized study %K dementia intervention %D 2021 %7 16.11.2021 %9 Original Paper %J JMIR Aging %G English %X Background: Promoting the health and well-being of couples where one partner has dementia is an overlooked area of care practice. Most postdiagnostic services currently lack a couple-centered approach and have a limited focus on the couple relationship. To help address this situation, we developed a tablet-based self-management guide (DemPower) focused on helping couples enhance their well-being and relationship quality. Objective: The aim of this study is to investigate the feasibility and acceptability of the DemPower app. Methods: A nonrandomized feasibility design was used to evaluate the DemPower intervention over 3 months among couples where a partner had a diagnosis of dementia. The study recruited 25 couples in the United Kingdom and 19 couples in Sweden. Outcome measures were obtained at baseline and postintervention. The study process and interventions were evaluated at various stages. Results: The study was completed by 48% (21/44) of couples where one partner had dementia, of whom 86% (18/21) of couples accessed all parts of the DemPower app. Each couple spent an average of 8 hours (SD 3.35 hours) using the app during the study period. In total, 90% (19/21) of couples reported that all sections of DemPower were useful in addressing various aspects of daily life and helped to focus on how they interacted in their relationship. Of the 4 core subjects on which the DemPower app was structured, home and neighborhood received the highest number of visits. Couples used activity sections more often than the core subject pages. The perception of DemPower’s utility varied with each couple’s lived experience of dementia, geographic location, relationship dynamics, and opportunities for social interaction. A 5.2-point increase in the dementia quality of life score for people with dementia and a marginal increase in the Mutuality scale (+1.23 points) for caregiver spouses were found. Design and navigational challenges were reported in the DemPower app. Conclusions: The findings suggest that the DemPower app is a useful resource for couples where one partner has dementia and that the implementation of the app requires the support of memory clinics to reach couples at early diagnosis. Trial Registration: ISRCTN Registry ISRCTN10122979; http://www.isrctn.com/ISRCTN10122979 %M 34783666 %R 10.2196/16824 %U https://aging.jmir.org/2021/4/e16824 %U https://doi.org/10.2196/16824 %U http://www.ncbi.nlm.nih.gov/pubmed/34783666 %0 Journal Article %@ 2291-9279 %I JMIR Publications %V 9 %N 4 %P e29044 %T Feasibility of a Sensor-Controlled Digital Game for Heart Failure Self-management: Randomized Controlled Trial %A Radhakrishnan,Kavita %A Julien,Christine %A Baranowski,Tom %A O'Hair,Matthew %A Lee,Grace %A Sagna De Main,Atami %A Allen,Catherine %A Viswanathan,Bindu %A Thomaz,Edison %A Kim,Miyong %+ School of Nursing, The University of Texas Austin, 1710 Red River St, Austin, TX, 78701, United States, 1 512 471 7936, Kradhakrishnan@mail.nur.utexas.edu %K heart failure %K digital game %K sensor %K self-management %K older adults %K weight monitoring %K physical activity %K behaviors %K mobile phone %D 2021 %7 8.11.2021 %9 Original Paper %J JMIR Serious Games %G English %X Background: Poor self-management of heart failure (HF) contributes to devastating health consequences. Our innovative sensor-controlled digital game (SCDG) integrates data from sensors to trigger game rewards, progress, and feedback based on the real-time behaviors of individuals with HF. Objective: The aim of this study is to compare daily weight monitoring and physical activity behavior adherence by older adults using an SCDG intervention versus a sensors-only intervention in a feasibility randomized controlled trial. Methods: English-speaking adults with HF aged 55 years or older who owned a smartphone and could walk unassisted were recruited from Texas and Oklahoma from November 2019 to August 2020. Both groups were given activity trackers and smart weighing scales to track behaviors for 12 weeks. The feasibility outcomes of recruitment, retention, intervention engagement, and satisfaction were assessed. In addition to daily weight monitoring and physical activity adherence, the participants’ knowledge, functional status, quality of life, self-reported HF behaviors, motivation to engage in behaviors, and HF-related hospitalization were also compared between the groups at baseline and at 6, 12, and 24 weeks. Results: A total of 38 participants with HF—intervention group (IG; 19/38, 50%) and control group (CG; 19/38, 50%)—were enrolled in the study. Of the 38 participants, 18 (47%) were women, 18 (47%) were aged 65 years or older, 21 (55%) had been hospitalized with HF in the past 6 months, and 29 (76%) were White. Furthermore, of these 38 participants, 31 (82%)—IG (15/19, 79%) and CG (16/19, 84%)—had both weight monitoring and physical activity data at the end of 12 weeks, and 27 (71%)—IG (14/19, 74%) and CG (13/19, 68%)—participated in follow-up assessments at 24 weeks. For the IG participants who installed the SCDG app (15/19, 79%), the number of days each player opened the game app was strongly associated with the number of days the player engaged in weight monitoring (r=0.72; P=.04) and the number of days with physical activity step data (r=0.9; P<.001). The IG participants who completed the satisfaction survey (13/19, 68%) reported that the SCDG was easy to use. Trends of improvement in daily weight monitoring and physical activity in the IG, as well as within-group improvements in HF functional status, quality of life, knowledge, self-efficacy, and HF hospitalization in both groups, were observed in this feasibility trial. Conclusions: Playing an SCDG on smartphones was feasible and acceptable for older adults with HF for motivating daily weight monitoring and physical activity. A larger efficacy trial of the SCDG intervention will be needed to validate trends of improvement in daily weight monitoring and physical activity behaviors. Trial Registration: ClinicalTrials.gov NCT03947983; https://clinicaltrials.gov/ct2/show/NCT03947983 %M 34747701 %R 10.2196/29044 %U https://games.jmir.org/2021/4/e29044 %U https://doi.org/10.2196/29044 %U http://www.ncbi.nlm.nih.gov/pubmed/34747701 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 11 %P e28322 %T A Digital Self-management Program (Help to Overcome Problems Effectively) for People Living With Cancer: Feasibility Randomized Controlled Trial %A Wright,Hayley %A Martin,Faith %A Clyne,Wendy %A Clark,Cain C T %A Matouskova,Gabriela %A McGillion,Michael %A Turner,Andrew %+ Centre for Intelligent Healthcare, Research Institute for Health and Wellbeing, Coventry University, Priory Street, Coventry, CV1 5FB, United Kingdom, 44 7599782465, hsx116@coventry.ac.uk %K self-management %K cancer %K survivorship %K digital %K positive psychology %D 2021 %7 5.11.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: We present the results of a feasibility, randomized waitlist control group (CG) parallel design study with a 1:1 allocation ratio. Participants were randomized into an intervention group (IG) or a waitlist CG. The intervention was a 6-week digital self-management program, Help to Overcome Problems Effectively (HOPE), for people with cancer. Objective: This study aims to test the feasibility of a digitally delivered self-management program for people with cancer. This will inform the design of a definitive randomized controlled trial. In addition, a preliminary assessment of the impact of the HOPE program via secondary outcomes will be used to assess signals of efficacy in a trial context. Methods: Participants were drawn from an opportunity sample, referred by Macmillan Cancer Support, and were invited via email to participate in the study (N=61). Primary outcomes were rates of recruitment, retention, follow-up, completion and adherence, sample size and effect size estimation, and assessment of progression criteria for a definitive trial. Secondary outcomes were self-report measures of participants’ positive mental well-being, depression, anxiety, and patient activation (ie, confidence in managing their cancer). The intervention and data collection took place on the web. Results: The recruitment rate was 77% (47/61). A total of 41 participants completed the baseline questionnaires and were randomized to either the IG (n=21) or the waitlist CG (n=20). The retention rate (attending all program sessions) was greater than 50% (all: 21/41, 51%, IG: 10/21, 48%; and CG: 11/20, 55%). The follow-up rate (completing all questionnaires) was greater than 80% (all: 33/41, 80%; IG: 16/21, 76%; and CG: 17/20, 85%). The completion rate (attending ≥3 sessions and completing all questionnaires) was greater than 60% (all: 25/41, 61%; IG: 13/21, 62%; and CG: 12/20, 60%). Engagement data showed that participants viewed between half (5.1/10, 51%) and three-quarters (12.2/16, 76%) of the pages in each session. Conclusions: All progression criteria for a definitive trial were met, as supported by the primary outcome data. The IG showed improved postprogram scores on measures of positive mental well-being, depression, anxiety, and patient activation. A full-scale trial of the digital HOPE program for people with cancer will allow us to fully evaluate the efficacy of the intervention relative to a CG. Trial Registration: ISRCTN Registry ISRCTN79623250; http://www.isrctn.com/ISRCTN79623250 International Registered Report Identifier (IRRID): RR2-10.2196/24264 %M 34738912 %R 10.2196/28322 %U https://www.jmir.org/2021/11/e28322 %U https://doi.org/10.2196/28322 %U http://www.ncbi.nlm.nih.gov/pubmed/34738912 %0 Journal Article %@ 2562-0959 %I JMIR Publications %V 4 %N 2 %P e25918 %T Supporting Self-management Among Young People With Acne Vulgaris Through a Web-Based Behavioral Intervention: Development and Feasibility Randomized Controlled Trial %A Ip,Athena %A Muller,Ingrid %A Geraghty,Adam W A %A Rumsby,Kate %A Stuart,Beth %A Little,Paul %A Santer,Miriam %+ Primary Care, Population Sciences and Medical Education, University of Southampton, Aldermoor Health Centre, Aldermoor Close, Southampton, SO16 5ST, United Kingdom, 44 (023) 8059 1779, a.ip@soton.ac.uk %K feasibility study %K acne vulgaris %K intervention study %K self-management %K primary care %K acne %K dermatology %D 2021 %7 3.11.2021 %9 Original Paper %J JMIR Dermatol %G English %X Background: Acne is a common skin condition that is most prevalent in young people. It can have a substantial impact on the quality of life, which can be minimized with the appropriate use of topical treatments. Nonadherence to topical treatments for acne is common and often leads to treatment failure. Objective: The aim of this study is to develop a web-based behavioral intervention to support the self-management of acne and to assess the feasibility of recruitment, retention, and engagement of users with the intervention. Methods: The intervention was developed iteratively using the LifeGuide software and following the person-based approach for intervention development. The target behavior was appropriate use of topical treatments. Barriers and facilitators identified from the qualitative research and evidence from the wider literature were used to identify techniques to improve and promote their use. Young people with acne aged 14-25 years who had received treatment for acne in the past 6 months were invited to participate through mail-out from primary care practices in the South of England in a parallel, unblinded randomized trial. Participants were automatically randomized using a computer-generated algorithm to usual care or to usual care plus access to the web-based intervention. Usage data was collected, and a series of questionnaires, including the primary outcome measure for skin-specific quality of life (Skindex-16), were collected at baseline and at the 4- and 6-week follow-ups. Results: A total of 1193 participants were invited, and 53 young people with acne were randomized to usual care (27/53, 51%) or usual care plus intervention (26/53, 49%). The response rate for the primary outcome measure (Skindex-16) was 87% at 4 weeks, 6 weeks, and at both time points. The estimate of mean scores between groups (with 95% CI) using linear regression showed a trend in the direction of benefit for the web-based intervention group in the primary outcome measure (Skindex-16) and secondary measures (Patient Health Questionnaire-4 and the Problematic Experiences of Therapy Scale). Intervention usage data showed high uptake of the core module in the usual care plus web-based intervention group, with 88% (23/26) of participants completing the module. Uptake of the optional modules was low, with less than half visiting each (myth-busting quiz: 27%; living with spots or acne: 42%; oral antibiotics: 19%; what are spots or acne: 27%; other treatments: 27%; talking to your general practitioner: 12%). Conclusions: This study demonstrated the feasibility of delivering a trial of a web-based intervention to support self-management in young people with acne. Additional work is needed before a full definitive trial, including enhancing engagement with the intervention, recruitment, and follow-up rates. Trial Registration: ISRCTN 78626638; https://tinyurl.com/n4wackrw %M 37632804 %R 10.2196/25918 %U https://derma.jmir.org/2021/2/e25918 %U https://doi.org/10.2196/25918 %U http://www.ncbi.nlm.nih.gov/pubmed/37632804 %0 Journal Article %@ 2561-7605 %I JMIR Publications %V 4 %N 4 %P e29188 %T Adapting Chinese Qigong Mind-Body Exercise for Healthy Aging in Older Community-Dwelling Low-income Latino Adults: Pilot Feasibility Study %A Yin,Zenong %A Martinez,Cristina E %A Li,Shiyu %A Martinez,Martha %A Peng,Kezhi %A Land,William M %A Ullevig,Sarah L %A Cantu,Adelita %A Falk,Sharon %A Hernández,Arthur E %A Ortega,Catherine %A Parra-Medina,Deborah %A Simmonds,Maureen J %+ Department of Public Health, The University of Texas at San Antonio, One UTSA Circle, San Antonio, TX, 78249, United States, 1 210 458 5650, zenong.yin@utsa.edu %K mHealth %K community-based participatory research %K five animal play %K wuqinxi %D 2021 %7 1.11.2021 %9 Original Paper %J JMIR Aging %G English %X Background: Research translating the evidence for the benefit of mind-body exercise in older Latinos with limited access to community-based healthy aging programs is sparse. Objective: This study aimed to evaluate the feasibility of Function Improvement Exercises for Older Sedentary Community-Dwelling Latino Residents (FITxOlder), a Community Health Worker (CHW)-led, mobile technology-facilitated Chinese Qigong mind-body exercise program for healthy aging and to explore its impact on physical and cognitive function and quality of life (QoL) in older community-dwelling low-income Latino adults. Methods: This study was designed as a Stage 1 feasibility study to develop and pilot-test FITxOlder. In Phase 1 (Stage 1A), a working group of seniors, CHWs, and senior center staff guided the adaptation of Chinese Qigong into a healthy aging program. In Phase 2 (Stage 1B), 49 older Latino adults participated in a 3-arm controlled study to test the feasibility and preliminary effect of CHW-led FITxOlder on physical and cognitive function and QoL measures over 16 weeks. Results: Although the COVID-19 pandemic disrupted the implementation of the study protocol, we found favorable results regarding participant recruitment, retention, and fidelity of implementation. Notable findings included an 89.3% participant retention, 79.4% of the participants completed at least 70% of the weekly exercise goal, and no report of adverse events. The effects on intervention outcome measures were modest. Conclusions: FITxOlder is feasible for promoting healthy aging in older Latino adults; future research needs to compare its feasibility with other low-impact exercise programs for healthy aging using a randomized controlled trial. Trial Registration: ClinicalTrials.gov NCT04284137; https://clinicaltrials.gov/ct2/show/NCT04284137 %M 34723824 %R 10.2196/29188 %U https://aging.jmir.org/2021/4/e29188 %U https://doi.org/10.2196/29188 %U http://www.ncbi.nlm.nih.gov/pubmed/34723824 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 10 %P e29755 %T Multiparameter Continuous Physiological Monitoring Technologies in Neonates Among Health Care Providers and Caregivers at a Private Tertiary Hospital in Nairobi, Kenya: Feasibility, Usability, and Acceptability Study %A Ginsburg,Amy Sarah %A Kinshella,Mai-Lei Woo %A Naanyu,Violet %A Rigg,Jessica %A Chomba,Dorothy %A Coleman,Jesse %A Hwang,Bella %A Ochieng,Roseline %A Ansermino,J Mark %A Macharia,William M %+ Department of Obstetrics and Gynecology, British Columbia Children’s and Women’s Hospital and The University of British Columbia, V344 - 950 W 28th Ave, Vancouver, BC, V5Z 4H4, Canada, 1 6048752253, maggie.kinshella@cw.bc.ca %K infants %K Africa %K medical technology design %K user perspectives %K in-depth interviews %K direct observations %D 2021 %7 28.10.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: Continuous physiological monitoring technologies are important for strengthening hospital care for neonates, particularly in resource-constrained settings, and understanding user perspectives is critical for informing medical technology design, development, and optimization. Objective: This study aims to assess the feasibility, usability, and acceptability of 2 noninvasive, multiparameter, continuous physiological monitoring technologies for use in neonates in an African health care setting. Methods: We assessed 2 investigational technologies from EarlySense and Sibel, compared with the reference Masimo Rad-97 technology through in-depth interviews and direct observations. A purposive sample of health care administrators, health care providers, and caregivers at Aga Khan University Hospital, a tertiary, private hospital in Nairobi, Kenya, were included. Data were analyzed using a thematic approach in NVivo 12 software. Results: Between July and August 2020, we interviewed 12 health care providers, 5 health care administrators, and 10 caregivers and observed the monitoring of 12 neonates. Staffing and maintenance of training in neonatal units are important feasibility considerations, and simple training requirements support the feasibility of the investigational technologies. Key usability characteristics included ease of use, wireless features, and reduced number of attachments connecting the neonate to the monitoring technology, which health care providers considered to increase the efficiency of care. The main factors supporting acceptability included caregiver-highlighted perceptions of neonate comfort and health care respondent technology familiarity. Concerns about the side effects of wireless connections, electromagnetic fields, and mistrust of unfamiliar technologies have emerged as possible acceptability barriers to investigational technologies. Conclusions: Overall, respondents considered the investigational technologies feasible, usable, and acceptable for the care of neonates at this health care facility. Our findings highlight the potential of different multiparameter continuous physiological monitoring technologies for use in different neonatal care settings. Simple and user-friendly technologies may help to bridge gaps in current care where there are many neonates; however, challenges in maintaining training and ensuring feasibility within resource-constrained health care settings warrant further research. International Registered Report Identifier (IRRID): RR2-10.1136/bmjopen-2019-035184 %M 34709194 %R 10.2196/29755 %U https://www.jmir.org/2021/10/e29755 %U https://doi.org/10.2196/29755 %U http://www.ncbi.nlm.nih.gov/pubmed/34709194 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 5 %N 10 %P e33113 %T Medical Students’ Perceptions of a Blockchain-Based Decentralized Work History and Credentials Portfolio: Qualitative Feasibility Study %A Hasselgren,Anton %A Kralevska,Katina %A Gligoroski,Danilo %A Faxvaag,Arild %+ Department of Neuromedicine and Movement Science, Norwegian University of Science and Technology, Mellomila 71, Trondheim, 7018, Norway, 47 46948498, anton.hasselgren@ntnu.no %K blockchain %K eHealth %K qualitative research %K VerifyMed %D 2021 %7 22.10.2021 %9 Original Paper %J JMIR Form Res %G English %X Background: Increased digitization of health care might challenge some of the trust functions that are established in a traditional health care system. We have, with the concept of VerifyMed, developed a decentralized service for work history and competence verification, as a means to increase trust in the virtual interaction between a patient and a caregiver, mitigate administrative burden, and provide patient-reported outcomes seamlessly for health professionals. Objective: This research aimed to validate the use case of a decentralized credentials service for health care professionals in Norway. We also aimed to evaluate the proof-of-concept of VerifyMed, a blockchain-based credential service for health care professionals. Methods: A qualitative approach was applied with data collection through 9 semistructured interviews and 2 focus groups (one with 4 participants and the other with 5 participants). The System Usability Scale (SUS) was used as a part of the interviews. Data were analyzed through the principles of systematic text condensation. The recruitment of participants ended when it was concluded that the data had reached saturation. Results: The following 5 themes were identified from the interviews and focus groups: (1) the need for aggregated storage of work- and study-related verification, (2) trust in a virtual health care environment, (3) the potential use of patient feedback, (4) trust in blockchain technology, and (5) improvements of the VerifyMed concept. The SUS questionnaire gave a score of 69.7. Conclusions: This study has validated the need for a decentralized system where health care professionals can control their credentials and, potentially, their reputation. Future work should update the VerifyMed system according to this input. We concluded that a decentralized system for the storage of work-related verifiable credentials could increase trust in a virtualized health care system. %M 34677137 %R 10.2196/33113 %U https://formative.jmir.org/2021/10/e33113 %U https://doi.org/10.2196/33113 %U http://www.ncbi.nlm.nih.gov/pubmed/34677137 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 10 %P e29273 %T Assessing the Feasibility of a Multicenter Transition Intervention Model Across Adolescent Secure Services in England (MOVING FORWARD): Protocol for a Feasibility Cluster Randomized Controlled Trial %A Livanou,Maria %A Lane,Rebecca %+ Department of Psychology, School of Law, Social and Behavioural Sciences, Kingston University, Penhryn Road, Kingston Upon Thames, KT1 2EE, United Kingdom, 44 07879056605, m.livanou@kingston.ac.uk %K transition %K intervention %K young people %K feasibility cluster randomized trial %K cluster randomized controlled trial %K secure hospitals %K outcomes %K adolescents %K patients %D 2021 %7 22.10.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: Young people moving from adolescent secure inpatient units to adult care in the United Kingdom have multiple and complex needs and are more likely to experience poor transition outcomes. Poorly managed transitions can lead to enduring use and dependency on mental health services. However, there is a lack of knowledge about the feasibility of transitional care models. Objective: This paper presents the protocol for a study that aims to test a feasibility cluster randomized controlled trial for young people transitioning from adolescent secure services to adult-oriented settings. The overarching aim of the MOVING FORWARD study is to provide a preliminary estimate of the effectiveness and cost-effectiveness of a new transition intervention model and to inform a future full-scale cluster randomized controlled trial. Methods: The design of the study is a 3-arm feasibility cluster randomized controlled trial comparing the MOVING FORWARD intervention against standard transition preparation conducted at 6 adolescent secure services, of which 4 units will receive the intervention and 2 will serve as controls. Eligible young people between 17-19 years, their parents/carers, and key workers will be invited to participate. Young people and parents/carers will be allocated to two conditions (young people alone and young people with a parent/carer) and will receive 4 transition preparation workshops across 6 months. Six adolescent secure hospitals will be randomly allocated, stratified by area and service type. Data will be collected at 3 time points: baseline (T0), 6-12 months postintervention (T1), and 18-24 months postbaseline (T2). Primary and secondary outcomes will be based on assessment measures and interviews conducted at T1 and T2. Results: A total of 13 young people and 17 staff members have contributed to the intervention design through online advisory groups on the design of the study and important themes for transition. We have also consulted members of the public (a steering group) including 2 young people who have transitioned to the community and 2 parents/carers. Common identified themes included appropriateness of module content and support during delayed transitions. The content of the intervention will be finalized during the first 6 months of the study. Participants will be recruited over the course of 6 months. An intraclass correlation coefficient will be calculated to inform the power of the sample size for a further large-scale trial. With a sample size of 50, we will be able to estimate a dropout rate of 80% (95% CI –11% to 11%). Conclusions: This research will provide practitioners and policy makers with an evidence-based framework of how training and familiarization with the prospective transitions can yield positive outcomes. This study will test whether a psychosocial intervention can be implemented in adolescent secure hospitals. The results will identify barriers and facilitators to the proposed intervention and will enable services to reflect on the quality of transitional care delivery. International Registered Report Identifier (IRRID): PRR1-10.2196/29273 %M 34677140 %R 10.2196/29273 %U https://www.researchprotocols.org/2021/10/e29273 %U https://doi.org/10.2196/29273 %U http://www.ncbi.nlm.nih.gov/pubmed/34677140 %0 Journal Article %@ 2371-4379 %I JMIR Publications %V 6 %N 4 %P e21405 %T Augmenting Traditional Support Groups for Adolescents With Type 1 Diabetes Using Instagram: Mixed Methods Feasibility Study %A Malik,Faisal S %A Lind,Cara %A Duncan,Sarah %A Mitrovich,Connor %A Pascual,Michael %A Yi-Frazier,Joyce P %+ Department of Pediatrics, University of Washington, 4800 Sand Point Way NE, M/S OC.7.820, PO Box 5371, Seattle, WA, WA, United States, 1 2069870121, faisal.malik@seattlechildrens.org %K diabetes mellitus, type 1 %K self-help groups %K social media %K adolescent %D 2021 %7 21.10.2021 %9 Original Paper %J JMIR Diabetes %G English %X Background: In-person support groups have been shown to benefit adolescents with type 1 diabetes (T1D) by helping to decrease perceived diabetes burden and improving knowledge related to chronic disease management. However, barriers exist to participation in traditional support groups, including the timing and location of meetings and resources needed to attend. Adolescents are increasingly utilizing online support groups, which may provide solutions to some of the challenges faced when implementing in-person support groups. Objective: The purpose of this study was to assess the feasibility and acceptability of a hybrid support group model where traditional in-person support groups were augmented with Instagram participation between monthly support group sessions for adolescents with T1D. Methods: Participants (13-18 years old with T1D for ≥6 months) were asked to post photos each week for 3 months based on predetermined topics related to diabetes management. At the end of each month, participants attended an in-person support group to discuss their photos using the Photovoice method. Feasibility was assessed through enrollment and retention, number of Instagram posts, poststudy questionnaire, and a template analysis of the focus groups. Results: Of 24 eligible participants, 16 (67%) enrolled in the study, with 3 dropping out prior to support group participation. The number of photos posted over 3 months ranged from 14 to 41. Among the 11 participants who completed a follow-up questionnaire, the majority of participants (6/11, 55%) reported that they very much enjoyed participating in the hybrid support group, and more than three-quarters (9/11, 82%) of participants reported that they “related to the photos posted.” Over half of participants (8/11, 73%) reported “learning something new from the photos posted,” which arose from sharing knowledge and experiences related to navigating the common challenges of diabetes management. Additionally, the use of Instagram posts helped facilitate peer discussions during the in-person support groups. Conclusions: The novel combination of using Instagram to augment traditional in-person support groups was feasible and acceptable to adolescents with T1D. The overall satisfaction with the hybrid support group model, combined with the observed engagement with peers between support group sessions over social media, suggests that a hybrid support group model may have the potential to provide more pronounced benefits to adolescents than in-person meetings alone. Future research should investigate the use of social media as part of the support group model and examine the potential improvement of self-esteem, benefit-finding, and social support using validated tools in adolescents with diabetes. %M 34673527 %R 10.2196/21405 %U https://diabetes.jmir.org/2021/4/e21405 %U https://doi.org/10.2196/21405 %U http://www.ncbi.nlm.nih.gov/pubmed/34673527 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 10 %P e25217 %T Feasibility of a Mobile Health App for Routine Outcome Monitoring and Feedback in SMART Recovery Mutual Support Groups: Stage 1 Mixed Methods Pilot Study %A Kelly,Peter J %A Beck,Alison K %A Deane,Frank P %A Larance,Briony %A Baker,Amanda L %A Hides,Leanne %A Manning,Victoria %A Shakeshaft,Anthony %A Neale,Joanne %A Kelly,John F %A Oldmeadow,Christopher %A Searles,Andrew %A Palazzi,Kerrin %A Lawson,Kenny %A Treloar,Carla %A Gray,Rebecca M %A Argent,Angela %A McGlaughlin,Ryan %+ School of Psychology, Faculty of Arts, Social Sciences and Humanities, University of Wollongong, Northfields Ave, Wollongong, 2522, Australia, 61 2 4239 2382, alisonbe@uow.edu.au %K mHealth %K SMART Recovery %K mutual support group %K mutual aid %K routine outcome monitoring %K treatment progress feedback %K addiction %K mobile phone %D 2021 %7 6.10.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: Mutual support groups are an important source of long-term help for people impacted by addictive behaviors. Routine outcome monitoring (ROM) and feedback are yet to be implemented in these settings. SMART Recovery mutual support groups focus on self-empowerment and use evidence-based techniques (eg, motivational and behavioral strategies). Trained facilitators lead all SMART Recovery groups, providing an opportunity to implement ROM. Objective: The aim of this stage 1 pilot study is to explore the feasibility, acceptability, and preliminary outcomes of a novel, purpose-built mobile health ROM and feedback app (SMART Track) in mutual support groups coordinated by SMART Recovery Australia (SRAU) over 8 weeks. Methods: SMART Track was developed during phase 1 of this study using participatory design methods and an iterative development process. During phase 2, 72 SRAU group participants were recruited to a nonrandomized, prospective, single-arm trial of the SMART Track app. Four modes of data collection were used: ROM data directly entered by participants into the app; app data analytics captured by Amplitude Analytics (number of visits, number of unique users, visit duration, time of visit, and user retention); baseline, 2-, and 8-week follow-up assessments conducted through telephone; and qualitative telephone interviews with a convenience sample of study participants (20/72, 28%) and facilitators (n=8). Results: Of the 72 study participants, 68 (94%) created a SMART Track account, 64 (88%) used SMART Track at least once, and 42 (58%) used the app for more than 5 weeks. During week 1, 83% (60/72) of participants entered ROM data for one or more outcomes, decreasing to 31% (22/72) by the end of 8 weeks. The two main screens designed to provide personal feedback data (Urges screen and Overall Progress screen) were the most frequently visited sections of the app. Qualitative feedback from participants and facilitators supported the acceptability of SMART Track and the need for improved integration into the SRAU groups. Participants reported significant reductions between the baseline and 8- week scores on the Severity of Dependence Scale (mean difference 1.93, SD 3.02; 95% CI 1.12-2.73) and the Kessler Psychological Distress Scale-10 (mean difference 3.96, SD 8.31; 95% CI 1.75-6.17), but no change on the Substance Use Recovery Evaluator (mean difference 0.11, SD 7.97; 95% CI –2.02 to 2.24) was reported. Conclusions: Findings support the feasibility, acceptability, and utility of SMART Track. Given that sustained engagement with mobile health apps is notoriously difficult to achieve, our findings are promising. SMART Track offers a potential solution for ROM and personal feedback, particularly for people with substance use disorders who attend mutual support groups. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12619000686101; https://anzctr.org.au/Trial/Registration/TrialReview.aspx?id=377336 International Registered Report Identifier (IRRID): RR2-10.2196/15113 %M 34612829 %R 10.2196/25217 %U https://www.jmir.org/2021/10/e25217 %U https://doi.org/10.2196/25217 %U http://www.ncbi.nlm.nih.gov/pubmed/34612829 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 5 %N 10 %P e15519 %T Assessing the Acceptability and Feasibility of a Web-Based Screening for Psychoactive Substance Users Among a French Sample of University Students and Workers: Mixed Methods Prospective Study %A Anthoine,Emmanuelle %A Caillon,Julie %A Deparis,Xavier %A Blanche,Michel %A Lebeaupin,Maxime %A Brochard,Marc-Antoine %A Venisse,Jean-Luc %A Moret,Leïla %+ PHU11 Public Health Department, Centre Hospitalier Universitaire (CHU) de Nantes, Hopital Saint-Jacques, 85 Rue Saint-Jacques, Nantes, 44093, France, 33 2 40 84 69 24, lmoret@chu-nantes.fr %K feasibility study %K preventive medicine %K addiction %K screening and brief intervention %K web-based app %D 2021 %7 1.10.2021 %9 Original Paper %J JMIR Form Res %G English %X Background: Early detection in the prevention of addictive behaviors remains a complex question in practice for most first-line health care workers (HCWs). Several prevention measures have successfully included a screening stage followed by a brief intervention in case of risk-related use or referral to an addiction center for problematic use. Whereas early detection is highly recommended by the World Health Organization, it is not usually performed in practice. Objective: The aim of this study was to assess the acceptability and feasibility of a web-based app, called Pulsio Santé, for health service users and first-line prevention HCW and to carry out an exhaustive process of early detection of psychoactive substance use behaviors. Methods: A mixed methods prospective study was conducted in 2 departments: HCWs from the regional occupational health department and from the university department of preventive medicine dedicated to students were invited to participate. Participants 18 years or older who had been seen in 2017 by a HCW from one of the departments were eligible. The study procedure comprised 5 phases: (1) inclusion of the participants after a face-to-face consultation with an HCW; (2) reception of a text message by participants on their smartphone or by email; (3) self-assessment by participants regarding their substance use with the Pulsio Santé app; (4) if participants agreed, transfer of the results to the HCW; and (5) if participants declined, a message to invite them to get in touch with their general practitioner should the assessment detect a risk. Several feasibility and acceptability criteria were assessed by an analysis of a focus group with the HCW that explored 4 themes (usefulness and advantages, problems and limitations, possible improvements, and finally, integration into routine practice). Results: A total of 1474 people were asked to participate, with 42 HCWs being involved. The percentage of people who agreed to receive a text message or an email, which was considered as the first level of acceptability, was 79.17% (1167/1474). The percentage of participants who clicked on the self-assessment link, considered as the second level of acceptability, was 60.24% (703/1167). The percentage of participants who completed their self-evaluation entirely, which was considered as the first level of feasibility, was 76.24% (536/703). The percentage of participants who shared the results of their evaluation with the HCWs, considered as the second level of feasibility, was 79.48% (426/536). The qualitative study showed that there were obstacles on the side of HCWs in carrying out the recommended interventions for people at risk based on their online screening, such as previous training or adaptations in accordance with specific populations. Conclusions: Quantitative results showed good acceptability and feasibility of the Pulsio Santé app by users and HCWs. There is a need for further studies more directly focused on the limitations highlighted by the qualitative results. %M 34596571 %R 10.2196/15519 %U https://formative.jmir.org/2021/10/e15519 %U https://doi.org/10.2196/15519 %U http://www.ncbi.nlm.nih.gov/pubmed/34596571 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 5 %N 9 %P e30990 %T Feasibility and Acceptability of a Web-Based Caregiver Decision Aid (Safety in Dementia) for Firearm Access: Pilot Randomized Controlled Trial %A Betz,Marian E %A Polzer,Evan %A Nearing,Kathryn %A Knoepke,Christopher E %A Johnson,Rachel L %A Meador,Lauren %A Matlock,Daniel D %+ Department of Emergency Medicine, University of Colorado Anschutz Medical Campus, 12401 E 17th Avenue, B-215, Aurora, CO, 80045, United States, 1 7208486777, marian.betz@ucdenver.edu %K dementia %K cognitive impairment %K firearm %K decision aid %K caregivers %K safety %K feasibility %K pilot trial %K Alzheimer disease %K caregiver support %D 2021 %7 22.9.2021 %9 Original Paper %J JMIR Form Res %G English %X Background: Firearms are common in the households of persons with Alzheimer disease and related dementias (ADRD). Safety in Dementia (SiD) is a free web-based decision aid that was developed to support ADRD caregivers in addressing firearm access. Objective: We aimed to evaluate the feasibility and acceptability of SiD among a web-based sample of ADRD caregivers. Methods: SiD was tested in 2 phases by using participants who were recruited from a web-based convenience sample (Amazon Mechanical Turk participants). In phase 1, caregivers were randomized to view either the intervention (SiD) or the control (Alzheimer’s Association materials), and the blinding of participants to the study arms was conducted. In phase 2, caregivers of individuals with ADRD and firearm access were recruited; all of these participants viewed the firearm section of SiD. In both phases, participants viewed SiD independently for as long as they wanted. Measures for evaluating decision-making and SiD acceptability were used, and these were assessed via a self-administered web-based questionnaire. Results: Participants were recruited for phases 1 (n=203) and 2 (n=54). Although it was feasible to collect the study outcome data in a web-based format, in phase 1, there were no significant differences between SiD and the control in terms of decision-making and self-efficacy. The majority (137/203, 67.5%) of phase 1 participants spent between 5 and 10 minutes reviewing the resources. In phase 2, 61% (33/54) of participants spent 5 to 10 minutes viewing the firearm section, and 31% (17/54) spent 10 to 20 minutes viewing this section. Usability and acceptability were high across the phases. Conclusions: SiD represents a new resource for promoting safety among people with dementia, and high acceptability was achieved in a pilot trial. In this sample, SiD performed similarly to Alzheimer’s Association materials in supporting decision-making and self-efficacy. %M 34550082 %R 10.2196/30990 %U https://formative.jmir.org/2021/9/e30990 %U https://doi.org/10.2196/30990 %U http://www.ncbi.nlm.nih.gov/pubmed/34550082 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 9 %P e29642 %T Stepwise-Hierarchical Pooled Analysis for Synergistic Interpretation of Meta-analyses Involving Randomized and Observational Studies: Methodology Development %A Shin,In-Soo %A Rim,Chai Hong %+ Department of Radiation Oncology, Ansan Hospital, Korea University, Jeokgeumro 123, Danwon Gu, Gyeonggido, 15355, Republic of Korea, 82 314126850, crusion3@naver.com %K meta-analysis %K observational study %K randomized study %K interpretation %K combination %K statistics %K synergy %K methodology %K interpretation %K hypothesis %K validity %D 2021 %7 2.9.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: The necessity of including observational studies in meta-analyses has been discussed in the literature, but a synergistic analysis method for combining randomized and observational studies has not been reported. Observational studies differ in validity depending on the degree of the confounders’ influence. Combining interpretations may be challenging, especially if the statistical directions are similar but the magnitude of the pooled results are different between randomized and observational studies (the ”gray zone”). Objective: To overcome these hindrances, in this study, we aim to introduce a logical method for clinical interpretation of randomized and observational studies. Methods: We designed a stepwise-hierarchical pooled analysis method to analyze both distribution trends and individual pooled results by dividing the included studies into at least three stages (eg, all studies, balanced studies, and randomized studies). Results: According to the model, the validity of a hypothesis is mostly based on the pooled results of randomized studies (the highest stage). Ascending patterns in which effect size and statistical significance increase gradually with stage strengthen the validity of the hypothesis; in this case, the effect size of the observational studies is lower than that of the true effect (eg, because of the uncontrolled effect of negative confounders). Descending patterns in which decreasing effect size and statistical significance gradually weaken the validity of the hypothesis suggest that the effect size and statistical significance of the observational studies is larger than the true effect (eg, because of researchers’ bias). Conclusions: We recommend using the stepwise-hierarchical pooled analysis approach for meta-analyses involving randomized and observational studies. %M 34315697 %R 10.2196/29642 %U https://www.jmir.org/2021/9/e29642 %U https://doi.org/10.2196/29642 %U http://www.ncbi.nlm.nih.gov/pubmed/34315697 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 5 %N 8 %P e23360 %T Development and Evaluation of Acceptability and Feasibility of a Web-Based Intervention for Patients With Bipolar Disorder in Iran: Implementation Study %A Ashrafi,Agaah %A Tabatabaee,Maryam %A Sharifi,Vandad %+ Department of Psychiatry, Roozbeh Hospital, Tehran University of Medical Sciences, South Kargar Avenue, Roozbeh Hospital, Tehran, Iran, 98 9123875869, vsharifi@tums.ac.ir %K bipolar disorder %K psychoeducation %K web-based intervention %K feasibility %K acceptability %D 2021 %7 17.8.2021 %9 Original Paper %J JMIR Form Res %G English %X Background: Psychoeducation for bipolar disorder has a significant impact on symptoms and treatment adherence. In Iran, as a low-resource setting, infrastructural barriers, such as inadequate mental health professionals, difficulties in transportation, and costs of care, may hinder optimum delivery of this evidence-based intervention to patients. Objective: This study sought to explore the acceptability and feasibility of a web-based intervention for bipolar patients in Iran. Methods: A website has been developed as a platform for providing psychoeducational content about bipolar disorder. Patients were chosen via a convenient sampling method in 2018-2019. The main component of the intervention included streaming 7 weekly video clips after attending a single in-person meeting, as well as a medication self-monitoring application. Information was collected about the feasibility and acceptability of the intervention. Results: We invited 45 patients from the day center and the outpatient clinic of Roozbeh psychiatric hospital and some private clinics in Tehran. Of the 23 patients (51%) who attended the first in-person session and provided informed consent, 14 patients dropped out during the study. While 9 patients completed the course (attended 4 or more online sessions), only 5 watched all the video sessions. The rate of adherence to the intervention and frequency of exposure to the website were much higher for those recruited from the private and outpatient clinics. Conclusions: This web-based intervention can be feasible and acceptable only for a subgroup of patients with specific educational status and socioeconomic level. %M 34402794 %R 10.2196/23360 %U https://formative.jmir.org/2021/8/e23360 %U https://doi.org/10.2196/23360 %U http://www.ncbi.nlm.nih.gov/pubmed/34402794 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 8 %P e31588 %T A Casual Video Game With Psychological Well-being Concepts for Young Adolescents: Protocol for an Acceptability and Feasibility Study %A Pine,Russell %A Mbinta,James %A Te Morenga,Lisa %A Fleming,Theresa %+ School of Health, Victoria University of Wellington, Kelburn, Wellington, 6032, New Zealand, 64 02040864377, Russell.pine@vuw.ac.nz %K digital mental health tools %K casual video games %K young people %D 2021 %7 12.8.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: Many face-to-face and digital therapeutic supports are designed for adolescents experiencing high levels of psychological distress. However, promoting psychological well-being among adolescents is often neglected despite significant short-term and long-term benefits. Objective: This research has 3 main objectives: (1) to assess the acceptability of Match Emoji, a casual video game with psychological well-being concepts among 13-15-year-old students in a New Zealand secondary school; (2) to identify the feasibility of the research process; and (3) to explore the preliminary well-being and therapeutic potential of Match Emoji. Methods: Approximately 40 participants aged 13-15 years from a local secondary college in Wellington, New Zealand, will be invited to download and play Match Emoji 3-4 times a week for 5-15 minutes over a 2-week period. Participants will complete 4 assessments at baseline, postintervention, and 3 weeks later to assess psychological well-being and therapeutic changes. Statistical analysis will be used to synthesize data from interviews and triangulated with assessment changes and game analytics. This synthesis will help to assess the acceptability and feasibility of the Match Emoji. Results: The key outputs from the project will include the acceptability, feasibility, and therapeutic potential of Match Emoji. It is anticipated that participants will have finished playing the recommended game play regimen by August 2021 with analysis of results completed by October 2021. Conclusions: Data from the study are expected to inform future research on Match Emoji including a randomized controlled trial and further adjustments to the design and development of the game. International Registered Report Identifier (IRRID): PRR1-10.2196/31588 %M 34387558 %R 10.2196/31588 %U https://www.researchprotocols.org/2021/8/e31588 %U https://doi.org/10.2196/31588 %U http://www.ncbi.nlm.nih.gov/pubmed/34387558 %0 Journal Article %@ 2369-1999 %I JMIR Publications %V 7 %N 2 %P e25569 %T Home-Based Telehealth Exercise Intervention in Early-On Survivors of Childhood Acute Lymphoblastic Leukemia: Feasibility Study %A Lambert,Genevieve %A Alos,Nathalie %A Bernier,Pascal %A Laverdière,Caroline %A Kairy,Dahlia %A Drummond,Kenneth %A Dahan-Oliel,Noémi %A Lemay,Martin %A Veilleux,Louis-Nicolas %+ Motion Analysis Center, Shriners Hospital for Children - Canada, 1003 Decarie Blvd, Montreal, QC, H4A 0A9, Canada, 1 514 282 7175, ln.veilleux@mcgill.ca %K exercise therapy %K rehabilitation %K acute lymphoblastic leukemia %K intervention study %K telehealth %K mobile phone %D 2021 %7 16.6.2021 %9 Original Paper %J JMIR Cancer %G English %X Background: Acute lymphoblastic leukemia is the most common type of pediatric cancer. Acute lymphoblastic leukemia causes an altered bone mineral homeostasis state, which can contribute to osteopenia, and bone fractures, most commonly vertebral fractures. With the increasing number of childhood cancer survivors, late adverse effects such as musculoskeletal comorbidities are often reported and are further influenced by inactive lifestyle habits. Physical activity has been shown to increase the mechanical workload of the bone, mitigating bone impairment in other cancer-specific populations. Objective: This interventional pilot study aims to investigate the use of telehealth to deliver a home-based exercise intervention for early-on survivors of bone marrow–related hematological malignancies and to assess its impact on survivors’ musculoskeletal and functional health. Methods: We aimed to recruit a group of 12 early-on survivors of acute lymphoblastic leukemia, within 6 months to 5 years of treatment, to participate in and complete the proposed telehealth intervention with a parent. The 16-week intervention included 40 potential home-based physical activity interventions supervised by a kinesiologist through a telehealth internet platform, with monthly progression. Patients were recruited to the cohort if they were able to participate in the intervention during the first month (minimum 12 weeks of intervention). Evaluation before and after the intervention protocol highlighted differences in functional capacities and musculoskeletal health of patients using mechanography, peripheral quantitative computed tomography, 6-minute walk test, and grip force test. Results: The recruitment rate for the intervention was low (12/57, 21% of contacted patients). Of 12 patients, 3 were excluded (1=relapse, 1=failure to meet technical requirements, and 1=abandoned). The 9 patients who completed the intervention (6 girls; mean age 10.93, SD 2.83 years; mean BMI 21.58, SD 6.55 kg/m2; mean time since treatment completion 36.67, SD 16.37 months) had a mean adherence of 89% and a completion rate of 75%. In addition, these patients showed functional improvements in lower limb muscle force and power as well as in the 6-minute walk test distance. Participants also showed improved bone health after the intervention on the following parameters: bone mineral content, stress-strain index, total and cortical cross-sectional area at the 14% site (P=.03, P=.01, P=.01, and P=.001, respectively) and 38% site of the tibia (P=.003, P=.04, P=.001, and P=.003, respectively). Conclusions: High adherence and participation rates suggest that telehealth is a feasible method to deliver exercise interventions to young early-on survivors of acute lymphoblastic leukemia. The proposed intervention seems promising in providing benefits to patients’ functional performance and bone health, but a large-scale study is needed to confirm this assumption. %M 34132645 %R 10.2196/25569 %U https://cancer.jmir.org/2021/2/e25569 %U https://doi.org/10.2196/25569 %U http://www.ncbi.nlm.nih.gov/pubmed/34132645 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 5 %P e24808 %T Phototherapy Using a Light-Emitting Fabric (BUBOLight) Device in the Treatment of Newborn Jaundice: Protocol for an Interventional Feasibility and Safety Study %A Lecomte,Fabienne %A Thecua,Elise %A Ziane,Laurine %A Deleporte,Pascal %A Duhamel,Alain %A Vamour,Clémence %A Mordon,Serge %A Rakza,Thameur %+ U1189 - Assisted Laser Therapy and Immunotherapy for Oncology, Univ- Lille, Inserm, CHU Lille, 1 avenue Oscar Lambret, F-59000 Lille, 59037, France, 33 320446722, fabienne.lecomte@inserm.fr %K jaundice %K light emitting fabrics %K light %K neonate %K newborn jaundice %K perinatal %K phototherapy %D 2021 %7 25.5.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: Neonatal jaundice is a common condition occurring in 60%-80% of all healthy-term and late-preterm neonates. In the majority of cases, neonatal jaundice resolves spontaneously and causes no harm; however, in some neonates, significant hyperbilirubinemia can develop and lead to kernicterus jaundice, a serious neurological disease. Phototherapy (PT) is the preferred treatment for jaundice; however, to be effective, PT devices need to have a broad light emission surface to generate no or little heat and to provide an optimal wavelength and light intensity (420-490 nm and ≥30 µW/cm²/nm, respectively). Objective: This study aimed to investigate the feasibility, safety, and level of satisfaction of parents and health care teams with the BUBOlight device, an innovative alternative to conventional hospital PT, in which luminous textiles have been incorporated in a sleeping bag. Methods: This interventional, exploratory, simple group, nonrandomized, single-center trial will be conducted at Lille Hospital. In total, 10-15 neonates and their parents will be included to obtain evaluable data from 10 parent-neonate pairs. Neonates weighing more than 2500 g at birth and born with ≥37 weeks of amenorrhea that required PT in accordance with the guidelines of the National Institute For Health and Clinical Excellence will receive one 4-hour session of illumination. Total serum bilirubin and transcutaneous bilirubin levels were obtained at the start and 2 hours after the end of PT. Cutaneous and rectal temperatures, heart rate, and oxygen saturation will be measured at the beginning and during PT. The number of subjects is therefore not calculated on the basis of statistical assumptions. We aim to obtain a minimum proportion of 90% (ie, 9 of 10) of the neonates included, who have been able to undergo 4-hour PT without unacceptable and unexpected toxicities. We will calculate the mean, median, quartiles, minimum and maximum values of the quantitative parameters, and the frequency of the qualitative parameters. The rate of patients with no unacceptable and unexpected toxicities (ie, the primary endpoint) will be calculated. Results: The first patient is expected to be enrolled at the end of 2020, and clinical investigations are intended for up to June 2021. The final results of this study are expected to be available at the end of 2021. Conclusions: Our findings will provide insights into the safety and feasibility of a new PT device based on light-emitting fabrics for the treatment of newborn jaundice. This new system, if proven effective, will improve the humanization of neonatal care and help avoid mother-child separation. Trial Registration: ClinicalTrials.gov NCT04365998; https://clinicaltrials.gov/ct2/show/NCT04365998 International Registered Report Identifier (IRRID): PRR1-10.2196/24808 %M 34032584 %R 10.2196/24808 %U https://www.researchprotocols.org/2021/5/e24808 %U https://doi.org/10.2196/24808 %U http://www.ncbi.nlm.nih.gov/pubmed/34032584 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 5 %N 4 %P e21357 %T Enabling Guidelines for the Adoption of eHealth Solutions: Scoping Review %A Støme,Linn Nathalie %A Wilhelmsen,Christian Ringnes %A Kværner,Kari Jorunn %+ Centre for Connected Care, Oslo University Hospital, Kirkeveien 166, Oslo, Norway, 47 94 88 08 25, linast@ous-hf.no %K eHealth %K feasibility %K global health %K implementation %D 2021 %7 30.4.2021 %9 Review %J JMIR Form Res %G English %X Background: Globally, public health care is under increasing pressure, an economic burden currently amplified by the COVID-19 outbreak. With the recognition that universal health coverage improves the health of a population and reduces health inequalities, universal health coverage has been acknowledged as a priority goal. To meet the global needs in a population with increased chronic illness and longer life expectancy, the health care system is in dire need of new, emerging technologies. eHealth solutions as a method of delivery may have an impact on quality of care and health care costs. As such, it is important to study methods previously used to avoid suboptimal implementation and promote general guidelines to further develop eHealth solutions. Objective: This study aims to explore and thematically categorize a selected representation of early phase studies on eHealth technologies, focusing on papers that are under development or undergoing testing. Further, we want to assess enablers and barriers in terms of usability, scaling, and data management of eHealth implementation. The aim of this study to explore early development phase and feasibility studies was an intentional effort to provide applicable guidelines for evaluation at different stages of implementation. Methods: A structured search was performed in PubMed, MEDLINE, and Cochrane to identify and provide insight in current eHealth technology and methodology under development and gain insight in the future potential of eHealth technologies. Results: In total, 27 articles were included in this review. The clinical studies were categorized thematically by illness comparing 4 technology types deemed relevant: apps/web-based technology, sensor technology, virtual reality, and television. All eHealth assessment and implementation studies were categorized by their focus point: usability, scaling, or data management. Studies assessing the effect of eHealth were divided into feasibility studies, qualitative studies, and heuristic assessments. Studies focusing on usability (16/27) mainly addressed user involvement and learning curve in the adoption of eHealth, while the majority of scaling studies (6/27) focused on strategic and organizational aspects of upscaling eHealth solutions. Studies focusing on data management (5/27) addressed data processing and data sensitivity in adoption and diffusion of eHealth. Efficient processing of data in a secure manner, as well as user involvement and feedback, both throughout small studies and during upscaling, were the important enablers considered for successful implementation of eHealth. Conclusions: eHealth interventions have considerable potential to improve lifestyle changes and adherence to treatment recommendations. To promote efficient implementation and scaling, user involvement to promote user-friendliness, secure and adaptable data management, and strategical considerations needs to be addressed early in the development process. eHealth should be assessed during its development into health services. The wide variation in interventions and methodology makes comparison of the results challenging and calls for standardization of methods. %M 33929330 %R 10.2196/21357 %U https://formative.jmir.org/2021/4/e21357 %U https://doi.org/10.2196/21357 %U http://www.ncbi.nlm.nih.gov/pubmed/33929330 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 9 %N 2 %P e24704 %T Heart Rate Variability and Firstbeat Method for Detecting Sleep Stages in Healthy Young Adults: Feasibility Study %A Kuula,Liisa %A Pesonen,Anu-Katriina %+ SleepWell Research Program, University of Helsinki, Haartmaninkatu 3 (PL 21), Helsinki, 00014, Finland, 358 02941 911, liisa.kuula@helsinki.fi %K electroencephalogram %K actigraphy %K polysomnography %K sleep %K heart rate %K rapid eye movements %D 2021 %7 3.2.2021 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Polysomnography (PSG) is considered the only reliable way to distinguish between different sleep stages. Wearable devices provide objective markers of sleep; however, these devices often rely only on accelerometer data, which do not enable reliable sleep stage detection. The alteration between sleep stages correlates with changes in physiological measures such as heart rate variability (HRV). Utilizing HRV measures may thus increase accuracy in wearable algorithms. Objective: We examined the validity of the Firstbeat sleep analysis method, which is based on HRV and accelerometer measurements. The Firstbeat method was compared against PSG in a sample of healthy adults. Our aim was to evaluate how well Firstbeat distinguishes sleep stages, and which stages are most accurately detected with this method. Methods: Twenty healthy adults (mean age 24.5 years, SD 3.5, range 20-37 years; 50% women) wore a Firstbeat Bodyguard 2 measurement device and a Geneactiv actigraph, along with taking ambulatory SomnoMedics PSG measurements for two consecutive nights, resulting in 40 nights of sleep comparisons. We compared the measures of sleep onset, wake, combined stage 1 and stage 2 (light sleep), stage 3 (slow wave sleep), and rapid eye movement (REM) sleep between Firstbeat and PSG. We calculated the sensitivity, specificity, and accuracy from the 30-second epoch-by-epoch data. Results: In detecting wake, Firstbeat yielded good specificity (0.77), and excellent sensitivity (0.95) and accuracy (0.93) against PSG. Light sleep was detected with 0.69 specificity, 0.67 sensitivity, and 0.69 accuracy. Slow wave sleep was detected with 0.91 specificity, 0.72 sensitivity, and 0.87 accuracy. REM sleep was detected with 0.92 specificity, 0.60 sensitivity, and 0.84 accuracy. There were two measures that differed significantly between Firstbeat and PSG: Firstbeat underestimated REM sleep (mean 18 minutes, P=.03) and overestimated wake time (mean 14 minutes, P<.001). Conclusions: This study supports utilizing HRV alongside an accelerometer as a means for distinguishing sleep from wake and for identifying sleep stages. The Firstbeat method was able to detect light sleep and slow wave sleep with no statistically significant difference to PSG. Firstbeat underestimated REM sleep and overestimated wake time. This study suggests that Firstbeat is a feasible method with sufficient validity to measure nocturnal sleep stage variation. %M 33533726 %R 10.2196/24704 %U http://mhealth.jmir.org/2021/2/e24704/ %U https://doi.org/10.2196/24704 %U http://www.ncbi.nlm.nih.gov/pubmed/33533726 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 9 %N 1 %P e14494 %T Physical Activity Monitoring Using a Fitbit Device in Ischemic Stroke Patients: Prospective Cohort Feasibility Study %A Katzan,Irene %A Schuster,Andrew %A Kinzy,Tyler %+ Neurological Institute Center for Outcomes Research and Evaluation, Cleveland Clinic, 9500 Euclid Avenue, S80, Cleveland, OH, 44195, United States, 1 12164452616, katzani@ccf.org %K physical activity %K accelerometer %K ischemic stroke %K step activity monitor %D 2021 %7 19.1.2021 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Continuous tracking of ambulatory activity in real-world settings using step activity monitors has many potential uses. However, feasibility, accuracy, and correlation with performance measures in stroke patients have not been well-established. Objective: The primary study objective was to determine adherence with wearing a consumer-grade step activity monitor, the Fitbit Charge HR, in home-going ischemic stroke patients during the first 90 days after hospital discharge. Secondary objectives were to (1) determine accuracy of step counts of the Fitbit Charge HR compared with a manual tally; (2) calculate correlations between the Fitbit step counts and the mobility performance scores at discharge and 30 days after stroke; (3) determine variability and change in weekly step counts over 90 days; and (4) evaluate patient experience with using the Fitbit Charge HR poststroke. Methods: A total of 15 participants with recent mild ischemic stroke wore a Fitbit Charge HR for 90 days after discharge and completed 3 mobility performance tests from the National Institutes of Health Toolbox at discharge and Day 30: (1) Standing Balance Test, (2) 2-Minute Walk Endurance Test, and (3) 4-Meter Walk Gait Speed Test. Accuracy of step activity monitors was assessed by calculating differences in steps recorded on the step activity monitor and a manual tally during 2-minute walk tests. Results: Participants had a mean age of 54 years and a median modified Rankin scale score of 1. Mean daily adherence with step activity monitor use was 83.6%. Mean daily step count in the first week after discharge was 4376. Daily step counts increased slightly during the first 30 days after discharge (average increase of 52.5 steps/day; 95% CI 32.2-71.8) and remained stable during the 30-90 day period after discharge. Mean step count difference between step activity monitor and manual tally was –4.8 steps (–1.8%). Intraclass correlation coefficients for step counts and 2-minute walk, standing balance, and 4-meter gait speed at discharge were 0.41 (95% CI –0.14 to 0.75), –0.12 (95% CI –0.67 to 0.64), and 0.17 (95% CI –0.46 to 0.66), respectively. Values were similarly poor at 30 days. Conclusions: The use of consumer-grade Fitbit Charge HR in patients with recent mild stroke is feasible with reasonable adherence and accuracy. There was poor correlation between step counts and gait speed, balance, and endurance. Further research is needed to evaluate the association between step counts and other outcomes relevant to patients, including patient-reported outcomes and measures of physical function. %M 33464213 %R 10.2196/14494 %U http://mhealth.jmir.org/2021/1/e14494/ %U https://doi.org/10.2196/14494 %U http://www.ncbi.nlm.nih.gov/pubmed/33464213 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 5 %N 1 %P e20410 %T The Use of Small Electronic Devices and Health: Feasibility of Interventions for a Forthcoming Crossover Design %A Larsen,Lisbeth Hoekjaer %A Lauritzen,Maja Hedegaard %A Gangstad,Sirin Wilhelmsen %A Kjaer,Troels Wesenberg %+ Department of Neurology, Zealand University Hospital, Sygehusvej 10, Roskilde, , Denmark, 45 41 55 85 92, lisbla@regionsjaelland.dk %K accelerometer %K activity trackers %K aerobic capacity %K insufficient sleep %K media use %K screen time %K sleep problems %K smartphones %K wearable tracking devices %D 2021 %7 4.1.2021 %9 Original Paper %J JMIR Form Res %G English %X Background: Modern lifestyle is heavily affected by technology such as smartphones, tablets, and other small computers; yet it remains unclear how our health and well-being are affected by the heavy use of these devices. Objective: This feasibility study aims to test two different interventions of an experimental protocol for a forthcoming large-scale community-based study and get estimates of parameters for sample size calculation. The aim of the large-scale study is to investigate the effect of (1) a wearable tracking device on aerobic capacity (VO2max/kg) and the effect of (2) restricting media use on total sleep time. Methods: Twenty healthy participants were included and equipped with a wrist-worn device tracking physical activity and sleep. Participants were allocated to either a physical activity group, which was instructed to use the wrist-worn device to support exercise, or a sleep silent group, which was instructed to remove or switch off all electronic devices in the bedroom (except the wrist-worn tracking device). The intervention lasted approximately 4 weeks. Data collected included blood pressure, submaximal cycle ergometer test, self-reported technology use, and compliance of using the wearable tracking device. Results: All participants wore the wearable tracking device 95.8% (SD 4.4%) of the time. Participants in the physical activity group increased aerobic capacity from 30.38 (SD 8.98) to 32.1 (SD 8.71) mL/kg/min (t=–2.31, P=.046) and decreased their systolic blood pressure from 126.5 (SD 15.8) mm Hg to 121.8 (SD 11.7) mm Hg (t=2.72, P=.02). The sleep silent group prolonged their time offline before bedtime from 18.1 (SD 19.4) minutes to 27.2 (SD 17.3) minutes (t=–2.94, P=.02). Conclusions: The two interventions are feasible to conduct. Participants were willing to wear the tracking device on their wrist and restrict all media use in their bedroom and thereby reduce bedtime technology use. Our results also suggest that tracking physical activity using a wearable device is accompanied by noteworthy health benefits. We outline necessary adjustments for a forthcoming large-scale study. %M 33393907 %R 10.2196/20410 %U https://formative.jmir.org/2021/1/e20410 %U https://doi.org/10.2196/20410 %U http://www.ncbi.nlm.nih.gov/pubmed/33393907 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 9 %N 12 %P e23414 %T Exploring Interactive Survivorship Care Plans to Support Breast Cancer Survivors: Protocol for a Randomized Controlled Trial %A Kapoor,Akshat %A Nambisan,Priya %+ Consumer Health Informatics Lab, Department of Health Services and Information Management, East Carolina University, 600 Moye Blvd MS 668, Greenville, NC, 27834-4300, United States, 1 252 744 6175, kapoora16@ecu.edu %K breast cancer %K cancer survivorship %K self-management %K patient education %D 2020 %7 4.12.2020 %9 Protocol %J JMIR Res Protoc %G English %X Background: Breast cancer is the most common form of cancer among American women, accounting for 23% of all cancer survivors nationally. Yet, the availability of adequate resources and tools for supporting breast cancer survivors has not kept up with the rapid advancement in treatment options, resulting in unmet supportive care needs, particularly among low-income and minority populations. This study explores an alternative means of delivering breast cancer survivorship care plans (SCPs), with the aim of improving survivor morbidity, patient knowledge, and self-management of treatment-related symptoms, as well as addressing inconsistencies in follow-up care visits. Objective: The overall goal of this study is to improve the uptake of SCP recommendations via an educational intervention for breast cancer survivors, to improve treatment-related morbidity, patient knowledge, self-management, and adherence to follow-up visits. The specific aims of the study are to (1) evaluate the feasibility of the online SCP, and (2) assess the impact of the online SCP on survivorship outcomes. Methods: We will enroll 50 breast cancer survivors who have completed initial breast cancer treatment into a 2-armed, randomized, waitlist-controlled pilot trial, and collect data at baseline and 6 months. For the first aim, we will use mixed methods, including surveys and personal interviews among the intervention group, to determine the feasibility of providing an online, interactive SCP (called ACESO) based on the survivors’ online user experience and their short-term adoption. For the secondary aim, we will compare the 2 groups to assess the primary outcomes of survivor knowledge, self-efficacy for self-management, perceived peer support, and adherence to SCP-recommended posttreatment follow-up visits to oncology and primary care; and the secondary outcomes of treatment-related morbidity (body weight, fatigue, depression, anxiety, sexual function, distress, and sleep quality). We assess these outcomes by using measurements from validated instruments with robust psychometric properties. Results: We have developed and refined the online breast cancer survivorship plan, ACESO, with consultation from breast cancer oncologists, nurses, and survivors. Approval for the study protocol has been obtained from the Institutional Review Board. An advisory board has also been established to provide oversight and recommendations on the conduct of the study. The study will be completed over a period of 2 years. Conclusions: The results of this pilot study will inform the feasibility and design of a larger-scale pragmatic trial to evaluate the impact of an online breast cancer SCP on treatment-related morbidity and self-efficacy for self-management. International Registered Report Identifier (IRRID): PRR1-10.2196/23414 %M 33274725 %R 10.2196/23414 %U https://www.researchprotocols.org/2020/12/e23414 %U https://doi.org/10.2196/23414 %U http://www.ncbi.nlm.nih.gov/pubmed/33274725 %0 Journal Article %@ 2561-7605 %I JMIR Publications %V 3 %N 2 %P e21964 %T Use of an Internet-of-Things Smart Home System for Healthy Aging in Older Adults in Residential Settings: Pilot Feasibility Study %A Choi,Yong K %A Thompson,Hilaire J %A Demiris,George %+ Department of Public Health Sciences, School of Medicine, University of California Davis, 4610 X Street, Suite 2301, Sacramento, CA, 95817, United States, 1 916 734 6083, ygchoi@ucdavis.edu %K Internet of Things %K smart home %K independent living %K aging %K healthy aging %D 2020 %7 10.11.2020 %9 Original Paper %J JMIR Aging %G English %X Background: The Internet-of-Things (IoT) technologies can create smart residences that integrate technology within the home to enhance residents’ safety as well as monitor their health and wellness. However, there has been little research on real-world testing of IoT smart home devices with older adults, and the feasibility and acceptance of such tools have not been systematically examined. Objective: This study aims to conduct a pilot study to investigate the feasibility of using IoT smart home devices in the actual residences of older adults to facilitate healthy aging. Methods: We conducted a 2-month feasibility study on community-dwelling older adults. Participants chose among different IoT devices to be installed and deployed within their homes. The IoT devices tested varied depending on the participant’s preference: a door and window sensor, a multipurpose sensor (motion, temperature, luminosity, and humidity), a voice-operated smart speaker, and an internet protocol (IP) video camera. Results: We recruited a total of 37 older adults for this study, with 35 (95%) successfully completing all procedures in the 2-month study. The average age of the sample was 78 (SD 9) years and primarily comprised women (29/37, 78%), those who were educated (31/37, 86%; bachelor’s degree or higher), and those affected by chronic conditions (33/37, 89%). The most widely chosen devices among the participants were multipurpose sensors and smart speakers. An IP camera was a significantly unpopular choice among participants in both phases. The participant feedback suggests that perceived privacy concerns, perceived usefulness, and curiosity to technology were strong factors when considering which device to have installed in their home. Conclusions: Overall, our deployment results revealed that the use of IoT smart home devices is feasible in actual residences of older adults. These findings may inform the follow-up assessment of IoT technologies and their impact on health-related outcomes and advance our understanding of the role of IoT home-based monitoring technologies to promote successful aging-in-place for older adults. Future trials should consider older adults’ preferences for the different types of smart home devices to be installed in real-world residential settings. %M 33170128 %R 10.2196/21964 %U http://aging.jmir.org/2020/2/e21964/ %U https://doi.org/10.2196/21964 %U http://www.ncbi.nlm.nih.gov/pubmed/33170128 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 9 %N 11 %P e21816 %T Methodological Challenges in Investigating Supracondylar Fractures of the Humerus From a Child’s Viewpoint: Evolution of Study Protocol %A Lim,Brittany Tara %A Chhina,Harpreet %A Pike,Ian %A Brussoni,Mariana %A Cooper,Anthony %+ British Columbia Children's Hospital Research Institute, 938 W 28th Ave, Vancouver, BC, Canada, 1 6048752000 ext 6008, externalfixators@cw.bc.ca %K supracondylar fracture %K pediatrics %K trauma %K protocol %K injury prevention %K child's viewpoint %D 2020 %7 2.11.2020 %9 Protocol %J JMIR Res Protoc %G English %X Background: Outdoor play and risk-taking behaviors, including play at heights, are important to children’s physical, social, and cognitive development. These aspects of play are important to consider when informing prevention policies for serious injuries that commonly occur on play structures. Supracondylar fractures of the humerus (SCH) are the most common type of elbow fractures that result from falls on an outstretched hand among healthy children. Despite being one of the leading causes of admission to the hospital and surgical intervention, the details surrounding the cause of these injuries are often not recorded. Previous research has correlated decreased overall playground safety with higher rates of SCH fractures. Play structure height and the type of undersurface have been identified as potential risk factors for severe injuries, including SCH fractures, in part due to low compliance with safety standards. This paper explores the challenges we encountered designing the study and the resulting insights and methodological modifications we made. Objective: The aim of this paper is to discuss the challenges related specifically to clinical research in pediatrics and strategies developed to conduct a study that prioritizes the engagement and perspective of children and their families. Methods: To explore the link between the severity of SCH fractures and children’s behavioral, environmental, and mechanistic factors, we conducted a mixed-methods study. Results: During phase 1 (the original methodology) from April 2017 to July 2018, there were 58 eligible study participants and 17 were recruited. For phase 2 (the revised methodology) between October 2018 and October 2019, there were 116 eligible participants and 47 were recruited. Conclusions: The changes in methodology made following the first phase of data collection were effective in our ability to recruit participants. By identifying and addressing challenges pertaining to recruitment and resource limitations, we were able to collect data in a concise manner while not compromising the quality of the data and make for an easily adoptable methodology for other sites interested in participating in the study. We hope that future studies that plan to employ a similar methodology can gain insight through the methodological challenges we have encountered and the way we adapted the methodology to build a more pragmatic approach. International Registered Report Identifier (IRRID): DERR1-10.2196/21816 %M 33136061 %R 10.2196/21816 %U https://www.researchprotocols.org/2020/11/e21816 %U https://doi.org/10.2196/21816 %U http://www.ncbi.nlm.nih.gov/pubmed/33136061 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 4 %N 10 %P e23893 %T Digital Self-Management in Support of Patients Living With Chronic Pain: Feasibility Pilot Study %A Bostrøm,Katrine %A Børøsund,Elin %A Varsi,Cecilie %A Eide,Hilde %A Flakk Nordang,Elise %A Schreurs,Karlein MG %A Waxenberg,Lori B %A Weiss,Karen E %A Morrison,Eleshia J %A Cvancarova Småstuen,Milada %A Stubhaug,Audun %A Solberg Nes,Lise %+ Department of Digital Health Research, Division of Medicine, Oslo University Hospital, Pb 4950 Nydalen, Oslo, Oslo, N-0424, Norway, 47 91332341, lise.solberg.nes@rr-research.no %K chronic pain %K feasibility %K acceptability %K self-management %K eHealth %K digital %K cognitive-behavioral pain %K usability %K user centered %D 2020 %7 23.10.2020 %9 Original Paper %J JMIR Form Res %G English %X Background: Chronic pain can be complex and taxing to live with, and treatment and support require a multicomponent approach, which may not always be offered or available. Smartphones, tablets, and personal computers are already incorporated into patients’ daily lives, and therefore, they can be used to communicate, educate, and support self-management. Although some web-based self-management interventions exist, research examining the evidence and effect of digital solutions supporting self-management for patients living with chronic pain is limited, findings are inconclusive, and new innovative ideas and solutions are needed. Objective: This feasibility pilot study aimed to explore the system use, perceived usefulness, ease of use, and preliminary effects of EPIO, an app-based cognitive-behavioral pain self-management intervention program for patients living with chronic pain. Methods: The EPIO intervention was delivered in a blended-care model containing (1) one face-to-face introduction session, (2) nine cognitive behavior–based pain self-management modules, delivered in an app-based format for smartphones or tablets, and (3) one follow-up phone call at 2 to 3 weeks after the introduction session. Patients living with chronic pain (N=50) completed pre-post outcome measures at baseline and 3 months after the introduction session, with registration of system use (ie, log data) until 6 months. The use, perceived usefulness, and ease of use of the EPIO program were examined through system use data, as well as a study-specific use/usability questionnaire and the System Usability Scale (SUS). Outcome measures to test feasibility of use and estimate preliminary effects included the Brief Pain Inventory, health-related quality of life (HRQoL) scale, Hospital Anxiety and Depression Scale, Self-Regulatory Fatigue scale, Pain Catastrophizing Scale, and Chronic Pain Acceptance Questionnaire. Results: Participants (N=50) had a median age of 52 years (range 29-74 years) at inclusion and were mainly female (40/50, 80%). Thirty-one participants completed at least six of the nine modules within the 3-month study period (62% completion rate). Forty-five participants completed outcome measures at 3 months, and the EPIO program was rated as useful (ie, “totally agree” or “agree”; 39/45, 87%) and easy to use (42/45, 93%), and as having easily understandable exercises (44/45, 98%). The average overall system usability (SUS) score was 85.7, indicating grade A and excellent system usability. Preliminary psychosocial outcome measure estimates showed primarily nonsignificant pre-post intervention improvements at 3 months, but with significant positive effects related to some aspects of HRQoL (bodily pain, P=.02 and change, P=.049). Conclusions:  Digital self-management intervention programs may be of use and support for patients living with chronic pain. In this feasibility study, EPIO showed an acceptable program completion rate and was rated as useful and easy to use, with excellent user satisfaction. Program optimization and efficacy testing in a large-scale randomized controlled trial are warranted and in progress. Trial Registration: ClinicalTrials.gov NCT03705104; https://clinicaltrials.gov/ct2/show/NCT03705104 %M 33094734 %R 10.2196/23893 %U http://formative.jmir.org/2020/10/e23893/ %U https://doi.org/10.2196/23893 %U http://www.ncbi.nlm.nih.gov/pubmed/33094734 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 9 %N 10 %P e14322 %T Use of a Smartphone App to Increase Physical Activity Levels in Insufficiently Active Adults: Feasibility Sequential Multiple Assignment Randomized Trial (SMART) %A Gonze,Bárbara De Barros %A Padovani,Ricardo Da Costa %A Simoes,Maria Do Socorro %A Lauria,Vinicius %A Proença,Neli Leite %A Sperandio,Evandro Fornias %A Ostolin,Thatiane Lopes Valentim Di Paschoale %A Gomes,Grace Angélica De Oliveira %A Castro,Paula Costa %A Romiti,Marcello %A Gagliardi,Antonio %A Arantes,Rodolfo Leite %A Dourado,Victor Zuniga %+ Laboratory of Epidemiology and Human Movement (EPIMOV), Department of Human Movement Sciences, Federal University of São Paulo, Rua Silva Jardim 136, Vila Mathias, Santos, 11015-020, Brazil, 55 1332290203, victor.dourado@unifesp.br %K tailored messages %K gamification %K steps per day %D 2020 %7 23.10.2020 %9 Original Paper %J JMIR Res Protoc %G English %X Background: The sequential multiple assignment randomized trial (SMART) design allows for changes in the intervention during the trial period. Despite its potential and feasibility for defining the best sequence of interventions, so far, it has not been utilized in a smartphone/gamified intervention for physical activity. Objective: We aimed to investigate the feasibility of the SMART design for assessing the effects of a smartphone app intervention to improve physical activity in adults. We also aimed to describe the participants’ perception regarding the protocol and the use of the app for physical activity qualitatively. Methods: We conducted a feasibility 24-week/two-stage SMART in which 18 insufficiently active participants (<10,000 steps/day) were first randomized to group 1 (smartphone app only), group 2 (smartphone app + tailored messages), and a control group (usual routine during the protocol). Participants were motivated to increase their step count by at least 2000 steps/day each week. Based on the 12-week intermediate outcome, responders continued the intervention and nonresponders were rerandomized to subsequent treatment, including a new group 3 (smartphone app + tailored messages + gamification) in which they were instructed to form groups to use several game elements available in the chosen app (Pacer). We considered responders as those with any positive slope in the linear relationship between weeks and steps per day at the end of the first stage of the intervention. We compared the accelerometer-based steps per day before and after the intervention, as well as the slopes of the app-based steps per day between the first and second stages of the intervention. Results: Twelve participants, including five controls, finished the intervention. We identified two responders in group 1. We did not observe relevant changes in the steps per day either throughout the intervention or compared with the control group. However, the rerandomization of five nonresponders led to a change in the slope of the steps per day (median −198 steps/day [IQR −279 to −103] to 20 steps/day [IQR −204 to 145]; P=.08). Finally, in three participants from group 2, we observed an increase in the number of steps per day up to the sixth week, followed by an inflection to baseline values or even lower (ie, a quadratic relationship). The qualitative analysis showed that participants’ reports could be classified into the following: (1) difficulty in managing the app and technology or problems with the device, (2) suitable response to the app, and (3) difficulties to achieve the goals. Conclusions: The SMART design was feasible and changed the behavior of steps per day after rerandomization. Rerandomization should be implemented earlier to take advantage of tailored messages. Additionally, difficulties with technology and realistic and individualized goals should be considered in interventions for physical activity using smartphones. Trial Registration: Brazilian Registry of Clinical Trials RBR-8xtc9c; http://www.ensaiosclinicos.gov.br/rg/RBR-8xtc9c/. %M 33094733 %R 10.2196/14322 %U https://www.researchprotocols.org/2020/10/e14322 %U https://doi.org/10.2196/14322 %U http://www.ncbi.nlm.nih.gov/pubmed/33094733 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 9 %N 8 %P e15623 %T Insights From Twitter Conversations on Lupus and Reproductive Health: Protocol for a Content Analysis %A Stens,Oleg %A Weisman,Michael H %A Simard,Julia %A Reuter,Katja %+ Southern California Clinical and Translational Science Institute, Keck School of Medicine of USC, University of Southern California, 2250 Alcazar St, Los Angeles, CA, 90089, United States, 1 323 442 2046, katja.reuter@gmail.com %K fertility %K infodemiology %K infoveillance %K listening %K lupus %K monitoring %K patient opinion %K reproductive health %K surveillance %K Twitter %K social media %K social network %D 2020 %7 26.8.2020 %9 Protocol %J JMIR Res Protoc %G English %X Background: Systemic lupus erythematosus (SLE) is the most common form of lupus. It is a chronic autoimmune disease that predominantly affects women of reproductive age, impacting contraception, fertility, and pregnancy. Although clinic-based studies have contributed to an increased understanding of reproductive health care needs of patients with SLE, misinformation abounds and perspectives on reproductive health issues among patients with lupus remain poorly understood. Social networks such as Twitter may serve as a data source for exploring how lupus patients communicate about their health issues, thus adding a dimension to enrich our understanding of communication regarding reproductive health in this unique patient population. Objective: The objective of this study is to conduct a content analysis of Twitter data published by users in English in the United States from September 1, 2017, to October 31, 2018, in order to examine people’s perspectives on reproductive health among patients with lupus. Methods: This study will analyze user-generated posts that include keywords related to lupus and reproductive health from Twitter. To access public Twitter user data, we will use Symplur Signals, a health care social media analytics platform. Text classifiers will be used to identify topics in posts. Posts will be classified manually into the a priori and emergent categories. Based on the information available in a user’s Twitter profile (ie, username, description, and profile image), we will further attempt to characterize the user who generated the post. We will use descriptive statistics to analyze the data and identify the most prevalent topics in the Twitter content among patients with lupus. Results: This study has been funded by the National Center for Advancing Translational Science (NCATS) through their Clinical and Translational Science Awards program. The Institutional Review Board at the University of Southern California approved the study (HS-18-00912). Data extraction and cleaning are complete. We obtained 47,715 Twitter posts containing terms related to “lupus” from users in the United States, published in English between September 1, 2017, and October 31, 2018. We will include 40,885 posts in the analysis, which will be completed in fall 2020. This study was supported by funds from the has been funded by the National Center for Advancing Translational Science (NCATS) through their Clinical and Translational Science Awards program. Conclusions: The findings from this study will provide pilot data on the use of Twitter among patients with lupus. Our findings will shed light on whether Twitter is a promising data source for learning about reproductive health issues expressed among patients with lupus. The data will also help to determine whether Twitter can serve as a potential outreach platform for raising awareness of lupus and reproductive health and for implementing relevant health interventions. International Registered Report Identifier (IRRID): DERR1-10.2196/15623 %M 32844753 %R 10.2196/15623 %U http://www.researchprotocols.org/2020/8/e15623/ %U https://doi.org/10.2196/15623 %U http://www.ncbi.nlm.nih.gov/pubmed/32844753 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 8 %P e18178 %T Feasibility of Real Time Internet-Based Teleconsultation in Patients With Multiple Sclerosis: Interventional Pilot Study %A D'Haeseleer,Miguel %A Eelen,Piet %A Sadeghi,Nima %A D'Hooghe,Marie B %A Van Schependom,Jeroen %A Nagels,Guy %+ Universitair Ziekenhuis Brussel, Laarbeeklaan 101, Brussels, Belgium, 32 2 477 60 12, miguel.dhaeseleer@uzbrussel.be %K multiple sclerosis %K teleconsultation %K internet %K feasibility %K eHealth %D 2020 %7 13.8.