@Article{info:doi/10.2196/66335, author="Po{\ss}-Doering, Regina and Brinkm{\"o}ller, Sabrina and Balzer, Alexandra and Wurmbach, Sophie Viktoria and Paul, Cinara and Stolz, Regina and Zugaj, Richard Marco and Tesarz, Jonas and Wensing, Michel and Stra{\ss}ner, Cornelia", title="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", journal="JMIR Res Protoc", year="2025", month="Apr", day="15", volume="14", pages="e66335", keywords="chronic noncancer pain", keywords="case management", keywords="primary care", keywords="general practice resource-oriented", keywords="chronic pain", keywords="analgesics", keywords="pharmacological treatment", keywords="pain medications", keywords="holistic approach", keywords="feasibility", keywords="single-arm", keywords="exploratory", keywords="pilot study", keywords="screening", keywords="questionnaire", keywords="survey", keywords="protocol", abstract="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-W{\"u}rttemberg, 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 ", doi="10.2196/66335", url="https://www.researchprotocols.org/2025/1/e66335" } @Article{info:doi/10.2196/67248, author="Carrillo, Beltran and Rubinos-Cuadrado, Marta and Parellada-Martin, Jazmin and Palacios-L{\'o}pez, Alejandra and Carrillo-Rubinos, Beltran and Canillas-Del Rey, Fernando and Bazt{\'a}n-Cortes, Jose Juan and G{\'o}mez-Pavon, Javier", title="Effectiveness of The Umbrella Collaboration Versus Traditional Umbrella Reviews for Evidence Synthesis in Health Care: Protocol for a Validation Study", journal="JMIR Res Protoc", year="2025", month="Apr", day="14", volume="14", pages="e67248", keywords="tertiary evidence synthesis", keywords="The Umbrella Collaboration", keywords="umbrella reviews", keywords="health research methodology", keywords="AI-assisted synthesis", keywords="AI-assisted", keywords="evidence-based decision making", keywords="machine learning", keywords="ML", keywords="artificial intelligence", keywords="AI", keywords="algorithms", keywords="models", keywords="analytics", keywords="digital health", keywords="digital technology", keywords="digital interventions", abstract="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 ", doi="10.2196/67248", url="https://www.researchprotocols.org/2025/1/e67248", url="http://www.ncbi.nlm.nih.gov/pubmed/40057944" } @Article{info:doi/10.2196/70575, author="Algadi, S. Iman and AlRuthia, Yazed and Mujammami, H. Muhammad and Aburisheh, Hani Khaled and Alotaibi, Metib and Al Issa, Sharifah and Al-Saif, A. Amal and Seftel, David and Tsai, Cheng-Ting and Al Khalifah, A. Reem", title="Early Detection of Type 1 Diabetes in First-Degree Relatives in Saudi Arabia (VISION-T1D): Protocol for a Pilot Implementation Study", journal="JMIR Res Protoc", year="2025", month="Apr", day="14", volume="14", pages="e70575", keywords="islet autoimmunity", keywords="type 1 diabetes mellitus", keywords="T1D", keywords="screening program", keywords="antibody detection by agglutination--polymerase chain reaction", keywords="PCR", keywords="ADAP", keywords="human leukocyte antigen", keywords="genetic risk score", abstract="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 ", doi="10.2196/70575", url="https://www.researchprotocols.org/2025/1/e70575" } @Article{info:doi/10.2196/66579, author="Churchill, Alexandra and Georgiou, Ektoras and Abruzzo, Veronica and Polyakov, Alex and Teh, Tinn Wan", title="Feasibility of a Progesterone-Modified Natural Protocol for Frozen Embryo Transfer: Protocol for a Pilot Cohort Study", journal="JMIR Res Protoc", year="2025", month="Apr", day="11", volume="14", pages="e66579", keywords="frozen embryo transfer", keywords="fertility care", keywords="reproductive health", keywords="infertility", keywords="progesterone-modified natural cycle protocol", keywords="in vitro fertilization", abstract="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 ", doi="10.2196/66579", url="https://www.researchprotocols.org/2025/1/e66579", url="http://www.ncbi.nlm.nih.gov/pubmed/40215104" } @Article{info:doi/10.2196/51434, author="Clements, Frances and Vedam, Hima and Chung, Yewon and Smoleniec, John and Sullivan, Colin and Shanmugalingam, Renuka and Hennessy, Annemarie and Makris, Angela", title="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", journal="JMIR Res Protoc", year="2025", month="Apr", day="11", volume="14", pages="e51434", keywords="obstructive sleep apnoea", keywords="OSA", keywords="sleep disordered breathing", keywords="pregnancy", keywords="CPAP", keywords="positional therapy", keywords="gestational diabetes", keywords="GDM", keywords="preeclampsia", keywords="fetomaternal", keywords="maternal", keywords="pregnant", keywords="fetus", keywords="fetal", keywords="breathing", keywords="apnoea", keywords="sleep", keywords="respiratory", keywords="eclampsia", keywords="pregnant women", keywords="pregnancy complications", keywords="hypertension", abstract="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 ", doi="10.2196/51434", url="https://www.researchprotocols.org/2025/1/e51434", url="http://www.ncbi.nlm.nih.gov/pubmed/40215099" } @Article{info:doi/10.2196/52121, author="Daniels, Joseph and van der Merwe, Leigh-Ann Leonashia and Portle, Sarah and Bongo, Cikizwa and Nadkarni, Shiv and Petrus Peters, Remco", title="Tailoring a Skills-Based Serostatus Disclosure Intervention for Transgender Women in South Africa: Protocol for a Usability and Feasibility Study", journal="JMIR Res Protoc", year="2025", month="Mar", day="26", volume="14", pages="e52121", keywords="transgender women", keywords="intervention development", keywords="relationships", keywords="HIV treatment", keywords="South Africa", keywords="mobile phones, smartphones", keywords="skills-based", keywords="serostatus disclosure", keywords="HIV", keywords="HIV prevention", keywords="transgender", keywords="treatment outcomes", keywords="transmission", keywords="HIV-discordant partnerships", keywords="behavioral intervention", keywords="safe sex", keywords="human-centered design", keywords="viral suppression", keywords="Speaking Out and Allying Relationships", keywords="LGBTQ2S", keywords="LGBTQ", keywords="2SILGBTQ", abstract="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 ", doi="10.2196/52121", url="https://www.researchprotocols.org/2025/1/e52121" } @Article{info:doi/10.2196/67128, author="Portela Dos Santos, Omar and Alves, Pereira Paulo Jorge and Verloo, Henk", title="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", journal="JMIR Res Protoc", year="2025", month="Mar", day="25", volume="14", pages="e67128", keywords="climate change", keywords="global warming", keywords="emergency department", keywords="emergency nursing", keywords="sustainable care", keywords="ecological medicine", keywords="cardiopulmonary", keywords="cardio health", keywords="Valais", keywords="Switzerland", keywords="pilot study", keywords="study protocol", keywords="humanity", keywords="air pollution", keywords="impact", keywords="comorbidities", keywords="adults", keywords="mixed methods design", keywords="feasibility", keywords="health promotion", keywords="disease prevention", keywords="acceptability", abstract="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 ", doi="10.2196/67128", url="https://www.researchprotocols.org/2025/1/e67128" } @Article{info:doi/10.2196/59326, author="Domann, Maximilian and Richters, Constanze and Stadler, Matthias", title="Student Acceptance of Digital Entrustable Professional Activities: Protocol for a Cohort Study", journal="JMIR Res Protoc", year="2025", month="Mar", day="25", volume="14", pages="e59326", keywords="medical education", keywords="entrustable professional activities", keywords="EPAs", keywords="digital EPAs", keywords="technology acceptance model", abstract="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 ", doi="10.2196/59326", url="https://www.researchprotocols.org/2025/1/e59326" } @Article{info:doi/10.2196/62935, author="Lee, Hocheol", title="Assessment of Digital Capabilities by 9 Countries in the Alliance for Healthy Cities Using AI: Cross-Sectional Analysis", journal="JMIR Form Res", year="2025", month="Feb", day="7", volume="9", pages="e62935", keywords="digital capabilities", keywords="digital health cities", keywords="digital transformation", keywords="Asian Forum of Healthy Cities", keywords="assessment", keywords="digital health", keywords="artificial intelligence", keywords="AI", keywords="World Health Organization", keywords="WHO", keywords="healthy city", keywords="data", keywords="health management", keywords="digital era", keywords="qualitative analysis", keywords="cross-sectional survey", keywords="database", keywords="digital health database", keywords="effectiveness", keywords="digital literacy", abstract="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. ", doi="10.2196/62935", url="https://formative.jmir.org/2025/1/e62935" } @Article{info:doi/10.2196/64970, author="Nijkamp, Nick and Calleja, Pauline and Sahay, Ashlyn and Jack, Leanne", title="Evaluation of the Transition-to-Practice Arrangements for Novice Perioperative Nurses: Protocol for a Mixed Methods Study", journal="JMIR Res Protoc", year="2025", month="Jan", day="23", volume="14", pages="e64970", keywords="transition to practice", keywords="perioperative nursing", keywords="novice nurses", keywords="nurse educators", keywords="mixed methods research", keywords="protocol", keywords="document analysis", keywords="semistructured interviews", keywords="pedagogy", abstract="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 ", doi="10.2196/64970", url="https://www.researchprotocols.org/2025/1/e64970", url="http://www.ncbi.nlm.nih.gov/pubmed/39847424" } @Article{info:doi/10.2196/51493, author="Grover, Ashoo and Nair, Saritha and Sharma, Saurabh and Gupta, Shefali and Shrivastava, Suyesh and Singh, Pushpendra and Kanungo, Srikanta and Ovung, Senthanro and Singh, Charan and Khan, Mabood Abdul and Sharma, Sandeep and Palo, Kumar Subrata and Chakma, Tapas and Bajaj, Anjali", title="Strengthening Cause of Death Statistics in Selected Districts of 3 States in India: Protocol for an Uncontrolled, Before-After, Mixed Method Study", journal="JMIR Res Protoc", year="2024", month="Dec", day="20", volume="13", pages="e51493", keywords="cause of death", keywords="Medical Certification of Cause of Death", keywords="capacity building", keywords="Civil Registration and Vital Statistics", keywords="training", abstract="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 ", doi="10.2196/51493", url="https://www.researchprotocols.org/2024/1/e51493" } @Article{info:doi/10.2196/60677, author="Melamed, C. Osnat and Mehra, Kamna and Panda, Roshni and Minian, Nadia and Veldhuizen, Scott and Zawertailo, Laurie and Buckley, Leslie and Maslej, Marta and Greaves, Lorraine and Brabete, C. Andreea and Rose, Jonathan and Ratto, Matt and Selby, Peter", title="A Gender-Informed Smoking Cessation App for Women: Protocol for an Acceptability and Feasibility Study", journal="JMIR Res Protoc", year="2024", month="Dec", day="10", volume="13", pages="e60677", keywords="smoking cessation", keywords="mHealth", keywords="co-development", keywords="feasibility", keywords="smoking", keywords="mobile app", keywords="cigarette smoking", keywords="tobacco cessation", keywords="gender-informed design", keywords="app design", keywords="women's health", keywords="behavior change", keywords="health behavior change", keywords="mobile phone", abstract="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 ", doi="10.2196/60677", url="https://www.researchprotocols.org/2024/1/e60677", url="http://www.ncbi.nlm.nih.gov/pubmed/39433391" } @Article{info:doi/10.2196/63907, author="Jeon, Sangha and Charles, Turk Susan", title="Internet-Based Social Activities and Cognitive Functioning 2 Years Later Among Middle-Aged and Older Adults: Prospective Cohort Study", journal="JMIR Aging", year="2024", month="Dec", day="10", volume="7", pages="e63907", keywords="online social interaction", keywords="cognitive health", keywords="age differences", keywords="Health and Retirement Study", keywords="social activity", keywords="internet use", keywords="isolation", abstract="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. ", doi="10.2196/63907", url="https://aging.jmir.org/2024/1/e63907" } @Article{info:doi/10.2196/64547, author="Levey, Nadine and Chen, Neal and Ditre, Joseph and Sylvia, Louisa and Mudgal, Chaitanya and Bhashyam, Abhiram and Garg, Rohit and Ring, David and Vranceanu, Ana-Maria and Bakhshaie, Jafar", title="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", journal="JMIR Res Protoc", year="2024", month="Dec", day="9", volume="13", pages="e64547", keywords="chronic pain", keywords="upper-extremity conditions", keywords="psychiatry", keywords="mindfulness", keywords="mind-body", keywords="substance use", keywords="web-based intervention development", abstract="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 ", doi="10.2196/64547", url="https://www.researchprotocols.org/2024/1/e64547" } @Article{info:doi/10.2196/56999, author="Stone, Chris and Essery, Rosie and Matthews, Joe and Naughton, Felix and Munafo, Marcus and Attwood, Angela and Skinner, Andy", title="Presenting and Evaluating a Smartwatch-Based Intervention for Smoking Relapse (StopWatch): Feasibility and Acceptability Study", journal="JMIR Form Res", year="2024", month="Nov", day="21", volume="8", pages="e56999", keywords="smoking", keywords="smoking cessation", keywords="passive detection", keywords="just-in-time intervention", keywords="JITAI", keywords="relapse prevention", keywords="relapse", keywords="smartwatch", keywords="wearable technology", keywords="wearable", keywords="mobile health", keywords="mHealth", keywords="mobile phone", abstract="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. ", doi="10.2196/56999", url="https://formative.jmir.org/2024/1/e56999", url="http://www.ncbi.nlm.nih.gov/pubmed/39570656" } @Article{info:doi/10.2196/63562, author="Fisher, J. Joshua and Grace, Tegan and Castles, A. Nathan and Jones, A. Elizabeth and Delforce, J. Sarah and Peters, E. Alexandra and Crombie, K. Gabrielle and Hoedt, C. Emily and Warren, E. Kirby and Kahl, GS Richard and Hirst, J. Jonathan and Pringle, G. Kirsty and Pennell, E. Craig", title="Methodology for Biological Sample Collection, Processing, and Storage in the Newcastle 1000 Pregnancy Cohort: Protocol for a Longitudinal, Prospective Population-Based Study in Australia", journal="JMIR Res Protoc", year="2024", month="Nov", day="15", volume="13", pages="e63562", keywords="pregnancy cohort study", keywords="biobanking protocol", keywords="toenails", keywords="blood", keywords="microbiome", keywords="urine", keywords="hair", keywords="pregnancy", keywords="cohort study", abstract="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 ", doi="10.2196/63562", url="https://www.researchprotocols.org/2024/1/e63562" } @Article{info:doi/10.2196/53447, author="Chung, Jane and Pretzer-Aboff, Ingrid and Parsons, Pamela and Falls, Katherine and Bulut, Eyuphan", title="Using a Device-Free Wi-Fi Sensing System to Assess Daily Activities and Mobility in Low-Income Older Adults: Protocol for a Feasibility Study", journal="JMIR Res Protoc", year="2024", month="Nov", day="12", volume="13", pages="e53447", keywords="Wi-Fi sensing", keywords="dementia", keywords="mild cognitive impairment", keywords="older adults", keywords="health disparities", keywords="in-home activities", keywords="mobility", keywords="machine learning", abstract="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 ", doi="10.2196/53447", url="https://www.researchprotocols.org/2024/1/e53447" } @Article{info:doi/10.2196/57165, author="Xiong, Eddy and Bonner, Carissa and King, Amanda and Bourne, Maxwell Zoltan and Morgan, Mark and Tolosa, Ximena and Stanton, Tony and Greaves, Kim", title="Insights From the Development of a Dynamic Consent Platform for the Australians Together Health Initiative (ATHENA) Program: Interview and Survey Study", journal="JMIR Form Res", year="2024", month="Nov", day="6", volume="8", pages="e57165", keywords="dynamic consent", keywords="research", keywords="clinical trials", keywords="consumer engagement", keywords="digital consent", keywords="development", keywords="decision making", keywords="decision", keywords="feedback", keywords="user platform", keywords="users", keywords="communication", abstract="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. ", doi="10.2196/57165", url="https://formative.jmir.org/2024/1/e57165" } @Article{info:doi/10.2196/56387, author="Werner, Marie and Kapetanovic, Sabina and Claesdotter-Knutsson, Emma", title="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", journal="JMIR Res Protoc", year="2024", month="Oct", day="8", volume="13", pages="e56387", keywords="gaming", keywords="family program", keywords="family intervention", keywords="pilot study,", keywords="adolescent", keywords="problematic gaming", keywords="excessive screen time", keywords="children", keywords="screen use", keywords="child-parent relationship", keywords="motivational interviewing", abstract="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 Sk{\aa}ne, 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 ", doi="10.2196/56387", url="https://www.researchprotocols.org/2024/1/e56387", url="http://www.ncbi.nlm.nih.gov/pubmed/39378066" } @Article{info:doi/10.2196/55511, author="Turjo, Das Manoshi and Mundada, Suchit Khushboo and Haque, Jabeen Nuzhat and Ahmed, Nova", title="Predicting the Transition From Depression to Suicidal Ideation Using Facebook Data Among Indian-Bangladeshi Individuals: Protocol for a Cohort Study", journal="JMIR Res Protoc", year="2024", month="Oct", day="7", volume="13", pages="e55511", keywords="human-computer interaction", keywords="depression", keywords="suicidal ideation", keywords="mental health", keywords="India", keywords="Bangladesh", keywords="Facebook", keywords="major depressive disorder", keywords="MDD", keywords="9-item Patient Health Questionnaire", keywords="PHQ-9", keywords="natural language processing", keywords="NLP", keywords="machine learning", keywords="ML", abstract="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 ", doi="10.2196/55511", url="https://www.researchprotocols.org/2024/1/e55511", url="http://www.ncbi.nlm.nih.gov/pubmed/39374059" } @Article{info:doi/10.2196/54914, author="Deribe, Leul and Girma, Eshetu and Lindstr{\"o}m, Nataliya and Gidey, Abdulkadir and Teferra, Solomon and Addissie, Adamu", title="Parent Education and Counseling (PairEd-C) Intervention to Improve Family-Centered Care: Protocol for a Prospective Acceptability Study Using the Theoretical Framework of Acceptability", journal="JMIR Res Protoc", year="2024", month="Oct", day="4", volume="13", pages="e54914", keywords="family-centered care", keywords="child cancer", keywords="theoretical framework of acceptability", keywords="education and counseling", keywords="acceptability", keywords="parent education", keywords="family centered", keywords="care service", keywords="theoretical framework", keywords="study protocol", keywords="family", keywords="health care", keywords="well-being", keywords="children", keywords="implementation", keywords="design intervention", abstract="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 ", doi="10.2196/54914", url="https://www.researchprotocols.org/2024/1/e54914", url="http://www.ncbi.nlm.nih.gov/pubmed/39365661" } @Article{info:doi/10.2196/60361, author="Kotov, Alexander and Idalski Carcone, April and Towner, Elizabeth", title="Neural Conversational Agent for Weight Loss Counseling: Protocol for an Implementation and Feasibility Study", journal="JMIR Res Protoc", year="2024", month="Sep", day="20", volume="13", pages="e60361", keywords="conversational agents", keywords="artificial intelligence", keywords="behavior change", keywords="weight loss", keywords="obesity", keywords="motivational interviewing", keywords="web-based application", keywords="deep learning", keywords="transformers", keywords="large language models", keywords="feasibility study", abstract="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 ", doi="10.2196/60361", url="https://www.researchprotocols.org/2024/1/e60361" } @Article{info:doi/10.2196/54859, author="Jabour, Abdulrahman", title="Integrating Health and Disability Data Into Academic Information Systems: Workflow Optimization Study", journal="JMIR Hum Factors", year="2024", month="Sep", day="4", volume="11", pages="e54859", keywords="disability", keywords="health data", keywords="student health", keywords="health measures", keywords="disability data", keywords="university setting", keywords="university system", keywords="student system", keywords="academic system", keywords="health informatics", keywords="health-related", keywords="health information", keywords="support", keywords="well-being", keywords="user-centered", keywords="data collection", keywords="analysis", keywords="development", keywords="privacy", keywords="confidentiality", keywords="timely communication", keywords="task automation", keywords="resources", keywords="quality of life", keywords="wellness", keywords="advisor", keywords="advisors", keywords="support system", keywords="interview", keywords="interviews", keywords="administrative staff", keywords="admin staff", keywords="physician", keywords="physicians", keywords="faculty", keywords="student", keywords="students", keywords="thematic analysis", keywords="focus group", abstract="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. ", doi="10.2196/54859", url="https://humanfactors.jmir.org/2024/1/e54859" } @Article{info:doi/10.2196/56957, author="Beuthin, Oliver and Shahid, Sadiya and Yu, Ly-Mee and Bhui, Kamaldeep", title="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", journal="JMIR Res Protoc", year="2024", month="Sep", day="2", volume="13", pages="e56957", keywords="cultural adaptation", keywords="digital mental health", keywords="suicidal ideation", keywords="refugee mental health", keywords="Syrian refugee", keywords="experience-based co-design", keywords="mental health", keywords="suicide", keywords="suicidal", keywords="refugee", keywords="immigrant", keywords="ethnic minority", keywords="asylum", keywords="user experience", keywords="cultural", keywords="Syria", keywords="Syrian", keywords="refugees", keywords="feasibility", keywords="acceptability", keywords="depression", keywords="anxiety", keywords="posttraumatic stress disorder", keywords="United Kingdom", keywords="Arabic-speaking", abstract="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 ", doi="10.2196/56957", url="https://www.researchprotocols.org/2024/1/e56957", url="http://www.ncbi.nlm.nih.gov/pubmed/39222345" } @Article{info:doi/10.2196/56170, author="Alexander, L. Gregory and Poghosyan, Lusine and Zhao, Yihong and Hobensack, Mollie and Kisselev, Sergey and Norful, A. Allison and McHugh, John and Wise, Keely and Schrimpf, Brooke M. and Kolanowski, Ann and Bhatia, Tamanna and Tasnova, Sabrina", title="Optimizing Response Rates to Examine Health IT Maturity and Nurse Practitioner Care Environments in US Nursing Homes: Mixed Mode Survey Recruitment Protocol", journal="JMIR Res Protoc", year="2024", month="Aug", day="29", volume="13", pages="e56170", keywords="surveys and questionnaires", keywords="survey methods", keywords="health care surveys", keywords="survey", keywords="survey design", keywords="mixed-mMode survey", keywords="nursing homes", keywords="nursing home", keywords="clinical informatics research", keywords="electronic health records", keywords="electronic health record", keywords="clinicians", keywords="HIT Maturity", keywords="Care Environments", keywords="United States", abstract="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 ", doi="10.2196/56170", url="https://www.researchprotocols.org/2024/1/e56170" } @Article{info:doi/10.2196/54272, author="Rabbani, Fauziah and Nafis, Javeria and Akhtar, Samina and Khan, Shahid Muhammad and Sayani, Saleem and Siddiqui, Amna and Siddiqi, Sameen and Merali, Zul", title="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", journal="JMIR Res Protoc", year="2024", month="Jul", day="23", volume="13", pages="e54272", keywords="anxiety", keywords="depression", keywords="feasibility", keywords="mental health", keywords="health workers", keywords="mPareshan app", keywords="implementation research", abstract="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 ", doi="10.2196/54272", url="https://www.researchprotocols.org/2024/1/e54272" } @Article{info:doi/10.2196/54407, author="Pretorius, Kelly", title="A Simple and Systematic Approach to Qualitative Data Extraction From Social Media for Novice Health Care Researchers: Tutorial", journal="JMIR Form Res", year="2024", month="Jul", day="9", volume="8", pages="e54407", keywords="social media analysis", keywords="data extraction", keywords="health care research", keywords="extraction tutorial", keywords="Facebook extraction", keywords="Facebook analysis", keywords="safe sleep", keywords="sudden unexpected infant death", keywords="social media", keywords="analysis", keywords="systematic approach", keywords="qualitative data", keywords="Facebook", keywords="health-related", keywords="maternal perspective", keywords="maternal perspectives", keywords="sudden infant death syndrome", keywords="mother", keywords="mothers", keywords="women", keywords="United States", keywords="SIDS", keywords="SUID", keywords="post", keywords="posts", doi="10.2196/54407", url="https://formative.jmir.org/2024/1/e54407", url="http://www.ncbi.nlm.nih.gov/pubmed/38980712" } @Article{info:doi/10.2196/52361, author="Moreno, I. Patricia and Worch, M. Sarah and Thomas, L. Jessica and Nguyen, L. Rebecca and Medina, N. Heidy and Penedo, J. Frank and Moskowitz, T. Judith and Yanez, Betina and Kircher, M. Sheetal and Kundu, D. Shilajit and Flury, C. Sarah and Cheung, O. Elaine", title="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", journal="JMIR Res Protoc", year="2024", month="Jun", day="18", volume="13", pages="e52361", keywords="quality of life", keywords="cancer", keywords="biopsy", keywords="couples", keywords="dyads", keywords="caregiver", keywords="patients", keywords="patient", keywords="cancer biopsy", keywords="spouse", keywords="spouses", keywords="partner", keywords="partners", keywords="diagnostic", keywords="diagnostic procedure", keywords="feasibility of recruitment", keywords="recruitment", keywords="prostate biopsy", keywords="breast biopsy", keywords="screening", keywords="electronic health record", keywords="survey", keywords="surveys", abstract="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 ", doi="10.2196/52361", url="https://www.researchprotocols.org/2024/1/e52361", url="http://www.ncbi.nlm.nih.gov/pubmed/38889402" } @Article{info:doi/10.2196/53454, author="Pike, E. Caitlin and Dohnt, C. Henriette and Tully, J. Phillip and Bartik, Warren and Welton-Mitchell, Courtney and Murray, V. Clara and Rice, Kylie and Cosh, M. Suzanne and Lykins, D. Amy", title="A Community Mental Health Integrated Disaster Preparedness Intervention for Bushfire Recovery in Rural Australian Communities: Protocol for a Multimethods Feasibility and Acceptability Pilot Study", journal="JMIR Res Protoc", year="2024", month="Jun", day="4", volume="13", pages="e53454", keywords="bushfires", keywords="wildfires", keywords="rural mental health", keywords="natural disasters", keywords="mental health", keywords="disaster preparedness", keywords="natural hazards resilience", keywords="community interventions", keywords="mixed-methods", keywords="pilot study", keywords="disaster", keywords="preparedness", keywords="preparation", keywords="natural hazard", keywords="psychological distress", keywords="resilience", keywords="help-seeking", abstract="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 ", doi="10.2196/53454", url="https://www.researchprotocols.org/2024/1/e53454", url="http://www.ncbi.nlm.nih.gov/pubmed/38833279" } @Article{info:doi/10.2196/53646, author="Glayzer, E. Jennifer and Bray, C. Bethany and Kobak, H. William and Steffen, D. Alana and Schlaeger, M. Judith", title="Lack of Diversity in Research on Females with Ehlers-Danlos Syndromes: Recruitment Protocol for a Quantitative Online Survey", journal="JMIR Res Protoc", year="2024", month="May", day="2", volume="13", pages="e53646", keywords="Ehlers-Danlos syndrome", keywords="hypermobility", keywords="social media", keywords="recruitment", keywords="Facebook", keywords="hereditary disease", keywords="connective tissue disorders", keywords="racial", keywords="ethnic", keywords="diversity", keywords="challenges", keywords="strategies", keywords="strategy", keywords="online", keywords="information seeking", keywords="cross-sectional survey", keywords="dyspareunia", keywords="painful sex", keywords="United States", abstract="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 ", doi="10.2196/53646", url="https://www.researchprotocols.org/2024/1/e53646", url="http://www.ncbi.nlm.nih.gov/pubmed/38696252" } @Article{info:doi/10.2196/51540, author="Ahmed, Sabbir Md and Hasan, Tanvir and Islam, Salekul and Ahmed, Nova", title="Investigating Rhythmicity in App Usage to Predict Depressive Symptoms: Protocol for Personalized Framework Development and Validation Through a Countrywide Study", journal="JMIR Res Protoc", year="2024", month="Apr", day="24", volume="13", pages="e51540", keywords="depressive symptoms", keywords="app usage rhythm", keywords="behavioral markers", keywords="personalization", keywords="multitask learning framework", abstract="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 ", doi="10.2196/51540", url="https://www.researchprotocols.org/2024/1/e51540", url="http://www.ncbi.nlm.nih.gov/pubmed/38657238" } @Article{info:doi/10.2196/47229, author="Tokunaga, Seiki and Sekiguchi, Takuya and Watanabe Miura, Kumi and Sugimoto, Hikaru and S Abe, Masato and Tamura, Kazuhiro and Kishimoto, Taishiro and Kudo, Takashi and Otake-Matsuura, Mihoko", title="Home-Based Cognitive Intervention for Healthy Older Adults Through Asking Robots Questions: Randomized Controlled Trial", journal="JMIR Aging", year="2024", month="Apr", day="22", volume="7", pages="e47229", keywords="cognitive intervention", keywords="home-based experiment", keywords="robots", keywords="older adults", keywords="technology adoption", keywords="digital health", abstract="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 ", doi="10.2196/47229", url="https://aging.jmir.org/2024/1/e47229" } @Article{info:doi/10.2196/52616, author="Awindaogo, Felix and Acheamfour-Akowuah, Emmanuel and Doku, Alfred and Kokuro, Collins and Agyekum, Francis and Owusu, Kofi Isaac", title="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", journal="JMIR Res Protoc", year="2024", month="Apr", day="8", volume="13", pages="e52616", keywords="clinical", keywords="cross-sectional", keywords="epidemiology", keywords="Ghana", keywords="heart failure", keywords="heart", keywords="management", keywords="medium-term", keywords="monitoring", keywords="mortality", keywords="outcome", keywords="patient data", keywords="prevention", keywords="protocol", keywords="teaching", keywords="treatment", abstract="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 ", doi="10.2196/52616", url="https://www.researchprotocols.org/2024/1/e52616", url="http://www.ncbi.nlm.nih.gov/pubmed/38588528" } @Article{info:doi/10.2196/53301, author="Short, E. Camille and Rawstorn, C. Jonathan and Jones, L. Tamara and Edbrooke, Lara and Hayes, C. Sandra and Maddison, Ralph and Nightingale, Sophie and Ismail, Hilmy and De Boer, Richard and Hegi-Johnson, Fiona and Sverdlov, L. Aaron and Bell, Robyn and Halligan, Irene and Denehy, Linda", title="Evaluating a Remotely Delivered Cardio-Oncology Rehabilitation Intervention for Patients With Breast Cancer (REMOTE-COR-B): Protocol for a Single-Arm Feasibility Trial", journal="JMIR Res Protoc", year="2024", month="Apr", day="5", volume="13", pages="e53301", keywords="breast cancer survivor", keywords="breast cancer", keywords="cancer survivor", keywords="cancer", keywords="cardiac rehabilitation", keywords="cardiac", keywords="cardiotoxicity", keywords="cardiovascular disease", keywords="digital health", keywords="efficacy", keywords="exercise", keywords="feasibility", keywords="fitness", keywords="rehabilitation intervention", keywords="rehabilitation", keywords="safety", abstract="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 ", doi="10.2196/53301", url="https://www.researchprotocols.org/2024/1/e53301", url="http://www.ncbi.nlm.nih.gov/pubmed/38578682" } @Article{info:doi/10.2196/48027, author="Chaves, Antonio and Arn{\'a}ez, Sandra and Garc{\'i}a-Soriano, Gemma", title="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", journal="JMIR Mhealth Uhealth", year="2024", month="Mar", day="29", volume="12", pages="e48027", keywords="obsessive-compulsive disorder", keywords="OCD", keywords="mental health literacy", keywords="stigma", keywords="app", keywords="help-seeking intention", keywords="seek help", keywords="mobile phone", abstract="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. ", doi="10.2196/48027", url="https://mhealth.jmir.org/2024/1/e48027", url="http://www.ncbi.nlm.nih.gov/pubmed/38551629" } @Article{info:doi/10.2196/55701, author="Yao, Jiasi and Roth, Heike and Anderson, Debra and Lu, Hong and Rong, Huijuan and Baird, Kathleen", title="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", journal="JMIR Res Protoc", year="2024", month="Mar", day="26", volume="13", pages="e55701", keywords="spontaneous pushing", keywords="directed pushing", keywords="labour stage, labour", keywords="labor", keywords="obstetric", keywords="obstetrics", keywords="child", keywords="birth", keywords="delivery", keywords="second", keywords="feasibility study", keywords="China", keywords="Chinese", keywords="women", keywords="protocol", keywords="maternal-neonatal outcomes", keywords="maternal", keywords="healthcare", keywords="labouring women", keywords="cohort", keywords="effectiveness", keywords="Midwives", keywords="midwife", keywords="midwifery", keywords="childbirth", abstract="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 ", doi="10.2196/55701", url="https://www.researchprotocols.org/2024/1/e55701", url="http://www.ncbi.nlm.nih.gov/pubmed/38530330" } @Article{info:doi/10.2196/55999, author="Jacobucci, Ross and Ammerman, Brooke and Ram, Nilam", title="Examining Passively Collected Smartphone-Based Data in the Days Prior to Psychiatric Hospitalization for a Suicidal Crisis: Comparative Case Analysis", journal="JMIR Form Res", year="2024", month="Mar", day="20", volume="8", pages="e55999", keywords="screenomics", keywords="digital phenotyping", keywords="passive assessment", keywords="intensive time sampling", keywords="suicide risk", keywords="suicidal behaviors", keywords="risk detection", keywords="Comparative Analysis", keywords="suicide", keywords="suicidal", keywords="risk", keywords="risks", keywords="behavior", keywords="behaviors", keywords="detection", keywords="prediction", keywords="Smartphone-Based", keywords="screenomic", keywords="case review", keywords="participant", keywords="participants", keywords="smartphone", keywords="smartphones", keywords="suicidal ideation", abstract="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. ", doi="10.2196/55999", url="https://formative.jmir.org/2024/1/e55999", url="http://www.ncbi.nlm.nih.gov/pubmed/38506916" } @Article{info:doi/10.2196/49857, author="O'Driscoll, Ciar{\'a}n and Singh, Aneesha and Chichua, Iya and Clodic, Joachim and Desai, Anjali and Nikolova, Dara and Yap, Jie Alex and Zhou, Irene and Pilling, Stephen", title="An Ecological Mobile Momentary Intervention to Support Dynamic Goal Pursuit: Feasibility and Acceptability Study", journal="JMIR Form Res", year="2024", month="Mar", day="20", volume="8", pages="e49857", keywords="goal pursuit", keywords="ecological momentary intervention", keywords="ecological momentary assessment", keywords="mood", keywords="dynamics", keywords="network analysis", keywords="MCII", keywords="COM-B", keywords="support", keywords="pilot study", keywords="training", keywords="feasibility", keywords="acceptability", keywords="self-monitoring", keywords="implementation", keywords="psychological", keywords="effectiveness", abstract="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. ", doi="10.2196/49857", url="https://formative.jmir.org/2024/1/e49857", url="http://www.ncbi.nlm.nih.gov/pubmed/38506904" } @Article{info:doi/10.2196/54823, author="Park, G. Linda and Chi, Serena and Pitsenbarger, Susan and Johnson, K. Julene and Shah, J. Amit and Elnaggar, Abdelaziz and von Oppenfeld, Julia and Cho, Evan and Harzand, Arash and Whooley, A. Mary", title="Cardiac Rehabilitation During the COVID-19 Pandemic and the Potential for Digital Technology to Support Physical Activity Maintenance: Qualitative Study", journal="JMIR Cardio", year="2024", month="Mar", day="14", volume="8", pages="e54823", keywords="cardiac rehabilitation", keywords="cardiac rehab", keywords="COVID-19", keywords="digital health", keywords="digital technology", keywords="physical activity", keywords="physical activity maintenance", keywords="social media", keywords="older adults", keywords="pandemic", keywords="social distancing", keywords="technology", keywords="wearables", keywords="CR", keywords="exercise", keywords="cardiovascular disease", keywords="gerontology", keywords="geriatric", keywords="geriatrics", keywords="hospital", keywords="medical facility", keywords="California", keywords="interview", keywords="thematic analysis", keywords="anxiety", abstract="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. ", doi="10.2196/54823", url="https://cardio.jmir.org/2024/1/e54823", url="http://www.ncbi.nlm.nih.gov/pubmed/38483450" } @Article{info:doi/10.2196/54251, author="Thibaudeau, Elisabeth and Peyroux, Elodie and Franck, Nicolas and Carling, Hannah and Lepage, Martin", title="Navigating Social Cognitive Impairments in Schizophrenia Spectrum Disorders: Protocol for a Pilot Pre-Post Quasi-Experimental Study for Remote Avatar-Assisted Cognitive Remediation Therapy", journal="JMIR Res Protoc", year="2024", month="Mar", day="13", volume="13", pages="e54251", keywords="social cognition", keywords="schizophrenia spectrum disorder", keywords="psychosis", keywords="cognitive remediation therapy", keywords="social cognitive training", keywords="digital relational simulation", keywords="cultural adaptation", keywords="feasibility", keywords="acceptability", keywords="mobile phone", abstract="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 (Rem{\'e}diation Cognitive de la Cognition Sociale dans la Schizophr{\'e}nie; 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 ", doi="10.2196/54251", url="https://www.researchprotocols.org/2024/1/e54251", url="http://www.ncbi.nlm.nih.gov/pubmed/38477975" } @Article{info:doi/10.2196/49492, author="Zheng, Amy and Bergh, Marissa and Patel Murali, Komal and Sadarangani, Tina", title="Using mHealth to Improve Communication in Adult Day Services Around the Needs of People With Dementia: Mixed Methods Assessment of Acceptability and Feasibility", journal="JMIR Form Res", year="2024", month="Mar", day="1", volume="8", pages="e49492", keywords="adult day services", keywords="primary health care", keywords="health communication", keywords="dementia", keywords="mobile health", keywords="mHealth", keywords="community-based", keywords="health care", keywords="older adults", keywords="older adult", keywords="chronic condition", keywords="health information", keywords="feasibility", keywords="acceptability", keywords="CareMOBI", keywords="mixed methods design", keywords="caregivers", keywords="caregiver", keywords="care workers", keywords="nurses", keywords="social workers", abstract="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. ", doi="10.2196/49492", url="https://formative.jmir.org/2024/1/e49492", url="http://www.ncbi.nlm.nih.gov/pubmed/38427418" } @Article{info:doi/10.2196/53659, author="Shinno, Seina and Matsumoto, Kazuki and Hamatani, Sayo and Inaba, Yosuke and Ozawa, Yoshihito and Kawasaki, Yohei and Ikai, Tomoki and Sutoh, Chihiro and Hayashi, Hiroyuki and Shimizu, Eiji", title="Feasibility of Guided Internet-Based Cognitive Behavioral Therapy for Panic Disorder and Social Anxiety Disorder in Japan: Pilot Single-Arm Trial", journal="JMIR Form Res", year="2024", month="Feb", day="29", volume="8", pages="e53659", keywords="cognitive behavioral therapy", keywords="internet intervention", keywords="panic disorder", keywords="social anxiety", keywords="feasibility trail", keywords="adult", keywords="adults", keywords="anxiety disorder", keywords="internet-based", keywords="e-learning", keywords="Japan", keywords="statistical analyses", keywords="therapist", keywords="therapists", keywords="intervention", keywords="severity", keywords="symptoms", keywords="therapeutic alliance", keywords="mobile phone", abstract="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 ", doi="10.2196/53659", url="https://formative.jmir.org/2024/1/e53659", url="http://www.ncbi.nlm.nih.gov/pubmed/38421717" } @Article{info:doi/10.2196/46522, author="Money, Annemarie and Hall, Alex and Harris, Danielle and Eost-Telling, Charlotte and McDermott, Jane and Todd, Chris", title="Barriers to and Facilitators of Older People's Engagement With Web-Based Services: Qualitative Study of Adults Aged >75 Years", journal="JMIR Aging", year="2024", month="Feb", day="28", volume="7", pages="e46522", keywords="digital exclusion", keywords="digital inclusion", keywords="older people", keywords="technology", keywords="aged", keywords="web-based", keywords="internet", abstract="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. ", doi="10.2196/46522", url="https://aging.jmir.org/2024/1/e46522", url="http://www.ncbi.nlm.nih.gov/pubmed/38416543" } @Article{info:doi/10.2196/47570, author="Ma, Shaoying and Kaareen, Aadeeba and Park, Hojin and He, Yanyun and Jiang, Shuning and Qiu, Zefeng and Xie, Zidian and Li, Dongmei and Chen, Jian and O'Connor, J. Richard and Fong, T. Geoffrey and Shang, Ce", title="How to Identify e-Cigarette Brands Available in the United States During 2020-2022: Development and Usability Study", journal="JMIR Form Res", year="2024", month="Feb", day="28", volume="8", pages="e47570", keywords="tobacco", keywords="electronic cigarette", keywords="e-cigarette", keywords="electronic nicotine delivery systems", keywords="electronic nicotine delivery