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: Telemedicine (TM) is currently flourishing in rural and emergency settings, but its implementation in the routine management of chronic neurological disorders has developed with more hesitation. Limited access to specialized care facilities and expanding patient populations, combined with unprecedented mobility restrictions imposed by the coronavirus disease pandemic, are currently stressing the need for remote solutions in this field. Studies in patients with multiple sclerosis (MS) have been heterogeneous in objectives and methodology but generally support the concept that TM interventions produce clinical benefits, cost-effectiveness, and user satisfaction. Nonetheless, data on live interaction between patients and health care providers for MS teleconsultation purposes remain scarce. Objective: The aim of this study is to demonstrate the feasibility of planned real time audiovisual teleconsultation over the internet for patients with MS. Methods: A total of 20 patients with MS presenting at a specialized MS center in Belgium were recruited for this study. One teleconsultation was scheduled for each participant. Patients were provided a unique hyperlink by mail in advance, leading them automatically and directly to the virtual waiting room, where they could accept or decline our incoming call. All teleconsultations were performed by a trained medical student with the intention to keep the conversation similar to what is usually discussed during a classic face-to-face MS consultation; no remote physical exams were performed. The approach was considered feasible if at least 80% of the planned TM visits could be successfully completed at the foreseen moment. Patient satisfaction (technical quality, convenience, and overall quality of care) was evaluated at the end of each teleconsultation by means of 5-point Likert scales containing the categories very unsatisfied, unsatisfied, neutral, satisfied, and highly satisfied. Results: Out of 20 consultations, 17 were successfully completed (85%). Failures were due to patients not responding (n=2) and technical issues (n=1). Out of the 17 consultations, 17 patients declared themselves satisfied or highly satisfied for technical quality, 15 patients for convenience, and 16 patients for overall quality of care. Conclusions: Planned real time audiovisual teleconsultation over the internet is feasible and highly appreciated in patients with MS. Incorporation of such services in routine clinical MS practice is expected to improve access to specialized care facilities for affected patients. %M 32447274 %R 10.2196/18178 %U https://www.jmir.org/2020/8/e18178 %U https://doi.org/10.2196/18178 %U http://www.ncbi.nlm.nih.gov/pubmed/32447274 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 9 %N 7 %P e15690 %T The Identification of Native Epitopes Eliciting a Protective High-Affinity Immunoglobulin Subclass Response to Blood Stages of Plasmodium falciparum: Protocol for Observational Studies %A Eisenhut,Michael %+ Luton&Dunstable University Hospital NHS Foundation Trust, Lewsey Road, Luton, LU40DZ, United Kingdom, 44 07784452559, michael_eisenhut@yahoo.com %K proteome %K immunome %K 2D electrophoresis %K Plasmodium falciparum %K immunoglobulin %K affinity %K avidity %K western blot %K conformational epitope %K nonlinear epitope %D 2020 %7 17.7.2020 %9 Protocol %J JMIR Res Protoc %G English %X Background: Antibodies to blood stages protective against complications of Plasmodium falciparum infection were found to be of immunoglobulin G 1 (IgG1) and IgG3 subclasses and of high affinity to the target epitopes. These target epitopes cannot be characterized using recombinant antigens because of a lack of appropriate glycosylation, phosphorylation, methylation, and bisulfide bond formation, which determine the structure of conformational and nonlinear epitopes within the tertiary and quaternary structures of native P. falciparum antigens. Objective: This study aims to develop a method for the comprehensive detection of all P. falciparum schizont antigens, eliciting a protective immune response. Methods: Purified parasitophorous vacuole membrane–enclosed merozoite structures (PEMSs) containing native schizont antigens are initially generated, separated by two-dimensional (2D) gel electrophoresis and blotted onto nitrocellulose. Antigens eliciting a protective antibody response are visualized by incubation with sera from patients with clinical immunity. This is followed by the elution of low-affinity antibodies with urea and detection of protective antibody responses by incubation with anti-IgG1 and anti-IgG3 antibodies, which were conjugated to horseradish peroxidase. This is followed by visualization with a color reaction. Blot signals are normalized by relating to the intensity of blot staining with a reference antibody and housekeeping antigens. Results are corrected for intensity of exposure by the relation of antibody responses to global P. falciparum antibody titers. Antigens eliciting the protective responses are identified as immunorelevant from the comparison of spot positions, indicating high-affinity IgG1 or IgG3 responses on the western blot, which is unique to or consistently more intensive in clinically immune individuals compared with nonimmune individuals. The results obtained are validated by using affinity chromatography. Results: Another group previously applied 2D western blotting to analyze antibody responses to P. falciparum. The sera of patients allowed the detection of 42 antigenic spots on the 2D immunoblot. The spots detected were excised and subjected to mass spectrometry for identification. A total of 19 protein spots were successfully identified and corresponded to 13 distinct proteins. Another group used immunoaffinity chromatography to identify antigens bound by IgGs produced by mice with enhanced immunity to Plasmodium yoelii. Immunorelevant antigens were isolated and identified by immobilizing immunoglobulin from immune mice to a Sephadex column and then passing a blood-stage antigen mixture through the column followed by the elution of specific bound antigens with sodium deoxycholate and the identification of those antigens by western blotting with specific antibodies. Conclusions: 2D western blotting using native antigens has the potential to identify antibody responses selective for specific defined isomeric forms of the same protein, including isoforms (protein species) generated by posttranscriptional modifications such as phosphorylation, glycosylation, and methylation. The process involved in 2D western blotting enables highly sensitive detection, high resolution, and preservation of antibody responses during blotting. Validation by immunoaffinity chromatography can compensate for the antigen loss associated with the blotting process. It has the potential for indirect quantification of protective antibody responses by enabling quantification of the amount of eluted antibody bound antigens through mass spectrometry. International Registered Report Identifier (IRRID): PRR1-10.2196/15690 %M 32706743 %R 10.2196/15690 %U https://www.researchprotocols.org/2020/7/e15690 %U https://doi.org/10.2196/15690 %U http://www.ncbi.nlm.nih.gov/pubmed/32706743 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 7 %N 7 %P e14536 %T A Digital Intervention for Adolescent Depression (MoodHwb): Mixed Methods Feasibility Evaluation %A Bevan Jones,Rhys %A Thapar,Anita %A Rice,Frances %A Mars,Becky %A Agha,Sharifah Shameem %A Smith,Daniel %A Merry,Sally %A Stallard,Paul %A Thapar,Ajay K %A Jones,Ian %A Simpson,Sharon A %+ Division of Psychological Medicine and Clinical Neurosciences, Medical Research Council Centre for Neuropsychiatric Genetics and Genomics, Cardiff University, Hadyn Ellis Building, Maindy Road, Cardiff, Wales, CF24 4HQ, United Kingdom, 44 02920688451, bevanjonesr1@cardiff.ac.uk %K adolescent %K depression %K internet %K education %K early medical intervention %K feasibility study %D 2020 %7 17.7.2020 %9 Original Paper %J JMIR Ment Health %G English %X Background: Treatment and prevention guidelines highlight the key role of health information and evidence-based psychosocial interventions for adolescent depression. Digital health technologies and psychoeducational interventions have been recommended to help engage young people and to provide accurate health information, enhance self-management skills, and promote social support. However, few digital psychoeducational interventions for adolescent depression have been robustly developed and evaluated in line with research guidance. Objective: We aimed to evaluate the feasibility, acceptability, and potential impact of a theory-informed, co-designed digital intervention program, MoodHwb. Methods: We used a mixed methods (quantitative and qualitative) approach to evaluate the program and the assessment process. Adolescents with or at elevated risk of depression and their parents and carers were recruited from mental health services, school counselors and nurses, and participants from a previous study. They completed a range of questionnaires before and after the program (related to the feasibility and acceptability of the program and evaluation process, and changes in mood, knowledge, attitudes, and behavior), and their Web usage was monitored. A subsample was also interviewed. A focus group was conducted with professionals from health, education, social, and youth services and charities. Interview and focus group transcripts were analyzed using thematic analysis with NVivo 10 (QSR International Pty Ltd). Results: A total of 44 young people and 31 parents or carers were recruited, of which 36 (82%) young people and 21 (68%) parents or carers completed follow-up questionnaires. In all, 19 young people and 12 parents or carers were interviewed. Overall, 13 professionals from a range of disciplines participated in the focus group. The key themes from the interviews and groups related to the design features, sections and content, and integration and context of the program in the young person’s life. Overall, the participants found the intervention engaging, clear, user-friendly, and comprehensive, and stated that it could be integrated into existing services. Young people found the “Self help” section and “Mood monitor” particularly helpful. The findings provided initial support for the intervention program theory, for example, depression literacy improved after using the intervention (difference in mean literacy score: 1.7, 95% CI 0.8 to 2.6; P<.001 for young people; 1.3, 95% CI 0.4 to 2.2; P=.006 for parents and carers). Conclusions: Findings from this early stage evaluation suggest that MoodHwb and the assessment process were feasible and acceptable, and that the intervention has the potential to be helpful for young people, families and carers as an early intervention program in health, education, social, and youth services and charities. A randomized controlled trial is needed to further evaluate the digital program. %M 32384053 %R 10.2196/14536 %U https://mental.jmir.org/2020/7/e14536 %U https://doi.org/10.2196/14536 %U http://www.ncbi.nlm.nih.gov/pubmed/32384053 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 8 %N 7 %P e15448 %T A Wearable Technology Delivering a Web-Based Diabetes Prevention Program to People at High Risk of Type 2 Diabetes: Randomized Controlled Trial %A Staite,Emily %A Bayley,Adam %A Al-Ozairi,Ebaa %A Stewart,Kurtis %A Hopkins,David %A Rundle,Jennifer %A Basudev,Neel %A Mohamedali,Zahra %A Ismail,Khalida %+ Institute of Psychiatry, Psychology and Neurosciences, King's College London, Western Education Centre, 10 Cutcombe Road, London, SE5 9RJ, United Kingdom, 44 207 848 5131, khalida.2.ismail@kcl.ac.uk %K motivational interviewing %K lifestyle %K diabetes prevention program %K theory of planned behavior %K type 2 diabetes mellitus %K wearable technology %K mobile phone %D 2020 %7 15.7.2020 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Intensive lifestyle interventions are effective in reducing the risk of type 2 diabetes, but the implementation of learnings from landmark studies is expensive and time consuming. The availability of digital lifestyle interventions is increasing, but evidence of their effectiveness is limited. Objective: This randomized controlled trial (RCT) aimed to test the feasibility of a web-based diabetes prevention program (DPP) with step-dependent feedback messages versus a standard web-based DPP in people with prediabetes. Methods: We employed a two-arm, parallel, single-blind RCT for people at high risk of developing diabetes. Patients with a hemoglobin A1c (HbA1c) level of 39-47 mmol/mol were recruited from 21 general practices in London. The intervention integrated a smartphone app delivering a web-based DPP course with SMS texts incorporating motivational interviewing techniques and step-dependent feedback messages delivered via a wearable device over 12 months. The control group received the wearable technology and access to the web-based DDP but not the SMS texts. As this was a feasibility study, the primary aim was to estimate potential sample size at different stages of the study, including the size of the target study population and the proportion of participants who consented, were randomized, and completed follow-up. We also measured the main outcomes for a full-scale RCT, namely, change in weight and physical activity at 6- and 12-month follow-ups, and secondary outcomes, including changes in the HbA1c level, blood pressure, waist circumference, waist-to-hip ratio, and lipid levels. Results: We enrolled 200 participants: 98 were randomized to the intervention and 102 were randomized to the control group. The follow-up rate was higher in the control group (87/102, 85.3%) than in the intervention group (69/98, 70%) at 12 months. There was no treatment effect on weight at 6 months (mean difference 0.15; 95% CI −0.93 to 1.23) or 12 months (mean difference 0.07 kg; 95% CI −1.29 to 1.44) or for physical activity levels at 6 months (mean difference −382.90 steps; 95% CI −860.65 to 94.85) or 12 months (mean difference 92.64 steps; 95% CI −380.92 to 566.20). We did not observe a treatment effect on the secondary outcomes measured at the 6-month or 12-month follow-up. For the intervention group, the mean weight was 92.33 (SD 15.67) kg at baseline, 91.34 (SD 16.04) kg at 6 months, and 89.41 (SD 14.93) kg at 12 months. For the control group, the mean weight was 92.59 (SD 17.43) kg at baseline, 91.71 (SD 16.48) kg at 6 months, and 91.10 (SD 15.82) kg at 12 months. In the intervention group, the mean physical activity was 7308.40 (SD 4911.93) steps at baseline, 5008.76 (SD 2733.22) steps at 6 months, and 4814.66 (SD 3419.65) steps at 12 months. In the control group, the mean physical activity was 7599.28 (SD 3881.04) steps at baseline, 6148.83 (SD 3433.77) steps at 6 months, and 5006.30 (SD 3681.1) steps at 12 months. Conclusions: This study demonstrates that it is feasible to successfully recruit and retain patients in an RCT of a web-based DPP. Trial Registration: ClinicalTrials.gov NCT02919397; http://clinicaltrials.gov/ct2/show/NCT02919397 %M 32459651 %R 10.2196/15448 %U https://mhealth.jmir.org/2020/7/e15448 %U https://doi.org/10.2196/15448 %U http://www.ncbi.nlm.nih.gov/pubmed/32459651 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 9 %N 7 %P e16543 %T Using Application Programming Interfaces to Access Google Data for Health Research: Protocol for a Methodological Framework %A Zepecki,Anne %A Guendelman,Sylvia %A DeNero,John %A Prata,Ndola %+ The Wallace Center for Maternal, Child, and Adolescent Health, School of Public Health, University of California, Berkeley, 2121 Berkeley Way #5302, Berkeley, CA, 94720, United States, 1 408 335 5009, annezepecki@berkeley.edu %K Google %K search data %K infodemiology %K infoveillance %K infodemic %K reproductive health %K abortion %K birth control %K Google Trends %K APIs %D 2020 %7 6.7.2020 %9 Protocol %J JMIR Res Protoc %G English %X Background: Individuals are increasingly turning to search engines like Google to obtain health information and access resources. Analysis of Google search queries offers a novel approach, which is part of the methodological toolkit for infodemiology or infoveillance researchers, to understanding population health concerns and needs in real time or near-real time. While searches predominantly have been examined with the Google Trends website tool, newer application programming interfaces (APIs) are now available to academics to draw a richer landscape of searches. These APIs allow users to write code in languages like Python to retrieve sample data directly from Google servers. Objective: The purpose of this paper is to describe a novel protocol to determine the top queries, volume of queries, and the top sites reached by a population searching on the web for a specific health term. The protocol retrieves Google search data obtained from three Google APIs: Google Trends, Google Health Trends (also referred to as Flu Trends), and Google Custom Search. Methods: Our protocol consisted of four steps: (1) developing a master list of top search queries for an initial search term using Google Trends, (2) gathering information on relative search volume using Google Health Trends, (3) determining the most popular sites using Google Custom Search, and (4) calculating estimated total search volume. We tested the protocol following key procedures at each step and verified its usefulness by examining search traffic on birth control in 2017 in the United States. Two separate programmers working independently achieved similar results with insignificant variation due to sample variability. Results: We successfully tested the methodology on the initial search term birth control. We identified top search queries for birth control, of which birth control pill was the most popular and obtained the relative and estimated total search volume for the top queries: relative search volume was 0.54 for the pill, corresponding to an estimated 9.3-10.7 million searches. We used the estimates of the proportion of search activity for the top queries to arrive at a generated list of the most popular websites: for the pill, the Planned Parenthood website was the top site. Conclusions: The proposed methodological framework demonstrates how to retrieve Google query data from multiple Google APIs and provides thorough documentation required to systematically identify search queries and websites, as well as estimate relative and total search volume of queries in real time or near-real time in specific locations and time periods. Although the protocol needs further testing, it allows researchers to replicate the steps and shows promise in advancing our understanding of population-level health concerns. International Registered Report Identifier (IRRID): RR1-10.2196/16543 %M 32442159 %R 10.2196/16543 %U https://www.researchprotocols.org/2020/7/e16543 %U https://doi.org/10.2196/16543 %U http://www.ncbi.nlm.nih.gov/pubmed/32442159 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 8 %N 6 %P e18204 %T Feasibility of a Home-Based Tablet App for Dexterity Training in Multiple Sclerosis: Usability Study %A van Beek,Judith Jantine Willemijn %A van Wegen,Erwin Everardus Henri %A Rietberg,Marc Berend %A Nyffeler,Thomas %A Bohlhalter,Stephan %A Kamm,Christian Philipp %A Nef,Tobias %A Vanbellingen,Tim %+ Neurocenter, Lucerne Cantonal Hospital, Spitalstrasse, Lucerne, 6000 16 Lucerne, Switzerland, 41 41 205 56 34, tim.vanbellingen@luks.ch %K dexterity %K feasibility %K multiple sclerosis %K rehabilitation %K app %K home-based training %D 2020 %7 9.6.2020 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Persons with multiple sclerosis (MS) often experience dexterous difficulties during the performance of activities of daily living, such as fastening buttons, handling coins, or writing, therefore impacting their health-related quality of life. Mobile health (mHealth) solutions, such as tablet apps, may be used to train impaired dexterous skills. The feasibility of a tablet app–based dexterity home-based intervention in MS (TAD-MS) has not been explored yet in persons with MS. Objective: The aim of this pilot study was to evaluate the feasibility and usability of home-based dexterity training with a tablet app in both persons with MS and healthy subjects. Methods: A total of 9 persons with MS, aged 35-71 years, with an Expanded Disability Status Scale score between 2 and 7.5, performed the TAD-MS for 4 weeks, five times a week, with each training session lasting approximately 30 minutes. Participants’ impaired dexterity was measured by the Nine-Hole Peg Test. A total of 10 age-matched healthy subjects also tested and rated the usability of the app. Outcome measures were the adherence rate as well as usability measured by the System Usability Scale and a Custom User Engagement Questionnaire (CUEQ). Results: High feasibility of the tablet app–based dexterity training program was shown by a 97% adherence rate to the training protocol (ie, mean 19.4/20 sessions completed, SD 0.8). High system usability scores (ie, mean 85.39%, SD 11.67) and overall high scores given in the CUEQ (ie, mean 8.2/10, SD 1.4) further point to high usability of the app. Neither demographic variables nor dexterity levels affected the use of the app. Conclusions: This pilot study is the first to demonstrate high feasibility and usability of a new tablet app–based dexterity home-based training program among both persons with MS and healthy individuals. Whether this kind of training improves dexterity will need to be evaluated in a randomized controlled trial. %M 32515747 %R 10.2196/18204 %U http://mhealth.jmir.org/2020/6/e18204/ %U https://doi.org/10.2196/18204 %U http://www.ncbi.nlm.nih.gov/pubmed/32515747 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 4 %N 6 %P e16371 %T Feasibility of In-Home Sensor Monitoring to Detect Mild Cognitive Impairment in Aging Military Veterans: Prospective Observational Study %A Seelye,Adriana %A Leese,Mira Isabelle %A Dorociak,Katherine %A Bouranis,Nicole %A Mattek,Nora %A Sharma,Nicole %A Beattie,Zachary %A Riley,Thomas %A Lee,Jonathan %A Cosgrove,Kevin %A Fleming,Nicole %A Klinger,Jessica %A Ferguson,John %A Lamberty,Greg John %A Kaye,Jeffrey %+ Minneapolis Veterans Affairs Health Care System, 1 Veterans Dr, Minneapolis, MN, , United States, 1 6127252000, adriana.seelye@va.gov %K aging %K mild cognitive impairment %K activities of daily living %K technology %D 2020 %7 8.6.2020 %9 Original Paper %J JMIR Form Res %G English %X Background: Aging military veterans are an important and growing population who are at an elevated risk for developing mild cognitive impairment (MCI) and Alzheimer dementia, which emerge insidiously and progress gradually. Traditional clinic-based assessments are administered infrequently, making these visits less ideal to capture the earliest signals of cognitive and daily functioning decline in older adults. Objective: This study aimed to evaluate the feasibility of a novel ecologically valid assessment approach that integrates passive in-home and mobile technologies to assess instrumental activities of daily living (IADLs) that are not well captured by clinic-based assessment methods in an aging military veteran sample. Methods: Participants included 30 community-dwelling military veterans, classified as healthy controls (mean age 72.8, SD 4.9 years; n=15) or MCI (mean age 74.3, SD 6.0 years; n=15) using the Clinical Dementia Rating Scale. Participants were in relatively good health (mean modified Cumulative Illness Rating Scale score 23.1, SD 2.9) without evidence of depression (mean Geriatrics Depression Scale score 1.3, SD 1.6) or anxiety (mean generalized anxiety disorder questionnaire 1.3, SD 1.3) on self-report measures. Participants were clinically assessed at baseline and 12 months later with health and daily function questionnaires and neuropsychological testing. Daily computer use, medication taking, and physical activity and sleep data were collected via passive computer monitoring software, an instrumented pillbox, and a fitness tracker watch in participants’ environments for 12 months between clinical study visits. Results: Enrollment began in October 2018 and continued until the study groups were filled in January 2019. A total of 201 people called to participate following public posting and focused mailings. Most common exclusionary criteria included nonveteran status 11.4% (23/201), living too far from the study site 9.4% (19/201), and having exclusionary health concerns 17.9% (36/201). Five people have withdrawn from the study: 2 with unanticipated health conditions, 2 living in a vacation home for more than half of the year, and 1 who saw no direct benefit from the research study. At baseline, MCI participants had lower Montreal Cognitive Assessment (P<.001) and higher Functional Activities Questionnaire (P=.04) scores than healthy controls. Over seven months, research personnel visited participants’ homes a total of 73 times for technology maintenance. Technology maintenance visits were more prevalent for MCI participants (P=.04) than healthy controls. Conclusions: Installation and longitudinal deployment of a passive in-home IADL monitoring platform with an older adult military veteran sample was feasible. Knowledge gained from this pilot study will be used to help develop acceptable and effective home-based assessment tools that can be used to passively monitor cognition and daily functioning in older adult samples. %M 32310138 %R 10.2196/16371 %U https://formative.jmir.org/2020/6/e16371 %U https://doi.org/10.2196/16371 %U http://www.ncbi.nlm.nih.gov/pubmed/32310138 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 8 %N 6 %P e16203 %T The Use of a Smartphone App and an Activity Tracker to Promote Physical Activity in the Management of Chronic Obstructive Pulmonary Disease: Randomized Controlled Feasibility Study %A Bentley,Claire L %A Powell,Lauren %A Potter,Stephen %A Parker,Jack %A Mountain,Gail A %A Bartlett,Yvonne Kiera %A Farwer,Jochen %A O'Connor,Cath %A Burns,Jennifer %A Cresswell,Rachel L %A Dunn,Heather D %A Hawley,Mark S %+ School of Health and Related Research, The University of Sheffield, Regent Court, 30 Regent Street, Sheffield, S1 4DA, United Kingdom, 44 114 222 1726, mark.hawley@sheffield.ac.uk %K mobile health %K mHealth %K chronic obstructive pulmonary disease %K feasibility %K physical activity %K activity tracker %K Fitbit %K self-management %K health behavior change %K pulmonary rehabilitation %D 2020 %7 3.6.2020 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Chronic obstructive pulmonary disease (COPD) is highly prevalent and significantly affects the daily functioning of patients. Self-management strategies, including increasing physical activity, can help people with COPD have better health and a better quality of life. Digital mobile health (mHealth) techniques have the potential to aid the delivery of self-management interventions for COPD. We developed an mHealth intervention (Self-Management supported by Assistive, Rehabilitative, and Telehealth technologies-COPD [SMART-COPD]), delivered via a smartphone app and an activity tracker, to help people with COPD maintain (or increase) physical activity after undertaking pulmonary rehabilitation (PR). Objective: This study aimed to determine the feasibility and acceptability of using the SMART-COPD intervention for the self-management of physical activity and to explore the feasibility of conducting a future randomized controlled trial (RCT) to investigate its effectiveness. Methods: We conducted a randomized feasibility study. A total of 30 participants with COPD were randomly allocated to receive the SMART-COPD intervention (n=19) or control (n=11). Participants used SMART-COPD throughout PR and for 8 weeks afterward (ie, maintenance) to set physical activity goals and monitor their progress. Questionnaire-based and physical activity–based outcome measures were taken at baseline, the end of PR, and the end of maintenance. Participants, and health care professionals involved in PR delivery, were interviewed about their experiences with the technology. Results: Overall, 47% (14/30) of participants withdrew from the study. Difficulty in using the technology was a common reason for withdrawal. Participants who completed the study had better baseline health and more prior experience with digital technology, compared with participants who withdrew. Participants who completed the study were generally positive about the technology and found it easy to use. Some participants felt their health had benefitted from using the technology and that it assisted them in achieving physical activity goals. Activity tracking and self-reporting were both found to be problematic as outcome measures of physical activity for this study. There was dissatisfaction among some control group members regarding their allocation. Conclusions: mHealth shows promise in helping people with COPD self-manage their physical activity levels. mHealth interventions for COPD self-management may be more acceptable to people with prior experience of using digital technology and may be more beneficial if used at an earlier stage of COPD. Simplicity and usability were more important for engagement with the SMART-COPD intervention than personalization; therefore, the intervention should be simplified for future use. Future evaluation will require consideration of individual factors and their effect on mHealth efficacy and use; within-subject comparison of step count values; and an opportunity for control group participants to use the intervention if an RCT were to be carried out. Sample size calculations for a future evaluation would need to consider the high dropout rates. %M 32490838 %R 10.2196/16203 %U https://mhealth.jmir.org/2020/6/e16203 %U https://doi.org/10.2196/16203 %U http://www.ncbi.nlm.nih.gov/pubmed/32490838 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 9 %N 5 %P e17603 %T An Ecologically Valid, Longitudinal, and Unbiased Assessment of Treatment Efficacy in Alzheimer Disease (the EVALUATE-AD Trial): Proof-of-Concept Study %A Thomas,Neil William Douglas %A Beattie,Zachary %A Marcoe,Jennifer %A Wright,Kirsten %A Sharma,Nicole %A Mattek,Nora %A Dodge,Hiroko %A Wild,Katherine %A Kaye,Jeffrey %+ Bruyère Research Institute, 43 Bruyère St, Ottawa, ON, K1N 5C8, Canada, 1 6135626322, nthomas@bruyere.org %K mild cognitive impairment %K Alzheimer disease %K mobile health %K clinical trial %K health information technology %D 2020 %7 27.5.2020 %9 Original Paper %J JMIR Res Protoc %G English %X Background: The current clinical trial assessment methodology relies on a combination of self-report measures, cognitive and physical function tests, and biomarkers. This methodology is limited by recall bias and recency effects in self-reporting and by assessments that are brief, episodic, and clinic based. Continuous monitoring of ecologically valid measures of cognition and daily functioning in the community may provide a more sensitive method to detect subtle, progressive changes in patients with cognitive impairment and dementia. Objective: This study aimed to present an alternative trial approach using a home-based sensing and computing system to detect changes related to common treatments employed in Alzheimer disease (AD). This paper introduces an ongoing study that aims to determine the feasibility of capturing sensor-based data at home and to compare the sensor-based outcomes with conventional outcomes. We describe the methodology used in the assessment protocol and present preliminary results of feasibility measures and examples of data related to medication-taking behavior, activity levels, and sleep. Methods: The EVALUATE-AD (Ecologically Valid, Ambient, Longitudinal and Unbiased Assessment of Treatment Efficacy in Alzheimer’s Disease) trial is a longitudinal naturalistic observational cohort study recruiting 30 patients and 30 spouse coresident care partners. Participants are monitored continuously using a home-based sensing and computing system for up to 24 months. Outcome measures of the automated system are compared with conventional clinical outcome measures in AD. Acceptance of the home system and protocol are assessed by rates of dropout and protocol adherence. After completion of the study monitoring period, a composite model using multiple functional outcome measures will be created that represents a behavioral-activity signature of initiating or discontinuing AD-related medications, such as cholinesterase inhibitors, memantine, or antidepressants. Results: The home-based sensing and computing system has been well accepted by individuals with cognitive impairment and their care partners. Participants showed good adherence to the completion of a weekly web-based health survey. Daily activity, medication adherence, and total time in bed could be derived from algorithms using data from the sensing and computing system. The mean monitoring time for current participants was 14.6 months. Medication adherence, as measured with an electronic pillbox, was 77% for participants taking AD-related medications. Conclusions: Continuous, home-based assessment provides a novel approach to test the impact of new or existing dementia treatments generating objective, clinically meaningful measures related to cognition and everyday functioning. Combining this approach with the current clinical trial methodology may ultimately reduce trial durations, sample size needs, and reliance on a clinic-based assessment. International Registered Report Identifier (IRRID): DERR1-10.2196/17603 %M 32459184 %R 10.2196/17603 %U http://www.researchprotocols.org/2020/5/e17603/ %U https://doi.org/10.2196/17603 %U http://www.ncbi.nlm.nih.gov/pubmed/32459184 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 4 %N 4 %P e14747 %T Interventions to Increase the Reachability of Migrants in Germany With Health Interview Surveys: Mixed-Mode Feasibility Study %A Zeisler,Marie-Luise %A Bilgic,Leman %A Schumann,Maria %A Wengler,Annelene %A Lemcke,Johannes %A Gößwald,Antje %A Lampert,Thomas %A Santos-Hövener,Claudia %A Schmich,Patrick %+ Robert Koch Institute, Berlin, Germany, 49 30 18754 3694, ZeislerM@rki.de %K transients and migrants %K surveys and questionnaires %K cross-sectional studies %K feasibility studies %K multilingualism and health monitoring %D 2020 %7 15.4.2020 %9 Original Paper %J JMIR Form Res %G English %X Background: Germany is a popular destination for immigrants, and migration has increased in recent years. It is therefore important to collect reliable data on migrants’ health. The Robert Koch Institute, Berlin, Germany, has launched the Improving Health Monitoring in Migrant Populations (IMIRA) project to sustainably integrate migrant populations into health monitoring in Germany. Objective: One of IMIRA’s objectives is to implement a feasibility study (the IMIRA survey) that focuses on testing various interventions to increase the reachability of migrants with health interview surveys. Possible causes of nonresponse should be identified so as to increase participation in future surveys. Methods: The survey target populations were Turkish, Polish, Romanian, Syrian, and Croatian migrants, who represent the biggest migrant groups living in Germany. We used probability sampling, using data from the registration offices in 2 states (Berlin and Brandenburg); we randomly selected 9068 persons by nationality in 7 sample points. We applied age (3 categories: 18-44, 45-64, and ≥65 years) and sex strata. Modes and methods used to test their usability were culturally sensitive materials, online questionnaires, telephone interviews, personal contact, and personal interviews, using multilingual materials and interviewers. To evaluate the effectiveness of the interventions, we used an intervention group (group A) and a control group (group B). There were also focus groups with the interviewers to get more information about the participants’ motivation. We used the European Health Interview Survey, with additional instruments on religious affiliation, experience of discrimination, and subjective social status. We evaluated results according to their final contact result (disposition code). Results: We collected data from January to May 2018 in Berlin and Brandenburg, Germany. The survey had an overall response rate of 15.88% (1190/7494). However, final disposition codes varied greatly with regard to citizenship. In addition to the quantitative results, interviewers reported in the focus groups a “feeling of connectedness” to the participants due to the multilingual interventions. The interviewers were particularly positive about the home visits, because “if you are standing at the front door, you will be let in for sure.” Conclusions: The IMIRA survey appraised the usability of mixed-mode or mixed-method approaches among migrant groups with a probability sample in 2 German states. When conducting the survey, we were confronted with issues regarding the translation of the questionnaire, as well as the validity of some instruments in the survey languages. A major result was that personal face-to-face contact was the most effective intervention to recruit our participants. We will implement the findings in the upcoming health monitoring study at the Robert Koch Institute. %M 32305950 %R 10.2196/14747 %U https://formative.jmir.org/2020/4/e14747 %U https://doi.org/10.2196/14747 %U http://www.ncbi.nlm.nih.gov/pubmed/32305950 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 8 %N 4 %P e16142 %T Evaluating the Feasibility of Frequent Cognitive Assessment Using the Mezurio Smartphone App: Observational and Interview Study in Adults With Elevated Dementia Risk %A Lancaster,Claire %A Koychev,Ivan %A Blane,Jasmine %A Chinner,Amy %A Wolters,Leona %A Hinds,Chris %+ Nuffield Department of Population Health, University of Oxford, Big Data Institute, Old Road Campus, Oxford, OX3 7LF, United Kingdom, 44 1865 743893, claire.lancaster@bdi.ox.ac.uk %K technology assessment %K cognition %K smartphone %K mhealth %K mobile phone %K Alzheimer disease %K early diagnosis %K feasibility study %K ecological momentary assessment %D 2020 %7 2.4.2020 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: By enabling frequent, sensitive, and economic remote assessment, smartphones will facilitate the detection of early cognitive decline at scale. Previous studies have sustained participant engagement with remote cognitive assessment over a week; extending this to a period of 1 month clearly provides a greater opportunity for measurement. However, as study durations are increased, the need to understand how participant burden and scientific value might be optimally balanced also increases. Objective: This study explored the little but often approach to assessment employed by the Mezurio app when prompting participants to interact every day for over a month. Specifically, this study aimed to understand whether this extended duration of remote study is feasible, and which factors promote sustained participant engagement over such periods. Methods: A total of 35 adults (aged 40-59 years) with no diagnosis of cognitive impairment were prompted to interact with the Mezurio smartphone app platform for up to 36 days, completing short, daily episodic memory tasks in addition to optional executive function and language tests. A subset (n=20) of participants completed semistructured interviews focused on their experience of using the app. Results: Participants complied with 80% of the daily learning tasks scheduled for subsequent tests of episodic memory, with 88% of participants still actively engaged by the final task. A thematic analysis of the participants’ experiences highlighted schedule flexibility, a clear user interface, and performance feedback as important considerations for engagement with remote digital assessment. Conclusions: Despite the extended study duration, participants demonstrated high compliance with the schedule of daily learning tasks and were extremely positive about their experiences. Long durations of remote digital interaction are therefore definitely feasible but only when careful attention is paid to the design of the users’ experience. %M 32238339 %R 10.2196/16142 %U https://mhealth.jmir.org/2020/4/e16142 %U https://doi.org/10.2196/16142 %U http://www.ncbi.nlm.nih.gov/pubmed/32238339 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 3 %P e16336 %T Love My Body: Pilot Study to Understand Reproductive Health Vulnerabilities in Adolescent Girls %A Tzilos Wernette,Golfo %A Countryman,Kristina %A Khatibi,Kristie %A Riley,Erin %A Stephenson,Rob %+ Department of Family Medicine, University of Michigan, 1018 Fuller Street, Ann Arbor, MI, 48104, United States, 1 (734) 998 7120, gtzilos@med.umich.edu %K adolescent %K alcohol %K sexually transmitted infections %K risky sex %K pregnancy %D 2020 %7 30.3.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: Sexually transmitted infections (STIs) are on the rise in the United States, and adolescent girls (15-19 years old) are more susceptible to acquiring STIs than their male peers. The co-occurrence of alcohol use and sexual risk taking contribute significantly to STI acquisition. Mobile health (mHealth) interventions are ideally suited for our target population and have demonstrated increases in STI testing in young people, as well as reductions in alcohol use. Objective: This pilot study used both qualitative and quantitative methods to explore the views of adolescent girls (age range 15-19 years old; 74.6%, 279/374 white) on the desired qualities and content of an mHealth app for sexual health. Methods: We conducted nine 60-min in-depth interviews (IDIs) to gather information and identify themes of sexual health and alcohol use, and we tested the feasibility of using a two-week social media campaign to collect survey information regarding sexual health risk in adolescent girls. Results: We iteratively coded IDIs and identified major themes around pressure of alcohol use, lack of STI knowledge, male pressure to not use condoms, and pregnancy as a worse outcome than STIs. Results from the web-based survey on risky health behaviors, which was completed by 367 participants, support the use of a sexual health app designed for girls. Conclusions: Future work will integrate these themes to inform the development of a culturally sensitive mHealth app to prevent STIs among adolescent girls. %M 32224484 %R 10.2196/16336 %U http://www.jmir.org/2020/3/e16336/ %U https://doi.org/10.2196/16336 %U http://www.ncbi.nlm.nih.gov/pubmed/32224484 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 8 %N 3 %P e16683 %T Using Mobile Health Tools to Engage Rural Underserved Individuals in a Diabetes Education Program in South Texas: Feasibility Study %A Yin,Zenong %A Lesser,Janna %A Paiva,Kristi A %A Zapata Jr,Jose %A Moreno-Vasquez,Andrea %A Grigsby,Timothy J %A Ryan-Pettes,Stacy R %A Parra-Medina,Deborah %A Estrada,Vanessa %A Li,Shiyu %A Wang,Jing %+ School of Nursing, The University of Texas Health Science Center at San Antonio, 7703 Floyd Curl Drive, San Antonio, TX, 78229, United States, 1 210 450 8561, wangj1@uthscsa.edu %K Screening, Brief Intervention, and Referral to Treatment (SBIRT) %K Hispanic Americans %K behavioral economics %K rural population %K diabetes %K screening %D 2020 %7 24.3.2020 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Access to diabetes education and resources for diabetes self-management is limited in rural communities, despite higher rates of diabetes in rural populations compared with urban populations. Technology and mobile health (mHealth) interventions can reduce barriers and improve access to diabetes education in rural communities. Screening, Brief Intervention, and Referral to Treatment (SBIRT) and financial incentives can be used with mHealth interventions to increase the uptake of diabetes education; however, studies have not examined their combined use for diabetes self-management in rural settings. Objective: This two-phase Stage 1 feasibility study aimed to use a mixed methods design to examine the feasibility and acceptability of an mHealth diabetes education program combining SBIRT and financial incentives to engage rural individuals. Methods: In Phase 1, we aimed to develop, adapt, and refine the intervention protocol. In Phase 2, a 3-month quasi-experimental study was conducted with individuals from 2 rural communities in South Texas. Study participants were individuals who attended free diabetes screening events in their community. Those with low or medium risk received health education material, whereas those with high risk or those with a previous diagnosis of diabetes participated in motivational interviewing and enrolled in the 6-week mHealth Diabetes Self-Management Education Program under either an unconditional or aversion incentive contract. The participants returned for a 3-month follow-up. Feasibility and acceptability of the intervention were determined by the rate of participant recruitment and retention, the fidelity of program delivery and compliance, and the participant’s satisfaction with the intervention program. Results: Of the 98 screened rural community members in South Texas, 72 individuals met the study eligibility and 62 individuals agreed to enroll in the study. The sample was predominately female and Hispanic, with an average age of 52.6 years. The feedback from study participants indicated high levels of satisfaction with the mHealth diabetes education program. In the poststudy survey, the participants reported high levels of confidence to continue lifestyle modifications, that is, weight loss, physical activity, and diet. The retention rate was 50% at the 3-month follow-up. Participation in the intervention was high at the beginning and dissipated in the later weeks regardless of the incentive contract type. Positive changes were observed in weight (mean -2.64, SD 6.01; P<.05) and glycemic control index (-.30; P<.05) in all participants from baseline to follow-up. Conclusions: The finding showed strong feasibility and acceptability of study recruitment and enrollment. The participants’ participation and retention were reasonable given the unforeseen events that impacted the study communities during the study period. Combining mHealth with SBIRT has the potential to reach individuals with need to participate in diabetes education in rural communities. %M 32207694 %R 10.2196/16683 %U http://mhealth.jmir.org/2020/3/e16683/ %U https://doi.org/10.2196/16683 %U http://www.ncbi.nlm.nih.gov/pubmed/32207694 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 2 %P e15424 %T Feasibility of an Electronic Health Tool to Promote Physical Activity in Primary Care: Pilot Cluster Randomized Controlled Trial %A Agarwal,Payal %A Kithulegoda,Natasha %A Bouck,Zachary %A Bosiak,Beth %A Birnbaum,Ilana %A Reddeman,Lindsay %A Steiner,Liane %A Altman,Liora %A Mawson,Robin %A Propp,Roni %A Thornton,Jane %A Ivers,Noah %+ Women’s College Hospital Institute for Health Systems Solutions and Virtual Care, Women's College Hospital, 76 Grenville St, Toronto, ON, M5S 1B2, Canada, 1 6474099450, payal.agarwal@wchospital.ca %K eHealth %K primary care %K physical activity %K patient-centered care %D 2020 %7 14.2.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: Physical inactivity is associated with increased health risks. Primary care providers (PCPs) are well positioned to support increased physical activity (PA) levels through screening and provision of PA prescriptions. However, PCP counseling on PA is not common. Objective: This study aimed to assess the feasibility of implementing an electronic health (eHealth) tool to support PA counseling by PCPs and estimate intervention effectiveness on patients’ PA levels. Methods: A pragmatic pilot study was conducted using a stepped wedge cluster randomized trial design. The study was conducted at a single primary care clinic, with 4 pre-existing PCP teams. Adult patients who had a periodic health review (PHR) scheduled during the study period were invited to participate. The eHealth tool involved an electronic survey sent to participants before their PHR via an email or a tablet; data were used to automatically produce tailored resources and a PA prescription in the electronic medical record of participants in the intervention arm. Participants assigned to the control arm received usual care from their PCP. Feasibility was assessed by the proportion of completed surveys and patient-reported acceptability and fidelity measures. The primary effectiveness outcome was patient-reported PA at 4 months post-PHR, measured as metabolic equivalent of task (MET) minutes per week. Secondary outcomes assessed determinants of PA, including self-efficacy and intention to change based on the Health Action Process Approach behavior change theory. Results: A total of 1028 patients receiving care from 34 PCPs were invited to participate and 530 (51.55%) consented (intervention [n=296] and control [n=234]). Of the participants who completed a process evaluation, almost half (88/178, 49.4%) stated they received a PA prescription, with only 42 receiving the full intervention including tailored resources from their PCP. A cluster-level linear regression analysis yielded a non–statistically significant positive difference in MET-minutes reported per week at follow-up between intervention and control conditions (mean difference 1027; 95% CI −155 to 2209; P=.09). No statistically significant differences were observed for secondary outcomes. Conclusions: Our results suggest that it is feasible to build an eHealth tool that screens and provides tailored resources for PA in a primary care setting but suboptimal intervention fidelity suggests greater work must be done to address PCP barriers to resource distribution. Participant responses to the primary effectiveness outcome (MET-minutes) were highly variable, reflecting a need for more robust measures of PA in future trials to address limitations in patient-reported data. Trial Registration: ClinicalTrials.gov NCT03181295; https://clinicaltrials.gov/ct2/show/NCT03181295 %M 32130122 %R 10.2196/15424 %U https://www.jmir.org/2020/2/e15424 %U https://doi.org/10.2196/15424 %U http://www.ncbi.nlm.nih.gov/pubmed/32130122 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 8 %N 1 %P e14557 %T The Florida Mobile Health Adherence Project for People Living With HIV (FL-mAPP): Longitudinal Assessment of Feasibility, Acceptability, and Clinical Outcomes %A Escobar-Viera,César %A Zhou,Zhi %A Morano,Jamie P %A Lucero,Robert %A Lieb,Spencer %A McIntosh,Sean %A Clauson,Kevin A %A Cook,Robert L %+ Center for Research on Media, Technology, and Health, University of Pittsburgh, 230 McKee Place, Suite 600, Pittsburgh, PA, 15213, United States, 1 412 692 4297, escobar-viera@pitt.edu %K mHealth %K HIV %K ART adherence %K feasibility %K acceptability %D 2020 %7 8.1.2020 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: For people living with HIV (PLWH), antiretroviral therapy (ART) adherence is crucial to attain better health outcomes. Although research has leveraged consumer health information technologies to enhance ART adherence, no study has evaluated feasibility and clinical outcomes associated with the usage of a commercially available, regularly updated mobile health (mHealth) app for improving ART adherence among PLWH. Objective: This study aimed to assess the feasibility, acceptability, and clinical outcomes of Care4Today, an existing, free, biprogrammatic mHealth app for improving ART adherence among PLWH. Methods: The Florida mHealth Application Adherence Project (FL-mAPP) was a 90-day longitudinal pilot study conducted in 3 public HIV clinics in Florida, United States. After obtaining informed consent, 132 participants completed a survey and then were given the option to try an existing mHealth app to help with ART adherence. Of these, 33.3% (44/132) declined, 31.1% (41/132) agreed but never used the app, and 35.6% (47/132) used the app. All were asked to complete follow-up surveys at 30 days and 90 days after enrollment. Usage data were used to assess feasibility. Clinical outcomes of self-reported ART adherence and chart-obtained HIV viral load and CD4+ T-cell counts were compared among those who used the platform (users) versus those who did not (nonusers). Participants and HIV care providers also provided responses to open-ended questions about what they liked and did not like about the app; comments were analyzed using thematic analysis. Results: Of 132 participants, 47 (35.6%) and 85 (64.4%) were categorized as users and nonusers, respectively. Among users, a Kaplan-Meier plot showed that 25 persons (53%) continued using the app after the 90-day follow-up. At 30-day follow-up, 13 (81.3%) of those who used the mHealth app reported ≥95% ART adherence, compared with 17 (58.6%) nonusers (P=.12). Overall, 39 (82%) users liked or somewhat liked using the platform. Participants’ favorite features were medication reminders, ability to create custom reminders, and adherence reports. Conclusions: This longitudinal study found that a commercially available medication adherence mHealth app was a feasible and acceptable intervention to improve ART adherence among PLWH and engaged in clinical care across 3 public HIV clinics in the state of Florida. Overall, participants liked the Care4Today app and thought the medication reminders were their favorite feature. Generally, self-reports of ART adherence were better among users than nonusers, both at 30- and 90-day follow-ups. Further clinical research needs to address user fatigue for improving app usage. %M 31913127 %R 10.2196/14557 %U https://mhealth.jmir.org/2020/1/e14557 %U https://doi.org/10.2196/14557 %U http://www.ncbi.nlm.nih.gov/pubmed/31913127 %0 Journal Article %@ 2371-4379 %I JMIR Publications %V 5 %N 1 %P e15744 %T Feasibility, Acceptability, and Impact of a Web-Based Structured Education Program for Type 2 Diabetes: Real-World Study %A Poduval,Shoba %A Marston,Louise %A Hamilton,Fiona %A Stevenson,Fiona %A Murray,Elizabeth %+ Research Department of Primary Care and Population Health, University College London, UCL Medical School (Royal Free Campus), Rowland Hill Street, London, NW3 2PF, United Kingdom, 44 (0) 20 7794 050 ext 36747, s.poduval@ucl.ac.uk %K diabetes mellitus, type 2 %K self-management %K patient education %K internet %K digital divide %K social class %K health literacy %K computer literacy %D 2020 %7 6.1.2020 %9 Original Paper %J JMIR Diabetes %G English %X Background: Structured education for people with type 2 diabetes improves outcomes, but uptake is low globally. In the United Kingdom in 2016, only 8.3% of people who were referred to education programs attended the program. We have developed a Web-based structured education program named Healthy Living for People with type 2 Diabetes (HeLP-Diabetes): Starting Out (HDSO), as an alternative to face-to-face courses. A Web-based program gives people more options for accessing structured education and may help improve overall uptake. Objective: The aim was to explore the feasibility and acceptability of delivering a Web-based structured education program (named HeLP-Diabetes: Starting Out) in routine primary health care and its potential impact on self-efficacy and diabetes-related distress. Methods: HDSO was delivered as part of routine diabetes services in primary health care in the United Kingdom, having been commissioned by local Clinical Commissioning Groups. Quantitative data were collected on uptake, use of the program, demographic characteristics, self-reported self-efficacy, and diabetes-related distress. A subsample of people with type 2 diabetes and health care professionals were interviewed about acceptability of the program. Results: It was feasible to deliver the program, but completion rates were low: of 791 people with type 2 diabetes registered, only 74 (9.0%) completed it. Completers improved their self-efficacy (change in median score 2.5, P=.001) and diabetes-related distress (change in median score 6.0, P=.001). Interview data suggested that the course was acceptable, and that uptake and completion may be related to nonprioritization of structured education. Conclusions: The study provides evidence of the feasibility and acceptability of a Web-based structured education. However, uptake and completion rates were low, limiting potential population impact. Further research is needed to improve completion rates, and to determine the relative effectiveness of Web-based versus face-to-face education. %M 31904580 %R 10.2196/15744 %U https://diabetes.jmir.org/2020/1/e15744 %U https://doi.org/10.2196/15744 %U http://www.ncbi.nlm.nih.gov/pubmed/31904580 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 7 %N 12 %P e13229 %T A Hospital-Community-Family–Based Telehealth Program for Patients With Chronic Heart Failure: Single-Arm, Prospective Feasibility Study %A Guo,Xiaorong %A Gu,Xiang %A Jiang,Jiang %A Li,Hongxiao %A Duan,Ruoyu %A Zhang,Yi %A Sun,Lei %A Bao,Zhengyu %A Shen,Jianhua %A Chen,Fukun %+ Clinical Medical College, Yangzhou University, No 98, Nantong West Road, Yangzhou, Jiangsu, 225009, China, 86 0514 87373366, guxiang@yzu.edu.cn %K telehealth %K chronic heart failure %K feasibility studies %K precise follow-up %K self-management %D 2019 %7 13.12.2019 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: An increasing number of patients with chronic heart failure (CHF) are demanding more convenient and efficient modern health care systems, especially in remote areas away from central cities. Telehealth is receiving increasing attention, which may be useful to patients with CHF. Objective: This study aimed to evaluate the feasibility of a hospital-community-family (HCF)–based telehealth program, which was designed to implement remote hierarchical management in patients with CHF. Methods: This was a single-arm prospective study in which 70 patients with CHF participated in the HCF-based telehealth program for remote intervention for at least 4 months. The participants were recruited from the clinic and educated on the use of smart health tracking devices and mobile apps to collect and manually upload comprehensive data elements related to the risk of CHF self-care management. They were also instructed on how to use the remote platform and mobile app to send text messages, check notifications, and open video channels. The general practitioners viewed the index of each participant on the mobile app and provided primary care periodically, and cardiologists in the regional central hospital offered remote guidance, if necessary. The assessed outcomes included accomplishments of the program, usability and satisfaction, engagement with the intervention, and changes of heart failure–related health behaviors. Results: As of February 2018, a total of 66 individuals, aged 40-79 years, completed the 4-month study. Throughout the study period, 294 electronic medical records were formed on the remote monitoring service platform. In addition, a total of 89 remote consultations and 196 remote ward rounds were conducted. Participants indicated that they were generally satisfied with the intervention for its ease of use and usefulness. More than 91% (21/23) of physicians believed the program was effective, and 87% (20/23) of physicians stated that their professional knowledge could always be refreshed and enhanced through a library hosted on the platform and remote consultation. More than 60% (40/66) of participants showed good adherence to the care plan in the study period, and 79% (52/66) of patients maintained a consistent pattern of reporting and viewing their data over the course of the 4-month follow-up period. The program showed a positive effect on self-management for patients (healthy diet: P=.046, more fruit and vegetable intake: P=.02, weight monitoring: P=.002, blood pressure: P<.001, correct time: P=.049, and daily dosages of medicine taken: P=.006). Conclusions: The HCF-based telehealth program is feasible and provided researchers with evidence of remote hierarchical management for patients with CHF, which can enhance participants’ and their families’ access and motivation to engage in self-management. Further prospective studies with a larger sample size are necessary to confirm the program’s effectiveness. %M 31833835 %R 10.2196/13229 %U https://mhealth.jmir.org/2019/12/e13229 %U https://doi.org/10.2196/13229 %U http://www.ncbi.nlm.nih.gov/pubmed/31833835 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 7 %N 12 %P e13671 %T Use of Mobile Health Apps and Wearable Technology to Assess Changes and Predict Pain During Treatment of Acute Pain in Sickle Cell Disease: Feasibility Study %A Johnson,Amanda %A Yang,Fan %A Gollarahalli,Siddharth %A Banerjee,Tanvi %A Abrams,Daniel %A Jonassaint,Jude %A Jonassaint,Charles %A Shah,Nirmish %+ Department of Pediatrics, Duke University, 2301 Erwin Road, Durham, NC, 27710, United States, 1 651 207 3255, amanda@ohsu.edu %K pain %K sickle cell disease %K SCD %K machine learning %D 2019 %7 2.12.2019 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Sickle cell disease (SCD) is an inherited red blood cell disorder affecting millions worldwide, and it results in many potential medical complications throughout the life course. The hallmark of SCD is pain. Many patients experience daily chronic pain as well as intermittent, unpredictable acute vaso-occlusive painful episodes called pain crises. These pain crises often require acute medical care through the day hospital or emergency department. Following presentation, a number of these patients are subsequently admitted with continued efforts of treatment focused on palliative pain control and hydration for management. Mitigating pain crises is challenging for both the patients and their providers, given the perceived unpredictability and subjective nature of pain. Objective: The objective of this study was to show the feasibility of using objective, physiologic measurements obtained from a wearable device during an acute pain crisis to predict patient-reported pain scores (in an app and to nursing staff) using machine learning techniques. Methods: For this feasibility study, we enrolled 27 adult patients presenting to the day hospital with acute pain. At the beginning of pain treatment, each participant was given a wearable device (Microsoft Band 2) that collected physiologic measurements. Pain scores from our mobile app, Technology Resources to Understand Pain Assessment in Patients with Pain, and those obtained by nursing staff were both used with wearable signals to complete time stamp matching and feature extraction and selection. Following this, we constructed regression and classification machine learning algorithms to build between-subject pain prediction models. Results: Patients were monitored for an average of 3.79 (SD 2.23) hours, with an average of 5826 (SD 2667) objective data values per patient. As expected, we found that pain scores and heart rate decreased for most patients during the course of their stay. Using the wearable sensor data and pain scores, we were able to create a regression model to predict subjective pain scores with a root mean square error of 1.430 and correlation between observations and predictions of 0.706. Furthermore, we verified the hypothesis that the regression model outperformed the classification model by comparing the performances of the support vector machines (SVM) and the SVM for regression. Conclusions: The Microsoft Band 2 allowed easy collection of objective, physiologic markers during an acute pain crisis in adults with SCD. Features can be extracted from these data signals and matched with pain scores. Machine learning models can then use these features to feasibly predict patient pain scores. %M 31789599 %R 10.2196/13671 %U https://mhealth.jmir.org/2019/12/e13671 %U https://doi.org/10.2196/13671 %U http://www.ncbi.nlm.nih.gov/pubmed/31789599 %0 Journal Article %@ 2369-1999 %I JMIR Publications %V 5 %N 2 %P e15539 %T Feasibility of an Interactive Patient Portal for Monitoring Physical Activity, Remote Symptom Reporting, and Patient Education in Oncology: Qualitative Study %A Marthick,Michael %A Janssen,Anna %A Cheema,Birinder S %A Alison,Jennifer %A Shaw,Tim %A Dhillon,Haryana %+ Research in Implementation Science and eHealth Group, Faculty of Medicine and Health, University of Sydney, Charles Perkins Centre, John Hopkins Drive, Camperdown, 2006, Australia, 61 02 86271616, mmar7320@uni.sydney.edu.au %K physical activity %K patient Web portals %K neoplasms %D 2019 %7 28.11.2019 %9 Original Paper %J JMIR Cancer %G English %X Background: Digital health interventions, such as the use of patient portals, have been shown to offer benefits to a range of patients including those with a diagnosis of cancer. Objective: This study aimed to explore the participant experience and perception of using an interactive Web-based portal for monitoring physical activity, remote symptom reporting, and delivering educational components. Methods: Participants who were currently under treatment or had recently completed intensive treatment for cancer were recruited to three cohorts and invited to join a Web-based portal to enhance their physical activity. Cohort 1 received Web portal access and an activity monitor; cohort 2 had additional summative messaging; and cohort 3 had additional personalized health coaching messaging. Following the 10-week intervention, participants were invited to participate in a semistructured interview. Interview recordings were transcribed and evaluated using qualitative thematic analysis. Results: A total of 17 semistructured interviews were carried out. Participants indicated that using the Web portal was feasible. Personalized messaging improved participant perceptions of the value of the intervention. There was a contrast between cohorts and levels of engagement with increasing health professional contact leading to an increase in engagement. Educational material needs to be tailored to the participants’ cancer treatment status, health literacy, and background. Conclusions: Participants reported an overall positive experience using the Web portal and that personalized messaging positively impacted on their health behaviors. Future studies should focus more on design of interventions, ensuring appropriate tailoring of information and personalization of behavioral support messaging. International Registered Report Identifier (IRRID): RR2-10.2196/9586 %M 31778123 %R 10.2196/15539 %U http://cancer.jmir.org/2019/2/e15539/ %U https://doi.org/10.2196/15539 %U http://www.ncbi.nlm.nih.gov/pubmed/31778123 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 6 %N 11 %P e14776 %T A Web-Based Self-Help Psychosocial Intervention for Adolescents Distressed by Appearance-Affecting Conditions and Injuries (Young Persons’ Face IT): Feasibility Study for a Parallel Randomized Controlled Trial %A Williamson,Heidi %A Hamlet,Claire %A White,Paul %A Marques,Elsa M R %A Paling,Thomas %A Cadogan,Julia %A Perera,Rohan %A Rumsey,Nichola %A Hayward,Leighton %A Harcourt,Diana %+ Faculty of Health and Applied Sciences, University of the West of England, Coldharbour Lane, Bristol, BS16 1QY, United Kingdom, 44 01173281572, Heidi3.Williamson@uwe.ac.uk %K physical appearance, body image, disfigurement %K visible difference %K adolescents %K young people %K psychological support %K online intervention. %D 2019 %7 22.11.2019 %9 Original Paper %J JMIR Ment Health %G English %X Background: Disfigurement (visible difference) from wide-ranging congenital or acquired conditions, injuries, or treatments can negatively impact adolescents’ psychological well-being, education and health behaviours. Alongside medical interventions, appearance-specific cognitive behavioural and social skills training to manage stigma and appearance anxiety may improve psychosocial outcomes. YP Face IT (YPF), is a Web-based seven session self-help program plus booster quiz, utilising cognitive behavioural and social skills training for young people (YP) struggling with a visible difference. Co-designed by adolescents and psychologists, it includes interactive multimedia and automated reminders to complete sessions/homework. Adolescents access YPF via a health professional who determines its suitability and remotely monitors clients’ usage. Objective: To establish the feasibility of evaluating YPF for 12-17 year olds self-reporting appearance-related distress and/or bullying associated with a visible difference. Methods: Randomized controlled trial with nested qualitative and economic study evaluating YPF compared with usual care (UC). Feasibility outcomes included: viability of recruiting via general practitioner (GP) practices (face to face and via patient databases) and charity advertisements; intervention acceptability and adherence; feasibility of study and data collection methods; and health professionals’ ability to monitor users’ online data for safeguarding issues. Primary psychosocial self-reported outcomes collected online at baseline, 13, 26, and 52 weeks were as follows: appearance satisfaction (Appearance Subscale from Mendleson et al’s (2001) Body Esteem Scale); social anxiety (La Greca’s (1999) Social Anxiety Scale for Adolescents). Secondary outcomes were; self-esteem; romantic concerns; perceived stigmatization; social skills and healthcare usage. Participants were randomised using remote Web-based allocation. Results: Thirteen charities advertised the study yielding 11 recruits, 13 primary care practices sent 687 invitations to patients on their databases with a known visible difference yielding 17 recruits (2.5% response rate), 4 recruits came from GP consultations. Recruitment was challenging, therefore four additional practices mass-mailed 3,306 generic invitations to all 12-17 year old patients yielding a further 15 participants (0.5% response rate). Forty-seven YP with a range of socioeconomic backgrounds and conditions were randomised (26% male, 91% white, mean age 14 years (SD 1.7)); 23 to YPF, 24 to UC). At 52 weeks, 16 (70%) in the intervention and 20 (83%) in UC groups completed assessments. There were no intervention-related adverse events; most found YPF acceptable with three withdrawing because they judged it was for higher-level concerns; 12 (52%) completed seven sessions. The study design was acceptable and feasible, with multiple recruitment strategies. Preliminary findings indicate no changes from baseline in outcome measures among the UC group and positive changes in appearance satisfaction and fear of negative evaluation among the YPF group when factoring in baseline scores and intervention adherence. Conclusions: YPF is novel, safe and potentially helpful. Its full psychosocial benefits should be evaluated in a large-scale RCT, which would be feasible with wide-ranging recruitment strategies. Trial Registration: ISRCTN registry ISRCTN40650639; http://www.isrctn.com/ISRCTN40650639 %M 31755870 %R 10.2196/14776 %U http://mental.jmir.org/2019/11/e14776/ %U https://doi.org/10.2196/14776 %U http://www.ncbi.nlm.nih.gov/pubmed/31755870 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 8 %N 9 %P e14406 %T Quality of Life of Patients With Osteosarcoma in the European American Osteosarcoma Study-1 (EURAMOS-1): Development and Implementation of a Questionnaire Substudy %A Calaminus,Gabriele %A Jenney,Meriel %A Hjorth,Lars %A Baust,Katja %A Bernstein,Mark %A Bielack,Stefan %A Vos,Patricia De %A Hogendoorn,Pancras C W %A Jovic,Gordana %A Krailo,Mark %A Kreitz,Kiana %A Marina,Neyssa %A Popoola,Babasola O %A Sauerland,Cristina %A Smeland,Sigbjørn %A Teske,Carmen %A Schweinitz,Clara V %A Whelan,Jeremy %A Wiener,Andreas %A Sydes,Matthew R %A Nagarajan,Rajaram %+ Department of Pediatric Hematology and Oncology, University Hospital Bonn, Adenauerallee 119, Bonn, 53113, Germany, 49 228287 ext 33254, gabriele.calaminus@ukbonn.de %K osteosarcoma %K quality of life %K cancer %K child %K adolescent %K young adult %K observational study %K sarcoma %K survivors of childhood cancer %D 2019 %7 26.9.2019 %9 Original Paper %J JMIR Res Protoc %G English %X Background: The quality of life (QoL) of patients with osteosarcoma (OS) may be adversely affected by the disease or its treatment. Therefore, it is important to understand the QoL of patients undergoing treatment for OS to improve the QoL. We report on the first prospective international QoL study that was embedded within a large randomized clinical trial from 4 national study groups. Objective: This paper aimed to describe the QoL study development, methodology, accrual details, and characteristics of the QoL cohort. Methods: A total of 2260 patients registered in the EURopean AMerican Osteosarcoma Study-1 (EURAMOS-1), of whom 97.92% (2213/2260) were eligible for the optional QoL assessment and could participate in terms of questionnaire availability. Overall, 61.86% (1369/2213) of patients and/or proxies completed the QoL evaluation at the first assessment time point (E1) after the start of preoperative treatment. The QoL measures used (self- and/or proxy reports) depending on the patient’s age and national study group. Participants and nonparticipants in the ancillary QoL study were compared regarding relevant demographic and disease-related characteristics at registration in the trial. Results: The participation rate at time point E1 did not differ with regard to age, gender, the occurrence of pathological fracture, or the presence of any metastases at diagnosis. No differences were found regarding the primary tumor site. Only the national study group affiliation had an influence on participation. Participation decreased linearly with trial progress up to 20% at the final time point of QoL assessment. Conclusions: This study demonstrates the feasibility of international cooperation for the purpose of assessing and understanding the QoL of pediatric and adolescent/young adult patients with cancer. Future outcomes of this QoL substudy will help to adapt interventions to improve QoL. %M 31573951 %R 10.2196/14406 %U https://www.researchprotocols.org/2019/9/e14406 %U https://doi.org/10.2196/14406 %U http://www.ncbi.nlm.nih.gov/pubmed/31573951 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 7 %N 9 %P e13725 %T Using Wearable Physiological Monitors With Suicidal Adolescent Inpatients: Feasibility and Acceptability Study %A Kleiman,Evan %A Millner,Alexander J %A Joyce,Victoria W %A Nash,Carol C %A Buonopane,Ralph J %A Nock,Matthew K %+ Rutgers, The State University of New Jersey, Department of Psychology, 53 Avenue E, Room 627, Piscataway, NJ, 08854, United States, 1 8484452345, evan.kleiman@rutgers.edu %K feasibility studies %K wearable electronic devices %K adolescent, hospitalized %K self-injurious behavior %K qualitative research %D 2019 %7 24.09.2019 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Wearable physiological monitoring devices enable the continuous measurement of human behavior and psychophysiology in the real world. Although such monitors are promising, their availability does not guarantee that participants will continuously wear and interact with them, especially during times of psychological distress. Objective: This study aimed to evaluate the feasibility and acceptability of using a wearable behavioral and physiological monitor, the Empatica E4, to continuously assess a group of suicidal adolescent inpatients. Methods: Participants (n=50 adolescent inpatients) were asked to wear an Empatica E4 on their wrist for the duration of their inpatient stay. In addition to assessing behavioral metadata (eg, hours worn per day), we also used qualitative interviews and self-report measures to assess participants’ experience of wearing the monitor. Results: Results supported the feasibility and acceptability of this approach. Participants wore the monitor for an average of 18 hours a day and reported that despite sometimes finding the monitor uncomfortable, they did not mind wearing it. Many of the participants noted that the part of the study they enjoyed most was contributing to scientific understanding, especially if it could help people similar to them in the future. Conclusions: These findings provide promising support for using wearable monitors in clinical samples in future studies, especially if participants are invested in being part of a research study. %M 31586364 %R 10.2196/13725 %U http://mhealth.jmir.org/2019/9/e13725/ %U https://doi.org/10.2196/13725 %U http://www.ncbi.nlm.nih.gov/pubmed/31586364 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 6 %N 9 %P e13887 %T An Immersive Virtual Reality Platform for Assessing Spatial Navigation Memory in Predementia Screening: Feasibility and Usability Study %A Ijaz,Kiran %A Ahmadpour,Naseem %A Naismith,Sharon L %A Calvo,Rafael A %+ Centre for Health Informatics, Australian Institute of Health Innovation, Macquarie University, Level 6, 75 Talavera Road, Macquarie University, North Ryde,, Sydney, 2109, Australia, 61 298502494, kiran.ijaz@mq.edu.au %K virtual reality %K healthy aging %K memory %K cognition %K dementia %D 2019 %7 03.09.2019 %9 Original Paper %J JMIR Ment Health %G English %X Background: Traditional methods for assessing memory are expensive and have high administrative costs. Memory assessment is important for establishing cognitive impairment in cases such as detecting dementia in older adults. Virtual reality (VR) technology can assist in establishing better quality outcome in such crucial screening by supporting the well-being of individuals and offering them an engaging, cognitively challenging task that is not stressful. However, unmet user needs can compromise the validity of the outcome. Therefore, screening technology for older adults must address their specific design and usability requirements. Objective: This study aimed to design and evaluate the feasibility of an immersive VR platform to assess spatial navigation memory in older adults and establish its compatibility by comparing the outcome to a standard screening platform on a personal computer (PC). Methods: VR-CogAssess is a platform integrating an Oculus Rift head-mounted display and immersive photorealistic imagery. In a pilot study with healthy older adults (N=42; mean age 73.22 years, SD 9.26), a landmark recall test was conducted, and assessment on the VR-CogAssess was compared against a standard PC (SPC) setup. Results: Results showed that participants in VR were significantly more engaged (P=.003), achieved higher landmark recall scores (P=.004), made less navigational mistakes (P=.04), and reported a higher level of presence (P=.002) than those in SPC setup. In addition, participants in VR indicated no significantly higher stress than SPC setup (P=.87). Conclusions: The study findings suggest immersive VR is feasible and compatible with SPC counterpart for spatial navigation memory assessment. The study provides a set of design guidelines for creating similar platforms in the future. %M 31482851 %R 10.2196/13887 %U https://mental.jmir.org/2019/9/e13887/ %U https://doi.org/10.2196/13887 %U http://www.ncbi.nlm.nih.gov/pubmed/31482851 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 8 %N 8 %P e13400 %T Noncontact Heart and Respiratory Rate Monitoring of Preterm Infants Based on a Computer Vision System: Protocol for a Method Comparison Study %A Gibson,Kim %A Al-Naji,Ali %A Fleet,Julie-Anne %A Steen,Mary %A Chahl,Javaan %A Huynh,Jasmine %A Morris,Scott %+ School of Nursing and Midwifery, University of South Australia, North Terrace, City East, Adelaide, 5000, Australia, 61 83022706, kim.gibson@unisa.edu.au %K heart rate %K respiratory rate %K infant %K electrocardiography %K computers %D 2019 %7 29.08.2019 %9 Protocol %J JMIR Res Protoc %G English %X Background: Biomedical research in the application of noncontact methods to measure heart rate (HR) and respiratory rate (RR) in the neonatal population has produced mixed results. This paper describes and discusses a protocol for conducting a method comparison study, which aims to determine the accuracy of a proposed noncontact computer vision system to detect HR and RR relative to the HR and RR obtained by 3-lead electrocardiogram (ECG) in preterm infants in the neonatal unit. Objective: The aim of this preliminary study is to determine the accuracy of a proposed noncontact computer vision system to detect HR and RR relative to the HR and RR obtained by 3-lead ECG in preterm infants in the neonatal unit. Methods: A single-center cross-sectional study was planned to be conducted in the neonatal unit at Flinders Medical Centre, South Australia, in May 2018. A total of 10 neonates and their ECG monitors will be filmed concurrently for 10 min using digital cameras. Advanced image processing techniques are to be applied later to determine their physiological data at 3 intervals. These data will then be compared with the ECG readings at the same points in time. Results: Study enrolment began in May 2018. Results of this study were published in July 2019. Conclusions: The study will analyze the data obtained by the noncontact system in comparison to data obtained by ECG, identify factors that may influence data extraction and accuracy when filming infants, and provide recommendations for how this noncontact system may be implemented into clinical applications. International Registered Report Identifier (IRRID): RR1-10.2196/13400 %M 31469077 %R 10.2196/13400 %U https://www.researchprotocols.org/2019/8/e13400 %U https://doi.org/10.2196/13400 %U http://www.ncbi.nlm.nih.gov/pubmed/31469077 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 21 %N 8 %P e14021 %T Using Facebook Advertising to Recruit Representative Samples: Feasibility Assessment of a Cross-Sectional Survey %A Shaver,Lance Garrett %A Khawer,Ahmed %A Yi,Yanqing %A Aubrey-Bassler,Kris %A Etchegary,Holly %A Roebothan,Barbara %A Asghari,Shabnam %A Wang,Peizhong Peter %+ Division of Community Health and Humanities, Faculty of Medicine, Memorial University of Newfoundland, Room 4M205, St John's, NL, A1B 3V6, Canada, 1 709 777 8571, pwang@mun.ca %K Facebook %K health surveys %K Canada %K research subject recruitment %K social media %K internet %K online recruitment %D 2019 %7 19.08.2019 %9 Original Paper %J J Med Internet Res %G English %X Background: Facebook has shown promise as an economical means of recruiting participants for health research. However, few studies have evaluated this recruitment method in Canada, fewer still targeting older adults, and, to our knowledge, none specifically in Newfoundland and Labrador (NL). Objective: This study aimed to assess Facebook advertising as an economical means of recruiting a representative sample of adults aged 35 to 74 years in NL for a cross-sectional health survey. Methods: Facebook advertising was used to recruit for a Web-based survey on cancer awareness and prevention during April and May 2018; during recruitment, additional advertisements were targeted to increase representation of demographics that we identified as being underrepresented in our sample. Sociodemographic and health characteristics of the study sample were compared with distributions of the underlying population to determine representativeness. Cramer V indicates the magnitude of the difference between the sample and population distributions, interpreted as small (Cramer V=0.10), medium (0.30), and large (0.50). Sample characteristics were considered representative if there was no statistically significant difference in distributions (chi-square P>.01) or if the difference was small (V≤0.10), and practically representative if 0.10.05), the decrease in body weight, BMI, body fat, visceral fat rating and leptin level, and increase in adiponectin level were notable in group 2 before and after the intervention. Conclusions: The high compliance rate and high satisfaction toward the trial arrangement indicate that AA can be used to achieve weight reduction and applied in future large-scale studies. AA integrated with the smartphone app has a more notable effect than using AA alone for weight reduction. Larger sample size should be considered in future trials to determine the causal relationship between treatment and effect. Trial Registration: ClinicalTrials.gov NCT03442712; https://clinicaltrials.gov/ct2/show/NCT03442712 (Archived by WebCite at http://www.webcitation.org/78L2tO8Ql) %M 31144666 %R 10.2196/14386 %U http://mhealth.jmir.org/2019/5/e14386/ %U https://doi.org/10.2196/14386 %U http://www.ncbi.nlm.nih.gov/pubmed/31144666 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 21 %N 5 %P e13387 %T Feasibility and Acceptability of a Mobile Technology Intervention to Support Postabortion Care in British Columbia: Phase I %A Gill,Roopan %A Ogilvie,Gina %A Norman,Wendy V %A Fitzsimmons,Brian %A Maher,Ciana %A Renner,Regina %+ Department of Obstetrics and Gynaecology, Women's Health Research Institute, University of British Columbia, 4500 Oak Street, Vancouver, BC,, Canada, 1 604 369 0774, roopan.gill@gmail.com %K mHealth %K family planning %K abortion, induced %K sexual health %K digital health %K user-centered design %D 2019 %7 29.05.2019 %9 Original Paper %J J Med Internet Res %G English %X Background: Over 30% of women in Canada undergo an abortion. Despite the prevalence of the procedure, stigma surrounding abortion in Canada leads to barriers for women to access this service. The vast majority of care is concentrated in urban settings. There is evidence to support utilization of innovative mobile and other technology solutions to empower women to safely and effectively self-manage aspects of the abortion process. This study is part 1 of a 3-phase study that utilizes user-centered design methodology to develop a digital health solution to specifically support follow-up after an induced surgical abortion. Objective: This study aimed to (1) understand how women at 3 surgical abortion clinics in an urban center of British Columbia utilize their mobile phones to access health care information and (2) understand women’s preferences of content and design of an intervention that will support follow-up care after an induced abortion, including contraceptive use. Methods: The study design was based on development-evaluation-implementation process from Medical Research Council Framework for Complex Medical Interventions. This was a mixed-methods formative study. Women (aged 14-45 years) were recruited from 3 urban abortion facilities in British Columbia who underwent an induced abortion. Adaptation of validated surveys and using the technology acceptance model and theory of reasoned action, a cross-sectional survey was designed. Interview topics included demographic information; type of wireless device used; cell phone usage; acceptable information to include in a mobile intervention to support women’s abortion care; willingness to use a mobile phone to obtain reproductive health information; optimal strategies to use a mobile intervention to support women; understand preferences for health information resources; and design qualities in a mobile intervention important for ease of use, privacy, and security. Responses to questions in the survey were summarized using descriptive statistics. Qualitative analysis was conducted with NVivo using a thematic analysis approach. This study was approved by the local ethics board. Results: A waiting-room survey was completed by 50 participants, and semistructured interviews were completed with 8 participants. The average age of participants was 26 years. Furthermore, 94% (47/50) owned a smartphone, 85% (41/48) used their personal phones to go online, and 85% would use their cell phone to assist in clinical care. Qualitative analysis demonstrated that women prefer a comprehensive website that included secure email or text notifications to provide tools and resources for emotional well-being, contraceptive decision making, general sexual health, and postprocedure care. Conclusions: A community-based mixed-methods approach allowed us to understand how women use their cell phones and what women desire in a mobile intervention to support their postabortion care. The findings from this formative phase will assist in the development and testing of a mobile intervention to support follow-up care after an induced surgical abortion. %M 31144668 %R 10.2196/13387 %U http://www.jmir.org/2019/5/e13387/ %U https://doi.org/10.2196/13387 %U http://www.ncbi.nlm.nih.gov/pubmed/31144668 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 8 %N 5 %P e12455 %T Feasibility of a Sleep Self-Management Intervention in Pregnancy Using a Personalized Health Monitoring Device: Protocol for a Pilot Randomized Controlled Trial %A Hawkins,Marquis %A Iradukunda,Favorite %A Paterno,Mary %+ Department of Epidemiology, University of Pittsburgh, 130 DeSoto Street, 5138 Public Health, Pittsburgh, PA,, United States, 1 412 383 1931, mah400@pitt.edu %K eHealth %K pregnancy %K personal health monitoring %K behavior %K maternal health %D 2019 %7 29.05.2019 %9 Protocol %J JMIR Res Protoc %G English %X Background: Sleep disruptions are common during pregnancy and associated with increased risk of adverse maternal outcomes such as preeclampsia, gestational diabetes, prolonged labor, and cesarean birth. Given the morbidity associated with poor sleep, cost-effective approaches to improving sleep that can be disseminated in community or clinical settings are needed. Personal health monitor (PHM) devices offer an opportunity to promote behavior change, but their acceptability and efficacy at improving sleep in pregnant women are unknown. Objective: The goal of the paper is to describe the protocol for an ongoing pilot randomized controlled trial that aims to establish the feasibility, acceptability, and preliminary efficacy of using a PHM device (Shine 2, Misfit) to promote sleep during pregnancy. Methods: The proposed pilot study is a 12-week, parallel arm, randomized controlled trial. Pregnant women, at 24 weeks gestation, will be randomized at a 1:1 ratio to a 12-week sleep education plus PHM device group or a sleep education alone comparison group. The primary outcomes will be measures of feasibility (ie, recruitment, enrollment, adherence) and acceptability (ie, participant satisfaction). The secondary outcomes will be self-reported sleep quality and duration, excessive daytime sleepiness, fatigue, and depressive symptoms. Results: Recruitment for this study began in September 2017 and ended in March 2018. Data collection for the primary and secondary aims was completed in August 2018. We anticipate that the data analysis for primary and secondary aims will be completed by December 2019. The results from this trial will inform the development of a larger National Institutes of Health grant application to test the efficacy of an enhanced version of the sleep intervention that we plan to submit in the year 2020. Conclusions: This study will be the first to apply a PHM device as a tool for promoting self-management of sleep among pregnant women. PHM devices have the potential to facilitate behavioral interventions because they include theory-driven, self-regulatory techniques such as behavioral self-monitoring. The results of the study will inform the development of a sleep health intervention for pregnant women. Trial Registration: ClinicalTrials.gov NCT03783663; https://clinicaltrials.gov/ct2/show/NCT03783663 (Archived by WebCite at http://www.webcitation.org/779Ou8hon) International Registered Report Identifier (IRRID): DERR1-10.2196/12455 %M 31144670 %R 10.2196/12455 %U https://www.researchprotocols.org/2019/5/e12455/ %U https://doi.org/10.2196/12455 %U http://www.ncbi.nlm.nih.gov/pubmed/31144670 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 3 %N 2 %P e13882 %T Feasibility and Acceptability of Using a Mobile Phone App for Characterizing Auditory Verbal Hallucinations in Adolescents With Early-Onset Psychosis: Exploratory Study %A Smelror,Runar Elle %A Bless,Josef Johann %A Hugdahl,Kenneth %A Agartz,Ingrid %+ Department of Psychiatric Research, Diakonhjemmet Hospital, PO Box 85 Vinderen, Oslo, 0319, Norway, 47 95744029, runar.smelror@medisin.uio.no %K experience sampling method %K ecological momentary assessment %K schizophrenia %K mHealth %K health care technology %D 2019 %7 14.05.2019 %9 Original Paper %J JMIR Form Res %G English %X Background: Auditory verbal hallucinations (AVH) are the most frequent symptom in early-onset psychosis (EOP) and a risk factor for increased suicide attempts in adolescents. Increased knowledge of AVH characteristics can lead to better prediction of risk and precision of diagnosis and help identify individuals with AVH who need care. As 98% of Norwegian adolescents aged 12 to 16 years own a mobile phone, the use of mobile phone apps in symptom assessment and patient communication is a promising new tool. However, when introducing new technology to patients, their subjective experiences are crucial in identifying risks, further development, and potential integration into clinical care. Objective: The objective was to explore the feasibility and acceptability of a newly developed mobile phone app in adolescents with EOP by examining compliance with the app and user experiences. Indication of validity was explored by examining associations between AVH dimensions, which were correlated and analyzed. Methods: Three adolescents with EOP and active AVH were enrolled. Real-time AVH were logged on an iPod touch using the experience sampling method (ESM), for seven or more consecutive days. The app included five dimensions of AVH characteristics and was programmed with five daily notifications. Feasibility and acceptability were examined using the mean response rate of data sampling and by interviewing the participants. Validity was assessed by examining associations between the AVH dimensions using nonparametric correlation analysis and by visual inspection of temporal fluctuations of the AVH dimensions. Results: One participant was excluded from the statistical analyses but completed the interview and was included in the examination of acceptability. The sampling period of the two participants was mean 12 (SD 6) days with overall completed sampling rate of 74% (SD 30%), indicating adequate to high compliance with the procedure. The user experiences from the interviews clustered into four categories: (1) increased awareness, (2) personal privacy, (3) design and procedure, and (4) usefulness and clinical care. One participant experienced more commenting voices during the sampling period, and all three participants had concerns regarding personal privacy when using electronic devices in symptom assessment. The AVH dimensions of content, control, and influence showed moderate to strong significant correlations with all dimensions (P<.001). Days of data sampling showed weak to moderate correlations with localization (P<.001) and influence (P=.03). Visual inspection indicated that the app was able to capture fluctuations within and across days for all AVH dimensions. Conclusions: This study demonstrates the value of including patients’ experiences in the development and pilot-testing of new technology. Based on the small sample size, the use of mobile phones with ESM seems feasible for patients with EOP, but the acceptability of using apps should be considered. Further investigation with larger samples is warranted before definitive conclusions are made. %M 31094321 %R 10.2196/13882 %U http://formative.jmir.org/2019/2/e13882/ %U https://doi.org/10.2196/13882 %U http://www.ncbi.nlm.nih.gov/pubmed/31094321 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 3 %N 2 %P e12662 %T Smartphone-Based Meditation for Myeloproliferative Neoplasm Patients: Feasibility Study to Inform Future Trials %A Huberty,Jennifer %A Eckert,Ryan %A Larkey,Linda %A Kurka,Jonathan %A Rodríguez De Jesús,Sue A %A Yoo,Wonsuk %A Mesa,Ruben %+ College of Health Solutions, Arizona State University, 500 North 3rd St, Phoenix, AZ, 85004, United States, 1 402 301 1304, jhuberty@asu.edu %K mindfulness %K meditation %K smartphone %K mHealth %K cancer %K quality of life %D 2019 %7 29.04.2019 %9 Original Paper %J JMIR Form Res %G English %X Background: Myeloproliferative neoplasm (MPN) patients often report high symptom burden that persists despite the best available pharmacologic therapy. Meditation has gained popularity in recent decades as a way to manage cancer patient symptoms. Objective: The aim of this study was to examine the feasibility of 2 different consumer-based meditation smartphone apps in MPN patients and to examine the limited efficacy of smartphone-based meditation on symptoms compared with an educational control group. Methods: Patients (n=128) were recruited nationally through organizational partners and social media. Eligible and consented patients were enrolled into 1 of 4 groups, 2 of which received varying orders of 2 consumer-based apps (10% Happier and Calm) and 2 that received one of the apps alone for the second 4 weeks of the 8-week intervention after an educational control condition. Participants were asked to perform 10 min of meditation per day irrespective of the app and the order in which they received the apps. Feasibility outcomes were measured at weeks 5 and 9 with a Web-based survey. Feasibility outcomes were acceptability, demand, and limited efficacy for depression, anxiety, pain intensity, sleep disturbance, sexual function, quality of life, global health, and total symptom burden. Results: A total of 128 patients were enrolled across all 4 groups, with 73.4% (94/128) patients completing the intervention. Of the participants who completed the 10% Happier app, 61% (46/76) enjoyed it, 66% (50/76) were satisfied with the content, and 77% (59/76) would recommend to others. Of those who completed the Calm app, 83% (56/68) enjoyed it, 84% (57/68) were satisfied with the content, and 97% (66/68) would recommend to others. Of those who completed the educational control, 91% (56/61) read it, 87% (53/61) enjoyed it, and 71% (43/61) learned something. Participants who completed the 10% Happier app averaged 31 (SD 33) min/week; patients completing the Calm app averaged 71 (SD 74) min/week. 10% Happier app participants saw small effects on anxiety (P<.001 d=−0.43), depression (P=.02; d=−0.38), sleep disturbance (P=.01; d=−0.40), total symptom burden (P=.13; d=−0.27), and fatigue (P=.06; d=−0.30), and moderate effects on physical health (P<.001; d=0.52). Calm app participants saw small effects on anxiety (P=.29; d=−0.22), depression (P=.09; d=−0.29), sleep disturbance (P=.002; d=−0.47), physical health (P=.005; d=0.44), total symptom burden (P=.13; d=−0.27), and fatigue (P=.13; d=−0.27). Educational control participants (n=61) did not have effects on any patient-reported outcome except for a moderate effect on physical health (P<.001; d=0.77). Conclusions: Delivering meditation via the Calm app is feasible and scored higher in terms of feasibility when compared with the 10% Happier app. The Calm app will be used to implement a randomized controlled trial, testing the effects of meditation on symptom burden in MPNs. Trial Registration: ClinicalTrials.gov NCT03726944; https://clinicaltrials.gov/ct2/show/NCT03726944 (Archived by WebCite at http://www.webcitation.org/77MVdFJwM) %M 31033443 %R 10.2196/12662 %U http://formative.jmir.org/2019/2/e12662/ %U https://doi.org/10.2196/12662 %U http://www.ncbi.nlm.nih.gov/pubmed/31033443 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 6 %N 4 %P e11401 %T Evaluating the Feasibility of an Innovative Self-Confidence Webinar Intervention for Depression in the Workplace: A Proof-of-Concept Study %A Wan Mohd Yunus,Wan Mohd Azam %A Musiat,Peter %A Brown,June SL %+ Department of Psychology, School of Human Resource Development and Psychology, Faculty of Social Sciences and Humanities, Universiti Teknologi Malaysia, UTM Johor Bahru, Skudai, Johor, 81310, Malaysia, 60 176136163, azam.yunus@kcl.ac.uk %K online %K videoconferencing %K cognitive behavioral therapy %K depression %K workplace %D 2019 %7 26.04.2019 %9 Original Paper %J JMIR Ment Health %G English %X Background: Depression in the workplace is a very common problem that exacerbates employees’ functioning and consequently influences the productivity of organizations. Despite the commonness of the problem and the currently available interventions, a high proportion of employees do not seek help. A new intervention, a webinar (Web-based seminar), was developed, which integrated the use of technology and the traditional guided therapist support to provide accessible help for the problem of depression in the workplace. Objective: The aim of this study was to explore the feasibility, preliminary outcome, and acceptability of the webinar intervention conducted in organizations. Methods: In total, 2 organizations were invited to participate, and 33 employees participated in this proof-of-concept study. The webinar intervention consisted of 6 1-hour sessions conducted via the Adobe Connect platform, developed by Adobe Inc. The intervention was developed based on a systematic review, focus group studies, and face-to-face self-confidence workshops that utilized cognitive behavior therapy (CBT). The final webinar intervention used CBT and the coping flexibility approach. The structure of the intervention included PowerPoint presentations, animation videos, utilization of chat panels, and whiteboard features. The intervention was conducted live and guided by a consultant psychologist assisted by a moderator. Study outcomes were self-assessed using self-reported Web surveys. The acceptability of the intervention was assessed using self-reported user experience Web surveys and open-ended questions. Results: The findings showed: (1) evidence of feasibility of the intervention: the webinar intervention was successfully conducted in 3 groups, with 6 1-hour sessions for each group, with 82% (23/28) participants completing all 6 sessions; (2) positive improvements in depression: the linear mixed effects modeling analysis recorded a significant overall effect of time primarily for depression (F2, 48.813=31.524; P<.001) with a Hedge g effect size of 0.522 at 1-month follow-up. Individually, 8 subjects showed significant reliable and clinically significant changes, with 3 subjects showing clinically significant change only; and (3) encouraging evidence regarding the acceptability of the webinar intervention among the employees: the user experience score was above average for 4 out of 6 domains measured (perspicuity mean 1.198 [95% CI 0.832-1.564], efficiency mean 1.000 [95% CI 0.571-1.429], dependability mean 1.208 [95% CI 0.899-1.517], and stimulation mean 1.323 [95% CI 0.987-1.659]). The open-ended questions also yielded 52% (47/91) of the responses that reported facilitators, whereas only 12% (11/91) of the responses reported barriers. Conclusions: The self-confidence webinar intervention appears to be a potentially feasible, effective, and acceptable intervention for depression in the workplace that merits further investigation. %M 31025943 %R 10.2196/11401 %U http://mental.jmir.org/2019/4/e11401/ %U https://doi.org/10.2196/11401 %U http://www.ncbi.nlm.nih.gov/pubmed/31025943 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 3 %N 2 %P e12982 %T An Adaptive Mobile Health System to Support Self-Management for Persons With Chronic Conditions and Disabilities: Usability and Feasibility Studies %A Setiawan,I Made Agus %A Zhou,Leming %A Alfikri,Zakiy %A Saptono,Andi %A Fairman,Andrea D %A Dicianno,Brad Edward %A Parmanto,Bambang %+ Department of Health Information Management, School of Health and Rehabilitation Sciences, University of Pittsburgh, 6025 Forbes Tower, Pittsburgh, PA, 15260, United States, 1 412 383 6649, parmanto@pitt.edu %K mHealth %K adaptive mHealth %K mobile apps %K telemedicine %K personalized medicine %K self-management %K self-care %K caregivers %K chronic disease %K persons with disabilities %D 2019 %7 25.04.2019 %9 Original Paper %J JMIR Form Res %G English %X Background: Persons with chronic conditions and disabilities (PwCCDs) are vulnerable to secondary complications. Many of these secondary complications are preventable with proactive self-management and proper support. To enhance PwCCDs' self-management skills and conveniently receive desired support, we have developed a mobile health (mHealth) system called iMHere. In 2 previous clinical trials, iMHere was successfully used to improve health outcomes of adult participants with spina bifida and spinal cord injury. To further expand use of iMHere among people with various types of disabilities and chronic diseases, the system needs to be more adaptive to address 3 unique challenges: 1) PwCCDs have very diverse needs with regards to self-management support, 2) PwCCDs’ self-management needs may change over time, and 3) it is a challenge to keep PwCCDs engaged and interested in long-term self-management. Objective: The aim of this study was to develop an adaptive mHealth system capable of supporting long-term self-management and adapting to the various needs and conditions of PwCCDs. Methods: A scalable and adaptive architecture was designed and implemented for the new version, iMHere 2.0. In this scalable architecture, a set of mobile app modules was created to provide various types of self-management support to PwCCDs with the ability to add more as needed. The adaptive architecture empowers PwCCDs with personally relevant app modules and allows clinicians to adapt these modules in response to PwCCDs’ evolving needs and conditions over time. Persuasive technologies, social support, and personalization features were integrated into iMHere 2.0 to engage and motivate PwCCDs and support long-term usage. Two initial studies were performed to evaluate the usability and feasibility of the iMHere 2.0 system. Results: The iMHere 2.0 system consists of cross-platform client and caregiver apps, a Web-based clinician portal, and a secure 2-way communication protocol for providing interactions among these 3 front-end components, all supported by a back-end server. The client and caregiver apps have 12 adaptive app modules to support various types of self-management tasks. The adaptive architecture makes it possible for PwCCDs to receive personalized app modules relevant to their conditions with or without support from various types of caregivers. The personalization and persuasive technologies in the architecture can be used to engage PwCCDs for long-term usage of the iMHere 2.0 system. Participants of the usability study were satisfied with the iMHere 2.0 client app. The feasibility evaluation revealed several practical issues to consider when implementing the system on a large scale. Conclusions: We developed an adaptive mHealth system as a novel method to support diverse needs in self-management for PwCCDs that can dynamically change over time. The usability of the client app is high, and it was feasible for PwCCDs to use in supporting personalized and evolving self-care needs. %M 31021324 %R 10.2196/12982 %U http://formative.jmir.org/2019/2/e12982/ %U https://doi.org/10.2196/12982 %U http://www.ncbi.nlm.nih.gov/pubmed/31021324 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 8 %N 4 %P e11865 %T Socioeconomic Status and Racial or Ethnic Differences in Participation: Web-Based Survey %A Jang,Myoungock %A Vorderstrasse,Allison %+ University of Wisconsin-Madison, 701 Highland Ave, 4165 Cooper Hall, Madison, WI, 53705, United States, 1 6082634711, mjang7@wisc.edu %K survey %K technology %K race %K socioeconomic status %D 2019 %7 10.04.2019 %9 Original Paper %J JMIR Res Protoc %G English %X Background: Web-based survey data collection has been widely used because of its advantages, although attaining and retaining participants can be challenging. There are several factors associated with successful Web-based survey participation; yet little is known regarding racial or ethnic and socioeconomic differences in the progress of a Web-based survey. Objective: This study aimed to examine racial or ethnic and socioeconomic status (SES) differences in participation in a Web-based survey. Methods: We conducted a secondary data analysis of a study dataset containing information on parents of preschool children. We used 2 phases of Web-based surveys: (1) screening questions including race or ethnicity information and (2) full survey with a consent form. Once potential participants submitted the screening questions, including their racial or ethnic information, the team sent the full survey link to potential participants who met study eligibility criteria. We calculated the proportion of racial or ethnic groups in each of the following areas: consent, partial survey completion, and total survey completion. Results: A total of 487 participants (236 non-Hispanic white, 44 Hispanic, 137 black, and 70 Asian) completed initial screening questions, and a total of 458 participants met study eligibility criteria. Compared with black participants, non-Hispanic white and Asian participants were more likely to consent to participate in the study (odds ratio [OR] 1.73, 95% CI 1.08-2.78, P=.02; OR 2.07, 95% CI 1.04-4.13, P=.04, respectively). There was no racial or ethnic difference with respect to the completion of demographic questions or completion of a partial survey. Finally, compared with black participants, non-Hispanic white participants were more likely to complete the entire survey (OR 3.36, 95% CI 1.51-7.06, P<.001). With respect to SES, less educated non-Hispanic white participants were less likely to complete the survey compared with their counterparts with more education (OR 0.15, 95% CI 0.50-1.48, P<.001). Conclusions: We found a significant difference among racial or ethnic groups as well as different education levels in Web-based survey participation. Survey researchers need to consider the SES and racial or ethnic differences in Web-based survey participation and develop strategies to address this bias in participation and completion in their research. %M 30969173 %R 10.2196/11865 %U https://www.researchprotocols.org/2019/4/e11865/ %U https://doi.org/10.2196/11865 %U http://www.ncbi.nlm.nih.gov/pubmed/30969173 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 8 %N 3 %P e10075 %T Identification of Complex Health Interventions Suitable for Evaluation: Development and Validation of the 8-Step Scoping Framework %A Davidson,Rosemary %A Randhawa,Gurch %A Cash,Stephanie %+ Institute for Health Research, University of Bedfordshire, University Square, Luton, LU1 3JU, United Kingdom, 44 (0)1234 400 400, rosemary.davidson@beds.ac.uk %K complex interventions %K early years %K evaluation %K multistakeholder provision %D 2019 %7 05.03.2019 %9 Original Paper %J JMIR Res Protoc %G English %X Background: There is extensive literature on the methodology of evaluation research and the development and evaluation of complex interventions but little guidance on the formative stages before evaluation and how to work with partner organizations that wish to have their provision evaluated. It is important to be able to identify suitable projects for evaluation from a range of provision and describe the steps required, often with academic institutions working in partnership with external organizations, in order to set up an evaluation. However, research evaluating programs or interventions rarely discusses these stages. Objective: This study aimed to extend work on evaluability assessment and pre-evaluation planning by proposing an 8-Step Scoping Framework to enable the appraisal of multiple programs in order to identify interventions suitable for evaluation. We aimed to add to the literature on evaluability assessment and more recent evaluation guidance by describing the processes involved in working with partner organizations. Methods: This paper documents the steps required to identify multiple complex interventions suitable for process and outcome evaluation. The steps were developed using an iterative approach by working alongside staff in a local government organization, to build an evidence base to demonstrate which interventions improve children’s outcomes. The process of identifying suitable programs for evaluation, thereby establishing the pre-evaluation steps, was tested using all Flying Start provision. Results: The 8-Step Scoping Framework was described using the example of the local government organization Flying Start to illustrate how each step contributes to finding projects suitable for process and outcome evaluation: (1) formulating overarching key questions that encompass all programs offered by an organization, (2) gaining an in-depth understanding of the work and provision of an organization and engaging staff, (3) completing a data template per project/program offered, (4) assessing the robustness/validity of data across all programs, (5) deciding on projects suitable for evaluation and those requiring additional data, (6) negotiating with chosen project leads, both within and outside the organization, (7) developing individual project evaluation protocols, and (8) applying for ethical approval from the university and partner organization. Conclusions: This paper describes the processes involved in identifying suitable projects for evaluation. It adds to the existing literature on the assessment of specific programs suitable for evaluation and guidance for conducting evaluations by establishing the formative steps required to identify suitable programs from a range of provision. This scoping framework particularly relates to academic partners and organizations tasked with delivering evidence-based services designed to meet local needs. The steps identified have been described in the context of early years provision but can be applied to a range of community-based evaluations, or more generally, to cases where an academic partner is working with external stakeholders to identify projects suitable for academic evaluation. %M 30835240 %R 10.2196/10075 %U https://www.researchprotocols.org/2019/3/e10075/ %U https://doi.org/10.2196/10075 %U http://www.ncbi.nlm.nih.gov/pubmed/30835240 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 8 %N 3 %P e11856 %T A Nurse-Led Self-Management Support Intervention (ZENN) for Kidney Transplant Recipients Using Intervention Mapping: Protocol for a Mixed-Methods Feasibility Study %A Beck,Denise %A Been-Dahmen,Janet %A Peeters,Mariëlle %A Grijpma,Jan Willem %A van der Stege,Heleen %A Tielen,Mirjam %A van Buren,Marleen %A Weimar,Willem %A Ista,Erwin %A Massey,Emma %A van Staa,AnneLoes %+ Section of Nephrology & Transplantation, Department of Internal Medicine, Erasmus MC, University Medical Center Rotterdam, Dr Molewaterplein 40, Rotterdam, 3015 GD, Netherlands, 31 650032252, d.beck@erasmusmc.nl %K chronic kidney disease %K evidence-based nursing %K self-management %K transplantation %D 2019 %7 01.03.2019 %9 Protocol %J JMIR Res Protoc %G English %X Background: Optimal self-management in kidney transplant recipients is essential for patient and graft survival, reducing comorbidity and health care costs while improving the quality of life. However, there are few effective interventions aimed at providing self-management support after kidney transplantation. Objective: This study aims to systematically develop a nurse-led, self-management (support) intervention for kidney transplant recipients. Methods: The Intervention Mapping protocol was used to develop an intervention that incorporates kidney transplant recipients’ and nurses’ needs, and theories as well as evidence-based methods. The needs of recipients and nurses were assessed by reviewing the literature, conducting focus groups, individual interviews, and observations (step 1). Based on the needs assessment, Self-Regulation Theory, and the “5A’s” model, change objectives were formulated (step 2). Evidence-based methods to achieve these objectives were selected and subsequently translated into practical implementation strategies (step 3). Then, program materials and protocols were developed accordingly (step 4). The implementation to test the feasibility and acceptability was scheduled for 2015-2017 (step 5). The last step of Intervention Mapping, evaluation of the intervention, falls outside the scope of this paper (step 6). Results: The intervention was developed to optimize self-management (support) after kidney transplantation and targeted both kidney transplant recipients and nurse practitioners who delivered the intervention. The intervention was clustered into four 15-minute sessions that were combined with regular appointments at the outpatient clinic. Nurses received a training syllabus and were trained in communication techniques based on the principles of Solution-Focused Brief Therapy and Motivational Interviewing; this entailed guiding the patients to generate their own goals and solutions and focus on strengths and successes. Kidney transplant recipients were encouraged to assess self-management challenges using the Self-Management Web and subsequently develop specific goals, action plans, and pursuit skills to solve these challenges. Conclusions: The Intervention Mapping protocol provided a rigorous framework to systematically develop a self-management intervention in which nurses and kidney transplant recipients’ needs, evidence-based methods, and theories were integrated. International Registered Report Identifier (IRRID): DERR1-10.2196/11856 %M 30821694 %R 10.2196/11856 %U https://www.researchprotocols.org/2019/3/e11856/ %U https://doi.org/10.2196/11856 %U http://www.ncbi.nlm.nih.gov/pubmed/30821694 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 8 %N 2 %P e12107 %T System Setup to Deliver Air Impact Forces to a Sheep Limb: Preparation for Model Development of Blast-Related Heterotopic Ossification %A Williams,Dustin L %A Epperson,Richard T %A Taylor,Nicholas B %A Nielsen,Mattias B %A Kawaguchi,Brooke S %A Rothberg,David L %A Pasquina,Paul F %A Isaacson,Brad M %+ Bone & Joint Research Laboratory, Department of Veterans Affairs, 500 Foothill Blvd (Bldg 2) Mail Code 151F, Salt Lake City, UT, 84148, United States, 1 801 582 1565 ext 4130, dustin.williams@utah.edu %K blast %K air %K sheep %K limb %K heterotopic ossification %D 2019 %7 22.02.2019 %9 Original Paper %J JMIR Res Protoc %G English %X Background: Heterotopic ossification (HO) is a significant complication for wounded warriors with traumatic limb loss. Although this pathologic condition negatively impacts the general population, ectopic bone has been observed with higher frequency for service members injured in Iraq and Afghanistan due to blast injuries. Several factors, including a traumatic insult, bioburden, tourniquet and wound vacuum usage, and bone fractures or fragments have been associated with increased HO for service members. A large combat-relevant animal model is needed to further understand ectopic bone etiology and develop new pragmatic solutions for reducing HO formation and recurrence. Objective: This study outlines the optimization of a blast system that may be used to simulate combat-relevant trauma for HO and replicate percussion blast experienced in theater. Methods: We tested the repeatability and reproducibility of an air impact device (AID) at various pressure settings and compared it with a model of blunt force trauma for HO induction. Furthermore, we assessed the ability of the higher-power air delivery system to injure host tissue, displace metal particulate, and disperse bone chips in cadaveric sheep limbs. Results: Data demonstrated that the air delivery setup generated battlefield-relevant blast forces. When the AID was charged to 40, 80, and 100 psi, the outputs were 229 (SD 13) N, 778 (SD 50) N, and 1085 (SD 114) N, respectively, compared with the blunt force model which proposed only 168 (SD 11) N. For the 100-psi AID setup, the force equaled a 5.8-kg charge weight of trinitrotoluene at a standoff distance of approximately 2.62 m, which would replicate a dismounted improvised explosive device blast in theater. Dispersion data showed that the delivery system would have the ability to cause host tissue trauma and effectively disperse metal particulate and host bone chips in local musculature compared with the standard blunt force model (13 mm vs 2 mm). Conclusions: Our data showed that a high-pressure AID was repeatable or reproducible, had the ability to function as a simulated battlefield blast that can model military HO scenarios, and will allow for factors including blast trauma to translate toward a large animal model. %M 30794203 %R 10.2196/12107 %U http://www.researchprotocols.org/2019/2/e12107/ %U https://doi.org/10.2196/12107 %U http://www.ncbi.nlm.nih.gov/pubmed/30794203 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 8 %N 1 %P e10974 %T Accelerating Research With Technology: Rapid Recruitment for a Large-Scale Web-Based Sleep Study %A Deering,Sean %A Grade,Madeline M %A Uppal,Jaspreet K %A Foschini,Luca %A Juusola,Jessie L %A Amdur,Adam M %A Stepnowsky,Carl J %+ Evidation Health, 167 2nd Avenue, San Mateo, CA, 94401, United States, 1 6502798855, jjuusola@evidation.com %K connected health %K engagement %K health %K mHealth %K mobile health %K mobile phone %K recruitment %K sleep %K sleep quality %K wearables %D 2019 %7 21.01.2019 %9 Original Paper %J JMIR Res Protoc %G English %X Background: Participant recruitment can be a significant bottleneck in carrying out research studies. Connected health and mobile health platforms allow for the development of Web-based studies that can offer improvement in this domain. Sleep is of vital importance to the mental and physical health of all individuals, yet is understudied on a large scale or beyond the focus of sleep disorders. For this reason and owing to the availability of digital sleep tracking tools, sleep is well suited to being studied in a Web-based environment. Objective: The aim of this study was to investigate a method for speeding up the recruitment process and maximizing participant engagement using a novel approach, the Achievement Studies platform (Evidation Health, Inc, San Mateo, CA, USA), while carrying out a study that examined the relationship between participant sleep and daytime function. Methods: Participants could access the Web-based study platform at any time from any computer or Web-enabled device to complete study procedures and track study progress. Achievement community members were invited to the study and assessed for eligibility. Eligible participants completed an electronic informed consent process to enroll in the study and were subsequently invited to complete an electronic baseline questionnaire. Then, they were asked to connect a wearable device account through their study dashboard, which shared their device data with the research team. The data were used to provide objective sleep and activity metrics for the study. Participants who completed the baseline questionnaires were subsequently sent a daily single-item Sleepiness Checker activity for 7 consecutive days at baseline and every 3 months thereafter for 1 year. Results: Overall, 1156 participants enrolled in the study within a 5-day recruitment window. In the 1st hour, the enrollment rate was 6.6 participants per minute (394 per hour). In the first 24 hours, the enrollment rate was 0.8 participants per minute (47 participants per hour). Overall, 1132 participants completed the baseline questionnaires (1132/1156, 97.9%) and 1047 participants completed the initial Sleepiness Checker activity (1047/1156, 90.6%). Furthermore, 1000 participants provided activity-specific wearable data (1000/1156, 86.5%) and 982 provided sleep-specific wearable data (982/1156, 84.9%). Conclusions: The Achievement Studies platform allowed for rapid recruitment and high study engagement (survey completion and device data sharing). This approach to carrying out research appears promising. However, conducting research in this way requires that participants have internet access and own and use a wearable device. As such, our sample may not be representative of the general population. %M 30664491 %R 10.2196/10974 %U http://www.researchprotocols.org/2019/1/e10974/ %U https://doi.org/10.2196/10974 %U http://www.ncbi.nlm.nih.gov/pubmed/30664491 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 8 %N 1 %P e10941 %T Neurological Disorders in Central Spain, Second Survey: Feasibility Pilot Observational Study %A Hernández-Gallego,Jesús %A Llamas-Velasco,Sara %A Bermejo-Pareja,Felix %A Vega,Saturio %A Tapias-Merino,Ester %A Rodríguez-Sánchez,Emiliano %A Boycheva,Elina %A Serrano,José Ignacio %A Gil-García,Juan-Francisco %A Trincado,Rocio %A Sánchez-Rodrigo,José-María Vizcaino %A Cacho,Jesús %A Contador,Israel %A Garcia-Ptacek,Sara %A Sierra-Hidalgo,Fernando %A Cubo,Esther %A Carro,Eva %A Villarejo-Galende,Alberto %A García García-Patino,Rosalía %A Benito-León,Julián %+ Department of Neurology, University Hospital “12 de Octubre”, Av de Córdoba km 5400, Madrid, ES-28041, Spain, 34 34 913908000, jbenitol67@gmail.com %K dementia %K essential tremor %K headache %K longitudinal study %K mild cognitive impairment %K NEDICES %K observational study %K Parkinson’s disease %K pilot study %K population-based study %K stroke %D 2019 %7 10.01.2019 %9 Original Paper %J JMIR Res Protoc %G English %X Background: The Neurological Disorders in Central Spain, second survey (NEDICES-2) is a population-based, closed-cohort study that will include over 8000 subjects aged ≥55 years. It will also include a biobank. Objective: The objective of this study was to evaluate all major aspects of the NEDICES-2 (methods, database, screening instruments, and questionnaires, as well as interexpert rating of the neurological diagnoses) in each one of the planned areas (all of them in central Spain) and to test the possibility of obtaining biological samples from each participant. Methods: A selection of patients and participants of the planned NEDICES-2 underwent face-to-face interviews including a comprehensive questionnaire on demographics, current medications, medical conditions, and lifestyle habits. Biological samples (blood, saliva, urine, and hair) were also obtained. Furthermore, every participant was examined by a neurologist. Results: In this pilot study, 567 study participants were enrolled (196 from hospitals and 371 from primary care physician lists). Of these 567, 310 completed all study procedures (questionnaires and the neurological evaluation). The study was time-consuming for several primary care physicians. Hence, a few primary care physicians from some areas refused to participate, which led to a reconfiguration of study areas. In addition, the central biobank needed to be supplemented by the biobanks of local Spanish National Health System hospitals. Conclusions: Population-based epidemiological surveys, such as the NEDICES-2, require a pilot study to evaluate the feasibility of all aspects of a future field study (population selection, methods and instruments to be used, neurological diagnosis agreement, and data collection). %M 30632964 %R 10.2196/10941 %U http://www.researchprotocols.org/2019/1/e10941/ %U https://doi.org/10.2196/10941 %U http://www.ncbi.nlm.nih.gov/pubmed/30632964 %0 Journal Article %@ 2371-4379 %I JMIR Publications %V 3 %N 4 %P e10909 %T Transition Education for Young Adults With Type 1 Diabetes: Pilot Feasibility Study for a Group Telehealth Intervention %A Albanese-O'Neill,Anastasia %A Beauchamp,Giovanna %A Thomas,Nicole %A Westen,Sarah C %A Johnson,Nicole %A Schatz,Desmond %A Haller,Michael J %+ Division of Pediatric Endocrinology, Department of Pediatrics, University of Florida, 1699 SW 16th Avenue, Gainesville, FL, 32608, United States, 1 352 273 9297, aalbanese@ufl.edu %K diabetes education %K mobile phone %K telehealth %K type 1 diabetes %K young adult %K transition %D 2018 %7 05.11.2018 %9 Original Paper %J JMIR Diabetes %G English %X Background: Young adults with type 1 diabetes (T1D) experience a decline in glycemic outcomes and gaps in clinical care. A diabetes education and support program designed for young adults was delivered through group videoconference and mobile Web. Objective: The objective of our study was to assess the feasibility, acceptability, and preliminary efficacy of the program as measured by attendance and webpage views, satisfaction, and pre- and postintervention psychosocial outcomes, respectively. Methods: Young adults aged 18-25 years were recruited to attend five 30-minute group diabetes education videoconferences during an 8-week period. Videoconferences included an expert presentation followed by a moderated group discussion. Within 48 hours of each videoconference, participants were sent a link to more information on the study website. Feasibility was assessed using data on videoconference attendance and webpage views. Acceptability was assessed via a Satisfaction Survey completed at the conclusion of the study. Descriptive statistics were generated. Preliminary efficacy was assessed via a survey to measure changes in diabetes-specific self-efficacy and diabetes distress. Pre- and postintervention data were compared using paired samples t tests. Results: In this study, 20 young adults (mean age 19.2 [SD 1.1] years) attended an average of 5.1 (SD 1.0) videoconferences equivalent to 153 (SD 30.6) minutes of diabetes education per participant during an 8-week period. Average participant satisfaction scores were 62.2 (SD 2.6) out of a possible 65 points. A total of 102 links sent via text message (short message service) or email resulted in 504 webpage views. There was no statistically significant difference between pre- and postintervention diabetes-specific self-efficacy or diabetes-related distress. Conclusions: Delivery of diabetes education via group videoconference using mobile Web follow-up is feasible and acceptable to young adults with T1D. This model of care delivery has the potential to improve attendance, social support, and patient-reported satisfaction. Nevertheless, further research is required to establish the effect on long-term psychosocial and glycemic outcomes. %M 30401674 %R 10.2196/10909 %U http://diabetes.jmir.org/2018/4/e10909/ %U https://doi.org/10.2196/10909 %U http://www.ncbi.nlm.nih.gov/pubmed/30401674 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 2 %N 2 %P e11025 %T Web-Delivered Multimedia Training Materials for the Self-Collection of Dried Blood Spots: A Formative Project %A Allen,Alicia M %A Lundeen,Kim %A Murphy,Sharon E %A Spector,Logan %A Harlow,Bernard L %+ Department of Family & Community Medicine, College of Medicine, University of Arizona, Suite 300, 3950 South Country Club Road, Tucson, AZ, 85713, United States, 1 5206268157, aliciaallen@email.arizona.edu %K dried blood spot %K internet %K feasibility studies %D 2018 %7 05.11.2018 %9 Original Paper %J JMIR Formativ Res %G English %X Background: The use of dried blood spots (DBS) in biomedical research has been increasing as an objective measure for variables that are typically plagued by self-report, such as smoking status and medication adherence. The development of training materials for the self-collection of DBS that can be delivered through the Web would allow for broader use of this methodology. Objective: The objective of this study was to evaluate the acceptability and feasibility of the self-collection of DBS using newly developed multimedia training materials that were delivered through the Web. We also aimed to assess the usability of the collected DBS samples. Methods: We recruited participants through Facebook advertising for two distinct studies. The first study evaluated the acceptability of our newly developed DBS training materials, while the second assessed the implementation of this protocol into a larger Web-based study. Results: In the first study, participants (N=115) were aged, on average, 26.1 (SD 6.4) years. Training materials were acceptable (113/115, 98.2%, of participants were willing to collect DBS again) and produced usable samples (110/115, 95.7%, collected DBS were usable). In the second study, response rate was 25.0% (41/164), with responders being significantly younger than nonresponders (20.3 [SD 0.2] vs 22.0 [SD 0.4]; P<.001), and 92% (31/41) of collected DBS samples were usable by the laboratory. Conclusions: Overall, while the protocol is acceptable, feasible, and produced usable samples, additional work is needed to improve response rates. %M 30684406 %R 10.2196/11025 %U http://formative.jmir.org/2018/2/e11025/ %U https://doi.org/10.2196/11025 %U http://www.ncbi.nlm.nih.gov/pubmed/30684406 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 20 %N 10 %P e10147 %T Feasibility and Acceptability of Mobile Phone–Based Auto-Personalized Physical Activity Recommendations for Chronic Pain Self-Management: Pilot Study on Adults %A Rabbi,Mashfiqui %A Aung,Min SH %A Gay,Geri %A Reid,M Cary %A Choudhury,Tanzeem %+ Department of Statistics, Harvard University, 1 Oxford Street, Cambridge, MA,, United States, 1 603 667 1797, mrabbi@fas.harvard.edu %K chronic pain %K machine learning %K personalization %K chronic back pain %K reinforcement learning %D 2018 %7 26.10.2018 %9 Original Paper %J J Med Internet Res %G English %X Background: Chronic pain is a globally prevalent condition. It is closely linked with psychological well-being, and it is often concomitant with anxiety, negative affect, and in some cases even depressive disorders. In the case of musculoskeletal chronic pain, frequent physical activity is beneficial. However, reluctance to engage in physical activity is common due to negative psychological associations (eg, fear) between movement and pain. It is known that encouragement, self-efficacy, and positive beliefs are effective to bolster physical activity. However, given that the majority of time is spent away from personnel who can give such encouragement, there is a great need for an automated ubiquitous solution. Objective: MyBehaviorCBP is a mobile phone app that uses machine learning on sensor-based and self-reported physical activity data to find routine behaviors and automatically generate physical activity recommendations that are similar to existing behaviors. Since the recommendations are based on routine behavior, they are likely to be perceived as familiar and therefore likely to be actualized even in the presence of negative beliefs. In this paper, we report the preliminary efficacy of MyBehaviorCBP based on a pilot trial on individuals with chronic back pain. Methods: A 5-week pilot study was conducted on people with chronic back pain (N=10). After a week long baseline period with no recommendations, participants received generic recommendations from an expert for 2 weeks, which served as the control condition. Then, in the next 2 weeks, MyBehaviorCBP recommendations were issued. An exit survey was conducted to compare acceptance toward the different forms of recommendations and map out future improvement opportunities. Results: In all, 90% (9/10) of participants felt positive about trying the MyBehaviorCBP recommendations, and no participant found the recommendations unhelpful. Several significant differences were observed in other outcome measures. Participants found MyBehaviorCBP recommendations easier to adopt compared to the control (βint=0.42, P<.001) on a 5-point Likert scale. The MyBehaviorCBP recommendations were actualized more (βint=0.46, P<.001) with an increase in approximately 5 minutes of further walking per day (βint=4.9 minutes, P=.02) compared to the control. For future improvement opportunities, participants wanted push notifications and adaptation for weather, pain level, or weekend/weekday. Conclusions: In the pilot study, MyBehaviorCBP’s automated approach was found to have positive effects. Specifically, the recommendations were actualized more, and perceived to be easier to follow. To the best of our knowledge, this is the first time an automated approach has achieved preliminary success to promote physical activity in a chronic pain context. Further studies are needed to examine MyBehaviorCBP’s efficacy on a larger cohort and over a longer period of time. %M 30368433 %R 10.2196/10147 %U http://www.jmir.org/2018/10/e10147/ %U https://doi.org/10.2196/10147 %U http://www.ncbi.nlm.nih.gov/pubmed/30368433 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 5 %N 4 %P e11383 %T The WorkingWell Mobile Phone App for Individuals With Serious Mental Illnesses: Proof-of-Concept, Mixed-Methods Feasibility Study %A Nicholson,Joanne %A Wright,Spenser M %A Carlisle,Alyssa M %A Sweeney,Mary Ann %A McHugo,Gregory J %+ Institute for Behavioral Health, The Heller School for Social Policy and Management, Brandeis University, 415 South Street, MS 035, Waltham, MA, 20453, United States, 1 781 736 3978, jnicholson@brandeis.edu %K mHealth %K mobile apps %K mental disorders %K employment %D 2018 %7 25.10.2018 %9 Original Paper %J JMIR Ment Health %G English %X Background: The disparities in employment for individuals with serious mental illnesses have been well documented, as have the benefits of work. Mobile technology can provide accessible in-the-moment support for these individuals. The WorkingWell mobile app was developed to meet the need for accessible follow-along supports for individuals with serious mental illnesses in the workplace. Objective: We explore the usability, usage, usefulness, and overall feasibility of the WorkingWell mobile app with individuals with serious mental illnesses who are actively employed and receiving community-based services. Methods: In this proof-of-concept, mixed-methods, 2-month feasibility study (N=40), employed individuals with serious mental illnesses were recruited in mental health agencies. Participants completed surveys regarding background characteristics and cellphone use at enrollment and responded to interview items regarding app usability, usage, and usefulness in technical assistance calls at 1, 2, 4, and 6 weeks of participation and in the exit interview at 8 weeks. Data on the frequency of app usage were downloaded on a daily basis. A version of the System Usability Scale (SUS) was administered in the exit interview. Overall feasibility was determined by the percent of users completing the study, responses to an interview item regarding continued use, and findings on usability, usage, and usefulness. General impressions were obtained from users regarding user support materials, technical assistance, and study procedures. Results: Most participants were male (60%, 24/40), aged 55 or younger (70%, 28/40), white (80%, 32/40), had less than a 4-year college education (78%, 31/40), were employed part-time (98%, 39/40), had been working more than 6 months (60%, 24/40), and indicated a diagnosis of bipolar, schizoaffective, or depressive disorder (84%, 16/25). The majority of participants owned cellphones (95%, 38/40) and used them multiple times per day (83%, 33/40). Their average rating on SUS usability items was 3.93 (SD 0.77, range 1.57-5.00), reflecting positive responses. In general, participants indicated WorkingWell was “very easy,” “straightforward,” “simple,” and “user friendly.” Usability challenges were related to personal issues (eg, memory) or to difficulties with the phone or app. Data on app usage varied considerably. The most frequent navigations were to the home screen, followed by Rate My Day and My Progress, and then by Manage the Moment and Remind Me. The app was described as useful by most participants; 86% (30/35) agreed the app would help them manage better on the job. Of the 40 original participants, 35 (87%) completed the study. Conclusions: The WorkingWell app is a feasible approach to providing accessible, as-needed employment support for individuals with serious mental illnesses. The app would benefit from modifications to address recommendations from feasibility testing. Controlled research with larger samples, more diverse in individual characteristics and workplace settings, is essential to demonstrating the effectiveness of the app. %M 30361199 %R 10.2196/11383 %U http://mental.jmir.org/2018/4/e11383/ %U https://doi.org/10.2196/11383 %U http://www.ncbi.nlm.nih.gov/pubmed/30361199 %0 Journal Article %@ 2291-9279 %I JMIR Publications %V 6 %N 4 %P e10213 %T Digital Gaming to Improve Adherence Among Adolescents and Young Adults Living With HIV: Mixed-Methods Study to Test Feasibility and Acceptability %A Castel,Amanda D %A Qasmieh,Saba %A Greenberg,Daniel %A Ellenberger,Nicole %A Howell,Tyriesa Howard %A Griffith,Caleb %A Wilbourn,Brittany C %A Ganesan,Kavitha %A Hussein,Nadia %A Ralte,Gabriel %A Rakhmanina,Natella %+ Department of Epidemiology and Biostatistics, Milken Institute School of Public Health, George Washington University, 5th Floor, 950 New Hampshire Avenue Northwest, Washington, DC,, United States, 1 202 994 8325, acastel@gwu.edu %K youth %K HIV %K adherence %K video games %K Wisepill %K adolescents %K digital technology %K serious games %D 2018 %7 15.10.2018 %9 Original Paper %J JMIR Serious Games %G English %X Background: An estimated 50% of adolescents and young adults (AYA) living with HIV are failing to adhere to prescribed antiretroviral treatment (ART). Digital games are effective in chronic disease management; however, research on gaming to improve ART adherence among AYA is limited. Objective: We assessed the feasibility and acceptability of video gaming to improve AYA ART adherence. Methods: Focus group discussions and surveys were administered to health care providers and AYA aged 13 to 24 years living with HIV at a pediatric HIV program in Washington, DC. During focus group discussions, AYA viewed demonstrations of 3 game prototypes linked to portable Wisepill medication dispensers. Content analysis strategies and thematic coding were used to identify adherence themes and gaming acceptance and feasibility. Likert scale and descriptive statistics were used to summarize response frequencies. Results: Providers (n=10) identified common adherence barriers and strategies, including use of gaming analogies to improve AYA ART adherence. Providers supported exploration of digital gaming as an adherence intervention. In 6 focus group discussions, 12 AYA participants identified disclosure of HIV status and irregular daily schedules as major barriers to ART and use of alarms and pillboxes as reminders. Most AYA were very or somewhat likely to use the demonstrated game prototypes to help with ART adherence and desired challenging, individually tailored, user-friendly games with in-game incentives. Game prototypes were modified accordingly. Conclusions: AYA and their providers supported the use of digital games for ART adherence support. Individualization and in-game incentives were preferable and informed the design of an interactive technology-based adherence intervention among AYA living with HIV. %M 30322838 %R 10.2196/10213 %U http://games.jmir.org/2018/4/e10213/ %U https://doi.org/10.2196/10213 %U http://www.ncbi.nlm.nih.gov/pubmed/30322838 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 6 %N 9 %P e10460 %T The Remote Food Photography Method and SmartIntake App for the Assessment of Alcohol Use in Young Adults: Feasibility Study and Comparison to Standard Assessment Methodology %A Fazzino,Tera L %A Martin,Corby K %A Forbush,Kelsie %+ Department of Psychology, University of Kansas, Fraser Hall, 4th Floor, 1415 Jayhawk Boulevard, Lawrence, KS, 66045, United States, 1 7858640062, tfazzino@ku.edu %K alcohol consumption %K alcohol college students %K alcohol assessment %K dietary assessment %K self report %K mobile phone %K mobile health %K ehealth %K photography %K young adults %D 2018 %7 24.9.2018 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Heavy drinking is prevalent among young adults and may contribute to obesity. However, measurement tools for assessing caloric intake from alcohol are limited and rely on self-report, which is prone to bias. Objective: The purpose of our study was to conduct feasibility testing of the Remote Food Photography Method and the SmartIntake app to assess alcohol use in young adults. Aims consisted of (1) quantifying the ability of SmartIntake to capture drinking behavior, (2) assessing app usability with the Computer System Usability Questionnaire (CSUQ), (3) conducting a qualitative interview, and (4) comparing preference, usage, and alcohol use estimates (calories, grams per drinking episode) between SmartIntake and online diet recalls that participants completed for a parent study. Methods: College students (N=15) who endorsed a pattern of heavy drinking were recruited from a parent study. Participants used SmartIntake to send photographs of all alcohol and food intake over a 3-day period and then completed a follow-up interview and the CSUQ. CSUQ items range from 1-7, with lower scores indicating greater usability. Total drinking occasions were determined by adding the number of drinking occasions captured by SmartIntake plus the number of drinking occasions participants reported that they missed capturing. Usage was defined by the number of days participants provided food/beverage photos through the app, or the number of diet recalls completed. Results: SmartIntake captured 87% (13/15) of total reported drinking occasions. Participants rated the app as highly usable in the CSUQ (mean 2.28, SD 1.23). Most participants (14/15, 93%) preferred using SmartIntake versus recalls, and usage was significantly higher with SmartIntake than recalls (42/45, 93% vs 35/45, 78%; P=.04). Triple the number of participants submitted alcohol reports with SmartIntake compared to the recalls (SmartIntake 9/15, 60% vs recalls 3/15, 20%; P=.06), and 60% (9/15) of participants reported drinking during the study. Conclusions: SmartIntake was acceptable to college students who drank heavily and captured most drinking occasions. Participants had higher usage of SmartIntake compared to recalls, suggesting SmartIntake may be well suited to measuring alcohol consumption in young adults. However, 40% (6/15) did not drink during the brief testing period and, although findings are promising, a longer trial is needed. %M 30249590 %R 10.2196/10460 %U http://mhealth.jmir.org/2018/9/e10460/ %U https://doi.org/10.2196/10460 %U http://www.ncbi.nlm.nih.gov/pubmed/30249590 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 6 %N 9 %P e10274 %T Development and Feasibility Testing of an mHealth (Text Message and WeChat) Intervention to Improve the Medication Adherence and Quality of Life of People Living with HIV in China: Pilot Randomized Controlled Trial %A Guo,Yan %A Xu,Zhimeng %A Qiao,Jiaying %A Hong,Y Alicia %A Zhang,Hanxi %A Zeng,Chengbo %A Cai,Weiping %A Li,Linghua %A Liu,Cong %+ Department of Health Promotion and Community Health Sciences, School of Public Health, Texas A&M University, 212 Adriance Lab Road, MS 1266, College Station, TX, 77843, United States, 1 979 436 9343, yhong@sph.tamhsc.edu %K mHealth %K social media %K medication adherence %K people living with HIV %K randomized controlled trial %D 2018 %7 04.09.2018 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Most people living with HIV (PLWH) reside in middle- and low-income countries with limited access to health services. Thus, cost-effective interventions that can reach a large number of PLWH are urgently needed. Objective: The objective of our study was to assess the feasibility and acceptability of an mHealth intervention among PLWH in China. Methods: Based on previous formative research, we designed an mHealth intervention program that included sending weekly reminders to participants via text messages (short message service, SMS) and articles on HIV self-management three times a week via a popular social media app WeChat. A total of 62 PLWH recruited from an HIV outpatient clinic were randomly assigned to intervention or control group. The intervention lasted for 3 months, and all participants were assessed for their medication adherence, presence of depression, quality of life (QoL), and CD4 (cluster of differentiation 4) counts. Upon completing the intervention, we interviewed 31 participants to further assess the feasibility and acceptability of the study. Results: At baseline, the intervention and control groups did not differ in terms of demographic characteristics or any of the major outcome measures. About 85% (53/62) of the participants completed the intervention, and they provided valuable feedback on the design and content of the intervention. Participants preferred WeChat as the platform for receiving information and interactive communication for ease of access. Furthermore, they made specific recommendations about building trust, interactive features, and personalized feedback. In the follow-up assessment, the intervention and control groups did not differ in terms of major outcome measures. Conclusions: This pilot study represents one of the first efforts to develop a text messaging (SMS)- and WeChat-based intervention that focused on improving the medication adherence and QoL of PLWH in China. Our data indicates that an mHealth intervention is feasible and acceptable to this population. The data collected through this pilot study will inform the future designs and implementations of mHealth interventions in this vulnerable population. We recommend more innovative mHealth interventions with rigorous designs for the PLWH in middle- and low-income countries. Trial Registration: Chinese Clinical Trial Registry ChiCTR1800017987; http://www.chictr.org.cn/showprojen.aspx?proj=30448 (Archived by WebCite at http://www.webcitation.org/71zC7Pdzs) Registered Report Ientifier: RR1-10.2196/ %M 30181109 %R 10.2196/10274 %U http://mhealth.jmir.org/2018/9/e10274/ %U https://doi.org/10.2196/10274 %U http://www.ncbi.nlm.nih.gov/pubmed/30181109 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 20 %N 8 %P e245 %T Effect and Process Evaluation of e-Powered Parents, a Web-Based Support Program for Parents of Children With a Chronic Kidney Disease: Feasibility Randomized Controlled Trial %A Geense,Wytske W %A van Gaal,Betsie GI %A Knoll,Jaqueline L %A Maas,Nienke M %A Kok,Gerjo %A Cornelissen,Elisabeth AM %A Nijhuis-van der Sanden,Maria WG %+ IQ Healthcare, Radboud Institute for Health Science, Radboud University Medical Center, PO Box 9101, 6500 HD, Nijmegen,, Netherlands, 31 24 36 66 868, wytske.geense@radboudumc.nl %K child %K chronic kidney failure %K chronic kidney disease %K effect evaluation %K health promotion %K process evaluation %D 2018 %7 01.08.2018 %9 Original Paper %J J Med Internet Res %G English %X Background: Parents of children with chronic kidney disease (CKD) experience high levels of stress in the daily management of their child’s illness. Parents need continuously available support and information, yet online support programs are lacking. e-Powered Parents was developed to fill this gap; it is an online program consisting of (1) medical information, (2) an interactive part, and (3) four training modules (stress management, setting limits, communication, and coping). Prior to a large-scale evaluation, we conducted a feasibility study that consisted of an effect study and a process evaluation. Objective: The objectives of our study were to (1) identify the outcome measures that are most likely to capture the potential benefit, (2) evaluate the potential effectiveness and effect size, and (3) evaluate recruitment, reach, the dose received, and context. Methods: We conducted a feasibility study with a two-armed, wait-list randomized controlled trial (RCT). Prior to baseline, parents (n=146) were randomly allocated to group 1 or group 2. After completing the baseline questionnaire, parents in group 1 were given access to e-Powered Parents, while those in group 2 received usual care. At the 6-month follow-up (T1), all parents received a questionnaire and parents in group 2 were given access to e-Powered Parents as well. After 1.5 years, through an extra measurement (T2), we evaluated the effect of long-term exposure. Outcomes were the child’s quality of life (Child Vulnerability Scale), parental stress (Pediatric Inventory for Parents) and fatigue (Multidimensional Fatigue Inventory), self-efficacy in communication with health care professionals (Perceived Efficacy in Patient-Physician Interactions, PEPPI-5), and parental perceptions of family management (Family Management Measure). Floor and ceiling effects and percentage of parents showing no change in scores were calculated. We used linear mixed models to evaluate the potential effectiveness and effect sizes using the intention-to-treat and per-protocol analyses. In the process evaluation, we evaluated recruitment, reach, the dose received, and context using a questionnaire sent to the parents, log-in data, and a focus group interview with health care professionals. Results: At T1 (n=86) and T2 (n=51), no significant effects were found on any of the five outcomes. The PEPPI-5 showed ceiling effects and high percentages of parents showing no change between the measurement times. The information and interactive part of the intervention were used by 84% (57/68) of the parents in group 1 and 49% (32/65) of the parents in group 2. The information pages were visited most often. Overall, 64% (85/133) of the parents logged in to the training platform and 31% (26/85) actually used the training modules. Conclusions: We did not observe any significant effect on any of the outcomes. This could possibly be explained by the minimal use of the intervention and by parents’ heterogeneity. For continued participation, we recommend a tailored intervention and further studies to find out whether and how online programs could be used to support parents in the management of their child’s CKD. Trial Registration: Netherlands Trial Registry NTR4808; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=4808 (Archived by WebCite at http://www.webcitation.org/719rCicvW) %M 30068502 %R 10.2196/jmir.9547 %U http://www.jmir.org/2018/8/e245/ %U https://doi.org/10.2196/jmir.9547 %U http://www.ncbi.nlm.nih.gov/pubmed/30068502 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 20 %N 7 %P e10756 %T Developing a Digital Marketplace for Family Planning: Pilot Randomized Encouragement Trial %A Green,Eric P %A Augustine,Arun %A Naanyu,Violet %A Hess,Anna-Karin %A Kiwinda,Lulla %+ Duke Global Health Institute, Duke University, Box 90519, Durham, NC, 27708, United States, 1 9196817289, eric.green@duke.edu %K family planning %K unmet need %K contraception %K digital health %K Kenya %D 2018 %7 31.07.2018 %9 Original Paper %J J Med Internet Res %G English %X Background: Family planning is an effective tool for preventing death among women who do not want to become pregnant and has been shown to improve newborn health outcomes, advance women’s empowerment, and bring socioeconomic benefits through reductions in fertility and population growth. Yet among the populations that would benefit the most from family planning, uptake remains too low. The emergence of digital health tools has created new opportunities to strengthen health systems and promote behavior change. In this study, women with an unmet need for family planning in Western Kenya were randomized to receive an encouragement to try an automated investigational digital health intervention that promoted the uptake of family planning. Objective: The objectives of the pilot study were to explore the feasibility of a full-scale trial—in particular, the recruitment, encouragement, and follow-up data collection procedures—and to examine the preliminary effect of the intervention on contraception uptake. Methods: This pilot study tested the procedures for a randomized encouragement trial. We recruited 112 women with an unmet need for family planning from local markets in Western Kenya, conducted an eligibility screening, and randomized half of the women to receive an encouragement to try the investigational intervention. Four months after encouraging the treatment group, we conducted a follow-up survey with enrolled participants via short message service (SMS) text message. Results: The encouragement sent via SMS text messages to the treatment group led to differential rates of intervention uptake between the treatment and control groups; however, uptake by the treatment group was lower than anticipated (19/56, 33.9% vs 1/56, 1.8%, in the control group). Study attrition was also substantial. We obtained follow-up data from 44.6% (50/112) of enrolled participants. Among those in the treatment group who tried the intervention, the instrumental variables estimate of the local average treatment effect was an increase in the probability of contraceptive uptake of 41.0 percentage points (95% uncertainty interval −0.03 to 0.85). Conclusions: This randomized encouragement design and study protocol is feasible but requires modifications to the recruitment, encouragement, and follow-up data collection procedures. Trial Registration: ClinicalTrials.gov NCT03224390; https://clinicaltrials.gov/ct2/show/NCT03224390 (Archived by WebCite at http://www.webcitation.org/70yitdJu8) %M 30064968 %R 10.2196/10756 %U http://www.jmir.org/2018/7/e10756/ %U https://doi.org/10.2196/10756 %U http://www.ncbi.nlm.nih.gov/pubmed/30064968 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 6 %N 7 %P e156 %T Mobile-Based Nutrition Counseling and Unconditional Cash Transfers for Improving Maternal and Child Nutrition in Bangladesh: Pilot Study %A Huda,Tanvir M %A Alam,Ashraful %A Tahsina,Tazeen %A Hasan,Mohammad Mehedi %A Khan,Jasmin %A Rahman,Mohammad Masudur %A Siddique,Abu Bakkar %A Arifeen,Shams El %A Dibley,Michael J %+ Sydney School of Public Health, University of Sydney, Edward Ford Building (A27), Sydney,, Australia, 61 412735284, huda.tanvir@gmail.com %K unconditional cash transfer %K mHealth %K voice message %K undernutrition %D 2018 %7 18.07.2018 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Inappropriate feeding practices, inadequate nutrition knowledge, and insufficient access to food are major risk factors for maternal and child undernutrition. There is evidence to suggest that the combination of cash transfer and nutrition education improves child growth. However, a cost-effective delivery platform is needed to achieve complete, population-wide coverage of these interventions. Objective: This study aimed to assess the feasibility, acceptability, and perceived appropriateness of an intervention package consisting of voice messaging, direct counseling, and unconditional cash transfers all on a mobile platform for changing perceptions on nutrition during pregnancy and the first year of a child’s life in a poor rural community in Bangladesh. Methods: We conducted a mixed-methods pilot study. We recruited 340 pregnant or recently delivered, lactating women from rural Bangladesh. The intervention consisted of an unconditional cash transfer combined with nutrition counseling, both delivered on a mobile platform. The participants received a mobile phone and BDT 787 per month (US $10). We used a voice messaging service to deliver nutrition-related messages. We provided additional nutrition counseling through a nutrition counselor from a call center. We carried out cross-sectional surveys at baseline and at the end of the study, focus group discussions, and in-depth interviews with participants and their family members. Results: Approximately 89% (245/275) of participants reported that they were able to operate the mobile phones without much trouble. Charging of the mobile handsets posed some challenges since only approximately 45% (124/275) households in our study had electricity at home. Approximately 26% (72/275) women reported they had charged their mobile phones at their neighbor’s house, while 34% (94/275) reported that they charged it at a marketplace. Less than 10% (22/275) of women reported difficulties understanding the voice messages or direct counseling through mobile phones, while only 3% (8/275) of women reported they had some problems withdrawing cash from the mobile bank agent. Approximately 87% (236/275) women reported spending the cash to purchase food for themselves and their children. Conclusions: The nature of our study precludes any conclusion about the effectiveness of the intervention package. However, the high coverage of our intervention and the positive feedback from the mothers were encouraging and support the feasibility, acceptability, and appropriateness of this program. Further research is needed to determine the efficacy and cost-effectiveness of mobile-based nutrition counseling and unconditional cash transfers in improving maternal and child nutrition in Bangladesh. %M 30021707 %R 10.2196/mhealth.8832 %U http://mhealth.jmir.org/2018/7/e156/ %U https://doi.org/10.2196/mhealth.8832 %U http://www.ncbi.nlm.nih.gov/pubmed/30021707 %0 Journal Article %@ 2369-1999 %I JMIR Publications %V 4 %N 2 %P e10073 %T Online Decision Support Tool for Personalized Cancer Symptom Checking in the Community (REACT): Acceptability, Feasibility, and Usability Study %A Nieroda,Marzena Ewa %A Lophatananon,Artitaya %A McMillan,Brian %A Chen,Li-Chia %A Hughes,John %A Daniels,Rona %A Clark,James %A Rogers,Simon %A Muir,Kenneth Ross %+ Division of Management Sciences and Marketing, Alliance Manchester Business School, The University of Manchester, Booth Street West, Manchester, M13 9PL, United Kingdom, 44 161 275 6739, marzena.nieroda@manchester.ac.uk %K early detection of cancer %K cancer education %K cancer symptoms %K cancer risk %K personalized risk %K website development %K REACT %D 2018 %7 04.07.2018 %9 Original Paper %J JMIR Cancer %G English %X Background: Improving cancer survival in the UK, despite recent significant gains, remains a huge challenge. This can be attributed to, at least in part, patient and diagnostic delays, when patients are unaware they are suffering from a cancerous symptom and therefore do not visit a general practitioner promptly and/or when general practitioners fail to investigate the symptom or refer promptly. To raise awareness of symptoms that may potentially be indicative of underlying cancer among members of the public a symptom-based risk assessment model (developed for medical practitioner use and currently only used by some UK general practitioners) was utilized to develop a risk assessment tool to be offered to the public in community settings. Such a tool could help individuals recognize a symptom, which may potentially indicate cancer, faster and reduce the time taken to visit to their general practitioner. In this paper we report results about the design and development of the REACT (Risk Estimation for Additional Cancer Testing) website, a tool to be used in a community setting allowing users to complete an online questionnaire and obtain personalized cancer symptom-based risk estimation. Objective: The objectives of this study are to evaluate (1) the acceptability of REACT among the public and health care practitioners, (2) the usability of the REACT website, (3) the presentation of personalized cancer risk on the website, and (4) potential approaches to adopt REACT into community health care services in the UK. Methods: Our research consisted of multiple stages involving members of the public (n=39) and health care practitioners (n=20) in the UK. Data were collected between June 2017 and January 2018. User views were collected by (1) the “think-aloud” approach when participants using the website were asked to talk about their perceptions and feelings in relation to the website, and (2) self-reporting of website experiences through open-ended questionnaires. Data collection and data analysis continued simultaneously, allowing for website iterations between different points of data collection. Results: The results demonstrate the need for such a tool. Participants suggest the best way to offer REACT is through a guided approach, with a health care practitioner (eg, pharmacist or National Health Service Health Check nurse) present during the process of risk evaluation. User feedback, which was generally consistent across members of public and health care practitioners, has been used to inform the development of the website. The most important aspects were: simplicity, ability to evaluate multiple cancers, content emphasizing an inviting community “feel,” use (when possible) of layperson language in the symptom screening questionnaire, and a robust and positive approach to cancer communication relying on visual risk representation both with affected individuals and the entire population at risk. Conclusions: This study illustrates the benefits of involving public and stakeholders in developing and implementing a simple cancer symptom check tool within community. It also offers insights and design suggestions for user-friendly interfaces of similar health care Web-based services, especially those involving personalized risk estimation. %M 29973334 %R 10.2196/10073 %U http://cancer.jmir.org/2018/2/e10073/ %U https://doi.org/10.2196/10073 %U http://www.ncbi.nlm.nih.gov/pubmed/29973334 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 5 %N 3 %P e10517 %T A New Online Mental Health Training Program for Workplace Managers: Pre-Post Pilot Study Assessing Feasibility, Usability, and Possible Effectiveness %A Gayed,Aimée %A LaMontagne,Anthony D %A Milner,Allison %A Deady,Mark %A Calvo,Rafael A %A Christensen,Helen %A Mykletun,Arnstein %A Glozier,Nick %A Harvey,Samuel B %+ School of Psychiatry, Faculty of Medicine, University of New South Wales, Black Dog Institute Building, Hospital Road, Randwick, 2031, Australia, 61 +61293824517, a.gayed@unsw.edu.au %K manager; supervisor training; workplace mental health; mental health education; online intervention; knowledge; attitudes; behaviour; eHealth %D 2018 %7 03.07.2018 %9 Original Paper %J JMIR Ment Health %G English %X Background: Mental health has become the leading cause of sickness absence in high-income countries. Managers can play an important role in establishing mentally healthy workplaces and coordinating their organization’s response to a mentally ill worker. Objective: This pilot study aims to evaluate the feasibility, usability, and likely effectiveness of a newly developed online training program for managers called HeadCoach. HeadCoach aims to build managers’ confidence in supporting the mental health needs of staff and promote managerial behavior most likely to result in a more mentally healthy workplace. Methods: In total, 66 managers from two organizations were invited to participate in this pre-post pilot study of HeadCoach, which was made available to managers to complete at their own pace over a 4-week period. Data were collected at baseline and post intervention via an online research platform. The difference in mean scores for each outcome between these two time points was calculated using paired samples t tests. Results: Of all the invited managers, 59.1% (39/66) participated in the trial, with complete pre–post data available for 56.4% (22/39) of the participants. The majority of respondents reported positive engagement with the program. During the study period, managers’ knowledge regarding their role in managing mental health issues (P=.01) and their confidence in communicating with employees regarding mental illness (P<.001) significantly increased. In addition, a significant increase was observed from the baseline in managers’ self-reported actions to use strategies to prevent and decrease stress among their team members (P=.02). Conclusions: Although caution is needed due to the absence of a control group, preliminary results of this study suggest that HeadCoach could be a feasible, acceptable, and efficient method of training managers in best workplace practices to help support the mental health needs of their staff. %M 29970359 %R 10.2196/10517 %U http://mental.jmir.org/2018/3/e10517/ %U https://doi.org/10.2196/10517 %U http://www.ncbi.nlm.nih.gov/pubmed/29970359 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 5 %N 2 %P e10144 %T Using Neural Networks with Routine Health Records to Identify Suicide Risk: Feasibility Study %A DelPozo-Banos,Marcos %A John,Ann %A Petkov,Nicolai %A Berridge,Damon Mark %A Southern,Kate %A LLoyd,Keith %A Jones,Caroline %A Spencer,Sarah %A Travieso,Carlos Manuel %+ Swansea University, Swansea University Medical School, Institute of Life Science 2, 3rd Floor, Swansa University Singleton Park Campus, Swansea, SA2 8PP, United Kingdom, 44 1792604094, M.DelPozoBanos@swansea.ac.uk %K suicide prevention %K risk assessment %K electronic health records %K routine data %K machine learning %K artificial neural networks %D 2018 %7 22.06.2018 %9 Original Paper %J JMIR Ment Health %G English %X Background: Each year, approximately 800,000 people die by suicide worldwide, accounting for 1–2 in every 100 deaths. It is always a tragic event with a huge impact on family, friends, the community and health professionals. Unfortunately, suicide prevention and the development of risk assessment tools have been hindered by the complexity of the underlying mechanisms and the dynamic nature of a person’s motivation and intent. Many of those who die by suicide had contact with health services in the preceding year but identifying those most at risk remains a challenge. Objective: To explore the feasibility of using artificial neural networks with routinely collected electronic health records to support the identification of those at high risk of suicide when in contact with health services. Methods: Using the Secure Anonymised Information Linkage Databank UK, we extracted the data of those who died by suicide between 2001 and 2015 and paired controls. Looking at primary (general practice) and secondary (hospital admissions) electronic health records, we built a binary feature vector coding the presence of risk factors at different times prior to death. Risk factors included: general practice contact and hospital admission; diagnosis of mental health issues; injury and poisoning; substance misuse; maltreatment; sleep disorders; and the prescription of opiates and psychotropics. Basic artificial neural networks were trained to differentiate between the suicide cases and paired controls. We interpreted the output score as the estimated suicide risk. System performance was assessed with 10x10-fold repeated cross-validation, and its behavior was studied by representing the distribution of estimated risk across the cases and controls, and the distribution of factors across estimated risks. Results: We extracted a total of 2604 suicide cases and 20 paired controls per case. Our best system attained a mean error rate of 26.78% (SD 1.46; 64.57% of sensitivity and 81.86% of specificity). While the distribution of controls was concentrated around estimated risks < 0.5, cases were almost uniformly distributed between 0 and 1. Prescription of psychotropics, depression and anxiety, and self-harm increased the estimated risk by ~0.4. At least 95% of those presenting these factors were identified as suicide cases. Conclusions: Despite the simplicity of the implemented system, the proposed methodology obtained an accuracy like other published methods based on specialized questionnaire generated data. Most of the errors came from the heterogeneity of patterns shown by suicide cases, some of which were identical to those of the paired controls. Prescription of psychotropics, depression and anxiety, and self-harm were strongly linked with higher estimated risk scores, followed by hospital admission and long-term drug and alcohol misuse. Other risk factors like sleep disorders and maltreatment had more complex effects. %M 29934287 %R 10.2196/10144 %U http://mental.jmir.org/2018/2/e10144/ %U https://doi.org/10.2196/10144 %U http://www.ncbi.nlm.nih.gov/pubmed/29934287 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 7 %N 5 %P e141 %T Recruitment and Participation of Recreational Runners in a Large Epidemiological and Genetic Research Study: Retrospective Data Analysis %A Manzanero,Silvia %A Kozlovskaia,Maria %A Vlahovich,Nicole %A Hughes,David C %+ Australian Institute of Sport, Department of Sports Medicine, Australian Sports Commission, Leverrier St, Bruce, 2617, Australia, 61 2 6214 1578, david.hughes@ausport.gov.au %K genetic research %K community participation %K epidemiologic methods %K informed consent %D 2018 %7 23.05.2018 %9 Original Paper %J JMIR Res Protoc %G English %X Background: With the increasing capacity for remote collection of both data and samples for medical research, a thorough assessment is needed to determine the association of population characteristics and recruitment methodologies with response rates. Objective: The aim of this research was to assess population representativeness in a two-stage study of health and injury in recreational runners, which consisted of an epidemiological arm and genetic analysis. Methods: The cost and success of various classical and internet-based methods were analyzed, and demographic representativeness was assessed for recruitment to the epidemiological survey, reported willingness to participate in the genetic arm of the study, actual participation, sample return, and approval for biobank storage. Results: A total of 4965 valid responses were received, of which 1664 were deemed eligible for genetic analysis. Younger age showed a negative association with initial recruitment rate, expressed willingness to participate in genetic analysis, and actual participation. Additionally, female sex was associated with higher initial recruitment rates, and ethnic origin impacted willingness to participate in the genetic analysis (all P<.001). Conclusions: The sharp decline in retention through the different stages of the study in young respondents suggests the necessity to develop specific recruitment and retention strategies when investigating a young, physically active population. %M 29792293 %R 10.2196/resprot.8243 %U http://www.researchprotocols.org/2018/5/e141/ %U https://doi.org/10.2196/resprot.8243 %U http://www.ncbi.nlm.nih.gov/pubmed/29792293 %0 Journal Article %@ 2152-7202 %I JMIR Publications %V 10 %N 2 %P e7 %T A Decision Aid to Support Shared Decision Making About Mechanical Ventilation in Severe Chronic Obstructive Pulmonary Disease Patients (InformedTogether): Feasibility Study %A Basile,Melissa %A Andrews,Johanna %A Jacome,Sonia %A Zhang,Meng %A Kozikowski,Andrzej %A Hajizadeh,Negin %+ Department of Medicine, Northwell Health, 600 Community Drive, Suite 403, Manhasset, NY, 11031, United States, 1 516 600 1405, Nhajizadeh@northwell.edu %K Chronic Obstructive Pulmonary Disease %K COPD %K shared decision making %K life support %D 2018 %7 14.05.2018 %9 Original Paper %J J Participat Med %G English %X Background: Severe Chronic Obstructive Pulmonary Disease patients are often unprepared to make decisions about accepting intubation for respiratory failure. We developed a Web-based decision aid, InformedTogether, to facilitate severe Chronic Obstructive Pulmonary Disease patients’ preparation for decision making about whether to accept invasive mechanical ventilation for respiratory failure. Objective: We describe feasibility testing of the InformedTogether decision aid. Methods: Mixed methods, pre- and postintervention feasibility study in outpatient pulmonary and geriatric clinics. Clinicians used InformedTogether with severe Chronic Obstructive Pulmonary Disease patients. Patient-participants completed pre- and postassessments about InformedTogether use. The outcomes measured were the following: feasibility/acceptability, communication (Combined Outcome Measure for Risk Communication [COMRADE], Medical Communication Competency Scale [MCCS], Observing Patient Involvement [OPTION] scales), and effectiveness of InformedTogether on changing patients' knowledge, Decisional Conflict Scale, and motivation. Results: We enrolled 11 clinicians and 38 Chronic Obstructive Pulmonary Disease patients at six sites. Feasibility/acceptability: Clinicians and patients gave positive responses to acceptability questions (mean 74.1/89 max [SD 7.24] and mean 59.63/61 [SD 4.49], respectively). Communication: 96% of clinicians stated InformedTogether improved communication (modified MCCS mean 44.54/49 [SD 2.97]; mean OPTION score 32.03/48 [SD 9.27]; mean COMRADE Satisfaction 4.31/5.0 [SD 0.58]; and COMRADE Confidence 4.18/5.0 [SD 0.56]). Preference: Eighty percent of patients discussed preferences with their surrogates by 1-month. Effectiveness: Knowledge scores increased significantly after using InformedTogether (mean difference 3.61 [SD 3. 