system", keywords="vaping", keywords="market surveillance", keywords="tobacco marketing", abstract="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. ", doi="10.2196/47570", url="https://formative.jmir.org/2024/1/e47570", url="http://www.ncbi.nlm.nih.gov/pubmed/38416562" } @Article{info:doi/10.2196/54530, author="Kormanis, Aryn and Quinones, Selina and Obermiller, Corey and Denizard-Thompson, Nancy and Palakshappa, Deepak", title="Feasibility of Using Text Messaging to Identify and Assist Patients With Hypertension With Health-Related Social Needs: Cross-Sectional Study", journal="JMIR Cardio", year="2024", month="Feb", day="13", volume="8", pages="e54530", keywords="social determinants of health", keywords="health-related social needs", keywords="mobile health", keywords="health information technology", keywords="feasibility", keywords="mobile phone", keywords="SMS text messaging", keywords="message", keywords="pilot study", keywords="patients", keywords="patient", keywords="hypertension", keywords="screening", abstract="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. ", doi="10.2196/54530", url="https://cardio.jmir.org/2024/1/e54530", url="http://www.ncbi.nlm.nih.gov/pubmed/38349714" } @Article{info:doi/10.2196/50735, author="Denny, Alanna and Curtin, Brian and Taylor-Robinson, Simon and Chirambo, Baxter Griphin and Cilliers, Liezel and Wu, Joseph Tsung-Shu and O'Meara, Ciara and Booth, Richard and O'Donoghue, John", title="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", journal="JMIR Res Protoc", year="2024", month="Feb", day="6", volume="13", pages="e50735", keywords="podcasting", keywords="podcast", keywords="nursing student", keywords="gestational diabetes", keywords="mental health", keywords="health", keywords="knowledge", abstract="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 ", doi="10.2196/50735", url="https://www.researchprotocols.org/2024/1/e50735", url="http://www.ncbi.nlm.nih.gov/pubmed/38319702" } @Article{info:doi/10.2196/52560, author="Laird, Breanne and Zuniga, Sabrina and Hook, N. Joshua and Van Tongeren, R. Daryl and Joeman, Lynda and Huberty, Jennifer", title="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", journal="JMIR Form Res", year="2024", month="Feb", day="2", volume="8", pages="e52560", keywords="religion", keywords="spirituality", keywords="mobile apps", keywords="mental health", keywords="well-being", keywords="app", keywords="ethnic", keywords="technology", keywords="engagement", keywords="stress", keywords="depression", keywords="anxiety", keywords="quality of life", keywords="spiritual well-being", keywords="racial", keywords="spiritual practices", keywords="spiritual practice", keywords="mobile phone", keywords="mobile health", keywords="mHealth", abstract="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. ", doi="10.2196/52560", url="https://formative.jmir.org/2024/1/e52560", url="http://www.ncbi.nlm.nih.gov/pubmed/38306173" } @Article{info:doi/10.2196/45506, author="Walker, Tim and Buckingham, Ann Sarah and Poole, Ria and Elliott, Roland Lewis and Menneer, Tamaryn and Tu, Gengyang and Morrissey, Karyn", title="Telephone-Based Training Intervention for Using Digital Communication Technologies for Social Housing Residents During the COVID-19 Pandemic: Mixed Methods Feasibility and Acceptability Evaluation", journal="JMIR Form Res", year="2024", month="Jan", day="26", volume="8", pages="e45506", keywords="digital training", keywords="telephone-based", keywords="social housing", keywords="feasibility", keywords="acceptability", keywords="communication technologies", keywords="sociodigital inequalities", keywords="mobile phone", abstract="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. ", doi="10.2196/45506", url="https://formative.jmir.org/2024/1/e45506", url="http://www.ncbi.nlm.nih.gov/pubmed/38277209" } @Article{info:doi/10.2196/47157, author="Daryabeygi-Khotbehsara, Reza and Rawstorn, C. Jonathan and Dunstan, W. David and Shariful Islam, Mohammed Sheikh and Abdelrazek, Mohamed and Kouzani, Z. Abbas and Thummala, Poojith and McVicar, Jenna and Maddison, Ralph", title="A Bluetooth-Enabled Device for Real-Time Detection of Sitting, Standing, and Walking: Cross-Sectional Validation Study", journal="JMIR Form Res", year="2024", month="Jan", day="24", volume="8", pages="e47157", keywords="activity tracker", keywords="algorithms", keywords="deep neural network", keywords="machine learning", keywords="real-time data", keywords="Sedentary behaviOR Detector", keywords="sedentary behavior", keywords="SORD", keywords="standing", keywords="validation", keywords="walking", keywords="wearables", abstract="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. ", doi="10.2196/47157", url="https://formative.jmir.org/2024/1/e47157", url="http://www.ncbi.nlm.nih.gov/pubmed/38265864" } @Article{info:doi/10.2196/48992, author="Adams, B. Leslie and Watts, Thomasina and DeVinney, Aubrey and Haroz, E. Emily and Thrul, Johannes and Stephens, Brooks Jasmin and Campbell, N. Mia and Antoine, Denis and L{\^e} Cook, Benjamin and Joe, Sean and Thorpe Jr, J. Roland", title="Acceptability and Feasibility of a Smartphone-Based Real-Time Assessment of Suicide Among Black Men: Mixed Methods Pilot Study", journal="JMIR Form Res", year="2024", month="Jan", day="22", volume="8", pages="e48992", keywords="Black men", keywords="suicide", keywords="ecological momentary assessment", keywords="feasibility", keywords="acceptability", keywords="mixed methods", keywords="smartphone", keywords="real-time assessment", keywords="suicide prevention", keywords="user experience", keywords="behavior", keywords="implementation", keywords="intervention", keywords="mobile phone", abstract="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 ", doi="10.2196/48992", url="https://formative.jmir.org/2024/1/e48992", url="http://www.ncbi.nlm.nih.gov/pubmed/38252475" } @Article{info:doi/10.2196/51925, author="de Hond, Anne and van Buchem, Marieke and Fanconi, Claudio and Roy, Mohana and Blayney, Douglas and Kant, Ilse and Steyerberg, Ewout and Hernandez-Boussard, Tina", title="Predicting Depression Risk in Patients With Cancer Using Multimodal Data: Algorithm Development Study", journal="JMIR Med Inform", year="2024", month="Jan", day="18", volume="12", pages="e51925", keywords="natural language processing", keywords="machine learning", keywords="artificial intelligence", keywords="oncology", keywords="depression", keywords="clinical decision support", keywords="decision support", keywords="cancer", keywords="patients with cancer", keywords="chemotherapy", keywords="mental health", keywords="prediction model", keywords="depression risk", keywords="cancer treatment", keywords="radiotherapy", keywords="diagnosis", keywords="validation", keywords="cancer care", keywords="care", abstract="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. ", doi="10.2196/51925", url="https://medinform.jmir.org/2024/1/e51925", url="http://www.ncbi.nlm.nih.gov/pubmed/38236635" } @Article{info:doi/10.2196/46367, author="Sommer, L. Jordana and Reynolds, Kristin and Hebbard, Pamela and Smith, D. Michael S. and Mota, Natalie and Mutch, C. W. Alan and Maples-Keller, Jessica and Roos, Leslie and El-Gabalawy, Ren{\'e}e", title="Preoperative Virtual Reality to Expose Patients With Breast Cancer to the Operating Room Environment: Feasibility and Pilot Case Series Study", journal="JMIR Form Res", year="2024", month="Jan", day="17", volume="8", pages="e46367", keywords="virtual reality", keywords="preoperative anxiety and distress", keywords="breast cancer surgery", keywords="anesthesia", keywords="feasibility", keywords="pilot", abstract="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 ", doi="10.2196/46367", url="https://formative.jmir.org/2024/1/e46367", url="http://www.ncbi.nlm.nih.gov/pubmed/38231570" } @Article{info:doi/10.2196/46284, author="Gill, Roopan and Ogilvie, Gina and Norman, V. Wendy and Fitzsimmons, Brian and Maher, Ciana and Renner, Regina", title="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", journal="JMIR Form Res", year="2024", month="Jan", day="9", volume="8", pages="e46284", keywords="mobile health", keywords="mHealth", keywords="digital health", keywords="abortion", keywords="human-centered design", keywords="sexual and reproductive health", keywords="qualitative research", keywords="mixed methods", abstract="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. ", doi="10.2196/46284", url="https://formative.jmir.org/2024/1/e46284", url="http://www.ncbi.nlm.nih.gov/pubmed/38194252" } @Article{info:doi/10.2196/46413, author="Valvi, Nimish and McFarlane, Timothy and Allen, S. Katie and Gibson, Joseph P. and Dixon, Edward Brian", title="Identification of Hypertension in Electronic Health Records Through Computable Phenotype Development and Validation for Use in Public Health Surveillance: Retrospective Study", journal="JMIR Form Res", year="2023", month="Dec", day="27", volume="7", pages="e46413", keywords="computable phenotypes", keywords="electronic health records", keywords="health information exchange", keywords="hypertension", keywords="population surveillance", keywords="public health informatics", abstract="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 $\kappa$. 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 $\kappa$ 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. ", doi="10.2196/46413", url="https://formative.jmir.org/2023/1/e46413", url="http://www.ncbi.nlm.nih.gov/pubmed/38150296" } @Article{info:doi/10.2196/47222, author="Post, Mareille Anne and Berends, I. Hanneke and van Royen, J. Barend", title="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", journal="JMIR Res Protoc", year="2023", month="Dec", day="25", volume="12", pages="e47222", keywords="adolescent idiopathic scoliosis", keywords="minimally invasive", keywords="nonfusion", keywords="posterior spinal surgery", keywords="protocol", keywords="one-way self-expanding rod", keywords="scoliosis", keywords="idiopathic scoliosis", keywords="spinal fusion", keywords="spinal deformity surgery", keywords="nonfusion techniques", keywords="surgery", keywords="intraoperative", keywords="surgical technique", keywords="operation", keywords="musculoskeletal", keywords="orthopedic", abstract="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 Conformit{\'e} Europ{\'e}enne-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{\textdegree} within 1 year). The patients are over 7 years of age, with a major Cobb angle of ?30{\textdegree}, 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 ", doi="10.2196/47222", url="https://www.researchprotocols.org/2023/1/e47222", url="http://www.ncbi.nlm.nih.gov/pubmed/38145474" } @Article{info:doi/10.2196/51202, author="Draucker, Claire and Carri{\'o}n, Andr{\'e}s and Ott, A. Mary and Knopf, Amelia", title="Assessing Facilitator Fidelity to Principles of Public Deliberation: Tutorial", journal="JMIR Form Res", year="2023", month="Dec", day="13", volume="7", pages="e51202", keywords="public deliberation", keywords="deliberative democracy", keywords="bioethics", keywords="engagement", keywords="theory", keywords="process", keywords="ethical conflict", keywords="ethical", keywords="ethics", keywords="coding", keywords="evaluation", keywords="tutorial", keywords="biomedical", keywords="HIV", keywords="HIV prevention", keywords="HIV research", doi="10.2196/51202", url="https://formative.jmir.org/2023/1/e51202", url="http://www.ncbi.nlm.nih.gov/pubmed/38090788" } @Article{info:doi/10.2196/50797, author="Desch{\^e}nes, Marie-France and Fernandez, Nicolas and Lechasseur, Kathleen and Caty, Marie-{\`E}ve and Azimzadeh, Dina and Mai, Tue-Chieu and Lavoie, Patrick", title="Transformation and Articulation of Clinical Data to Understand Students' and Health Professionals' Clinical Reasoning: Protocol for a Scoping Review", journal="JMIR Res Protoc", year="2023", month="Dec", day="13", volume="12", pages="e50797", keywords="clinical reasoning", keywords="semantic qualifiers", keywords="discourse", keywords="linguistics", keywords="education", keywords="natural language processing", keywords="scoping review", keywords="clinical data", keywords="educational strategy", keywords="student", keywords="health care professional", keywords="semantic transformation", abstract="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 ", doi="10.2196/50797", url="https://www.researchprotocols.org/2023/1/e50797", url="http://www.ncbi.nlm.nih.gov/pubmed/38090795" } @Article{info:doi/10.2196/49135, author="Jia, Si Si and Allman-Farinelli, Margaret and Roy, Rajshri and Phongsavan, Philayrath and Hyun, Karice and Gibson, Anne Alice and Partridge, Ruth Stephanie", title="Using Mobile Ecological Momentary Assessment to Understand Consumption and Context Around Online Food Delivery Use: Pilot Feasibility and Acceptability Study", journal="JMIR Mhealth Uhealth", year="2023", month="Nov", day="29", volume="11", pages="e49135", keywords="ecological momentary assessment", keywords="mobile applications", keywords="mobile apps", keywords="feasibility studies", keywords="online food delivery", keywords="smartphone", keywords="young adult", keywords="adolescent", keywords="food environment", keywords="consumer behavior", keywords="mobile phone", abstract="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. ", doi="10.2196/49135", url="https://mhealth.jmir.org/2023/1/e49135", url="http://www.ncbi.nlm.nih.gov/pubmed/38019563" } @Article{info:doi/10.2196/46835, author="Hazelton, Lara and da Luz Dias, Raquel and Esliger, Mandy and Tibbo, Philip and Sinha, Nachiketa and Njoku, Anthony and Satyanarayana, Satyendra and Siddhartha, Sanjay and Alexiadis-Brown, Peggy and Rahman, Faisal and Maguire, Hugh and Gray, Gerald and Bosma, Mark and Parker, Deborah and Connolly, Owen and Raji, Adewale and Manning, Alexandra and Bagnell, Alexa and Israel Opoku Agyapong, Vincent", title="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", journal="JMIR Res Protoc", year="2023", month="Nov", day="27", volume="12", pages="e46835", keywords="distributed learning sites", keywords="medical education", keywords="psychiatry", keywords="environmental scan", keywords="needs assessment", keywords="strategic plan", keywords="distributed medical education", keywords="rural area", keywords="physician", keywords="mixed methods approach", keywords="education program", abstract="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 ", doi="10.2196/46835", url="https://www.researchprotocols.org/2023/1/e46835", url="http://www.ncbi.nlm.nih.gov/pubmed/38010790" } @Article{info:doi/10.2196/52336, author="Williams, Jess A. and Townsend, Ellen and Naeche, Nkem and Chapman-Nisar, Amelia and Hollis, Chris and Slovak, Petr and ", title="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", journal="JMIR Form Res", year="2023", month="Nov", day="22", volume="7", pages="e52336", keywords="digital intervention", keywords="self-harm", keywords="young people", keywords="emotion regulation", keywords="experience sampling", keywords="interviews", abstract="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. ", doi="10.2196/52336", url="https://formative.jmir.org/2023/1/e52336", url="http://www.ncbi.nlm.nih.gov/pubmed/37991838" } @Article{info:doi/10.2196/52036, author="Liew, Huiling and Pienkowska, Anita and Ang, Chin-Siang and Mahadzir, Azlan Muhammad Daniel and Goh, Ing Kelley Fann and Lodh, Nandika and Bojic, Iva and Lawate, Ashwini and Ong, Chwen Qi and Venkataraman, Kavita and Car, Josip and Ho, Yan Andy Hau", title="Empowering Foot Care Literacy Among People Living With Diabetes and Their Carers With an mHealth App: Protocol for a Feasibility Study", journal="JMIR Res Protoc", year="2023", month="Nov", day="21", volume="12", pages="e52036", keywords="digital therapeutics", keywords="mHealth", keywords="diabetes mellitus", keywords="diabetes foot ulcer", keywords="feasibility study", keywords="mobile phone", abstract="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 ", doi="10.2196/52036", url="https://www.researchprotocols.org/2023/1/e52036", url="http://www.ncbi.nlm.nih.gov/pubmed/37988150" } @Article{info:doi/10.2196/42916, author="El Dahr, Yola and Perquier, Florence and Moloney, Madison and Woo, Guyyunge and Dobrin-De Grace, Roksana and Carvalho, Daniela and Addario, Nicole and Cameron, E. Emily and Roos, E. Leslie and Szatmari, Peter and Aitken, Madison", title="Feasibility of Using Research Electronic Data Capture (REDCap) to Collect Daily Experiences of Parent-Child Dyads: Ecological Momentary Assessment Study", journal="JMIR Form Res", year="2023", month="Nov", day="9", volume="7", pages="e42916", keywords="ambulatory assessment", keywords="children", keywords="ecological momentary assessment", keywords="longitudinal", keywords="parents", keywords="survey", abstract="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. ", doi="10.2196/42916", url="https://formative.jmir.org/2023/1/e42916", url="http://www.ncbi.nlm.nih.gov/pubmed/37943593" } @Article{info:doi/10.2196/51884, author="Brommeyer, Mark and Liang, Zhanming and Whittaker, Maxine and Mackay, Mark", title="Developing Health Management Competency for Digital Health Transformation: Protocol for a Qualitative Study", journal="JMIR Res Protoc", year="2023", month="Nov", day="3", volume="12", pages="e51884", keywords="health care management", keywords="health service manager", keywords="digital health", keywords="health informatics", keywords="competency", keywords="workforce development", keywords="innovation", keywords="research protocol", keywords="informatics", keywords="manager", keywords="managers", keywords="service", keywords="services", keywords="delivery", keywords="organization", keywords="organizational", keywords="workforce", keywords="management", keywords="managerial", keywords="qualification", keywords="qualifications", keywords="focus group", keywords="focus groups", keywords="interview", keywords="interviews", keywords="scoping", keywords="review methods", keywords="review methodology", abstract="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 ", doi="10.2196/51884", url="https://www.researchprotocols.org/2023/1/e51884", url="http://www.ncbi.nlm.nih.gov/pubmed/37921855" } @Article{info:doi/10.2196/47167, author="S{\"u}kei, Emese and Romero-Medrano, Lorena and de Leon-Martinez, Santiago and Herrera L{\'o}pez, Jes{\'u}s and Campa{\~n}a-Montes, Jos{\'e} Juan and Olmos, M. Pablo and Baca-Garcia, Enrique and Art{\'e}s, Antonio", title="Continuous Assessment of Function and Disability via Mobile Sensing: Real-World Data-Driven Feasibility Study", journal="JMIR Form Res", year="2023", month="Oct", day="30", volume="7", pages="e47167", keywords="WHODAS", keywords="functional limitations", keywords="mobile sensing", keywords="passive ecological momentary assessment", keywords="predictive modeling", keywords="interpretable machine learning", keywords="machine learning", keywords="disability", keywords="clinical outcome", abstract="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. ", doi="10.2196/47167", url="https://formative.jmir.org/2023/1/e47167", url="http://www.ncbi.nlm.nih.gov/pubmed/37902823" } @Article{info:doi/10.2196/49319, author="Sharma, Nikita and Braakman-Jansen, A. Louise M. and Oinas-Kukkonen, Harri and Croockewit, Hendrik Jan and Gemert-Pijnen, van JEWC", title="Exploring the Needs and Requirements of Informal Caregivers of Older Adults With Cognitive Impairment From Sensor-Based Care Solutions: Multimethod Study", journal="JMIR Aging", year="2023", month="Oct", day="25", volume="6", pages="e49319", keywords="informal caregiving", keywords="cognitive impairment", keywords="unobtrusive sensing solutions", keywords="in-home care", keywords="aging in place", keywords="assistive technologies", abstract="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. ", doi="10.2196/49319", url="https://aging.jmir.org/2023/1/e49319", url="http://www.ncbi.nlm.nih.gov/pubmed/37878353" } @Article{info:doi/10.2196/45715, author="Kaburi, Benduri Basil and Wyss, Kaspar and Kenu, Ernest and Asiedu-Bekoe, Franklin and Hauri, M. Anja and Laryea, Odai Dennis and Klett-Tammen, J. Carolina and Leone, Fr{\'e}d{\'e}ric and Walter, Christin and Krause, G{\'e}rard", title="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", journal="JMIR Form Res", year="2023", month="Oct", day="20", volume="7", pages="e45715", keywords="implementation", keywords="Surveillance Outbreak Response Management and Analysis System", keywords="SORMAS", keywords="barriers", keywords="facilitators", keywords="digital disease surveillance", keywords="outbreak response", keywords="COVID-19", keywords="pandemic", keywords="Ghana", keywords="mobile phone", abstract="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. ", doi="10.2196/45715", url="https://formative.jmir.org/2023/1/e45715", url="http://www.ncbi.nlm.nih.gov/pubmed/37862105" } @Article{info:doi/10.2196/48641, author="Chau, Brian and Taba, Melody and Dodd, Rachael and McCaffery, Kirsten and Bonner, Carissa", title="Twitch Data in Health Promotion Research: Protocol for a Case Study Exploring COVID-19 Vaccination Views Among Young People", journal="JMIR Res Protoc", year="2023", month="Oct", day="18", volume="12", pages="e48641", keywords="twitch", keywords="social