44], P=.001) and Decisional Conflict decreased (mean difference Decisional Conflict Scale pre/post -13.76 [SD 20.39], P=.006). Motivation increased after viewing the decision aid. Conclusions: InformedTogether supports high-quality communication and shared decision making among Chronic Obstructive Pulmonary Disease patients, clinicians, and surrogates. The increased knowledge and opportunity to deliberate and discuss treatment choices after using InformedTogether should lead to improved decision making at the time of critical illness. %M 32461812 %R 10.2196/jopm.9877 %U http://jopm.jmir.org/2018/2/e7/ %U https://doi.org/10.2196/jopm.9877 %U http://www.ncbi.nlm.nih.gov/pubmed/32461812 %0 Journal Article %@ 2369-1999 %I JMIR Publications %V 4 %N 1 %P e8 %T A Web-Based Intervention to Reduce Distress After Prostate Cancer Treatment: Development and Feasibility of the Getting Down to Coping Program in Two Different Clinical Settings %A Cockle-Hearne,Jane %A Barnett,Deborah %A Hicks,James %A Simpson,Mhairi %A White,Isabel %A Faithfull,Sara %+ School of Health Sciences, Faculty of Health and Medical Sciences, University of Surrey, Duke of Kent Building, Stag Hill Campus, Guildford, GU2 7XH, United Kingdom, 44 1483 684585, j.cockle-hearne@surrey.ac.uk %K prostatic neoplasms %K Internet %K self-management %K cognitive behavior therapy %K primary health care %K secondary care %D 2018 %7 30.04.2018 %9 Original Paper %J JMIR Cancer %G English %X Background: Distress after prostate cancer treatment is a substantial burden for up to one-third of men diagnosed. Physical and emotional symptoms and health service use can intensify, yet men are reticent to accept support. To provide accessible support that can be cost effectively integrated into care pathways, we developed a unique, Web-based, self-guided, cognitive-behavior program incorporating filmed and interactive peer support. Objective: To assess feasibility of the intervention among men experiencing distress after prostate cancer treatment. Demand, acceptability, change in distress and self-efficacy, and challenges for implementation in clinical practice were measured. Methods: A pre-post, within-participant comparison, mixed-methods research design was followed. Phase I and II were conducted in primary care psychological service and secondary care cancer service, respectively. Men received clinician-generated postal invitations: phase I, 432 men diagnosed <5 years; phase II, 606 men diagnosed <3.5 years. Consent was Web-based. Men with mild and moderate distress were enrolled. Web-based assessment included demographic, disease, treatment characteristics; distress (General Health Questionnaire-28); depression (Patient Health Questionnaire-9); anxiety (General Anxiety Disorder Scale-7); self-efficacy (Self-Efficacy for Symptom Control Inventory); satisfaction (author-generated, Likert-type questionnaire). Uptake and adherence were assessed with reference to the persuasive systems design model. Telephone interviews explored participant experience (phase II, n=10); interviews with health care professionals (n=3) explored implementation issues. Results: A total of 135 men consented (phase I, 61/432, 14.1%; phase II, 74/606, 12.2%); from 96 eligible men screened for distress, 32% (30/96) entered the intervention (phase I, n=10; phase II, n=20). Twenty-four completed the Web-based program and assessments (phase I, n=8; phase II, n=16). Adherence for phase I and II was module completion rate 63% (mean 2.5, SD 1.9) versus 92% (mean 3.7, SD 1.0); rate of completing cognitive behavior therapy exercises 77% (mean 16.1, SD 6.2) versus 88% (mean 18.6, SD 3.9). Chat room activity occurred among 63% (5/8) and 75% (12/16) of men, respectively. In phase I, 75% (6/8) of men viewed all the films; in phase II, the total number of unique views weekly was 16, 11, 11, and 10, respectively. The phase II mood diary was completed by 100% (16/16) of men. Satisfaction was high for the program and films. Limited efficacy testing indicated improvement in distress baseline to post intervention: phase I, P=.03, r=−.55; phase II, P=.001, r=−.59. Self-efficacy improved for coping P=.02, r=−.41. Service assessment confirmed ease of assimilation into clinical practice and clarified health care practitioner roles. Conclusions: The Web-based program is acceptable and innovative in clinical practice. It was endorsed by patients and has potential to positively impact the experience of men with distress after prostate cancer treatment. It can potentially be delivered in a stepped model of psychological support in primary or secondary care. Feasibility evidence is compelling, supporting further evaluative research to determine clinical and cost effectiveness. %M 29712628 %R 10.2196/cancer.8918 %U http://cancer.jmir.org/2018/1/e8/ %U https://doi.org/10.2196/cancer.8918 %U http://www.ncbi.nlm.nih.gov/pubmed/29712628 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 7 %N 4 %P e96 %T Addressing Participant Validity in a Small Internet Health Survey (The Restore Study): Protocol and Recommendations for Survey Response Validation %A Dewitt,James %A Capistrant,Benjamin %A Kohli,Nidhi %A Rosser,B R Simon %A Mitteldorf,Darryl %A Merengwa,Enyinnaya %A West,William %+ Division of Epidemiology & Community Health, School of Public Health, University of Minnesota, 1300 S. 2nd St., Room 300, Minneapolis, MN, 55410, United States, 1 6126240358, rosser@umn.edu %K fraudulent data %K data accuracy %K research and design %K research activities %K data analysis %D 2018 %7 24.04.2018 %9 Protocol %J JMIR Res Protoc %G English %X Background: While deduplication and cross-validation protocols have been recommended for large Web-based studies, protocols for survey response validation of smaller studies have not been published. Objective: This paper reports the challenges of survey validation inherent in a small Web-based health survey research. Methods: The subject population was North American, gay and bisexual, prostate cancer survivors, who represent an under-researched, hidden, difficult-to-recruit, minority-within-a-minority population. In 2015-2016, advertising on a large Web-based cancer survivor support network, using email and social media, yielded 478 completed surveys. Results: Our manual deduplication and cross-validation protocol identified 289 survey submissions (289/478, 60.4%) as likely spam, most stemming from advertising on social media. The basic components of this deduplication and validation protocol are detailed. An unexpected challenge encountered was invalid survey responses evolving across the study period. This necessitated the static detection protocol be augmented with a dynamic one. Conclusions: Five recommendations for validation of Web-based samples, especially with smaller difficult-to-recruit populations, are detailed. %M 29691203 %R 10.2196/resprot.7655 %U http://www.researchprotocols.org/2018/4/e96/ %U https://doi.org/10.2196/resprot.7655 %U http://www.ncbi.nlm.nih.gov/pubmed/29691203 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 7 %N 4 %P e116 %T Perceptions About Disseminating Health Information Among Mommy Bloggers: Quantitative Study %A Burke-Garcia,Amelia %A Kreps,Gary L %A Wright,Kevin B %+ Department of Communication, George Mason University, 4400 University Drive, MSN 3D6, Fairfax, VA, 22030, United States, 1 2023205060, ameliaburke-garcia@westat.com %K mommy bloggers %K social media %K health messages %K health information dissemination %D 2018 %7 24.04.2018 %9 Original Paper %J JMIR Res Protoc %G English %X Background: Social media are potentially powerful channels for communicating relevant health information in culturally sensitive and influential ways to key audiences. Moreover, these channels hold promise for promoting awareness and knowledge of health risks, prevention, and treatment by utilizing opinion leaders for message dissemination. Despite limited empirical evidence to-date, early promising results suggest that blogs are a form of social media that should be examined as worthy channels for health communication. Objectives: This formative study explored mommy bloggers’ perceptions about sharing health-related information on their blogs with their readers. It also sought to analyze which topics would be of most interest to mommy bloggers, what motivates them to write about health issues, and how they perceive interest in these topics among their readers. Methods: This study employed survey methodology, including the use of open-ended questions, the responses to which were coded for analysis. Specifically, a 14-item survey was fielded with mommy bloggers between October 1 and October 28, 2016. Bloggers were recruited through The Motherhood network. A total of 461 mommy bloggers responded to the survey; 163 were removed for low quality responses and incomplete data. As a result, 298 eligible participants completed the survey. For open-ended questions in the survey, a sample of responses were coded and analyzed. Results: The majority of the respondents (87.2%, 260/298) reported that they have written about health issues in the past; 97.3% (290/298) of the respondents reported that they would consider writing about health issues sometime in the future, and 96.3% (287/298) of the respondents reported that their readers like to read about health issues on their blogs. In terms of content priorities for this sample of bloggers, Nutrition and Physical Activity dominate the current conversation and similarly, Physical Activity and Nutrition remain top content priorities for these bloggers for the future. Moreover, 21.3% of the respondents reported that their readers would be interested in these topics. Finally, having a personal connection with a health issue was found to be positively associated with likeliness to write about health issues on their blog (P<.001). Conclusions: This study illustrates that there are potentially rich opportunities for working with mommy bloggers to communicate with key health decision makers (moms) on important health issues. There is a great support among mommy bloggers for health information dissemination as well as interest for accessing relevant health information from their readers. This presents an opportunity for public health research and communication campaigns to more broadly promote their messages, thereby contributing to their behavior change objectives. Limitations included overrepresentation of white, higher-educated, and younger women. It suggests a need for more targeted engagement of a diverse sample for future work. %M 29691204 %R 10.2196/resprot.7764 %U http://www.researchprotocols.org/2018/4/e116/ %U https://doi.org/10.2196/resprot.7764 %U http://www.ncbi.nlm.nih.gov/pubmed/29691204 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 6 %N 4 %P e90 %T The Interactive Child Distress Screener: Development and Preliminary Feasibility Testing %A March,Sonja %A Day,Jamin %A Zieschank,Kirsty %A Ireland,Michael %+ Institute for Resilient Regions, University of Southern Queensland, Sinnathamby Blvd, Springfield Central, 4300, Australia, 61 34704434, sonja.march@usq.edu.au %K child %K preschool %K mental health %K symptom assessment %K self-assessment (psychology) %D 2018 %7 19.04.2018 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Early identification of child emotional and behavioral concerns is essential for the prevention of mental health problems; however, few suitable child-reported screening measures are available. Digital tools offer an exciting opportunity for obtaining clinical information from the child’s perspective. Objective: The aim of this study was to describe the initial development and pilot testing of the Interactive Child Distress Screener (ICDS). The ICDS is a Web-based screening instrument for the early identification of emotional and behavioral problems in children aged between 5 and 12 years. Methods: This paper utilized a mixed-methods approach to (1) develop and refine item content using an expert review process (study 1) and (2) develop and refine prototype animations and an app interface using codesign with child users (study 2). Study 1 involved an iterative process that comprised the following four steps: (1) the initial development of target constructs, (2) preliminary content validation (face validity, item importance, and suitability for animation) from an expert panel of researchers and psychologists (N=9), (3) item refinement, and (4) a follow-up validation with the same expert panel. Study 2 also comprised four steps, which are as follows: (1) the development of prototype animations, (2) the development of the app interface and a response format, (3) child interviews to determine feasibility and obtain feedback, and (4) refinement of animations and interface. Cognitive interviews were conducted with 18 children aged between 4 and 12 years who tested 3 prototype animated items. Children were asked to describe the target behavior, how well the animations captured the intended behavior, and provide suggestions for improvement. Their ability to understand the wording of instructions was also assessed, as well as the general acceptability of character and sound design. Results: In study 1, a revised list of 15 constructs was generated from the first and second round of expert feedback. These were rated highly in terms of importance (mean 6.32, SD 0.42) and perceived compatibility of items (mean 6.41, SD 0.45) on a 7-point scale. In study 2, overall feedback regarding the character design and sounds was positive. Children’s ability to understand intended behaviors varied according to target items, and feedback highlighted key objectives for improvements such as adding contextual cues or improving character detail. These design changes were incorporated through an iterative process, with examples presented. Conclusions: The ICDS has potential to obtain clinical information from the child’s perspective that may otherwise be overlooked. If effective, the ICDS will provide a quick, engaging, and easy-to-use screener that can be utilized in routine care settings. This project highlights the importance of involving an expert review and user codesign in the development of digital assessment tools for children. %M 29674310 %R 10.2196/mhealth.9456 %U http://mhealth.jmir.org/2018/4/e90/ %U https://doi.org/10.2196/mhealth.9456 %U http://www.ncbi.nlm.nih.gov/pubmed/29674310 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 7 %N 4 %P e102 %T Capturing Ultraviolet Radiation Exposure and Physical Activity: Feasibility Study and Comparison Between Self-Reports, Mobile Apps, Dosimeters, and Accelerometers %A Hacker,Elke %A Horsham,Caitlin %A Allen,Martin %A Nathan,Andrea %A Lowe,John %A Janda,Monika %+ Institute of Health and Biomedical Innovation, School of Public Health and Social Work, Queensland University of Technology, 60 Musk Avenue, Kelvin Grove, Brisbane, 4059, Australia, 61 7 3138 9674, elke.hacker@qut.edu.au %K sun-protection %K sunburn %K health behaviour %K health promotion %K formative research %D 2018 %7 17.04.2018 %9 Original Paper %J JMIR Res Protoc %G English %X Background: Skin cancer is the most prevalent cancer in Australia. Skin cancer prevention programs aim to reduce sun exposure and increase sun protection behaviors. Effectiveness is usually assessed through self-report. Objective: It was the aim of this study to test the acceptance and validity of a newly developed ultraviolet radiation (UVR) exposure app, designed to reduce the data collection burden to research participants. Physical activity data was collected because a strong focus on sun avoidance may result in unhealthy reductions in physical activity. This paper provides lessons learned from collecting data from participants using paper diaries, a mobile app, dosimeters, and accelerometers for measuring end-points of UVR exposure and physical activity. Methods: Two participant groups were recruited through social and traditional media campaigns 1) Group A—UVR Diaries and 2) Group B—Physical Activity. In Group A, nineteen participants wore an UVR dosimeter wristwatch (University of Canterbury, New Zealand) when outside for 7 days. They also recorded their sun exposure and physical activity levels using both 1) the UVR diary app and 2) a paper UVR diary. In Group B, 55 participants wore an accelerometer (Actigraph, Pensacola, FL, USA) for 14 days and completed the UVR diary app. Data from the UVR diary app were compared with UVR dosimeter wristwatch, accelerometer, and paper UVR diary data. Cohen kappa coefficient score was used to determine if there was agreement between categorical variables for different UVR data collection methods and Spearman rank correlation coefficient was used to determine agreement between continuous accelerometer data and app-collected self-report physical activity. Results: The mean age of participants in Groups A (n=19) and B (n=55) was 29.3 and 25.4 years, and 63% (12/19) and 75% (41/55) were females, respectively. Self-reported sun exposure data in the UVR app correlated highly with UVR dosimetry (κ=0.83, 95% CI 0.64-1.00, P<.001). Correlation between self-reported UVR app and accelerometer-collected moderate to vigorous physical activity data was low (ρ=0.23, P=.10), while agreement for low-intensity physical activity was significantly different (ρ=-0.49, P<.001). Seventy-nine percent of participants preferred the app over the paper diary for daily self-report of UVR exposure and physical activity. Conclusions: This feasibility study highlights self-report using an UVR app can reliably collect personal UVR exposure, but further improvements are required before the app can also be used to collect physical activity data. %M 29666044 %R 10.2196/resprot.9695 %U http://www.researchprotocols.org/2018/4/e102/ %U https://doi.org/10.2196/resprot.9695 %U http://www.ncbi.nlm.nih.gov/pubmed/29666044 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 7 %N 4 %P e101 %T Comparison of Online Survey Recruitment Platforms for Hard-to-Reach Pregnant Smoking Populations: Feasibility Study %A Ibarra,Jose Luis %A Agas,Jessica Marie %A Lee,Melissa %A Pan,Julia Lily %A Buttenheim,Alison Meredith %+ Department of Family and Community Health, University of Pennsylvania, Fagin Hall, 4th Fl., 418 Curie Boulevard, Philadelphia, PA, 19104, United States, 1 215 573 5314, ibarraj@upenn.edu %K socioeconomic status %K smoking %K nicotine %K cognitive bias %K Web-based methods %K crowdsourcing %K delay discounting %K vulnerable populations %D 2018 %7 16.04.2018 %9 Original Paper %J JMIR Res Protoc %G English %X Background: Recruiting hard-to-reach populations for health research is challenging. Web-based platforms offer one way to recruit specific samples for research purposes, but little is known about the feasibility of online recruitment and the representativeness and comparability of samples recruited through different Web-based platforms. Objective: The objectives of this study were to determine the feasibility of recruiting a hard-to-reach population (pregnant smokers) using 4 different Web-based platforms and to compare participants recruited through each platform. Methods: A screener and survey were distributed online through Qualtrics Panel, Soapbox Sample, Reddit, and Amazon Mechanical Turk (mTurk). Descriptive statistics were used to summarize results of each recruitment platform, including eligibility yield, quality yield, income, race, age, and gestational age. Results: Of the 3847 participants screened for eligibility across all 4 Web-based platforms, 535 were eligible and 308 completed the survey. Amazon mTurk yielded the fewest completed responses (n=9), 100% (9/9) of which passed several quality metrics verifying pregnancy and smoking status. Qualtrics Panel yielded 14 completed responses, 86% (12/14) of which passed the quality screening. Soapbox Sample produced 107 completed surveys, 67% (72/107) of which were found to be quality responses. Advertising through Reddit produced the highest completion rate (n=178), but only 29.2% (52/178) of those surveys passed the quality metrics. We found significant differences in eligibility yield, quality yield, age, number of previous pregnancies, age of smoking initiation, current smokers, race, education, and income (P<.001). Conclusions: Although each platform successfully recruited pregnant smokers, results varied in quality, cost, and percentage of complete responses. Moving forward, investigators should pay careful attention to the percentage yield and cost of online recruitment platforms to maximize internal and external validity. %M 29661751 %R 10.2196/resprot.8071 %U http://www.researchprotocols.org/2018/4/e101/ %U https://doi.org/10.2196/resprot.8071 %U http://www.ncbi.nlm.nih.gov/pubmed/29661751 %0 Journal Article %@ 2291-5222 %I JMIR Publications %V 6 %N 3 %P e66 %T An mHealth Pain Coping Skills Training Intervention for Hematopoietic Stem Cell Transplantation Patients: Development and Pilot Randomized Controlled Trial %A Somers,Tamara J %A Kelleher,Sarah A %A Dorfman,Caroline S %A Shelby,Rebecca A %A Fisher,Hannah M %A Rowe Nichols,Krista %A Sullivan,Keith M %A Chao,Nelson J %A Samsa,Gregory P %A Abernethy,Amy P %A Keefe,Francis J %+ Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, 2200 W Main St, Ste 340, Durham, NC, 27705, United States, 1 919 416 3408, tamara.somers@duke.edu %K stem cell transplantation %K hematopoietic stem cell %K cancer-related pain %K coping skills %D 2018 %7 19.03.2018 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Pain is a challenge for patients following hematopoietic stem cell transplantation (HCT). Objective: This study aimed to develop and test the feasibility, acceptability, and initial efficacy of a Web-based mobile pain coping skills training (mPCST) protocol designed to address the needs of HCT patients. Methods: Participants had undergone HCT and reported pain following transplant (N=68). To guide intervention development, qualitative data were collected from focus group participants (n=25) and participants who completed user testing (n=7). After their input was integrated into the mPCST intervention, a pilot randomized controlled trial (RCT, n=36) was conducted to examine the feasibility, acceptability, and initial efficacy of the intervention. Measures of acceptability, pain severity, pain disability, pain self-efficacy, fatigue, and physical disability (self-report and 2-min walk test [2MWT]) were collected. Results: Participants in the focus groups and user testing provided qualitative data that were used to iteratively refine the mPCST protocol. Focus group qualitative data included participants’ experiences with pain following transplant, perspectives on ways to cope with pain, and suggestions for pain management for other HCT patients. User testing participants provided feedback on the HCT protocol and information on the use of videoconferencing. The final version of the mPCST intervention was designed to bridge the intensive outpatient (1 in-person session) and home settings (5 videoconferencing sessions). A key component of the intervention was a website that provided personalized messages based on daily assessments of pain and activity. The website also provided intervention materials (ie, electronic handouts, short videos, and audio files). The intervention content included pain coping advice from other transplant patients and instructions on how to apply pain coping skills while engaging in meaningful and leisure activities. In the RCT phase of this research, HCT patients (n=36) were randomized to receive the mPCST intervention or to proceed with the treatment as usual. Results revealed that the mPCST participants completed an average of 5 out of 6 sessions. The participants reported that the intervention was highly acceptable (mean 3/4), and they found the sessions to be helpful (mean 8/10) and easy to understand (mean 7/7). The mPCST participants demonstrated significant improvements in pre- to post-treatment pain, self-efficacy (P=.03, d=0.61), and on the 2MWT (P=.03, d=0.66), whereas the patients in the treatment-as-usual group did not report any such improvements. Significant changes in pain disability and fatigue were found in both groups (multiple P<.02); the magnitudes of the effect sizes were larger for the mPCST group than for the control group (pain disability: d=0.79 vs 0.69; fatigue: d=0.94 vs 0.81). There were no significant changes in pain severity in either group. Conclusions: Using focus groups and user testing, we developed an mPCST protocol that was feasible, acceptable, and beneficial for HCT patients with pain. Trial Registration: ClinicalTrials.gov NCT01984671; https://clinicaltrials.gov/ct2/show/NCT01984671 (Archived by WebCite at http://www.webcitation.org/6xbpx3clZ) %M 29555620 %R 10.2196/mhealth.8565 %U http://mhealth.jmir.org/2018/3/e66/ %U https://doi.org/10.2196/mhealth.8565 %U http://www.ncbi.nlm.nih.gov/pubmed/29555620 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 2 %N 1 %P e4 %T A Web-Based Platform for People With Memory Problems and Their Caregivers (CAREGIVERSPRO-MMD): Mixed-Methods Evaluation of Usability %A Zafeiridi,Paraskevi %A Paulson,Kevin %A Dunn,Rosie %A Wolverson,Emma %A White,Caroline %A Thorpe,Jonathan Adrian %A Antomarini,Marco %A Cesaroni,Francesca %A Scocchera,Francesca %A Landrin-Dutot,Isabelle %A Malherbe,Laëtitia %A Lingiah,Hendi %A Bérard,Marie %A Gironès,Xavier %A Quintana,Maria %A Cortés,Ulises %A Barrué,Cristian %A Cortés,Atia %A Paliokas,Ioannis %A Votis,Konstantinos %A Tzovaras,Dimitrios %+ School of Engineering and Computer Science, University of Hull, Aire Building, Cottingham Road, Hull, HU67RX, United Kingdom, 44 01482464571 ext 4571, P.Zafeiridi@hull.ac.uk %K dementia %K technology %K social support %K caregivers %D 2018 %7 12.03.2018 %9 Original Paper %J JMIR Formativ Res %G English %X Background: The increasing number of people with dementia (PwD) drives research exploring Web-based support interventions to provide effective care for larger populations. In this concept, a Web-based platform (CAREGIVERSPRO-MMD, 620911) was designed to (1) improve the quality of life for PwD, (2) reduce caregiver burden, (3) reduce the financial costs for care, and (4) reduce administration time for health and social care professionals. Objective: The objective of this study was to evaluate the usability and usefulness of CAREGIVERSPRO-MMD platform for PwD or mild cognitive impairment (MCI), informal caregivers, and health and social care professionals with respect to a wider strategy followed by the project to enhance the user-centered approach. A secondary aim of the study was to collect recommendations to improve the platform before the future pilot study. Methods: A mixed methods design was employed for recruiting PwD or MCI (N=24), informal caregivers (N=24), and professionals (N=10). Participants were asked to rate their satisfaction, the perceived usefulness, and ease of use of each function of the platform. Qualitative questions about the improvement of the platform were asked when participants provided low scores for a function. Testing occurred at baseline and 1 week after participants used the platform. The dropout rate from baseline to the follow-up was approximately 10% (6/58). Results: After 1 week of platform use, the system was useful for 90% (20.75/23) of the caregivers and for 89% (5.36/6) of the professionals. When users responded to more than 1 question per platform function, the mean of satisfied users per function was calculated. These user groups also provided positive evaluations for the ease of use (caregivers: 82%, 18.75/23; professionals: 97%, 5.82/6) and their satisfaction with the platform (caregivers: 79%, 18.08/23; professionals: 73%, 4.36/6). Ratings from PwD were lower than the other groups for usefulness (57%, 13/23), ease of use (41%, 9.4/23), and overall satisfaction (47%, 11/23) with the platform (P<.05). Qualitative comments related to both improvements for functionality and the platform interface. Conclusions: Although caregivers and professionals were overall satisfied with the platform, further adaptations were recommended by PwD. This reiterates the importance of the involvement of end users in the development of Web-based interventions. Recommendations from users in this paper apply for the interface and functionality of a wider range of Web-based support interventions. %M 30684403 %R 10.2196/formative.9083 %U http://formative.jmir.org/2018/1/e4/ %U https://doi.org/10.2196/formative.9083 %U http://www.ncbi.nlm.nih.gov/pubmed/30684403 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 5 %N 1 %P e18 %T Targeted Secure Messages to Facilitate Access to Tobacco Treatment Counseling for Veterans: Feasibility Study %A Shahani,Shaun %A Korenblit,Pearl %A Thomas,Pauline %A Passannante,Marian R %A Carr,Richard %A Davis,Lynn %+ Rutgers New Jersey Medical School, 185 S Orange Ave, Newark, NJ, 07103, United States, 1 732 445 4636, shaun.shahani@tu.edu %K secure messaging %K tobacco use %K smoking cessation %D 2018 %7 05.03.2018 %9 Original Paper %J JMIR Ment Health %G English %X Background: Studies show that combining nicotine replacement therapy (NRT) with tobacco treatment counseling is most effective for smoking cessation. However, tobacco treatment counseling has been underutilized across the nation. A secure email message sent to patients already taking NRT was hypothesized to increase the utilization of tobacco treatment counseling among Veterans in New Jersey. Secure messaging for communication between patients and providers was implemented through a web-based password-protected, secure messaging account, where Veterans get notified through their personal email when they have a message awaiting them. Objective: The main objective of this project was to determine if there was a significant increase in adoption of tobacco treatment counseling among Veterans who received a secure message describing the options for tobacco treatment counseling available to them. Secondary objectives were to demographically characterize Veterans who were and were not enrolled in secure messaging, as well as those who opened or did not open a message. Finally, because the language and content of the messages were changed across project phases, this project also sought to determine (by analysis of response rates) the type of language that was most effective at eliciting a response. Methods: Over two phases, messages were sent to two samples of Veterans prescribed NRT within the prior 90 days of each phase. In phase 1, one message was sent in December 2015 (message 1). In phase 2, one message was sent in July 2016 (message 2) and the same message (message 3) was resent in August 2016 to persons who did not open message 2. Messages 2 and 3 were more directive than message 1. Response rates to message 1 versus message 2 were compared. A logistic regression analysis determined effect of age and gender on enrollment in secure messaging across both phases. The effectiveness of each phase at increasing tobacco treatment counseling was analyzed using a McNemar test. Results: Message 2, sent to 423 Veterans, had a significantly higher response rate than message 1, sent to 348 Veterans (18%, 17/93 vs 8%, 6/78, P=.04). Phase 2 (ie, messages 2 and 3) significantly increased utilization of tobacco treatment counseling (net increase of six tobacco treatment counseling adopters, P=.04), whereas phase 1 (ie, message 1) did not (net increase of two tobacco treatment counseling adopters, P=.48). Women (odds ratio [OR] 1.6, 95% CI 1.1-2.3) and those aged 30 to 49 years (compared to other age groups) were more likely to be enrolled in secure messaging. Gender and age were not significant predictors of opening or replying to either message. Conclusions: Although the effect was small, secure messaging was a useful modality to increase tobacco treatment counseling. Directive content with a follow-up message appeared useful. Female Veterans and/or Veterans aged between 30 and 49 years are more likely to use secure messaging. %M 29506969 %R 10.2196/mental.7957 %U http://mental.jmir.org/2018/1/e18/ %U https://doi.org/10.2196/mental.7957 %U http://www.ncbi.nlm.nih.gov/pubmed/29506969 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 5 %N 1 %P e15 %T A Mobile Health Platform for Clinical Monitoring in Early Psychosis: Implementation in Community-Based Outpatient Early Psychosis Care %A Kumar,Divya %A Tully,Laura M %A Iosif,Ana-Maria %A Zakskorn,Lauren N %A Nye,Kathleen E %A Zia,Aqsa %A Niendam,Tara Ann %+ Department of Psychiatry and Behavioral Sciences, University of California, Davis, 4701 X Street, Sacramento, CA, 95817, United States, 1 916 734 7927, lmtully@ucdavis.edu %K mHealth %K schizophrenia %K smartphone %K ecological momentary assessment %K experience sampling %D 2018 %7 27.02.2018 %9 Original Paper %J JMIR Ment Health %G English %X Background: A growing body of literature indicates that smartphone technology is a feasible add-on tool in the treatment of individuals with early psychosis (EP) . However, most studies to date have been conducted independent of outpatient care or in a research clinic setting, often with financial incentives to maintain user adherence to the technology. Feasibility of dissemination and implementation of smartphone technology into community mental health centers (CMHCs) has yet to be tested, and whether young adults with EP will use this technology for long periods of time without incentive is unknown. Furthermore, although EP individuals willingly adopt smartphone technology as part of their treatment, it remains unclear whether providers are amenable to integrating smartphone technology into treatment protocols. Objective: This study aimed to establish the feasibility of implementing a smartphone app and affiliated Web-based dashboard in 4 community outpatient EP clinics in Northern California. Methods: EP individuals in 4 clinics downloaded an app on their smartphone and responded to daily surveys regarding mood and symptoms for up to 5 months. Treatment providers at the affiliated clinics viewed survey responses on a secure Web-based dashboard in sessions with their clients and between appointments. EP clients and treatment providers filled out satisfaction surveys at study end regarding usability of the app. Results: Sixty-one EP clients and 20 treatment providers enrolled in the study for up to 5 months. Forty-one EP clients completed the study, and all treatment providers remained in the study for their duration in the clinic. Survey completion for all 61 EP clients was moderate: 40% and 39% for daily and weekly surveys, respectively. Completion rates were slightly higher in the participants who completed the study: 44% and 41% for daily and weekly surveys, respectively. Twenty-seven of 41 (66%) EP clients who completed the study and 11 of 13 (85%) treatment providers who responded to satisfaction surveys reported they would continue to use the app as part of treatment services. Six (15%; 6/41) clients and 3 providers (23%; 3/13) stated that technological glitches impeded their engagement with the platform. Conclusions: EP clients and treatment providers in community-based outpatient clinics are responsive to integrating smartphone technology into treatment services. There were logistical and technical challenges associated with enrolling individuals in CMHCs. To be most effective, implementing smartphone technology in CMHC EP care necessitates adequate technical staff and support for utilization of the platform. %M 29487044 %R 10.2196/mental.8551 %U http://mental.jmir.org/2018/1/e15/ %U https://doi.org/10.2196/mental.8551 %U http://www.ncbi.nlm.nih.gov/pubmed/29487044 %0 Journal Article %@ 2562-0959 %I JMIR Publications %V 1 %N 1 %P e1 %T Acceptability and Feasibility of a Trial Testing Allocation to Sunscreen and a Smartphone App for Sun Protection: Discontinued Randomized Controlled Trial %A Rodrigues,Angela M %A Sniehotta,Falko F %A Birch-Machin,Mark A %A Olivier,Patrick %A Araújo-Soares,Vera %+ Newcastle University, Baddiley-Clark Building, Richardson Road, Newcastle, NE2 4AX, United Kingdom, 44 191 208 8974, angela.rodrigues@newcastle.ac.uk %K sunscreening agents %K sun protection factor %K smartphone %K mobile applications %K feasibility studies %K randomized controlled trial %K skin neoplasms %K melanoma %K skin aging %K holidays %K health promotion %K health behavior %D 2018 %7 27.02.2018 %9 Original Paper %J JMIR Dermatol %G English %X Background: Recreational sun exposure has been associated with melanoma prevalence, and tourism settings are of particular interest for skin cancer prevention. Effective, affordable, and geographically flexible interventions to promote sun protection are needed. Objective: The aim of this study was to describe the protocol for a definitive randomized controlled trial (RCT) evaluating a smartphone mobile intervention (mISkin app) promoting sun protection in holidaymakers and to assess the acceptability and feasibility of the mISkin app and associated trial procedures in an internal pilot study. Methods: Participants were recruited from the general community. Holidaymakers traveling abroad and owning a smartphone were enrolled in the internal pilot of a 2 (mISkin vs control) x 2 (sun protection factor [SPF] 15 vs SPF 30) RCT with a postholiday follow-up. The smartphone app is fully automated and entails a behavioral intervention to promote sun protection. It consisted of five components: skin assessment, educational videos, ultraviolet (UV) photos, gamification, and prompts for sun protection. Participants were also randomly allocated to receive sunscreen SPF 15 or SPF 30. Primary outcomes for the internal pilot study were acceptability and feasibility of trial procedures and intervention features. Secondary outcomes were collected at baseline and after holidays through face-to-face-assessments and included skin sun damage, sunscreen use (residual weight and application events), and sun protection practices (Web-based questionnaire). Results: From 142 registers of interest, 42 participants were randomized (76% [32/42] female; mean age 35.5 years). Outcome assessments were completed by all participants. Random allocation to SPF 15 versus SPF 30 was found not to be feasible in a definitive trial protocol. Of the 21 people allocated to the mISkin intervention, 19 (91%) installed the mISkin on their phones, and 18 (86%) used it at least once. Participants were satisfied with the mISkin app and made suggestions for further improvements. Due to difficulties with the random allocation to SPF and slow uptake, the trial was discontinued. Conclusions: The internal pilot study concluded that randomization to SPF was not feasible and that recruitment rate was slower than expected because of difficulties with gatekeeper engagement. Possible solutions to the problems identified are discussed. Further refinements to the mISkin app are needed before a definitive trial. Trial Registration: International Standard Randomized Controlled Trial Number ISRCTN63943558; http://www.isrctn.com/ISRCTN63943558 (Archived by WebCite at http://www.webcitation.org/6xOLvbab8) %R 10.2196/derma.8608 %U https://derma.jmir.org/2018/1/e1/ %U https://doi.org/10.2196/derma.8608 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 5 %N 1 %P e17 %T Supporting Our Valued Adolescents (SOVA), a Social Media Website for Adolescents with Depression and/or Anxiety: Technological Feasibility, Usability, and Acceptability Study %A Radovic,Ana %A Gmelin,Theresa %A Hua,Jing %A Long,Cassandra %A Stein,Bradley D %A Miller,Elizabeth %+ Department of Pediatrics, Children's Hospital of Pittsburgh of UPMC, University of Pittsburgh School of Medicine, 3420 Fifth Avenue, Pittsburgh, PA, 15213, United States, 1 412 692 7227, ana.radovic@chp.edu %K adolescent %K adolescent health services %K technology %K depression %K anxiety %D 2018 %7 26.02.2018 %9 Original Paper %J JMIR Ment Health %G English %X Background: Supporting Our Valued Adolescents (SOVA), a social media website for adolescents, was designed to increase mental health literacy and address negative health beliefs toward depression and/or anxiety diagnosis and treatment. This stakeholder-informed site underwent iterative user testing to evolve into its current version with daily blog posts, round-the-clock site moderation, and Web-based peer interaction to create an online support community. Objective: The aim of this study was to evaluate the technological feasibility (at least 100 users on the site, logging in 12 to 18 times in the first 6 weeks) and acceptability of the SOVA site determined by the System Usability Scale (SUS). Methods: Adolescents and young adults (aged 14-26 years) with a self-reported history of depressive and/or anxiety symptoms were recruited to access the research website (sova.pitt.edu). Participants were screened out if they reported active suicidality or a prior suicide attempt. Baseline survey measures included demographics, symptomatology using the Patient Health Questionnaire-9 modified for adolescents (PHQ-9A) and Screen for Child Anxiety Related Disorders (SCARED-C), and mental health treatment history. The 6-week follow-up measures taken in addition to the symptomatology, included feasibility (total number of log-ins), usability, and acceptability of SOVA using SUS. Results: Most of the 96 participants identified as female (75% [72/96]) and white (67% [64/96]). Most participants (73% [70/96]) reported having taken prior professional psychological help. The average PHQ-9A score was 11.8 (SD 5.5), and for SCARED-C, 85% (80/94) of the participants reported a score consistent with being susceptible to a diagnosed anxiety disorder. There were 46% (41/90) of eligible users who ever logged in. Out of the total users who ever logged in, the mean of total log-ins over the entire study was 4.1 (SD 6.9). Median number of users rated the user-friendliness of the site as “good.” The average SUS score was 71.2% (SD 18.7), or a “C-grade,” which correlated to an acceptable range. The participants reported to have liked the “easy-to-understand format” and “positive, helpful atmosphere,” but they also reported a desire for greater social interaction. Iterative recruitment resulted in incremental improvements to the site. Conclusions: The SOVA site met feasibility goals of recruiting almost 100 users and establishing acceptable usability. Subsequent interventions are planned to increase site engagement and to evaluate efficacy in increasing uptake of primary care–recommended depression and/or anxiety treatment. %M 29483067 %R 10.2196/mental.9441 %U http://mental.jmir.org/2018/1/e17/ %U https://doi.org/10.2196/mental.9441 %U http://www.ncbi.nlm.nih.gov/pubmed/29483067 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 7 %N 2 %P e43 %T Telehealth Rehabilitation for Cognitive Impairment: Randomized Controlled Feasibility Trial %A Burton,Rachel L %A O'Connell,Megan E %+ Department of Psychology, University of Saskatchewan, 9 Campus Drive, Saskatoon, SK,, Canada, 1 306 966 2496, megan.oconnell@usask.ca %K cognitive rehabilitation %K Alzheimer disease %K dementia %K telehealth %D 2018 %7 08.02.2018 %9 Original Paper %J JMIR Res Protoc %G English %X Background: Nonpharmacological interventions are needed to support the function of older adults struggling with subjective cognitive impairment (SCI), mild cognitive impairment (MCI), and dementia due to Alzheimer disease (AD). Telerehabilitation aims to provide rehabilitation at a distance, but cognitive rehabilitation by videoconferencing has not been explored. Objective: The objective of this study was to compare goal-oriented cognitive rehabilitation delivered in-person with videoconferencing to determine whether telehealth cognitive rehabilitation appears feasible. Methods: Random assignment to in-person or telehealth videoconferencing cognitive rehabilitation with a combined between-subjects, multiple baseline single-case experimental design, cognitive rehabilitation was delivered by a therapist to 6 participants with SCI (n=4), MCI (n=1), or dementia due to AD (n=1). Results: Two of the 6 participants randomly assigned to the telehealth condition withdrew before beginning the intervention. For those who participated in the intervention, 6 out of 6 goals measured with the Canadian Occupational Performance Measure improved for those in the in-person group, and 7 out of 9 goals improved for those in the telehealth group. Conclusions: Delivery of cognitive rehabilitation by telehealth appeared feasible but required modifications such as greater reliance on caregivers and clients for manipulating materials. %M 29422453 %R 10.2196/resprot.9420 %U http://www.researchprotocols.org/2018/2/e43/ %U https://doi.org/10.2196/resprot.9420 %U http://www.ncbi.nlm.nih.gov/pubmed/29422453 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 7 %N 2 %P e18 %T Lessons From Recruitment to an Internet-Based Survey for Degenerative Cervical Myelopathy: Comparison of Free and Fee-Based Methods %A Davies,Benjamin %A Kotter,Mark %+ Department of Academic Neurosurgery, University of Cambridge, Hills Road, Cambridge, CB2 0SZ, United Kingdom, 44 1223 763366, mrk25@cam.ac.uk %K cervical %K myelopathy %K spondylosis %K spondylotic %K stenosis %K disc herniation %K ossification posterior longitudinal ligament %K degeneration %K disability %K recovery %K questionnaire %K Internet survey %K Google Adwords %K advertising %K social media %K electronic survey %K Internet %K survey %D 2018 %7 05.02.2018 %9 Original Paper %J JMIR Res Protoc %G English %X Background: Degenerative Cervical Myelopathy (DCM) is a syndrome of subacute cervical spinal cord compression due to spinal degeneration. Although DCM is thought to be common, many fundamental questions such as the natural history and epidemiology of DCM remain unknown. In order to answer these, access to a large cohort of patients with DCM is required. With its unrivalled and efficient reach, the Internet has become an attractive tool for medical research and may overcome these limitations in DCM. The most effective recruitment strategy, however, is unknown. Objective: To compare the efficacy of fee-based advertisement with alternative free recruitment strategies to a DCM Internet health survey. Methods: An Internet health survey (SurveyMonkey) accessed by a new DCM Internet platform (myelopathy.org) was created. Using multiple survey collectors and the website’s Google Analytics, the efficacy of fee-based recruitment strategies (Google AdWords) and free alternatives (including Facebook, Twitter, and myelopathy.org) were compared. Results: Overall, 760 surveys (513 [68%] fully completed) were accessed, 305 (40%) from fee-based strategies and 455 (60%) from free alternatives. Accounting for researcher time, fee-based strategies were more expensive ($7.8 per response compared to $3.8 per response for free alternatives) and identified a less motivated audience (Click-Through-Rate of 5% compared to 57% using free alternatives) but were more time efficient for the researcher (2 minutes per response compared to 16 minutes per response for free methods). Facebook was the most effective free strategy, providing 239 (31%) responses, where a single message to 4 existing communities yielded 133 (18%) responses within 7 days. Conclusions: The Internet can efficiently reach large numbers of patients. Free and fee-based recruitment strategies both have merits. Facebook communities are a rich resource for Internet researchers. %M 29402760 %R 10.2196/resprot.6567 %U http://www.researchprotocols.org/2018/2/e18/ %U https://doi.org/10.2196/resprot.6567 %U http://www.ncbi.nlm.nih.gov/pubmed/29402760 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 7 %N 1 %P e31 %T mHealth Intervention Promoting Cardiovascular Health Among African-Americans: Recruitment and Baseline Characteristics of a Pilot Study %A Brewer,LaPrincess C %A Jenkins,Sarah %A Lackore,Kandace %A Johnson,Jacqueline %A Jones,Clarence %A Cooper,Lisa A %A Radecki Breitkopf,Carmen %A Hayes,Sharonne N %A Patten,Christi %+ Department of Cardiovascular Medicine, Mayo Clinic College of Medicine, 200 First Street SW, Rochester, MN, 55905, United States, 1 507 266 1376, brewer.laprincess@mayo.edu %K mHealth intervention %K community-based participatory research %K cardiovascular disease %K cardiovascular health %K health disparities %K African-Americans %K faith-based intervention %D 2018 %7 31.01.2018 %9 Original Paper %J JMIR Res Protoc %G English %X Background: Mobile health (mHealth) interventions are promising avenues to promote cardiovascular (CV) health among African-Americans (AAs) and culturally tailored technology-based interventions are emerging for this population. Objective: The objectives of this study were to use a community-based participatory research (CBPR) approach to recruit AAs into a pilot intervention study of an innovative mHealth CV health promotion program and to characterize technology use patterns and eHealth literacy (EHL). Methods: Community partners from five predominately AA churches in southeast Minnesota collaborated with our academic institution to recruit AA congregants into the pilot study. Field notes as well as communications between the study team and community partners were used to design the recruitment strategy and its implementation with a goal of enrolling 50 participants. At its core, the recruitment strategy included community kickoff events to detail the state-of-the-art nature of the mHealth intervention components, the utility of CV health assessments (physical examination, laboratory studies and surveys) and the participants’ role in advancing our understanding of the efficacy of mHealth interventions among racial/ethnic minority groups. Detailed recruitment data were documented throughout the study. A self-administered, electronic survey measured sociodemographics, technology use and EHL (eHEALS scale). Results: A total of 50 participants (70% women) from five AA churches were recruited over a one-month period. The majority (>90%) of participants reported using some form of mobile technology with all utilizing these technologies within their homes. Greater than half (60% [30/50]) reported being “very comfortable” with mobile technologies. Overall, participants had high EHL (84.8% [39/46] with eHEALS score ≥26) with no differences by sex. Conclusions: This study illustrates the feasibility and success of a CBPR approach in recruiting AAs into mHealth intervention research and contributes to the growing body of evidence that AAs have high EHL, are high-users of mobile technologies, and thus are likely to be receptive to mHealth interventions. %M 29386174 %R 10.2196/resprot.8842 %U http://www.researchprotocols.org/2018/1/e31/ %U https://doi.org/10.2196/resprot.8842 %U http://www.ncbi.nlm.nih.gov/pubmed/29386174 %0 Journal Article %@ 2369-2960 %I JMIR Publications %V 4 %N 1 %P e12 %T Web-Based Survey Application to Collect Contextually Relevant Geographic Data With Exposure Times: Application Development and Feasibility Testing %A Rudolph,Abby %A Tobin,Karin %A Rudolph,Jonathan %A Latkin,Carl %+ Department of Epidemiology, Boston University School of Public Health, 715 Albany St, T418E, Boston, MA, 02118, United States, 1 617 358 3423, arudolph@bu.edu %K spatial analysis %K geographic mapping %K substance-related disorder %D 2018 %7 19.01.2018 %9 Original Paper %J JMIR Public Health Surveill %G English %X Background: Although studies that characterize the risk environment by linking contextual factors with individual-level data have advanced infectious disease and substance use research, there are opportunities to refine how we define relevant neighborhood exposures; this can in turn reduce the potential for exposure misclassification. For example, for those who do not inject at home, injection risk behaviors may be more influenced by the environment where they inject than where they live. Similarly, among those who spend more time away from home, a measure that accounts for different neighborhood exposures by weighting each unique location proportional to the percentage of time spent there may be more correlated with health behaviors than one’s residential environment. Objective: This study aimed to develop a Web-based application that interacts with Google Maps application program interfaces (APIs) to collect contextually relevant locations and the amount of time spent in each. Our analysis examined the extent of overlap across different location types and compared different approaches for classifying neighborhood exposure. Methods: Between May 2014 and March 2017, 547 participants enrolled in a Baltimore HIV care and prevention study completed an interviewer-administered Web-based survey that collected information about where participants were recruited, worked, lived, socialized, injected drugs, and spent most of their time. For each location, participants gave an address or intersection which they confirmed using Google Map and Street views. Geographic coordinates (and hours spent in each location) were joined to neighborhood indicators by Community Statistical Area (CSA). We computed a weighted exposure based on the proportion of time spent in each unique location. We compared neighborhood exposures based on each of the different location types with one another and the weighted exposure using analysis of variance with Bonferroni corrections to account for multiple comparisons. Results: Participants reported spending the most time at home, followed by the location where they injected drugs. Injection locations overlapped most frequently with locations where people reported socializing and living or sleeping. The least time was spent in the locations where participants reported earning money and being recruited for the study; these locations were also the least likely to overlap with other location types. We observed statistically significant differences in neighborhood exposures according to the approach used. Overall, people reported earning money in higher-income neighborhoods and being recruited for the study and injecting in neighborhoods with more violent crime, abandoned houses, and poverty. Conclusions: This analysis revealed statistically significant differences in neighborhood exposures when defined by different locations or weighted based on exposure time. Future analyses are needed to determine which exposure measures are most strongly associated with health and risk behaviors and to explore whether associations between individual-level behaviors and neighborhood exposures are modified by exposure times. %M 29351899 %R 10.2196/publichealth.8581 %U http://publichealth.jmir.org/2018/1/e12/ %U https://doi.org/10.2196/publichealth.8581 %U http://www.ncbi.nlm.nih.gov/pubmed/29351899 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 20 %N 1 %P e14 %T Leveraging Social Networking Sites for an Autoimmune Hepatitis Genetic Repository: Pilot Study to Evaluate Feasibility %A Comerford,Megan %A Fogel,Rachel %A Bailey,James Robert %A Chilukuri,Prianka %A Chalasani,Naga %A Lammert,Craig Steven %+ Division of Digestive and Liver Diseases, Indiana University School of Medicine, 702 Rotary Circle, Indianapolis, IN,, United States, 1 317 274 6492, clammert@iu.edu %K autoimmune hepatitis %K social media %K rare disease %D 2018 %7 18.01.2018 %9 Original Paper %J J Med Internet Res %G English %X Background: Conventional approaches to participant recruitment are often inadequate in rare disease investigation. Social networking sites such as Facebook may provide a vehicle to circumvent common research limitations and pitfalls. We report our preliminary experience with Facebook-based methodology for participant recruitment and participation into an ongoing study of autoimmune hepatitis (AIH). Objective: The goal of our research was to conduct a pilot study to assess whether a Facebook-based methodology is capable of recruiting geographically widespread participants into AIH patient-oriented research and obtaining quality phenotypic data. Methods: We established a Facebook community, the Autoimmune Hepatitis Research Network (AHRN), in 2014 to provide a secure and reputable distillation of current literature and AIH research opportunities. Quarterly advertisements for our ongoing observational AIH study were posted on the AHRN over 2 years. Interested and self-reported AIH participants were subsequently enrolled after review of study materials and completion of an informed consent by our study coordinator. Participants returned completed study materials, including epidemiologic questionnaires and genetic material, to our facility via mail. Outside medical records were obtained and reviewed by a study physician. Results: We successfully obtained all study materials from 29 participants with self-reported AIH within 2 years from 20 different states. Liver biopsy results were available for 90% (26/29) of participants, of which 81% (21/29) had findings consistent with AIH, 15% (4/29) were suggestive of AIH with features of primary biliary cholangitis (PBC), and 4% (1/29) had PBC alone. A total of 83% (24/29) had at least 2 of 3 proposed criteria: positive autoimmune markers, consistent histologic findings of AIH on liver biopsy, and reported treatment with immunosuppressant medications. Self-reported and physician records were discrepant for immunosuppressant medications or for AIH/PBC diagnoses in 4 patients. Conclusions: Facebook can be an effective ancillary tool for facilitating patient-oriented research in rare diseases. A social media-based approach transcends established limitations in rare disease research and can further develop research communities. %M 29348111 %R 10.2196/jmir.7683 %U http://www.jmir.org/2018/1/e14/ %U https://doi.org/10.2196/jmir.7683 %U http://www.ncbi.nlm.nih.gov/pubmed/29348111 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 4 %N 4 %P e30 %T An eHealth Application of Self-Reported Sports-Related Injuries and Illnesses in Paralympic Sport: Pilot Feasibility and Usability Study %A Fagher,Kristina %A Jacobsson,Jenny %A Dahlström,Örjan %A Timpka,Toomas %A Lexell,Jan %+ Rehabilitation Medicine Research Group, Department of Health Sciences, Lund University, PO Box 157, Lund,, Sweden, 46 46 222 1991, kristina.fagher@med.lu.se %K epidemiology %K feasibility studies %K sports medicine %K sports for persons with disabilities %K telemedicine %D 2017 %7 29.11.2017 %9 Original Paper %J JMIR Hum Factors %G English %X Background: Sport participation is associated with a risk of sports-related injuries and illnesses, and Paralympic athletes’ additional medical issues can be a challenge to health care providers and medical staff. However, few prospective studies have assessed sports-related injuries and illnesses in Paralympic sport (SRIIPS) over time. Advances in mobile phone technology and networking systems offer novel opportunities to develop innovative eHealth applications for collection of athletes’ self-reports. Using eHealth applications for collection of self-reported SRIIPS is an unexplored area, and before initiation of full-scale research of SRIIPS, the feasibility and usability of such an approach needs to be ascertained. Objective: The aim of this study was to perform a 4-week pilot study and (1) evaluate the monitoring feasibility and system usability of a novel eHealth application for self-reported SRIIPS and (2) report preliminary data on SRIIPS. Methods: An eHealth application for routine collection of data from athletes was developed and adapted to Paralympic athletes. A 4-week pilot study was performed where Paralympic athletes (n=28) were asked to weekly self-report sport exposure, training load, general well-being, pain, sleep, anxiety, and possible SRIIPS. The data collection was followed by a poststudy use assessment survey. Quantitative data related to the system use (eg, completed self-reports, missing responses, and errors) were analyzed using descriptive statistics. The qualitative feasibility and usability data provided by the athletes were condensed and categorized using thematic analysis methods. Results: The weekly response rate was 95%. The athletes were of the opinion that the eHealth application was usable and feasible but stated that it was not fully adapted to Paralympic athletes and their impairments. For example, it was difficult to understand how a new injury or illness should be identified when the impairment was involved. More survey items related to the impairments were requested, as the athletes perceived that injuries and illnesses often occurred because of the impairment. Options for description of multifactorial incidents including an injury, an illness, and the impairment were also insufficient. Few technical issues were encountered, but athletes with visual impairment reported usability difficulties with the speech synthesizer. An incidence rate of 1.8 injuries and 1.7 illnesses per 100 hours of athlete exposure were recorded. The weekly pain prevalence was 56% and the impairment contributed to 20% of the reported incidents. Conclusions: The novel eHealth-based application for self-reported SRIIPS developed and tested in this pilot study was generally feasible and usable. With some adaptation to accommodate Paralympic athletes’ prerequisites and improved technical support for athletes with visual impairment, this application can be recommended for use in prospective studies of SRIIPS. Trial Registration: ClinicalTrials.gov NCT02788500; https://clinicaltrials.gov/ct2/show/NCT02788500 (Archived by WebCite at http://www.webcitation.org/6v56OqTeP) %M 29187343 %R 10.2196/humanfactors.8117 %U http://humanfactors.jmir.org/2017/4/e30/ %U https://doi.org/10.2196/humanfactors.8117 %U http://www.ncbi.nlm.nih.gov/pubmed/29187343 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 6 %N 10 %P e205 %T Examining Factors of Engagement With Digital Interventions for Weight Management: Rapid Review %A Sharpe,Emma Elizabeth %A Karasouli,Eleni %A Meyer,Caroline %+ Division of Clinical Trials, Warwick Medical School, University of Warwick, Gibbet Hill Road, Coventry, CV4 7AL, United Kingdom, 44 02476151404, e.karasouli@warwick.ac.uk %K weight loss %K obesity %K patient engagement %K self-help devices %K health technology %K eHealth %K mobile apps %K patient adherence %K review %D 2017 %7 23.10.2017 %9 Original Paper %J JMIR Res Protoc %G English %X Background: Digital interventions for weight management provide a unique opportunity to target daily lifestyle choices and eating behaviors over a sustained period of time. However, recent evidence has demonstrated a lack of user engagement with digital health interventions, impacting on the levels of intervention effectiveness. Thus, it is critical to identify the factors that may facilitate user engagement with digital health interventions to encourage behavior change and weight management. Objective: The aim of this study was to identify and synthesize the available evidence to gain insights about users’ perspectives on factors that affect engagement with digital interventions for weight management. Methods: A rapid review methodology was adopted. The search strategy was executed in the following databases: Web of Science, PsycINFO, and PubMed. Studies were eligible for inclusion if they investigated users’ engagement with a digital weight management intervention and were published from 2000 onwards. A narrative synthesis of data was performed on all included studies. Results: A total of 11 studies were included in the review. The studies were qualitative, mixed-methods, or randomized controlled trials. Some of the studies explored features influencing engagement when using a Web-based digital intervention, others specifically explored engagement when accessing a mobile phone app, and some looked at engagement after text message (short message service, SMS) reminders. Factors influencing engagement with digital weight management interventions were found to be both user-related (eg, perceived health benefits) and digital intervention–related (eg, ease of use and the provision of personalized information). Conclusions: The findings highlight the importance of incorporating user perspectives during the digital intervention development process to encourage engagement. The review contributes to our understanding of what facilitates user engagement and points toward a coproduction approach for developing digital interventions for weight management. Particularly, it highlights the importance of thinking about user-related and digital tool–related factors from the very early stages of the intervention development process. %M 29061557 %R 10.2196/resprot.6059 %U http://www.researchprotocols.org/2017/10/e205/ %U https://doi.org/10.2196/resprot.6059 %U http://www.ncbi.nlm.nih.gov/pubmed/29061557 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 6 %N 10 %P e196 %T Knowledge Management Framework for Emerging Infectious Diseases Preparedness and Response: Design and Development of Public Health Document Ontology %A Zhang,Zhizun %A Gonzalez,Mila C %A Morse,Stephen S %A Venkatasubramanian,Venkat %+ Fu Foundation School of Engineering and Applied Science, Department of Chemical Engineering, Columbia University, 500 W. 120th St., Mudd 801, New York, NY,, United States, 1 212 854 2487, venkat@columbia.edu %K EIDs %K public health %K systems engineering %K knowledge representation %K teleological function %K knowledge management %K ontology %K semantic reasoning %D 2017 %7 11.10.2017 %9 Original Paper %J JMIR Res Protoc %G English %X Background: There are increasing concerns about our preparedness and timely coordinated response across the globe to cope with emerging infectious diseases (EIDs). This poses practical challenges that require exploiting novel knowledge management approaches effectively. Objective: This work aims to develop an ontology-driven knowledge management framework that addresses the existing challenges in sharing and reusing public health knowledge. Methods: We propose a systems engineering-inspired ontology-driven knowledge management approach. It decomposes public health knowledge into concepts and relations and organizes the elements of knowledge based on the teleological functions. Both knowledge and semantic rules are stored in an ontology and retrieved to answer queries regarding EID preparedness and response. Results: A hybrid concept extraction was implemented in this work. The quality of the ontology was evaluated using the formal evaluation method Ontology Quality Evaluation Framework. Conclusions: Our approach is a potentially effective methodology for managing public health knowledge. Accuracy and comprehensiveness of the ontology can be improved as more knowledge is stored. In the future, a survey will be conducted to collect queries from public health practitioners. The reasoning capacity of the ontology will be evaluated using the queries and hypothetical outbreaks. We suggest the importance of developing a knowledge sharing standard like the Gene Ontology for the public health domain. %M 29021130 %R 10.2196/resprot.7904 %U http://www.researchprotocols.org/2017/10/e196/ %U https://doi.org/10.2196/resprot.7904 %U http://www.ncbi.nlm.nih.gov/pubmed/29021130 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 6 %N 9 %P e179 %T The Adverse Drug Reactions from Patient Reports in Social Media Project: Five Major Challenges to Overcome to Operationalize Analysis and Efficiently Support Pharmacovigilance Process %A Bousquet,Cedric %A Dahamna,Badisse %A Guillemin-Lanne,Sylvie %A Darmoni,Stefan J %A Faviez,Carole %A Huot,Charles %A Katsahian,Sandrine %A Leroux,Vincent %A Pereira,Suzanne %A Richard,Christophe %A Schück,Stéphane %A Souvignet,Julien %A Lillo-Le Louët,Agnès %A Texier,Nathalie %+ Service de Santé Publique et de l'Information Médicale, Centre Hospitalier Universitaire de Saint Etienne, Chemin de la Marandière, Bâtiment CIM42 - Hôpital Nord, Saint-Etienne,, France, 33 477 27974, cedric.bousquet@chu-st-etienne.fr %K pharmacovigilance %K social media %K big data %K natural language processing %K medical terminology %D 2017 %7 21.09.2017 %9 Original Paper %J JMIR Res Protoc %G English %X Background: Adverse drug reactions (ADRs) are an important cause of morbidity and mortality. Classical Pharmacovigilance process is limited by underreporting which justifies the current interest in new knowledge sources such as social media. The Adverse Drug Reactions from Patient Reports in Social Media (ADR-PRISM) project aims to extract ADRs reported by patients in these media. We identified 5 major challenges to overcome to operationalize the analysis of patient posts: (1) variable quality of information on social media, (2) guarantee of data privacy, (3) response to pharmacovigilance expert expectations, (4) identification of relevant information within Web pages, and (5) robust and evolutive architecture. Objective: This article aims to describe the current state of advancement of the ADR-PRISM project by focusing on the solutions we have chosen to address these 5 major challenges. Methods: In this article, we propose methods and describe the advancement of this project on several aspects: (1) a quality driven approach for selecting relevant social media for the extraction of knowledge on potential ADRs, (2) an assessment of ethical issues and French regulation for the analysis of data on social media, (3) an analysis of pharmacovigilance expert requirements when reviewing patient posts on the Internet, (4) an extraction method based on natural language processing, pattern based matching, and selection of relevant medical concepts in reference terminologies, and (5) specifications of a component-based architecture for the monitoring system. Results: Considering the 5 major challenges, we (1) selected a set of 21 validated criteria for selecting social media to support the extraction of potential ADRs, (2) proposed solutions to guarantee data privacy of patients posting on Internet, (3) took into account pharmacovigilance expert requirements with use case diagrams and scenarios, (4) built domain-specific knowledge resources embeding a lexicon, morphological rules, context rules, semantic rules, syntactic rules, and post-analysis processing, and (5) proposed a component-based architecture that allows storage of big data and accessibility to third-party applications through Web services. Conclusions: We demonstrated the feasibility of implementing a component-based architecture that allows collection of patient posts on the Internet, near real-time processing of those posts including annotation, and storage in big data structures. In the next steps, we will evaluate the posts identified by the system in social media to clarify the interest and relevance of such approach to improve conventional pharmacovigilance processes based on spontaneous reporting. %M 28935617 %R 10.2196/resprot.6463 %U http://www.researchprotocols.org/2017/9/e179/ %U https://doi.org/10.2196/resprot.6463 %U http://www.ncbi.nlm.nih.gov/pubmed/28935617 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 1 %N 1 %P e2 %T A Novel Patient Engagement Platform Using Accessible Text Messages and Calls (Epharmix): Feasibility Study %A Som,Avik %A Patel,Kunjan %A Sink,Eric %A Peters,Robert Mattson %A Javaherian,Kavon %A Groenendyk,Jacob %A An,Tonya %A Xu,Zhuchen %A Polites,Gregory M %A Blanchard,Melvin %A Ross,Will %+ Department of Internal Medicine, Renal Division, Washington University School of Medicine, Box 8023, 660 South Euclid Avenue, St. Louis, MO,, United States, 1 314 362 6861, rossw@wustl.edu %K telemedicine %K mobile health %K eHealth %K telehealth %K mHealth innovations %K bioinformatics %K multiple chronic conditions %D 2017 %7 18.09.2017 %9 Original Paper %J JMIR Formativ Res %G English %X Background: Patient noncompliance with therapy, treatments, and appointments represents a significant barrier to improving health care delivery and reducing the cost of care. One method to improve therapeutic adherence is to improve feedback loops in getting clinically acute events and issues to the relevant clinical providers as necessary (ranging from detecting hypoglycemic events for patients with diabetes to notifying the provider when patients are out of medications). Patients often don’t know which information should prompt a call to their physician and proactive checks by the clinics themselves can be very resource intensive. We hypothesized that a two-way SMS system combined with a platform web service for providers would enable both high patient engagement but also the ability to detect relevant clinical alerts. Objective: The objectives of this study are to develop a feasible two-way automated SMS/phone call + web service platform for patient-provider communication, and then study the feasibility and acceptability of the Epharmix platform. First, we report utilization rates over the course of the first 18 months of operation including total identified clinically significant events, and second, review results of patient user-satisfaction surveys for interventions for patients with diabetes, COPD, congestive heart failure, hypertension, surgical site infections, and breastfeeding difficulties. Methods: To test this question, we developed a web service + SMS/phone infrastructure (“Epharmix”). Utilization results were measured based on the total number of text messages or calls sent and received, with percentage engagement defined as a patient responding to a text message at least once in a given week, including the number of clinically significant alerts generated. User satisfaction surveys were sent once per month over the 18 months to measure satisfaction with the system, frequency and degree of communication. Descriptive statistics were used to describe the above information. Results: In total, 28,386 text messages and 24,017 calls were sent to 929 patients over 9 months. Patients responded to 80% to 90% of messages allowing the system to detect 1164 clinically significant events. Patients reported increased satisfaction and communication with their provider. Epharmix increased the number of patient-provider interactions to over 10 on average in any given month for patients with diabetes, COPD, congestive heart failure, hypertension, surgical site infections, and breastfeeding difficulties. Conclusions: Engaging high-risk patients remains a difficult process that may be improved through novel, digital health interventions. The Epharmix platform enables increased patient engagement with very low risk to improve clinical outcomes. We demonstrated that engagement among high-risk populations is possible when health care comes conveniently to where they are. %M 30684401 %R 10.2196/formative.7211 %U http://formative.jmir.org/2017/1/e2/ %U https://doi.org/10.2196/formative.7211 %U http://www.ncbi.nlm.nih.gov/pubmed/30684401 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 6 %N 9 %P e169 %T Effect of Caffeine on Attention and Alertness Measured in a Home-Setting, Using Web-Based Cognition Tests %A Pasman,Wilrike J %A Boessen,Ruud %A Donner,Yoni %A Clabbers,Nard %A Boorsma,André %+ TNO, Department of Microbiology and Systems Biology, Utrechtseweg 48, Zeist, 3704 HE, Netherlands, 31 888665129, wilrike.pasman@tno.nl %K caffeine %K at-home testing %K cognition %K EFSA claim %D 2017 %7 07.09.2017 %9 Original Paper %J JMIR Res Protoc %G English %X Background: There is an increasing interest among nutritional researchers to perform lifestyle and nutritional intervention studies in a home setting instead of testing subjects in a clinical unit. The term used in other disciplines is ‘ecological validity’ stressing a realistic situation. This becomes more and more feasible because devices and self-tests that enable such studies are more commonly available. Here, we present such a study in which we reproduced the effect of caffeine on attention and alertness in an at-home setting. Objective: The study was aimed to reproduce the effect of caffeine on attention and alertness using a Web-based study environment of subjects, at home, performing different Web-based cognition tests. Methods: The study was designed as a randomized, placebo-controlled, double-blind, crossover study. Subjects were provided with coffee sachets (2 with and 2 without caffeine). They were also provided with a written instruction of the test days. Healthy volunteers consumed a cup of coffee after an overnight fast. Each intervention was repeated once. Before and 1 hour after coffee consumption subjects performed Web-based cognitive performance tests at home, which measured alertness and attention, established by 3 computerized tests provided by QuantifiedMind. Each test was performed for 5 minutes. Results: Web-based recruitment was fast and efficient. Within 2 weeks, 102 subjects applied, of whom 70 were eligible. Of the 66 subjects who started the study, 53 completed all 4 test sessions (80%), indicating that they were able to perform the do it yourself tests, at home, correctly. The Go-No Go cognition test performed at home showed the same significant improvement in reaction time with caffeine as found in controlled studies in a metabolic ward (P=.02). For coding and N-back the second block was performed approximately 10% faster. No effect was seen on correctness. Conclusions: The study showed that the effects of caffeine consumption on a cognition test in an at-home setting revealed similar results as in a controlled setting. The Go-No Go test applied showed improved results after caffeine intake, similar as seen in clinical trials. This type of study is a fast, reliable, economical, and easy way to demonstrate effectiveness of a supplement and is rapidly becoming a viable alternative for the classical randomized control trial to evaluate life style and nutritional interventions. Trial Registration: Clinicaltrials.gov NCT02061982; https://clinicaltrials.gov/ct2/show/NCT02061982 (Archived by WebCite at https://clinicaltrials.gov/ct2/show/NCT02061982) %M 28882811 %R 10.2196/resprot.6727 %U http://www.researchprotocols.org/2017/9/e169/ %U https://doi.org/10.2196/resprot.6727 %U http://www.ncbi.nlm.nih.gov/pubmed/28882811 %0 Journal Article %@ 2561-1011 %I JMIR Publications %V 1 %N 2 %P e4 %T A Web-Based Tailored Intervention to Support Illness Management in Patients With an Acute Coronary Syndrome: Pilot Study %A Cossette,Sylvie %A Côté,José %A Rouleau,Geneviève %A Robitaille,Marie %A Heppell,Sonia %A Mailhot,Tanya %A Fontaine,Guillaume %A Cournoyer,Catherine %A Gagnon,Marie-Pierre %A Gallani,Maria-Cecilia %A Tanguay,Jean-Francois %A Dupuis,Jocelyn %A Nigam,Anil %A Guertin,Marie-Claude %+ Montreal Heart Institute Research Center, Room S-2510, 5000 Belanger Street, Montréal, QC, H1T 1C8, Canada, 1 514 376 3330 ext 4012, sylvie.cossette.inf@umontreal.ca %K nursing informatics %K health behavior %K self-care %K acute coronary syndrome %K pilot study %D 2017 %7 06.09.2017 %9 Original Paper %J JMIR Cardio %G English %X Background: Illness management after an acute coronary syndrome (ACS) is crucial to prevent cardiac complications, to foster participation in a cardiac rehabilitation (CR) program, and to optimize recovery. Web-based tailored interventions have the potential to provide individualized information and counseling to optimize patient’s illness management after hospital discharge. Objective: We aimed to assess the feasibility and acceptability of a Web-based tailored intervention (TAVIE@COEUR) designed to improve illness management in patients hospitalized for an ACS. Illness management outcomes were operationalized by self-care, medication adherence, anxiety management, cardiac risk factors reduction, and enrollment in a CR program. Methods: This posttest pilot study was conducted with one group (N=30) of patients hospitalized for an ACS on the coronary care unit of a tertiary cardiology center. TAVIE@COEUR comprises three Web-based sessions, with a duration ranging from 10 to 45 min and is structured around an algorithm to allow the tailoring of the intervention to different pathways according to patients’ responses to questions. TAVIE@COEUR includes 90 pages, 85 videos, and 47 PDF documents divided across session 1 (S1), session 2 (S2), and session 3 (S3). These sessions concern self-care and self-observation skills related to medication-taking (S1), emotional control and problem-solving skills (S2), and social skills and interacting with health professionals (S3). Throughout the videos, a virtual nurse (providing the intervention virtually) guides the participants in the acquisition of self-care skills. Patients completed S1 of TAVIE@COEUR before hospital discharge and were asked to complete S2 and S3 within 2 weeks after discharge. Feasibility indicators were extracted from the TAVIE@COEUR system. Data regarding acceptability (satisfaction and appreciation of the platform) and preliminary effect (self-care, medication adherence, anxiety management, risk factor reduction, and CR enrollment) were assessed through questionnaires at 1 month following discharge. Preliminary effect was assessed by comparing baseline and 1-month illness management variables. Results: Of the 30 participants, 20 completed S1, 10 completed S2, and 5 completed S3. Good acceptability scores were observed for ease of navigation (mean=3.58, standard deviation [SD]=0.70; scale=0-4), ease of understanding (mean=3.46, SD=0.63; scale=0-4), and applicability (mean=3.55, SD=0.74; scale=0-4). The lowest acceptability scores were observed for information tailoring (mean=2.93, SD=0.68; scale=0-4) and individual relevance (mean=2.56, SD=0.96; scale=0-4). With regard to preliminary effect, we observed an overall self-care at 1 month following discharge score higher than at baseline (mean at 1 month=54.07, SD=3.99 vs mean at baseline=49.09, SD=6.92; scale-0-60). Conclusions: Although participants reported general satisfaction and appreciation of TAVIE@COEUR, acceptability and feasibility results show the need for further development of the Web-based intervention to enhance its tailoring before undertaking a full-fledged randomized controlled trial. This may be accomplished by optimizing the adaptability of TAVIE@COEUR to patients’ knowledge, needs, interests, individual capabilities, and emotional and cognitive responses during session completion. %M 31758758 %R 10.2196/cardio.7342 %U http://cardio.jmir.org/2017/2/e4/ %U https://doi.org/10.2196/cardio.7342 %U http://www.ncbi.nlm.nih.gov/pubmed/31758758 %0 Journal Article %@ 2291-9279 %I JMIR Publications %V 5 %N 3 %P e17 %T Exergames Encouraging Exploration of Hemineglected Space in Stroke Patients With Visuospatial Neglect: A Feasibility Study %A Tobler-Ammann,Bernadette C %A Surer,Elif %A de Bruin,Eling D %A Rabuffetti,Marco %A Borghese,N Alberto %A Mainetti,Renato %A Pirovano,Michele %A Wittwer,Lia %A Knols,Ruud H %+ Physiotherapy and Occupational Therapy Research Center, Directorate of Research and Education, University Hospital Zurich, OST U 103A, Rämistrasse 100, Zurich,, Switzerland, 41 44 255 24 91, bernadette.tobler@usz.ch %K exergames %K eye tracking %K virtual reality %K visuospatial neglect %K feasibility %D 2017 %7 25.08.2017 %9 Original Paper %J JMIR Serious Games %G English %X Background: Use of exergames can complement conventional therapy and increase the amount and intensity of visuospatial neglect (VSN) training. A series of 9 exergames—games based on therapeutic principles—aimed at improving exploration of the neglected space for patients with VSN symptoms poststroke was developed and tested for its feasibility. Objectives: The goal was to determine the feasibility of the exergames with minimal supervision in terms of (1) implementation of the intervention, including adherence, attrition and safety, and (2) limited efficacy testing, aiming to document possible effects on VSN symptoms in a case series of patients early poststroke. Methods: A total of 7 patients attended the 3-week exergames training program on a daily basis. Adherence of the patients was documented in a training diary. For attrition, the number of participants lost during the intervention was registered. Any adverse events related to the exergames intervention were noted to document safety. Changes in cognitive and spatial exploration skills were measured with the Zürich Maxi Mental Status Inventory and the Neglect Test. Additionally, we developed an Eye Tracker Neglect Test (ETNT) using an infrared camera to detect and measure neglect symptoms pre- and postintervention. Results: The median was 14 out of 15 (93%) attended sessions, indicating that the adherence to the exergames training sessions was high. There were no adverse events and no drop-outs during the exergame intervention. The individual cognitive and spatial exploration skills slightly improved postintervention (P=.06 to P=.98) and continued improving at follow-up (P=.04 to P=.92) in 5 out of 7 (71%) patients. Calibration of the ETNT was rather error prone. The ETNT showed a trend for a slight median group improvement from 15 to 16 total located targets (+6%). Conclusions: The high adherence rate and absence of adverse events showed that these exergames were feasible and safe for the participants. The results of the amount of exergames use is promising for future applications and warrants further investigations—for example, in the home setting of patients to augment training frequency and intensity. The preliminary results indicate the potential of these exergames to cause improvements in cognitive and spatial exploration skills over the course of training for stroke patients with VSN symptoms. Thus, these exergames are proposed as a motivating training tool to complement usual care. The ETNT showed to be a promising assessment for quantifying spatial exploration skills. However, further adaptations are needed, especially regarding calibration issues, before its use can be justified in a larger study sample. %M 28842388 %R 10.2196/games.7923 %U http://games.jmir.org/2017/3/e17/ %U https://doi.org/10.2196/games.7923 %U http://www.ncbi.nlm.nih.gov/pubmed/28842388 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 6 %N 8 %P e158 %T Conventional Cognitive Behavioral Therapy Facilitated by an Internet-Based Support System: Feasibility Study at a Psychiatric Outpatient Clinic %A Månsson,Kristoffer NT %A Klintmalm,Hugo %A Nordqvist,Ragnar %A Andersson,Gerhard %+ Department of Psychology, Stockholm University, Frescati Hagväg 8, Stockholm, 106 91, Sweden, 46 (0)705803267, kristoffer.mansson@psychology.su.se %K cognitive behavioral therapy %K Internet-treatment %K psychiatry %K blended therapy %D 2017 %7 24.08.2017 %9 Original Paper %J JMIR Res Protoc %G English %X Background: Cognitive behavioral therapies have been shown to be effective for a variety of psychiatric and somatic disorders, but some obstacles can be noted in regular psychiatric care; for example, low adherence to treatment protocols may undermine effects. Treatments delivered via the Internet have shown promising results, and it is an open question if the blend of Internet-delivered and conventional face-to-face cognitive behavioral therapies may help to overcome some of the barriers of evidence-based treatments in psychiatric care. Objective: We evaluated the feasibility of an Internet-based support system at an outpatient psychiatric clinic in Sweden. For instance, the support system made it possible to send messages and share information between the therapist and the patient before and after therapy sessions at the clinic. Methods: Nine clinical psychologists participated and 33 patients were enrolled in the current study. We evaluated the usability and technology acceptance after 12 weeks of access. Moreover, clinical data on common psychiatric symptoms were assessed before and after the presentation of the support system. Results: In line with our previous study in a university setting, the Internet-based support system has the potential to be feasible also when delivered in a regular psychiatric setting. Notably, some components in the system were less frequently used. We also found that patients improved on common outcome measures for depressive and anxious symptoms (effect sizes, as determined by Cohen d, ranged from 0.20-0.69). Conclusions: This study adds to the literature suggesting that modern information technology could be aligned with conventional face-to-face services. %M 28838884 %R 10.2196/resprot.6035 %U http://www.researchprotocols.org/2017/8/e158/ %U https://doi.org/10.2196/resprot.6035 %U http://www.ncbi.nlm.nih.gov/pubmed/28838884 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 19 %N 8 %P e287 %T Sugarsquare, a Web-Based Patient Portal for Parents of a Child With Type 1 Diabetes: Multicenter Randomized Controlled Feasibility Trial %A Boogerd,Emiel %A Maas-Van Schaaijk,Nienke M %A Sas,Theo C %A Clement-de Boers,Agnes %A Smallenbroek,Mischa %A Nuboer,Roos %A Noordam,Cees %A Verhaak,Chris M %+ Department of Medical Psychology, Radboud University Medical Center, Geert Groote Plein Zuid 10, PO Box 9101, Nijmegen, 6500 BH, Netherlands, 31 0243655232, emiel.boogerd@radboudumc.nl %K diabetes mellitus, type 1 %K parenting %K health communication %K peer group %K telemedicine %K Internet %D 2017 %7 22.08.2017 %9 Original Paper %J J Med Internet Res %G English %X Background: Raising a child with type 1 diabetes (T1D) means combining the demands of the disease management with everyday parenting, which is associated with increased levels of distress. A Web-based patient portal, Sugarsquare, was developed to support parents, by providing online parent-professional communication, online peer support and online disease information. Objective: The first aim of this study was to assess the feasibility of conducting a multicenter, randomized controlled trial in Dutch parents of a child with T1D. The second aim was to assess the feasibility of implementing Sugarsquare in clinical practice. Methods: The parents of 105 children (N=105) with T1D below the age of 13 participated in a 6-month multicenter randomized controlled feasibility trial. They were randomly assigned to an experimental (n=54, usual care and Sugarsquare) or a control group (n=51, usual care). Attrition rates and user statistics were gathered to evaluate feasibility of the trial and implementation. To determine potential efficacy, the parenting stress index (PSI-SF) was assessed at baseline (T0) and after 6 months (T1). Results: Of a potential population of parents of 445 children, 189 were willing to participate (enrollment refusal=57.5%, n=256), 142 filled in the baseline questionnaire (baseline attrition rate=25%, n=47), and 105 also filled in the questionnaire at T1 (post randomization attrition rate during follow-up=26%, n=32). As such, 24% of the potential population participated. Analysis in the experimental group (n=54) revealed a total of 32 (59%) unique users, divided into 12 (38%) frequent users, 9 (28%) incidental users, and 11 (34%) low-frequent users. Of the total of 44 professionals, 34 (77%) logged in, and 32 (73%) logged in repeatedly. Analysis of the user statistics in the experimental group further showed high practicability and integration in all users, moderate acceptability and demand in parents, and high acceptability and demand in health care professionals. Baseline parenting stress index scores were related to the parents’ frequency of logging on (ρ=.282, P=.03) and page-views (ρ=.304, P=.01). No significant differences in change in parenting stress between experimental and control group were found (F3,101=.49, P=.49). Conclusions: The trial can be considered feasible, considering the average enrollment refusal rate, baseline attrition rate and postrandomization attrition rate, compared to other eHealth studies, although lower than hypothesized. Implementing Sugarsquare in clinical practice was partly feasible, given moderate demand and acceptability in parent users and lack of potential efficacy. Parents who reported higher levels of parenting stress used Sugarsquare more often than other parents, although Sugarsquare did not reduce parenting stress. These results indicate that Web-based interventions are a suitable way of providing parents of children with T1D with additional support. Future studies should determine how Sugarsquare could reduce parenting stress, for instance by adding targeted interventions. Factors potentially contributing to successful implementation are suggested. Trial Registration: Nederlands Trial Register Number: NTR3643; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=3643 (Archived by WebCite at http://www.webcitation.org/6qihOVCi6) %M 28830853 %R 10.2196/jmir.6639 %U http://www.jmir.org/2017/8/e287/ %U https://doi.org/10.2196/jmir.6639 %U http://www.ncbi.nlm.nih.gov/pubmed/28830853 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 6 %N 8 %P e162 %T Feasibility of a Facebook Intervention for Exercise Motivation and Cardiac Rehabilitation Adherence: Study Protocol %A Siegmund,Lee Anne %A Ahmed,Haitham M %A Crawford,Michael Todd %A Bena,James Frank %+ Nursing Institute, Office of Nursing Research and Innovation, The Cleveland Clinic, T4, 9500 Euclid Ave, Cleveland, OH, 44195, United States, 1 216 445 3457, siegmul@ccf.org %K cardiac rehabilitation %K social media %K adherence %K motivation %K Facebook %K Self-Determination Theory %K Behavioral Regulation in Exercise Questionnaire-3 %K BREQ-3 %K Psychological Need Satisfaction in Exercise scale %D 2017 %7 18.08.2017 %9 Protocol %J JMIR Res Protoc %G English %X Background: While cardiac rehabilitation has been shown to be effective at improving coronary heart disease (CHD), participation is generally poor. Attempts to increase uptake and adherence often fail. Use of a Facebook intervention for this population may be a unique opportunity to support self-determined motivation and affect adherence. Objective: To evaluate the impact of a Facebook intervention on motivation for exercise and adherence to cardiac rehabilitation in patients with CHD during a 12-week, Phase II cardiac rehabilitation program. Methods: A prospective, randomized controlled pilot study, grounded in Self-Determination Theory, will be conducted. Participants will be recruited from inpatient, or the intake visit to outpatient, cardiac rehabilitation, and then randomly assigned to the intervention or comparison group. Participants in the intervention group will take part in a private Facebook group. Weekly posts will be designed to support self-determined motivation, measured at baseline and postcardiac rehabilitation by the Behavioral Regulation in Exercise Questionnaire-3 (BREQ-3). The Psychological Need Satisfaction for Exercise (PNSE) scale will measure fulfillment of needs that affect motivation. Participants in the comparison group will be given the same materials, but these will be supplied via handouts and email. The number of sessions attended will be tallied and analyzed using t tests. Overall motivation will be evaluated using analysis of covariance (ANCOVA) models. Multivariate analysis of variance models will be used to evaluate differences in the change across motivation subtypes. If significant, ANCOVA models for each subtype will be fit. ANCOVA models will be used to compare changes in needs satisfaction, overall and separately among the three subscales, between groups. Engagement in the Facebook group will be measured by number of “likes” and self-report of weekly visits to the group. Results: This project was funded in July 2017 and recruitment is currently underway. The recruitment goal is 60 cardiac rehabilitation patients. Data collection is anticipated to be complete by July 2018. Conclusions: This pilot study will be the first to examine the effect of a Facebook intervention on patient adherence and motivation for exercise in a cardiac rehabilitation setting. Engagement in the Facebook group and participation in the study will help to determine the feasibility of using Facebook to affect adherence and motivation in cardiac rehabilitation patients, potentially improving outcomes through the use of a unique intervention. Trial Registration: ClinicalTrials.gov NCT02971813; https://clinicaltrials.gov/ct2/show/NCT02971813 (Archived by WebCite at http://www.webcitation.org/6sRsz8Zpa) %M 28821473 %R 10.2196/resprot.7554 %U http://www.researchprotocols.org/2017/8/e162/ %U https://doi.org/10.2196/resprot.7554 %U http://www.ncbi.nlm.nih.gov/pubmed/28821473 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 6 %N 8 %P e157 %T An Electronic Health Record–Based Strategy to Systematically Assess Medication Use Among Primary Care Patients With Multidrug Regimens: Feasibility Study %A Bailey,Stacy Cooper %A Oramasionwu,Christine U %A Infanzon,Alexandra C %A Pfaff,Emily R %A Annis,Izabela E %A Reuland,Daniel S %+ Division of Pharmaceutical Outcomes and Policy, Eshelman School of Pharmacy, University of North Carolina at Chapel Hill, 2204 Kerr Hall, Campus Box 7573, Chapel Hill, NC,, United States, 1 919 843 9834, scbailey@unc.edu %K patient portal %K medication adherence %K health literacy %D 2017 %7 10.08.2017 %9 Original Paper %J JMIR Res Protoc %G English %X Background: Medication nonadherence and misuse are public health and patient safety concerns. With the increased adoption of electronic health records (EHRs), greater opportunities exist to communicate directly with, and collect data from, patients through secure portals linked to EHRs. Objective: The study objectives were to develop and pilot test a method of monitoring patient medication use in outpatient settings and determine the feasibility and acceptability of this approach. Methods: Adult primary care patients on multidrug regimens were recruited from an academic internal medicine clinic by a trained research assistant. After completing a baseline, in-person interview, patients were sent a link to a questionnaire about medication use via the patient portal. One week later, the RA contacted patients to complete a follow-up telephone interview assessing patient satisfaction and experience with the questionnaire. Patient EHRs were also reviewed to determine the questionnaire completion rate. Results: Of 100 patients enrolled, 89 completed the follow-up interview and 82 completed the portal questionnaire. The mean age of the sample was 61.8 (range 31-88) years. Approximately half (54/100, 54%) of the sample was male, two-thirds were white (67/100, 67%) and 26% (26/100) African-American. A total of 44% reported an annual household income of <$50,000 per year, and 17% (17/100) reported a high school or less level of education. No significant differences were found in questionnaire completion rates by sociodemographic characteristics or prior portal use. Most (68/73, 93%) found the questionnaire easy to access, easy to complete (72/73, 99%), and valuable (73/89, 82%). Time constraints and log-in difficulties were the main reasons for noncompletion. Conclusions: The portal questionnaire was well received by a socioeconomically diverse group of patients with high completion rates achieved. Routine use of a portal-based questionnaire could provide a valuable signal to providers and care teams about patient medication use and identify patients needing additional support. %M 28798013 %R 10.2196/resprot.7986 %U http://www.researchprotocols.org/2017/8/e157/ %U https://doi.org/10.2196/resprot.7986 %U http://www.ncbi.nlm.nih.gov/pubmed/28798013 %0 Journal Article %@ 2369-1999 %I JMIR Publications %V 3 %N 2 %P e10 %T Supporting Lung Cancer Patients With an Interactive Patient Portal: Feasibility Study %A Groen,Wim G %A Kuijpers,Wilma %A Oldenburg,Hester SA %A Wouters,Michel WJM %A Aaronson,Neil K %A van Harten,Wim H %+ Division of Psychosocial Research and Epidemiology, The Netherlands Cancer Institute, Plesmanlaan 121, Amsterdam,, Netherlands, 31 20 5122861, w.v.harten@nki.nl %K non-small cell lung cancer %K patient empowerment %K patient portal %K supportive care %K eHealth %K feasibility %D 2017 %7 08.08.2017 %9 Original Paper %J JMIR Cancer %G English %X Background: MyAVL is an interactive portal for cancer patients that aims to support lung cancer patients. Objective: We aimed to evaluate the feasibility and usability of the patient portal and generate preliminary evidence on its impact. Methods: Lung cancer patients currently or recently treated with curative intent could use MyAVL noncommittally for 4 months. Feasibility, usability, and preliminary impact (ie, patient activation, quality of life, and physical activity) were studied by means of questionnaires, a focus group, and analysis of user log data. Results: We included 37 of 123 eligible patients (mean age 59.6 years). The majority of responses (82%) were positive about using MyAVL, 69% saw it as a valuable addition to care, and 56% perceived increased control over their health. No positive effects could be substantiated on the impact measures. Conclusions: MyAVL appears to be a feasible and user-friendly, multifunctional eHealth program for a selected group of lung cancer patients. However, it needs further improvements to positively impact patient outcomes. %M 28790025 %R 10.2196/cancer.7443 %U http://cancer.jmir.org/2017/2/e10/ %U https://doi.org/10.2196/cancer.7443 %U http://www.ncbi.nlm.nih.gov/pubmed/28790025 %0 Journal Article %@ 2371-4379 %I JMIR Publications %V 2 %N 2 %P e14 %T Web-Based Weight Loss Intervention for Men With Type 2 Diabetes: Pilot Randomized Controlled Trial %A Haste,Anna %A Adamson,Ashley J %A McColl,Elaine %A Araujo-Soares,Vera %A Bell,Ruth %+ Institute of Health and Society, Faculty of Medical Sciences, Newcastle University, Baddiley Clark Building, Richardson Road, Newcastle upon Tyne, NE2 4AX, United Kingdom, 44 0 191 208 7045, anna.haste@newcastle.ac.uk %K weight loss %K Web-based intervention %K feasibility studies %K pilot RCT %K randomized controlled trial %K pilot projects %K type 2 diabetes %K diabetes mellitus, type 2 %K men %K men's health %K process evaluation %D 2017 %7 07.07.2017 %9 Original Paper %J JMIR Diabetes %G English %X Background: Rising obesity levels remain a major public health concern due to the clear link with several comorbidities such as diabetes. Diabetes now affects 6% of the UK population. Modest weight loss of 5% to 10% has been shown to be associated with significant reductions in blood sugar, lipid, and blood pressure levels. Men have been shown to be attracted to programs that do not require extensive face-to-face time commitments, illustrating the potential audience available for health behavior change via the Web. Objective: The objective of our study was to evaluate the feasibility and acceptability of a Web-based weight loss intervention in men with type 2 diabetes. Methods: We conducted a pilot, parallel 2-arm, individually randomized controlled trial with embedded process evaluation. Participants were randomly assigned in a one-to-one ratio to the usual care group or the 12-month Web-based weight loss intervention, including dietitian and exercise expert feedback. Face-to-face recruitment and assessment were performed by the researcher unblinded. Data collected included weight, height, body mass index (BMI), and waist circumference, together with an audit trail of eligibility, recruitment, retention, and adherence rates. A process evaluation (website use data and qualitative interviews) monitored adherence, acceptability, and feasibility of the intervention. Results: General practice database searches achieved the recruitment target (n=61) for the population of men with type 2 diabetes, of whom 66% (40/61) completed 3-month follow-up measurements. By 12 months, the retention rate was 52% (32/61), with 12 of the 33 men allocated to the intervention group still active on the website. The intervention was seen as acceptable by the majority of participants. We gained insights about acceptability and use of the website from the parallel process evaluation. Conclusions: Recruitment to the Web-based weight loss intervention was successful. Results are descriptive, but there were positive indications of increased weight loss (in kilograms and as a percentage), and reduced waist circumference and BMI for the intervention group from 3 to 12 months, in comparison with control. This research adds to the evidence base in relation to incorporating a Web-based weight loss intervention within the UK National Health Service (NHS). NHS weight loss services are struggling to provide sufficient referrals. Therefore, alternative modes of delivery, with the potential to reduce health professional input and time per patient while still enabling individual and tailored care, need to be investigated to identify whether they can be effective and thus benefit the NHS. Trial Registration: International Standard Randomized Controlled Trial Number (ISRCTN): 48086713; http://www.isrctn.com/ISRCTN48086713 (Archived by WebCite at http://www.webcitation.org/6rO4xSlhI) %M 30291100 %R 10.2196/diabetes.7430 %U http://diabetes.jmir.org/2017/2/e14/ %U https://doi.org/10.2196/diabetes.7430 %U http://www.ncbi.nlm.nih.gov/pubmed/30291100 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 6 %N 6 %P e114 %T Phone-Based Interventions in Adolescent Psychiatry: A Perspective and Proof of Concept Pilot Study With a Focus on Depression and Autism %A Chen,Robert Yuzen %A Feltes,Jordan Robert %A Tzeng,William Shun %A Lu,Zoe Yunzhu %A Pan,Michael %A Zhao,Nan %A Talkin,Rebecca %A Javaherian,Kavon %A Glowinski,Anne %A Ross,Will %+ Washington University School of Medicine, Farrell Learning and Teaching Center, 660 S Euclid Avenue, St. Louis, MO, 63110, United States, 1 425 753 4101, robert.chen@wustl.edu %K telemedicine %K depression %K autistic disorder %K mobile applications %K text messaging %K child %K mental health %D 2017 %7 16.06.2017 %9 Viewpoint %J JMIR Res Protoc %G English %X Background: Telemedicine has emerged as an innovative platform to diagnose and treat psychiatric disorders in a cost-effective fashion. Previous studies have laid the functional framework for monitoring and treating child psychiatric disorders electronically using videoconferencing, mobile phones (smartphones), and Web-based apps. However, phone call and text message (short message service, SMS) interventions in adolescent psychiatry are less studied than other electronic platforms. Further investigations on the development of these interventions are needed. Objective: The aim of this paper was to explore the utility of text message interventions in adolescent psychiatry and describe a user feedback-driven iterative design process for text message systems. Methods: We developed automated text message interventions using a platform for both depression (EpxDepression) and autism spectrum disorder (ASD; EpxAutism) and conducted 2 pilot studies for each intervention (N=3 and N=6, respectively). The interventions were prescribed by and accessible to the patients’ healthcare providers. EpxDepression and EpxAutism utilized an automated system to triage patients into 1 of 3 risk categories based on their text responses and alerted providers directly via phone and an online interface when patients met provider-specified risk criteria. Rapid text-based feedback from participants and interviews with providers allowed for quick iterative cycles to improve interventions. Results: Patients using EpxDepression had high weekly response rates (100% over 2 to 4 months), but exhibited message fatigue with daily prompts with mean (SD) overall response rates of 66.3% (21.6%) and 64.7% (8.2%) for mood and sleep questionnaires, respectively. In contrast, parents using EpxAutism displayed both high weekly and overall response rates (100% and 85%, respectively, over 1 to 4 months) that did not decay significantly with time. Monthly participant feedback surveys for EpxDepression (7 surveys) and EpxAutism (18 surveys) preliminarily indicated that for both interventions, daily messages constituted the “perfect amount” of contact and that EpxAutism, but not EpxDepression, improved patient communication with providers. Notably, EpxDepression detected thoughts of self-harm in patients before their case managers or caregivers were aware of such ideation. Conclusions: Text-message interventions in adolescent psychiatry can provide a cost-effective and engaging method to track symptoms, behavior, and ideation over time. Following the collection of pilot data and feedback from providers and patients, larger studies are already underway to validate the clinical utility of EpxDepression and EpxAutism. Trial Registration: Clinicaltrials.gov NCT03002311; https://clinicaltrials.gov/ct2/show/NCT03002311 (Archived by WebCite at http://www.webcitation.org/6qQtlCIS0) %M 28623183 %R 10.2196/resprot.7245 %U http://www.researchprotocols.org/2017/6/e114/ %U https://doi.org/10.2196/resprot.7245 %U http://www.ncbi.nlm.nih.gov/pubmed/28623183 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 19 %N 6 %P e204 %T Young People, Adult Worries: Randomized Controlled Trial and Feasibility Study of the Internet-Based Self-Support Method “Feel the ViBe” for Adolescents and Young Adults Exposed to Family Violence %A van Rosmalen-Nooijens,Karin %A Lo Fo Wong,Sylvie %A Prins,Judith %A Lagro-Janssen,Toine %+ Gender & Women’s Health, Department of Primary and Community Care, Radboud university medical center, Internal post 117, P.O. Box 9101, Nijmegen, 6500HB, Netherlands, 31 0 243613110, karin.vanrosmalen-nooijens@radboudumc.nl %K domestic violence %K child abuse %K exposure to violence %K adolescent %K young adult %K telemedicine %K peer group %K peer influence %K Internet %K feasibility studies %K randomized controlled trial %K delivery of health care %D 2017 %7 12.06.2017 %9 Original Paper %J J Med Internet Res %G English %X Background: Adolescents and young adults (AYAs) are of special interest in a group of children exposed to family violence (FV). Past-year prevalence of exposure to FV is known to be highest in AYAs and has severe consequences. Peer support is an effective approach to behavior change and the Internet is considered suitable as a mode of delivery. Objective: The study aimed to evaluate both effectiveness and feasibility of a randomized controlled trial (RCT) and feasibility study of the Internet-based self-support method “Feel the ViBe” (FtV) using mixed-methods approach to fully understand the strengths and weaknesses of a new intervention. Methods: AYAs aged 12-25 years and exposed to FV were randomized in an intervention group (access to FtV + usual care) and a control group (minimally enhanced usual care) after they self-registered themselves. From June 2012 to July 2014, participants completed the Impact of Event Scale (IES) and Depression (DEP) and Anxiety (ANX) subscales of the Symptom CheckList-90-R (SCL-90) every 6 weeks. The Web Evaluation Questionnaire was completed after 12 weeks. Quantitative usage data were collected using Google analytics and content management system (CMS) logs and data files. A univariate analysis of variance (UNIANOVA) and mixed model analysis (intention-to-treat [ITT], complete case) were used to compare groups. Pre-post t tests were used to find within-group effects. Feasibility measures structurally address the findings. The CONsolidated Standards Of Reporting Trials of Electronic and Mobile HEalth Applications and onLine TeleHealth (CONSORT-EHEALTH) checklist was closely followed. Results: In total, 31 out of 46 participants in the intervention group and 26 out of 47 participants in the control group started FtV. Seventeen participants (intervention: n=8, control: n=9) completed all questionnaires. Mixed model analysis showed significant differences between groups on the SCL-90 DEP (P=.04) and ANX (P=.049) subscales between 6 and 12 weeks after participation started. UNIANOVA showed no significant differences. Pre-post paired sample t tests showed significant improvements after 12 weeks for the SCL-90 DEP (P=.03) and ANX (P=.046) subscales. Reported mean Web-based time per week was 2.83 with a session time of 36 min. FtV was rated a mean 7.47 (1-10 Likert scale) with a helpfulness score of 3.16 (1-5 Likert scale). All participants felt safe. Two-thirds of the intervention participants started regular health care. Conclusions: No changes on the IES were found. SCL-90 DEP and ANX showed promising results; however, the calculated sample size was not reached (n=18). FtV functions best as a first step for adolescents and young adults in an early stage of change. FtV can be easily implemented without extensive resources and fits best in the field of public health care or national governmental care. Trial Registration: Netherlands National Trial Register (NTR): NTR3692; http://www.trialregister.nl/trialreg/admin/ rctview.asp?TC=3692 (Archived by WebCite at http://www.webcitation.org/6qIeKyjA4) %M 28606893 %R 10.2196/jmir.6004 %U http://www.jmir.org/2017/6/e204/ %U https://doi.org/10.2196/jmir.6004 %U http://www.ncbi.nlm.nih.gov/pubmed/28606893 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 6 %N 6 %P e108 %T A Cloud-Based Virtual Reality App for a Novel Telemindfulness Service: Rationale, Design and Feasibility Evaluation %A Cikajlo,Imre %A Cizman Staba,Ursa %A Vrhovac,Suzana %A Larkin,Frances %A Roddy,Mark %+ University Rehabilitation Institute, Republic of Slovenia, Linhartova c 51, Ljubljana, 1000, Slovenia, 386 14758158, imre.cikajlo@ir-rs.si %K Virtual reality %K headset %K Samsung %K psychology %K mindfulness %K telepsychology %K telehealth technology %K telemedicine %D 2017 %7 05.06.2017 %9 Original Paper %J JMIR Res Protoc %G English %X Background: Worldwide, there has been a marked increase in stress and anxiety, also among patients with traumatic brain injury (TBI). Access to psychology services is limited, with some estimates suggesting that over 50% of sufferers are not accessing the existing services available to them for reasons such as inconvenience, embarrassment, or stigmatization concerns around mental health. Health service providers have increasingly been turning to drug-free therapies, such as mindfulness programs, as complementary treatments. Objective: Virtual reality (VR) as a new delivery method for meditation-based stress and anxiety reduction therapy offers configurable environments and privacy protection. Our objective was to design a serious learning-meditation environment and to test the feasibility of the developed telemindfulness approach based on cloud technologies. Methods: We developed a cloud-based system, which consisted of a Web interface for the mindfulness instructor and remote clients, who had 3D VR headsets. The mindfulness instructor could communicate over the Web interface with the participants using the headset. Additionally, the Web app enabled group sessions in virtual rooms, 360-degree videos, and real interactions or standalone meditation. The mindfulness program was designed as an 8-week Mindfulness-Based Stress Reduction course specifically for the developed virtual environments. The program was tested with four employees and four patients with TBI. The effects were measured with psychometric tests, the Mindful Attention Awareness Scale (MAAS) and the Satisfaction With Life Scale (SWLS). Patients also carried out the Mini-Mental State Examination (MMSE). An additional objective evaluation has also been carried out by tracking head motion. Additionally, the power spectrum analyses of similar tasks between sessions were tested. Results: The patients achieved a higher level of life satisfaction during the study (SWLS: mean 23.0, SD 1.8 vs mean 18.3, SD 3.9) and a slight increase of the MAAS score (mean 3.4, SD 0.6 vs mean 3.3, SD 0.4). Particular insight into the MAAS items revealed that one patient had a lower MAAS score (mean 2.3). Employees showed high MAAS scores (mean 4.3, SD 0.7) and although their SWLS dropped to mean 26, their SWLS was still high (mean 27.3, SD 2.8). The power spectrum showed that the employees had a considerable reduction in high-frequency movements less than 0.34 Hz, particularly with the 360-degree video. As expected, the patients demonstrated a gradual decrease of high-frequency movements while sitting during the mindfulness practices in the virtual environment. Conclusions: With such a small sample size, it is too early to make any specific conclusions, but the presented results may accelerate the use of innovative technologies and challenge new ideas in research and development in the field of mindfulness/telemindfulness. %M 28583904 %R 10.2196/resprot.6849 %U http://www.researchprotocols.org/2017/6/e108/ %U https://doi.org/10.2196/resprot.6849 %U http://www.ncbi.nlm.nih.gov/pubmed/28583904 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 6 %N 5 %P e84 %T Comparison of Ecological Momentary Assessment Versus Direct Measurement of E-Cigarette Use With a Bluetooth-Enabled E-Cigarette: A Pilot Study %A Pearson,Jennifer L %A Elmasry,Hoda %A Das,Babita %A Smiley,Sabrina L %A Rubin,Leslie F %A DeAtley,Teresa %A Harvey,Emily %A Zhou,Yitong %A Niaura,Raymond %A Abrams,David B %+ Truth Initiative, Schroeder Institute for Tobacco Research and Policy Studies, 900 G St NW, Fourth Floor, Washington, DC,, United States, 1 202 454 5768, jpearson@truthinitiative.org %K smoking %K humans %K tobacco products/utilization %K electronic cigarettes %K observational study %K United States %D 2017 %7 29.05.2017 %9 Original Paper %J JMIR Res Protoc %G English %X Background: Assessing the frequency and intensity of e-cigarette use presents special challenges beyond those posed by cigarette use. Accurate measurement of e-cigarette consumption, puff duration, and the stability of these measures over time will be informative for estimating the behavioral and health effects of e-cigarette use. Objective: The purpose of this pilot study was to compare the accuracy of self-reported e-cigarette puff counts collected via ecological momentary assessment (EMA) to objective puff count data collected by a Bluetooth-enabled e-cigarette device and to examine the feasibility and acceptability of using a second-generation e-cigarette among adult smokers. Methods: A total of 5 adult smokers were enrolled in a longitudinal parent study assessing how e-cigarette use affects cigarette use among e-cigarette–naïve smokers. Using a text message–based EMA system, participants reported e-cigarette puffs for 2 weeks. Participants were also given a Bluetooth-enabled e-cigarette (Smokio) that passively collected puff counts and puff duration. Comparisons between mean reports of Smokio (device-report) and EMA (self-report) use were evaluated using paired t tests. Correlation and agreement between device- and self-reports were evaluated using Pearson correlation and the concordance correlation coefficient (CCC), respectively. A linear mixed effect model was used to determine the fixed effect of timing and Smokio-reported daily puffs on report accuracy. We examined the relationship between time of day and reporting accuracy using Tukey's test for multiple pairwise comparisons. Results: A total of 5 African American participants, 4 men and 1 woman, who ranged in age from 24 to 59 years completed the study, resulting in 5180 observations (device-report) of e-cigarette use. At baseline, participants reported smoking for 5 to 25 years and consumed a mean of 7 to 13 cigarettes per day (CPD); 4 smoked within 30 minutes of waking. At the 30-day follow-up, CPD range decreased to 1 to 3 cigarettes; 4 participants reported past 7-day e-cigarette use, and 1 participant reported no cigarette smoking in the past 7 days. Over 2 weeks of e-cigarette use, participants took an average of 1074 e-cigarette (SD 779.0) puffs per person as captured by the device reports. Each participant took a mean of 75.0 (SD 58.8) puffs per day, with each puff lasting an average of 3.6 (SD 2.4) seconds. Device reports captured an average of 33.3 (SD 47.8) more puffs per person per day than the self-reported e-cigarette puffs. In 87% of days, participants underestimated the number of puffs they had taken on the Smokio. There was significant moderate correlation (r=.47, P<.001) but poor agreement (pc=0.31, 95% CI 0.15-0.46) between the device- and self-reported data. Reporting accuracy was affected by amount and timing of e-cigarette use. Conclusions: Compared to self-reported e-cigarette use, the Bluetooth-enabled device captured significantly more e-cigarette use and allowed for examination of puff duration in addition to puff counts. A Bluetooth-enabled e-cigarette is a powerful and feasible tool for objective collection of e-cigarette use behavior in the real world. %M 28554877 %R 10.2196/resprot.6501 %U http://www.researchprotocols.org/2017/5/e84/ %U https://doi.org/10.2196/resprot.6501 %U http://www.ncbi.nlm.nih.gov/pubmed/28554877 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 6 %N 5 %P e96 %T A Personalized and Interactive Web-Based Health Care Innovation to Advance the Quality of Life and Care of Patients With Heart Failure (ACQUIRE-HF): A Mixed Methods Feasibility Study %A Pedersen,Susanne S %A Schmidt,Thomas %A Skovbakke,Søren Jensen %A Wiil,Uffe Kock %A Egstrup,Kenneth %A Smolderen,Kim G %A Spertus,John A %+ Department of Psychology, University of Southern Denmark, Campusvej 55, Odense,, Denmark, 45 65 50 79 92, sspedersen@health.sdu.dk %K feasibility %K heart failure %K patient-centered tools %K mixed methods %K Internet %D 2017 %7 23.05.2017 %9 Original Paper %J JMIR Res Protoc %G English %X Background: Heart failure (HF) is a progressive, debilitating, and complex disease, and due to an increasing incidence and prevalence, it represents a global health and economic problem. Hence, there is an urgent need to evaluate alternative care modalities to current practice to safeguard a high level of care for this growing population. Objective: Our goal was to examine the feasibility of engaging patients to use patient-centered and personalized tools coupled with a Web-based, shared care and interactive platform in order to empower and enable them to live a better life with their disease. Methods: We used a mixed methods, single-center, pre-post design. Patients with HF and reduced left ventricular ejection fraction (n=26) were recruited from the outpatient HF clinic at Odense University Hospital (Svendborg Hospital), Denmark, between October 2015 and March 2016. Patients were asked to monitor their health status via the platform using the standardized, disease-specific measure, the Kansas City Cardiomyopathy Questionnaire (KCCQ), and to register their weight. A subset of patients and nursing staff were interviewed after 3-month follow-up about their experiences with the platform. Results: Overall, patients experienced improvement in patient-reported health status but deterioration in self-care behavior between baseline and 3-month follow-up. The mean score reflecting patient expectations toward use prior to start of the study was lower (16 [SD 5]) than their actual experiences with use of the platform (21 [SD 5]) after 3-month follow-up. Of all patients, 19 completed both a baseline and follow-up KCCQ. A total of 9 experienced deterioration in their health status (range from 3-34 points), while 10 experienced an improvement (range from 1-23 points). The qualitative data indicated that the majority of patients found the registration and monitoring on the platform useful. Both nursing staff and patients indicated that such monitoring could be a useful tool to engage and empower patients, in particular when patients are just diagnosed with HF. Conclusions: The use of patient tracking and monitoring of health status in HF using a standardized and validated measure seems feasible and may lead to insights that will help educate, empower, and engage patients more in their own disease management, although it is not suitable for all patients. Nursing staff found the patient-centered tool beneficial as a communication tool with patients but were more reticent with respect to using it as a replacement for the personal contact in the outpatient clinic. %M 28536092 %R 10.2196/resprot.7110 %U http://www.researchprotocols.org/2017/5/e96/ %U https://doi.org/10.2196/resprot.7110 %U http://www.ncbi.nlm.nih.gov/pubmed/28536092 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 6 %N 5 %P e92 %T Development of an Evidence-Informed Blog to Promote Healthy Eating Among Mothers: Use of the Intervention Mapping Protocol %A Dumas,Audrée-Anne %A Lemieux,Simone %A Lapointe,Annie %A Provencher,Véronique %A Robitaille,Julie %A Desroches,Sophie %+ Institute of Nutrition and Functional Foods, Laval University, 2440 Hochelaga Boulevard, Quebec City, QC, G1V 0A6, Canada, 1 418 656 2131 ext 5564, sophie.desroches@fsaa.ulaval.ca %K blogs %K healthy eating %K knowledge translation %K theory-driven design %K intervention mapping %K clinical research protocol %D 2017 %7 19.05.2017 %9 Protocol %J JMIR Res Protoc %G English %X Background: Low adherence to dietary guidelines and a concurrent rise of obesity-related chronic diseases emphasize the need for effective interventions to promote healthy eating. There is growing recognition that behavior change interventions should draw on theories of behavior change. Online interventions grounded in theory lead to increased effectiveness for health behavior change; however, few theory-driven social media-based health promotion interventions have been described in the literature. Objective: The objective of this study was to describe the application of the Intervention Mapping (IM) protocol to develop an evidence-informed blog to promote healthy eating among French-Canadian mothers of preschool and school-aged children. Methods: The following six steps of the IM protocol were performed. In Step 1, a preliminary needs assessment included a literature search on theoretical domains predicting Vegetables and Fruits intakes and Milk and Alternatives intakes in adults (ie, knowledge, beliefs about capabilities, beliefs about consequences, intention/goals) and a qualitative study including focus groups to identify female Internet users’ perceptions of their use of healthy eating blogs. In Step 2, two behavioral outcomes were selected (ie, increase daily intakes of Vegetables and Fruits and Milk and Alternatives of mothers to reach Canadian dietary recommendations) and subsequently divided into six performance objectives inspired by national and international dietary recommendations such as planning for healthy meals. A matrix of change objectives was then created by crossing performance objectives with theoretical domains predicting Vegetables and Fruits intakes and Milk and Alternatives intakes in adults. Step 3 consisted of selecting theory-based intervention methods (eg, modeling and goal setting) and translating them into practical applications for the context of a dietary intervention delivered through a blog. A 6-month intervention was developed in Step 4 in which we aimed to address one performance objective per month in weekly blog publications written by a registered dietitian. For Step 5, we sought to include engagement-promoting methods (eg, peer and counselor support) to promote mothers’ use of the blog and adherence to the intervention. Finally in Step 6, a randomized controlled trial has been launched to evaluate the effects of the blog on dietary behaviors of French-Canadian mothers. Results: The intervention study is expected to be completed in March 2018. Conclusions: An intervention mapping protocol allowed for effective decision making in the development of a novel knowledge translation tool to increase adherence to dietary recommendations among mothers of preschool and school-aged children. %M 28526669 %R 10.2196/resprot.7147 %U http://www.researchprotocols.org/2017/5/e92/ %U https://doi.org/10.2196/resprot.7147 %U http://www.ncbi.nlm.nih.gov/pubmed/28526669 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 6 %N 5 %P e88 %T Using Text Messaging in Long-Term Arthroplasty Follow-Up: A Pilot Study %A Blocker,Oliver %A Bullock,Alison %A Morgan-Jones,Rhidian %A Ghandour,Adel %A Richardson,James %+ Department of Trauma and Orthopaedics, University Hospital of Wales, Cardiff and Vale University Health Board, Heath Park, Cardiff,, United Kingdom, 44 292 074 8044, drblocker@gmail.com %K texting %K text messages %K short message service %K patient outcome assessment %K follow-up studies %K arthroplasty %D 2017 %7 16.05.2017 %9 Original Paper %J JMIR Res Protoc %G English %X Background: Patient-reported outcome measures (PROMs) and mobile technology have the potential to change the way patients are monitored following joint replacement surgery. Objective: The aim of this study was to determine the feasibility of text messaging to record PROMs in long-term follow-up of hip and knee arthroplasty. Our participants were 17 patients 2-years-plus post hip or knee arthroplasty attending clinic with a mobile telephone number on record. Methods: A simple PROM (Oswestry Very Short Form) was texted to the patient. Responses were compared to clinical, radiographic, and existing PROM findings. Patients were interviewed to discover their opinions on this use of texting. Results: A total of 11 patients engaged with the text messaging. Reasons for not engaging included wrong numbers, physical barriers, and lack of understanding. A total of 8 patients attending clinic allowed comparison of text messaging with clinical findings. The average age was 70 years. A total of 4 patient text messaging responses matched clinical and radiographic findings; 3 also matched PROM scores collected in clinic. The 3 patients with mixed responses had abnormal clinical, radiographic, or PROM findings. One patient’s text responses conflicted with clinical outcome. Analysis of patients’ views showed a generally positive opinion: patients were happy to communicate with surgeons by text. Practical problems, PROM limitations, and trustworthiness of texting were highlighted. Conclusions: Engaging with changing technology creates challenges for patients and health care professionals. Despite this, our results suggest text messaging is a promising way to communicate with arthroplasty patients. Earlier integration of text communication in the patient pathway may be important and needs further research. %M 28512080 %R 10.2196/resprot.6047 %U http://www.researchprotocols.org/2017/5/e88/ %U https://doi.org/10.2196/resprot.6047 %U http://www.ncbi.nlm.nih.gov/pubmed/28512080 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 6 %N 5 %P e83 %T Crowdsourced Identification of Possible Allergy-Associated Factors: Automated Hypothesis Generation and Validation Using Crowdsourcing Services %A Aramaki,Eiji %A Shikata,Shuko %A Ayaya,Satsuki %A Kumagaya,Shin-Ichiro %+ Social Computing Lab, Graduate School of Information Science, Nara Institute of Science and Technology, Takayama-cho, BLD.405, Ikoma, 630-0192, Japan, 81 0743 72 6065, aramaki@is.naist.jp %K allergy %K crowdsourcing %K disease risk %K automatic abduction %K Tohjisha-Kenkyu %K self-support study %D 2017 %7 16.05.2017 %9 Original Paper %J JMIR Res Protoc %G English %X Background: Hypothesis generation is an essential task for clinical research, and it can require years of research experience to formulate a meaningful hypothesis. Recent studies have endeavored to apply crowdsourcing to generate novel hypotheses for research. In this study, we apply crowdsourcing to explore previously unknown allergy-associated factors. Objective: In this study, we aimed to collect and test hypotheses of unknown allergy-associated factors using a crowdsourcing service. Methods: Using a series of questionnaires, we asked crowdsourcing participants to provide hypotheses on associated factors for seven different allergies, and validated the candidate hypotheses with odds ratios calculated for each associated factor. We repeated this abductive validation process to identify a set of reliable hypotheses. Results: We obtained two primary findings: (1) crowdsourcing showed that 8 of the 13 known hypothesized allergy risks were statically significant; and (2) among the total of 157 hypotheses generated by the crowdsourcing service, 75 hypotheses were statistically significant allergy-associated factors, comprising the 8 known risks and 53 previously unknown allergy-associated factors. These findings suggest that there are still many topics to be examined in future allergy studies. Conclusions: Crowdsourcing generated new hypotheses on allergy-associated factors. In the near future, clinical trials should be conducted to validate the hypotheses generated in this study. %M 28512079 %R 10.2196/resprot.5851 %U http://www.researchprotocols.org/2017/5/e83/ %U https://doi.org/10.2196/resprot.5851 %U http://www.ncbi.nlm.nih.gov/pubmed/28512079 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 6 %N 5 %P e79 %T Recruitment of Community College Students Into a Web-Assisted Tobacco Intervention Study %A McIntosh,Scott %A Johnson,Tye %A Wall,Andrew F %A Prokhorov,Alexander V %A Calabro,Karen Sue %A Ververs,Duncan %A Assibey-Mensah,Vanessa %A Ossip,Deborah J %+ Department of Public Health Sciences, University of Rochester School of Medicine & Dentistry, 265 Crittenden Blvd, CU 420644, Rochester, NY, 14642, United States, 1 5858029944, scott_mcintosh@urmc.rochester.edu %K community colleges %K tobacco control %K study recruitment %K qualitative research %K baseline %D 2017 %7 08.05.2017 %9 Original Paper %J JMIR Res Protoc %G English %X Background: United States college students, particularly those attending community colleges, have higher smoking rates than the national average. Recruitment of such smokers into research studies has not been studied in depth, despite a moderate amount information on study recruitment success with smokers from traditional four-year colleges. Recruitment channels and success are evolving as technology evolves, so it is important to understand how to best target, implement, and evaluate recruitment strategies. Objective: The aim of this paper is to both qualitatively and quantitatively explore recruitment channels (eg, mass email, in-person referral, posted materials) and their success with enrollment into a Web-Assisted Tobacco Intervention study in this priority population of underserved and understudied smokers. Methods: Qualitative research methods included key informant interviews (n=18) and four focus groups (n=37). Quantitative research methods included observed online responsiveness to any channel (n=10,914), responses from those completing online screening and study consent (n=2696), and responses to a baseline questionnaire from the fully enrolled study participants (n=1452). Results: Qualitative results prior to recruitment provided insights regarding the selection of a variety of recruitment channels proposed to be successful, and provided context for the unique attributes of the study sample. Quantitative analysis of self-reported channels used to engage with students, and to enroll participants into the study, revealed the relative utilization of channels at several recruitment points. The use of mass emails to the student body was reported by the final sample as the most influential channel, accounting for 60.54% (879/1452) of the total enrolled sample. Conclusions: Relative channel efficiency was analyzed across a wide variety of channels. One primary channel (mass emails) and a small number of secondary channels (including college websites and learning management systems) accounted for most of the recruitment success. Trial Registration: ClinicalTrials.gov NCT01692730; https://clinicaltrials.gov/ct2/show/NCT01692730 (Archived by WebCite at http://www.webcitation.org/6qEcFQN9Q) %M 28483741 %R 10.2196/resprot.6485 %U http://www.researchprotocols.org/2017/5/e79/ %U https://doi.org/10.2196/resprot.6485 %U http://www.ncbi.nlm.nih.gov/pubmed/28483741 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 6 %N 4 %P e61 %T Using Mobile Phones to Collect Patient Data: Lessons Learned From the SIMPle Study %A Duane,Sinead %A Tandan,Meera %A Murphy,Andrew W %A Vellinga,Akke %+ Discipline of General Practice, National University of Ireland Galway, 1 Distillery Road, Galway,, Ireland, 353 91493855, sinead.duane@nuigalway.ie %K mobile phone apps %K mobile survey %K antimicrobial resistance %K primary care %K quantitative %K prescribing %K urinary tract infection %D 2017 %7 25.04.2017 %9 Original Paper %J JMIR Res Protoc %G English %X Background: Mobile phones offer new opportunities to efficiently and interactively collect real-time data from patients with acute illnesses, such as urinary tract infections (UTIs). One of the main benefits of using mobile data collection methods is automated data upload, which can reduce the chance of data loss, an issue when using other data collection methods such as paper-based surveys. Objective: The aim was to explore differences in collecting data from patients with UTI using text messaging, a mobile phone app (UTI diary), and an online survey. This paper provides lessons learned from integrating mobile data collection into a randomized controlled trial. Methods: Participants included UTI patients consulting in general practices that were participating in the Supporting the Improvement and Management of UTI (SIMPle) study. SIMPle was designed to improve prescribing antimicrobial therapies for UTI in the community. Patients were invited to reply to questions regarding their UTI either via a prospective text message survey, a mobile phone app (UTI diary), or a retrospective online survey. Data were collected from 329 patients who opted in to the text message survey, 71 UTI patients through the mobile phone UTI symptom diary app, and 91 online survey participants. Results: The age profile of UTI diary app users was younger than that of the text message and online survey users. The largest dropout for both the text message survey respondents and UTI diary app users was after the initial opt-in message; once the participants completed question 1 of the text message survey or day 2 in the UTI diary app, they were more likely to respond to the remaining questions/days. Conclusions: This feasibility study highlights the potential of using mobile data collection methods to capture patient data. As well as improving the efficiency of data collection, these novel approaches highlight the advantage of collecting data in real time across multiple time points. There was little variation in the number of patients responding between text message survey, UTI diary, and online survey, but more patients participated in the text message survey than the UTI diary app. The choice between designing a text message survey or UTI diary app will depend on the age profile of patients and the type of information the researchers’ desire. Trial Registration: ClinicalTrials.gov NCT01913860; https://clinicaltrials.gov/ct2/show/NCT01913860 (Archived by WebCite at http://www.webcitation.org/6pfgCztgT). %M 28442451 %R 10.2196/resprot.6389 %U http://www.researchprotocols.org/2017/4/e61/ %U https://doi.org/10.2196/resprot.6389 %U http://www.ncbi.nlm.nih.gov/pubmed/28442451 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 6 %N 4 %P e59 %T Increasing Fruit and Vegetable Consumption Through a Healthy Eating Blog: A Feasibility Study %A Caplette,Marie-Eve %A Provencher,Véronique %A Bissonnette-Maheux,Véronique %A Dugrenier,Marilyn %A Lapointe,Annie %A Gagnon,Marie-Pierre %A Straus,Sharon %A Desroches,Sophie %+ Institute of Nutrition and Functional Foods, Laval University, Pavillon des services, office 2729-P, 2440 Hochelaga Boulevard, Quebec, QC, G1V 0A6, Canada, 1 418 656 2131 ext 5564, sophie.desroches@fsaa.ulaval.ca %K blogs %K nutrition %K healthy eating %K knowledge translation %K feasibility %D 2017 %7 18.04.2017 %9 Original Paper %J JMIR Res Protoc %G English %X Background: Despite efforts made by public health organizations to improve consumption of fruits and vegetables, populations in developed countries usually eat less than the minimum recommended. Social media, such as blogs, represent a unique opportunity for improving knowledge translation in health care because they facilitate interactive communication between the public and health professionals. However, no studies have yet evaluated the effect of blogs to promote dietary behavior changes. Objective: Our study aims to conduct a preliminary assessment before undertaking a full randomized controlled trial (RCT) of the feasibility of using an evidence-based healthy eating blog promoting the consumption of fruits and vegetables among adult women. Methods: A total of 80 women aged 18 years and older (mean 42, SD 13 years) eating less than five servings per day of fruit and vegetables (mean 2.75, SD 1.84 servings) were recruited. Participants were randomized to the healthy eating blog group (n=40), which included a weekly blog post over a 6-month period, or to a control group (n=40) that had no exposure to the healthy eating blog. Blog posts were written by a registered dietitian and focused on the improvement of fruit and vegetable consumption. We targeted four main determinants of the behavior that were identified as the best predictors for fruit and vegetable intake by two systematic reviews: (1) knowledge, (2) attitude, (3) self-efficacy, and (4) motivation. The intervention was considered feasible if (1) more than 70% of questionnaires were completed, (2) attendance rate was more than 90% for in-person appointments with the research coordinator, (3) participants accessed at least 75% of the blog posts, and (4) the attrition rate was less than 25%. Blog access was assessed by collecting the blog browsing history data for each participant. Results: During the intervention, 26 posts were published on the blog. Pre- (baseline) and postintervention (6 months) questionnaires were completed by mean 97% (SD 3%) of participants. All participants attended their in-person appointments. Women accessed mean 87% (SD 7%) of the posts published during the intervention. Only 3% (2/80) of participants dropped out of the study. Between the healthy eating blog and control groups, a difference of 1.0 servings of fruits and vegetables (P<.001) indicated moderate effects of the intervention (Cohen d=0.54). Conclusions: These results suggest that an intervention using a healthy eating blog meets preestablished feasibility criteria. A larger-scale RCT using the same methodology will be conducted to assess the impact of a healthy eating blog on the dietary habits of women. %M 28420600 %R 10.2196/resprot.6622 %U http://www.researchprotocols.org/2017/4/e59/ %U https://doi.org/10.2196/resprot.6622 %U http://www.ncbi.nlm.nih.gov/pubmed/28420600 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 6 %N 4 %P e56 %T Comparing Crowdsourcing and Friendsourcing: A Social Media-Based Feasibility Study to Support Alzheimer Disease Caregivers %A Bateman,Daniel Robert %A Brady,Erin %A Wilkerson,David %A Yi,Eun-Hye %A Karanam,Yamini %A Callahan,Christopher M %+ Indiana University Center for Aging Research, 1101 West Tenth Street, Indianapolis, IN, 46202, United States, 1 317 274 9334, darbate@iupui.edu %K Alzheimer disease %K Alzheimer disease and related dementias %K caregivers %K mobile health %K social media %K crowdsourcing %K friendsourcing %K emotional support %K informational support %K online support %D 2017 %7 10.04.2017 %9 Original Paper %J JMIR Res Protoc %G English %X Background: In the United States, over 15 million informal caregivers provide unpaid care to people with Alzheimer disease (AD). Compared with others in their age group, AD caregivers have higher rates of stress, and medical and psychiatric illnesses. Psychosocial interventions improve the health of caregivers. However, constraints of time, distance, and availability inhibit the use of these services. Newer online technologies, such as social media, online groups, friendsourcing, and crowdsourcing, present alternative methods of delivering support. However, limited work has been done in this area with caregivers. Objective: The primary aims of this study were to determine (1) the feasibility of innovating peer support group work delivered through social media with friendsourcing, (2) whether the intervention provides an acceptable method for AD caregivers to obtain support, and (3) whether caregiver outcomes were affected by the intervention. A Facebook app provided support to AD caregivers through collecting friendsourced answers to caregiver questions from participants’ social networks. The study’s secondary aim was to descriptively compare friendsourced answers versus crowdsourced answers. Methods: We recruited AD caregivers online to participate in a 6-week-long asynchronous, online, closed group on Facebook, where caregivers received support through moderator prompts, group member interactions, and friendsourced answers to caregiver questions. We surveyed and interviewed participants before and after the online group to assess their needs, views on technology, and experience with the intervention. Caregiver questions were pushed automatically to the participants’ Facebook News Feed, allowing participants’ Facebook friends to see and post answers to the caregiver questions (Friendsourced answers). Of these caregiver questions, 2 were pushed to crowdsource workers through the Amazon Mechanical Turk platform. We descriptively compared characteristics of these crowdsourced answers with the friendsourced answers. Results: In total, 6 AD caregivers completed the initial online survey and semistructured telephone interview. Of these, 4 AD caregivers agreed to participate in the online Facebook closed group activity portion of the study. Friendsourcing and crowdsourcing answers to caregiver questions had similar rates of acceptability as rated by content experts: 90% (27/30) and 100% (45/45), respectively. Rates of emotional support and informational support for both groups of answers appeared to trend with the type of support emphasized in the caregiver question (emotional vs informational support question). Friendsourced answers included more shared experiences (20/30, 67%) than did crowdsourced answers (4/45, 9%). Conclusions: We found an asynchronous, online, closed group on Facebook to be generally acceptable as a means to deliver support to caregivers of people with AD. This pilot is too small to make judgments on effectiveness; however, results trended toward an improvement in caregivers’ self-efficacy, sense of support, and perceived stress, but these results were not statistically significant. Both friendsourced and crowdsourced answers may be an acceptable way to provide informational and emotional support to caregivers of people with AD. %M 28396304 %R 10.2196/resprot.6904 %U http://www.researchprotocols.org/2017/4/e56/ %U https://doi.org/10.2196/resprot.6904 %U http://www.ncbi.nlm.nih.gov/pubmed/28396304 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 19 %N 4 %P e88 %T Pregnant Women’s Views on the Feasibility and Acceptability of Web-Based Mental Health E-Screening Versus Paper-Based Screening: A Randomized Controlled Trial %A Kingston,Dawn %A Austin,Marie-Paule %A Veldhuyzen van Zanten,Sander %A Harvalik,Paula %A Giallo,Rebecca %A McDonald,Sarah D %A MacQueen,Glenda %A Vermeyden,Lydia %A Lasiuk,Gerri %A Sword,Wendy %A Biringer,Anne %+ Faculty of Nursing, University of Calgary, 2500 University Ave NW, Calgary, AB, T2N 1N4, Canada, 1 4032202634, dawn.kingston@ucalgary.ca %K pregnancy %K mental health %K screening %K prenatal care %K computers %D 2017 %7 07.04.2017 %9 Original Paper %J J Med Internet Res %G English %X Background: Major international guidelines recommend mental health screening during the perinatal period. However, substantial barriers to screening have been reported by pregnant and postpartum women and perinatal care providers. E-screening offers benefits that may address implementation challenges. Objective: The primary objective of this randomized controlled trial was to evaluate the feasibility and acceptability of Web-based mental health e-screening compared with paper-based screening among pregnant women. A secondary objective was to identify factors associated with women’s preferences for e-screening and disclosure of mental health concerns. Methods: Pregnant women recruited from community and hospital-based antenatal clinics and hospital-based prenatal classes were computer-randomized to a fully automated Web-based e-screening intervention group or a paper-based control group. Women were eligible if they spoke or read English, were willing to be randomized to e-screening, and were willing to participate in a follow-up diagnostic interview. The intervention group completed the Antenatal Psychosocial Health Assessment and the Edinburgh Postnatal Depression Scale on a tablet computer, while controls completed them on paper. All women completed self-report baseline questions and were telephoned 1 week after randomization by a blinded research assistant for a MINI International Neuropsychiatric Interview. Renker and Tonkin’s tool of feasibility and acceptability of computerized screening was used to assess the feasibility and acceptability of e-screening compared with paper-based screening. Intention-to-treat analysis was used. To identify factors associated with preference for e-screening and disclosure, variables associated with each outcome at P<.20 were simultaneously entered into final multivariable models to estimate adjusted odds ratios (AORs) and 95% CIs. Results: Of the 675 eligible women approached, 636 agreed to participate (participation rate 94.2%) and were randomized to the intervention (n=305) or control (n=331) groups. There were no significant baseline differences between groups. More women in the e-screening group strongly or somewhat agreed that they would like to use a tablet for answering questions on emotional health (57.9%, 175/302 vs 37.2%, 121/325) and would prefer using a tablet to paper (46.0%, 139/302 vs 29.2%, 95/325), compared with women in the paper-based screening group. There were no differences between groups in women’s disclosure of emotional health concerns (94.1%, 284/302 vs 90.2%, 293/325). Women in the e-screening group consistently reported the features of e-screening more favorably than controls (more private or confidential, less impersonal, less time-consuming). In the multivariable models, being in the e-screening group was significantly associated with preferring e-screening (AOR 2.29, 95% CI 1.66-3.17), while no factors were significantly associated with disclosure. Conclusions: The findings suggest that mental health e-screening is feasible and acceptable to pregnant women. Trial Registration: Clinicaltrials.gov NCT01899534; https://clinicaltrials.gov/ct2/show/NCT01899534 (Archived by WebCite at http://www.webcitation.org/6ntWg1yWb) %M 28389421 %R 10.2196/jmir.6866 %U http://www.jmir.org/2017/4/e88/ %U https://doi.org/10.2196/jmir.6866 %U http://www.ncbi.nlm.nih.gov/pubmed/28389421 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 6 %N 3 %P e47 %T Internet-based Self-Management Support for Patients With Well-Controlled Type 2 Diabetes: A Real-Life Study %A Hart,Huberta E %A Geilen,Inge ETM %A de Leeuw,Elke %A Rutten,Guy EHM %A Vos,Rimke C %+ University Medical Center Utrecht, Julius Center for Health Sciences and Primary Care, Huispost STR 6.131, P.O.Box 85500, Utrecht, 3508 GA, Netherlands, 31 616950844, h.e.hart@umcutrecht.nl %K type 2 diabetes mellitus %K self-care %K telemedicine %K mild cognitive impairment %D 2017 %7 23.03.2017 %9 Original Paper %J JMIR Res Protoc %G English %X Background: Little attention has been paid to self-management support of patients with well-controlled type 2 diabetes mellitus (T2DM). Most studies evaluated the addition of self-management support to regular diabetes care, but self-management as an alternative for part of regular diabetes care has hardly been studied. In this study, we offered patients with well-controlled T2DM the opportunity to perform the 3 quarterly monitoring sessions at home using an Internet-based self-management program, resulting in online personalized advice. Objective: The aim of our study was to assess the reach and feasibility of an Internet-based diabetes self-management support program for patients with well-controlled T2DM, addressing both primary care providers’ (PCPs) opinions and patients’ willingness to participate in such a support program. Methods: PCPs assessed patients’ eligibility for Internet-based self-management, and patients were offered the opportunity to participate. Characteristics of eligible and ineligible patients were compared, as well as those of participants and nonparticipants, also with regard to quality of life, treatment satisfaction, and illness perceptions. Multivariate logistic regression models were performed and odds ratios (ORs) calculated with 95% CIs. Results: Almost half (128/282, 45.4%) of the patients with well-controlled T2DM were considered ineligible by their PCPs mainly because of cognitive impairment and language barriers (8.2% and 8.9%). Older patients (OR for each year 1.06, 95% CI 1.03-1.09, P<.001), non–Western European patients (OR 3.64, 95% CI 1.67-7.92, P=.001), and patients with a longer diabetes duration (OR for each year 1.56, 95% CI 1.04-2.34, P=.03) were more often regarded as ineligible. Of the 154 patients considered eligible, 57 (37.0%) consented to participate and 30 (10.6%) started the program. Of 57 participants, 45 returned the 3 questionnaires; 21 of 97 nonparticipants returned the questionnaires. Nonparticipants less often thought that their disease would last their entire life (median 8.0 vs 10.0, P=.03) and they were more satisfied with their current treatment than participants (DTSQ total score 44.0 vs 40.0, P=.05). There was no significant difference in quality of life between the 2 groups. Conclusions: PCPs considered half of their patients with well-controlled T2DM incapable of Internet-based self-management mainly because of cognitive impairment and language barriers; of the selected patients, about 1 out of 3 was willing to participate. Older patients, non–Western European patients, and patients with a higher BMI were less likely to participate. Predominantly, practical issues (such as Internet problems) hindered implementation of the Internet-based self-management program. %M 28336505 %R 10.2196/resprot.6910 %U http://www.researchprotocols.org/2017/3/e47/ %U https://doi.org/10.2196/resprot.6910 %U http://www.ncbi.nlm.nih.gov/pubmed/28336505 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 6 %N 3 %P e45 %T Use of the Total Cancer Care System to Enrich Screening for CD30-Positive Solid Tumors for Patient Enrollment Into a Brentuximab Vedotin Clinical Trial: A Pilot Study to Evaluate Feasibility %A Li,Bin %A Eschrich,Steven A %A Berglund,Anders %A Mitchell,Melissa %A Fenstermacher,David %A Danaee,Hadi %A Dai,Hongyue %A Sullivan,Daniel %A Trepicchio,William L %A Dalton,William S %+ Takeda Pharmaceuticals International Company, Takeda Data Science Institute, 40 Landsdowne Street, Cambridge, MA,, United States, 1 617 679 7041, Bin.Li2@takeda.com %K antitumor agents %K CD30 antigen %K clinical trial %K database management systems %K medical oncology %D 2017 %7 20.03.2017 %9 Original Paper %J JMIR Res Protoc %G English %X Background: One approach to identify patients who meet specific eligibility criteria for target-based clinical trials is to use patient and tumor registries to prescreen patient populations. Objective: Here we demonstrate that the Total Cancer Care (TCC) Protocol, an ongoing, observational study, may provide a solution for rapidly identifying patients with CD30-positive tumors eligible for CD30-targeted therapies such as brentuximab vedotin. Methods: The TCC patient gene expression profiling database was retrospectively screened for CD30 gene expression determined using HuRSTA-2a520709 Affymetrix arrays (GPL15048). Banked tumor tissue samples were used to determine CD30 protein expression by semiquantitative immunohistochemistry. Statistical comparisons of Z- and H-scores were performed using R statistical software (The R Foundation), and the predictive value, accuracy, sensitivity, and specificity of CD30 gene expression versus protein expression was estimated. Results: As of March 2015, 120,887 patients have consented to the institutional review board–approved TCC Protocol. A total of 39,157 fresh frozen tumor specimens have been collected, from which over 14,000 samples have gene expression data available. CD30 RNA was expressed in a number of solid tumors; the highest median CD30 RNA expression was observed in primary tumors from lymph node, soft tissue (many sarcomas), lung, skin, and esophagus (median Z-scores 1.011, 0.399, 0.202, 0.152, and 1.011, respectively). High level CD30 gene expression significantly enriches for CD30-positive protein expression in breast, lung, skin, and ovarian cancer; accuracy ranged from 72% to 79%, sensitivity from 75% to 100%, specificity from 70% to 76%, positive predictive value from 20% to 40%, and negative predictive value from 95% to 100%. Conclusions: The TCC gene expression profiling database guided tissue selection that enriched for CD30 protein expression in a number of solid tumor types. Such an approach may improve screening efficiency for enrolling patients into biomarker-based clinical trials. %M 28320689 %R 10.2196/resprot.7289 %U http://www.researchprotocols.org/2017/3/e45/ %U https://doi.org/10.2196/resprot.7289 %U http://www.ncbi.nlm.nih.gov/pubmed/28320689 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 6 %N 3 %P e46 %T Implementation of a Home Monitoring System for Heart Failure Patients: A Feasibility Study %A Kohn,Martin Steven %A Haggard,Jeffrey %A Kreindler,Jack %A Birkeland,Kade %A Kedan,Ilan %A Zimmer,Raymond %A Khandwalla,Raj %+ Sentrian, Suite 100, 31910 Del Obispo, San Juan Capistrano, CA, 92675, United States, 1 949 373 9640, marty@sentrian.com %K heart failure %K home monitoring %K predictive analytics %K patient engagement %D 2017 %7 20.03.2017 %9 Original Paper %J JMIR Res Protoc %G English %X Background: Improving the management of patients with complex chronic disease is a substantial undertaking with the simultaneous goals of improving patient outcomes and controlling costs. Reducing avoidable hospitalization for such patients is a step toward both objectives. Some of the deterioration experienced in chronic disease patients occurs outside the view of their clinicians, and before the patient becomes overtly symptomatic. Home monitoring has been used for more than 20 years to detect deterioration earlier so that the patients could be treated before they became ill enough to require hospitalization. Patient participation is an important requirement for successful home monitoring. There has been some concern that patients would be unwilling or unable to engage in a program that collected multiple measurements. The Cedars-Sinai Cardiology Center provides a high-touch, intense management program for patients with congestive heart failure (CHF). A group of their patients were chosen to join a complex, multidevice home monitoring system to see whether such patients would find value in the additional effort. Objective: The objective of our study was to determine whether patients already actively engaged in a high-touch intensive management program for CHF would take on the additional burden of a complex home monitoring effort. Methods: A total of 20 patients from the Cedars-Sinai group were enrolled in a monitoring program utilizing 5 different devices. Anonymous surveys were collected from the patients to assess their satisfaction with the program. Results: In total, 90% (18/20) completed the program, and 61% (11/20) submitted the survey. Among the 18 patients, overall compliance with the requested measurements was 70%. It was found that 73% (8/11) felt better about their health as a result of the program, whereas another 73% (8/11) believed that the care team now had a better picture of their health. Conclusions: Substantial patient compliance and satisfaction can be achieved in a sophisticated home monitoring program. %M 28320688 %R 10.2196/resprot.5744 %U http://www.researchprotocols.org/2017/3/e46/ %U https://doi.org/10.2196/resprot.5744 %U http://www.ncbi.nlm.nih.gov/pubmed/28320688 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 19 %N 3 %P e66 %T Mobile Device–Based Electronic Data Capture System Used in a Clinical Randomized Controlled Trial: Advantages and Challenges %A Zhang,Jing %A Sun,Lei %A Liu,Yu %A Wang,Hongyi %A Sun,Ningling %A Zhang,Puhong %+ The George Institute for Global Health at Peking University Health Science Center, Level 18, Tower B, Horizon Tower, No. 6 Zhichun Rd Haidian District | Beijing, 100088 P.R. China, Beijing,, China, 86 1082800577 ext 512, zpuhong@georgeinstitute.org.cn %K mEDC %K electronic data capture %K mobile data capture %K mhealth %K randomized controlled trial %K clinical research %D 2017 %7 08.03.2017 %9 Original Paper %J J Med Internet Res %G English %X Background: Electronic data capture (EDC) systems have been widely used in clinical research, but mobile device–based electronic data capture (mEDC) system has not been well evaluated. Objective: The aim of our study was to evaluate the feasibility, advantages, and challenges of mEDC in data collection, project management, and telemonitoring in a randomized controlled trial (RCT). Methods: We developed an mEDC to support an RCT called “Telmisartan and Hydrochlorothiazide Antihypertensive Treatment (THAT)” study, which was a multicenter, double-blinded, RCT, with the purpose of comparing the efficacy of telmisartan and hydrochlorothiazide (HCTZ) monotherapy in high-sodium-intake patients with mild to moderate hypertension during a 60 days follow-up. Semistructured interviews were conducted during and after the trial to evaluate the feasibility, advantage, and challenge of mEDC. Nvivo version 9.0 (QSR International) was used to analyze records of interviews, and a thematic framework method was used to obtain outcomes. Results: The mEDC was successfully used to support the data collection and project management in all the 14 study hospitals. A total of 1333 patients were recruited with support of mEDC, of whom 1037 successfully completed all 4 visits. Across all visits, the average time needed for 141 questions per patient was 53 min, which were acceptable to both doctors and patients. All the interviewees, including 24 doctors, 53 patients, 1 clinical research associate (CRA), 1 project manager (PM), and 1 data manager (DM), expressed their satisfaction to nearly all the functions of the innovative mEDC in randomization, data collection, project management, quality control, and remote monitoring in real time. The average satisfaction score was 9.2 (scale, 0-10). The biggest challenge came from the stability of the mobile or Wi-Fi signal although it was not a problem in THAT study. Conclusions: The innovative mEDC has many merits and is well acceptable in supporting data collection and project management in a timely manner in clinical trial. %M 28274907 %R 10.2196/jmir.6978 %U http://www.jmir.org/2017/3/e66/ %U https://doi.org/10.2196/jmir.6978 %U http://www.ncbi.nlm.nih.gov/pubmed/28274907 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 6 %N 2 %P e9 %T Feasibility of Ecological Momentary Assessment of Daily Sexting and Substance Use Among Young Adult African American Gay and Bisexual Men: A Pilot Study %A Smiley,Sabrina L %A Elmasry,Hoda %A Webb Hooper,Monica %A Niaura,Raymond S %A Hamilton,Alison B %A Milburn,Norweeta G %+ Schroeder Institute for Tobacco Research and Policy Studies at Truth Initiative, 900 G Street, NW, Fourth Floor, Washington, DC,, United States, 1 202 454 5928, ssmiley@truthinitiative.org %K ecological momentary assessment %K mobile phone %K text messaging %K sexting %K marijuana %K alcohol %K young adult %K gay and bisexual %K African American men %D 2017 %7 02.02.2017 %9 Original Paper %J JMIR Res Protoc %G English %X Background: Recent evidence suggests that sexualized text communication (“sexting”) is associated with substance use and sexual risk behaviors among young adults, yet little is known about this relationship among young adult African American gay and bisexual men, a population disproportionately impacted by HIV in the United States. Rapid advances in mobile phone technology indicate a clear need for research using mobile health (mHealth) methods such as ecological momentary assessment (EMA) to serve as a viable counterpart to retrospective evaluation methods by using real-time data collection to assess sexting and substance use among this population. Objective: The objective of this pilot study was to (1) describe the EMA study design and protocol, (2) characterize the study population, and (3) assess the feasibility of a random prompt text message-based thrice-daily EMA over 14 days, as a means of prospectively studying sexting, marijuana, and alcohol use among a sample of young adult African American gay and bisexual men ages 21 to 25. Methods: Participants were recruited through flyers and snowball sampling during spring and summer 2015 at a community-based HIV/AIDS prevention, care, and support organization in Washington, DC. Eligible participants were enrolled in a one-time in-person study visit that consisted of informed written consent to participate in the study, a self-administered survey, a semi-structured interview, and enrollment and training in EMA data collection. Commencing the day after the study visit, a random prompt survey was texted to participants on their personal mobile phones 3 times a day over a 14-day data collection period assessing mood, texts sent, texts received, sexts sent, sexts received, marijuana want, marijuana use, and alcohol use. Results: EMA feasibility was tested with 25 self-identified African American gay (n=16) and bisexual (n=9) men (mean age of 23.48 years, SD 1.5). Each random prompt survey had 8 questions with responses including yes/no and Likert scale options. There were 104 total days of EMA observation, and the retention rate was 72% (18 out of 25 participants). Participants responded to the random prompt surveys with a 57.3% compliance rate providing a total of 544 completed surveys out of 949 surveys. The overall mean response time to complete a survey was 6.1 minutes. There were significant positive associations between EMA texts sent and received questions (ρ 0.84, P<.001) as well as sexts sent and received queries (ρ 0.72, P<.001). Conclusions: The use of an EMA protocol has the potential to be a very useful research tool for understanding episodic behaviors such as sexting and substance use in this relatively understudied and underserved population, and has implications for practice. Additional research is needed on how to maximize survey compliance. %M 28153816 %R 10.2196/resprot.6520 %U http://www.researchprotocols.org/2017/2/e9/ %U https://doi.org/10.2196/resprot.6520 %U http://www.ncbi.nlm.nih.gov/pubmed/28153816 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 6 %N 1 %P e12 %T The Use of Social Media to Recruit Participants With Rare Conditions: Lynch Syndrome as an Example %A Burton-Chase,Allison M %A Parker,Wendy M %A Hennig,Kelsey %A Sisson,Faith %A Bruzzone,Linda L %+ Albany College of Pharmacy and Health Sciences, 106 New Scotland Avenue, Albany, NY, 12208, United States, 1 518 694 7362, allison.burton-chase@acphs.edu %K social media recruitment %K Lynch syndrome %K participation rates %K response rates %K data collection %D 2017 %7 23.01.2017 %9 Original Paper %J JMIR Res Protoc %G English %X Background: Social media is increasingly being used as a means of recruiting participants, particularly for investigators whose areas of interest involve rare conditions or hard-to-reach populations. However, much of the literature to date has focused on paid advertisement recruitment. Objective: We used Lynch syndrome (LS), a rare hereditary cancer syndrome, as a model to demonstrate the successful partnership between researchers and a Web-based patient education and advocacy organization to facilitate participant recruitment. Methods: Recruitment was undertaken in partnership with Lynch Syndrome International (LSI), an advocacy organization with a strong social media presence. After LSI published our study information, participants followed up via email or phone call. Following prescreening and consent, interested and eligible participants were then sent a secure survey link. Results: Within 36 hours of a single Facebook post by the site administrators for LSI, over 150 individuals responded via phone or email. Sixty-five individuals were sent the survey link and 57 individuals completed the survey (88% response rate). Of note, these 57 individuals were geographically diverse within the Unites States, representing LS patients from 26 different states. Conclusions: This approach has several advantages, including recruitment through a trusted source outside of a clinical setting, higher response rates, and cost-effectiveness with a small research team in a relatively short amount of time. Overall, social media recruitment with a trusted online partner can be highly effective in hard-to-reach clinical populations, such as patients with LS. However, this approach requires additional effort for eligibility screening. %M 28115298 %R 10.2196/resprot.6066 %U http://www.researchprotocols.org/2017/1/e12/ %U https://doi.org/10.2196/resprot.6066 %U http://www.ncbi.nlm.nih.gov/pubmed/28115298 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 6 %N 1 %P e6 %T The Epital Care Model: A New Person-Centered Model of Technology-Enabled Integrated Care for People With Long Term Conditions %A Phanareth,Klaus %A Vingtoft,Søren %A Christensen,Anders Skovbo %A Nielsen,Jakob Sylvest %A Svenstrup,Jørgen %A Berntsen,Gro Karine Rosvold %A Newman,Stanton Peter %A Kayser,Lars %+ Section of Social Medicine, Department of Public Health, University of Copenhagen, Øster Farimagsgade 5, Copenhagen, 1014, Denmark, 45 28757291, lk@sund.ku.dk %K integrated care %K technology enabled %K innovative care %K chronic obstructive pulmonary disease (COPD) %K frail %D 2017 %7 16.01.2017 %9 Original Paper %J JMIR Res Protoc %G English %X Background: There is worldwide recognition that the future provision of health care requires a reorganization of provision of care, with increased empowerment and engagement of patients, along with skilled health professionals delivering services that are coordinated across sectors and organizations that provide health care. Technology may be a way to enable the creation of a coherent, cocreative, person-centered method to provide health care for individuals with one or more long-term conditions (LTCs). It remains to be determined how a new care model can be introduced that supports the intentions of the World Health Organization (WHO) to have integrated people-centered care. Objective: To design, pilot, and test feasibility of a model of health care for people with LTCs based on a cocreative, iterative, and stepwise process in a way that recognizes the need for person-centered care, and embraces the use of digital technology. Methods: The overall research method was inspired by action research and used an agile, iterative approach. In 2012, a living lab was established in a Danish municipality which allowed for the freedom of redesigning health care processes. As the first step, a wide group of stakeholders was gathered to create a layout for the reorganization of services and development of technology, based on established principles for innovative management of people with chronic conditions. The next three steps were (1) a proof of concept in 2012, (2) a pilot study, and (3) a feasibility study from 2013 to 2015, in which a total of 93 chronic obstructive pulmonary disease (COPD) patients were enrolled. Citizens were provided a tablet-based solution for remote follow-up and communication purposes, and access to a 24/7 response and coordination center that coordinated both virtual and face-to-face support for COPD management. In step five the initial model was extended with elements that support continuity of care. Beginning in the autumn of 2013, 1102 frail elderly individuals were included and offered two additional services: an outgoing acute medical team and a local subacute bed function. Results: Based on the findings from the iterative process, and evolving technology and workflow solutions, we propose a robust and feasible model that can provide a framework for developing solutions to support an active life with one or more LTCs. The resulting Epital Care Model (ECM) consists of six stages, and serves as a template for how a digitally-enhanced health service can be provided based on patients’ medical needs. The model is designed to be a proactive, preventive, and monitoring health care system that involves individuals in the management of their own health conditions. Conclusions: The ECM is in accordance with WHO’s framework for integrated people-centered health services, and may serve as a framework for the development of new technologies and provide a template for future reorganization. %M 28093379 %R 10.2196/resprot.6506 %U http://www.researchprotocols.org/2017/1/e6/ %U https://doi.org/10.2196/resprot.6506 %U http://www.ncbi.nlm.nih.gov/pubmed/28093379 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 5 %N 4 %P e235 %T Design, Response Rates, and Population Characteristics of a Cross-Sectional Study in Zanzibar, Tanzania %A Nyangasa,Maria Adam %A Kelm,Soerge %A Sheikh,Mohammed Ali %A Hebestreit,Antje %+ Leibniz Institute for Prevention Research and Epidemiology-BIPS, Achterstrasse 30, Bremen, 28359, Germany, 49 421218 56849, hebestr@leibniz-bips.de %K cross-sectional study %K anthropometric measures %K blood pressure %K biosamples %K response rates %K sub-Saharan Africa %D 2016 %7 01.12.2016 %9 Original Paper %J JMIR Res Protoc %G English %X Background: Data on nutritional status and correlates of noncommunicable diseases are scarce for resource-poor settings in sub-Saharan countries. With the scope of a project, “Access to Food and Nutrition Status of the Zanzibari Population,” data for investigating public health questions were collected using proven measurement and laboratory standards. Objective: The present study aims at providing a descriptive overview of recruitment approaches, standardization, quality control measures, and data collection, with special attention to the design, responses, and participant characteristics of the overall project. Methods: A cross-sectional study across 80 randomly selected Shehias (wards) was conducted in 2013 in Unguja Island, Zanzibar. Examinations included all members living in 1 household, face-to-face interviews and anthropometric measurements (weight, height, mid-upper arm circumference, waist and hip circumference, and body composition) were assessed for all household members, blood pressure was taken from participants older than 2 years, and biosamples (urine and blood) from eligible household members were collected. Data collected from the core sample included sociodemographic data, nutritional status, and medical history (hypertension). Physical activity data was collected from a subsample of children between 3 and 16 years of age. Results: A total of 1314 participants (mean age 23.6 ± 18.9 years, 54.54% female) completed all anthropometric measurements and were included in the analysis. Out of which, 98.40% (1293/1314) completed the household member’s questionnaire, 93.32% (1229/1314) participants older than 2 years completed blood pressure measurements, and 64.31% (845/1314) blood samples were collected from participants older than 5 years. Underweight prevalence for the total study population was 36.53% (480/1314) with the highest prevalence in children under 14 years. Overweight and obesity was highest among females with the prevalence of 7.61% (100/1314) and 6.62% (87/1314), respectively; obesity was rare among male participants. Conclusions: The study provides valuable data to investigate the interplay of socioeconomic, demographic, environmental, physiological, and behavioral factors in the development of diet-related disorders in a representative sample of the Zanzibari population. %M 27908845 %R 10.2196/resprot.6621 %U http://www.researchprotocols.org/2016/4/e235/ %U https://doi.org/10.2196/resprot.6621 %U http://www.ncbi.nlm.nih.gov/pubmed/27908845 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 5 %N 4 %P e237 %T Can a Free Wearable Activity Tracker Change Behavior? The Impact of Trackers on Adults in a Physician-Led Wellness Group %A Gualtieri,Lisa %A Rosenbluth,Sandra %A Phillips,Jeffrey %+ Department of Public Health and Community Medicine, Tufts University School of Medicine, 136 Harrison Avenue, Boston, MA, 02111, United States, 1 617 636 0438, lisa.gualtieri@tufts.edu %K wearable activity trackers %K fitness trackers %K trackers %K physical activity %K chronic disease %K behavior change %K wellness group %K wellness %K older adults %K digital health %D 2016 %7 30.11.2016 %9 Original Paper %J JMIR Res Protoc %G English %X Background: Wearable activity trackers (trackers) are increasingly popular devices used to track step count and other health indicators. Trackers have the potential to benefit those in need of increased physical activity, such as adults who are older and face significant health challenges. These populations are least likely to purchase trackers and most likely to face challenges in using them, yet may derive educational, motivational, and health benefits from their use once these barriers are removed. Objective: The aim of this pilot research is to investigate the use of trackers by adults with chronic medical conditions who have never used trackers previously. Specifically, we aim to determine (1) if participants would accept and use trackers to increase their physical activity; (2) if there were barriers to use besides cost and training; (3) if trackers would educate participants on their baseline and ongoing activity levels and support behavior change; and (4) if clinical outcomes would show improvements in participants’ health. Methods: This study was conducted with patients (N=10) in a 12-week physician-led wellness group offered by Family Doctors, LLC. Patients were given trackers in the second week of The Wellness Group and were interviewed 2 to 4 weeks after it ended. The study investigators analyzed the interview notes to extract themes about the participants’ attitudes and behavior changes and collected and analyzed participants’ clinical data, including weight and low-density lipoprotein (LDL) cholesterol over the course of the study. Results: Over the 12 to 14 weeks of tracker use, improvements were seen in clinical outcomes, attitudes towards the trackers, and physical activity behaviors. Participants lost an average of 0.5 lbs per week (SD 0.4), with a mean total weight loss of 5.97 lbs (P=.004). Other short-term clinical outcomes included a 9.2% decrease in LDL levels (P=.038). All participants reported an increase in well-being and confidence in their ability to lead more active lives. We identified the following 6 major attitudinal themes from our qualitative analysis of the interview notes: (1) barriers to tracker purchase included cost, perceived value, and choice confusion; (2) attitudes towards the trackers shifted for many, from half of the participants expressing excitement and hope and half expressing hesitation or trepidation, to all participants feeling positive towards their tracker at the time of the interviews; (3) trackers served as educational tools for baseline activity levels; (4) trackers provided concrete feedback on physical activity, which motivated behavior change; (5) tracker use reinforced wellness group activities and goals; and (6) although commitment to tracker use did not waver, external circumstances influenced some participants’ ongoing use. Conclusions: Our findings suggest that adding trackers to wellness groups comprising primarily older adults with chronic medical conditions can support education and behavior change to be more physically active. The trackers increased participant self-efficacy by providing a tangible, visible reminder of a commitment to increasing activity and immediate feedback on step count and progress towards a daily step goal. While acceptance was high and attitudes ultimately positive, training and support are needed and short-term drop-off in participant use is to be expected. Future research will further consider the potential of trackers in older adults with chronic medical conditions who are unlikely to purchase them, and studies will use larger samples, continue over a longer period of time, and evaluate outcomes independent of a wellness group. %M 27903490 %R 10.2196/resprot.6534 %U http://www.researchprotocols.org/2016/4/e237/ %U https://doi.org/10.2196/resprot.6534 %U http://www.ncbi.nlm.nih.gov/pubmed/27903490 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 18 %N 11 %P e311 %T Survey Email Scheduling and Monitoring in eRCTs (SESAMe): A Digital Tool to Improve Data Collection in Randomized Controlled Clinical Trials %A Skonnord,Trygve %A Steen,Finn %A Skjeie,Holgeir %A Fetveit,Arne %A Brekke,Mette %A Klovning,Atle %+ Institute of Health and Society, Department of General Practice, University of Oslo, Postbox 1130 Blindern, Oslo, N-0318, Norway, 47 41323232, trygve.skonnord@medisin.uio.no %K randomized controlled trials %K data collection %K surveys and questionnaires %K quality improvement %K sample size %K Internet %K email %K text messaging %D 2016 %7 22.11.2016 %9 Original Paper %J J Med Internet Res %G English %X Background: Electronic questionnaires can ease data collection in randomized controlled trials (RCTs) in clinical practice. We found no existing software that could automate the sending of emails to participants enrolled into an RCT at different study participant inclusion time points. Objective: Our aim was to develop suitable software to facilitate data collection in an ongoing multicenter RCT of low back pain (the Acuback study). For the Acuback study, we determined that we would need to send a total of 5130 emails to 270 patients recruited at different centers and at 19 different time points. Methods: The first version of the software was tested in a pilot study in November 2013 but was unable to deliver multiuser or Web-based access. We resolved these shortcomings in the next version, which we tested on the Web in February 2014. Our new version was able to schedule and send the required emails in the full-scale Acuback trial that started in March 2014. The system architecture evolved through an iterative, inductive process between the project study leader and the software programmer. The program was tested and updated when errors occurred. To evaluate the development of the software, we used a logbook, a research assistant dialogue, and Acuback trial participant queries. Results: We have developed a Web-based app, Survey Email Scheduling and Monitoring in eRCTs (SESAMe), that monitors responses in electronic surveys and sends reminders by emails or text messages (short message service, SMS) to participants. The overall response rate for the 19 surveys in the Acuback study increased from 76.4% (655/857) before we introduced reminders to 93.11% (1149/1234) after the new function (P<.001). Further development will aim at securing encryption and data storage. Conclusions: The SESAMe software facilitates consecutive patient data collection in RCTs and can be used to increase response rates and quality of research, both in general practice and in other clinical trial settings. %M 27876689 %R 10.2196/jmir.6560 %U http://www.jmir.org/2016/11/e311/ %U https://doi.org/10.2196/jmir.6560 %U http://www.ncbi.nlm.nih.gov/pubmed/27876689 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 5 %N 4 %P e200 %T Testing the Feasibility of Remote Patient Monitoring in Prenatal Care Using a Mobile App and Connected Devices: A Prospective Observational Trial %A Marko,Kathryn I %A Krapf,Jill M %A Meltzer,Andrew C %A Oh,Julia %A Ganju,Nihar %A Martinez,Anjali G %A Sheth,Sheetal G %A Gaba,Nancy D %+ Center for Healthcare Innovation and Policy Research, George Washington University School of Medicine and Health Sciences, 2120 L Street NW, Suite 450, Washington, DC, 20037, United States, 1 2024457044, ameltzer@mfa.gwu.edu %K prenatal care %K pregnancy %K mobile app %K remote pateint monitoring %D 2016 %7 18.11.2016 %9 Original Paper %J JMIR Res Protoc %G English %X Background: Excessive weight gain and elevated blood pressure are significant risk factors for adverse pregnancy outcomes such as gestational diabetes, premature birth, and preeclampsia. More effective strategies to facilitate adherence to gestational weight gain goals and monitor blood pressure may have a positive health benefit for pregnant women and their babies. The impact of utilizing a remote patient monitoring system to monitor blood pressure and weight gain as a component of prenatal care has not been previously assessed. Objective: The objective of this study is to determine the feasibility of monitoring patients remotely in prenatal care using a mobile phone app and connected digital devices. Methods: In this prospective observational study, 8 women with low risk pregnancy in the first trimester were recruited at an urban academic medical center. Participants received a mobile phone app with a connected digital weight scale and blood pressure cuff for at-home data collection for the duration of pregnancy. At-home data was assessed for abnormal values of blood pressure or weight to generate clinical alerts to the patient and provider. As measures of the feasibility of the system, participants were studied for engagement with the app, accuracy of remote data, efficacy of alert system, and patient satisfaction. Results: Patient engagement with the mobile app averaged 5.5 times per week over the 6-month study period. Weight data collection and blood pressure data collection averaged 1.5 times and 1.1 times per week, respectively. At-home measurements of weight and blood pressure were highly accurate compared to in-office measurements. Automatic clinical alerts identified two episodes of abnormal weight gain with no false triggers. Patients demonstrated high satisfaction with the system. Conclusions: In this pilot study, we demonstrated that a system using a mobile phone app coupled to remote monitoring devices is feasible for prenatal care. %M 27864167 %R 10.2196/resprot.6167 %U http://www.researchprotocols.org/2016/4/e200/ %U https://doi.org/10.2196/resprot.6167 %U http://www.ncbi.nlm.nih.gov/pubmed/27864167 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 5 %N 4 %P e219 %T Pixel or Paper? Validation of a Mobile Technology for Collecting Patient-Reported Outcomes in Rheumatoid Arthritis %A Epis,Oscar Massimiliano %A Casu,Cinzia %A Belloli,Laura %A Schito,Emanuela %A Filippini,Davide %A Muscarà,Marina %A Gentile,Maria Giovanna %A Perez Cagnone,Paula Carina %A Venerelli,Chiara %A Sonnati,Massimo %A Schiavetti,Irene %A Bruschi,Eleonora %+ Hippocrates Sintech Srl, via XX Settembre 30/4, Genova, 16121, Italy, 39 3491720506, p.perez@hippocrates-sintech.it %K validation %K rheumatoid arthritis %K PROs %K monitoring %K electronic device %K tablet %K questionnaire %K paper %D 2016 %7 16.11.2016 %9 Original Paper %J JMIR Res Protoc %G English %X Background: In the management of chronic disease, new models for telemonitoring of patients combined with the choice of electronic patient-reported outcomes (ePRO) are being encouraged, with a clear improvement of both patients’ and parents’ quality of life. An Italian study demonstrated that ePRO were welcome in patients with rheumatoid arthritis (RA), with excellent matching data. Objective: The aim of this study is to evaluate the level of agreement between electronic and paper-and-pencil questionnaire responses. Methods: This is an observational prospective study. Patients were randomly assigned to first complete the questionnaire by paper and pencil and then by tablet or in the opposite order. The questionnaire consisted of 3 independent self-assessment visual rating scales (Visual Analog Scale, Global Health score, Patient Global Assessment of Disease Activity) commonly used in different adult patients, including those with rheumatic diseases. Results: A total of 185 consecutive RA patients were admitted to hospital and were enrolled and completed the questionnaire both on paper and on electronic versions. For all the evaluated items, the intrarater degree of agreement between 2 approaches was found to be excellent (intraclass correlation coefficient>0.75, P<.001). Conclusions: An electronic questionnaire is uploaded in a dedicated Web-based tool that could implement a telemonitoring system aimed at improving the follow-up of RA patients. High intrarater reliability between paper and electronic methods of data collection encourage the use of a new digital app with consequent benefit for the overall health care system. %M 27852561 %R 10.2196/resprot.5631 %U http://www.researchprotocols.org/2016/4/e219/ %U https://doi.org/10.2196/resprot.5631 %U http://www.ncbi.nlm.nih.gov/pubmed/27852561 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 5 %N 3 %P e183 %T Use of Web 2.0 Social Media Platforms to Promote Community-Engaged Research Dialogs: A Preliminary Program Evaluation %A Valdez Soto,Miguel %A Balls-Berry,Joyce E %A Bishop,Shawn G %A Aase,Lee A %A Timimi,Farris K %A Montori,Victor M %A Patten,Christi A %+ Center for Clinical and Translational Science, Office for Community Engagement in Research, Mayo Clinic, 200 First Street, SW, Rochester, MN,, United States, 1 507 255 9173, ballsberry.joyce@mayo.edu %K Web 2.0 %K social media %K platforms %K analytics %K community %K engagement %K stakeholders %K WordPress %K Twitter %K Facebook %D 2016 %7 09.09.2016 %9 Original Paper %J JMIR Res Protoc %G English %X Background: Community-engaged research is defined by the Institute of Medicine as the process of working collaboratively with groups of people affiliated by geographic proximity, special interests, or similar situations with respect to issues affecting their well-being. Traditional face-to-face community-engaged research is limited by geographic location, limited in resources, and/or uses one-way communications. Web 2.0 technologies including social media are novel communication channels for community-engaged research because these tools can reach a broader audience while promoting bidirectional dialogs. Objective: This paper reports on a preliminary program evaluation of the use of social media platforms for promoting engagement of researchers and community representatives in dialogs about community-engaged research. Methods: For this pilot program evaluation, the Clinical and Translational Science Office for Community Engagement in Research partnered with the Social Media Network at our institution to create a WordPress blog and Twitter account. Both social media platforms were facilitated by a social media manager. We used descriptive analytics for measuring engagement with WordPress and Twitter over an 18-month implementation period during 2014-2016. For the blog, we examined type of user (researcher, community representative, other) and used content analysis to generate the major themes from blog postings. For use of Twitter, we examined selected demographics and impressions among followers. Results: There were 76 blog postings observed from researchers (48/76, 64%), community representatives (23/76, 32%) and funders (5/76, 8%). The predominant themes of the blog content were research awareness and dissemination of community-engaged research (35/76, 46%) and best practices (23/76, 30%). For Twitter, we obtained 411 followers at the end of the 18-month evaluation period, with an increase of 42% (from 280 to 411) over the final 6 months. Followers reported varied geographic location (321/411, 78%, resided in the United States); 99% (407/411) spoke English; and about half (218/411, 53%) were female. Followers produced 132,000 Twitter impressions. Conclusions: Researchers and community stakeholders use social medial platforms for dialogs related to community-engaged research. This preliminary work is novel because we used Web 2.0 social media platforms to engage these stakeholders whereas prior work used face-to-face formats. Future research is needed to explore additional social media platforms; expanded reach to other diverse stakeholders including patients, providers, and payers; and additional outcomes related to engagement. %M 27613231 %R 10.2196/resprot.4808 %U http://www.researchprotocols.org/2016/3/e183/ %U https://doi.org/10.2196/resprot.4808 %U http://www.ncbi.nlm.nih.gov/pubmed/27613231 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 5 %N 3 %P e179 %T Twitter Strategies for Web-Based Surveying: Descriptive Analysis From the International Concussion Study %A Hendricks,Sharief %A Düking,Peter %A Mellalieu,Stephen D %+ Division of Exercise Science and Sports Medicine, Department of Human Biology, University of Cape Town, Boundary Road, Newlands., Cape Town,, South Africa, 27 216504567, sharief.hendricks01@gmail.com %K Twitter %K social media %K Web-based surveying %K concussion %K rugby %D 2016 %7 01.09.2016 %9 Original Paper %J JMIR Res Protoc %G English %X Background: Social media provides researchers with an efficient means to reach and engage with a large and diverse audience. Twitter allows for the virtual social interaction among a network of users that enables researchers to recruit and administer surveys using snowball sampling. Although using Twitter to administer surveys for research is not new, strategies to improve response rates are yet to be reported. Objective: To compare the potential and actual reach of 2 Twitter accounts that administered a Web-based concussion survey to rugby players and trainers using 2 distinct Twitter-targeting strategies. Furthermore, the study sought to determine the likelihood of receiving a retweet based on the time of the day and day of the week of posting. Methods: A survey based on previous concussion research was exported to a Web-based survey website Survey Monkey. The survey comprised 2 questionnaires, one for players, and one for those involved in the game (eg, coaches and athletic trainers). The Web-based survey was administered using 2 existing Twitter accounts, with each account executing a distinct targeting strategy. A list of potential Twitter accounts to target was drawn up, together with a list of predesigned tweets. The list of accounts to target was divided into ‘High-Profile’ and ‘Low-Profile’, based on each accounts’ position to attract publicity with a high social interaction potential. The potential reach (number of followers of the targeted account), and actual reach (number of retweets received by each post) between the 2 strategies were compared. The number of retweets received by each account was further analyzed to understand when the most likely time of day, and day of the week, a retweet would be received. Results: The number of retweets received by a Twitter account decreased by 72% when using the ‘high-profile strategy’ compared with the ‘low-profile strategy’ (incidence rate ratio (IRR); 0.28, 95% confidence interval (CI) 0.21-0.37, P<.001). When taking into account strategy and day of the week, the IRR for the number of retweets received during the hours of 12 AM to 5:59 AM (IRR 2.98, 95% CI 1.88-4.71, P>.001) and 6 PM to 11:59 PM (IRR 1.48, 95% CI 1.05-2.09, P>.05) were significantly increased relative to 6 AM to 11:59 AM. However, posting tweets during the hours of 12 PM to 5:59 PM, decreased the IRR for retweets by 40% (IRR 0.60, 95% CI 0.46-0.79, P<.001) compared with 6 AM to 11:59 AM. Posting on a Monday (IRR 3.57, 95% CI 2.50-5.09, P<.001) or Wednesday (IRR 1.50, 95% CI 1.11-1.11, P<.01) significantly increased the IRR compared with posting on a Thursday. Conclusions: Surveys are a useful tool to measure the knowledge, attitudes, and behaviors of a given population. Strategies to improve Twitter engagement include targeting low-profile accounts, posting tweets in the morning (12 AM-11:59 AM) or late evenings (6 PM-11:59 PM), and posting on Mondays and Wednesdays. %M 27589958 %R 10.2196/resprot.4542 %U http://www.researchprotocols.org/2016/3/e179/ %U https://doi.org/10.2196/resprot.4542 %U http://www.ncbi.nlm.nih.gov/pubmed/27589958 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 5 %N 3 %P e166 %T Cloud Based Surveys to Assess Patient Perceptions of Health Care: 1000 Respondents in 3 days for US $300 %A Bardos,Jonah %A Friedenthal,Jenna %A Spiegelman,Jessica %A Williams,Zev %+ Program for Early and Recurrent Pregnancy Loss (PEARL), Department of Obstetrics and Gynecology and Women’s Health, Albert Einstein College of Medicine, 1301 Morris Park Ave, Room 474, Bronx, NY, 10461, United States, 1 718 405 8590, zev.williams@einstein.yu.edu %K Mechanical Turk %K MTurk %K crowdsourcing %K medical survey %K cloud-based survey %K health care perceptions %D 2016 %7 23.08.2016 %9 Original Paper %J JMIR Res Protoc %G English %X Background: There are many challenges in conducting surveys of study participants, including cost, time, and ability to obtain quality and reproducible work. Cloudsourcing (an arrangement where a cloud provider is paid to carry out services that could be provided in-house) has the potential to provide vastly larger, less expensive, and more generalizable survey pools. Objective: The objective of this study is to evaluate, using Amazon's Mechanical Turk (MTurk), a cloud-based workforce to assess patients’ perspectives of health care. Methods: A national online survey posted to Amazon's MTurk consisted of 33 multiple choice and open-ended questions. Continuous attributes were compared using t tests. Results: We obtained 1084 responses for a total cost of US $298.10 in less than 3 days with 300 responses in under 6 hours. Of those, 44.74% (485/1084) were male and 54.80% (594/1084) female, representing 49 out of 50 states and aged 18 to 69 years. Conclusions: Amazon’s MTurk is a potentially useful survey method for attaining information regarding public opinions and/or knowledge with the distinct advantage of cost, speed, and a wide and relatively good representation of the general population, in a confidential setting for respondents. %M 27554915 %R 10.2196/resprot.5772 %U http://www.researchprotocols.org/2016/3/e166/ %U https://doi.org/10.2196/resprot.5772 %U http://www.ncbi.nlm.nih.gov/pubmed/27554915 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 5 %N 3 %P e161 %T The Effectiveness Of Social Media (Facebook) Compared With More Traditional Advertising Methods for Recruiting Eligible Participants To Health Research Studies: A Randomized, Controlled Clinical Trial %A Frandsen,Mai %A Thow,Megan %A Ferguson,Stuart G %+ School of Health Sciences, Faculty of Health, University of Tasmania, Locked Bag 1377, Launceston,, Australia, +61 3 6777 8167, Mai.Frandsen@utas.edu.au %K Facebook %K recruitment methods %K smoking %K clinical trial %D 2016 %7 10.08.2016 %9 Original Paper %J JMIR Res Protoc %G English %X Background: Recruiting participants for research studies can be difficult and costly. The popularity of social media platforms (eg, Facebook) has seen corresponding growth in the number of researchers turning to social networking sites and their embedded advertising frameworks to locate eligible participants for studies. Compared with traditional recruitment strategies such as print media, social media advertising has been shown to be favorable in terms of its reach (especially with hard-to-reach populations), cost effectiveness, and usability. However, to date, no studies have examined how participants recruited via social media progress through a study compared with those recruited using more traditional recruitment strategies. Objectives: (1) Examine whether visiting the study website prior to being contacted by researchers creates self-screened participants who are more likely to progress through all study phases (eligible, enrolled, completed); (2) compare conversion percentages and cost effectiveness of each recruitment method at each study phase; and, (3) compare demographic and smoking characteristics of participants recruited through each strategy to determine if they attract similar samples. Methods: Participants recruited to a smoking cessation clinical trial were grouped by how they had become aware of the study: via social media (Facebook) or traditional media (eg, newspaper, flyers, radio, word of mouth). Groups were compared based on throughput data (conversion percentages and cost) as well as demographic and smoking characteristics. Results: Visiting the study website did not result in individuals who were more likely to be eligible for (P=.24), enroll in (P=.20), or complete (P=.25) the study. While using social media was more cost effective than traditional methods when we examined earlier endpoints of the recruitment process (cost to obtain a screened respondent: AUD $22.73 vs $29.35; cost to obtain an eligible respondent: $37.56 vs $44.77), it was less cost effective in later endpoints (cost per enrolled participant: $56.34 vs $52.33; cost per completed participant: $103.66 vs $80.43). Participants recruited via social media were more likely to be younger (P=.001) and less confident in their quit attempts (P=.004) compared to those recruited via traditional methods. Conclusions: Our study suggests that while social media advertising may be effective in generating interest from potential participants, this strategy’s ability to attract conscientious recruits is more questionable. Researchers considering using online resources (eg, social media advertising, matrix codes) should consider including prescreening questions to promote conversion percentages. Ultimately, researchers seeking to maximize their recruitment budget should consider using a combination of advertising strategies. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN 12614000329662; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=365947l (Archived by WebCite at http://www.webcitation.org/6jc6zXWZI) %M 27511829 %R 10.2196/resprot.5747 %U http://www.researchprotocols.org/2016/3/e161/ %U https://doi.org/10.2196/resprot.5747 %U http://www.ncbi.nlm.nih.gov/pubmed/27511829 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 5 %N 3 %P e159 %T A Social Media Peer Group Intervention for Mothers to Prevent Obesity and Promote Healthy Growth from Infancy: Development and Pilot Trial %A Gruver,Rachel S %A Bishop-Gilyard,Chanelle T %A Lieberman,Alexandra %A Gerdes,Marsha %A Virudachalam,Senbagam %A Suh,Andrew W %A Kalra,Gurpreet K %A Magge,Sheela N %A Shults,Justine %A Schreiner,Mark S %A Power,Thomas J %A Berkowitz,Robert I %A Fiks,Alexander G %+ Division of General Pediatrics, The Children's Hospital of Philadelphia, 3535 Market St., Rm 1546, Philadelphia, PA, 19104, United States, 1 267 426 2304, fiks@email.chop.edu %K obesity %K social media %K behavior change %K intervention %K internet %K peer group %K pediatrics %K prevention and control %K infant %K mothers %D 2016 %7 02.08.2016 %9 Original Paper %J JMIR Res Protoc %G English %X Background: Evidence increasingly indicates that childhood obesity prevention efforts should begin as early as infancy. However, few interventions meet the needs of families whose infants are at increased obesity risk due to factors including income and maternal body mass index (BMI). Social media peer groups may offer a promising new way to provide these families with the knowledge, strategies, and support they need to adopt obesity prevention behaviors. Objective: The aim of this study is to develop and pilot test a Facebook-based peer group intervention for mothers, designed to prevent pediatric obesity and promote health beginning in infancy. Methods: We conducted in-depth semi-structured interviews with 29 mothers of infants and focus groups with 30 pediatric clinicians, to inform the development of a theory-based intervention. We then conducted a single-group pilot trial with 8 mothers to assess its feasibility and acceptability. All participants were recruited offline at pediatric primary care practices. Participants in the pilot trial joined a private Facebook group, moderated by a psychologist, with a weekly video-based curriculum, and also had the option to meet at a face-to-face event. Within the Facebook group, mothers were encouraged to chat, ask questions, and share photos and videos of themselves and babies practicing healthy behaviors. Consistent with the literature on obesity prevention, the curriculum addressed infant feeding, sleep, activity, and maternal well-being. Feasibility was assessed using the frequency and content of group participation by mothers, and acceptability was measured using online surveys and phone interviews. Results: Based on preferences of mothers interviewed (mean BMI 35 kg/m2, all Medicaid-insured, mean age 27, all Black), we designed the intervention to include frequent posts with new information, videos showing parents of infants demonstrating healthy behaviors, and an optional face-to-face meeting. We developed a privacy and safety plan that met the needs of participants as well as the requirements of the local institutional review board (IRB), which included use of a “secret” group and frequent screening of participant posts. Clinicians, 97% (29/30) women and 87% (26/30) pediatricians, preferred no direct involvement in the intervention, but were supportive of their patients’ participation. In our 8-week, single group pilot trial, all participants (mean BMI 35 kg/m2, all Medicaid-insured, mean age 28, all Black) viewed every weekly video post, and interacted frequently, with a weekly average of 4.4 posts/comments from each participant. All participant posts were related to parenting topics. Participants initiated conversations about behaviors related to healthy infant growth including solid food introduction, feeding volume, and managing stress. All 8 pilot group participants reported that they found the group helpful and would recommend it to others. Conclusions: Our methodology was feasible and acceptable to low-income mothers of infants at high risk of obesity, and could be adapted to implement peer groups through social media for underserved populations in varied settings. ClinicalTrial: ClinicalTrials.gov NCT01977105; https://clinicaltrials.gov/ct2/show/NCT01977105 (Archived by WebCite at http://www.webcitation.org/6iMFfOBat) %M 27485934 %R 10.2196/resprot.5276 %U http://www.researchprotocols.org/2016/3/e159/ %U https://doi.org/10.2196/resprot.5276 %U http://www.ncbi.nlm.nih.gov/pubmed/27485934 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 5 %N 3 %P e154 %T Targeted Facebook Advertising is a Novel and Effective Method of Recruiting Participants into a Human Papillomavirus Vaccine Effectiveness Study %A Subasinghe,Asvini K %A Nguyen,Margaret %A Wark,John D %A Tabrizi,Sepehr N %A Garland,Suzanne M %+ Murdoch Childrens Research Institute, Infection and Immunity Theme, Level 1 Building 404 Bio 21 Institute, 30 Flemington Road, Parkville, 3052, Australia, 61 402492637, asvini.subasinghe@mcri.edu.au %K online recruitment %K social media %K Facebook %K human papillomavirus %K HPV %D 2016 %7 22.07.2016 %9 Original Paper %J JMIR Res Protoc %G English %X Background: Targeted advertising using social networking sites (SNS) as a recruitment strategy in health research is in its infancy. Objective: The aim of this study was to determine the feasibility of targeted Facebook advertisements to increase recruitment of unvaccinated women into a human papillomavirus (HPV) vaccine effectiveness study. Methods: Between September 2011 and November 2013, females aged 18 to 25 years, residing in Victoria, Australia, were recruited through Facebook advertisements relating to general women’s health. From November 2013 to June 2015, targeted advertising campaigns were implemented to specifically recruit women who had not received the HPV vaccine. Consenting participants were invited to complete an online questionnaire and those who had ever had sexual intercourse were asked to provide a self-collected vaginal swab. The HPV vaccination status of participants was confirmed from the National HPV Vaccination Program Register (NHVPR). Results: The campaign comprised 10 advertisements shown between September 2011 and June 2015 which generated 55,381,637 impressions, yielding 23,714 clicks, at an overall cost of AUD $22,078.85. A total of 919 participants were recruited. A greater proportion of unvaccinated women (50.4%, 131/260) were recruited into the study following targeted advertising, compared with those recruited (19.3%, 127/659) prior to showing the modified advertisement (P<.001). A greater proportion of the total sample completed tertiary education and resided in inner regional Victoria, compared with National population census data (P<.001), but was otherwise representative of the general population. Conclusions: Targeted Facebook advertising is a rapid and cost-effective way of recruiting young unvaccinated women into a HPV vaccine effectiveness study. %M 27450586 %R 10.2196/resprot.5679 %U http://www.researchprotocols.org/2016/3/e154/ %U https://doi.org/10.2196/resprot.5679 %U http://www.ncbi.nlm.nih.gov/pubmed/27450586 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 5 %N 2 %P e139 %T Feasibility of an Electronic Survey on iPads with In-Person Data Collectors for Data Collection with Health Care Professionals and Health Care Consumers in General Emergency Departments %A Scott,Shannon D %A Albrecht,Lauren %A Given,Lisa M %A Arseneau,Danielle %A Klassen,Terry P %+ University of Alberta, Faculty of Nursing, 3rd floor, Edmonton Clinic Health Adacemy, 11405 87 Ave, Edmonton, AB, T6G 1C9, Canada, 1 7804921037, ss14@ualberta.ca %K survey development %K electronic survey %K survey implementation %K needs assessment %K pediatric emergency medicine %D 2016 %7 29.06.2016 %9 Original Paper %J JMIR Res Protoc %G English %X Background: Translating Emergency Knowledge for Kids was established to bridge the research-practice gap in pediatric emergency care by bringing the best evidence to Canadian general emergency departments (EDs). The first step in this process was to conduct a national needs assessment to determine the information needs and preferences of health professionals and parents in this clinical setting. Objective: To describe the development and implementation of two electronic surveys, and determine the feasibility of collecting electronic survey data on iPads with in-person data collectors in a busy clinical environment. Methods: Two descriptive surveys were conducted in 32 general EDs. Specific factors were addressed in four survey development and implementation stages: survey design, survey delivery, survey completion, and survey return. Feasibility of the data collection approach was determined by evaluating participation rates, completion rates, average survey time to completion, and usability of the platform. Usability was assessed with the in-person data collectors on five key variables: interactivity, portability, innovativeness, security, and proficiency. Results: Health professional participation rates (1561/2575, 60.62%) and completion rates (1471/1561, 94.23%) were strong. Parental participation rates (974/1099, 88.63%) and completion rates (897/974, 92.09%) were excellent. Mean time to survey completion was 28.08 minutes for health professionals and 43.23 minutes for parents. Data collectors rated the platform “positively” to “very positively” on all five usability variables. Conclusions: A number of design and implementation considerations were explored and integrated into this mixed-mode survey data collection approach. Feasibility was demonstrated by the robust survey participation and completion rates, reasonable survey completion times, and very positive usability evaluation results. %M 27358205 %R 10.2196/resprot.5170 %U http://www.researchprotocols.org/2016/2/e139/ %U https://doi.org/10.2196/resprot.5170 %U http://www.ncbi.nlm.nih.gov/pubmed/27358205 %0 Journal Article %@ 2368-7959 %I JMIR Publications %V 3 %N 2 %P e28 %T Feasibility of an Immersive Virtual Reality Intervention for Hospitalized Patients: An Observational Cohort Study %A Mosadeghi,Sasan %A Reid,Mark William %A Martinez,Bibiana %A Rosen,Bradley Todd %A Spiegel,Brennan Mason Ross %+ Cedars-Sinai Health System, Health Services Research, 116 N Robertson Boulevard, Suite 400, Los Angeles, CA, 90048, United States, 1 310 423 6467, Brennan.Spiegel@cshs.org %K virtual reality therapy %K hospitalization %K feasibility studies %D 2016 %7 27.06.2016 %9 Original Paper %J JMIR Ment Health %G English %X Background: Virtual reality (VR) offers immersive, realistic, three-dimensional experiences that “transport” users to novel environments. Because VR is effective for acute pain and anxiety, it may have benefits for hospitalized patients; however, there are few reports using VR in this setting. Objective: The aim was to evaluate the acceptability and feasibility of VR in a diverse cohort of hospitalized patients. Methods: We assessed the acceptability and feasibility of VR in a cohort of patients admitted to an inpatient hospitalist service over a 4-month period. We excluded patients with motion sickness, stroke, seizure, dementia, nausea, and in isolation. Eligible patients viewed VR experiences (eg, ocean exploration; Cirque du Soleil; tour of Iceland) with Samsung Gear VR goggles. We then conducted semistructured patient interview and performed statistical testing to compare patients willing versus unwilling to use VR. Results: We evaluated 510 patients; 423 were excluded and 57 refused to participate, leaving 30 participants. Patients willing versus unwilling to use VR were younger (mean 49.1, SD 17.4 years vs mean 60.2, SD 17.7 years; P=.01); there were no differences by sex, race, or ethnicity. Among users, most reported a positive experience and indicated that VR could improve pain and anxiety, although many felt the goggles were uncomfortable. Conclusions: Most inpatient users of VR described the experience as pleasant and capable of reducing pain and anxiety. However, few hospitalized patients in this “real-world” series were both eligible and willing to use VR. Consistent with the “digital divide” for emerging technologies, younger patients were more willing to participate. Future research should evaluate the impact of VR on clinical and resource outcomes. ClinicalTrial: Clinicaltrials.gov NCT02456987; https://clinicaltrials.gov/ct2/show/NCT02456987 (Archived by WebCite at http://www.webcitation.org/6iFIMRNh3) %M 27349654 %R 10.2196/mental.5801 %U http://mental.jmir.org/2016/2/e28/ %U https://doi.org/10.2196/mental.5801 %U http://www.ncbi.nlm.nih.gov/pubmed/27349654 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 5 %N 2 %P e134 %T The SmokefreeTXT (SFTXT) Study: Web and Mobile Data Collection to Evaluate Smoking Cessation for Young Adults %A Squiers,Linda %A Brown,Derick %A Parvanta,Sarah %A Dolina,Suzanne %A Kelly,Bridget %A Dever,Jill %A Southwell,Brian G %A Sanders,Amy %A Augustson,Erik %+ RTI International, Center for Communication Science, 6110 Executive Boulevard, Suite 902, Rockville, MD, 20852-3907, United States, 1 919 597 5128, lsquiers@rti.org %K tobacco use cessation %K text messaging %K clinical trial %K survey methods %K cell phones %K telemedicine %D 2016 %7 27.06.2016 %9 Original Paper %J JMIR Res Protoc %G English %X Background: Text messaging (short message service, SMS) has been shown to be effective in delivering interventions for various diseases and health conditions, including smoking cessation. While there are many published studies regarding smoking cessation text messaging interventions, most do not provide details about the study’s operational methods. As a result, there is a gap in our understanding of how best to design studies of smoking cessation text messaging programs. Objective: The purpose of this paper is to detail the operational methods used to conduct a randomized trial comparing three different versions of the National Cancer Institute’s SmokefreeText (SFTXT) program, designed for smokers 18 to 29 years of age. We detail our methods for recruiting participants from the Internet, reducing fraud, conducting online data collection, and retaining panel study participants. Methods: Participants were recruited through website advertisements and market research online panels. Screening questions established eligibility for the study (eg, 18 to 29 years of age, current smoker). Antifraud measures screened out participants who could not meet the study requirements. After completing a baseline survey, participants were randomized to one of three study arms, which varied by type and timing of text message delivery. The study offered US $20 gift cards as incentives to complete each of four follow-up surveys. Automated email reminders were sent at designated intervals to increase response rates. Researchers also provided telephone reminders to those who had not completed the survey after multiple email reminders. We calculated participation rates across study arms and compared the final sample characteristics to the Current Population Survey to examine generalizability. Results: Recruitment methods drove 153,936 unique visitors to the SFTXT Study landing page and 27,360 began the screener. Based on the screening questions, 15,462 out of 27,360 responders (56.51%) were eligible to participate. Of the 15,462 who were eligible, 9486 passed the antifraud measures that were implemented; however, 3882 failed to verify their email addresses or cell phone numbers, leaving 5604 who were invited to complete the baseline survey. Of the 5604 who were invited, 4432 completed the baseline survey, but only 4027 were retained for analysis because 405 did not receive the intervention. Conclusions: Although antifraud measures helped to catch participants who failed study requirements and could have biased the data collected, it is possible that the email and cell phone verification check excluded some potentially eligible participants from the study. Future research should explore ways to implement verification methods without risking the loss of so many potential participants. ClinicalTrial: Clinical Trials.gov NCT01885052; https://clinicaltrials.gov/ct2/show/NCT01885052; (Archived by WebCite at http://www.webcitation.org/6iWzcmFdw) %M 27349898 %R 10.2196/resprot.5653 %U http://www.researchprotocols.org/2016/2/e134/ %U https://doi.org/10.2196/resprot.5653 %U http://www.ncbi.nlm.nih.gov/pubmed/27349898 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 5 %N 2 %P e132 %T Electronic Adherence Monitoring in a High-Utilizing Pediatric Asthma Cohort: A Feasibility Study %A Kenyon,Chén Collin %A Chang,Joyce %A Wynter,Sheri-Ann %A Fowler,Jessica C %A Long,Jin %A Bryant-Stephens,Tyra C %+ Center for Pediatric Clinical Effectiveness and PolicyLab, Department of Pediatrics, The Children's Hospital of Philadelphia, 3401 Civic Center Blvd, CHOP North, 15th floor, Rm 1509, Philadelphia, PA, 19104, United States, 1 267 426 6339, kenyonc@email.chop.edu %K electronic medication monitoring %K adherence %K beta-agonists %K inhaled steroids %K motivational interviewing %K community health workers %D 2016 %7 22.06.2016 %9 Original Paper %J JMIR Res Protoc %G English %X Background: Inner-city, minority children with asthma have the highest rates of morbidity and death from asthma and the lowest rates of asthma controller medication adherence. Some recent electronic medication monitoring interventions demonstrated dramatic improvements in adherence in lower-risk populations. The feasibility and acceptability of such an intervention in the highest-risk children with asthma has not been studied. Objective: Our objective was to assess the feasibility and acceptability of a community health worker-delivered electronic adherence monitoring intervention among the highest utilizers of acute asthma care in an inner-city practice. Methods: This was a prospective cohort pilot study targeting children with the highest frequency of asthma-related emergency department and hospital care within a local managed care Medicaid plan. The 3-month intervention included motivational interviewing, electronic monitoring of controller and rescue inhaler use, and outreach by a community health worker for predefined medication alerts. We measured acceptability by using a modified technology acceptability model and changes in asthma control using the Asthma Control Test (ACT). Given prominent feasibility issues, we describe qualitative patterns of medication use at baseline only. Results: We enrolled 14 non-Hispanic black children with a median age of 3.5 years. Participants averaged 7.8 emergency or hospital visits in the year preceding enrollment. We observed three distinct patterns of baseline controller use: 4 patients demonstrated sustained use, 5 patients had periodic use, and 5 patients lapsed within 2 weeks. All participants initiated use of the electronic devices; however, no modem signal was transmitted for 5 or the 14 participants after a mean of 45 days. Of the 9 (64% of total) caregivers who completed the final study visit, all viewed the electronic monitoring device favorably and would recommend it to friends, and 5 (56%) believed that the device helped to improve asthma control. ACT scores improved by a mean of 2.7 points (P=.05) over the 3-month intervention. Conclusions: High-utilizer, minority families who completed a community health worker-delivered electronic adherence intervention found it generally acceptable. Prominent feasibility concerns, however, such as recruitment, data transmission failure, and lost devices, should be carefully considered when designing interventions in this setting. %M 27335355 %R 10.2196/resprot.5362 %U http://www.researchprotocols.org/2016/2/e132/ %U https://doi.org/10.2196/resprot.5362 %U http://www.ncbi.nlm.nih.gov/pubmed/27335355 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 5 %N 2 %P e108 %T The Functional Fitness MOT Test Battery for Older Adults: Protocol for a Mixed-Method Feasibility Study %A de Jong,Lex D %A Peters,Andy %A Hooper,Julie %A Chalmers,Nina %A Henderson,Claire %A Laventure,Robert ME %A Skelton,Dawn A %+ Glasgow Caledonian University, Institute for Applied Health Research, School of Health and Life Sciences, Cowcaddens Road, Glasgow, G4 0BA, United Kingdom, 44 3318792, Dawn.Skelton@gcu.ac.uk %K physical activity %K physical fitness %K physical therapists %K aged %K health behavior %K health services for the aged %K feasibility studies %D 2016 %7 20.06.2016 %9 Protocol %J JMIR Res Protoc %G English %X Background: Increasing physical activity (PA) brings many health benefits, but engaging people in higher levels of PA after their 60s is not straightforward. The Functional Fitness MOT (FFMOT) is a new approach which aims to raise awareness about the importance of components of fitness (strength, balance, flexibility), highlight benefits of PA, engages older people in health behavior change discussions, and directs them to local activity resources. This battery of tests combined with a brief motivational interview has not been tested in terms of feasibility or effectiveness. Objective: To assess whether the FFMOT, provided in a health care setting, is appealing to older patients of a community physiotherapy service and to understand the views and perceptions of the older people undergoing the FFMOT regarding the intervention, as well as the views of the physiotherapy staff delivering the intervention. Secondary aims are to assess the feasibility of carrying out a phase 2 pilot randomized controlled trial of the FFMOT, in the context of a community physiotherapy service, by establishing whether enough patients can be recruited and retained in the study, and enough outcome data can be generated. Methods: A mixed-methods feasibility study will be conducted in two physiotherapy outpatient clinics in the United Kingdom. A total of 30 physically inactive, medically stable older adults over the age of 60 will be provided with an individual FFMOT, comprising a set of six standardized, validated, age-appropriate tests aimed at raising awareness of the different components of fitness. The results of these tests will be used to provide the participants with feedback on performance in comparison to sex and age-referenced norms. This will be followed by tailored advice on how to become more active and improve fitness, including advice on local opportunities to be more active. Subsequently, participants will be invited to attend a focus group to discuss barriers and motivators to being more active, health behavior change, and the scope for individuals to improve their PA levels. To inform the design of a future trial, descriptive (eg, recruitment and retention rates), quantitative (Community Healthy Activities Model Program for Seniors; CHAMPS physical activity questionnaire), and qualitative data (focus group discussions, semi-structured staff interviews) will be collected. Results: Recruitment and enrolment for the trial started in September 2015. Follow-up will be completed in June 2016. Results are expected to be available at the end of 2016. Discussion: Allied health professionals play a key role in encouraging older adults to increase their PA, but with little evidence on how best to do this within their clinical practice. The purpose of this feasibility study is to examine the introduction of a new service: The FFMOT. The views and perceptions of the older people undergoing the FFMOT and relating to its delivery in clinical practice will be explored. Data, which will inform the feasibility of a randomized controlled trial of effectiveness of the FFMOT in promoting improved PA, will be reported. Trial Registration: International Standard Randomized Controlled Trial Number (ISRCTN): ISRCTN38950042; http://www.isrctn.com/ISRCTN38950042 %M 27324114 %R 10.2196/resprot.5682 %U http://www.researchprotocols.org/2016/2/e108/ %U https://doi.org/10.2196/resprot.5682 %U http://www.ncbi.nlm.nih.gov/pubmed/27324114 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 5 %N 2 %P e121 %T Using Social Media Data to Identify Potential Candidates for Drug Repurposing: A Feasibility Study %A Rastegar-Mojarad,Majid %A Liu,Hongfang %A Nambisan,Priya %+ Division of Biomedical Statistics and Informatics, Mayo Clinic, 200 1st St SW, Rochester, MN, 55902, United States, 1 (414) 229 1122, rastegar.83@gmail.com %K social media %K drug repurposing %K natural language processing %K patient comments %D 2016 %7 16.06.2016 %9 Original Paper %J JMIR Res Protoc %G English %X Background: Drug repurposing (defined as discovering new indications for existing drugs) could play a significant role in drug development, especially considering the declining success rates of developing novel drugs. Typically, new indications for existing medications are identified by accident. However, new technologies and a large number of available resources enable the development of systematic approaches to identify and validate drug-repurposing candidates. Patients today report their experiences with medications on social media and reveal side effects as well as beneficial effects of those medications. Objective: Our aim was to assess the feasibility of using patient reviews from social media to identify potential candidates for drug repurposing. Methods: We retrieved patient reviews of 180 medications from an online forum, WebMD. Using dictionary-based and machine learning approaches, we identified disease names in the reviews. Several publicly available resources were used to exclude comments containing known indications and adverse drug effects. After manually reviewing some of the remaining comments, we implemented a rule-based system to identify beneficial effects. Results: The dictionary-based system and machine learning system identified 2178 and 6171 disease names respectively in 64,616 patient comments. We provided a list of 10 common patterns that patients used to report any beneficial effects or uses of medication. After manually reviewing the comments tagged by our rule-based system, we identified five potential drug repurposing candidates. Conclusions: To our knowledge, this is the first study to consider using social media data to identify drug-repurposing candidates. We found that even a rule-based system, with a limited number of rules, could identify beneficial effect mentions in patient comments. Our preliminary study shows that social media has the potential to be used in drug repurposing. %M 27311964 %R 10.2196/resprot.5621 %U http://www.researchprotocols.org/2016/2/e121/ %U https://doi.org/10.2196/resprot.5621 %U http://www.ncbi.nlm.nih.gov/pubmed/27311964 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 5 %N 2 %P e118 %T Enhancing the Return to Work of Cancer Survivors: Development and Feasibility of the Nurse-Led eHealth Intervention Cancer@Work %A Tamminga,Sietske J %A van Hezel,Sanne %A de Boer,Angela GEM %A Frings-Dresen,Monique HW %+ Coronel Institute of Occupational Health, Academic Medical Center, Meibergdreef 9 / K0-110, Amsterdam, 1105 AZ, Netherlands, 31 205663279, s.j.tamminga@amc.nl %K cancer %K return to work %K eHealth %K survivorship %K feasibility studies %K self-management %D 2016 %7 10.06.2016 %9 Original Paper %J JMIR Res Protoc %G English %X Background: It is important to enhance the return to work of cancer survivors with an appropriate intervention, as cancer survivors experience problems upon their return to work but consider it an essential part of their recovery. Objective: The objective of our study was to develop an eHealth intervention to enhance the return to work of cancer survivors and to test the feasibility of the eHealth intervention with end users. Methods: To develop the intervention we 1) searched the literature, 2) interviewed 7 eHealth experts, 3) interviewed 7 cancer survivors, 2 employers, and 7 occupational physicians, and 4) consulted experts. To test feasibility, we enrolled 39 cancer survivors, 9 supervisors, 7 occupational physicians, 9 general physicians and 2 social workers and gave them access to the eHealth intervention. We also interviewed participants, asked them to fill in a questionnaire, or both, to test which functionalities of the eHealth intervention were appropriate and which aspects needed improvement. Results: Cancer survivors particularly want information and support regarding the possibility of returning to work, and on financial and legal aspects of their situation. Furthermore, the use of blended care and the personalization of the eHealth intervention were preferred features for increasing compliance. The first version of the eHealth intervention consisted of access to a personal and secure website containing various functionalities for cancer survivors blended with support from their specialized nurse, and a public website for employers, occupational physicians, and general physicians. The eHealth intervention appeared feasible. We adapted it slightly by adding more information on different cancer types and their possible effects on return to work. Conclusions: A multistakeholder and mixed-method design appeared useful in the development of the eHealth intervention. It was challenging to meet all end user requirements due to legal and privacy constraints. The eHealth intervention appeared feasible, although implementation in daily practice needs to be subject of further research. ClinicalTrial: Dutch Trial Register number (NTR): 5190; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=5190 (Archived by WebCite at http://www.webcitation.org/6hm4WQJqC) %M 27286819 %R 10.2196/resprot.5565 %U http://www.researchprotocols.org/2016/2/e118/ %U https://doi.org/10.2196/resprot.5565 %U http://www.ncbi.nlm.nih.gov/pubmed/27286819 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 5 %N 2 %P e95 %T Mediators of Atherosclerosis in South Asians Living in America: Use of Web-Based Methods for Follow-Up and Collection of Patient-Reported Outcome Measures %A Kandula,Namratha R %A Puri-Taneja,Ankita %A Victorson,David E %A Dave,Swapna S %A Kanaya,Alka M %A Huffman,Mark D %+ Feinberg School of Medicine, Division of General Internal Medicine, Department of Preventive Medicine, Northwestern University, 750 N Lake Shore Drive, 10th Floor, Chicago, IL, 60611, United States, 1 3125036470, nkandula@nm.org %K cardiovascular diseases %K cohort studies %K Internet %K South Asian %D 2016 %7 08.06.2016 %9 Original Paper %J JMIR Res Protoc %G English %X Background: A key challenge for longitudinal cohort studies is follow-up and retention of study participants. Participant follow-up in longitudinal cohort studies is costly and time-consuming for research staff and participants. Objective: This study determined the feasibility and costs of using Web-based technologies for follow-up and collection of patient-reported outcomes in the Mediators of Atherosclerosis in South Asians Living in America (MASALA) study. Methods: The MASALA study is a community-based cohort of 906 South Asians in the United States. Since the baseline in-person visits (2010-2013), a yearly telephone follow-up survey was used to assess participants’ health status and incidence of cardiovascular disease. A Web-based version of the follow-up survey was developed using the REDCap (Research Electronic Data Capture) Web app. Participants from the Chicago field center who were due for their annual follow-up and who had a valid email address were sent an email link to a secure online portal where they could complete the survey. Telephone follow-up was used with nonresponders. Results: A link to the Web survey was emailed to 285 participants (February to October 2014) and the overall completion rate was 47.7% (136/285). One-third of participants who were unresponsive (n=36) to annual telephone follow-up completed the Web survey. Web responders were younger, more likely to be married, and to have higher education and income compared (P<.05) to telephone-only responders. Web survey development involved 240 hours of research staff time. Since launching, the Web-based survey has required 3 hours per week of staff time. Conclusions: Although electronic follow-up will not be a panacea for cohort operations, it will serve as an adjunctive strategy to telephonic follow-up for maximizing cohort retention with lower costs. %M 27278905 %R 10.2196/resprot.5448 %U http://www.researchprotocols.org/2016/2/e95/ %U https://doi.org/10.2196/resprot.5448 %U http://www.ncbi.nlm.nih.gov/pubmed/27278905 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 5 %N 2 %P e104 %T Consumers’ Patient Portal Preferences and Health Literacy: A Survey Using Crowdsourcing %A Zide,Mary %A Caswell,Kaitlyn %A Peterson,Ellen %A Aberle,Denise R %A Bui,Alex AT %A Arnold,Corey W %+ Department of Bioengineering, University of California, Los Angeles, 924 Westwood Blvd, Suite 420, Los Angeles, CA, 90024, United States, 1 5102075012, mmcnamara@ucla.edu %K consumer health information %K health literacy %K eHealth %K patient portal %D 2016 %7 08.06.2016 %9 Original Paper %J JMIR Res Protoc %G English %X Background: eHealth apps have the potential to meet the information needs of patient populations and improve health literacy rates. However, little work has been done to document perceived usability of portals and health literacy of specific topics. Objective: Our aim was to establish a baseline of lung cancer health literacy and perceived portal usability. Methods: A survey based on previously validated instruments was used to assess a baseline of patient portal usability and health literacy within the domain of lung cancer. The survey was distributed via Amazon’s Mechanical Turk to 500 participants. Results: Our results show differences in preferences and literacy by demographic cohorts, with a trend of chronically ill patients having a more positive reception of patient portals and a higher health literacy rate of lung cancer knowledge (P<.05). Conclusions: This article provides a baseline of usability needs and health literacy that suggests that chronically ill patients have a greater preference for patient portals and higher level of health literacy within the domain of lung cancer. %M 27278634 %R 10.2196/resprot.5122 %U http://www.researchprotocols.org/2016/2/e104/ %U https://doi.org/10.2196/resprot.5122 %U http://www.ncbi.nlm.nih.gov/pubmed/27278634 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 5 %N 2 %P e101 %T Web Health Monitoring Survey: A New Approach to Enhance the Effectiveness of Telemedicine Systems %A Romano,Maria Francesca %A Sardella,Maria Vittoria %A Alboni,Fabrizio %+ Institute of Economics, Scuola Superiore Sant'Anna, piazza Martiri della Libertà 33, Pisa, 56127, Italy, 39 50883388, mariafrancesca.romano@sssup.it %K Web questionnaire %K Web health monitoring survey %K telemedicine %K virtual checkup %K survey quality %K quality indicators %K paradata %D 2016 %7 06.06.2016 %9 Original Paper %J JMIR Res Protoc %G English %X Background: Aging of the European population and interest in a healthy population in western countries have contributed to an increase in the number of health surveys, where the role of survey design, data collection, and data analysis methodology is clear and recognized by the whole scientific community. Survey methodology has had to couple with the challenges deriving from data collection through information and communications technology (ICT). Telemedicine systems have not used patients as a source of information, often limiting them to collecting only biometric data. A more effective telemonitoring system would be able to collect objective and subjective data (biometric parameters and symptoms reported by the patients themselves), and to control the quality of subjective data collected: this goal be achieved only by using and merging competencies from both survey methodology and health research. Objective: The objective of our study was to propose new metrics to control the quality of data, along with the well-known indicators of survey methodology. Web questionnaires administered daily to a group of patients for an extended length of time are a Web health monitoring survey (WHMS) in a telemedicine system. Methods: We calculated indicators based on paradata collected during a WHMS study involving 12 patients, who signed in to the website daily for 2 months. Results: The patients’ involvement was very high: the patients’ response rate ranged between 1.00 and 0.82, with an outlier of 0.65. Item nonresponse rate was very low, ranging between 0.0% and 7.4%. We propose adherence to the chosen time to connect to the website as a measure of involvement and cooperation by the patients: the difference from the median time ranged between 11 and 24 minutes, demonstrating very good cooperation and involvement from all patients. To measure habituation to the questionnaire, we also compared nonresponse rates to the items between the first and the second month of the study, and found no significant difference. We computed the time to complete the questionnaire both as a measure of possible burden for patient, and to detect the risk of automatic responses. Neither of these hypothesis was confirmed, and differences in time to completion seemed to depend on health conditions. Focus groups with patients confirmed their appreciation for this “new” active role in a telemonitoring system. Conclusions: The main and innovative aspect of our proposal is the use of a Web questionnaire to virtually recreate a checkup visit, integrating subjective (patient’s information) with objective data (biometric information). Our results, although preliminary and if need of further study, appear promising in proposing more effective telemedicine systems. Survey methodology could have an effective role in this growing field of research and applications. %M 27268949 %R 10.2196/resprot.5187 %U http://www.researchprotocols.org/2016/2/e101/ %U https://doi.org/10.2196/resprot.5187 %U http://www.ncbi.nlm.nih.gov/pubmed/27268949 %0 Journal Article %@ 1929-0748 %I JMIR Publications Inc. %V 5 %N 2 %P e81 %T Acceptance, Usability and Health Applications of Virtual Worlds by Older Adults: A Feasibility Study %A Cook,Nicole %A Winkler,Sandra L %+ Master of Public Health program, College of Osteopathic Medicine, Nova Southeastern University, 3200 South University Drive, Fort Lauderdale, FL, 33314, United States, 1 9542621505, nc570@nova.edu %K Second Life %K virtual worlds %K older adults %K seniors %K health care %K training %D 2016 %7 02.06.2016 %9 Original Paper %J JMIR Res Protoc %G English %X Background: Virtual worlds allow users to communicate and interact across various environments, scenarios, and platforms. Virtual worlds present opportunities in health care to reduce the burden of illness and disability by supporting education, rehabilitation, self-management, and social networking. The application of virtual worlds to older adults who bear the burden and cost of health conditions associated with age has not been evaluated. Objective: The aim of this study is to explore the usability, ease of use, and enjoyment of a virtual world by older adults, the types of virtual world activities that older adults may engage in, and the perceptions of older adults regarding the application of virtual worlds in health care. Methods: This quasi-experimental pre-post design research was guided by the Technology Acceptance Model (TAM). Participants were recruited from a Lifelong Learning Institute (LLI) program at Nova Southeastern University. Participants attended four training sessions over a 5-week period in the Second Life (SL) virtual world. Subjects were surveyed before and after the training on perceived ease of use, attitudes towards technology, behavioral intention to use the system, facilitating conditions, effort expectancy, and self-efficacy. Results: Older adults (N=19) completed the informed consent and attended the first training session, and 11 participants (58%, 11/19) completed the full training and the post survey. Completers (82%, 9/11) were more likely than non-completers (37%, 3/8) to consider themselves technologically savvy (P=.048), and to express confidence in being able to use the virtual world (100%, 11/11 vs 37%, 3/8; P=.002). All completers (100%, 11/11) perceived that SL has application in health behaviors and disease and reducing social isolation among people who are homebound. Of the completers, 10 (91%, 10/11) responded that they enjoyed learning how to use SL. Completers suggested that future trainings include more assistants and smaller groups. Conclusions: This pilot study suggests that virtual worlds can be both a feasible and an applicable method to promote health among some seniors. Future research on virtual worlds with older populations should consider using state-of-the art technology including large monitors, providing a minimum of one trainer for every two to three participants, and distributing a comprehensive training manual at the start of the training to support organization and recall. %M 27256457 %R 10.2196/resprot.5423 %U http://www.researchprotocols.org/2016/2/e81/ %U https://doi.org/10.2196/resprot.5423 %U http://www.ncbi.nlm.nih.gov/pubmed/27256457 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 5 %N 2 %P e96 %T Prevalence of Depression in Medical Students at the Lebanese University and Exploring its Correlation With Facebook Relevance: A Questionnaire Study %A Naja,Wadih J %A Kansoun,Alaa H %A Haddad,Ramzi S %+ Faculty of Medical Sciences, Lebanese University, Lebanon, Beirut, Hadath, Lebanese University Dorms, Beirut,, Lebanon, 961 3619661, a.kanso@hotmail.com %K depression %K Facebook %K PHQ-9 %K FbRQ %K Lebanese University Faculty of Medicine %D 2016 %7 31.05.2016 %9 Original Paper %J JMIR Res Protoc %G English %X Background: The prevalence of major depression is particularly high in medical students, affecting around one-third of this population. Moreover, online social media, in particular Facebook, is becoming an intrinsic part in the life of a growing proportion of individuals worldwide. Objective: Our primary objective is to identify the prevalence of depression in medical students at the Lebanese University Faculty of Medicine, a unique state university in Lebanon, its correlation with the utilization of the interactive features of Facebook, and the way students may resort to these features. Methods: Students of the Lebanese University Faculty of Medicine were assessed for (1) depression and (2) Facebook activity. To screen for major depression, we used the Patient Health Questionnaire-9 (PHQ-9) scale. To test for Facebook activity, we developed the Facebook Resorting Questionnaire (FbRQ), which measures the degree to which students resort to Facebook. Results: A total of 365 out of 480 students (76.0%) participated in the survey. A total of 25 students were excluded, hence 340 students were included in the final analysis. Current depression was reported in 117 students out of 340 (34.4%) and t tests showed female predominance. Moreover, PHQ-9 score multiple regression analysis showed that feeling depressed is explained 63.5% of the time by specific independent variables studied from the PHQ-9 and the FbRQ. Depression varied significantly among the different academic years (P<.001) and it peaked in the third-year students. One-way analysis of variance (ANOVA) showed that depression and resorting to Facebook had a positive and significant relationship (P=.003) and the different FbRQ categories had significant differences in resorting-to-Facebook power. The like, add friend, and check-in features students used when resorting to Facebook were significantly associated with depression. Conclusions: This study showed that depression was highly prevalent among students of the Faculty of Medicine at the Lebanese University. Moreover, Facebook may be a promising, helpful, psychological tool for optimizing the management of depression. Our study brought to bear further questions that now prompt further observation and scrutiny to know more about the high rates of depression in this student population, more so in the part of the world studied, and to the growing role of social media. %M 27246394 %R 10.2196/resprot.4551 %U http://www.researchprotocols.org/2016/2/e96/ %U https://doi.org/10.2196/resprot.4551 %U http://www.ncbi.nlm.nih.gov/pubmed/27246394 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 5 %N 2 %P e94 %T An Evaluation of Web- and Print-Based Methods to Attract People to a Physical Activity Intervention %A Alley,Stephanie %A Jennings,Cally %A Plotnikoff,Ronald C %A Vandelanotte,Corneel %+ Physical Activity Research Group, School of Human Health and Social Science, Central Queensland University, Building 77, Bruce Highway, Rockhampton, 4700, Australia, 61 749232263, s.alley@cqu.edu.au %K physical activity %K web-based intervention %K Internet %K research subject recruitment %K Facebook %D 2016 %7 27.05.2016 %9 Original Paper %J JMIR Res Protoc %G English %X Background: Cost-effective and efficient methods to attract people to Web-based health behavior interventions need to be identified. Traditional print methods including leaflets, posters, and newspaper advertisements remain popular despite the expanding range of Web-based advertising options that have the potential to reach larger numbers at lower cost. Objective: This study evaluated the effectiveness of multiple Web-based and print-based methods to attract people to a Web-based physical activity intervention. Methods: A range of print-based (newspaper advertisements, newspaper articles, letterboxing, leaflets, and posters) and Web-based (Facebook advertisements, Google AdWords, and community calendars) methods were applied to attract participants to a Web-based physical activity intervention in Australia. The time investment, cost, number of first time website visits, the number of completed sign-up questionnaires, and the demographics of participants were recorded for each advertising method. Results: A total of 278 people signed up to participate in the physical activity program. Of the print-based methods, newspaper advertisements totaled AUD $145, letterboxing AUD $135, leaflets AUD $66, posters AUD $52, and newspaper article AUD $3 per sign-up. Of the Web-based methods, Google AdWords totaled AUD $495, non-targeted Facebook advertisements AUD $68, targeted Facebook advertisements AUD $42, and community calendars AUD $12 per sign-up. Although the newspaper article and community calendars cost the least per sign-up, they resulted in only 17 and 6 sign-ups respectively. The targeted Facebook advertisements were the next most cost-effective method and reached a large number of sign-ups (n=184). The newspaper article and the targeted Facebook advertisements required the lowest time investment per sign-up (5 and 7 minutes respectively). People reached through the targeted Facebook advertisements were on average older (60 years vs 50 years, P<.001) and had a higher body mass index (32 vs 30, P<.05) than people reached through the other methods. Conclusions: Overall, our results demonstrate that targeted Facebook advertising is the most cost-effective and efficient method at attracting moderate numbers to physical activity interventions in comparison to the other methods tested. Newspaper advertisements, letterboxing, and Google AdWords were not effective. The community calendars and newspaper articles may be effective for small community interventions. ClinicalTrial: Australian New Zealand Clinical Trials Registry: ACTRN12614000339651; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=363570&isReview=true (Archived by WebCite at http://www.webcitation.org/6hMnFTvBt) %M 27235075 %R 10.2196/resprot.4826 %U http://www.researchprotocols.org/2016/2/e94/ %U https://doi.org/10.2196/resprot.4826 %U http://www.ncbi.nlm.nih.gov/pubmed/27235075 %0 Journal Article %@ 1929-0748 %I JMIR Publications Inc. %V 5 %N 2 %P e86 %T Online Focus Group Discussion is a Valid and Feasible Mode When Investigating Sensitive Topics Among Young Persons With a Cancer Experience %A Wettergren,Lena %A Eriksson,Lars E %A Nilsson,Jenny %A Jervaeus,Anna %A Lampic,Claudia %+ Division of Nursing, Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, 23 300, Huddinge, SE-141 83, Sweden, 46 524 836 50, lena.wettergren@ki.se %K adolescent %K data collection %K focus groups %K Internet %K neoplasms %K young adult %D 2016 %7 09.05.2016 %9 Short Paper %J JMIR Res Protoc %G English %X Background: Clinical research often lacks participants of young age. Adding to the small amount of scientific studies that focus on the population entering adulthood, there are also difficulties to recruit them. To overcome this, there is a need to develop and scientifically evaluate modes for data collection that are suitable for adolescents and young adults. With this in mind we performed 39 online focus group discussions among young survivors of childhood cancer to explore thoughts and experiences around dating, being intimate with someone, and having children. Objective: The aim of the study was to evaluate online focus group discussions as a mode for data collection on sensitive issues among young persons with a cancer experience. Methods: One hundred thirty-three young persons (16-25 years) previously diagnosed with cancer, participated in 39 synchronous online focus group discussions (response rate 134/369, 36%). The mode of administration was evaluated by analyzing participant characteristics and interactions during discussions, as well as group members’ evaluations of the discussions. Results: Persons diagnosed with central nervous tumors (n=30, 27%) participated to a lower extent than those with other cancer types (n=103, 39%; χ 2= 4.89, P=.03). The participants described various health impairments that correspond to what would be expected among cancer survivors including neuropsychiatric conditions and writing disabilities. Even though participants were interested in others’ experiences, sexual issues needed more probing by the moderators than did fertility-related issues. Group evaluations revealed that participants appreciated communicating on the suggested topics and thought that it was easier to discuss sex when it was possible to be anonymous toward other group members. Conclusions: Online focus group discussions, with anonymous participation, are suggested to be a feasible and valid mode for collecting sensitive data among young persons with a cancer experience. %M 27161146 %R 10.2196/resprot.5616 %U http://www.researchprotocols.org/2016/2/e86/ %U https://doi.org/10.2196/resprot.5616 %U http://www.ncbi.nlm.nih.gov/pubmed/27161146 %0 Journal Article %@ 1929-0748 %I JMIR Publications Inc. %V 5 %N 2 %P e50 %T Measuring Health Information Dissemination and Identifying Target Interest Communities on Twitter: Methods Development and Case Study of the @SafetyMD Network %A Kandadai,Venk %A Yang,Haodong %A Jiang,Ling %A Yang,Christopher C %A Fleisher,Linda %A Winston,Flaura Koplin %+ College of Computing and Informatics, Drexel University, 3401 Market Street, Philadelphia, PA,, United States, 1 215 895 1631, chris.yang@drexel.edu %K Twitter %K health information %K dissemination %K health communication %K digital health %D 2016 %7 05.05.2016 %9 Original Paper %J JMIR Res Protoc %G English %X Background: Little is known about the ability of individual stakeholder groups to achieve health information dissemination goals through Twitter. Objective: This study aimed to develop and apply methods for the systematic evaluation and optimization of health information dissemination by stakeholders through Twitter. Methods: Tweet content from 1790 followers of @SafetyMD (July-November 2012) was examined. User emphasis, a new indicator of Twitter information dissemination, was defined and applied to retweets across two levels of retweeters originating from @SafetyMD. User interest clusters were identified based on principal component analysis (PCA) and hierarchical cluster analysis (HCA) of a random sample of 170 followers. Results: User emphasis of keywords remained across levels but decreased by 9.5 percentage points. PCA and HCA identified 12 statistically unique clusters of followers within the @SafetyMD Twitter network. Conclusions: This study is one of the first to develop methods for use by stakeholders to evaluate and optimize their use of Twitter to disseminate health information. Our new methods provide preliminary evidence that individual stakeholders can evaluate the effectiveness of health information dissemination and create content-specific clusters for more specific targeted messaging. %M 27151100 %R 10.2196/resprot.4203 %U http://www.researchprotocols.org/2016/2/e50/ %U https://doi.org/10.2196/resprot.4203 %U http://www.ncbi.nlm.nih.gov/pubmed/27151100 %0 Journal Article %@ 1929-0748 %I JMIR Publications Inc. %V 5 %N 2 %P e77 %T Feasibility of PRIME: A Cognitive Neuroscience-Informed Mobile App Intervention to Enhance Motivated Behavior and Improve Quality of Life in Recent Onset Schizophrenia %A Schlosser,Danielle %A Campellone,Timothy %A Kim,Daniel %A Truong,Brandy %A Vergani,Silvia %A Ward,Charlie %A Vinogradov,Sophia %+ University of California, San Francisco, Department of Psychiatry, 401 Parnassus Ave, San Francisco, CA, 94134, United States, 1 415 476 8721, danielle.schlosser@ucsf.edu %K schizophrenia %K mobile app %K smartphone %K motivation %K technology-based intervention %K social networking %K coaching %K negative symptoms %K quality of life %D 2016 %7 28.04.2016 %9 Original Paper %J JMIR Res Protoc %G English %X Background: Despite improvements in treating psychosis, schizophrenia remains a chronic and debilitating disorder that affects approximately 1% of the US population and costs society more than depression, dementia, and other medical illnesses across most of the lifespan. Improving functioning early in the course of illness could have significant implications for long-term outcome of individuals with schizophrenia. Yet, current gold-standard treatments do not lead to clinically meaningful improvements in outcome, partly due to the inherent challenges of treating a population with significant cognitive and motivational impairments. The rise of technology presents an opportunity to develop novel treatments that may circumvent the motivational and cognitive challenges observed in schizophrenia. Objective: The purpose of this study was two-fold: (1) to evaluate the feasibility and acceptability of implementing a Personalized Real-Time Intervention for Motivation Enhancement (PRIME), a mobile app intervention designed to target reward-processing impairments, enhance motivation, and thereby improve quality of life in recent onset schizophrenia, and (2) evaluate the empirical benefits of using an iterative, user-centered design (UCD) process. Methods: We conducted two design workshops with 15 key stakeholders, followed by a series of in-depth interviews in collaboration with IDEO, a design and innovation firm. The UCD approach ultimately resulted in the first iteration of PRIME, which was evaluated by 10 RO participants. Results from the Stage 1 participants were then used to guide the next iteration that is currently being evaluated in an ongoing RCT. Participants in both phases were encouraged to use the app daily with a minimum frequency of 1/week over a 12-week period. Results: The UCD process resulted in the following feature set: (1) delivery of text message (short message service, SMS)-based motivational coaching from trained therapists, (2) individualized goal setting in prognostically important psychosocial domains, (3) social networking via direct peer-to-peer messaging, and (4) community “moments feed” to capture and reinforce rewarding experiences and goal achievements. Users preferred an experience that highlighted several of the principles of self-determination theory, including the desire for more control of their future (autonomy and competence) and an approach that helps them improve existing relationships (relatedness). IDEO, also recommended an approach that was casual, friendly, and nonstigmatizing, which is in line with the recovery model of psychosis. After 12-weeks of using