media", keywords="COVID-19", keywords="vaccination communication", keywords="video gaming", keywords="gaming", keywords="health promotion", keywords="streaming", abstract="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 ", doi="10.2196/48641", url="https://www.researchprotocols.org/2023/1/e48641", url="http://www.ncbi.nlm.nih.gov/pubmed/37851494" } @Article{info:doi/10.2196/46765, author="Raff, Christian and D{\"o}rr-Harim, Colette and Otto, Stephanie and Thiele, Johanna and Mihaljevic, Andre and Kramer, Klaus", title="Prehabilitation in an Integrative Medicine Day Clinic for Patients Undergoing Neoadjuvant Treatment: Single-Center Feasibility Pilot Study", journal="JMIR Res Protoc", year="2023", month="Oct", day="18", volume="12", pages="e46765", keywords="supportive care", keywords="prehabilitation", keywords="neoadjuvant treatment", keywords="integrative medicine", keywords="multimodal prehabilitation", keywords="cancer", keywords="oncology", keywords="surgery", keywords="preoperative", keywords="feasibility", keywords="integrative", keywords="naturopathy", keywords="naturopathic", keywords="diet", keywords="nutrition", abstract="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 ", doi="10.2196/46765", url="https://www.researchprotocols.org/2023/1/e46765", url="http://www.ncbi.nlm.nih.gov/pubmed/37851493" } @Article{info:doi/10.2196/46209, author="Dreesmann, J. Nathan and Buchanan, Diana and Tang, Jean Hsin-Yi and Furness III, Thomas and Thompson, Hilaire", title="Virtual Reality Meditation for Fatigue in Persons With Rheumatoid Arthritis: Mixed Methods Pilot Study", journal="JMIR Form Res", year="2023", month="Oct", day="17", volume="7", pages="e46209", keywords="anxiety", keywords="chronic pain", keywords="depression", keywords="fatigue", keywords="feasibility study", keywords="feasibility", keywords="head-mounted display", keywords="meditation", keywords="mixed method", keywords="mood", keywords="pain", keywords="rheumatoid arthritis", keywords="symptom", keywords="virtual reality", keywords="VR", abstract="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 ", doi="10.2196/46209", url="https://formative.jmir.org/2023/1/e46209", url="http://www.ncbi.nlm.nih.gov/pubmed/37847542" } @Article{info:doi/10.2196/44887, author="Prado, Silva Aneliana da and Kohls, Elisabeth and Baldofski, Sabrina and Rummel-Kluge, Christine and Freitas, Lucas Joanneliese de", title="Acceptability and Feasibility of Online Support Groups for Mental Health Promotion in Brazilian Graduate Students During the COVID-19 Pandemic: Longitudinal Observational Study", journal="JMIR Form Res", year="2023", month="Oct", day="13", volume="7", pages="e44887", keywords="support group", keywords="online group", keywords="COVID-19 pandemic", keywords="higher education", keywords="graduate students", keywords="university students", keywords="mental health", keywords="online intervention", keywords="internet intervention", keywords="e--mental health", keywords="mental health promotion", keywords="feasibility", keywords="students", keywords="acceptability", abstract="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. ", doi="10.2196/44887", url="https://formative.jmir.org/2023/1/e44887", url="http://www.ncbi.nlm.nih.gov/pubmed/37831483" } @Article{info:doi/10.2196/49096, author="Jenci?t?, Gabriel? and Kasputyt?, Gabriel? and Bunevi{\v c}ien?, Inesa and Korobeinikova, Erika and Vaitiekus, Domas and In{\v c}i?ra, Arturas and Jaru{\vs}evi{\v c}ius, Laimonas and Bunevi{\v c}ius, Romas and Krik{\vs}tolaitis, Ri{\v c}ardas and Krilavi{\v c}ius, Tomas and Juozaityt?, Elona and Bunevi{\v c}ius, Adomas", title="Digital Phenotyping for Monitoring and Disease Trajectory Prediction of Patients With Cancer: Protocol for a Prospective Observational Cohort Study", journal="JMIR Res Protoc", year="2023", month="Oct", day="10", volume="12", pages="e49096", keywords="cancer", keywords="digital phenotyping", keywords="biomarkers", keywords="oncology", keywords="digital phenotype", keywords="biomarker", keywords="data collection", keywords="data generation", keywords="monitor", keywords="monitoring", keywords="predict", keywords="prediction", keywords="model", keywords="models", keywords="mobile phone", abstract="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 ", doi="10.2196/49096", url="https://www.researchprotocols.org/2023/1/e49096", url="http://www.ncbi.nlm.nih.gov/pubmed/37815850" } @Article{info:doi/10.2196/45161, author="Chong, K. Min and Hickie, B. Ian and Cross, P. Shane and McKenna, Sarah and Varidel, Mathew and Capon, William and Davenport, A. Tracey and LaMonica, M. Haley and Sawrikar, Vilas and Guastella, Adam and Naismith, L. Sharon and Scott, M. Elizabeth and Iorfino, Frank", title="Digital Application of Clinical Staging to Support Stratification in Youth Mental Health Services: Validity and Reliability Study", journal="JMIR Form Res", year="2023", month="Sep", day="8", volume="7", pages="e45161", keywords="clinical staging", keywords="digital health solution", keywords="online diagnosis", keywords="service transformation", keywords="staged care", keywords="stratified care", keywords="youth mental health", abstract="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 ($\kappa$=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. ", doi="10.2196/45161", url="https://formative.jmir.org/2023/1/e45161", url="http://www.ncbi.nlm.nih.gov/pubmed/37682588" } @Article{info:doi/10.2196/46526, author="Hildebrand, D. Nicole and Wijma, G. Allard and Bongers, C. Bart and Rensen, S. Sander and den Dulk, Marcel and Klaase, M. Joost and Olde Damink, M. Steven W.", title="Supervised Home-Based Exercise Prehabilitation in Unfit Patients Scheduled for Pancreatic Surgery: Protocol for a Multicenter Feasibility Study", journal="JMIR Res Protoc", year="2023", month="Sep", day="7", volume="12", pages="e46526", keywords="preoperative care", keywords="prehabilitation", keywords="preoperative training", keywords="high-intensity interval training", keywords="pancreatic resection", keywords="cardiorespiratory fitness", abstract="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 ", doi="10.2196/46526", url="https://www.researchprotocols.org/2023/1/e46526", url="http://www.ncbi.nlm.nih.gov/pubmed/37676715" } @Article{info:doi/10.2196/46508, author="Parkes, Steven and Croak, Bethany and Brooks, K. Samantha and Stevelink, M. Sharon A. and Leightley, Daniel and Fear, T. Nicola and Rafferty, Laura and Greenberg, Neil", title="Evaluating a Smartphone App (MeT4VeT) to Support the Mental Health of UK Armed Forces Veterans: Feasibility Randomized Controlled Trial", journal="JMIR Ment Health", year="2023", month="Aug", day="28", volume="10", pages="e46508", keywords="military", keywords="veteran", keywords="mental health", keywords="military to civilian transition", keywords="digital health", keywords="mobile apps", keywords="smartphone", keywords="mobile phone", keywords="mobile health", keywords="mHealth", keywords="digital intervention", keywords="support", keywords="app", keywords="feasibility", keywords="acceptability", keywords="engagement", keywords="usability", abstract="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 ", doi="10.2196/46508", url="https://mental.jmir.org/2023/1/e46508", url="http://www.ncbi.nlm.nih.gov/pubmed/37639295" } @Article{info:doi/10.2196/49284, author="Jones, Grant and Herrmann, Felipe and Nock, K. Matthew", title="A Digital Music-Based Mindfulness Intervention for Black Americans With Elevated Race-Based Anxiety: A Multiple-Baseline Pilot Study", journal="JMIR Form Res", year="2023", month="Aug", day="16", volume="7", pages="e49284", keywords="Black music", keywords="mindfulness", keywords="meditation", keywords="single-case experiment", keywords="race", keywords="anxiety", keywords="digital health intervention", keywords="low income", keywords="Black community", keywords="racial disparity", abstract="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. ", doi="10.2196/49284", url="https://formative.jmir.org/2023/1/e49284", url="http://www.ncbi.nlm.nih.gov/pubmed/37585252" } @Article{info:doi/10.2196/45438, author="de Winter, P. Remco F. and Meijer, M. Connie and Enterman, H. John and Kool-Goudzwaard, Nienke and Gemen, Manuela and van den Bos, T. Anne and Steentjes, Danielle and van Son, E. Gabrielle and Hazewinkel, C. Mirjam and de Beurs, P. Derek and de Groot, H. Marieke", title="A Clinical Model for the Differentiation of Suicidality: Protocol for a Usability Study of the Proposed Model", journal="JMIR Res Protoc", year="2023", month="Aug", day="11", volume="12", pages="e45438", keywords="differentiation", keywords="suicidality", keywords="suicidal behavior", keywords="subtype", keywords="subcategory", keywords="category", keywords="categories", keywords="categorize", keywords="subcategories", keywords="validation study", keywords="mental health", keywords="suicide", keywords="suicidal", keywords="classification", keywords="psychiatry", keywords="classify", keywords="psychiatric", keywords="suicide prevention", keywords="suicidal ideation", keywords="mental illness", keywords="suicidal thought", keywords="dying", keywords="perceptual disintegration", keywords="PD", keywords="primary depressive cognition", keywords="PDC", keywords="psychosocial turmoil", keywords="inadequate communication", keywords="intraclass correlation coefficients", keywords="ICC", abstract="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 ", doi="10.2196/45438", url="https://www.researchprotocols.org/2023/1/e45438", url="http://www.ncbi.nlm.nih.gov/pubmed/37566444" } @Article{info:doi/10.2196/45666, author="Eyllon, Mara and Dalal, Michelle and Jans, Laura and Sotomayor, Ian and Peloquin, Gabrielle and Yon, James and Fritz, Rochelle and Schleider, Jessica", title="Referring Adolescent Primary Care Patients to Single-Session Interventions for Anxiety and Depression: Protocol for a Feasibility Study", journal="JMIR Res Protoc", year="2023", month="Aug", day="9", volume="12", pages="e45666", keywords="adolescents", keywords="behavioral health care", keywords="mental health", keywords="primary care", keywords="single-session interventions", abstract="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 ", doi="10.2196/45666", url="https://www.researchprotocols.org/2023/1/e45666", url="http://www.ncbi.nlm.nih.gov/pubmed/37556202" } @Article{info:doi/10.2196/40277, author="Stewart, Ian and Welch, Charles and An, Lawrence and Resnicow, Ken and Pennebaker, James and Mihalcea, Rada", title="Expressive Interviewing Agents to Support Health-Related Behavior Change: Randomized Controlled Study of COVID-19 Behaviors", journal="JMIR Form Res", year="2023", month="Aug", day="1", volume="7", pages="e40277", keywords="expressive writing", keywords="motivational interviewing", keywords="dialogue systems", keywords="counseling", keywords="behavior change", keywords="text analysis", keywords="COVID-19", keywords="mental health", keywords="automated writing", keywords="writing system", keywords="stress", keywords="psychological health", abstract="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 ({\textasciitilde}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 ", doi="10.2196/40277", url="https://formative.jmir.org/2023/1/e40277", url="http://www.ncbi.nlm.nih.gov/pubmed/37074948" } @Article{info:doi/10.2196/44701, author="K{\"o}tting, Lukas and Derksen, Christina and Keller, Maria Franziska and Lippke, Sonia", title="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", journal="JMIR Pediatr Parent", year="2023", month="Jul", day="24", volume="6", pages="e44701", keywords="Health Action Process Approach", keywords="HAPA", keywords="intention", keywords="safe communication behavior", keywords="patient safety", keywords="obstetric patients", keywords="digital intervention", keywords="web-based app", abstract="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; $\eta$p2=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 $\eta$p2=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 ", doi="10.2196/44701", url="https://pediatrics.jmir.org/2023/1/e44701", url="http://www.ncbi.nlm.nih.gov/pubmed/37486755" } @Article{info:doi/10.2196/47025, author="Hofstetter, Sebastian and Ritter-Herschbach, Madeleine and Behr, Dominik and Jahn, Patrick", title="Ultrasound-Assisted Continence Care Support in an Inpatient Care Setting: Protocol for a Pilot Implementation Study", journal="JMIR Res Protoc", year="2023", month="Jul", day="13", volume="12", pages="e47025", keywords="bladder control", keywords="bladder dysfunction", keywords="continence care", keywords="digitization", keywords="incontinence", keywords="nursing", keywords="selfmanagement", keywords="ultrasound", keywords="urology", keywords="user requirements", abstract="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 ", doi="10.2196/47025", url="https://www.researchprotocols.org/2023/1/e47025", url="http://www.ncbi.nlm.nih.gov/pubmed/37317590" } @Article{info:doi/10.2196/47516, author="Hallgren, A. Kevin and Duncan, H. Mark and Iles-Shih, D. Matthew and Cohn, B. Eliza and McCabe, J. Connor and Chang, M. Yanni and Saxon, J. Andrew", title="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", journal="JMIR Form Res", year="2023", month="Jul", day="6", volume="7", pages="e47516", keywords="contingency management", keywords="methamphetamine use disorder", keywords="mobile health", keywords="mHealth", keywords="mobile phone", abstract="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. ", doi="10.2196/47516", url="https://formative.jmir.org/2023/1/e47516", url="http://www.ncbi.nlm.nih.gov/pubmed/37410529" } @Article{info:doi/10.2196/45477, author="Bottani, Eleonora and Bellini, Valentina and Mordonini, Monica and Pellegrino, Mattia and Lombardo, Gianfranco and Franchi, Beatrice and Craca, Michelangelo and Bignami, Elena", title="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", journal="JMIR Res Protoc", year="2023", month="Jul", day="5", volume="12", pages="e45477", keywords="internet of things", keywords="artificial intelligence", keywords="machine learning", keywords="perioperative organization", keywords="operating rooms", abstract="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 ", doi="10.2196/45477", url="https://www.researchprotocols.org/2023/1/e45477", url="http://www.ncbi.nlm.nih.gov/pubmed/37405821" } @Article{info:doi/10.2196/46659, author="Chikwetu, Lucy and Daily, Shaundra and Mortazavi, J. Bobak and Dunn, Jessilyn", title="Automated Diet Capture Using Voice Alerts and Speech Recognition on Smartphones: Pilot Usability and Acceptability Study", journal="JMIR Form Res", year="2023", month="May", day="16", volume="7", pages="e46659", keywords="automatic dietary monitoring", keywords="ADM", keywords="food logging", keywords="diet logging", keywords="voice technologies", keywords="voice alert", keywords="speech recognition", keywords="natural language processing", keywords="NLP", abstract="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. ", doi="10.2196/46659", url="https://formative.jmir.org/2023/1/e46659", url="http://www.ncbi.nlm.nih.gov/pubmed/37191989" } @Article{info:doi/10.2196/44385, author="Auxier, Jennifer and Savolainen, T. Kaisu and Bender, Miriam and Rahmani, M. Amir and Sarhaddi, Fatemeh and Azimi, Iman and Axelin, M. Anna", title="Exploring Access as a Process of Adaptation in a Self-Monitoring Perinatal eHealth System: Mixed Methods Study From a Sociomaterial Perspective", journal="JMIR Form Res", year="2023", month="May", day="15", volume="7", pages="e44385", keywords="patient engagement", keywords="eHealth", keywords="pregnancy", keywords="motivation", keywords="pregnant", keywords="maternal", keywords="cocreation", keywords="participatory", keywords="codesign", keywords="use pattern", keywords="usage", keywords="self-monitor", keywords="sociomaterial", abstract="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. ", doi="10.2196/44385", url="https://formative.jmir.org/2023/1/e44385", url="http://www.ncbi.nlm.nih.gov/pubmed/37184929" } @Article{info:doi/10.2196/44632, author="Dechsling, Anders and Cogo-Moreira, Hugo and Gangestad, Spydevold Jonathan and Johannessen, Nettum Sandra and Nordahl-Hansen, Anders", title="Evaluating the Feasibility of Emotion Expressions in Avatars Created From Real Person Photos: Pilot Web-Based Survey of Virtual Reality Software", journal="JMIR Form Res", year="2023", month="May", day="11", volume="7", pages="e44632", keywords="avatar", keywords="emotion recognition", keywords="emotion", keywords="face", keywords="facial expression", keywords="facial", keywords="images", keywords="real images", keywords="software", keywords="virtual reality", abstract="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. ", doi="10.2196/44632", url="https://formative.jmir.org/2023/1/e44632", url="http://www.ncbi.nlm.nih.gov/pubmed/37166970" } @Article{info:doi/10.2196/40437, author="Smith, L. Crystal and Keever, Abigail and Bowden, Theresa and Olson, Katie and Rodin, Nicole and McDonell, G. Michael and Roll, M. John and Smoody, Gillian and LeBrun, Jeff and Miguel, QC Andre and McPherson, M. Sterling", title="Patient Feedback on a Mobile Medication Adherence App for Buprenorphine and Naloxone: Closed and Open-Ended Survey on Feasibility and Acceptability", journal="JMIR Form Res", year="2023", month="Apr", day="19", volume="7", pages="e40437", keywords="opioids", keywords="mobile technology", keywords="medication adherence", keywords="buprenorphine", keywords="naloxone", keywords="opioid use disorder", keywords="opioid agonist therapy", keywords="medication-assisted treatment", keywords="medications for opioid use disorder", keywords="opioid", keywords="opioid use", keywords="well-being", keywords="quality of life", keywords="clinic", keywords="technology", keywords="medication", keywords="remote", keywords="coaching", keywords="tracking", keywords="stress", keywords="incentive", keywords="tool", keywords="mobile phone", abstract="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. ", doi="10.2196/40437", url="https://formative.jmir.org/2023/1/e40437", url="http://www.ncbi.nlm.nih.gov/pubmed/37074780" } @Article{info:doi/10.2196/43512, author="Chen-Sankey, Julia and Elhabashy, Maryam and Gratale, Stefanie and Geller, Jason and Mercincavage, Melissa and Strasser, A. Andrew and Delnevo, D. Cristine and Jeong, Michelle and Wackowski, A. Olivia", title="Examining Visual Attention to Tobacco Marketing Materials Among Young Adult Smokers: Protocol for a Remote Webcam-Based Eye-Tracking Experiment", journal="JMIR Res Protoc", year="2023", month="Apr", day="13", volume="12", pages="e43512", keywords="eye tracking", keywords="remote eye tracking", keywords="e-cigarette marketing", keywords="young adults", keywords="mobile phone", abstract="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 ", doi="10.2196/43512", url="https://www.researchprotocols.org/2023/1/e43512", url="http://www.ncbi.nlm.nih.gov/pubmed/37052989" } @Article{info:doi/10.2196/43503, author="Koschollek, Carmen and Zeisler, Marie-Luise and Houben, A. Robin and Geerlings, Julia and Kajikhina, Katja and Bug, Marleen and Blume, Miriam and Hoffmann, Robert and Hintze, Marcel and Kuhnert, Ronny and G{\"o}{\ss}wald, Antje and Schmich, Patrick and H{\"o}vener, Claudia", title="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", journal="JMIR Res Protoc", year="2023", month="Apr", day="12", volume="12", pages="e43503", keywords="migration", keywords="interview survey", keywords="hard-to-survey", keywords="health inequalities", keywords="mixed-mode", keywords="multilingual", abstract="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 ", doi="10.2196/43503", url="https://www.researchprotocols.org/2023/1/e43503", url="http://www.ncbi.nlm.nih.gov/pubmed/36790192" } @Article{info:doi/10.2196/38042, author="Elledge, K. Daniel and Lee, Craddock Simon and Stewart, M. Sunita and Pop, Radu and Trivedi, H. Madhukar and Hughes, L. Jennifer", title="Examining a Resilience Mental Health App in Adolescents: Acceptability and Feasibility Study", journal="JMIR Form Res", year="2023", month="Mar", day="22", volume="7", pages="e38042", keywords="youth", keywords="prevention", keywords="resilience", keywords="mental health app", keywords="mobile phone", abstract="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. ", doi="10.2196/38042", url="https://formative.jmir.org/2023/1/e38042", url="http://www.ncbi.nlm.nih.gov/pubmed/36947113" } @Article{info:doi/10.2196/40675, author="Poland, Stephanie and Stern, Michael and English, Ned and Pedlow, Steven and Archambeau, Katherine and Carris, Kari", title="Design and Implementation of the Surveys of Women: Protocol for an Address-Based Sampling Multimodal Study", journal="JMIR Res Protoc", year="2023", month="Mar", day="15", volume="12", pages="e40675", keywords="multimode", keywords="web survey", keywords="cross-sectional", keywords="women's health", keywords="reproductive health", keywords="methods", keywords="data collection", keywords="implementation", keywords="survey", keywords="contraceptive health", keywords="contraception", keywords="survey methods", keywords="data processing", abstract="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 ", doi="10.2196/40675", url="https://www.researchprotocols.org/2023/1/e40675", url="http://www.ncbi.nlm.nih.gov/pubmed/36920469" } @Article{info:doi/10.2196/45887, author="Reilly, D. Erin and Kathawalla, Ummul-Kiram and Robins, E. Hannah and Heapy, A. Alicia and Hogan, P. Timothy and Waring, E. Molly and Quigley, S. Karen and Drebing, E. Charles and Bickmore, Timothy and Volonte, Matias and Kelly, M. Megan", title="An Online Acceptance and Mindfulness Intervention for Chronic Pain in Veterans: Development and Protocol for a Pilot Feasibility Randomized Controlled Trial", journal="JMIR Res Protoc", year="2023", month="Mar", day="7", volume="12", pages="e45887", keywords="chronic pain", keywords="randomized controlled trial", keywords="usability", keywords="acceptance and commitment therapy", keywords="embodied conversational agent", abstract="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 ", doi="10.2196/45887", url="https://www.researchprotocols.org/2023/1/e45887", url="http://www.ncbi.nlm.nih.gov/pubmed/36881446" } @Article{info:doi/10.2196/40536, author="Askman, Sanna and L{\"o}f, Marie and Maddison, Ralph and Nourse, Rebecca", title="Feasibility and Acceptability of Wearable Cameras to Assess Self-care in People With Heart Failure: Pilot Study", journal="JMIR Form Res", year="2023", month="Feb", day="17", volume="7", pages="e40536", keywords="heart failure", keywords="HF", keywords="life logging", keywords="self-management", keywords="cardiovascular disease", keywords="wearable devices", keywords="self management", keywords="self-care", abstract="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. ", doi="10.2196/40536", url="https://formative.jmir.org/2023/1/e40536", url="http://www.ncbi.nlm.nih.gov/pubmed/36800215" } @Article{info:doi/10.2196/40867, author="Hoeppner, B. Bettina and Siegel, R. Kaitlyn and Dickerman, R. Sarah and Todi, A. Akshiti and Kahler, W. Christopher and Park, R. Elyse and Hoeppner, S. Susanne", title="Testing the Outcomes of a Smoking Cessation Smartphone App for Nondaily Smokers: Protocol for a Proof-of-concept Randomized Controlled Trial", journal="JMIR Res Protoc", year="2023", month="Feb", day="14", volume="12", pages="e40867", keywords="mobile health", keywords="mHealth", keywords="smartphone", keywords="smartphone app", keywords="smoking", keywords="smoking cessation", keywords="nondaily smoking", keywords="positive psychology", keywords="happiness", keywords="positive affect", keywords="clinical trial", keywords="feasibility", keywords="acceptability", keywords="app use", keywords="mobile phone", abstract="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 ", doi="10.2196/40867", url="https://www.researchprotocols.org/2023/1/e40867", url="http://www.ncbi.nlm.nih.gov/pubmed/36787172" } @Article{info:doi/10.2196/42390, author="Loveys, Kate and Antoni, Michael and Donkin, Liesje and Sagar, Mark and Broadbent, Elizabeth", title="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", journal="JMIR Form Res", year="2023", month="Feb", day="9", volume="7", pages="e42390", keywords="stress", keywords="cognitive behavioral stress management", keywords="telehealth", keywords="conversational agent", keywords="virtual human", keywords="e-manual", keywords="pilot randomized controlled trial", abstract="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 ", doi="10.2196/42390", url="https://formative.jmir.org/2023/1/e42390", url="http://www.ncbi.nlm.nih.gov/pubmed/36757790" } @Article{info:doi/10.2196/41416, author="Clay, Philippa and Beeke, Suzanne and Volkmer, Anna and Dangerfield, Lynn and Bloch, Steven", title="A Communication Partner Training Program Delivered via Telehealth for People Living With Parkinson's (Better Conversations With Parkinson's): Protocol for a Feasibility Study", journal="JMIR Res Protoc", year="2023", month="Feb", day="3", volume="12", pages="e41416", keywords="Parkinson's", keywords="conversation", keywords="speech and language therapy", keywords="communication partner training", keywords="speech therapy", keywords="language therapy", keywords="communication difficulty", keywords="conversation skills", abstract="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 ", doi="10.2196/41416", url="https://www.researchprotocols.org/2023/1/e41416", url="http://www.ncbi.nlm.nih.gov/pubmed/36735301" } @Article{info:doi/10.2196/43557, author="d'Offay, Christine and Ng, Yi Xin and Alexander, Laura and Grant, Alison and Grahamslaw, Julia and Pagliari, Claudia and Reed, J. Matthew and Carson, Alan and Gillespie, C. David and Jamjoom, B. Aimun A.", title="A Digital Health Intervention for Concussion: Development and Clinical Feasibility Study", journal="JMIR Form Res", year="2023", month="Feb", day="1", volume="7", pages="e43557", keywords="concussion", keywords="digital intervention", keywords="behavior change", keywords="feasibility study", abstract="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 ", doi="10.2196/43557", url="https://formative.jmir.org/2023/1/e43557", url="http://www.ncbi.nlm.nih.gov/pubmed/36724010" } @Article{info:doi/10.2196/40145, author="Tan, Leona and Deady, Mark and Mead, Olivia and Foright, M. Rebecca and Brenneman, M. Eric and Yeager, R. Jamie and Bryant, A. Richard and Harvey, B. Samuel", title="Web-Based Mind-Body Tactical Resilience Training Program for First Responders: Pre-Post Study Assessing Feasibility, Acceptability, and Usability", journal="JMIR Form Res", year="2023", month="Feb", day="1", volume="7", pages="e40145", keywords="resilience training", keywords="first responders", keywords="web-based intervention", keywords="mental health", keywords="mind-body", keywords="posttraumatic stress disorder", keywords="PTSD", keywords="prevention", abstract="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. ", doi="10.2196/40145", url="https://formative.jmir.org/2023/1/e40145", url="http://www.ncbi.nlm.nih.gov/pubmed/36724011" } @Article{info:doi/10.2196/39724, author="Vojtila, Lenka and Sherifali, Diana and Dragonetti, Rosa and Ashfaq, Iqra and Veldhuizen, Scott and Naeem, Farooq and Agarwal, Mahavir Sri and Melamed, C. Osnat and Crawford, Allison and Gerretsen, Philip and Hahn, Margaret and Hill, Sean and Kidd, Sean and Mulsant, Benoit and Serhal, Eva and Tackaberry-Giddens, Leah and Whitmore, Carly and Marttila, Jennifer and Tang, Frank and Ramdass, Seeta and Lourido, Gloria and Sockalingam, Sanjeev and Selby, Peter", title="Technology-Enabled Collaborative Care for Concurrent Diabetes and Distress Management During the COVID-19 Pandemic: Protocol for a Mixed Methods Feasibility Study", journal="JMIR Res Protoc", year="2023", month="Jan", day="17", volume="12", pages="e39724", keywords="collaborative care", keywords="type 2 diabetes mellitus", keywords="technology", keywords="mental health", keywords="diabetes", keywords="diabetic", keywords="feasibility", keywords="coaching", keywords="patient education", keywords="satisfaction", keywords="qualitative", keywords="nursing", keywords="nurse", keywords="virtual care", keywords="eHealth", keywords="digital health", keywords="health outcome", keywords="substance use", abstract="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 ", doi="10.2196/39724", url="https://www.researchprotocols.org/2023/1/e39724", url="http://www.ncbi.nlm.nih.gov/pubmed/36649068" } @Article{info:doi/10.2196/42754, author="Wang, Bin and Lai, Junkai and Jin, Feifei and Liao, Xiwen and Zhu, Huan and Yao, Chen", title="Clinical Source Data Production and Quality Control in Real-world Studies: Proposal for Development of the eSource Record System", journal="JMIR Res Protoc", year="2022", month="Dec", day="23", volume="11", number="12", pages="e42754", keywords="electronic medical record", keywords="electronic health record", keywords="eSource", keywords="real-world data", keywords="eSource record", keywords="clinical research", keywords="data collection", keywords="data transcription", keywords="data quality", keywords="interoperability", abstract="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. ", doi="10.2196/42754", url="https://www.researchprotocols.org/2022/12/e42754", url="http://www.ncbi.nlm.nih.gov/pubmed/36563036" } @Article{info:doi/10.2196/40352, author="van der Linden, W. Manouk J. and Nahar van Venrooij, W. Lenny M. and Verdaasdonk, G. Emiel G.", title="Personal Devices to Monitor Physical Activity and Nutritional Intake After Colorectal Cancer Surgery: Feasibility Study", journal="JMIR Perioper Med", year="2022", month="Dec", day="13", volume="5", number="1", pages="e40352", keywords="eHealth", keywords="fitness trackers", keywords="diet records", keywords="colorectal neoplasm", keywords="colorectal cancer", keywords="surgery", keywords="self management", keywords="patient care", keywords="physical activity", keywords="tracking", keywords="activity tracking", keywords="self-monitoring", keywords="feasibility", keywords="usability", abstract="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. ", doi="10.2196/40352", url="https://periop.jmir.org/2022/1/e40352", url="http://www.ncbi.nlm.nih.gov/pubmed/36512385" } @Article{info:doi/10.2196/38496, author="Nicol, Ginger and Jansen, Madeline and Haddad, Rita and Ricchio, Amanda and Yingling, D. Michael and Schweiger, A. Julia and Keenoy, Katie and Evanoff, A. Bradley and Newcomer, W. John", title="Use of an Interactive Obesity Treatment Approach in Individuals With Severe Mental Illness: Feasibility, Acceptability, and Proposed Engagement Criteria", journal="JMIR Form Res", year="2022", month="Dec", day="13", volume="6", number="12", pages="e38496", keywords="obesity", keywords="mentally ill people/persons", keywords="health services", keywords="mobile health", abstract="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. ", doi="10.2196/38496", url="https://formative.jmir.org/2022/12/e38496", url="http://www.ncbi.nlm.nih.gov/pubmed/36512399" } @Article{info:doi/10.2196/39238, author="Thai, Y. Janus and McCaffrey, Tracy and Ramadas, Amutha and Chandrasekara, Dharshani and Koh, M. Sharon G. and Choi, Ting Tammie Suet and Malini, Hema and Xie, Jue and Olivier, Patrick and Md Zain, Zaini Anuar and Watterson, Jessica", title="Collective Action for Wellness in the Malaysian Workplace: Protocol for a Feasibility Study", journal="JMIR Res Protoc", year="2022", month="Dec", day="5", volume="11", number="12", pages="e39238", keywords="workplace wellness", keywords="healthy behaviours", keywords="chronic diseases", keywords="digital health", keywords="Malaysia", keywords="wellness", keywords="workplace", keywords="disease", keywords="digital wellness", keywords="digital", keywords="promote", keywords="health knowledge", keywords="diet", keywords="employee", keywords="mobile device", keywords="intervention", keywords="social", keywords="social group", abstract="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 ", doi="10.2196/39238", url="https://www.researchprotocols.org/2022/12/e39238/", url="http://www.ncbi.nlm.nih.gov/pubmed/36469407" } @Article{info:doi/10.2196/37609, author="Harrison, Anna and Folk, Johanna and Rodriguez, Christopher and Wallace, Amanda and Tolou-Shams, Marina", title="Using Social Media to Engage Justice-Involved Young Adults in Digital Health Interventions for Substance Use: Pilot Feasibility Survey Study", journal="JMIR Form Res", year="2022", month="Dec", day="2", volume="6", number="12", pages="e37609", keywords="substance use", keywords="young adult", keywords="social media", keywords="digital health technology", keywords="mobile phone", abstract="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. ", doi="10.2196/37609", url="https://formative.jmir.org/2022/12/e37609", url="http://www.ncbi.nlm.nih.gov/pubmed/36459404" } @Article{info:doi/10.2196/33952, author="Mughal, Fiza and Raffe, William and Stubbs, Peter and Kneebone, Ian and Garcia, Jaime", title="Fitbits for Monitoring Depressive Symptoms in Older Aged Persons: Qualitative Feasibility Study", journal="JMIR Form Res", year="2022", month="Nov", day="29", volume="6", number="11", pages="e33952", keywords="digital mental health", keywords="Fitbit", keywords="smartwatch", keywords="smart wearable", keywords="geriatric", keywords="aging", keywords="health informatics", keywords="feasibility", keywords="usability", keywords="older aged", abstract="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. ", doi="10.2196/33952", url="https://formative.jmir.org/2022/11/e33952", url="http://www.ncbi.nlm.nih.gov/pubmed/36268552" } @Article{info:doi/10.2196/36782, author="Kenjrawi, Yazan and Dashash, Mayssoon", title="The First Asynchronous Online Evidence-Based Medicine Course for Syrian Health Workforce: Effectiveness and Feasibility Pilot Study", journal="JMIR Form Res", year="2022", month="Oct", day="25", volume="6", number="10", pages="e36782", keywords="evidence-based medicine", keywords="continuous medical education", keywords="web-based learning", keywords="Syria", keywords="medical graduates", keywords="medical education", keywords="web-based course", abstract="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. ", doi="10.2196/36782", url="https://formative.jmir.org/2022/10/e36782", url="http://www.ncbi.nlm.nih.gov/pubmed/36282556" } @Article{info:doi/10.2196/41445, author="Amarti, Khadicha and Schulte, J. Mieke H. and Kleiboer, Annet and Van Genugten, Rosalie Claire and Oudega, Mardien and Sonnenberg, Caroline and Gon{\c{c}}alves, C. Gon{\c{c}}alo and Rocha, Artur and Riper, Heleen", title="Feasibility of Digital Cognitive Behavioral Therapy for Depressed Older Adults With the Moodbuster Platform: Protocol for 2 Pilot Feasibility Studies", journal="JMIR Res Protoc", year="2022", month="Oct", day="25", volume="11", number="10", pages="e41445", keywords="iCBT", keywords="study protocol", keywords="feasibility study", keywords="acceptance", keywords="satisfaction", keywords="usability", keywords="engagement", keywords="depression severity", keywords="older adults", abstract="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 ", doi="10.2196/41445", url="https://www.researchprotocols.org/2022/10/e41445", url="http://www.ncbi.nlm.nih.gov/pubmed/36282565" } @Article{info:doi/10.2196/34055, author="Coffin, Tara and Bowen, Deborah and Swisher, Elizabeth and Lu, Karen and Rayes, Nadine and Norquist, Barbara and Blank, Stephanie and Levine, Douglas and Bakkum-Gamez, Jamie and Fleming, Gini and Olopade, Olufunmilayo and D'Andrea, Alan and Nebgen, Denise and Peterson, Christine and Munsell, Mark and Gavin, Kathleen and Lechner, Rebecca and Crase, Jamie and Polinsky, Deborah and Romero, Iris", title="An Accessible Communication System for Population-Based Genetic Testing: Development and Usability Study", journal="JMIR Form Res", year="2022", month="Oct", day="17", volume="6", number="10", pages="e34055", keywords="genetic testing", keywords="internet", keywords="social media", keywords="accessibility", abstract="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. ", doi="10.2196/34055", url="https://formative.jmir.org/2022/10/e34055", url="http://www.ncbi.nlm.nih.gov/pubmed/36251350" } @Article{info:doi/10.2196/39017, author="Gurtner, Marcus and Smith, Moira and Gage, Ryan and Howey-Brown, Anna and Wang, Xinyi and Latavao, Tevita and D Deng, Jeremiah and P Zwanenburg, Sander and Stanley, James and Signal, Louise", title="Objective Assessment of the Nature and Extent of Children's Internet-Based World: Protocol for the Kids Online Aotearoa Study", journal="JMIR Res Protoc", year="2022", month="Oct", day="11", volume="11", number="10", pages="e39017", keywords="public health", keywords="child health", keywords="internet", keywords="policy", keywords="methods", keywords="child", keywords="youth", keywords="methodology", keywords="student", keywords="human-computer interaction", keywords="digital health", keywords="eHealth", keywords="technology use", keywords="computer use", keywords="user experience", keywords="perception", keywords="attitude", keywords="internet use", keywords="screen time", keywords="perceived behavior", keywords="phone use", keywords="social media", abstract="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 ", doi="10.2196/39017", url="https://www.researchprotocols.org/2022/10/e39017", url="http://www.ncbi.nlm.nih.gov/pubmed/36129809" } @Article{info:doi/10.2196/37316, author="Lian, Tyler and Reid, Hadley and Rader, Abigail and Dewitt-Feldman, Sarah and Hezarkhani, Elmira and Gu, Elizabeth and Scott, Malik and Kutzer, Kate and Sandhu, Sahil and Crowder, Carolyn and Ito, Kristin and Eisenson, Howard and Bettger, Prvu Janet and Shaw, J. Ryan and Lewinski, A. Allison and Ming, Y. David and Bosworth, B. Hayden and Zullig, L. Leah and Batch, C. Bryan and Drake, Connor", title="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", journal="JMIR Res Protoc", year="2022", month="Oct", day="11", volume="11", number="10", pages="e37316", keywords="text messaging", keywords="primary health care", keywords="social determinants of health", keywords="needs assessment", keywords="community health centers", keywords="vulnerable populations", abstract="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 ", doi="10.2196/37316", url="https://www.researchprotocols.org/2022/10/e37316", url="http://www.ncbi.nlm.nih.gov/pubmed/36222790" } @Article{info:doi/10.2196/39140, author="Drisdelle, Sara and Power, Liam and Thieu, Scott and Sheriko, Jordan", title="Developing an Immersive Virtual Reality Training System for Novel Pediatric Power Wheelchair Users: Protocol for a Feasibility Study", journal="JMIR Res Protoc", year="2022", month="Oct", day="6", volume="11", number="10", pages="e39140", keywords="immersive virtual reality", keywords="power wheelchair", keywords="training", keywords="pediatric rehabilitation", keywords="feasibility", abstract="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 ", doi="10.2196/39140", url="https://www.researchprotocols.org/2022/10/e39140", url="http://www.ncbi.nlm.nih.gov/pubmed/36201405" } @Article{info:doi/10.2196/36275, author="Horne, Maria and Hardy, Maryann and Murrells, Trevor and Ugail, Hassan and Hill, John Andrew", title="Using Personalized Avatars as an Adjunct to an Adult Weight Loss Management Program: Randomized Controlled Feasibility Study", journal="JMIR Form Res", year="2022", month="Oct", day="5", volume="6", number="10", pages="e36275", keywords="avatar", keywords="feasibility", keywords="obesity", keywords="weight loss", keywords="weight management", abstract="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 ", doi="10.2196/36275", url="https://formative.jmir.org/2022/10/e36275", url="http://www.ncbi.nlm.nih.gov/pubmed/36197703" } @Article{info:doi/10.2196/37626, author="Steen-Olsen, Balch Emma and Pappot, Helle and Green, Allan and Langberg, Henning and Holl{\"a}nder-Mieritz, Cecilie", title="Feasibility of Monitoring Patients Who Have Cancer With a Smart T-shirt: Protocol for the OncoSmartShirt Study", journal="JMIR Res Protoc", year="2022", month="Oct", day="3", volume="11", number="10", pages="e37626", keywords="biometric sensor technology", keywords="cancer", keywords="home monitoring", keywords="patient-generated health data", keywords="sensor", keywords="smart t-shirt", keywords="remote monitoring", keywords="adolescent", keywords="protocol", keywords="patient", keywords="youth", keywords="health care professional", keywords="cancer treatment", abstract="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 ", doi="10.2196/37626", url="https://www.researchprotocols.org/2022/10/e37626", url="http://www.ncbi.nlm.nih.gov/pubmed/36190744" } @Article{info:doi/10.2196/40572, author="Parker, Hannah and Burkart, Sarah and Reesor-Oyer, Layton and Smith, T. Michal and Dugger, Roddrick and von Klinggraeff, Lauren and Weaver, Glenn R. and Beets, W. Michael and Armstrong, Bridget", title="Feasibility of Measuring Screen Time, Activity, and Context Among Families With Preschoolers: Intensive Longitudinal Pilot Study", journal="JMIR Form Res", year="2022", month="Sep", day="29", volume="6", number="9", pages="e40572", keywords="ecological momentary assessment", keywords="accelerometry", keywords="objective digital media use", keywords="screen time", keywords="sleep", keywords="activity", keywords="preschool", keywords="dyads", keywords="mobile phone", abstract="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 ", doi="10.2196/40572", url="https://formative.jmir.org/2022/9/e40572", url="http://www.ncbi.nlm.nih.gov/pubmed/36173677" } @Article{info:doi/10.2196/38262, author="Miller, N. Hailey and Voils, I. Corrine and Cronin, A. Kate and Jeanes, Elizabeth and Hawley, Jeffrey and Porter, S. Laura and Adler, R. Rachel and Sharp, Whitney and Pabich, Samantha and Gavin, L. Kara and Lewis, A. Megan and Johnson, M. Heather and Yancy Jr, S. William and Gray, E. Kristen and Shaw, J. Ryan", title="A Method to Deliver Automated and Tailored Intervention Content: 24-month Clinical Trial", journal="JMIR Form Res", year="2022", month="Sep", day="6", volume="6", number="9", pages="e38262", keywords="text message", keywords="weight management", keywords="automation", keywords="clinical trial", keywords="engagement", keywords="digital technology", keywords="electronic data capture", keywords="REDCap", keywords="automated text message", keywords="digital health