PRIME, participants used the app, on average, every other day, were actively engaged with its various features each time they logged in and retention and satisfaction was high (20/20, 100% retention, high satisfaction ratings). The iterative design process lead to a 2- to 3-fold increase in engagement from Stage 1 to Stage 2 in almost each aspect of the platform. Conclusions: These results indicate that the neuroscience-informed mobile app, PRIME, is a feasible and acceptable intervention for young people with schizophrenia. %M 27125771 %R 10.2196/resprot.5450 %U http://www.researchprotocols.org/2016/2/e77/ %U https://doi.org/10.2196/resprot.5450 %U http://www.ncbi.nlm.nih.gov/pubmed/27125771 %0 Journal Article %@ 1929-0748 %I JMIR Publications Inc. %V 5 %N 2 %P e62 %T Cardiac Rhythm Monitoring After Acute Decompensation for Heart Failure: Results from the CARRYING ON for HF Pilot Study %A Vanoli,Emilio %A Mortara,Andrea %A Diotallevi,Paolo %A Gallone,Giuseppe %A Mariconti,Barbara %A Gronda,Edoardo %A Gentili,Alessandra %A Bisetti,Silvia %A Botto,Giovanni Luca %+ Dept Molecular Medicine, University of Pavia, Italy, IRCCS MultiMedica, Via Milanese 300,, Sesto San Giovanni, Milano,, 20099, Italy, 39 3482638297, emivano@gmail.com %K continuous cardiac monitoring %K implantable loop recorder %K acute heart failure %K arrhythmias %D 2016 %7 26.04.2016 %9 Original Paper %J JMIR Res Protoc %G English %X Background: There’s scarce evidence about cardiovascular events (CV) in patients with hospitalization for acute heart failure (HF) and no indication for immediate device implant. Objective: The CARdiac RhYthm monitorING after acute decompensatiON for Heart Failure study was designed to assess the incidence of prespecified clinical and arrhythmic events in this patient population. Methods: In this pilot study, 18 patients (12 (67%) male; age 72±10; 16 (89%) NYHA II-III), who were hospitalized for HF with low left ventricular ejection fraction (LVEF) (<40%) and no immediate indication for device implant received an implantable loop recorder (ILR) before hospital discharge. Follow-up visits were scheduled at 3 and 6 months, and at every 6 months until study closure; device data were remotely reviewed monthly. CV mortality, unplanned CV hospitalization, and major arrhythmic events during follow-up were analyzed. Results: During a median follow-up of 593 days, major CV occurred in 13 patients (72%); of those, 7 patients had at least 1 cardiac arrhythmic event, 2 had at least a clinical event (CV hospitalization or CV death), and 4 had both an arrhythmic and a CV event. Six (33%) patients experienced 10 major clinical events, 5 of them (50%) were HF related. During follow-up, 2 (11%) patients died due to a CV cause and 3 (16%) patients received a permanent cardiac device. Conclusions: After an acute HF hospitalization, patients with LVEF<40% and who are not readily eligible for permanent cardiac device implant have a known high incidence of major CV event. In these patients, ILR allows early detection of major cardiac arrhythmias and the ability to react appropriately in a timely manner. Trial Registration: ClinicalTrials.gov NCT01216670; https://clinicaltrials.gov/ct2/show/NCT01216670 %M 27118481 %R 10.2196/resprot.4380 %U http://www.researchprotocols.org/2016/2/e62/ %U https://doi.org/10.2196/resprot.4380 %U http://www.ncbi.nlm.nih.gov/pubmed/27118481 %0 Journal Article %@ 1929-0748 %I JMIR Publications Inc. %V 5 %N 2 %P e40 %T Using Nonexperts for Annotating Pharmacokinetic Drug-Drug Interaction Mentions in Product Labeling: A Feasibility Study %A Hochheiser,Harry %A Ning,Yifan %A Hernandez,Andres %A Horn,John R %A Jacobson,Rebecca %A Boyce,Richard D %+ Department of Biomedical Informatics, School of Medicine, University of Pittsburgh, 5607 Baum Blvd, Suite 523, Pittsburgh, PA, , United States, 1 412 648 9300, harryh@pitt.edu %K crowdsourcing %K natural language processing %K drug interactions, drug product labeling, structured product labels %D 2016 %7 11.04.2016 %9 Original Paper %J JMIR Res Protoc %G English %X Background: Because vital details of potential pharmacokinetic drug-drug interactions are often described in free-text structured product labels, manual curation is a necessary but expensive step in the development of electronic drug-drug interaction information resources. The use of nonexperts to annotate potential drug-drug interaction (PDDI) mentions in drug product label annotation may be a means of lessening the burden of manual curation. Objective: Our goal was to explore the practicality of using nonexpert participants to annotate drug-drug interaction descriptions from structured product labels. By presenting annotation tasks to both pharmacy experts and relatively naïve participants, we hoped to demonstrate the feasibility of using nonexpert annotators for drug-drug information annotation. We were also interested in exploring whether and to what extent natural language processing (NLP) preannotation helped improve task completion time, accuracy, and subjective satisfaction. Methods: Two experts and 4 nonexperts were asked to annotate 208 structured product label sections under 4 conditions completed sequentially: (1) no NLP assistance, (2) preannotation of drug mentions, (3) preannotation of drug mentions and PDDIs, and (4) a repeat of the no-annotation condition. Results were evaluated within the 2 groups and relative to an existing gold standard. Participants were asked to provide reports on the time required to complete tasks and their perceptions of task difficulty. Results: One of the experts and 3 of the nonexperts completed all tasks. Annotation results from the nonexpert group were relatively strong in every scenario and better than the performance of the NLP pipeline. The expert and 2 of the nonexperts were able to complete most tasks in less than 3 hours. Usability perceptions were generally positive (3.67 for expert, mean of 3.33 for nonexperts). Conclusions: The results suggest that nonexpert annotation might be a feasible option for comprehensive labeling of annotated PDDIs across a broader range of drug product labels. Preannotation of drug mentions may ease the annotation task. However, preannotation of PDDIs, as operationalized in this study, presented the participants with difficulties. Future work should test if these issues can be addressed by the use of better performing NLP and a different approach to presenting the PDDI preannotations to users during the annotation workflow. %M 27066806 %R 10.2196/resprot.5028 %U http://www.researchprotocols.org/2016/2/e40/ %U https://doi.org/10.2196/resprot.5028 %U http://www.ncbi.nlm.nih.gov/pubmed/27066806 %0 Journal Article %@ 1929-0748 %I JMIR Publications Inc. %V 5 %N 1 %P e41 %T Predicting Appropriate Admission of Bronchiolitis Patients in the Emergency Department: Rationale and Methods %A Luo,Gang %A Stone,Bryan L %A Johnson,Michael D %A Nkoy,Flory L %+ School of Medicine, Department of Biomedical Informatics, University of Utah, 421 Wakara Way, Suite 140, Salt Lake City, UT, 84108, United States, 1 801 213 3565, gangluo@cs.wisc.edu %K Decision support techniques %K forecasting %K computer simulation %K machine learning %D 2016 %7 07.03.2016 %9 Protocol %J JMIR Res Protoc %G English %X Background: In young children, bronchiolitis is the most common illness resulting in hospitalization. For children less than age 2, bronchiolitis incurs an annual total inpatient cost of $1.73 billion. Each year in the United States, 287,000 emergency department (ED) visits occur because of bronchiolitis, with a hospital admission rate of 32%-40%. Due to a lack of evidence and objective criteria for managing bronchiolitis, ED disposition decisions (hospital admission or discharge to home) are often made subjectively, resulting in significant practice variation. Studies reviewing admission need suggest that up to 29% of admissions from the ED are unnecessary. About 6% of ED discharges for bronchiolitis result in ED returns with admission. These inappropriate dispositions waste limited health care resources, increase patient and parental distress, expose patients to iatrogenic risks, and worsen outcomes. Existing clinical guidelines for bronchiolitis offer limited improvement in patient outcomes. Methodological shortcomings include that the guidelines provide no specific thresholds for ED decisions to admit or to discharge, have an insufficient level of detail, and do not account for differences in patient and illness characteristics including co-morbidities. Predictive models are frequently used to complement clinical guidelines, reduce practice variation, and improve clinicians’ decision making. Used in real time, predictive models can present objective criteria supported by historical data for an individualized disease management plan and guide admission decisions. However, existing predictive models for ED patients with bronchiolitis have limitations, including low accuracy and the assumption that the actual ED disposition decision was appropriate. To date, no operational definition of appropriate admission exists. No model has been built based on appropriate admissions, which include both actual admissions that were necessary and actual ED discharges that were unsafe. Objective: The goal of this study is to develop a predictive model to guide appropriate hospital admission for ED patients with bronchiolitis. Methods: This study will: (1) develop an operational definition of appropriate hospital admission for ED patients with bronchiolitis, (2) develop and test the accuracy of a new model to predict appropriate hospital admission for an ED patient with bronchiolitis, and (3) conduct simulations to estimate the impact of using the model on bronchiolitis outcomes. Results: We are currently extracting administrative and clinical data from the enterprise data warehouse of an integrated health care system. Our goal is to finish this study by the end of 2019. Conclusions: This study will produce a new predictive model that can be operationalized to guide and improve disposition decisions for ED patients with bronchiolitis. Broad use of the model would reduce iatrogenic risk, patient and parental distress, health care use, and costs and improve outcomes for bronchiolitis patients. %M 26952700 %R 10.2196/resprot.5155 %U http://www.researchprotocols.org/2016/1/e41/ %U https://doi.org/10.2196/resprot.5155 %U http://www.ncbi.nlm.nih.gov/pubmed/26952700 %0 Journal Article %@ 1929-0748 %I JMIR Publications Inc. %V 5 %N 1 %P e29 %T An Electronic Wellness Program to Improve Diet and Exercise in College Students: A Pilot Study %A Schweitzer,Amy L %A Ross,Jamisha T %A Klein,Catherine J %A Lei,Kai Y %A Mackey,Eleanor R %+ Children's National Health System, Clinical Research Center, 111 Michigan Avenue NW Room 3233A, Washington, DC, 20010, United States, 1 202 476 6331, aschweit@childrensnational.org %K college students, eHealth, telemedicine, diet, intervention studies, obesity, exercise %D 2016 %7 29.02.2016 %9 Original Paper %J JMIR Res Protoc %G English %X Background: In transitioning from adolescence to adulthood, college students are faced with significant challenges to their health habits. Independence, stress, and perceived lack of time by college students have been known to result in poor eating and exercise habits, which can lead to increased disease risk. Objective: To assess the feasibility and to determine preliminary efficacy of an electronic wellness program in improving diet and physical activity in college students. Methods: A 24-week diet and physical activity program was delivered via email to 148 college students. The intervention involved weekly, tailored, and interactive diet and physical activity goals. The control group received nondiet and nonexercise-related health fact sheets. Anthropometric and blood pressure measurements, as well as food frequency and physical activity surveys were conducted at baseline, week 12, and week 24. Students’ choice of fruit as a snack was also monitored at study visits. Results: Students were 18-20 years old, 69% female, and from a diverse college campus (46% Caucasian, 23% Asian, 20% African American, 11% other). At week 24, 84% of students reported reading at least half of all emails. Mean change (standard error [SE]) from baseline of saturated fat intake was marginally significant between the treatment groups at week 24, 0.7 (SE 0.42) % kcal for control and -0.3 (SE 0.30) % kcal for intervention (P=0.048). A significant difference in percent of snacks chosen that were fruit (χ21, N=221 = 11.7, P<0.001) was detected between the intervention and control group at week 24. Conclusions: Use of an electronic wellness program is feasible in college students and resulted in a decrease in saturated fat intake and an increase in observed fruit intake compared to a control group. %M 26929118 %R 10.2196/resprot.4855 %U http://www.researchprotocols.org/2016/1/e29/ %U https://doi.org/10.2196/resprot.4855 %U http://www.ncbi.nlm.nih.gov/pubmed/26929118 %0 Journal Article %@ 1929-0748 %I JMIR Publications Inc. %V 5 %N 1 %P e30 %T Assessing the Feasibility of a Web-Based Weight Loss Intervention for Low-Income Women of Reproductive Age: A Pilot Study %A Cavallo,David N %A Sisneros,Jessica A %A Ronay,Ashley A %A Robbins,Cheryl L %A Jilcott Pitts,Stephanie B %A Keyserling,Thomas C %A Ni,Ai %A Morrow,John %A Vu,Maihan B %A Johnston,Larry F %A Samuel-Hodge,Carmen D %+ Case Western Reserve University, Department of Nutrition, School of Medicine – WG48, 10900 Euclid Avenue, Cleveland, OH, 44106-4954, United States, 1 216 368 6627, david.cavallo@case.edu %K Obesity %K Nutrition %K Physical Activity %K Minority Health %K Healthcare Disparities %K Intervention Studies %K Internet %K women %K weight loss %K mhealth %D 2016 %7 26.02.2016 %9 Original Paper %J JMIR Res Protoc %G English %X Background: Low-income women of reproductive age are at increased risk for obesity and resulting increases in the risk of maternal/fetal complications and mortality and morbidity. Very few weight-loss interventions, however, have been targeted to this high-risk group. Based on the high prevalence of social media use among young and low-income individuals and previous successes using group formats for weight-loss interventions, the use of social media as a platform for weight-loss intervention delivery may benefit low-income women of reproductive age. Objective: Examine the feasibility of delivering group-based weight-loss interventions to low-income women of reproductive age using face-to-face meetings and Web-based modalities including social media. Methods: Participants attended a family planning clinic in eastern North Carolina and received a 5-month, group- and Web-based, face-to-face weight-loss intervention. Measures were assessed at baseline and 20 weeks. Results: Forty participants enrolled, including 29 (73%) African American women. The mean body mass index of enrollees was 39 kg/m2. Among the 12 women who completed follow-up, mean weight change was -1.3 kg. Participation in the intervention was modest and retention at 5 months was 30%. Returnees suggested sending reminders to improve participation and adding activities to increase familiarity among participants. Conclusions: Engagement with the intervention was limited and attrition was high. Additional formative work on the barriers and facilitators to participation may improve the intervention’s feasibility with low-income women of reproductive age. %M 26920252 %R 10.2196/resprot.4865 %U http://www.researchprotocols.org/2016/1/e30/ %U https://doi.org/10.2196/resprot.4865 %U http://www.ncbi.nlm.nih.gov/pubmed/26920252 %0 Journal Article %@ 1929-0748 %I JMIR Publications Inc. %V 5 %N 1 %P e31 %T The Australian Longitudinal Study on Women's Health: Using Focus Groups to Inform Recruitment %A Tavener,Meredith %A Mooney,Rosemary %A Thomson,Clare %A Loxton,Deborah %+ University of Newcastle, Research Centre for Generational Health and Ageing, c/- University of Newcastle,, University Drive,, Callaghan, 2308, Australia, 61 (0)2 4042 0684, meredith.tavener@newcastle.edu.au %K Focus groups %K methodology %K surveys %K longitudinal studies %K participant recruitment %K social media %K web-based survey %K mobile phones %D 2016 %7 22.02.2016 %9 Original Paper %J JMIR Res Protoc %G English %X Background: Recruitment and retention of participants to large-scale, longitudinal studies can be a challenge, particularly when trying to target young women. Qualitative inquiries with members of the target population can prove valuable in assisting with the development of effective recruiting techniques. Researchers in the current study made use of focus group methodology to identify how to encourage young women aged 18-23 to participate in a national cohort online survey. Objective: Our objectives were to gain insight into how to encourage young women to participate in a large-scale, longitudinal health survey, as well as to evaluate the survey instrument and mode of administration. Methods: The Australian Longitudinal Study on Women’s Health used focus group methodology to learn how to encourage young women to participate in a large-scale, longitudinal Web-based health survey and to evaluate the survey instrument and mode of administration. Nineteen groups, involving 75 women aged 18-23 years, were held in remote, regional, and urban areas of New South Wales and Queensland. Results: Focus groups were held in 2 stages, with discussions lasting from 19 minutes to over 1 hour. The focus groups allowed concord to be reached regarding survey promotion using social media, why personal information was needed, strategies to ensure confidentiality, how best to ask sensitive questions, and survey design for ease of completion. Recruitment into the focus groups proved difficult: the groups varied in size between 1 and 8 participants, with the majority conducted with 2 participants. Conclusions: Intense recruitment efforts and variation in final focus group numbers highlights the “hard to reach” character of young women. However, the benefits of conducting focus group discussions as a preparatory stage to the recruitment of a large cohort for a longitudinal Web-based health survey were upheld. %M 26902160 %R 10.2196/resprot.5020 %U http://www.researchprotocols.org/2016/1/e31/ %U https://doi.org/10.2196/resprot.5020 %U http://www.ncbi.nlm.nih.gov/pubmed/26902160 %0 Journal Article %@ 1929-0748 %I JMIR Publications Inc. %V 5 %N 1 %P e6 %T Digital Gaming for Improving the Functioning of People With Traumatic Brain Injury: Protocol of a Feasibility Study %A Välimäki,Maritta %A Korkeila,Jyrki %A Kauppi,Kaisa %A Kaakinen,Johanna K %A Holm,Suvi %A Vahlo,Jukka %A Tenovuo,Olli %A Hämäläinen,Heikki %A Sarajuuri,Jaana %A Rantanen,Pekka %A Orenius,Tage %A Koponen,Aki %+ Faculty of Medicine, Department of Nursing Science, Lemminkäisenkatu 1, University of Turku, 20014, Finland, 358 23338495, mava@utu.fi %K digital games %K brain injury %K cognitive rehabilitation %D 2016 %7 09.02.2016 %9 Protocol %J JMIR Res Protoc %G English %X Background: Traumatic brain injury (TBI) is a critical public health problem. The recovery process for people with TBI is typically slow and dependent on complex and intensive assisted rehabilitation programs. Objective: To evaluate the effects and feasibility of digital games for cognitive functioning and general well-being among people with traumatic brain injury. Methods: This is a single-site feasibility study conducted in Finland, which uses a pragmatic, randomized controlled trial with three arms, and will recruit patients from the Turku University Hospital, Division of Clinical Neurosciences in Finland. Participants must meet the following inclusion criteria: (1) a Finnish speaking adult, aged 18-65 years; (2) diagnosed with a traumatic brain injury (diagnostic criteria ICD-10, S06.X, T90.5) in the University Hospital; (3) access to a TV, a computer, and the Internet at home; (4) not an active digital gamer (5 hours or less a week); (5) willing to participate in the study. Participants must have been discharged from the neurologic treatment period for traumatic brain injury for over 12 months before the commencement of the trial, and they may not have actively participated in cognitive rehabilitation during the 3 months prior to the trial. Written informed consent will be mandatory for acceptance into the trial. Exclusion criteria are as follows: (1) sensory, cognitive, or physical impairment (eg, severe cognitive impairment); (2) a deficiency restricting the use of computers or computer game control system unaided (eg, impairment in vision, severe astigmatism, hemiplegia, disorder in visuospatial perception, dysfunction of the central vestibular system); (3) apathy identified in previous neuropsychological evaluations; (4) diagnosed severe mental disorders (eg, schizophrenia or severe depressive disorders to be identified in medical records as the secondary diagnosis). Results: The preparatory phase for the study is fulfilled. Recruitment started in June 2015 and finished November 2015. Results will be reported in 2016. Conclusions: The specific outcomes such as primary outcome measures were selected because they are widely used psychological tests and thought to be sensitive to changes in the cognitive functions related to TBI. Trial Registration: Clinicaltrials.gov NCT02425527; https://clinicaltrials.gov/ct2/show/NCT02425527 (Archived by WebCite at http://www.webcitation.org/6esKI1uDH) %M 26860741 %R 10.2196/resprot.4841 %U http://www.researchprotocols.org/2016/1/e6/ %U https://doi.org/10.2196/resprot.4841 %U http://www.ncbi.nlm.nih.gov/pubmed/26860741 %0 Journal Article %@ 1929-0748 %I JMIR Publications Inc. %V 5 %N 1 %P e11 %T Assessing the Usability of Web-Based Alcohol Education for Older Adults: A Feasibility Study %A Fink,Arlene %A Kwan,Lorna %A Osterweil,Dan %A Van Draanen,Jenna %A Cooke,Alexis %A Beck,John C %+ Arlene Fink Associates, 1562 Casale Road, Pacific Palisades, CA, 90272, United States, 1 3104544296, arlene.fink@gmail.com %K alcohol %K older adults %K elderly %K web-based %K education %K online alcohol education %D 2016 %7 01.02.2016 %9 Original Paper %J JMIR Res Protoc %G English %X Background: Older adults can experience unfavorable health effects from drinking at relatively low consumption levels because of age-related physiological changes and alcohol’s potentially adverse interactions with declining health, increased medication-use and diminishing functional status. At the same time, alcohol use in older adults may be protective against heart disease, stroke, and other disorders associated with aging. We developed “A Toast to Health in Later Life! Wise Drinking as We Age,” a web-based educational intervention to teach older adults to balance drinking risks and benefits. Objective: To examine the intervention’s feasibility in a sample of community-dwelling current drinkers ≥55 years of age and examine its effects on their quantity and frequency of alcohol use, adherence to standard drinking guidelines, and alcohol-related risks. Methods: Participants were recruited in person, by mail and by telephone between September and October 2014 from a community-based social services organization serving Los Angeles County. Once enrolled, participants were randomly assigned to the intervention or to a control group. The conceptual frameworks for the intervention were the Health Belief Model, models of adult learning, and the US Department of Health and Human Services guidelines for designing easy-to-use websites. The intervention’s content focuses on the relationship between drinking and its effects on older adults’ medical conditions, use of medications, and ability to perform daily activities. It also addresses quantity and frequency of alcohol use, drinking and driving and binge drinking. The control group did not receive any special intervention. Data on alcohol use and risks for both groups came from the online version of the Alcohol-Related Problems Survey and were collected at baseline and four weeks later. Data on usability were collected online from the intervention group immediately after it completed its review of the website. Results: The 49 intervention and 47 control participants did not differ at baseline in age, ethnicity, medication use, medical conditions, or alcohol use and both groups were mostly female, college-educated, and in good health. Of the intervention participants, 94% (46/49) had little or no difficulty using the website, with 67% (33/49) reporting that they will change the way they think about drinking because of their exposure to the education. At the 4-week follow-up, the intervention group reported drinking less (P=.02). No changes between groups were found in quantity and frequency, adherence to recommended guidelines, or risk status. Conclusions: Community-dwelling older adults are receptive to online alcohol education. To be most effective, the education should be included as a component of a larger effort consisting of screening and counseling preferably in a health care setting. %M 26832213 %R 10.2196/resprot.4545 %U http://www.researchprotocols.org/2016/1/e11/ %U https://doi.org/10.2196/resprot.4545 %U http://www.ncbi.nlm.nih.gov/pubmed/26832213 %0 Journal Article %@ 1929-0748 %I JMIR Publications Inc. %V 5 %N 1 %P e17 %T Patient Recruitment 2.0: Become a Partner in the Patient Journey Using Digital Media %A Lindemann,Michael %A Freeman,Tobe %A Kilchenmann,Timothy %A Harrison,Shuree %A Chan,Margaret %A Wygonik,Mark %A Haines,Lea %A Gossens,Christian %+ Roche Pharma Research and Early Development, pRED Informatics, Roche Innovation Center Basel, F. Hoffmann-La Roche Ltd, Grenzacherstrasse 124, Basel, 4070, Switzerland, 41 61 68 75113, christian.gossens@roche.com %K Internet intervention %K patient empowerment %K cancer survivor %K systematic review %K web 2.0 %K social media %D 2016 %7 27.01.2016 %9 Viewpoint %J JMIR Res Protoc %G English %X We describe a digital platform, Pioneering Healthcare, designed to inform and empower people who are impacted by lung cancer. The platform enables Roche to support an online conversation with patients and caregivers about lung cancer, and about the role of lung cancer clinical studies in the development of future treatment options. This conversation is live and ongoing on the platform. It provides insights about the views and motivations of patients, and about how to better support patients pursuing treatment for life-threatening illness. We discuss the strategies used to deploy Pioneering Healthcare, and the advantages of using digital platforms for raising disease awareness, increasing patient engagement and, ultimately, for boosting patient enrollment into clinical trials. %M 26818938 %R 10.2196/resprot.5045 %U http://www.researchprotocols.org/2016/1/e17/ %U https://doi.org/10.2196/resprot.5045 %U http://www.ncbi.nlm.nih.gov/pubmed/26818938 %0 Journal Article %@ 1929-0748 %I JMIR Publications Inc. %V 5 %N 1 %P e14 %T A Web-Based Intervention to Encourage Walking (StepWise): Pilot Randomized Controlled Trial %A Hargreaves,Elaine Anne %A Mutrie,Nanette %A Fleming,Jade Dallas %+ School of Physical Education, Sport & Exercise Sciences, University of Otago, PO Box 56, Dunedin, 9054, New Zealand, 64 34798941, elaine.hargreaves@otago.ac.nz %K physical activity, behavior change strategies, pedometer, self-monitoring, step goal walking program %D 2016 %7 25.01.2016 %9 Original Paper %J JMIR Res Protoc %G English %X Background: Despite Internet-based interventions that incorporate pedometers with appropriate goal-setting processes and other theoretically-based behavior change strategies being proposed as a means of increasing walking behavior, few have incorporated all of these key features or assessed maintenance of behavior change. Objective: The objective of our study was to investigate the effect of a 12-week pedometer step goal walking program individually tailored to baseline step counts, combined with an interactive support website for step counts, health parameters and motivation over 12 and 24 weeks. Methods: Low active participants (mean [SD] 46.2 [11.2] years) were randomly assigned to the Stepwise (SW) intervention group (n=49) or a comparison (CP) group (n=48). SW received a pedometer, step goal walking program and access to the SW website (containing interactive self-monitoring and goal feedback tools, motivational messages and action and coping planning strategies). CP received a pedometer and locally available physical activity information. Step counts, BMI, resting heart rate, blood pressure and glucose, cholesterol and triglyceride levels, psychological well-being, perceived health, self-efficacy and self-determined motivation were measured at baseline, 12 and 24 weeks. Results: Linear mixed model analysis found that both groups’ step counts increased from baseline to week 12 (β = 11,002, CI 5739-16,266, P<.001) and 24 (β = 6810, CI 1190-12,431; P=.02). Group step counts were significantly different at week 24 with SW taking 8939 (CI 274-17604, P=.04) more steps compared to CP. Compared to baseline, both groups had improved triglyceride levels (0.14 mmol/L, CI -0.25 to -0.02, P=.02) at week 12, decreased diastolic blood pressure (4.22 mmHg, CI -6.73 to -1.72) at weeks 12 and 24 (3.17 mmHg, CI -5.55 to -0.78), improved positive (β = .21, CI 0.03-0.38, P=.02) and negative affect (β = -.15, CI -0.28 to -0.03, P=.02) at week 12, and perceived health at week 12 (β = 6.37, CI 2.10-10.65, P=.004) and 24 (β = 8.52, CI 3.98-13.06, P<.001). Total cholesterol increased at week 12 (0.26 mmol/L, CI 0.099-0.423, P=.006) and week 24 (0.38 mmol/L, CI 0.20-0.56, P<.001). Repeated measures ANOVA found motivation for walking improved from baseline with higher task self-efficacy (P<.001, η2 = .13) and autonomous motivation (P<.001, η2=.14) at weeks 12 and 24 and decreased controlled motivation (P=.004, η2=.08) at week 24. Conclusions: Both groups had similar improvements in step counts and physical and psychological health after 12 weeks but only the SW group successfully maintained the increased step-counts 24 weeks post-intervention. This suggests the step-goal based walking program combined with Internet-based behavior change tools were important for sustained behavior change. %M 26810251 %R 10.2196/resprot.4288 %U http://www.researchprotocols.org/2016/1/e14/ %U https://doi.org/10.2196/resprot.4288 %U http://www.ncbi.nlm.nih.gov/pubmed/26810251 %0 Journal Article %@ 1929-0748 %I JMIR Publications Inc. %V 5 %N 1 %P e4 %T How to Conduct Multimethod Field Studies in the Operating Room: The iPad Combined With a Survey App as a Valid and Reliable Data Collection Tool %A Tscholl,David W %A Weiss,Mona %A Spahn,Donat R %A Noethiger,Christoph B %+ Institute for Anesthesiology, University and University Hospital Zurich, Raemistrasse 100, Zurich, , Switzerland, 41 044 255 2695, christoph.noethiger@usz.ch %K data collection %K empirical research %K observation %K computers %K informatics %K anesthesiology %D 2016 %7 05.01.2016 %9 Original Paper %J JMIR Res Protoc %G English %X Background: Tablet computers such as the Apple iPad are progressively replacing traditional paper-and-pencil-based data collection. We combined the iPad with the ready-to-use survey software, iSurvey (from Harvestyourdata), to create a straightforward tool for data collection during the Anesthesia Pre-Induction Checklist (APIC) study, a hospital-wide multimethod intervention study involving observation of team performance and team member surveys in the operating room (OR). Objective: We aimed to provide an analysis of the factors that led to the use of the iPad- and iSurvey-based tool for data collection, illustrate our experiences with the use of this data collection tool, and report the results of an expert survey about user experience with this tool. Methods: We used an iPad- and iSurvey-based tool to observe anesthesia inductions conducted by 205 teams (N=557 team members) in the OR. In Phase 1, expert raters used the iPad- and iSurvey-based tool to rate team performance during anesthesia inductions, and anesthesia team members were asked to indicate their perceptions after the inductions. In Phase 2, we surveyed the expert raters about their perceptions regarding the use of the iPad- and iSurvey-based tool to observe, rate, and survey teams in the ORs. Results: The results of Phase 1 showed that training data collectors on the iPad- and iSurvey-based data collection tool was effortless and there were no serious problems during data collection, upload, download, and export. Interrater agreement of the combined data collection tool was found to be very high for the team observations (median Fleiss’ kappa=0.88, 95% CI 0.78-1.00). The results of the follow-up expert rater survey (Phase 2) showed that the raters did not prefer a paper-and-pencil-based data collection method they had used during other earlier studies over the iPad- and iSurvey-based tool (median response 1, IQR 1-1; 1=do not agree, 2=somewhat disagree, 3=neutral, 4=somewhat agree, 5=fully agree). They found the iPad (median 5, IQR 4.5-5) and iSurvey (median 4, IQR 4-5) to be working flawlessly and easy to use (median 5, IQR 4-5). Expert ratings also showed that the anesthesia team members (ie, the surveyed doctors and nurses) who used the iPad- and iSurvey-based tool in the OR liked it (median 4, IQR 3-4.5). Conclusions: The combination of the iPad and iSurvey provides an efficient and unobtrusive method to observe teams in their natural environment in the OR and to survey team members immediately after completing their task (ie, anesthesia induction). The expert raters positively evaluated the use of the device and user perceptions. Considering these comprehensive results, we can recommend the use of the iPad- and iSurvey-based tool for studying team performance and team member perceptions in the OR. %M 26732090 %R 10.2196/resprot.4713 %U http://www.researchprotocols.org/2016/1/e4/ %U https://doi.org/10.2196/resprot.4713 %U http://www.ncbi.nlm.nih.gov/pubmed/26732090 %0 Journal Article %@ 1929-0748 %I JMIR Publications Inc. %V 5 %N 1 %P e3 %T Collecting Biospecimens From an Internet-Based Prospective Cohort Study of Inflammatory Bowel Disease (CCFA Partners): A Feasibility Study %A Randell,Rachel L %A Gulati,Ajay S %A Cook,Suzanne F %A Martin,Christopher F %A Chen,Wenli %A Jaeger,Elizabeth L %A Schoenborn,Alexi A %A Basta,Patricia V %A Dejong,Hendrik %A Luo,Jingchun %A Gallant,Marisa %A Sandler,Robert S %A Long,Millie D %A Kappelman,Michael D %+ Department of Pediatrics, Duke University School of Medicine, Duke University, 2301 Erwin Road, Durham, NC, 27710, United States, 1 919 684 8111, rachelrandell88@gmail.com %K inflammatory bowel disease %K biobank %K Internet cohort %K CCFA Partners %D 2016 %7 05.01.2016 %9 Original Paper %J JMIR Res Protoc %G English %X Background: The Internet has successfully been used for patient-oriented survey research. Internet-based translational research may also be possible. Objective: Our aim was to study the feasibility of collecting biospecimens from CCFA Partners, an Internet-based inflammatory bowel disease (IBD) cohort. Methods: From August 20, 2013, to January 4, 2014, we randomly sampled 412 participants, plus 179 from a prior validation study, and invited them to contribute a biospecimen. Participants were randomized to type (blood, saliva), incentive (none, US $20, or US $50), and collection method for blood. The first 82 contributors were also invited to contribute stool. We used descriptive statistics and t tests for comparisons. Results: Of the 591 participants, 239 (40.4%) indicated interest and 171 (28.9%) contributed a biospecimen. Validation study participants were more likely to contribute than randomly selected participants (44% versus 23%, P<.001). The return rate for saliva was higher than blood collected by mobile phlebotomist and at doctors’ offices (38%, 31%, and 17% respectively, P<.001). For saliva, incentives were associated with higher return rates (43-44% versus 26%, P=.04); 61% contributed stool. Fourteen IBD-associated single nucleotide polymorphisms were genotyped, and risk allele frequencies were comparable to other large IBD populations. Bacterial DNA was successfully extracted from stool samples and was of sufficient quality to permit quantitative polymerase chain reaction for total bacteria. Conclusions: Participants are willing to contribute and it is feasible to collect biospecimens from an Internet-based IBD cohort. Home saliva kits yielded the highest return rate, though mobile phlebotomy was also effective. All samples were sufficient for genetic testing. These data support the feasibility of developing a centralized collection of biospecimens from this cohort to facilitate IBD translational studies. %M 26732016 %R 10.2196/resprot.5171 %U http://www.researchprotocols.org/2016/1/e3/ %U https://doi.org/10.2196/resprot.5171 %U http://www.ncbi.nlm.nih.gov/pubmed/26732016 %0 Journal Article %@ 2369-2529 %I JMIR Publications Inc. %V 2 %N 2 %P e11 %T Automated Management of Exercise Intervention at the Point of Care: Application of a Web-Based Leg Training System %A Dedov,Vadim N %A Dedova,Irina V %+ MedExercise Project, Research and Development, MDXD Pty Ltd, Unit 7, 65 Sandringham Street, Sydney, 2219, Australia, 61 425 216 056, vdedov@tpg.com.au %K digital intervention %K exercise intervention %K cardiac rehabilitation %K training equipment %K online monitoring %K exercise dose %K telerehabilitation %K leg mobilization %K Web-based apps %K eHealth recordings %D 2015 %7 23.11.2015 %9 Original Paper %J JMIR Rehabil Assist Technol %G English %X Background: Recent advances in information and communication technology have prompted development of Web-based health tools to promote physical activity, the key component of cardiac rehabilitation and chronic disease management. Mobile apps can facilitate behavioral changes and help in exercise monitoring, although actual training usually takes place away from the point of care in specialized gyms or outdoors. Daily participation in conventional physical activities is expensive, time consuming, and mostly relies on self-management abilities of patients who are typically aged, overweight, and unfit. Facilitation of sustained exercise training at the point of care might improve patient engagement in cardiac rehabilitation. Objective: In this study we aimed to test the feasibility of execution and automatic monitoring of several exercise regimens on-site using a Web-enabled leg training system. Methods: The MedExercise leg rehabilitation machine was equipped with wireless temperature sensors in order to monitor its usage by the rise of temperature in the resistance unit (Δt°). Personal electronic devices such as laptop computers were fitted with wireless gateways and relevant software was installed to monitor the usage of training machines. Cloud-based software allowed monitoring of participant training over the Internet. Seven healthy participants applied the system at various locations with training protocols typically used in cardiac rehabilitation. The heart rates were measured by fingertip pulse oximeters. Results: Exercising in home chairs, in bed, and under an office desk was made feasible and resulted in an intensity-dependent increase of participants’ heart rates and Δt° in training machine temperatures. Participants self-controlled their activities on smart devices, while a supervisor monitored them over the Internet. Individual Δt° reached during 30 minutes of moderate-intensity continuous training averaged 7.8°C (SD 1.6). These Δt° were used as personalized daily doses of exercise with automatic email alerts sent upon achieving them. During 1-week training at home, automatic notifications were received on 4.4 days (SD 1.8). Although the high intensity interval training regimen was feasible on-site, it was difficult for self- and remote management. Opportunistic leg exercise under the desk, while working with a computer, and training in bed while viewing television were less intensive than dosed exercise bouts, but allowed prolonged leg mobilization of 73.7 minutes/day (SD 29.7). Conclusions: This study demonstrated the feasibility of self-control exercise training on-site, which was accompanied by online monitoring, electronic recording, personalization of exercise doses, and automatic reporting of adherence. The results suggest that this technology and its applications are useful for the delivery of Web-based exercise rehabilitation and cardiac training programs at the point of care. %M 28582243 %R 10.2196/rehab.4812 %U http://rehab.jmir.org/2015/2/e11/ %U https://doi.org/10.2196/rehab.4812 %U http://www.ncbi.nlm.nih.gov/pubmed/28582243 %0 Journal Article %@ 2369-1999 %I JMIR Publications Inc. %V 1 %N 2 %P e12 %T Feasibility and Preliminary Efficacy of an Online Intervention to Increase Physical Activity in Nova Scotian Cancer Survivors: A Randomized Controlled Trial %A Forbes,Cynthia C %A Blanchard,Chris M %A Mummery,W Kerry %A Courneya,Kerry S %+ University of Alberta, Van Vliet Complex, University Hall, Edmonton, AB, , Canada, 1 780 492 2829, kerry.courneya@ualberta.ca %K Web-based %K survivorship %K home-based %K exercise %K efficacy %K feasibility %D 2015 %7 23.11.2015 %9 Original Paper %J JMIR Cancer %G English %X Background: Physical activity (PA) behavior change interventions among cancer survivors have used face-to-face, telephone, email, and print-based methods. However, computer-tailored, Internet-delivered programs may be a more viable option to achieve PA behavior change. Objective: The objective of this study is to test the feasibility and preliminary efficacy of a Web-based PA behavior change program among cancer survivors. Methods: Nova Scotian cancer survivors (N=415) who previously expressed interest in a research study were approached. Interested participants were asked to complete an online assessment of PA and quality of life (QOL) before being randomized to either a theory-based PA behavior change program using the PA tracking website UWALK (UCAN; n=48) or usual care (UC; n=47). After the intervention (9 weeks), participants completed another online assessment of PA and QOL as well as measures to evaluate the program and website. Descriptive analyses from surveys and Web analytic software were used to assess feasibility and mean change scores were used to test efficacy. Results: Of all contacted survivors, 95 (22.3%, 95/415) completed baseline measures and were randomized with 84 (88%, 84/95) completing the 9-week assessment. The behavior change program and website were rated highly on the satisfaction items. Average logins were 10.3 (1.1 per week) and 26.0% (111/432) of the weekly modules were completed. Most participants (71%, 29/41) indicated they were more aware of their daily PA levels and 68% (28/41) found the site easily navigable. Adjusted group differences in total exercise minutes favored the UCAN group by an increase of 42 minutes (95% CI -65 to 150; P=.44, d=0.17). Results were more pronounced, though still nonsignificant, among those not meeting guidelines at baseline where UCAN increased PA by 52 minutes compared to a decrease of 15 minutes in UC (adjusted between group difference=75, 95% CI -95 to 244; P=.38, d=0.27). Conclusions: We found that Internet-delivery may be a feasible alternative to more costly methods to promote PA among Nova Scotian cancer survivors. Moreover, there was a trend toward increased PA among those in the UCAN group, especially among those who were not meeting PA guidelines at baseline. Future research should focus on recruiting inactive cancer survivors and engaging them in the website to determine the optimal potential of Web-based interventions for promoting PA in cancer survivors. %M 28410166 %R 10.2196/cancer.4586 %U http://cancer.jmir.org/2015/2/e12/ %U https://doi.org/10.2196/cancer.4586 %U http://www.ncbi.nlm.nih.gov/pubmed/28410166 %0 Journal Article %@ 1929-0748 %I JMIR Publications Inc. %V 4 %N 4 %P e129 %T Changes in Physical Activity and Psychological Variables Following a Web-Based Motivational Interviewing Intervention: Pilot Study %A Karnes,Sasha L %A Meyer,Barbara B %A Berger,Lisa M %A Brondino,Michael J %+ University of Wisconsin--Whitewater, Department of Psychology, Laurentide Hall, 800 W. Main St., Whitewater, WI, , United States, 1 262 472 3037, karness@uww.edu %K motivational interviewing %K physical activity %K adults %K Web-based %K intervention %K health care %K psychology %D 2015 %7 29.10.2015 %9 Original Paper %J JMIR Res Protoc %G English %X Background: Web-based interventions for enhancing physical activity participation are in demand for application in health care settings. Recent research suggests Web-based interventions that are based on motivational interviewing are effective to increase physical activity. It is unclear whether motivational interviewing can influence targeted psychological variables such as perceived readiness, willingness, and ability to participate in physical activity. Objective: The aims of this study were to determine whether there were changes in physical activity and psychological variables associated with readiness, willingness, and perceived ability to participate in physical activity following completion of a novel Web-based intervention. The goal of the motivational interviewing–based intervention was to increase physical activity. Methods: Twenty-three underactive or inactive urban dwelling adults were recruited at a medical office for participation in a 4-session Web-based intervention lasting approximately 15 minutes per week. Sessions were based on principles of motivational interviewing. Assessment of physical activity was conducted using pedometers immediately prior to intervention participation (pre) and immediately post intervention (post1). Self-report assessments of physical activity and psychological variables were conducted using online surveys at pre, post1, and again at one month following intervention participation (post2). Results: Comparisons of pre and post1 pedometer recordings revealed significant increases in steps per day (t22=2.09, P=.049). There were also significant changes in total physical activity energy expenditure per week (χ22=8.4, P=.02) and in moderate intensity physical activity energy expenditure per week (χ22=13.9, P<.001) over time following participation in the Web-based intervention. Significant changes in psychological variables following participation in the Web-based intervention included: (1) change in stage classification over time (χ22=21.5, P<.001), where the percentage of participants classified in the action or maintenance stages of change in physical activity increased over time (pre=25% [6/24], post1=71% [17/24], post2=68% [15/22]); (2) decreases in self-reported decisional balance cons (F2,42=12.76, P<.001); (3) increases in self-reported decisional balance pros (F2,42=16.19, P<.001); (4) increases in physical activity enjoyment (F2,20=3.85, P=.04); and (5) increases in self-efficacy (F2,42=3.30, P=.047). Conclusions: The Web-based intervention piloted in this study shows preliminary promise as a tool to promote physical activity in health care settings. Additional research is needed to test the effectiveness of motivational interviewing compared to a control condition and to refine content by considering mediation by psychological variables in a larger sample. %M 26515668 %R 10.2196/resprot.4623 %U http://www.researchprotocols.org/2015/4/e129/ %U https://doi.org/10.2196/resprot.4623 %U http://www.ncbi.nlm.nih.gov/pubmed/26515668 %0 Journal Article %@ 1929-0748 %I JMIR Publications Inc. %V 4 %N 4 %P e119 %T A Novel Health Information Technology Communication System to Increase Caregiver Activation in the Context of Hospital-Based Pediatric Hematopoietic Cell Transplantation: A Pilot Study %A Maher,Molly %A Hanauer,David A %A Kaziunas,Elizabeth %A Ackerman,Mark S %A Derry,Holly %A Forringer,Rachel %A Miller,Kristen %A O'Reilly,Dennis %A An,Lawrence %A Tewari,Muneesh %A Choi,Sung Won %+ Department of Pediatrics, University of Michigan, 1500 E Medical Center Dr, D4118 Medical Professional Building, SPC 5718, Ann Arbor, MI, 48109, United States, 1 734 615 5707, sungchoi@med.umich.edu %K health IT %K caregiver %K activation %K engagement %K pediatric %K hematopoietic cell transplantation %D 2015 %7 27.10.2015 %9 Original Paper %J JMIR Res Protoc %G English %X Background: Pediatric hematopoietic cell transplantation (HCT), commonly referred to as blood and marrow transplantation (BMT), is an intense treatment modality that requires the involvement of engaged caregivers during the patient’s (child’s) prolonged hospitalization. The ubiquity of electronic health records (EHRs) and a trend toward patient-centered care could allow a novel health information technology (IT) system to increase parental engagement. The paucity of research on acute care, hospital-based (inpatient) health IT applications for patients or caregivers provides an opportunity for testing the feasibility of such applications. The pediatric BMT population represents an ideal patient group to conduct an evaluation due to the lengthy inpatient stays and a heightened need for patient activation. Objective: The primary objective of this study is to assess the feasibility of implementing the BMT Roadmap in caregivers as an intervention during their child’s inpatient hospitalization. The BMT Roadmap is an inpatient portal prototype optimized for tablet with a user-centered design. It integrates patient-specific laboratory and medication data from the EHR in real-time and provides support in terms of discharge goals, home care education, and other components. Feasibility will be proven if (1) the BMT Roadmap functions and can be managed by the study team without unexpected effort, (2) the system is accessed by users at a defined minimum threshold, and (3) the qualitative and quantitative research conducted provides quality data that address the perceived usefulness of the BMT Roadmap and could inform a study in a larger sample size. Methods: This will be a single-arm, nonrandomized feasibility study. We aim to enroll 10 adult caregivers (age ≥ 18 years) of pediatric patients (aged 0-25 years) undergoing autologous (self-donor) or allogeneic (alternative donor) BMT. Assenting minors (aged 10-18) will also be invited to participate. Recruitment of study participants will take place in the outpatient pediatric BMT clinic. After signing an informed consent, the research study team will provide participants with the BMT Roadmap, available on an Apple iPad, which will used throughout the inpatient hospitalization. To measure the study outcomes, approximately 6-8 semistructured qualitative interviews will be conducted periodically from pre-BMT to 100 days post-BMT and an additional 15-20 semistructured interviews will be conducted among BMT health care providers to assess perceived usefulness and usability of the system, as well as any associated workflow impacts. Quantitative survey instruments will only be administered to adult participants (age ≥ 18 years). Results: Recruitment will begin in September 2015, and preliminary findings are expected in 2016. Conclusions: This protocol offers a framework for the design and analysis of a personalized health IT system that has the potential to increase patient and caregiver engagement in acute care, hospital-based contexts. International Registered Report Identifier (IRRID): PRR1-10.2196/4918 %M 26508379 %R 10.2196/resprot.4918 %U http://www.researchprotocols.org/2015/4/e119/ %U https://doi.org/10.2196/resprot.4918 %U http://www.ncbi.nlm.nih.gov/pubmed/26508379 %0 Journal Article %@ 1929-0748 %I JMIR Publications Inc. %V 4 %N 4 %P e123 %T Twitter-Delivered Behavioral Weight-Loss Interventions: A Pilot Series %A Pagoto,Sherry L %A Waring,Molly E %A Schneider,Kristin L %A Oleski,Jessica L %A Olendzki,Effie %A Hayes,Rashelle B %A Appelhans,Bradley M %A Whited,Matthew C %A Busch,Andrew M %A Lemon,Stephenie C %+ Division of Preventive and Behavioral Medicine, Department of Medicine, University of Massachusetts Medical School, 55 Lake Avenue North, Worcester, MA, 01655, United States, 1 508 856 2092, Sherry.Pagoto@umassmed.edu %K social networks %K Twitter %K obesity %K weight loss %K online social networking %K peer-to-peer health care %K digital health %D 2015 %7 23.10.2015 %9 Original Paper %J JMIR Res Protoc %G English %X Background: Lifestyle interventions are efficacious at reducing risk for diabetes and cardiovascular disease but have not had a significant public health impact given high cost and patient and provider burden. Objective: Online social networks may reduce the burden of lifestyle interventions to the extent that they displace in-person visits and may enhance opportunities for social support for weight loss. Methods: We conducted an iterative series of pilot studies to evaluate the feasibility and acceptability of using online social networks to deliver a lifestyle intervention. Results: In Study 1 (n=10), obese participants with depression received lifestyle counseling via 12 weekly group visits and a private group formed using the online social network, Twitter. Mean weight loss was 2.3 pounds (SD 7.7; range -19.2 to 8.2) or 1.2% (SD 3.6) of baseline weight. A total of 67% (6/9) of participants completing exit interviews found the support of the Twitter group at least somewhat useful. In Study 2 (n=11), participants were not depressed and were required to be regular users of social media. Participants lost, on average, 5.6 pounds (SD 6.3; range -15 to 0) or 3.0% (SD 3.4) of baseline weight, and 100% (9/9) completing exit interviews found the support of the Twitter group at least somewhat useful. To explore the feasibility of eliminating in-person visits, in Study 3 (n=12), we delivered a 12-week lifestyle intervention almost entirely via Twitter by limiting the number of group visits to one, while using the same inclusion criteria as that used in Study 2. Participants lost, on average, 5.4 pounds (SD 6.4; range -14.2 to 3.9) or 3.0% (SD 3.1) of baseline weight, and 90% (9/10) completing exit interviews found the support of the Twitter group at least somewhat useful. Findings revealed that a private Twitter weight-loss group was both feasible and acceptable for many patients, particularly among regular users of social media. Conclusions: Future research should evaluate the efficacy and cost-effectiveness of online social network-delivered lifestyle interventions relative to traditional modalities. %M 26500186 %R 10.2196/resprot.4864 %U http://www.researchprotocols.org/2015/4/e123/ %U https://doi.org/10.2196/resprot.4864 %U http://www.ncbi.nlm.nih.gov/pubmed/26500186 %0 Journal Article %@ 1929-0748 %I JMIR Publications Inc. %V 4 %N 4 %P e117 %T Exercise-Induced Tendon and Bone Injury in Recreational Runners: A Test-Retest Reliability Study %A Domaschenz,Renae %A Vlahovich,Nicole %A Keogh,Justin %A Compton,Stacey %A Hughes,David C %A , %+ Department of Sports Medicine, Australian Institute of Sport, Australian Sports Commission, Leverrier St, Bruce, 2621, Australia, 61 2 6214 7319, nicole.vlahovich@ausport.gov.au %K exercise %K genetics %K injury %K reliability %K survey %D 2015 %7 07.10.2015 %9 Original Paper %J JMIR Res Protoc %G English %X Background: Long-distance runners are prone to injuries including Achilles tendinopathy and medial tibial stress syndrome. We have developed an Internet comprehensive self-report questionnaire examining the medical history, injury history, and running habits of adult recreational runners. Objective: The objective of the study was to evaluate two alternative forms of test-retest reliability of a comprehensive self-report Internet questionnaire retrospectively examining the medical history, injury history, and running habits among a sample of adult recreational runners. This will contribute to the broad aims of a wider study investigating genetics and running injury. Methods: Invitations to complete an Internet questionnaire were sent by email to a convenience pilot population (test group 1). Inclusion criteria required participants to be a recreational runner age 18 or over, who ran over 15 km per week on a consistent basis. The survey questions addressed regular running habits and any injuries (including signs, symptoms, and diagnosis) of the lower limbs that resulted in discontinuation of running for a period of 2 consecutive weeks or more, within the last 2 years. Questions also addressed general health, age, sex, height, weight, and ethnic background. Participants were then asked to repeat the survey using the Internet platform again after 10-14 days. Following analysis of test group 1, we soft-launched the survey to a larger population (test group 2), through a local running club of 900 members via email platform. The same inclusion criteria applied, however, participants were asked to complete a repeat of the survey by telephone interview after 7-10 days. Selected key questions, important to clarify inclusion or exclusion from the wider genetics study, were selected to evaluate test-retest reliability. Reliability was quantified using the kappa coefficient for categorical data. Results: In response to the invitation, 28 participants accessed the survey from test group 1, 23 completed the Internet survey on the first occasion, and 20 completed the Internet retest within 10-21 days. Test-retest reliability scored moderate to almost perfect (kappa=.41 to .99) for 19/19 of the key questions analyzed. Following the invitation, 122 participants accessed the survey from test group 2, 101 completed the Internet survey on the first occasion, and 50 were randomly selected and contacted by email inviting them to repeat the survey by telephone interview. There were 33 participants that consented to the telephone interview and 30 completed the questionnaire within 7-10 days. Test-retest reliability scored moderate to almost perfect for 18/19 (kappa=.41 to .99) and slight for 1/19 of the key questions analyzed. %M 36262008 %R 10.2196/resprot.4585 %U http://www.researchprotocols.org/2002/4/e117/ %U https://doi.org/10.2196/resprot.4585 %U http://www.ncbi.nlm.nih.gov/pubmed/36262008 %0 Journal Article %@ 1929-0748 %I JMIR Publications Inc. %V 4 %N 3 %P e115 %T An Internet-Based Means of Monitoring Quality of Life in Post-Prostate Radiation Treatment: A Prospective Cohort Study %A Parker,Brent %A Rajapakshe,Rasika %A Moldovan,Andrew %A Araujo,Cynthia %A Crook,Juanita %+ British Columbia Cancer Agency, Sindi Ahluwalia Hawkins Centre for the Southern Interior, 399 Royal Avenue, Kelowna, BC, , Canada, 1 250 712 3966 ext 686912, brent.parker2@interiorhealth.ca %K prostate cancer %K radiation oncology %K quality of life %K patient-reported outcomes %K Internet survey %K prospective study %D 2015 %7 28.09.2015 %9 Original Paper %J JMIR Res Protoc %G English %X Background: Widespread integration of the Internet has resulted in an increase in the feasibility of using Web-based technologies as a means of communicating with patients. It may be possible to develop secure and standardized systems that facilitate Internet-based patient-reported outcomes which could be used to improve patient care. Objective: This study investigates patient interest in participating in an online post-treatment disease outcomes and quality of life monitoring program developed specifically for patients who have received radiation treatment for prostate cancer at a regional oncology center. Methods: Patients treated for prostate cancer between 2007 and 2011 (N=1113) at the British Columbia Cancer Agency, Centre for the Southern Interior were invited by mail to participate in a standardized questionnaire related to their post-treatment health. Overall participation rates were calculated. In addition, demographics, access to broadband Internet services, and treatment modalities were compared between participants and nonparticipants. Results: Of the 1030 eligible invitees, 358 (358/1030, 34.7%) completed the online questionnaire. Participation rates were higher in individuals younger than age 60 when compared to those age 60 or older (42% vs 31%) and also for those living in urban areas compared with rural (37% vs 29%) and in those who received brachytherapy versus external beam radiotherapy (EBRT) (41% vs 31%). Better participation rates were seen in individuals who had access to Internet connectivity based on the different types of broadband services (DSL 35% for those with DSL connectivity vs 29% for those without DSL connectivity; cable 35% vs 32%; wireless 38% vs 26%). After adjusting for age, the model indicates that lack of access to wireless broadband connectivity, living in a rural area, and receiving EBRT were significant predictors of lower participation. Conclusions: This study demonstrates that participation rates vary in patient populations within the interior region of British Columbia, especially with older patients, those in rural areas, and those with limited access to quality Internet services. %M 26416584 %R 10.2196/resprot.3974 %U http://www.researchprotocols.org/2015/3/e115/ %U https://doi.org/10.2196/resprot.3974 %U http://www.ncbi.nlm.nih.gov/pubmed/26416584 %0 Journal Article %@ 2368-7959 %I JMIR Publications Inc. %V 2 %N 3 %P e22 %T Feasibility of "CopeSmart": A Telemental Health App for Adolescents %A Kenny,Rachel %A Dooley,Barbara %A Fitzgerald,Amanda %+ School of Psychology, University College Dublin, Belfield, Dublin 4, , Ireland, 353 1 7168147, rachel.kenny.3@ucdconnect.ie %K adolescents %K emotional self-monitoring %K feasibility %K mobile apps %K positive mental health %D 2015 %7 10.08.2015 %9 Original Paper %J JMIR Mental Health %G English %X Background: Early intervention is important in order to improve mental health outcomes for young people. Given the recent rise in mobile phone ownership among adolescents, an innovative means of delivering such intervention is through the use of mobile phone applications (apps). Objective: The aim of this study was to evaluate the feasibility of “CopeSmart”, a telemental health app developed to foster positive mental health in adolescents through emotional self-monitoring and the promotion of positive coping strategies. Methods: Forty-three adolescents (88% female) aged 15-17 years downloaded the app and used it over a one-week period. They then completed self-report questionnaires containing both open-ended and closed-ended questions about their experiences of using the app. The app itself captured data related to user engagement. Results: On average participants engaged with the app on 4 of the 7 days within the intervention period. Feedback from users was reasonably positive, with 70% of participants reporting that they would use the app again and 70% reporting that they would recommend it to a friend. Thematic analysis of qualitative data identified themes pertaining to users’ experiences of the app, which were both positive (eg, easy to use, attractive layout, emotional self-monitoring, helpful information, notifications, unique) and negative (eg, content issues, did not make user feel better, mood rating issues, password entry, interface issues, engagement issues, technical fixes). Conclusions: Overall findings suggest that telemental health apps have potential as a feasible medium for promoting positive mental health, with the majority of young people identifying such technologies as at least somewhat useful and displaying a moderate level of engagement with them. Future research should aim to evaluate the efficacy of such technologies as tools for improving mental health outcomes in young people. %M 26552425 %R 10.2196/mental.4370 %U http://mental.jmir.org/2015/3/e22/ %U https://doi.org/10.2196/mental.4370 %U http://www.ncbi.nlm.nih.gov/pubmed/26552425 %0 Journal Article %@ 1929-0748 %I JMIR Publications Inc. %V 4 %N 3 %P e101 %T Using Social Media While Waiting in Pain: A Clinical 12-Week Longitudinal Pilot Study %A Merolli,Mark %A Gray,Kathleen %A Martin-Sanchez,Fernando %A Mantopoulos,Steven %A Hogg,Malcolm %+ Health and Biomedical Informatics Centre, The University of Melbourne, Level 1, 202 Berkeley St, Melbourne, 3010, Australia, 61 390354943, mmerolli@student.unimelb.edu.au %K chronic pain %K chronic disease %K participatory health %K patient-reported outcomes %K self-management %K social media %K therapeutic affordances %K pilot study %D 2015 %7 07.08.2015 %9 Original Paper %J JMIR Res Protoc %G English %X Background: Chronic pain places an enormous burden on health care systems. Multidisciplinary pain management services are well documented as an effective means to improve patient outcomes. However, waiting lists to access these services are long and outcomes deteriorate. Innovative solutions such as social media are gaining attention as a way to decrease this burden and improve outcomes. It is a challenge to design research that demonstrates whether social media are acceptable to patients and clinically effective. Objective: The aim was to conduct a longitudinal pilot study to understand what aspects of research design are key to the success of running a larger-scale study of social media use in the clinical management of chronic pain. Methods: A 12-week study examined social media use by patients on the waiting list for the Royal Melbourne Hospital Pain Management Service. Selected social media resources were suggested for use by patients waiting for an appointment at the clinic. Patients filled out measures for pain interference and pain self-efficacy before and after the study. Follow-up was conducted at monthly intervals via telephone semistructured interviews to discuss engagement and garner individual perceptions towards social media use. A social media-use instrument was also administered as part of the after-study questionnaire. Results: Targeted recruitment refined 235 patient referrals to 138 (58.7%) suitable potential participants. Contact was made with 84 out of 138 (60.9%) patients. After a further exclusion of 54 out of 84 (64%) patients for various reasons, this left 30 out of 84 (36%) patients fitting the inclusion criteria and interested in study participation. A final study cohort of 17 out of 30 (57%) was obtained. Demographics of the 17 patients were mixed. Low back pain was the primary condition reported as leading to chronic pain. Semistructured interviews collected data from 16 out of 17 (94%) patients who started the trial, and at final follow-up 9 out of 17 (53%) patients completed questionnaires. Low specificity of the resources to one’s condition and time poorness may have been barriers to engagement. Conclusions: Results suggest that with refinements, this study design can be implemented successfully when conducting a larger social media study. At present, comment cannot be made on what effect using social media can have on patients on hospital waiting lists, nor whether those who use social media while waiting in pain achieve better outcomes from eventual participation in a chronic pain program. Long-term follow-up should be included in future studies to answer this. Future research should focus on multicenter randomized controlled trials, involving patients in the intervention design for improved participation and outcomes and for evidence to be sound. %M 26254245 %R 10.2196/resprot.4621 %U http://www.researchprotocols.org/2015/3/e101/ %U https://doi.org/10.2196/resprot.4621 %U http://www.ncbi.nlm.nih.gov/pubmed/26254245 %0 Journal Article %@ 1929-0748 %I JMIR Publications Inc. %V 4 %N 3 %P e100 %T Ecological Momentary Assessments and Automated Time Series Analysis to Promote Tailored Health Care: A Proof-of-Principle Study %A van der Krieke,Lian %A Emerencia,Ando C %A Bos,Elisabeth H %A Rosmalen,Judith GM %A Riese,Harriëtte %A Aiello,Marco %A Sytema,Sjoerd %A de Jonge,Peter %+ University of Groningen, University Medical Center Groningen, University Center for Psychiatry, Hanzeplein 1, Groningen, 9700 RB, Netherlands, 31 503612108, j.a.j.van.der.krieke@umcg.nl %K ecological momentary assessment %K time series analysis %K vector autoregressive modeling %K Web-based, dynamic effects, automatization %K tailored treatment %D 2015 %7 07.08.2015 %9 Original Paper %J JMIR Res Protoc %G English %X Background: Health promotion can be tailored by combining ecological momentary assessments (EMA) with time series analysis. This combined method allows for studying the temporal order of dynamic relationships among variables, which may provide concrete indications for intervention. However, application of this method in health care practice is hampered because analyses are conducted manually and advanced statistical expertise is required. Objective: This study aims to show how this limitation can be overcome by introducing automated vector autoregressive modeling (VAR) of EMA data and to evaluate its feasibility through comparisons with results of previously published manual analyses. Methods: We developed a Web-based open source application, called AutoVAR, which automates time series analyses of EMA data and provides output that is intended to be interpretable by nonexperts. The statistical technique we used was VAR. AutoVAR tests and evaluates all possible VAR models within a given combinatorial search space and summarizes their results, thereby replacing the researcher’s tasks of conducting the analysis, making an informed selection of models, and choosing the best model. We compared the output of AutoVAR to the output of a previously published manual analysis (n=4). Results: An illustrative example consisting of 4 analyses was provided. Compared to the manual output, the AutoVAR output presents similar model characteristics and statistical results in terms of the Akaike information criterion, the Bayesian information criterion, and the test statistic of the Granger causality test. Conclusions: Results suggest that automated analysis and interpretation of times series is feasible. Compared to a manual procedure, the automated procedure is more robust and can save days of time. These findings may pave the way for using time series analysis for health promotion on a larger scale. AutoVAR was evaluated using the results of a previously conducted manual analysis. Analysis of additional datasets is needed in order to validate and refine the application for general use. %M 26254160 %R 10.2196/resprot.4000 %U http://www.researchprotocols.org/2015/3/e100/ %U https://doi.org/10.2196/resprot.4000 %U http://www.ncbi.nlm.nih.gov/pubmed/26254160 %0 Journal Article %@ 1929-0748 %I JMIR Publications Inc. %V 4 %N 3 %P e90 %T Social Media Use in Research: Engaging Communities in Cohort Studies to Support Recruitment and Retention %A Farina-Henry,Eva %A Waterston,Leo B %A Blaisdell,Laura L %+ Center for Outcomes Research and Evaluation, Maine Medical Center Research Institute, 509 Forest Ave Suite 200, Portland, ME, , United States, 1 207 661 7603, LWaterston@mmc.org %K social media %K longitudinal studies %K pilot project %K community outreach %D 2015 %7 22.07.2015 %9 Original Paper %J JMIR Res Protoc %G English %X Background: This paper presents the first formal evaluation of social media (SM) use in the National Children’s Study (NCS). The NCS is a prospective, longitudinal study of the effects of environment and genetics on children’s health, growth and development. The Study employed a multifaceted community outreach campaign in combination with a SM campaign to educate participants and their communities about the Study. SM essentially erases geographic differences between people due to its omnipresence, which was an important consideration in this multi-site national study. Using SM in the research setting requires an understanding of potential threats to confidentiality and privacy and the role that posted content plays as an extension of the informed consent process. Objective: This pilot demonstrates the feasibility of creating linkages and databases to measure and compare SM with new content and engagement metrics. Methods: Metrics presented include basic use metrics for Facebook as well as newly created metrics to assist with Facebook content and engagement analyses. Results: Increasing Likes per month demonstrates that online communities can be quickly generated. Content and Engagement analyses describe what content of posts NCS Study Centers were using, what content they were posting about, and what the online NCS communities found most engaging. Conclusions: These metrics highlight opportunities to optimize time and effort while determining the content of future posts. Further research about content analysis, optimal metrics to describe engagement in research, the role of localized content and stakeholders, and social media use in participant recruitment is warranted. %M 26201259 %R 10.2196/resprot.4260 %U http://www.researchprotocols.org/2015/3/e90/ %U https://doi.org/10.2196/resprot.4260 %U http://www.ncbi.nlm.nih.gov/pubmed/26201259 %0 Journal Article %@ 1929-0748 %I JMIR Publications Inc. %V 4 %N 3 %P e87 %T Mobile App-Delivered Cognitive Behavioral Therapy for Insomnia: Feasibility and Initial Efficacy Among Veterans With Cannabis Use Disorders %A Babson,Kimberly A %A Ramo,Danielle E %A Baldini,Lisa %A Vandrey,Ryan %A Bonn-Miller,Marcel O %+ National Center for PTSD, VA Palo Alto Health Care System, 795 Willow Road, Menlo Park, CA, 94025, United States, 1 650 493 5000, kimberly.babson@gmail.com %K cannabis %K marijuana %K sleep %K CBT-I %K intervention %D 2015 %7 17.07.2015 %9 Original Paper %J JMIR Res Protoc %G English %X Background: Cannabis is the most frequently used illicit substance in the United States resulting in high rates of cannabis use disorders. Current treatments for cannabis use are often met with high rates of lapse/relapse, tied to (1) behavioral health factors that impact cannabis use such as poor sleep, and (2) access, stigma, supply, and cost of receiving a substance use intervention. Objective: This pilot study examined the feasibility, usability, and changes in cannabis use and sleep difficulties following mobile phone–delivered Cognitive Behavioral Therapy for Insomnia (CBT-I) in the context of a cannabis cessation attempt. Methods: Four male veterans with DSM-5 cannabis use disorder and sleep problems were randomized to receive a 2-week intervention: CBT-I Coach mobile app (n=2) or a placebo control (mood-tracking app) (n=2). Cannabis and sleep measures were assessed pre- and post-treatment. Participants also reported use and helpfulness of each app. Changes in sleep and cannabis use were evaluated for each participant individually. Results: Both participants receiving CBT-I used the app daily over 2 weeks and found the app user-friendly, helpful, and would use it in the future. In addition, they reported decreased cannabis use and improved sleep efficiency; one also reported increased sleep quality. In contrast, one participant in the control group dropped out of the study, and the other used the app minimally and reported increased sleep quality but also increased cannabis use. The mood app was rated as not helpful, and there was low likelihood of future participation. Conclusions: This pilot study examined the feasibility and initial patient acceptance of mobile phone delivery of CBT-I for cannabis dependence. Positive ratings of the app and preliminary reports of reductions in cannabis use and improvements in sleep are both encouraging and support additional evaluation of this intervention. %M 26187404 %R 10.2196/resprot.3852 %U http://www.researchprotocols.org/2015/3/e87/ %U https://doi.org/10.2196/resprot.3852 %U http://www.ncbi.nlm.nih.gov/pubmed/26187404 %0 Journal Article %@ 1929-0748 %I JMIR Publications Inc. %V 4 %N 3 %P e78 %T Collecting and Analyzing Patient Experiences of Health Care From Social Media %A Rastegar-Mojarad,Majid %A Ye,Zhan %A Wall,Daniel %A Murali,Narayana %A Lin,Simon %+ The Research Institute at Nationwide Children's Hospital, 575 Children’s Crossroad, Columbus, OH, 43017, United States, 1 614 355 6629, Simon.Lin@NationwideChildrens.org %K patient satisfaction %K social media %K health care %K natural language processing %K consumer health information %D 2015 %7 02.07.2015 %9 Original Paper %J JMIR Res Protoc %G English %X Background: Social Media, such as Yelp, provides rich information of consumer experience. Previous studies suggest that Yelp can serve as a new source to study patient experience. However, the lack of a corpus of patient reviews causes a major bottleneck for applying computational techniques. Objective: The objective of this study is to create a corpus of patient experience (COPE) and report descriptive statistics to characterize COPE. Methods: Yelp reviews about health care-related businesses were extracted from the Yelp Academic Dataset. Natural language processing (NLP) tools were used to split reviews into sentences, extract noun phrases and adjectives from each sentence, and generate parse trees and dependency trees for each sentence. Sentiment analysis techniques and Hadoop were used to calculate a sentiment score of each sentence and for parallel processing, respectively. Results: COPE contains 79,173 sentences from 6914 patient reviews of 985 health care facilities near 30 universities in the United States. We found that patients wrote longer reviews when they rated the facility poorly (1 or 2 stars). We demonstrated that the computed sentiment scores correlated well with consumer-generated ratings. A consumer vocabulary to describe their health care experience was constructed by a statistical analysis of word counts and co-occurrences in COPE. Conclusions: A corpus called COPE was built as an initial step to utilize social media to understand patient experiences at health care facilities. The corpus is available to download and COPE can be used in future studies to extract knowledge of patients’ experiences from their perspectives. Such information can subsequently inform and provide opportunity to improve the quality of health care. %M 26137885 %R 10.2196/resprot.3433 %U http://www.researchprotocols.org/2015/3/e78/ %U https://doi.org/10.2196/resprot.3433 %U http://www.ncbi.nlm.nih.gov/pubmed/26137885 %0 Journal Article %@ 1929-0748 %I JMIR Publications Inc. %V 4 %N 2 %P e76 %T Using Ecological Momentary Assessment to Study Tobacco Behavior in Urban India: There’s an App for That %A Soong,Andrea %A Chen,Julia Cen %A Borzekowski,Dina LG %+ Institute for Global Tobacco Control, Department of Health, Behavior & Society, Johns Hopkins Bloomberg School of Public Health, 2213 McElderry St, 4th Floor, Baltimore, MD, 21205, United States, 1 410 502 2482, asoong@jhu.edu %K ecological momentary assessment %K tobacco control %K cell phones %K mobile phones %K mHealth %K telemedicine %K smoking %D 2015 %7 24.06.2015 %9 Original Paper %J JMIR Res Protoc %G English %X Background: Ecological momentary assessment (EMA) uses real-time data collection to assess participants’ behaviors and environments. This paper explores the strengths and limitations of using EMA to examine social and environmental exposure to tobacco in urban India among older adolescents and adults. Objective: Objectives of this study were (1) to describe the methods used in an EMA study of tobacco use in urban India using a mobile phone app for data collection, (2) to determine the feasibility of using EMA in the chosen setting by drawing on participant completion and compliance rates with the study protocol, and (3) to provide recommendations on implementing mobile phone EMA research in India and other low- and middle-income countries. Methods: Via mobile phones and the Internet, this study used two EMA surveys: (1) a momentary survey, sent multiple times per day at random to participants, which asked about their real-time tobacco use (smoked and smokeless) and exposure to pro- and antitobacco messaging in their location, and 2) an end-of-day survey sent at the end of each study day. Trained participants, from Hyderabad and Kolkata, India, reported on their social and environmental exposure to tobacco over 10 consecutive days. This feasibility study examined participant compliance, exploring factors related to the successful completion of surveys and the validity of EMA data. Results: The sample included 205 participants, the majority of whom were male (135/205, 65.9%). Almost half smoked less than daily (56/205, 27.3%) or daily (43/205, 21.0%), and 4.4% (9/205) used smokeless tobacco products. Participants completed and returned 46.87% and 73.02% of momentary and end-of-day surveys, respectively. Significant predictors of momentary survey completion included employment and completion of end-of-day surveys. End-of-day survey completion was only significantly predicted by momentary survey completion. Conclusions: This first study of EMA in India offers promising results, although more research is needed on how to increase compliance. End-of-day survey completion, which has a lower research burden, may be the more appropriate approach to understanding behaviors such as tobacco use within vulnerable populations in challenging locations. Compliance may also be improved by increasing the number of study visits, compliance checks, or opportunities for retraining participants before and during data collection. %M 26109369 %R 10.2196/resprot.4408 %U http://www.researchprotocols.org/2015/2/e76/ %U https://doi.org/10.2196/resprot.4408 %U http://www.ncbi.nlm.nih.gov/pubmed/26109369 %0 Journal Article %@ 1929-0748 %I JMIR Publications Inc. %V 4 %N 2 %P e73 %T Rural Versus Urban Health Service Utilization and Outcomes for Renal Patients in New South Wales: Protocol for a Data Linkage Study %A Kotwal,Sradha %A Webster,Angela %A Cass,Alan %A Gallagher,Martin %+ The George Institute for Global Health, Sydney Medical School, University of Sydney, PO M201, Missenden Road, Sydney, 2050, Australia, 61 299934500, skotwal@georgeinstitute.org.au %K end stage kidney disease %K chronic kidney disease %K kidney transplant %K data linkage %K dialysis %K rural health care %K cohort study %D 2015 %7 16.06.2015 %9 Protocol %J JMIR Res Protoc %G English %X Background: Kidney disease is a significant burden on health systems globally, with the rising prevalence of end stage kidney disease in Australia mirrored in many other countries. Approximately 25% of the Australian population lives in regional and rural areas and accessing complex tertiary services is challenging. Objective: We aim to compare the burden and outcomes of chronic kidney disease and end stage kidney disease in rural and urban regions of New South Wales (Australia’s most populous state) using linked health data. Methods: This is a retrospective cohort study and we have defined two cohorts: one with end stage kidney disease and one with chronic kidney disease. The end stage kidney disease cohort was defined using the Australia and New Zealand Dialysis and Transplant Registry, identifying all patients living in NSW receiving renal replacement therapy at any time between 01/07/2000 and 31/07/2010. The chronic kidney disease cohort used the NSW Admitted Patient Data Collection (APDC) to identify patients with a diagnostic code relating to chronic renal failure during any admission between 01/07/2000 and 31/07/2010. Both cohorts were linked to the NSW APDC, the Registry of Births, Deaths and Marriages, and the Central Cancer Registry allowing derivation of outcomes by categories of geographical remoteness. Results: To date, we have identified 10,505 patients with 2,384,218 records in the end stage kidney disease cohort and 159,033 patients with 1,599,770 records in the chronic kidney disease cohort. Conclusions: This study will define the geographical distribution of end stage and chronic kidney disease and compare the health service utilization between rural and urban renal populations. %M 26082088 %R 10.2196/resprot.3299 %U http://www.researchprotocols.org/2015/2/e73/ %U https://doi.org/10.2196/resprot.3299 %U http://www.ncbi.nlm.nih.gov/pubmed/26082088 %0 Journal Article %@ 1929-0748 %I JMIR Publications Inc. %V 4 %N 2 %P e66 %T Effective Strategies to Recruit Young Adults Into the TXT2BFiT mHealth Randomized Controlled Trial for Weight Gain Prevention %A Partridge,Stephanie R %A Balestracci,Kate %A Wong,Annette TY %A Hebden,Lana %A McGeechan,Kevin %A Denney-Wilson,Elizabeth %A Harris,Mark F %A Phongsavan,Philayrath %A Bauman,Adrian %A Allman-Farinelli,Margaret %+ School of Molecular Bioscience, The University of Sydney, Level 4 East, Charles Perkins Centre, Sydney, 2006, Australia, 61 286271697, stephanie.partridge@sydney.edu.au %K recruitment %K young adults %K mHealth %K eHealth %K weight gain prevention %K external validity %K cost %D 2015 %7 05.06.2015 %9 Original Paper %J JMIR Res Protoc %G English %X Background: Younger adults are difficult to engage in preventive health, yet in Australia they are gaining more weight and increasing in waist circumference faster than middle-to-older adults. A further challenge to engaging 18- to 35-year-olds in interventions is the limited reporting of outcomes of recruitment strategies. Objective: This paper describes the outcomes of strategies used to recruit young adults to a randomized controlled trial (RCT), healthy lifestyle mHealth program, TXT2BFiT, for prevention of weight gain. The progression from enquiry through eligibility check to randomization into the trial and the costs of recruitment strategies are reported. Factors associated with nonparticipation are explored. Methods: Participants were recruited either via letters of invitation from general practitioners (GPs) or via electronic or print advertisements, including Facebook and Google—social media and advertising—university electronic newsletters, printed posters, mailbox drops, and newspapers. Participants recruited from GP invitation letters had an appointment booked with their GP for eligibility screening. Those recruited from other methods were sent an information pack to seek approval to participate from their own GP. The total number and source of enquiries were categorized according to eligibility and subsequent completion of steps to enrolment. Cost data and details of recruitment strategies were recorded. Results: From 1181 enquiries in total from all strategies, 250 (21.17%) participants were randomized. A total of 5311 invitation letters were sent from 12 GP practices—16 participating GPs. A total of 131 patients enquired with 68 participants randomized (68/74 of those eligible, 92%). The other recruitment methods yielded the remaining 182 randomized participants. Enrolment from print media was 26% of enquiries, from electronic media was 20%, and from other methods was 3%. Across all strategies the average cost of recruitment was Australian Dollar (AUD) $139 per person. The least expensive modality was electronic (AUD $37), largely due to a free feature story on one university Web home page, despite Facebook advertising costing AUD $945 per enrolment. The most expensive was print media at AUD $213 and GP letters at AUD $145 per enrolment. Conclusions: The research indicated that free electronic media was the most cost-effective strategy, with GP letters the least expensive of the paid strategies in comparison to the other strategies. This study is an important contribution for future research into efficacy, translation, and implementation of cost-effective programs for the prevention of weight gain in young adults. Procedural frameworks for recruitment protocols are required, along with systematic reporting of recruitment strategies to reduce unnecessary expenditure and allow for valuable public health prevention programs to go beyond the research setting. Trial Registration: Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12612000924853; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=362872 (Archived by WebCite at http://www.webcitation.org/6YpNfv1gI). %M 26048581 %R 10.2196/resprot.4268 %U http://www.researchprotocols.org/2015/2/e66/ %U https://doi.org/10.2196/resprot.4268 %U http://www.ncbi.nlm.nih.gov/pubmed/26048581 %0 Journal Article %@ 1929-0748 %I JMIR Publications Inc. %V 4 %N 2 %P e67 %T Feasibility of a Dynamic Web Guidance Approach for Personalized Physical Activity Prescription Based on Daily Information From Wearable Technology %A Coolbaugh,Crystal L %A Raymond Jr,Stephen C %A Hawkins,David A %+ University of California - Davis, Department of Neurobiology, Physiology and Behavior, Room 196 Briggs Hall, One Shields Avenue, Davis, CA, 95616, United States, 1 530 752 2748, dahawkins@ucdavis.edu %K exercise %K Web-based interventions %K activity monitoring %K physical fitness %K algorithms %D 2015 %7 04.06.2015 %9 Original Paper %J JMIR Res Protoc %G English %X Background: Computer tailored, Web-based interventions have emerged as an effective approach to promote physical activity. Existing programs, however, do not adjust activities according to the participant’s compliance or physiologic adaptations, which may increase risk of injury and program attrition in sedentary adults. To address this limitation, objective activity monitor (AM) and heart rate data could be used to guide personalization of physical activity, but improved Web-based frameworks are needed to test such interventions. Objective: The objective of this study is to (1) develop a personalized physical activity prescription (PPAP) app that combines dynamic Web-based guidance with multi-sensor AM data to promote physical activity and (2) to assess the feasibility of using this system in the field. Methods: The PPAP app was constructed using an open-source software platform and a custom, multi-sensor AM capable of accurately measuring heart rate and physical activity. A novel algorithm was written to use a participant’s compliance and physiologic response to aerobic training (ie, changes in daily resting heart rate) recorded by the AM to create daily, personalized physical activity prescriptions. In addition, the PPAP app was designed to (1) manage the transfer of files from the AM to data processing software and a relational database, (2) provide interactive visualization features such as calendars and training tables to encourage physical activity, and (3) enable remote administrative monitoring of data quality and participant compliance. A 12-week feasibility study was performed to assess the utility and limitations of the PPAP app used by sedentary adults in the field. Changes in physical activity level and resting heart rate were monitored throughout the intervention. Results: The PPAP app successfully created daily, personalized physical activity prescriptions and an interactive Web environment to guide and promote physical activity by the participants. The varied compliance of the participants enabled evaluation of administrative features of the app including the generation of automated email reminders, participation surveys, and daily AM file upload logs. Conclusions: This study describes the development of the PPAP app, a closed-loop technology framework that enables personalized physical activity prescription and remote monitoring of an individual’s compliance and health response to the intervention. Data obtained during a 12-week feasibility study demonstrated the ability of the PPAP app to use objective AM data to create daily, personalized physical activity guidance, provide interactive feedback to users, and enable remote administrative monitoring of data quality and subject compliance. Using this approach, public health professionals, clinicians, and researchers can adapt the PPAP app to facilitate a range of personalized physical activity interventions to improve health outcomes, assess injury risk, and achieve fitness performance goals in diverse populations. %M 26043793 %R 10.2196/resprot.3966 %U http://www.researchprotocols.org/2015/2/e67/ %U https://doi.org/10.2196/resprot.3966 %U http://www.ncbi.nlm.nih.gov/pubmed/26043793 %0 Journal Article %@ 1929-0748 %I JMIR Publications Inc. %V 4 %N 2 %P e63 %T Using Facebook to Recruit Young Adult Veterans: Online Mental Health Research %A Pedersen,Eric R %A Helmuth,Eric D %A Marshall,Grant N %A Schell,Terry L %A PunKay,Marc %A Kurz,Jeremy %+ RAND, Department of Behavioral and Policy Sciences, 1776 Main Street, Santa Monica, CA, 90407, United States, 1 13103930411 ext 6078, ericp@rand.org %K alcohol %K Facebook %K Internet %K mental health %K online %K young adult veterans %D 2015 %7 01.06.2015 %9 Original Paper %J JMIR Res Protoc %G English %X Background: Veteran research has primarily been conducted with clinical samples and those already involved in health care systems, but much is to be learned about veterans in the community. Facebook is a novel yet largely unexplored avenue for recruiting veteran participants for epidemiological and clinical studies. Objective: In this study, we utilized Facebook to recruit a sample of young adult veterans for the first phase of an online alcohol intervention study. We describe the successful Facebook recruitment process, including data collection from over 1000 veteran participants in approximately 3 weeks, procedures to verify participation eligibility, and comparison of our sample with nationally available norms. Methods: Participants were young adult veterans aged 18-34 recruited through Facebook as part of a large study to document normative drinking behavior among a large community sample of veterans. Facebook ads were targeted toward young veterans to collect information on demographics and military characteristics, health behaviors, mental health, and health care utilization. Results: We obtained a sample of 1023 verified veteran participants over a period of 24 days for the advertising price of approximately US $7.05 per verified veteran participant. Our recruitment strategy yielded a sample similar to the US population of young adult veterans in most demographic areas except for race/ethnicity and previous branch of service, which when we weighted the sample on race/ethnicity and branch a sample better matched with the population data was obtained. The Facebook sample recruited veterans who were engaged in a variety of risky health behaviors such as binge drinking and marijuana use. One fourth of veterans had never since discharge been to an appointment for physical health care and about half had attended an appointment for service compensation review. Only half had attended any appointment for a mental health concern at any clinic or hospital. Despite more than half screening positive for current probable mental health disorders such as post-traumatic stress disorder, depression, anxiety, only about 1 in 3 received mental health care in the past year and only 1 in 50 received such care within the past month. Conclusions: This work expands on the work of other studies that have examined clinical samples of veterans only and suggests Facebook can be an adequate method of obtaining samples of veterans in need of care. Trial Registration: Clinicaltrials.gov NCT02187887; http://clinicaltrials.gov/ct2/show/NCT02187887 (Archived by WebCite at http://www.webcitation.org/6YiUKRsXY). %M 26033209 %R 10.2196/resprot.3996 %U http://www.researchprotocols.org/2015/2/e63/ %U https://doi.org/10.2196/resprot.3996 %U http://www.ncbi.nlm.nih.gov/pubmed/26033209 %0 Journal Article %@ 1929-0748 %I JMIR Publications Inc. %V 4 %N 2 %P e53 %T Feasibility of Using a Multilingual Web Survey in Studying the Health of Ethnic Minority Youth %A Kinnunen,Jaana Maarit %A Malin,Maili %A Raisamo,Susanna Ulrika %A Lindfors,Pirjo Liisa %A Pere,Lasse Antero %A Rimpelä,Arja Hannele %+ School of Health Sciences, University of Tampere, FI-33014 University of Tampere, Tampere, 33014, Finland, 358 40 190 1667, jaana.m.kinnunen@uta.fi %K feasibility %K Web survey %K ethnic minority %K adolescents %K response rate %K representativeness %K multilingual %D 2015 %7 07.05.2015 %9 Original Paper %J JMIR Res Protoc %G English %X Background: Monolingual Web survey is a common tool for studying adolescent health. However, national languages may cause difficulties for some immigrant-origin youths, which lower their participation rate. In national surveys, the number of ethnic minority groups is often too small to assess their well-being. Objective: We studied the feasibility of a multilingual Web survey targeted at immigrant-origin youths by selection of response language, and compared participation in different language groups with a monolingual survey. Methods: The Adolescent Health and Lifestyle Survey (AHLS), Finland, with national languages (Finnish/Swedish) was modified into a multilingual Web survey targeted at a representative sample of 14- and 16-year olds (N=639) whose registry-based mother tongue was other than the national languages. The survey was conducted in 2010 (16-year olds) and 2011 (14-year olds). The response rate of the multilingual survey in 2011 is compared with the AHLS of 2011. We also describe the translation process and the e-form modification. Results: Of the respondents, 57.6% answered in Finnish, whereas the remaining 42.4% used their mother tongue (P=.002). A majority of youth speaking Somali, Middle Eastern, Albanian, and Southeast Asian languages chose Finnish. The overall response rate was 48.7% with some nonsignificant variation between the language groups. The response rate in the multilingual Web survey was higher (51.6%, 163/316) than the survey with national languages (46.5%, 40/86) in the same age group; however, the difference was not significant (P=.47). The adolescents who had lived in Finland for 5 years or less (58.0%, 102/176) had a higher response rate than those having lived in Finland for more than 5 years (45.1%, 209/463; P=.005). Respondents and nonrespondents did not differ according to place of birth (Finland/other) or residential area (capital city area/other). The difference in the response rates of girls and boys was nearly significant (P=.06). Girls of the Somali and Middle Eastern language groups were underrepresented among the respondents. Conclusions: A multilingual Web survey is a feasible method for gathering data from ethnic youth, although it does not necessarily yield a higher response rate than a monolingual survey. The respondents answered more often in the official language of the host country than their mother tongue. The varying response rates by time of residence, ethnicity, and gender pose challenges for developing tempting surveys for youth. %M 25953412 %R 10.2196/resprot.3655 %U http://www.researchprotocols.org/2015/2/e53/ %U https://doi.org/10.2196/resprot.3655 %U http://www.ncbi.nlm.nih.gov/pubmed/25953412 %0 Journal Article %@ 1929-0748 %I JMIR Publications Inc. %V 4 %N 2 %P e46 %T Recruiting Migrants for Health Research Through Social Network Sites: An Online Survey Among Chinese Migrants in Australia %A Hu,Jie %A Wong,Kam Cheong %A Wang,Zhiqiang %+ Center for Chronic Disease, School of Medicine, University of Queensland, 828B, Health Science Building, Royal Brisbane and Women's Hospital, Herston, 4029, Australia, 61 7 33464831, j.hu1@uq.edu.au %K Chinese migrants %K online survey %K recruiting %D 2015 %7 27.04.2015 %9 Original Paper %J JMIR Res Protoc %G English %X Background: Traditionally, postal surveys or face to face interviews are the main approaches for health researchers to obtain essential research data. However, with the prevalence of information technology and Internet, Web-based surveys are gaining popularity in health research. Objective: This study aims to report the process and outcomes of recruiting Chinese migrants through social network sites in Australia and to examine the sample characteristics of online recruitment by comparing the sample which was recruited by an online survey to a sample of Australian Chinese migrants collected by a postal survey. Methods: Descriptive analyses were performed to describe and compare the process and outcomes of online recruitment with postal survey questionnaires. Chi square tests and t tests were performed to assess the differences between the two samples for categorical and continuous variables respectively. Results: In total, 473 Chinese migrants completed the online health survey from July to October 2013. Out of 426 participants recruited through the three Chinese social network sites in Australia, over 86.6% (369/426) were recruited within six weeks. Participants of the Web-based survey were younger, with a higher education level or had resided in Australia for less time compared to those recruited via a postal survey. However, there was no significant difference in gender, marital status, and professional occupation. Conclusions: The recruitment of Chinese migrants through social network sites in our online survey was feasible. Compared to a postal survey of Chinese migrants, the online survey attracted different group of Chinese migrants who may have diverse health needs and concerns. Our findings provided insightful information for researchers who are considering employing a Web-based approach to recruit migrants and ethnic minority participants. %M 25917837 %R 10.2196/resprot.3960 %U http://www.researchprotocols.org/2015/2/e46/ %U https://doi.org/10.2196/resprot.3960 %U http://www.ncbi.nlm.nih.gov/pubmed/25917837 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 17 %N 4 %P e95 %T A New Method for Assessing Content Validity in Model-Based Creation and Iteration of eHealth Interventions %A Kassam-Adams,Nancy %A Marsac,Meghan L %A Kohser,Kristen L %A Kenardy,Justin A %A March,Sonja %A Winston,Flaura K %+ Center for Injury Research and Prevention, Children's Hospital of Philadelphia, 3535 Market St, Suite 1150, Philadelphia, PA, 19104, United States, 1 2155903118, nlkaphd@mail.med.upenn.edu %K telemedicine %K methods %K stress disorders, post-traumatic %K child %K secondary prevention %D 2015 %7 15.04.2015 %9 Original Paper %J J Med Internet Res %G English %X Background: The advent of eHealth interventions to address psychological concerns and health behaviors has created new opportunities, including the ability to optimize the effectiveness of intervention activities and then deliver these activities consistently to a large number of individuals in need. Given that eHealth interventions grounded in a well-delineated theoretical model for change are more likely to be effective and that eHealth interventions can be costly to develop, assuring the match of final intervention content and activities to the underlying model is a key step. We propose to apply the concept of “content validity” as a crucial checkpoint to evaluate the extent to which proposed intervention activities in an eHealth intervention program are valid (eg, relevant and likely to be effective) for the specific mechanism of change that each is intended to target and the intended target population for the intervention. Objective: The aims of this paper are to define content validity as it applies to model-based eHealth intervention development, to present a feasible method for assessing content validity in this context, and to describe the implementation of this new method during the development of a Web-based intervention for children. Methods: We designed a practical 5-step method for assessing content validity in eHealth interventions that includes defining key intervention targets, delineating intervention activity-target pairings, identifying experts and using a survey tool to gather expert ratings of the relevance of each activity to its intended target, its likely effectiveness in achieving the intended target, and its appropriateness with a specific intended audience, and then using quantitative and qualitative results to identify intervention activities that may need modification. We applied this method during our development of the Coping Coach Web-based intervention for school-age children. Results: In the evaluation of Coping Coach content validity, 15 experts from five countries rated each of 15 intervention activity-target pairings. Based on quantitative indices, content validity was excellent for relevance and good for likely effectiveness and age-appropriateness. Two intervention activities had item-level indicators that suggested the need for further review and potential revision by the development team. Conclusions: This project demonstrated that assessment of content validity can be straightforward and feasible to implement and that results of this assessment provide useful information for ongoing development and iterations of new eHealth interventions, complementing other sources of information (eg, user feedback, effectiveness evaluations). This approach can be utilized at one or more points during the development process to guide ongoing optimization of eHealth interventions. %M 25881584 %R 10.2196/jmir.3811 %U http://www.jmir.org/2015/4/e95/ %U https://doi.org/10.2196/jmir.3811 %U http://www.ncbi.nlm.nih.gov/pubmed/25881584 %0 Journal Article %@ 2291-5222 %I JMIR Publications Inc. %V 3 %N 2 %P e34 %T Identifying Factors Associated With Dropout During Prerandomization Run-in Period From an mHealth Physical Activity Education Study: The mPED Trial %A Fukuoka,Yoshimi %A Gay,Caryl %A Haskell,William %A Arai,Shoshana %A Vittinghoff,Eric %+ Institute for Health & Aging, Department of Social and Behavioral Sciences, University of California, San Francisco, #LHts-340, 3333 California St, San Francisco, CA, 94143-0646, United States, 1 415 476 8419, Yoshimi.Fukuoka@ucsf.edu %K run-in period %K eligibility %K randomized controlled trial %K pedometer %K mobile phone %K mHealth %D 2015 %7 13.04.2015 %9 Original Paper %J JMIR mHealth uHealth %G English %X Background: The mobile phone-based physical activity education (mPED) trial is a randomized controlled trial (RCT) evaluating a mobile phone-delivered physical activity intervention for women. The study includes a run-in period to maximize the internal validity of the intervention trial, but little is known about factors related to successful run-in completion, and thus about potential threats to external validity. Objective: Objectives of this study are (1) to determine the timing of dropout during the run-in period, reasons for dropout, optimum run-in duration, and relevant run-in components, and (2) to identify predictors of failure to complete the run-in period. Methods: A total of 318 physically inactive women met preliminary eligibility criteria and were enrolled in the study between May 2011 and April 2014. A 3-week run-in period was required prior to randomization and included using a mobile phone app and wearing a pedometer. Cross-sectional analysis identified predictors of dropout. Results: Out of 318 participants, 108 (34.0%) dropped out prior to randomization, with poor adherence using the study equipment being the most common reason. Median failure time was 17 days into the run-in period. In univariate analyses, nonrandomized participants were younger, had lower income, were less likely to drive regularly, were less likely to have used a pedometer prior to the study, were generally less healthy, had less self-efficacy for physical activity, and reported more depressive symptoms than randomized participants. In multivariate competing risks models, not driving regularly in the past month and not having used a pedometer prior to the study were significantly associated with failure to be randomized (P=.04 and .006, respectively), controlling for age, race/ethnicity, education, shift work, and use of a study-provided mobile phone. Conclusions: Regular driving and past pedometer use were associated with reduced dropout during the prerandomization run-in period. Understanding these characteristics is important for identifying higher-risk participants, and implementing additional help strategies may be useful for reducing dropout. Trial Registration: ClinicalTrials.gov NCT01280812; https://clinicaltrials.gov/ct2/show/NCT01280812 (Archived by WebCite at http://www.webcitation.org/6XFC5wvrP). %M 25872754 %R 10.2196/mhealth.3928 %U http://mhealth.jmir.org/2015/2/e34/ %U https://doi.org/10.2196/mhealth.3928 %U http://www.ncbi.nlm.nih.gov/pubmed/25872754 %0 Journal Article %@ 1929-0748 %I JMIR Publications Inc. %V 4 %N 1 %P e34 %T Focus Groups Move Online: Feasibility of Tumblr Use for eHealth Curriculum Development %A Elliot,Diane %A Rohlman,Diane %A Parish,Megan %+ Oregon Health & Science University, Department of Medicine, CR110, 3181 SW Sam Jackson Park Road, Portland, OR, 97239, United States, 1 503 494 6554, elliotd@ohsu.edu %K Tumblr %K focus group %K crowdsourcing %K curriculum development %K Internet %D 2015 %7 27.03.2015 %9 Short Paper %J JMIR Res Protoc %G English %X Background: Constructing successful online programs requires engaging potential users in development. However, assembling focus groups can be costly and time consuming. Objective: The aim of this study is to assess whether Tumblr can be used to prioritize activities for an online younger worker risk reduction and health promotion program. Methods: Younger summer parks and recreation employees were encouraged to visit Tumblr using weekly announcements and competitions. Each week, new activities were posted on Tumblr with linked survey questions. Responses were downloaded and analyzed. Results: An average of 36 young workers rated each activity on its likeability and perceived educational value. The method was feasible, efficient, and sustainable across the summer weeks. Ratings indicated significant differences in likeability among activities (P<.005). Conclusions: Tumblr is a means to crowdsource formative feedback on potential curricular components when assembling an online intervention. This paper describes its initial use as well as suggestions for future refinements. %M 25831197 %R 10.2196/resprot.3432 %U http://www.researchprotocols.org/2015/1/e34/ %U https://doi.org/10.2196/resprot.3432 %U http://www.ncbi.nlm.nih.gov/pubmed/25831197 %0 Journal Article %@ 1929-0748 %I JMIR Publications Inc. %V 4 %N 1 %P e32 %T Care Models of eHealth Services: A Case Study on the Design of a Business Model for an Online Precare Service %A van Meeuwen,Dorine PD %A van Walt Meijer,Quirine J %A Simonse,Lianne WL %+ Product Innovation Management department, Faculty of Industrial Design Engineering, Delft University of Technology, Building 32 B-4-160, Landbergstraat 15, Delft, 2628 CE, Netherlands, 31 15 27 89054, L.W.L.Simonse@tudelft.nl %K eHealth %K business model innovation %K strategic design %K precare %K service design %K visual modeling method %K care model %D 2015 %7 24.03.2015 %9 Original Paper %J JMIR Res Protoc %G English %X Background: With a growing population of health care clients in the future, the organization of high-quality and cost-effective service providing becomes an increasing challenge. New online eHealth services are proposed as innovative options for the future. Yet, a major barrier to these services appears to be the lack of new business model designs. Although design efforts generally result in visual models, no such artifacts have been found in the literature on business model design. This paper investigates business model design in eHealth service practices from a design perspective. It adopts a research by design approach and seeks to unravel what characteristics of business models determine an online service and what are important value exchanges between health professionals and clients. Objective: The objective of the study was to analyze the construction of care models in-depth, framing the essential elements of a business model, and design a new care model that structures these elements for the particular context of an online pre-care service in practice. Methods: This research employs a qualitative method of an in-depth case study in which different perspectives on constructing a care model are investigated. Data are collected by using the visual business modeling toolkit, designed to cocreate and visualize the business model. The cocreated models are transcribed and analyzed per actor perspective, transactions, and value attributes. Results: We revealed eight new actors in the business model for providing the service. Essential actors are: the intermediary network coordinator connecting companies, the service dedicated information technology specialists, and the service dedicated health specialist. In the transactions for every service providing we found a certain type of contract, such as a license contract and service contracts for precare services and software products. In addition to the efficiency, quality, and convenience, important value attributes appeared to be: timelines, privacy and credibility, availability, pleasantness, and social interaction. Based on the in-depth insights from the actor perspectives, the business model for online precare services is modeled with a visual design. A new care model of the online precare service is designed and compiled of building blocks for the business model. Conclusions: For the construction of a care model, actors, transactions, and value attributes are essential elements. The design of a care model structures these elements in a visual way. Guided by the business modeling toolkit, the care model design artifact is visualized in the context of an online precare service. Important building blocks include: provision of an online flow of information with regular interactions to the client stimulates self-management of personal health and service-dedicated health expert ensure an increase of the perceived quality of the eHealth service. %M 25831094 %R 10.2196/resprot.3501 %U http://www.researchprotocols.org/2015/1/e32/ %U https://doi.org/10.2196/resprot.3501 %U http://www.ncbi.nlm.nih.gov/pubmed/25831094 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 17 %N 3 %P e73 %T Web-Based Self-Reported Height, Weight, and Body Mass Index Among Swedish Adolescents: A Validation Study %A Ekström,Sandra %A Kull,Inger %A Nilsson,Sara %A Bergström,Anna %+ Institute of Environmental Medicine, Karolinska Institutet, BOX 210, Stockholm, 17177, Sweden, 46 852487010, Sandra.Ekstrom@ki.se %K adolescent %K body height %K body weight %K body mass index %K validity %K Internet %D 2015 %7 18.03.2015 %9 Original Paper %J J Med Internet Res %G English %X Background: Web-collected height and weight are increasingly used in epidemiological studies; however, the validity has rarely been evaluated. Objective: The aim of the study was to validate self-reported height, weight, and corresponding body mass index (BMI) among Swedish adolescents aged approximately 16 years. A secondary aim was to investigate possible prediction factors for validity of self-reported BMI. Methods: The study included 1698 adolescents from the population-based cohort BAMSE. Height and weight were collected through a Web-based questionnaire and subsequently measured using standard procedures. Differences between reported and measured height, weight, and corresponding BMI were compared by t tests and agreement was evaluated by Pearson correlation and Bland-Altman plots. Multivariable linear regression analysis was used to investigate whether lifestyle and demographic factors predicted validity of self-reported BMI. Results: On average, weight was underestimated by 1.1 kg and height was overestimated by 0.5 cm, leading to an underestimation of BMI by 0.5 kg/m2. Correlation coefficients were .98 for height, .97 for weight, and .94 for BMI, and highly significant. Females underestimated weight to a higher extent than males and overweight and obese participants underestimated weight to a higher extent than normal-weight participants, which resulted in higher underestimation of BMI. Underweight participants, on the contrary, overestimated weight and correspondingly BMI. Overall, a high proportion of participants were classified into the correct BMI category; however, among overweight and obese participants, only 60.2% (139/231) and 46% (20/44) were correctly classified, respectively. In the multivariable prediction model, only gender and BMI status significantly predicted discrepancy between reported and measured BMI. Conclusions: Web-collected BMI may be used as a valid, quick, and cost-effective alternative to measured BMI among Swedish adolescents. The accuracy of self-reported BMI declines with increasing BMI and self-reported BMI should not be used to estimate the prevalence of overweight or obesity. %M 25791395 %R 10.2196/jmir.3947 %U http://www.jmir.org/2015/3/e73/ %U https://doi.org/10.2196/jmir.3947 %U http://www.ncbi.nlm.nih.gov/pubmed/25791395 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 17 %N 1 %P e28 %T Developing Internet-Based Health Interventions: A Guide for Public Health Researchers and Practitioners %A Horvath,Keith J %A Ecklund,Alexandra M %A Hunt,Shanda L %A Nelson,Toben F %A Toomey,Traci L %+ Division of Epidemiology and Community Health, University of Minnesota, 1300 S. 2nd Street, Suite 300, Minneapolis, MN, 55454, United States, 1 612 626 1799, horva018@umn.edu %K Internet %K public health %K intervention %K development %D 2015 %7 23.01.2015 %9 Original Paper %J J Med Internet Res %G English %X Background: Researchers and practitioners interested in developing online health interventions most often rely on Web-based and print resources to guide them through the process of online intervention development. Although useful for understanding many aspects of best practices for website development, missing from these resources are concrete examples of experiences in online intervention development for health apps from the perspective of those conducting online health interventions. Objective: This study aims to serve as a series of case studies in the development of online health interventions to provide insights for researchers and practitioners who are considering technology-based interventional or programmatic approaches. Methods: A convenience sample of six study coordinators and five principal investigators at a large, US-based land grant university were interviewed about the process of developing online interventions in the areas of alcohol policy, adolescent health, medication adherence, and human immunodeficiency virus prevention in transgender persons and in men who have sex with men. Participants were asked questions that broadly addressed each of the four phases of the User-Centered Design Process Map from the US Department of Health and Human Services' Research-Based Web Design & Usability Guidelines. Interviews were audio recorded and transcribed. Qualitative codes were developed using line-by-line open coding for all transcripts, and all transcripts were coded independently by at least 2 authors. Differences among coders were resolved with discussion. Results: We identified the following seven themes: (1) hire a strong (or at least the right) research team, (2) take time to plan before beginning the design process, (3) recognize that vendors and researchers have differing values, objectives, and language, (4) develop a detailed contract, (5) document all decisions and development activities, (6) use a content management system, and (7) allow extra time for testing and debugging your intervention. Each of these areas is discussed in detail, with supporting quotations from principal investigators and study coordinators. Conclusions: The values held by members of each participating organization involved in the development of the online intervention or program, as well as the objectives that are trying to be met with the website, must be considered. These defined values and objectives should prompt an open and explicit discussion about the scope of work, budget, and other needs from the perspectives of each organization. Because of the complexity of developing online interventions, researchers and practitioners should become familiar with the process and how it may differ from the development and implementation of in-person interventions or programs. To assist with this, the intervention team should consider expanding the team to include experts in computer science or learning technologies, as well as taking advantage of institutional resources that will be needed for successful completion of the project. Finally, we describe the tradeoff between funds available for online intervention or program development and the complexity of the project. %M 25650702 %R 10.2196/jmir.3770 %U http://www.jmir.org/2015/1/e28/ %U https://doi.org/10.2196/jmir.3770 %U http://www.ncbi.nlm.nih.gov/pubmed/25650702 %0 Journal Article %@ 1929-0748 %I JMIR Publications Inc. %V 4 %N 1 %P e5 %T An Accumulated Activity Effective Index for Promoting Physical Activity: A Design and Development Study in a Mobile and Pervasive Health Context %A Liu,Chung-Tse %A Chan,Chia-Tai %+ Department of Biomedical Engineering, National Yang-Ming University, No.155, Sec.2, Linong Street, Taipei, , Taiwan, 886 2 2826 7000 ext 7371, ctchan@ym.edu.tw %K accumulated activity effective index (AAEI) %K physical activity %K activity level %D 2015 %7 06.01.2015 %9 Original Paper %J JMIR Res Protoc %G English %X Background: Increased physical activity has become a principal personal health goal worldwide because sufficient physical activity can reduce the risk of many adverse conditions. Motivating individuals to increase their levels of physical activity can increase life expectancy and contribute to a healthy life. Sharing and comparison of physical activity information by using the Internet, with fewer privacy concerns, might also help encourage people to promote and maintain sufficient physical activity. To promote and manage physical activity, an accumulated activity effective index (AAEI) is proposed in this paper. Objective: The purpose of the AAEI design is to maintain and promote physical activity. The public can easily accept a clear indicator that reveals the current status of physical activity. The AAEI is not only an assessment and tracking tool for personal physical activity, but is also useful for goal setting and for sharing content with the Internet community. Methods: The AAEI is derived from input in the form of accumulated physical activity, and evaluates the status of physical activities and days spent exercising. The term AAEI(t1,t2) is an index of the accumulated physical activity in the time interval (t1,t2), where the base unit of time is the day. The AAEI is determined according to accumulated physical activity and is adjusted using the previous status of physical activity. The previous status of physical activity is estimated according to the number of days spent exercising and the accumulated physical activity that has been performed. An analysis of the AAEI performance was conducted using a simulation model and a real-world trial with 2 participants. Results: The AAEI increased as the physical activity and days spent exercising accumulated. Conversely, the AAEI decreased with lack of physical activity and increased resting days. In simulation, the shape of the AAEI line indicated different types of exercise. The moving average AAEI represented long-term exercise. In the real-world trial, the AAEI confirmed that the simulation results were comparable to actual conditions. Conclusions: The AAEI proposed in this paper is a method that can be used to evaluate the status of a person’s physical activity. The AAEI is a simple numeric indication that is estimated by analyzing accumulated physical activity and the average number of days spent exercising. The AAEI is suitable for tracking personal physical activity, reminding the user of achievement goals, and allows data sharing by using the Internet. The results have demonstrated that the AAEI is a useful tool for physical activity management. %M 25563899 %R 10.2196/resprot.3336 %U http://www.researchprotocols.org/2015/1/e5/ %U https://doi.org/10.2196/resprot.3336 %U http://www.ncbi.nlm.nih.gov/pubmed/25563899 %0 Journal Article %@ 1929-0748 %I JMIR Publications Inc. %V 4 %N 1 %P e4 %T Do Extreme Values of Daily-Life Gait Characteristics Provide More Information About Fall Risk Than Median Values? %A Rispens,Sietse M %A van Schooten,Kimberley S %A Pijnappels,Mirjam %A Daffertshofer,Andreas %A Beek,Peter J %A van Dieën,Jaap H %+ MOVE Research Institute Amsterdam, Faculty of Human Movement Sciences, VU University Amsterdam, van der Boechorststraat 9, Amsterdam, 1081 BT, Netherlands, 31 20 59 88467, m.pijnappels@vu.nl %K accidental falls %K risk assessment %K accelerometry %K activities of daily living %K gait %K walking %K logistic models %K aged %D 2015 %7 05.01.2015 %9 Original Paper %J JMIR Res Protoc %G English %X Background: Gait characteristics estimated from daily-life trunk accelerations reflect gait quality and are associated with fall incidence in older adults. While associations are based on median values of these gait characteristics, their extreme values may reflect either high-risk situations or steady-state gait and may thus be more informative in relation to fall risk. Objective: The objective of this study was to improve fall-risk prediction models by examining whether the use of extreme values strengthens the associations with falls. Methods: Trunk acceleration data (Dynaport MoveMonitor) were collected from 202 older adults over a full week. From all walking episodes, we estimated the median and, as reliable estimates of the extremes, the 10th and 90th percentiles of gait characteristics, all over 10-second epochs. In addition, the amount of daily activities was derived from the acceleration data, and participants completed fall-risk questionnaires. Participants were classified as fallers based on one or more falls during 6 months of follow-up. Univariate analyses were performed to investigate whether associations with falls were stronger for the extremes than for the medians. Subsequently, three fall-risk models were compared: (1) using questionnaire data only, (2) adding the amount of activities and medians of gait characteristics, and (3) using extreme values instead of medians in the case of stronger univariate associations of the extremes. Results: Stronger associations were found for the extreme characteristics reflecting high regularity, low frequency variability, and low local instability in anterior-posterior direction, for high symmetry in all directions and for low entropy in anterior-posterior and vertical directions. The questionnaire-only model improved significantly by adding activities and gait characteristics’ medians. Replacing medians by extremes with stronger associations did improve the fall prediction model, but not significantly. Conclusions: Associations were stronger for extreme values, indicating “high gait quality” situations (ie, 10th and 90th percentiles in case of positive and negative associations, respectively) and not for “low gait quality” situations. This suggests that gait characteristics during optimal performance gait provide more information about the risk of falling than high-risk situations. However, their added value over medians in prediction is limited. %M 25560937 %R 10.2196/resprot.3931 %U http://www.researchprotocols.org/2015/1/e4/ %U https://doi.org/10.2196/resprot.3931 %U http://www.ncbi.nlm.nih.gov/pubmed/25560937 %0 Journal Article %@ 1929-0748 %I JMIR Publications Inc. %V 3 %N 4 %P e77 %T Gestational Age Assessment in the Ghana Randomized Air Pollution and Health Study (GRAPHS): Ultrasound Capacity Building, Fetal Biometry Protocol Development, and Ongoing Quality Control %A Boamah,Ellen A %A Asante,KP %A Ae-Ngibise,KA %A Kinney,Patrick L %A Jack,Darby W %A Manu,Grace %A Azindow,Irene T %A Owusu-Agyei,Seth %A Wylie,Blair J %+ Massachusetts General Hospital, Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Harvard Medical School, 55 Fruit Street, Boston, MA, 02114, United States, 1 617 643 4331, bwylie@partners.org %K ultrasound %K capacity building %K gestational age %K biometry %K household air pollution %D 2014 %7 18.12.2014 %9 Protocol %J JMIR Res Protoc %G English %X Background: Four million premature deaths occur yearly as a result of smoke from cooking fires. The Ghana Randomized Air Pollution and Health Study (GRAPHS) is underway in the Kintampo North municipality and South district of rural Ghana to evaluate the impact of improved cook stoves introduced during pregnancy on birth weight and childhood pneumonia. These hypotheses are being tested in a cluster-randomized intervention trial among 1415 maternal-infant pairs within 35 communities assigned to a control arm (traditional cooking) or one of two intervention arms (cooking with an improved biomass stove; cooking with liquefied petroleum gas stoves). Objective: The trial is designed to ensure delivery of the stove intervention prior to the period of maximal fetal growth. To answer questions about the impact of household air pollution on pregnancy outcome, accurate gestational age assessment is critical. This manuscript describes in detail the development of the gestational dating protocol, intensive ultrasound training involved, ultrasound capacity building, and ultrasound quality control program. Methods: Ultrasound training occurred in several phases over the course of 2 years. Training included a basic obstetric ultrasound course offered to all midwives performing antenatal care at the two study hospitals, followed by a more intense period of hands-on training focused on fetal biometry for a select group of providers demonstrating aptitude in the basic course. A standard operating procedure was developed describing how to obtain all fetal biometric measurements. Consensus was obtained on how biometric images are used in the trial to establish gestational age and estimate the delivery date. An ongoing ultrasound quality control program including the use of an image scorecard was also designed. Results: Publication of trial results is anticipated in late 2016. Conclusions: Use of ultrasound should be strongly considered in field-based trials involving pregnant women to accurately establish gestational age, as menstrual dates may be incorrect or unknown. The inclusion of ultrasound in areas where ultrasound capacity does not previously exist requires a significant investment of time and resources. Such investment ensures appropriate training, high quality images, and accurate dating pregnancies. We outline our ultrasound training, image acquisition, quality control, and dating protocols in detail. Trial Registration: Clinicaltrials.gov NCT01335490; http://clinicaltrials.gov/ct2/show/NCT01335490 (Archived by WebCite at http://www.webcitation.org/6UbERJNO6). %M 25525828 %R 10.2196/resprot.3797 %U http://www.researchprotocols.org/2014/4/e77/ %U https://doi.org/10.2196/resprot.3797 %U http://www.ncbi.nlm.nih.gov/pubmed/25525828 %0 Journal Article %@ 1929-0748 %I JMIR Publications Inc. %V 3 %N 4 %P e75 %T “Real-World” Practical Evaluation Strategies: A Review of Telehealth Evaluation %A Agboola,Stephen %A Hale,Timothy M %A Masters,Caitlin %A Kvedar,Joseph %A Jethwani,Kamal %+ Partners Healthcare Center for Connected Health, Suite 300, 25 New Chardon Street, Boston, MA, 02114, United States, 1 617 643 0291, sagboola@partners.org %K telehealth %K eHealth %K evaluation %K evaluation framework %K diabetes mellitus %K technology %D 2014 %7 17.12.2014 %9 Review %J JMIR Res Protoc %G English %X Background: Currently, the increasing interest in telehealth and significant technological breakthroughs of the past decade create favorable conditions for the widespread adoption of telehealth services. Therefore, expectations are high that telehealth can help alleviate prevailing challenges in health care delivery. However, in order to translate current research to policy and facilitate adoption by patients and health care providers, there is need for compelling evidence of the effectiveness of telehealth interventions. Such evidence is gathered from rigorously designed research studies, which may not always be practical in many real-world settings. Objective: Our aim was to summarize current telehealth evaluation strategies and challenges and to outline practical approaches to conduct evaluation in real-world settings using one of our previously reported telehealth initiatives, the Diabetes Connect program, as a case study. Methods: We reviewed commonly used current evaluation frameworks and strategies, as well as best practices based on successful evaluative efforts to date to address commonly encountered challenges in telehealth evaluation. These challenges in telehealth evaluation and commonly used frameworks are described relevant to the evaluation of Diabetes Connect, a 12-month Web-based blood glucose monitoring program. Results: Designers of telehealth evaluation frameworks must give careful consideration to the elements of planning, implementation, and impact assessment of interventions. Evaluating performance at each of these phases is critical to the overall success of an intervention. Although impact assessment occurs at the end of a program, our review shows that it should begin at the point of problem definition. Critical to the success of an evaluative strategy is early planning that involves all stakeholders to identify the overall goals of the program and key measures of success at each phase of the program life cycle. This strategy should enable selection of an appropriate evaluation strategy and measures to aid in the ongoing development and implementation of telehealth and provide better evidence of program impact. Conclusions: We recommend a pragmatic, multi-method, multi-phase approach to telehealth evaluation that is flexible and can be adapted to the characteristics and challenges unique to each telehealth program. %M 25524892 %R 10.2196/resprot.3459 %U http://www.researchprotocols.org/2014/4/e75/ %U https://doi.org/10.2196/resprot.3459 %U http://www.ncbi.nlm.nih.gov/pubmed/25524892 %0 Journal Article %@ 1929-0748 %I JMIR Publications Inc. %V 3 %N 4 %P e59 %T Active Patient Participation in the Development of an Online Intervention %A van Bruinessen,Inge Renske %A van Weel-Baumgarten,Evelyn M %A Snippe,Harm Wouter %A Gouw,Hans %A Zijlstra,Josée M %A van Dulmen,Sandra %+ NIVEL (Netherlands Institute for Health Services Research), Otterstraat 118-124, Utrecht, 3500bn, Netherlands, 31 302729680, i.vanbruinessen@nivel.nl %K communication %K malignant lymphoma %K online intervention %K self-help application %K patient participation %K intervention development %D 2014 %7 06.11.2014 %9 Original Paper %J JMIR Res Protoc %G English %X Background: An important and challenging part of living with cancer relates to the repeated visits to the hospital. Since how patients cope between these post-diagnostic visits depends partly on the information and support received from their physician during the visits, it is important to make the most of them. Recent findings reinforce the importance of training not only the health care professionals in communication skills, but providing patients with support in communication as well. Delivering such supportive interventions online can have potential benefits in terms of accessibility, cost-effectiveness, and ability to tailor information to personal needs. However, problems with attrition (dropout, non-usage) during the test phase and poor uptake after implementation are frequently reported. The marginal level of engagement of the patient as end user seems to play a role in this. Therefore, recent research suggests integrating theory-based development methods with methods that promote involvement of the patient at an early stage. This paper describes a participatory protocol, used to let patients guide a theory-informed development process. Objective: The objective of this project was to apply a bottom-up inspired procedure to develop a patient-centered intervention with corresponding evaluation and implementation plan. Methods: The applied development protocol was based on the intervention mapping framework, combined with patient participatory methods that were inspired by the participation ladder and user-centred design methods. Results: The applied protocol led to a self-directed online communication intervention aimed at helping patients gain control during their communications with health care professionals. It also led to an evaluation plan and an implementation plan. The protocol enabled the continuous involvement of patient research partners and the partial involvement of patient service users, which led to valuable insights and improvements. Conclusions: The applied protocol realized patient participation on different levels throughout the entire project. Early involvement, involvement on different levels, and flexibility in terms of planning and setup seem to be preconditions to creating a bottom-up inspired development procedure with (seriously ill) patients. Further research is necessary to find out if a more patient-centered approach improves the implementation and uptake of eHealth interventions. Trial Registration: Netherlands National Trial Register ID number: NTR3779; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=3779 (Archived by WebCite at http://www.webcitation.org/6TdfALKxV). %M 25379679 %R 10.2196/resprot.3695 %U http://www.researchprotocols.org/2014/4/e59/ %U https://doi.org/10.2196/resprot.3695 %U http://www.ncbi.nlm.nih.gov/pubmed/25379679 %0 Journal Article %@ 1929-0748 %I JMIR Publications Inc. %V 3 %N 4 %P e49 %T Development of a Communication Protocol for Telephone Disclosure of Genetic Test Results for Cancer Predisposition %A Patrick-Miller,Linda J %A Egleston,Brian L %A Fetzer,Dominique %A Forman,Andrea %A Bealin,Lisa %A Rybak,Christina %A Peterson,Candace %A Corbman,Melanie %A Albarracin,Julio %A Stevens,Evelyn %A Daly,Mary B %A Bradbury,Angela R %+ Department of Medicine, Division of Hematology-Oncology, Center for Clinical Cancer Genetics and Global Health, University of Chicago, Pritzker School of Medicine, 5851 South Maryland Avenue, MC 2115, Chicago, IL, 60637-1470, United States, 1 7737024678, lpatrickmiller@medicine.bsd.uchicago.edu %K genetic testing %K test result disclosure %K communication %K telemedicine %K cancer risk assessment %K self-regulation theory of health behavior %D 2014 %7 29.10.2014 %9 Protocol %J JMIR Res Protoc %G English %X Background: Dissemination of genetic testing for disease susceptibility, one application of “personalized medicine”, holds the potential to empower patients and providers through informed risk reduction and prevention recommendations. Genetic testing has become a standard practice in cancer prevention for high-risk populations. Heightened consumer awareness of “cancer genes” and genes for other diseases (eg, cardiovascular and Alzheimer’s disease), as well as the burgeoning availability of increasingly complex genomic tests (ie, multi-gene, whole-exome and -genome sequencing), has escalated interest in and demand for genetic risk assessment and the specialists who provide it. Increasing demand is expected to surpass access to genetic specialists. Thus, there is urgent need to develop effective and efficient models of delivery of genetic information that comparably balance the risks and benefits to the current standard of in-person communication. Objective: The aim of this pilot study was to develop and evaluate a theoretically grounded and rigorously developed protocol for telephone communication of BRCA1/2 (breast cancer) test results that might be generalizable to genetic testing for other hereditary cancer and noncancer syndromes. Methods: Stakeholder data, health communication literature, and our theoretical model grounded in Self-Regulation Theory of Health Behavior were used to develop a telephone communication protocol for the communication of BRCA1/2 genetic test results. Framework analysis of selected audiotapes of disclosure sessions and stakeholders’ feedback were utilized to evaluate the efficacy and inform refinements to this protocol. Results: Stakeholder feedback (n=86) and audiotapes (38%, 33/86) of telephone disclosures revealed perceived disadvantages and challenges including environmental factors (eg, non-private environment), patient-related factors (eg, low health literacy), testing-related factors (eg, additional testing needed), and communication factors (eg, no visual cues). Resulting modifications to the communication protocol for BRCA1/2 test results included clarified patient instructions, scheduled appointments, refined visual aids, expanded disclosure checklist items, and enhanced provider training. Conclusions: Analyses of stakeholders’ experiences and audiotapes of telephone disclosure of BRCA1/2 test results informed revisions to communication strategies and a protocol to enhance patient outcomes when utilizing telephone to disclose genetic test results. %M 25355401 %R 10.2196/resprot.3337 %U http://www.researchprotocols.org/2014/4/e49/ %U https://doi.org/10.2196/resprot.3337 %U http://www.ncbi.nlm.nih.gov/pubmed/25355401 %0 Journal Article %@ 1929-0748 %I JMIR Publications Inc. %V 3 %N 3 %P e48 %T Social Networking Versus Facebook Advertising to Recruit Survey Respondents: A Quasi-Experimental Study %A Gilligan,Conor %A Kypri,Kypros %A Bourke,Jesse %+ School of Medicine and Public Health, Faculty of Health and Medicine, University of Newcastle, HMRI Building, Callaghan, 2308, Australia, 61 240420553, Conor.Gilligan@newcastle.edu.au %K Facebook advertising %K recruitment %K Facebook %D 2014 %7 17.09.2014 %9 Original Paper %J JMIR Res Protoc %G English %X Background: Increasingly, social contact and knowledge of other people’s attitudes and behavior are mediated by online social media such as Facebook. The main research to which this recruitment study pertains investigates the influence of parents on adolescent alcohol consumption. Given the pervasiveness of online social media use, Facebook may be an effective means of recruitment and intervention delivery. Objective: The objective of the study was to determine the efficacy of study recruitment via social networks versus paid advertising on Facebook. Methods: We conducted a quasi-experimental sequential trial with response rate as the outcome, and estimates of cost-effectiveness. The target population was parents of 13-17 year old children attending high schools in the Hunter region of New South Wales, Australia. Recruitment occurred via: method (1) social recruitment using Facebook, email-based, social networks, and media coverage followed by method (2) Facebook advertising. Results: Using a range of online and other social network approaches only: method (1) 74 parents were recruited to complete a survey over eight months, costing AUD58.70 per completed survey. After Facebook advertising: method (2) 204 parents completed the survey over four weeks, costing AUD5.94 per completed survey. Participants were representative of the parents recruited from the region’s schools using standard mail and email. Conclusions: Facebook advertising is a cost-effective means of recruiting parents, a group difficult to reach by other methods. %M 25230740 %R 10.2196/resprot.3317 %U http://www.researchprotocols.org/2014/3/e48/ %U https://doi.org/10.2196/resprot.3317 %U http://www.ncbi.nlm.nih.gov/pubmed/25230740 %0 Journal Article %@ 1929-0748 %I JMIR Publications Inc. %V 3 %N 3 %P e41 %T Designing Clinically Valuable Telehealth Resources: Processes to Develop a Community-Based Palliative Care Prototype %A Tieman,Jennifer Joy %A Morgan,Deidre Diane %A Swetenham,Kate %A To,Timothy Hong Man %A Currow,David Christopher %+ Discipline of Palliative and Supportive Services, Department of Health Sciences, Flinders University of South Australia, GPO Box 2100, Adelaide, 5001, Australia, 61 08 7221 8237, jennifer.tieman@flinders.edu.au %K telemedicine %K palliative care %K delivery of care %K home care %D 2014 %7 04.09.2014 %9 Original Paper %J JMIR Res Protoc %G English %X Background: Changing population demography and patterns of disease are increasing demands on the health system. Telehealth is seen as providing a mechanism to support community-based care, thus reducing pressure on hospital services and supporting consumer preferences for care in the home. Objective: This study examined the processes involved in developing a prototype telehealth intervention to support palliative care patients involved with a palliative care service living in the community. Methods: The challenges and considerations in developing the palliative care telehealth prototype were reviewed against the Center for eHealth Research (CeHRes) framework, a telehealth development model. The project activities to develop the prototype were specifically mapped against the model’s first four phases: multidisciplinary project management, contextual inquiry, value specification, and design. This project has been developed as part of the Telehealth in the Home: Aged and Palliative Care in South Australia initiative. Results: Significant issues were identified and subsequently addressed during concept and prototype development. The CeHRes approach highlighted the implicit diversity in views and opinions among participants and stakeholders and enabled issues to be considered, resolved, and incorporated during design through continuous engagement. Conclusions: The CeHRes model provided a mechanism that facilitated “better” solutions in the development of the palliative care prototype by addressing the inherent but potentially unrecognized differences in values and beliefs of participants. This collaboration enabled greater interaction and exchange among participants resulting in a more useful and clinically valuable telehealth prototype. %M 25189279 %R 10.2196/resprot.3266 %U http://www.researchprotocols.org/2014/3/e41/ %U https://doi.org/10.2196/resprot.3266 %U http://www.ncbi.nlm.nih.gov/pubmed/25189279 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 16 %N 8 %P e188 %T The Behavioral Intervention Technology Model and Intervention Mapping: The Best of Both Worlds %A Crutzen,Rik %+ CAPHRI, Department of Health Promotion, Maastricht University, PO Box 616, Maastricht, 6200 MD, Netherlands, 31 433882828, rik.crutzen@maastrichtuniversity.nl %K mHealth %K eHealth %K behavioral intervention technology %K intervention mapping %D 2014 %7 05.08.2014 %9 Letter to the Editor %J J Med Internet Res %G English %X %M 25095730 %R 10.2196/jmir.3620 %U http://www.jmir.org/2014/8/e188/ %U https://doi.org/10.2196/jmir.3620 %U http://www.ncbi.nlm.nih.gov/pubmed/25095730 %0 Journal Article %@ 1929-0748 %I JMIR Publications Inc. %V 3 %N 3 %P e37 %T The Comparability of Men Who Have Sex With Men Recruited From Venue-Time-Space Sampling and Facebook: A Cohort Study %A Hernandez-Romieu,Alfonso C %A Sullivan,Patrick S %A Sanchez,Travis H %A Kelley,Colleen F %A Peterson,John L %A del Rio,Carlos %A Salazar,Laura F %A Frew,Paula M %A Rosenberg,Eli S %+ Rollins School of Public Health, Department of Epidemiology, Emory University, Room 444 GCR Bldg, 1518 Clifton Rd, Atlanta, GA, 30322, United States, 1 404 727 8974, alfonso.claudio.hernandez@emory.edu %K men who have sex with men, MSM %K Facebook %K venue-based time sampling %K online MSM %K social media recruitment of MSM %D 2014 %7 17.07.2014 %9 Original Paper %J JMIR Res Protoc %G English %X Background: Recruiting valid samples of men who have sex with men (MSM) is a key component of the US human immunodeficiency virus (HIV) surveillance and of research studies seeking to improve HIV prevention for MSM. Social media, such as Facebook, may present an opportunity to reach broad samples of MSM, but the extent to which those samples are comparable with men recruited from venue-based, time-space sampling (VBTS) is unknown. Objective: The objective of this study was to assess the comparability of MSM recruited via VBTS and Facebook. Methods: HIV-negative and HIV-positive black and white MSM were recruited from June 2010 to December 2012 using VBTS and Facebook in Atlanta, GA. We compared the self-reported venue attendance, demographic characteristics, sexual and risk behaviors, history of HIV-testing, and HIV and sexually transmitted infection (STI) prevalence between Facebook- and VTBS-recruited MSM overall and by race. Multivariate logistic and negative binomial models estimated age/race adjusted ratios. The Kaplan-Meier method was used to assess 24-month retention. Results: We recruited 803 MSM, of whom 110 (34/110, 30.9% black MSM, 76/110, 69.1% white MSM) were recruited via Facebook and 693 (420/693, 60.6% black MSM, 273/693, 39.4% white MSM) were recruited through VTBS. Facebook recruits had high rates of venue attendance in the previous month (26/34, 77% among black and 71/76, 93% among white MSM; between-race P=.01). MSM recruited on Facebook were generally older, with significant age differences among black MSM (P=.02), but not white MSM (P=.14). In adjusted multivariate models, VBTS-recruited MSM had fewer total partners (risk ratio [RR]=0.78, 95% CI 0.64-0.95; P=.01) and unprotected anal intercourse (UAI) partners (RR=0.54, 95% CI 0.40-0.72; P<.001) in the previous 12 months. No significant differences were observed in HIV testing or HIV/STI prevalence. Retention to the 24-month visit varied from 81% for black and 70% for white MSM recruited via Facebook, to 77% for black and 78% for white MSM recruited at venues. There was no statistically significant differences in retention between the four groups (log-rank P=.64). Conclusions: VBTS and Facebook recruitment methods yielded similar samples of MSM in terms of HIV-testing patterns, and prevalence of HIV/STI, with no differences in study retention. Most Facebook-recruited men also attended venues where VTBS recruitment was conducted. Surveillance and research studies may recruit via Facebook with little evidence of bias, relative to VBTS. %M 25048694 %R 10.2196/resprot.3342 %U http://www.researchprotocols.org/2014/3/e37/ %U https://doi.org/10.2196/resprot.3342 %U http://www.ncbi.nlm.nih.gov/pubmed/25048694 %0 Journal Article %@ 1929-0748 %I JMIR Publications Inc. %V 3 %N 3 %P e38 %T A Comparison of Tablet Computer and Paper-Based Questionnaires in Healthy Aging Research %A Fanning,Jason %A McAuley,Edward %+ Exercise Psychology Laboratory, Department of Kinesiology and Community Health, University of Illinois at Urbana-Champaign, Freer Hall, 906 S Goodwin Ave, Urbana, IL, 61801, United States, 1 217 300 5306, fanning4@illinois.edu %K healthy aging %K questionnaire %K tablet computer %K behavioral psychology %D 2014 %7 16.07.2014 %9 Original Paper %J JMIR Res Protoc %G English %X Background: Digital questionnaire delivery offers many advantages to investigators and participants alike; however, evidence supporting digital questionnaire delivery via touchscreen device in the older adult population is lacking. Objective: The objective of this study was to compare the use of tablet computer-delivered and printed questionnaires as vehicles for the collection of psychosocial data from older adults to determine whether this digital platform would be readily adopted by the sample, and to identify whether tablet delivery influences the content of data received. Methods: The participants completed three questionnaires using both delivery methods, followed by a brief evaluation. Results: A nonparametric one-sample binomial test indicated a significantly greater proportion of individuals preferred the tablet-delivered questionnaires (z=4.96, SE 3.428, P<.001). Paired sample t tests and Wilcoxon sign-rank tests indicated that measures collected by each method were not significantly different (all P≥.273). Ease of use of the tablet interface and anxiety while completing the digital questionnaires were significantly correlated with preferences, (rs=.665, P<.001 and rs=.552, P<.001, respectively). Participants most frequently reported that the tablet delivery increased speed of use and improved data entry, although navigation was perceived as being more difficult. By comparison, participants felt that the paper packet was easier to read and navigate, but was slow and cumbersome, and they disliked the lack of dynamic features. Conclusions: This study provides preliminary evidence suggesting that questionnaires delivered to older adults using contemporary tablet computers may be acceptable and do not substantively influence the content of the collected data. %M 25048799 %R 10.2196/resprot.3291 %U http://www.researchprotocols.org/2014/3/e38/ %U https://doi.org/10.2196/resprot.3291 %U http://www.ncbi.nlm.nih.gov/pubmed/25048799 %0 Journal Article %@ 1438-8871 %I JMIR Publications Inc. %V 16 %N 6 %P e146 %T The Behavioral Intervention Technology Model: An Integrated Conceptual and Technological Framework for eHealth and mHealth Interventions %A Mohr,David C %A Schueller,Stephen M %A Montague,Enid %A Burns,Michelle Nicole %A Rashidi,Parisa %+ Center for Behavioral Intervention Technologies, Department of Preventive Medicine, Northwestern University, 680 N Lakeshore Drive, Suite 1400, Chicago, IL, 60611, United States, 1 312 503 1403, d-mohr@northwestern.edu %K mhealth %K ehealth %K behavioral intervention technology %D 2014 %7 05.06.2014 %9 Viewpoint %J J Med Internet Res %G English %X A growing number of investigators have commented on the lack of models to inform the design of behavioral intervention technologies (BITs). BITs, which include a subset of mHealth and eHealth interventions, employ a broad range of technologies, such as mobile phones, the Web, and sensors, to support users in changing behaviors and cognitions related to health, mental health, and wellness. We propose a model that conceptually defines BITs, from the clinical aim to the technological delivery framework. The BIT model defines both the conceptual and technological architecture of a BIT. Conceptually, a BIT model should answer the questions why, what, how (conceptual and technical), and when. While BITs generally have a larger treatment goal, such goals generally consist of smaller intervention aims (the "why") such as promotion or reduction of specific behaviors, and behavior change strategies (the conceptual "how"), such as education, goal setting, and monitoring. Behavior change strategies are instantiated with specific intervention components or “elements” (the "what"). The characteristics of intervention elements may be further defined or modified (the technical "how") to meet the needs, capabilities, and preferences of a user. Finally, many BITs require specification of a workflow that defines when an intervention component will be delivered. The BIT model includes a technological framework (BIT-Tech) that can integrate and implement the intervention elements, characteristics, and workflow to deliver the entire BIT to users over time. This implementation may be either predefined or include adaptive systems that can tailor the intervention based on data from the user and the user’s environment. The BIT model provides a step towards formalizing the translation of developer aims into intervention components, larger treatments, and methods of delivery in a manner that supports research and communication between investigators on how to design, develop, and deploy BITs. %M 24905070 %R 10.2196/jmir.3077 %U http://www.jmir.org/2014/6/e146/ %U https://doi.org/10.2196/jmir.3077 %U http://www.ncbi.nlm.nih.gov/pubmed/24905070 %0 Journal Article %@ 1929-0748 %I JMIR Publications Inc. %V 3 %N 2 %P e28 %T The Origin and Impact of Ideals in eHealth Research: Experiences From the U-CARE Research Environment %A Sjöström,Jonas %A von Essen,Louise %A Grönqvist,Helena %+ U-CARE, Department of Public Health and Caring Sciences, Uppsala University, Box 564, Uppsala, 75122, Sweden, 46 738171359, jonas.sjostrom@im.uu.se %K research management %K stakeholders %K innovation %K accountability %K rigor %K relevance %K sustainability %D 2014 %7 23.05.2014 %9 Original Paper %J JMIR Res Protoc %G English %X Background: The prevalence of information technology (IT) in society is a foundation for new modes of interaction between patients and health specialists. IT plays an important role in the renewal of care. Several countries have incorporated eHealth plans into their national health strategies. Part of the eHealth evolution concerns Internet psychological treatment and psychosocial care. These interventions are complex to design and evaluate due to legal, ethical, organizational, technical, and methodological challenges. Objective: The objective of our study was to seek to make explicit contributions to the understanding of ideals in eHealth research, and illuminate their implications for establishing an effective research environment. Our analysis draws from three years of experience in establishing an eHealth research environment, and the literature. Methods: We worked inductively to characterize challenging research ideals, and their origins, in our environment. Thereafter, we made a selective search of the literature to scrutinize and illuminate each ideal and it’s implications. Results: In this work, we propose a structured approach to address ideals in eHealth research. The scrutinized ideals are accountability, innovation, rigor, relevance, and sustainability. The approach supports researchers to systematically understand the ideals, their origin, and to manage their implications within an eHealth research environment. Conclusions: The complexity of eHealth research causes a need for sustainable, multi-disciplinary research environments. There is a need for a structured approach to organize eHealth research. The proposed approach helps to systematically scrutinize ideals, thus promoting high quality research. %M 24860071 %R 10.2196/resprot.3202 %U http://www.researchprotocols.org/2014/2/e28/ %U https://doi.org/10.2196/resprot.3202 %U http://www.ncbi.nlm.nih.gov/pubmed/24860071 %0 Journal Article %@ 1929-0748 %I JMIR Publications Inc. %V 3 %N 2 %P e24 %T Use of a Google Map Tool Embedded in an Internet Survey Instrument: Is it a Valid and Reliable Alternative to Geocoded Address Data? %A Dasgupta,Sharoda %A Vaughan,Adam S %A Kramer,Michael R %A Sanchez,Travis H %A Sullivan,Patrick S %+ Department of Epidemiology, Rollins School of Public Health, Emory University, 1518 Clifton Rd NE, Mailstop: 1518-002-4AA, Atlanta, GA, 30322, United States, 1 404 727 2773, sdasgu4@emory.edu %K HIV %K geographic mapping %K survey %K validity %K reliability %D 2014 %7 10.04.2014 %9 Original Paper %J JMIR Res Protoc %G English %X Background: Men who have sex with men (MSM) in the United States are at high risk for human immunodeficiency virus (HIV) and poor HIV related outcomes. Maps can be used to identify, quantify, and address gaps in access to HIV care among HIV-positive MSM, and tailor intervention programs based on the needs of patients being served. Objective: The objective of our study was to assess the usability of a Google map question embedded in a Web-based survey among Atlanta-based, HIV-positive MSM, and determine whether it is a valid and reliable alternative to collection of address-based data on residence and last HIV care provider. Methods: Atlanta-based HIV-positive MSM were recruited through Facebook and from two ongoing studies recruiting primarily through venue-based sampling or peer referral (VBPR). Participants were asked to identify the locations of their residence and last attended HIV care provider using two methods: (1) by entering the street address (gold standard), and (2) “clicking” on the locations using an embedded Google map. Home and provider addresses were geocoded, mapped, and compared with home and provider locations from clicked map points to assess validity. Provider location error values were plotted against home location error values, and a kappa statistic was computed to assess agreement in degree of error in identifying residential location versus provider location. Results: The median home location error across all participants was 0.65 miles (interquartile range, IQR, 0.10, 2.5 miles), and was lower among Facebook participants (P<.001), whites (P<.001), and those reporting higher annual household income (P=.04). Median home location error was lower, although not statistically significantly, among older men (P=.08) and those with higher educational attainment (P=.05). The median provider location error was 0.32 miles (IQR, 0.12, 1.2 miles), and did not vary significantly by age, recruitment method, race, income, or level of educational attainment. Overall, the kappa was 0.20, indicating poor agreement between the two error measures. However, those recruited through Facebook had a greater level of agreement (κ=0.30) than those recruited through VBPR methods (κ=0.16), demonstrating a greater level of consistency in using the map question to identify home and provider locations for Facebook-recruited individuals. Conclusions: Most participants were able to click within 1 mile of their home address and their provider’s office, and were not always able to identify the locations on a map consistently, although some differences were observed across recruitment methods. This map tool may serve as the basis of a valid and reliable tool to identify residence and HIV provider location in the absence of geocoded address data. Further work is needed to improve and compare map tool usability with the results from this study. %M 24726954 %R 10.2196/resprot.2946 %U http://www.researchprotocols.org/2014/2/e24/ %U https://doi.org/10.2196/resprot.2946 %U http://www.ncbi.nlm.nih.gov/pubmed/24726954 %0 Journal Article %@ 2291-5222 %I JMIR Publications Inc. %V 2 %N 1 %P e7 %T Customized-Language Voice Survey on Mobile Devices for Text and Image Data Collection Among Ethnic Groups in Thailand: A Proof-of-Concept Study %A Jandee,Kasemsak %A Lawpoolsri,Saranath %A Taechaboonsermsak,Pimsurang %A Khamsiriwatchara,Amnat %A Wansatid,Peerawat %A Kaewkungwal,Jaranit %+ Center of Excellence for Biomedical and Public Health Informatics (BIOPHICS), Mahidol University, Faculty of Tropical Medicine, Mahidol University, 420/6 Ratchawithi Road, Ratchathewi, Bangkok, 10400, Thailand, 66 23549181 ext 412, jaranit.kae@mahidol.ac.th %K expanded program on immunization %K EPI %K ethnicity %K mobile technology %K smartphone questionnaire survey %K voiced question %D 2014 %7 06.03.2014 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Public health surveys are often conducted using paper-based questionnaires. However, many problems are associated with this method, especially when collecting data among ethnic groups who speak a different language from the survey interviewer. The process can be time-consuming and there is the risk of missing important data due to incomplete surveys. Objective: This study was conducted as a proof-of-concept to develop a new electronic tool for data collection, and compare it with standard paper-based questionnaire surveys using the research setting of assessing Knowledge Attitude and Practice (KAP) toward the Expanded Program on Immunization (EPI) among 6 ethnic groups in Chiang Rai Province, Thailand. The two data collection methods were compared on data quality in terms of data completeness and time consumed in collecting the information. In addition, the initiative assessed the participants’ satisfaction toward the use of a smartphone customized-language voice-based questionnaire in terms of perceived ease of use and perceived usefulness. Methods: Following a cross-over design, all study participants were interviewed using two data collection methods after a one-week washout period. Questions in the paper-based questionnaires in Thai language were translated to each ethnic language by the interviewer/translator when interviewing the study participant. The customized-language voice-based questionnaires were programmed to a smartphone tablet in six, selectable dialect languages and used by the trained interviewer when approaching participants. Results: The study revealed positive data quality outcomes when using the smartphone, voice-based questionnaire survey compared with the paper-based questionnaire survey, both in terms of data completeness and time consumed in data collection process. Since the smartphone questionnaire survey was programmed to ask questions in sequence, no data was missing and there were no entry errors. Participants had positive attitudes toward answering the smartphone questionnaire; 69% (48/70) reported they understood the questions easily, 71% (50/70) found it convenient, and 66% (46/70) reported a reduced time in data collection. The smartphone data collection method was acceptable by both the interviewers and by the study participants of different ethnicities. Conclusions: To our knowledge, this is the first study showing that the application of specific features of mobile devices like smartphone tablets (including dropdown choices, capturing pictures, and voiced questions) can be successfully used for data collection. The mobile device can be effectively used for capturing photos of secondary data and collecting primary data with customized-language and voiced questionnaire survey. Using smartphone questionnaires can minimize or eliminate missing data and reduce the time consumed during the data collection process. Smartphone customized-language, voice-based questionnaires for data collection can be an alternative and better approach than standard translated paper-based questionnaires for public health surveys, especially when collecting data among ethnic and hard-to-reach groups residing in multilanguage-speaking settings. %M 25098776 %R 10.2196/mhealth.3058 %U http://mhealth.jmir.org/2014/1/e7/ %U https://doi.org/10.2196/mhealth.3058 %U http://www.ncbi.nlm.nih.gov/pubmed/25098776 %0 Journal Article %@ 1929-0748 %I JMIR Publications Inc. %V 3 %N 1 %P e7 %T Development and Content Validation of the Information Assessment Method for Patients and Consumers %A Pluye,Pierre %A Granikov,Vera %A Bartlett,Gillian %A Grad,Roland M %A Tang,David L %A Johnson-Lafleur,Janique %A Shulha,Michael %A Barbosa Galvão,Maria Cristiane %A Ricarte,Ivan LM %A Stephenson,Randolph %A Shohet,Linda %A Hutsul,Jo-Anne %A Repchinsky,Carol A %A Rosenberg,Ellen %A Burnand,Bernard %A Légaré,France %A Dunikowski,Lynn %A Murray,Susan %A Boruff,Jill %A Frati,Francesca %A Kloda,Lorie %A Macaulay,Ann %A Lagarde,François %A Doray,Geneviève %+ Department of Family Medicine, McGill University, 5858, chemin de la Côte-des-Neige, 3rd floor, Montreal, QC, H3S 1Z1, Canada, 1 514 398 8483, pierre.pluye@mcgill.ca %K information use %K information retrieval %K push technology %K consumer health information %K consumer-centered outcomes %K content validity %D 2014 %7 18.02.2014 %9 Original Paper %J JMIR Res Protoc %G English %X Background: Online consumer health information addresses health problems, self-care, disease prevention, and health care services and is intended for the general public. Using this information, people can improve their knowledge, participation in health decision-making, and health. However, there are no comprehensive instruments to evaluate the value of health information from a consumer perspective. Objective: We collaborated with information providers to develop and validate the Information Assessment Method for all (IAM4all) that can be used to collect feedback from information consumers (including patients), and to enable a two-way knowledge translation between information providers and consumers. Methods: Content validation steps were followed to develop the IAM4all questionnaire. The first version was based on a theoretical framework from information science, a critical literature review and prior work. Then, 16 laypersons were interviewed on their experience with online health information and specifically their impression of the IAM4all questionnaire. Based on the summaries and interpretations of interviews, questionnaire items were revised, added, and excluded, thus creating the second version of the questionnaire. Subsequently, a panel of 12 information specialists and 8 health researchers participated in an online survey to rate each questionnaire item for relevance, clarity, representativeness, and specificity. The result of this expert panel contributed to the third, current, version of the questionnaire. Results: The current version of the IAM4all questionnaire is structured by four levels of outcomes of information seeking/receiving: situational relevance, cognitive impact, information use, and health benefits. Following the interviews and the expert panel survey, 9 questionnaire items were confirmed as relevant, clear, representative, and specific. To improve readability and accessibility for users with a lower level of literacy, 19 items were reworded and all inconsistencies in using a passive or active voice have been solved. One item was removed due to redundancy. The current version of the IAM4all questionnaire contains 28 items. Conclusions: We developed and content validated the IAM4all in partnership with information providers, information specialists, researchers and representatives of information consumers. This questionnaire can be integrated within electronic knowledge resources to stimulate users’ reflection (eg, their intention to use information). We claim that any organization (eg, publishers, community organizations, or patient associations), can evaluate and improve their online consumer health information from a consumers’ perspective using this method. %M 24550180 %R 10.2196/resprot.2908 %U http://www.researchprotocols.org/2014/1/e7/ %U https://doi.org/10.2196/resprot.2908 %U http://www.ncbi.nlm.nih.gov/pubmed/24550180 %0 Journal Article %@ 1929-0748 %I JMIR Publications Inc. %V 3 %N 1 %P e1 %T Stress and Mental Health in Families With Different Income Levels: A Strategy to Collect Multi-Actor Data %A Ponnet,Koen %A Wouters,Edwin %+ Department of Sociology, University of Antwerp, Sint-Jacobstraat 2, Antwerp, B2000, Belgium, 32 484147972, koen.ponnet@uantwerpen.be %K stress %K mental health %K well-being %K family process %K multi-actor approach %D 2014 %7 02.01.2014 %9 Original Paper %J JMIR Res Protoc %G English %X Background: Several studies have focused on family stress processes, examining the association between various sources of stress and the mental health and well-being of parents and adolescents. The majority of these studies take the individual as the unit of analysis. Multi-actor panel data make it possible to examine the dynamics of the family context over time and the differentiating effects of individual roles within the same family. Accurate information about family processes allows practitioners to provide support that enhances family resilience and minimizes the risk of mental health problems. Objective: Our study contributes to the research on family stress processes by focusing on families with different income levels, and by collecting panel data from mothers, fathers, and adolescents within the same family. Methods: The relationship between mothers, fathers, and children (RMFC) study is an ongoing Flemish multi-actor panel study that aims to enhance our understanding of family processes that protect the mental health and well-being of two-parent families with a target adolescent between 11 and 17 years old. Mothers, fathers, and children provide information about various aspects of family life, including finances, sources of stress, health, mental health, parenting, and coping strategies. Measures have been chosen whenever possible that have sound conceptual underpinnings and robust psychometric properties. The study posed two challenges. First, economically disadvantaged families are difficult to reach. Second, the collection of multi-actor data is often plagued by high nonresponse. To ensure that the families were targeted as successfully as possible, the study employed a purposive nonprobability sampling method. Results: The RMFC study is one of the largest triadic panel studies of its kind. The first wave of quantitative data collection was conducted between February 2012 and January 2013. A total of 2566 individuals of 880 families participated in our study. The second wave of data collection will be undertaken 6-12 months later. Conclusions: The strength of the RMFC study is its multi-actor panel approach of data collection among families with different income levels. Strategies that were followed to address the empirical issues involved with the sampling design are discussed, together with theoretical and practical implications. %M 24384456 %R 10.2196/resprot.2832 %U http://www.researchprotocols.org/2014/1/e1/ %U https://doi.org/10.2196/resprot.2832 %U http://www.ncbi.nlm.nih.gov/pubmed/24384456 %0 Journal Article %@ 1929-0748 %I JMIR Publications Inc. %V 2 %N 2 %P e27 %T Purposive Facebook Recruitment Endows Cost-Effective Nutrition Education Program Evaluation %A Lohse,Barbara %A Wamboldt,Patricia %+ Department of Nutritional Sciences, The Pennsylvania State University, 205 Chandlee Lab, University Park, PA, United States, 1 814 865 5169, lohseb@psu.edu %K nutrition education %K folic acid %K family meals %K low-income %K food security %K Facebook %K SNAP-Ed %D 2013 %7 15.08.2013 %9 Original Paper %J JMIR Res Protoc %G English %X Background: Recent legislation established a requirement for nutrition education in federal assistance programs to be evidence-based. Recruitment of low-income persons to participate and evaluate nutrition education activities can be challenging and costly. Facebook has been shown to be a cost-effective strategy to recruit this target audience to a nutrition program. Objective: The purpose of our study was to examine Facebook as a strategy to recruit participants, especially Supplemental Nutrition Assistance Program Education (SNAP-Ed) eligible persons, to view and evaluate an online nutrition education program intended to be offered as having some evidence base for SNAP-Ed programming. Methods: English-speaking, low-income Pennsylvania residents, 18-55 years with key profile words (eg, Supplemental Nutrition Assistance Program, Food bank), responded to a Facebook ad inviting participation in either Eating Together as a Family is Worth It (WI) or Everyone Needs Folic Acid (FA). Participants completed an online survey on food-related behaviors, viewed a nutrition education program, and completed a program evaluation. Facebook set-up functions considered were costing action, daily spending cap, and population reach. Results: Respondents for both WI and FA evaluations were similar; the majority were white, <40 years, overweight or obese body mass index, and not eating competent. A total of 807 Facebook users clicked on the WI ad with 73 unique site visitors and 47 of them completing the program evaluation (ie, 47/807, 5.8% of clickers and 47/73, 64% of site visitors completed the evaluation). Cost per completed evaluation was US $25.48; cost per low-income completer was US $39.92. Results were similar for the FA evaluation; 795 Facebook users clicked on the ad with 110 unique site visitors, and 73 completing the evaluation (ie, 73/795, 9.2% of ad clickers and 73/110, 66% of site visitors completed the evaluation). Cost per valid completed survey with program evaluation was US $18.88; cost per low-income completer was US $27.53. Conclusions: With Facebook we successfully recruited low-income Pennsylvanians to online nutrition program evaluations. Benefits using Facebook as a recruitment strategy included real-time recruitment management with lower costs and more efficiency compared to previous data from traditional research recruitment strategies reported in the literature. Limitations prompted by repeated survey attempts need to be addressed to optimize this recruitment strategy. %M 23948573 %R 10.2196/resprot.2713 %U http://www.researchprotocols.org/2013/2/e27/ %U https://doi.org/10.2196/resprot.2713 %U http://www.ncbi.nlm.nih.gov/pubmed/23948573