intervention", keywords="health intervention", keywords="health database", keywords="digital health", abstract="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 ", doi="10.2196/38262", url="https://formative.jmir.org/2022/9/e38262", url="http://www.ncbi.nlm.nih.gov/pubmed/36066936" } @Article{info:doi/10.2196/37856, author="Tulsiani, Shreya and Ichimiya, Megumi and Gerard, Raquel and Mills, Sarah and Bingenheimer, B. Jeffrey and Hair, C. Elizabeth and Vallone, Donna and Evans, Douglas W.", title="Assessing the Feasibility of Studying Awareness of a Digital Health Campaign on Facebook: Pilot Study Comparing Young Adult Subsamples", journal="JMIR Form Res", year="2022", month="Aug", day="29", volume="6", number="8", pages="e37856", keywords="campaign evaluation", keywords="outcome evaluation", keywords="young adults", keywords="social marketing", keywords="health communications", keywords="tobacco control and policy", keywords="health campaign", keywords="youth", keywords="Facebook", keywords="digital media", abstract="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. ", doi="10.2196/37856", url="https://formative.jmir.org/2022/8/e37856", url="http://www.ncbi.nlm.nih.gov/pubmed/36036974" } @Article{info:doi/10.2196/36741, author="Reamer, Courtney and Chi, Ning Wei and Gordon, Robert and Sarswat, Nitasha and Gupta, Charu and Gaznabi, Safwan and White VanGompel, Emily and Szum, Izabella and Morton-Jost, Melissa and Vaughn, Jorma and Larimer, Karen and Victorson, David and Erwin, John and Halasyamani, Lakshmi and Solomonides, Anthony and Padman, Rema and Shah, S. Nirav", title="Continuous Remote Patient Monitoring in Patients With Heart Failure (Cascade Study): Protocol for a Mixed Methods Feasibility Study", journal="JMIR Res Protoc", year="2022", month="Aug", day="25", volume="11", number="8", pages="e36741", keywords="continuous remote patient monitoring", keywords="remote patient monitoring", keywords="feasibility", keywords="heart failure", keywords="wearable biosensor", keywords="preliminary efficacy", keywords="mobile phone", abstract="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 ", doi="10.2196/36741", url="https://www.researchprotocols.org/2022/8/e36741", url="http://www.ncbi.nlm.nih.gov/pubmed/36006689" } @Article{info:doi/10.2196/35442, author="Curcic, Jelena and Vallejo, Vanessa and Sorinas, Jennifer and Sverdlov, Oleksandr and Praestgaard, Jens and Piksa, Mateusz and Deurinck, Mark and Erdemli, Gul and B{\"u}gler, Maximilian and Tarnanas, Ioannis and Taptiklis, Nick and Cormack, Francesca and Anker, Rebekka and Mass{\'e}, Fabien and Souillard-Mandar, William and Intrator, Nathan and Molcho, Lior and Madero, Erica and Bott, Nicholas and Chambers, Mieko and Tamory, Josef and Shulz, Matias and Fernandez, Gerardo and Simpson, William and Robin, Jessica and Sn{\ae}dal, G. J{\'o}n and Cha, Jang-Ho and Hannesdottir, Kristin", title="Description of the Method for Evaluating Digital Endpoints in Alzheimer Disease Study: Protocol for an Exploratory, Cross-sectional Study", journal="JMIR Res Protoc", year="2022", month="Aug", day="10", volume="11", number="8", pages="e35442", keywords="digital endpoints", keywords="cognition", keywords="Alzheimer disease", keywords="brain amyloid", keywords="methodology study", keywords="clinical trial design", keywords="mobile phone", abstract="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 ", doi="10.2196/35442", url="https://www.researchprotocols.org/2022/8/e35442", url="http://www.ncbi.nlm.nih.gov/pubmed/35947423" } @Article{info:doi/10.2196/36213, author="Michalak, E. Erin and Barnes, J. Steven and Morton, Emma and O'Brien, L. Heather and Murray, Greg and Hole, Rachelle and Meyer, Denny", title="Supporting Self-management and Quality of Life in Bipolar Disorder With the PolarUs App (Alpha): Protocol for a Mixed Methods Study", journal="JMIR Res Protoc", year="2022", month="Aug", day="4", volume="11", number="8", pages="e36213", keywords="eHealth", keywords="mobile health", keywords="mHealth", keywords="bipolar disorder", keywords="self-management", keywords="engagement", keywords="mobile phone", abstract="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 ", doi="10.2196/36213", url="https://www.researchprotocols.org/2022/8/e36213", url="http://www.ncbi.nlm.nih.gov/pubmed/35925666" } @Article{info:doi/10.2196/37929, author="Burns, Joy and Rivers, Patrick and LeClair, B. Lindsay and Jovel, S. Krystal and Rai, P. Ramona and Lowe, A. Ashley and Edwards, J. Laura and Khan, M. Sana and Mathenge, Clare and Ferraris, Maria and Kuntz, L. Jennifer and Lamberte, Mayo Julie and Hegmann, T. Kurt and Odean, J. Marilyn and McLeland-Wieser, Hilary and Beitel, Shawn and Odame-Bamfo, Leah and Schaefer Solle, Natasha and Mak, Josephine and Phillips, L. Andrew and Sokol, E. Brian and Hollister, James and Ochoa, S. Jezahel and Grant, Lauren and Thiese, S. Matthew and Jacoby, B. Keya and Lutrick, Karen and Pubillones, A. Felipe and Yoo, M. Young and Rentz Hunt, Danielle and Ellingson, Katherine and Berry, C. Mark and Gerald, K. Joe and Lopez, Joanna and Gerald, B. Lynn and Wesley, G. Meredith and Krupp, Karl and Herring, K. Meghan and Madhivanan, Purnima and Caban-Martinez, J. Alberto and Tyner, L. Harmony and Meece, K. Jennifer and Yoon, K. Sarang and Fowlkes, L. Ashley and Naleway, L. Allison and Gwynn, Lisa and Burgess, L. Jefferey and Thompson, G. Mark and Olsho, EW Lauren and Gaglani, Manjusha", title="Pediatric Research Observing Trends and Exposures in COVID-19 Timelines (PROTECT): Protocol for a Multisite Longitudinal Cohort Study", journal="JMIR Res Protoc", year="2022", month="Jul", day="28", volume="11", number="7", pages="e37929", keywords="COVID-19", keywords="SARS-CoV-2", keywords="vaccine effectiveness", keywords="vaccine", keywords="efficacy", keywords="effectiveness", keywords="cohort study", keywords="pediatric", keywords="child", keywords="inoculation", keywords="vaccination", keywords="public health", keywords="children", keywords="health care professional", keywords="health care", keywords="caregiver", keywords="health data", keywords="online survey", keywords="incidence", abstract="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 ", doi="10.2196/37929", url="https://www.researchprotocols.org/2022/7/e37929", url="http://www.ncbi.nlm.nih.gov/pubmed/35635842" } @Article{info:doi/10.2196/39004, author="Dobias, L. Mallory and Morris, R. Robert and Schleider, L. Jessica", title="Single-Session Interventions Embedded Within Tumblr: Acceptability, Feasibility, and Utility Study", journal="JMIR Form Res", year="2022", month="Jul", day="25", volume="6", number="7", pages="e39004", keywords="web-based intervention", keywords="internet intervention", keywords="digital intervention", keywords="single-session intervention", keywords="mental health", abstract="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. ", doi="10.2196/39004", url="https://formative.jmir.org/2022/7/e39004", url="http://www.ncbi.nlm.nih.gov/pubmed/35877163" } @Article{info:doi/10.2196/33717, author="Noble, M. Jasmine and Zamani, Ali and Gharaat, MohamadAli and Merrick, Dylan and Maeda, Nathanial and Lambe Foster, Alex and Nikolaidis, Isabella and Goud, Rachel and Stroulia, Eleni and Agyapong, O. Vincent I. and Greenshaw, J. Andrew and Lambert, Simon and Gallson, Dave and Porter, Ken and Turner, Debbie and Zaiane, Osmar", title="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", journal="JMIR Res Protoc", year="2022", month="Jul", day="25", volume="11", number="7", pages="e33717", keywords="eHealth", keywords="chatbot", keywords="conversational agent", keywords="health system navigation", keywords="electronic health care", keywords="mobile phone", abstract="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 ", doi="10.2196/33717", url="https://www.researchprotocols.org/2022/7/e33717", url="http://www.ncbi.nlm.nih.gov/pubmed/35877158" } @Article{info:doi/10.2196/21994, author="von Tottleben, Malte and Grinyer, Katie and Arfa, Ali and Traore, Lamine and Verdoy, Dolores and Lim Choi Keung, N. Sarah and Larranaga, Igor and Jaulent, Marie-Christine and De Manuel Keenoy, Esteban and Lilja, Mikael and Beach, Marie and Marguerie, Christopher and Yuksel, Mustafa and Laleci Erturkmen, Banu Gokce and Klein, O. Gunnar and Lindman, Pontus and Mar, Javier and Kalra, Dipak and and Arvanitis, N. Theodoros", title="An Integrated Care Platform System (C3-Cloud) for Care Planning, Decision Support, and Empowerment of Patients With Multimorbidity: Protocol for a Technology Trial", journal="JMIR Res Protoc", year="2022", month="Jul", day="13", volume="11", number="7", pages="e21994", keywords="multimorbidity", keywords="polypharmacy", keywords="guidelines reconciliation", keywords="clinical decision support", keywords="personalized care plans", keywords="diabetes mellitus type 2", keywords="heart failure", keywords="depression", keywords="renal failure", keywords="acceptability", keywords="usability", keywords="evaluation", keywords="cost-benefit evaluation", keywords="predictive modeling", abstract="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 ", doi="10.2196/21994", url="https://www.researchprotocols.org/2022/7/e21994", url="http://www.ncbi.nlm.nih.gov/pubmed/35830239" } @Article{info:doi/10.2196/32288, author="Noublanche, Fr{\'e}d{\'e}ric and Simon, Romain and Ben-Sadoun, Gr{\'e}gory and Annweiler, C{\'e}dric", title="Physical Activity and Fall Prevention in Geriatric Inpatients in an Acute Care Unit (AGIR Study): Protocol for a Usability Study", journal="JMIR Res Protoc", year="2022", month="Jul", day="11", volume="11", number="7", pages="e32288", keywords="fall prevention", keywords="physical activity", keywords="older patients", keywords="geriatric acute care unit", abstract="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 ", doi="10.2196/32288", url="https://www.researchprotocols.org/2022/7/e32288", url="http://www.ncbi.nlm.nih.gov/pubmed/35816381" } @Article{info:doi/10.2196/34424, author="Kamulegeya, Henry Louis and Bwanika, JohnMark and Banonya, Joy and Atuhaire, Joan and Musinguzi, Davis and Nakate, Vivian and Kyenkya, Joshua and Namatende, Lydia and Horvath, J. Keith and Kiragga, Agnes", title="Feasibility and Acceptability of a Ugandan Telehealth Engagement Platform for Informational Messaging on Modern Contraception: Pilot Cross-sectional Study", journal="JMIR Form Res", year="2022", month="Jun", day="28", volume="6", number="6", pages="e34424", keywords="telehealth", keywords="mHealth", keywords="digital health", keywords="family planning", keywords="contraception", keywords="messaging", keywords="male involvement", keywords="health education", keywords="Uganda", abstract="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. ", doi="10.2196/34424", url="https://formative.jmir.org/2022/6/e34424", url="http://www.ncbi.nlm.nih.gov/pubmed/35763336" } @Article{info:doi/10.2196/37414, author="Chwyl, Christina and Wright, Nicholas and M Turner-McGrievy, Gabrielle and L Butryn, Meghan and M Forman, Evan", title="Remotely Delivered Behavioral Weight Loss Intervention Using an Ad Libitum Plant-Based Diet: Pilot Acceptability, Feasibility, and Preliminary Results", journal="JMIR Form Res", year="2022", month="Jun", day="23", volume="6", number="6", pages="e37414", keywords="vegetarian diet", keywords="vegan diet", keywords="overweight", keywords="eHealth", keywords="behavioral intervention", abstract="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 ", doi="10.2196/37414", url="https://formative.jmir.org/2022/6/e37414", url="http://www.ncbi.nlm.nih.gov/pubmed/35737443" } @Article{info:doi/10.2196/38162, author="Stiles-Shields, Colleen and Batts, R. Kathryn and Reyes, M. Karen and Archer, Joseph and Crosby, Sharad and Draxler, M. Janel and Lennan, Nia and Held, Philip", title="Digital Screening and Automated Resource Identification System to Address COVID-19--Related Behavioral Health Disparities: Feasibility Study", journal="JMIR Form Res", year="2022", month="Jun", day="22", volume="6", number="6", pages="e38162", keywords="digital mental health", keywords="underserved", keywords="health disparities", keywords="COVID-19", keywords="screening", keywords="referral", keywords="mental health", keywords="digital health", keywords="feasibility study", keywords="mobile app", keywords="mHealth", keywords="mobile health", keywords="emotional need", keywords="digital health tool", keywords="health resource", keywords="health care cost", abstract="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. ", doi="10.2196/38162", url="https://formative.jmir.org/2022/6/e38162", url="http://www.ncbi.nlm.nih.gov/pubmed/35696607" } @Article{info:doi/10.2196/35365, author="Thorup, Brun Charlotte and Villadsen, Anne and Andreasen, Jesper Jan and Aar{\o}e, Jens and Andreasen, Jane and Brocki, Cristina Barbara", title="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", journal="JMIR Form Res", year="2022", month="Jun", day="20", volume="6", number="6", pages="e35365", keywords="transcatheter aortic valve implantation", keywords="aortic valve", keywords="implant", keywords="TAVI", keywords="telerehabilitation", keywords="rehabilitation", keywords="aortic stenosis", keywords="patients' perspective", keywords="older people", keywords="elder", keywords="aged", keywords="geriatric", keywords="gerontology", keywords="patient experience", keywords="user experience", keywords="health professional experience", keywords="physician experience", keywords="telehealth", keywords="older adult", keywords="telemedicine", keywords="cardiac", keywords="cardiology", keywords="heart", keywords="perspective", keywords="home-based", keywords="exercise", keywords="activity tracker", keywords="physical activity", keywords="mHealth", keywords="mobile health", keywords="fitness", abstract="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. ", doi="10.2196/35365", url="https://formative.jmir.org/2022/6/e35365", url="http://www.ncbi.nlm.nih.gov/pubmed/35723925" } @Article{info:doi/10.2196/38283, author="Saha, Sanjoy and Lozano, Panizza Chloe and Broyles, Stephanie and Martin, K. Corby and Apolzan, W. John", title="Assessing the Initial Validity of the PortionSize App to Estimate Dietary Intake Among Adults: Pilot and Feasibility App Validation Study", journal="JMIR Form Res", year="2022", month="Jun", day="15", volume="6", number="6", pages="e38283", keywords="dietary assessment", keywords="eating", keywords="food intake", keywords="energy intake", keywords="portion size", keywords="mHealth", keywords="digital health", keywords="eHealth", keywords="nutrition", keywords="food groups", abstract="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 ({\textpm}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. ", doi="10.2196/38283", url="https://formative.jmir.org/2022/6/e38283", url="http://www.ncbi.nlm.nih.gov/pubmed/35704355" } @Article{info:doi/10.2196/32955, author="Mehrabi, Samira and Mu{\~n}oz, E. John and Basharat, Aysha and Boger, Jennifer and Cao, Shi and Barnett-Cowan, Michael and Middleton, E. Laura", title="Immersive Virtual Reality Exergames to Promote the Well-being of Community-Dwelling Older Adults: Protocol for a Mixed Methods Pilot Study", journal="JMIR Res Protoc", year="2022", month="Jun", day="13", volume="11", number="6", pages="e32955", keywords="virtual reality", keywords="exergames", keywords="community-dwelling older adults", keywords="pilot protocol", keywords="feasibility", keywords="well-being", keywords="physical activity", keywords="cognition", keywords="perception", keywords="mood", keywords="COVID-19", abstract="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 ", doi="10.2196/32955", url="https://www.researchprotocols.org/2022/6/e32955", url="http://www.ncbi.nlm.nih.gov/pubmed/35700014" } @Article{info:doi/10.2196/37084, author="Yu, Hong and Tan, Lingcan and Teng, Yi and Xu, Zhao and Xiao, Kun and Yin, Jin and Zuo, Yunxia and Zhu, Tao and Deng, Xiaoqian", title="The First National Remote Emergency System for Malignant Hyperthermia (MH-NRES) in China: Protocol for the Design, Development, and Evaluation of a WeChat Applet", journal="JMIR Res Protoc", year="2022", month="Jun", day="10", volume="11", number="6", pages="e37084", keywords="malignant hyperthermia", keywords="hyperthermia", keywords="anesthetic", keywords="anesthesia", keywords="anesthesiology", keywords="anesthesiologist", keywords="mHealth", keywords="mobile health", keywords="health app", keywords="evaluation", keywords="user experience", keywords="perception", keywords="development", keywords="uni-app", keywords="digital health", keywords="national remote emergency system", keywords="WeChat", keywords="emergency", keywords="WeChat applet", keywords="dantrolene", keywords="China", keywords="Chinese", keywords="applet", keywords="messaging app", keywords="calling app", keywords="diagnosis", keywords="diagnostic service", abstract="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 ", doi="10.2196/37084", url="https://www.researchprotocols.org/2022/6/e37084", url="http://www.ncbi.nlm.nih.gov/pubmed/35687418" } @Article{info:doi/10.2196/34951, author="Pace, W. Thaddeus W. and Zeiders, H. Katharine and Cook, H. Stephanie and Sarsar, D. Evelyn and Hoyt, T. Lindsay and Mirin, L. Nicholas and Wood, P. Erica and Tatar, Raquel and Davidson, J. Richard", title="Feasibility, Acceptability, and Preliminary Efficacy of an App-Based Meditation Intervention to Decrease Firefighter Psychological Distress and Burnout: A One-Group Pilot Study", journal="JMIR Form Res", year="2022", month="Jun", day="8", volume="6", number="6", pages="e34951", keywords="firefighter", keywords="meditation", keywords="smartphone app", keywords="anxiety", keywords="cortisol", keywords="digital health", keywords="mobile health", keywords="mHealth", keywords="mental health", keywords="burnout", keywords="stress management", abstract="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. ", doi="10.2196/34951", url="https://formative.jmir.org/2022/6/e34951", url="http://www.ncbi.nlm.nih.gov/pubmed/35675115" } @Article{info:doi/10.2196/37975, author="LeBaron, Virginia and Boukhechba, Mehdi and Edwards, James and Flickinger, Tabor and Ling, David and Barnes, E. Laura", title="Exploring the Use of Wearable Sensors and Natural Language Processing Technology to Improve Patient-Clinician Communication: Protocol for a Feasibility Study", journal="JMIR Res Protoc", year="2022", month="May", day="20", volume="11", number="5", pages="e37975", keywords="communication", keywords="technology", keywords="ubiquitous computing, natural language processing", keywords="cancer", keywords="palliative care", abstract="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 ", doi="10.2196/37975", url="https://www.researchprotocols.org/2022/5/e37975", url="http://www.ncbi.nlm.nih.gov/pubmed/35594139" } @Article{info:doi/10.2196/35674, author="Sivananthan, Arun and Gueroult, Aurelien and Zijlstra, Geiske and Martin, Guy and Baheerathan, Aravindhan and Pratt, Philip and Darzi, Ara and Patel, Nisha and Kinross, James", title="Using Mixed Reality Headsets to Deliver Remote Bedside Teaching During the COVID-19 Pandemic: Feasibility Trial of HoloLens 2", journal="JMIR Form Res", year="2022", month="May", day="17", volume="6", number="5", pages="e35674", keywords="mixed reality", keywords="remote learning", keywords="HoloLens", keywords="bedside teaching", keywords="COVID-19", keywords="personal protective equipment", keywords="digital education", keywords="medical education", keywords="e-learning", keywords="protection", keywords="feasibility", keywords="medical student", keywords="virtual reality", abstract="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. ", doi="10.2196/35674", url="https://formative.jmir.org/2022/5/e35674", url="http://www.ncbi.nlm.nih.gov/pubmed/35389347" } @Article{info:doi/10.2196/36845, author="Daniels, Joseph and Peters, H. Remco P. and Medina-Marino, Andrew and Bongo, Cikizwa and Stephenson, Rob", title="A Skills-Based HIV Serostatus Disclosure Intervention for Sexual Minority Men in South Africa: Protocol for Intervention Adaptation and a Pilot Randomized Controlled Trial", journal="JMIR Res Protoc", year="2022", month="May", day="16", volume="11", number="5", pages="e36845", keywords="gay", keywords="bisexual", keywords="men who have sex with men", keywords="HIV intervention adaptation", keywords="videoconference delivery", keywords="HIV", keywords="public health", keywords="mobile phone", abstract="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 ", doi="10.2196/36845", url="https://www.researchprotocols.org/2022/5/e36845", url="http://www.ncbi.nlm.nih.gov/pubmed/35576574" } @Article{info:doi/10.2196/36673, author="Al-Jabr, Hiyam and Windle, Karen and Thompson, R. David and Jenkins, M. Zoe and Castle, J. David and Ski, F. Chantal", title="Long COVID Optimal Health Program (LC-OHP) to Enhance Psychological and Physical Health: Protocol for a Feasibility Randomized Controlled Trial", journal="JMIR Res Protoc", year="2022", month="May", day="12", volume="11", number="5", pages="e36673", keywords="long COVID", keywords="COVID-19", keywords="optimal health program", keywords="telemedicine", keywords="integrated care", keywords="telehealth", keywords="patient care", keywords="health intervention", keywords="mental health", keywords="physical health", keywords="psychological health", keywords="pandemic", keywords="patient support", abstract="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 ", doi="10.2196/36673", url="https://www.researchprotocols.org/2022/5/e36673", url="http://www.ncbi.nlm.nih.gov/pubmed/35468586" } @Article{info:doi/10.2196/35325, author="Zolnoori, Maryam and Vergez, Sasha and Kostic, Zoran and Jonnalagadda, Reddy Siddhartha and V McDonald, Margaret and Bowles, H. Kathryn K. and Topaz, Maxim", title="Audio Recording Patient-Nurse Verbal Communications in Home Health Care Settings: Pilot Feasibility and Usability Study", journal="JMIR Hum Factors", year="2022", month="May", day="11", volume="9", number="2", pages="e35325", keywords="patients", keywords="HHC", keywords="communications", keywords="nurse", keywords="audio recording", keywords="device", abstract="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. ", doi="10.2196/35325", url="https://humanfactors.jmir.org/2022/2/e35325", url="http://www.ncbi.nlm.nih.gov/pubmed/35544296" } @Article{info:doi/10.2196/33498, author="McCloud, Rachel and Perez, Carly and Bekalu, Awoke Mesfin and Viswanath, K.", title="Using Smart Speaker Technology for Health and Well-being in an Older Adult Population: Pre-Post Feasibility Study", journal="JMIR Aging", year="2022", month="May", day="9", volume="5", number="2", pages="e33498", keywords="technology", keywords="older adults", keywords="communication inequalities", keywords="digital health", keywords="elderly population", keywords="smart technology", keywords="smart speaker", keywords="well-being", keywords="health technology", keywords="mobile phone", abstract="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. ", doi="10.2196/33498", url="https://aging.jmir.org/2022/2/e33498", url="http://www.ncbi.nlm.nih.gov/pubmed/35532979" } @Article{info:doi/10.2196/35277, author="Timon, M. Claire and Heffernan, Emma and Kilcullen, M. Sophia and Lee, Hyowon and Hopper, Louise and Quinn, Joe and McDonald, David and Gallagher, Pamela and Smeaton, F. Alan and Moran, Kieran and Hussey, Pamela and Murphy, Catriona", title="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", journal="JMIR Res Protoc", year="2022", month="May", day="5", volume="11", number="5", pages="e35277", keywords="independent living", keywords="older adults", keywords="Internet of Things", keywords="wearable electronic devices", keywords="activities of daily living", keywords="mobile phone", abstract="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 ", doi="10.2196/35277", url="https://www.researchprotocols.org/2022/5/e35277", url="http://www.ncbi.nlm.nih.gov/pubmed/35511224" } @Article{info:doi/10.2196/31003, author="Cahill, Caitlin and Kruger, Natalia and Heine, John", title="Buccal Mucosal Grafts as a Novel Treatment for the Repair of Rectovaginal Fistulas: Protocol for an Upcoming Prospective Single-Surgeon Case Series", journal="JMIR Res Protoc", year="2022", month="Apr", day="29", volume="11", number="4", pages="e31003", keywords="surgical protocol", keywords="colorectal surgery, rectovaginal fistulas", keywords="fistula", keywords="surgery", keywords="gynecology", keywords="grafts", keywords="perioperative medicine", abstract="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 ", doi="10.2196/31003", url="https://www.researchprotocols.org/2022/4/e31003", url="http://www.ncbi.nlm.nih.gov/pubmed/35486431" } @Article{info:doi/10.2196/31835, author="Stearns-Yoder, A. Kelly and Ryan, T. Arthur and Smith, A. Alexandra and Forster, E. Jeri and Barnes, M. Sean and Brenner, A. Lisa", title="Computerized Cognitive Behavioral Therapy Intervention for Depression Among Veterans: Acceptability and Feasibility Study", journal="JMIR Form Res", year="2022", month="Apr", day="25", volume="6", number="4", pages="e31835", keywords="computerized cognitive behavioral therapy", keywords="depression", keywords="veterans", keywords="acceptability", keywords="feasibility", abstract="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. ", doi="10.2196/31835", url="https://formative.jmir.org/2022/4/e31835", url="http://www.ncbi.nlm.nih.gov/pubmed/35468088" } @Article{info:doi/10.2196/37009, author="Bilodeau, Karine and Gouin, Marie-Michelle and Lecours, Alexandra and Lederer, Val{\'e}rie and Durand, Marie-Jos{\'e} and Kilpatrick, Kelley and Lepage, David and Ladouceur-Deslauriers, Lauriane and Dorta, Tomas", title="Acceptability and Feasibility of a Return-to-Work Intervention for Posttreatment Breast Cancer Survivors: Protocol for a Co-design and Development Study", journal="JMIR Res Protoc", year="2022", month="Apr", day="22", volume="11", number="4", pages="e37009", keywords="co-design", keywords="breast cancer", keywords="intervention", keywords="return-to-work", keywords="primary care", keywords="qualitative", abstract="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 ", doi="10.2196/37009", url="https://www.researchprotocols.org/2022/4/e37009", url="http://www.ncbi.nlm.nih.gov/pubmed/35451972" } @Article{info:doi/10.2196/34827, author="Mande, Archana and Moore, L. Susan and Banaei-Kashani, Farnoush and Echalier, Benjamin and Bull, Sheana and Rosenberg, A. Michael", title="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", journal="JMIR Form Res", year="2022", month="Apr", day="12", volume="6", number="4", pages="e34827", keywords="mHealth", keywords="patient-specific modeling", keywords="chronic disease", keywords="smartphone", keywords="implementation and deployment", keywords="facilitators and barriers", abstract="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. ", doi="10.2196/34827", url="https://formative.jmir.org/2022/4/e34827", url="http://www.ncbi.nlm.nih.gov/pubmed/35412460" } @Article{info:doi/10.2196/34297, author="Diepstraten, A. Franciscus and Meijer, JM Annelot and van Grotel, Martine and Plasschaert, LA Sabine and Hoetink, E. Alexander and Fiocco, Marta and Janssens, O. Geert and Stokroos, J. Robert and van den Heuvel-Eibrink, M. Marry", title="A Study on Prevalence and Determinants of Ototoxicity During Treatment of Childhood Cancer (SOUND): Protocol for a Prospective Study", journal="JMIR Res Protoc", year="2022", month="Apr", day="7", volume="11", number="4", pages="e34297", keywords="pediatrics", keywords="ototoxicity", keywords="audiometry", keywords="antibiotics", keywords="diuretics", keywords="radiotherapy", keywords="solid tumors", keywords="neuro-oncology", keywords="audiology", keywords="cancer", keywords="children", abstract="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 ", doi="10.2196/34297", url="https://www.researchprotocols.org/2022/4/e34297", url="http://www.ncbi.nlm.nih.gov/pubmed/35389352" } @Article{info:doi/10.2196/32423, author="James, Peter and Trudel-Fitzgerald, Claudia and Lee, H. Harold and Koga, K. Hayami and Kubzansky, D. Laura and Grodstein, Francine", title="Linking Individual-Level Facebook Posts With Psychological and Health Data in an Epidemiological Cohort: Feasibility Study", journal="JMIR Form Res", year="2022", month="Apr", day="7", volume="6", number="4", pages="e32423", keywords="social media", keywords="cohort", keywords="psychological factors", keywords="recruitment", keywords="feasibility", keywords="middle-aged and older adults", keywords="women", abstract="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. ", doi="10.2196/32423", url="https://formative.jmir.org/2022/4/e32423", url="http://www.ncbi.nlm.nih.gov/pubmed/35389368" } @Article{info:doi/10.2196/33581, author="Win, Hninyee and Russell, Samantha and Wertheim, C. Betsy and Maizes, Victoria and Crocker, Robert and Brooks, J. Audrey and Mesa, Ruben and Huberty, Jennifer and Geyer, Holly and Eckert, Ryan and Larsen, Ashley and Gowin, Krisstina", title="Mobile App Intervention on Reducing the Myeloproliferative Neoplasm Symptom Burden: Pilot Feasibility and Acceptability Study", journal="JMIR Form Res", year="2022", month="Mar", day="31", volume="6", number="3", pages="e33581", keywords="myeloproliferative neoplasm", keywords="mobile application", keywords="symptom burden", keywords="wellness", keywords="self-management", keywords="mobile phone", abstract="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. ", doi="10.2196/33581", url="https://formative.jmir.org/2022/3/e33581", url="http://www.ncbi.nlm.nih.gov/pubmed/35357315" } @Article{info:doi/10.2196/34201, author="Liu, Nan and Xie, Feng and Siddiqui, Javaid Fahad and Ho, Wah Andrew Fu and Chakraborty, Bibhas and Nadarajan, Devi Gayathri and Tan, Kiat Kenneth Boon and Ong, Hock Marcus Eng", title="Leveraging Large-Scale Electronic Health Records and Interpretable Machine Learning for Clinical Decision Making at the Emergency Department: Protocol for System Development and Validation", journal="JMIR Res Protoc", year="2022", month="Mar", day="25", volume="11", number="3", pages="e34201", keywords="electronic health records", keywords="machine learning", keywords="clinical decision making", keywords="emergency department", abstract="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 ", doi="10.2196/34201", url="https://www.researchprotocols.org/2022/3/e34201", url="http://www.ncbi.nlm.nih.gov/pubmed/35333179" } @Article{info:doi/10.2196/29943, author="Timiliotis, Joanna and Bl{\"u}mke, Bibiana and Serf{\"o}z{\"o}, Daniel Peter and Gilbert, Stephen and Ondr{\'e}sik, Marta and T{\"u}rk, Ewelina and Hirsch, Christian Martin and Eckstein, Jens", title="A Novel Diagnostic Decision Support System for Medical Professionals: Prospective Feasibility Study", journal="JMIR Form Res", year="2022", month="Mar", day="24", volume="6", number="3", pages="e29943", keywords="diagnostic decision support system", keywords="DDSS", keywords="probabilistic reasoning", keywords="artificial intelligence", keywords="dyspnea", keywords="emergency department", keywords="internal medicine", keywords="symptom checker", abstract="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 ", doi="10.2196/29943", url="https://formative.jmir.org/2022/3/e29943", url="http://www.ncbi.nlm.nih.gov/pubmed/35323125" } @Article{info:doi/10.2196/16430, author="Nugent, Lisa and Anthony Kouyate, Robin and Jackson, Shawna and Smith, Y. Meredith", title="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", journal="JMIR Res Protoc", year="2022", month="Mar", day="22", volume="11", number="3", pages="e16430", keywords="human-centered design", keywords="patient-reported outcomes", keywords="rheumatoid arthritis", keywords="digital journal", keywords="patient diaries", keywords="data visualization", keywords="mobile phone", abstract="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 ", doi="10.2196/16430", url="https://www.researchprotocols.org/2022/3/e16430", url="http://www.ncbi.nlm.nih.gov/pubmed/35315784" } @Article{info:doi/10.2196/30606, author="Militello, Lisa and Sobolev, Michael and Okeke, Fabian and Adler, A. Daniel and Nahum-Shani, Inbal", title="Digital Prompts to Increase Engagement With the Headspace App and for Stress Regulation Among Parents: Feasibility Study", journal="JMIR Form Res", year="2022", month="Mar", day="21", volume="6", number="3", pages="e30606", keywords="Headspace", keywords="engagement", keywords="mHealth", keywords="mindfulness", keywords="mental health", keywords="mobile phone", abstract="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. ", doi="10.2196/30606", url="https://formative.jmir.org/2022/3/e30606", url="http://www.ncbi.nlm.nih.gov/pubmed/35311675" } @Article{info:doi/10.2196/33329, author="Kamath, Sowmya and Kappaganthu, Karthik and Painter, Stefanie and Madan, Anmol", title="Improving Outcomes Through Personalized Recommendations in a Remote Diabetes Monitoring Program: Observational Study", journal="JMIR Form Res", year="2022", month="Mar", day="21", volume="6", number="3", pages="e33329", keywords="personalization", keywords="type 2 diabetes", keywords="recommendation", keywords="causal", keywords="observational", keywords="mobile health", keywords="machine learning", keywords="engagement", keywords="glycemic control", keywords="mHealth", keywords="recommender systems", abstract="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. ", doi="10.2196/33329", url="https://formative.jmir.org/2022/3/e33329", url="http://www.ncbi.nlm.nih.gov/pubmed/35311691" } @Article{info:doi/10.2196/34029, author="Ozieh, N. Mukoso and Egede, E. Leonard", title="A Lifestyle Intervention to Delay Early Chronic Kidney Disease in African Americans With Diabetic Kidney Disease: Pre-Post Pilot Study", journal="JMIR Form Res", year="2022", month="Mar", day="15", volume="6", number="3", pages="e34029", keywords="type 2 diabetes mellitus", keywords="chronic kidney insufficiency", keywords="healthy lifestyle", keywords="outcomes research", keywords="African Americans", keywords="quasiexperimental study", abstract="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. ", doi="10.2196/34029", url="https://formative.jmir.org/2022/3/e34029", url="http://www.ncbi.nlm.nih.gov/pubmed/35289751" } @Article{info:doi/10.2196/27921, author="Turek, R. Janice and Bansal, Vikas and Tekin, Aysun and Singh, Shuchita and Deo, Neha and Sharma, Mayank and Bogojevic, Marija and Qamar, Shahraz and Singh, Romil and Kumar, Vishakha and Kashyap, Rahul", title="Lessons From a Rapid Project Management Exercise in the Time of Pandemic: Methodology for a Global COVID-19 VIRUS Registry Database", journal="JMIR Res Protoc", year="2022", month="Mar", day="15", volume="11", number="3", pages="e27921", keywords="COVID-19", keywords="critical care", keywords="global", keywords="program management", keywords="registry", abstract="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 ", doi="10.2196/27921", url="https://www.researchprotocols.org/2022/3/e27921", url="http://www.ncbi.nlm.nih.gov/pubmed/34762062" } @Article{info:doi/10.2196/23589, author="Behrens, Anders and Berglund, Sanmartin Johan and Anderberg, Peter", title="CoGNIT Automated Tablet Computer Cognitive Testing in Patients With Mild Cognitive Impairment: Feasibility Study", journal="JMIR Form Res", year="2022", month="Mar", day="11", volume="6", number="3", pages="e23589", keywords="internet", keywords="cognitive testing", keywords="software", keywords="testing", keywords="impairment", keywords="cognition", keywords="feasibility", keywords="diagnosis", keywords="app", keywords="assessment", keywords="cognitive impairment", abstract="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. ", doi="10.2196/23589", url="https://formative.jmir.org/2022/3/e23589", url="http://www.ncbi.nlm.nih.gov/pubmed/35275064" } @Article{info:doi/10.2196/32338, author="Lok, YW Kris and Ko, WT Rachel and Fan, SL Heidi and Chau, PH and Wong, YH Janet and Wang, MP and Tsang, Vicky", title="Feasibility and Acceptability of an Online WhatsApp Support Group on Breastfeeding: Protocol for a Randomized Controlled Trial", journal="JMIR Res Protoc", year="2022", month="Mar", day="9", volume="11", number="3", pages="e32338", keywords="mHealth", keywords="breastfeeding", keywords="peer support", keywords="mobile health", keywords="parenting", keywords="instant messaging", keywords="online support", keywords="women's health", keywords="postpartum health", keywords="postpartum support", abstract="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 ", doi="10.2196/32338", url="https://www.researchprotocols.org/2022/3/e32338", url="http://www.ncbi.nlm.nih.gov/pubmed/35262504" } @Article{info:doi/10.2196/28877, author="Hiragi, Shusuke and Hatanaka, Jun and Sugiyama, Osamu and Saito, Kenichi and Nambu, Masayuki and Kuroda, Tomohiro", title="Token Economy--Based Hospital Bed Allocation to Mitigate Information Asymmetry: Proof-of-Concept Study Through Simulation Implementation", journal="JMIR Form Res", year="2022", month="Mar", day="4", volume="6", number="3", pages="e28877", keywords="hospital administration", keywords="resource allocation", keywords="token economy", keywords="bed occupancy", keywords="hospital management", keywords="simulation", keywords="decision-making", keywords="organization", abstract="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. ", doi="10.2196/28877", url="https://formative.jmir.org/2022/3/e28877", url="http://www.ncbi.nlm.nih.gov/pubmed/35254264" } @Article{info:doi/10.2196/33701, author="Banerjee, Rahul and Huang, Chiung-Yu and Dunn, Lisa and Knoche, Jennifer and Ryan, Chloe and Brassil, Kelly and Jackson, Lindsey and Patel, Dhiren and Lo, Mimi and Arora, Shagun and Wong, W. Sandy and Wolf, Jeffrey and Martin III, Thomas and Dhruva, Anand and Shah, Nina", title="Digital Life Coaching During Stem Cell Transplantation: Development and Usability Study", journal="JMIR Form Res", year="2022", month="Mar", day="4", volume="6", number="3", pages="e33701", keywords="digital health", keywords="life coaching", keywords="multiple myeloma", keywords="stem cell transplantation", keywords="stem cell therapy", keywords="cancer", keywords="high-dose chemotherapy", keywords="patient engagement", keywords="feasibility", keywords="digital life coaching", keywords="mobile phone", abstract="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. ", doi="10.2196/33701", url="https://formative.jmir.org/2022/3/e33701", url="http://www.ncbi.nlm.nih.gov/pubmed/35039279" } @Article{info:doi/10.2196/34032, author="Economides, Marcos and Bolton, Heather and Male, Rhian and Cavanagh, Kate", title="Feasibility and Preliminary Efficacy of Web-Based and Mobile Interventions for Common Mental Health Problems in Working Adults: Multi-Arm Randomized Pilot Trial", journal="JMIR Form Res", year="2022", month="Mar", day="3", volume="6", number="3", pages="e34032", keywords="mHealth", keywords="workplace", keywords="CBT", keywords="ACT", keywords="feasibility", keywords="stress", keywords="anxiety", keywords="depression", keywords="resilience", keywords="mobile phone", abstract="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 ", doi="10.2196/34032", url="https://formative.jmir.org/2022/3/e34032", url="http://www.ncbi.nlm.nih.gov/pubmed/35238794" } @Article{info:doi/10.2196/30052, author="Kerckhove, Nicolas and Delage, No{\'e}mie and Cambier, S{\'e}bastien and Cantagrel, Nathalie and Serra, Eric and Marcaillou, Fabienne and Maindet, Caroline and Picard, Pascale and Martin{\'e}, Gaelle and Deleens, Rodrigue and Trouvin, Anne-Priscille and Fourel, Lauriane and Espagne-Dubreuilh, Gaelle and Douay, Ludovic and Foulon, St{\'e}phane and Dufraisse, B{\'e}n{\'e}dicte and Gov, Christian and Viel, Eric and Jedryka, Fran{\c{c}}ois and Pouplin, Sophie and Lestrade, C{\'e}cile and Combe, Emmanuel and Perrot, Serge and Perocheau, Dominique and De Brisson, Valentine and Vergne-Salle, Pascale and Mertens, Patrick and Pereira, Bruno and Djiberou Mahamadou, Jalil Abdoul and Antoine, Violaine and Corteval, Alice and Eschalier, Alain and Dual{\'e}, Christian and Attal, Nadine and Authier, Nicolas", title="eDOL mHealth App and Web Platform for Self-monitoring and Medical Follow-up of Patients With Chronic Pain: Observational Feasibility Study", journal="JMIR Form Res", year="2022", month="Mar", day="2", volume="6", number="3", pages="e30052", keywords="mHealth", keywords="chronic pain", keywords="feasibility study", keywords="eHealth", keywords="self-monitoring", abstract="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 ", doi="10.2196/30052", url="https://formative.jmir.org/2022/3/e30052", url="http://www.ncbi.nlm.nih.gov/pubmed/35234654" } @Article{info:doi/10.2196/33636, author="Gram, Torhild Inger and Skeie, Guri and Oyeyemi, Oluwafemi Sunday and Borch, Benjaminsen Kristin and Hopstock, Arnesdatter Laila and L{\o}chen, Maja-Lisa", title="A Smartphone-Based Information Communication Technology Solution for Primary Modifiable Risk Factors for Noncommunicable Diseases: Pilot and Feasibility Study in Norway", journal="JMIR Form Res", year="2022", month="Feb", day="25", volume="6", number="2", pages="e33636", keywords="eHealth", keywords="feasibility study", keywords="modifiable risk factor", keywords="noncommunicable disease", keywords="pilot study", keywords="smartphone-based information communication technology solution", keywords="short text message service", keywords="feasibility", keywords="risk", keywords="factor", keywords="information communication technology", keywords="smartphone", keywords="development", keywords="monitoring", abstract="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. ", doi="10.2196/33636", url="https://formative.jmir.org/2022/2/e33636", url="http://www.ncbi.nlm.nih.gov/pubmed/35212636" } @Article{info:doi/10.2196/31595, author="Ng, H. Ashley and Greenwood, A. Deborah and Iacob, Eli and Allen, A. Nancy and Ferrer, Mila and Rodriguez, Bruno and Litchman, L. Michelle", title="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", journal="JMIR Res Protoc", year="2022", month="Feb", day="24", volume="11", number="2", pages="e31595", keywords="type 2 diabetes", keywords="hispanic", keywords="social support", keywords="online community", keywords="technology", keywords="peer support", keywords="diabetes", keywords="T2D", keywords="continuous glucose monitoring", keywords="behavior change", keywords="patient education", abstract="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 ", doi="10.2196/31595", url="https://www.researchprotocols.org/2022/2/e31595", url="http://www.ncbi.nlm.nih.gov/pubmed/35200153" } @Article{info:doi/10.2196/32240, author="Nguyen, Binh and Torres, Andrei and Sim, Walter and Kenny, Deborah and Campbell, M. Douglas and Beavers, Lindsay and Lou, Wendy and Kapralos, Bill and Peter, Elizabeth and Dubrowski, Adam and Krishnan, Sridhar and Bhat, Venkat", title="Digital Interventions to Reduce Distress Among Health Care Providers at the Frontline: Protocol for a Feasibility Trial", journal="JMIR Res Protoc", year="2022", month="Feb", day="16", volume="11", number="2", pages="e32240", keywords="virtual reality", keywords="mobile app", keywords="moral distress", keywords="simulation", keywords="moral injury", keywords="COVID-19", abstract="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 ", doi="10.2196/32240", url="https://www.researchprotocols.org/2022/2/e32240", url="http://www.ncbi.nlm.nih.gov/pubmed/34871178" } @Article{info:doi/10.2196/27500, author="Bassi, Giulia and Donadello, Ivan and Gabrielli, Silvia and Salcuni, Silvia and Giuliano, Claudio and Forti, Stefano", title="Early Development of a Virtual Coach for Healthy Coping Interventions in Type 2 Diabetes Mellitus: Validation Study", journal="JMIR Form Res", year="2022", month="Feb", day="11", volume="6", number="2", pages="e27500", keywords="virtual coach", keywords="early development", keywords="type 2 diabetes mellitus", keywords="healthy coping", keywords="Wizard of Oz", keywords="ORBIT model", keywords="pilot study", keywords="mobile phone", abstract="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. ", doi="10.2196/27500", url="https://formative.jmir.org/2022/2/e27500", url="http://www.ncbi.nlm.nih.gov/pubmed/35147505" } @Article{info:doi/10.2196/30782, author="Cooper, Rowena and Giangreco, Adam and Duffy, Michelle and Finlayson, Elaine and Hamilton, Shellie and Swanson, Mahri and Colligan, Judith and Gilliatt, Joanna and McIvor, Mairi and Sage, Kathryn Elizabeth", title="Evaluation of myCOPD Digital Self-management Technology in a Remote and Rural Population: Real-world Feasibility Study", journal="JMIR Mhealth Uhealth", year="2022", month="Feb", day="7", volume="10", number="2", pages="e30782", keywords="digital self-management", keywords="COPD", keywords="remote and rural", keywords="mobile health", keywords="application", keywords="chronic pulmonary obstructive disease", keywords="rural communities", abstract="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. ", doi="10.2196/30782", url="https://mhealth.jmir.org/2022/2/e30782", url="http://www.ncbi.nlm.nih.gov/pubmed/35129453" } @Article{info:doi/10.2196/33449, author="Zucchelli, Fabio and Donnelly, Olivia and Rush, Emma and White, Paul and Gwyther, Holly and Williamson, Heidi and ", title="An Acceptance and Commitment Therapy Prototype Mobile Program for Individuals With a Visible Difference: Mixed Methods Feasibility Study", journal="JMIR Form Res", year="2022", month="Jan", day="21", volume="6", number="1", pages="e33449", keywords="mobile health", keywords="acceptance and commitment therapy", keywords="appearance", keywords="mixed methods", keywords="mobile phone", abstract="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. ", doi="10.2196/33449", url="https://formative.jmir.org/2022/1/e33449", url="http://www.ncbi.nlm.nih.gov/pubmed/35060908" } @Article{info:doi/10.2196/33776, author="Sado, Mitsuhiro and Ninomiya, Akira and Nagaoka, Maki and Koreki, Akihiro and Goto, Naho and Sasaki, Yohei and Takamori, Chie and Kosugi, Teppei and Yamada, Masashi and Park, Sunre and Sato, Yasunori and Fujisawa, Daisuke and Nakagawa, Atsuo and Mimura, Masaru", title="Effectiveness of Mindfulness-Based Cognitive Therapy With Follow-Up Sessions for Pharmacotherapy-Refractory Anxiety Disorders: Protocol for a Feasibility Randomized Controlled Trial", journal="JMIR Res Protoc", year="2022", month="Jan", day="21", volume="11", number="1", pages="e33776", keywords="mindfulness-based cognitive therapy", keywords="anxiety disorders", keywords="long-term effects", keywords="randomized controlled trial", keywords="cost-effectiveness", abstract="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 ", doi="10.2196/33776", url="https://www.researchprotocols.org/2022/1/e33776", url="http://www.ncbi.nlm.nih.gov/pubmed/34787573" } @Article{info:doi/10.2196/31989, author="Smart, H. Mary and Nabulsi, A. Nadia and Gerber, S. Ben and Gupta, Itika and Di Eugenio, Barbara and Ziebart, Brian and Sharp, K. Lisa", title="A Remote Health Coaching, Text-Based Walking Program in Ethnic Minority Primary Care Patients With Overweight and Obesity: Feasibility and Acceptability Pilot Study", journal="JMIR Form Res", year="2022", month="Jan", day="19", volume="6", number="1", pages="e31989", keywords="mHealth", keywords="Fitbit", keywords="SMART goals", keywords="texting", keywords="health coach", keywords="mobile phone", abstract="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. ", doi="10.2196/31989", url="https://formative.jmir.org/2022/1/e31989", url="http://www.ncbi.nlm.nih.gov/pubmed/35044308" } @Article{info:doi/10.2196/34573, author="Petsani, Despoina and Ahmed, Sara and Petronikolou, Vasileia and Kehayia, Eva and Alastalo, Mika and Santonen, Teemu and Merino-Barbancho, Beatriz and Cea, Gloria and Segkouli, Sofia and Stavropoulos, G. Thanos and Billis, Antonis and Doumas, Michael and Almeida, Rosa and Nagy, Enik? and Broeckx, Leen and Bamidis, Panagiotis and Konstantinidis, Evdokimos", title="Digital Biomarkers for Supporting Transitional Care Decisions: Protocol for a Transnational Feasibility Study", journal="JMIR Res Protoc", year="2022", month="Jan", day="19", volume="11", number="1", pages="e34573", keywords="Living Lab", keywords="cocreation", keywords="transitional care", keywords="technology", keywords="feasibility study", abstract="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 ", doi="10.2196/34573", url="https://www.researchprotocols.org/2022/1/e34573", url="http://www.ncbi.nlm.nih.gov/pubmed/35044303" } @Article{info:doi/10.2196/32627, author="Egerton, Thorlene and Lawford, J. Belinda and Campbell, K. Penny and Plinsinga, L. Melanie and Spiers, Libby and Mackenzie, A. David and Graham, Bridget and Mills, Kathryn and Eyles, Jillian and Knox, Gabrielle and Metcalf, Ben and Maclachlan, R. Liam and Besomi, Manuela and Dickson, Chris and Abraham, Charles and Vicenzino, Bill and Hodges, W. Paul and Hunter, J. David and Bennell, L. Kim", title="Expert-Moderated Peer-to-Peer Online Support Group for People With Knee Osteoarthritis: Mixed Methods Randomized Controlled Pilot and Feasibility Study", journal="JMIR Form Res", year="2022", month="Jan", day="17", volume="6", number="1", pages="e32627", keywords="support group", keywords="online support group", keywords="knee", keywords="osteoarthritis", keywords="arthritis", keywords="online forums", keywords="patient education", keywords="self-efficacy", keywords="health literacy", keywords="self-management", keywords="qualitative", abstract="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 ", doi="10.2196/32627", url="https://formative.jmir.org/2022/1/e32627", url="http://www.ncbi.nlm.nih.gov/pubmed/35037880" } @Article{info:doi/10.2196/29559, author="Possemato, Kyle and Wu, Justina and Greene, Carolyn and MacQueen, Rex and Blonigen, Daniel and Wade, Michael and Owen, Jason and Keane, Terence and Brief, Deborah and Lindley, Steven and Prins, Annabel and Mackintosh, Margaret-Anne and Carlson, Eve", title="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", journal="J Med Internet Res", year="2022", month="Jan", day="13", volume="24", number="1", pages="e29559", keywords="problem-solving training", keywords="mHealth", keywords="peer specialists", keywords="veterans", abstract="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 ", doi="10.2196/29559", url="https://www.jmir.org/2022/1/e29559", url="http://www.ncbi.nlm.nih.gov/pubmed/35023846" } @Article{info:doi/10.2196/32550, author="Cornelius, Judith and Whitaker-Brown, Charlene and Smoot, Jaleesa and Hart, Sonia and Lewis, Zandria and Smith, Olivia", title="A Text Messaging--Enhanced Intervention for African American Patients With Heart Failure, Depression, and Anxiety (TXT COPE-HF): Protocol for a Pilot Feasibility Study", journal="JMIR Res Protoc", year="2022", month="Jan", day="7", volume="11", number="1", pages="e32550", keywords="African American", keywords="heart failure", keywords="depression", keywords="anxiety", keywords="assessment", keywords="decision", keywords="administration", keywords="production", keywords="topical expert", keywords="integration", keywords="training and testing model", keywords="text messaging", keywords="SMS", keywords="minorities", keywords="behavior therapy", abstract="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 ", doi="10.2196/32550", url="https://www.researchprotocols.org/2022/1/e32550", url="http://www.ncbi.nlm.nih.gov/pubmed/34994709" } @Article{info:doi/10.2196/31545, author="Gundersen, Alexander Daniel and Wivagg, Jonathan and Young, J. William and Yan, Ting and Delnevo, D. Cristine", title="The Use of Multimode Data Collection in Random Digit Dialing Cell Phone Surveys for Young Adults: Feasibility Study", journal="J Med Internet Res", year="2021", month="Dec", day="20", volume="23", number="12", pages="e31545", keywords="web mode", keywords="web survey", keywords="random digit dialing", keywords="mixed mode surveys", keywords="survey methodology", keywords="data capture", keywords="research methods", keywords="recruitment", keywords="survey", keywords="feasibility", keywords="smoking", abstract="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. ", doi="10.2196/31545", url="https://www.jmir.org/2021/12/e31545", url="http://www.ncbi.nlm.nih.gov/pubmed/34932017" } @Article{info:doi/10.2196/31541, author="Lowe, Cabella and Hanuman Sing, Harry and Marsh, William and Morrissey, Dylan", title="Validation of a Musculoskeletal Digital Assessment Routing Tool: Protocol for a Pilot Randomized Crossover Noninferiority Trial", journal="JMIR Res Protoc", year="2021", month="Dec", day="13", volume="10", number="12", pages="e31541", keywords="mHealth", keywords="mobile health", keywords="eHealth", keywords="digital health", keywords="digital technology", keywords="musculoskeletal", keywords="triage", keywords="physiotherapy triage", keywords="validation", keywords="mobile phone", abstract="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 ", doi="10.2196/31541", url="https://www.researchprotocols.org/2021/12/e31541", url="http://www.ncbi.nlm.nih.gov/pubmed/34898461" } @Article{info:doi/10.2196/28307, author="Hu, Alvin", title="Conjugation of Silver Nanoparticles With De Novo--Engineered Cationic Antimicrobial Peptides: Exploratory Proposal", journal="JMIR Res Protoc", year="2021", month="Dec", day="8", volume="10", number="12", pages="e28307", keywords="antimicrobial peptides", keywords="silver nanoparticles", keywords="ESKAPE pathogens", keywords="research proposal", abstract="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 ", doi="10.2196/28307", url="https://www.researchprotocols.org/2021/12/e28307", url="http://www.ncbi.nlm.nih.gov/pubmed/34780345" } @Article{info:doi/10.2196/27956, author="Dhinagaran, Ardhithy Dhakshenya and Sathish, Thirunavukkarasu and Soong, AiJia and Theng, Yin-Leng and Best, James and Tudor Car, Lorainne", title="Conversational Agent for Healthy Lifestyle Behavior Change: Web-Based Feasibility Study", journal="JMIR Form Res", year="2021", month="Dec", day="3", volume="5", number="12", pages="e27956", keywords="chatbot", keywords="conversational agents", keywords="behavior change", keywords="healthy lifestyle behavior change", keywords="pilot study", keywords="feasibility trial", keywords="usability", keywords="acceptability", keywords="preliminary efficacy", keywords="mobile phone", abstract="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. ", doi="10.2196/27956", url="https://formative.jmir.org/2021/12/e27956", url="http://www.ncbi.nlm.nih.gov/pubmed/34870611" } @Article{info:doi/10.2196/24840, author="Mastorci, Francesca and Piaggi, Paolo and Trivellini, Gabriele and Doveri, Cristina and Casu, Anselmo and Bastiani, Luca and Marinaro, Irene and Vassalle, Cristina and Pingitore, Alessandro", title="Development of a Web-Based School Support System Within the AVATAR Project for Psychosocial Well-being in Adolescents: Pilot Feasibility Study", journal="JMIR Form Res", year="2021", month="Dec", day="2", volume="5", number="12", pages="e24840", keywords="adolescent", keywords="well-being management", keywords="schools", keywords="web tool", keywords="health promotion", abstract="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. ", doi="10.2196/24840", url="https://formative.jmir.org/2021/12/e24840", url="http://www.ncbi.nlm.nih.gov/pubmed/34860668" } @Article{info:doi/10.2196/28652, author="Goodridge, Donna and Reis, Nathan and Neiser, Jenna and Haubrich, Tim and Westberg, Bev and Erickson-Lumb, Laura and Storozinski, Jo and Gonzales, Cesar and Michael, Joanne and Cammer, Allison and Osgood, Nathaniel", title="An App-Based Mindfulness-Based Self-compassion Program to Support Caregivers of People With Dementia: Participatory Feasibility Study", journal="JMIR Aging", year="2021", month="Nov", day="26", volume="4", number="4", pages="e28652", keywords="virtual support programs", keywords="caregivers", keywords="dementia", keywords="mindfulness", keywords="self-compassion", keywords="mobile health", keywords="mobile applications", keywords="elderly", keywords="older adults", keywords="usability", keywords="feasibility", keywords="smartphone app", keywords="mobile phone", abstract="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. ", doi="10.2196/28652", url="https://aging.jmir.org/2021/4/e28652", url="http://www.ncbi.nlm.nih.gov/pubmed/34842530" } @Article{info:doi/10.2196/26964, author="Matthiesen, Stina and Diederichsen, Z{\"o}ga S{\o}ren and Hansen, Hartmann Mikkel Klitzing and Villumsen, Christina and Lassen, H{\o}jbjerg Mats Christian and Jacobsen, Karl Peter and Risum, Niels and Winkel, Gregers Bo and Philbert, T. Berit and Svendsen, Hastrup Jesper and Andersen, Osman Tariq", title="Clinician Preimplementation Perspectives of a Decision-Support Tool for the Prediction of Cardiac Arrhythmia Based on Machine Learning: Near-Live Feasibility and Qualitative Study", journal="JMIR Hum Factors", year="2021", month="Nov", day="26", volume="8", number="4", pages="e26964", keywords="cardiac arrhythmia", keywords="short-term prediction", keywords="clinical decision support systems", keywords="machine learning", keywords="artificial intelligence", keywords="preimplementation", keywords="qualitative study", keywords="implantable cardioverter defibrillator", keywords="remote follow-up", keywords="sociotechnical", abstract="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. ", doi="10.2196/26964", url="https://humanfactors.jmir.org/2021/4/e26964", url="http://www.ncbi.nlm.nih.gov/pubmed/34842528" } @Article{info:doi/10.2196/29330, author="Xu, Wenge and Liang, Hai-Ning and Baghaei, Nilufar and Ma, Xiaoyue and Yu, Kangyou and Meng, Xuanru and Wen, Shaoyue", title="Effects of an Immersive Virtual Reality Exergame on University Students' Anxiety, Depression, and Perceived Stress: Pilot Feasibility and Usability Study", journal="JMIR Serious Games", year="2021", month="Nov", day="22", volume="9", number="4", pages="e29330", keywords="university students", keywords="depression", keywords="anxiety", keywords="stress", keywords="immersive virtual reality", keywords="exergame", abstract="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. ", doi="10.2196/29330", url="https://games.jmir.org/2021/4/e29330", url="http://www.ncbi.nlm.nih.gov/pubmed/34813487" } @Article{info:doi/10.2196/16824, author="Lasrado, Reena and Bielsten, Therese and Hann, Mark and Schumm, James and Reilly, Theresa Siobhan and Davies, Linda and Swarbrick, Caroline and Dowlen, Robyn and Keady, John and Hellstr{\"o}m, Ingrid", title="Developing a Management Guide (the DemPower App) for Couples Where One Partner Has Dementia: Nonrandomized Feasibility Study", journal="JMIR Aging", year="2021", month="Nov", day="16", volume="4", number="4", pages="e16824", keywords="dementia guide", keywords="self-management for couples with dementia", keywords="dementia self-help", keywords="dementia app", keywords="dementia resource", keywords="feasibility study", keywords="nonrandomized study", keywords="dementia intervention", abstract="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 ", doi="10.2196/16824", url="https://aging.jmir.org/2021/4/e16824", url="http://www.ncbi.nlm.nih.gov/pubmed/34783666" } @Article{info:doi/10.2196/29044, author="Radhakrishnan, Kavita and Julien, Christine and Baranowski, Tom and O'Hair, Matthew and Lee, Grace and Sagna De Main, Atami and Allen, Catherine and Viswanathan, Bindu and Thomaz, Edison and Kim, Miyong", title="Feasibility of a Sensor-Controlled Digital Game for Heart Failure Self-management: Randomized Controlled Trial", journal="JMIR Serious Games", year="2021", month="Nov", day="8", volume="9", number="4", pages="e29044", keywords="heart failure", keywords="digital game", keywords="sensor", keywords="self-management", keywords="older adults", keywords="weight monitoring", keywords="physical activity", keywords="behaviors", keywords="mobile phone", abstract="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 ", doi="10.2196/29044", url="https://games.jmir.org/2021/4/e29044", url="http://www.ncbi.nlm.nih.gov/pubmed/34747701" } @Article{info:doi/10.2196/28322, author="Wright, Hayley and Martin, Faith and Clyne, Wendy and Clark, T. Cain C. and Matouskova, Gabriela and McGillion, Michael and Turner, Andrew", title="A Digital Self-management Program (Help to Overcome Problems Effectively) for People Living With Cancer: Feasibility Randomized Controlled Trial", journal="J Med Internet Res", year="2021", month="Nov", day="5", volume="23", number="11", pages="e28322", keywords="self-management", keywords="cancer", keywords="survivorship", keywords="digital", keywords="positive psychology", abstract="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 ", doi="10.2196/28322", url="https://www.jmir.org/2021/11/e28322", url="http://www.ncbi.nlm.nih.gov/pubmed/34738912" } @Article{info:doi/10.2196/25918, author="Ip, Athena and Muller, Ingrid and Geraghty, A. Adam W. and Rumsby, Kate and Stuart, Beth and Little, Paul and Santer, Miriam", title="Supporting Self-management Among Young People With Acne Vulgaris Through a Web-Based Behavioral Intervention: Development and Feasibility Randomized Controlled Trial", journal="JMIR Dermatol", year="2021", month="Nov", day="3", volume="4", number="2", pages="e25918", keywords="feasibility study", keywords="acne vulgaris", keywords="intervention study", keywords="self-management", keywords="primary care", keywords="acne", keywords="dermatology", abstract="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 ", doi="10.2196/25918", url="https://derma.jmir.org/2021/2/e25918", url="http://www.ncbi.nlm.nih.gov/pubmed/37632804" } @Article{info:doi/10.2196/29188, author="Yin, Zenong and Martinez, E. Cristina and Li, Shiyu and Martinez, Martha and Peng, Kezhi and Land, M. William and Ullevig, L. Sarah and Cantu, Adelita and Falk, Sharon and Hern{\'a}ndez, E. Arthur and Ortega, Catherine and Parra-Medina, Deborah and Simmonds, J. Maureen", title="Adapting Chinese Qigong Mind-Body Exercise for Healthy Aging in Older Community-Dwelling Low-income Latino Adults: Pilot Feasibility Study", journal="JMIR Aging", year="2021", month="Nov", day="1", volume="4", number="4", pages="e29188", keywords="mHealth", keywords="community-based participatory research", keywords="five animal play", keywords="wuqinxi", abstract="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 ", doi="10.2196/29188", url="https://aging.jmir.org/2021/4/e29188", url="http://www.ncbi.nlm.nih.gov/pubmed/34723824" } @Article{info:doi/10.2196/29755, author="Ginsburg, Sarah Amy and Kinshella, Woo Mai-Lei and Naanyu, Violet and Rigg, Jessica and Chomba, Dorothy and Coleman, Jesse and Hwang, Bella and Ochieng, Roseline and Ansermino, Mark J. and Macharia, M. William", title="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", journal="J Med Internet Res", year="2021", month="Oct", day="28", volume="23", number="10", pages="e29755", keywords="infants", keywords="Africa", keywords="medical technology design", keywords="user perspectives", keywords="in-depth interviews", keywords="direct observations", abstract="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 ", doi="10.2196/29755", url="https://www.jmir.org/2021/10/e29755", url="http://www.ncbi.nlm.nih.gov/pubmed/34709194" } @Article{info:doi/10.2196/33113, author="Hasselgren, Anton and Kralevska, Katina and Gligoroski, Danilo and Faxvaag, Arild", title="Medical Students' Perceptions of a Blockchain-Based Decentralized Work History and Credentials Portfolio: Qualitative Feasibility Study", journal="JMIR Form Res", year="2021", month="Oct", day="22", volume="5", number="10", pages="e33113", keywords="blockchain", keywords="eHealth", keywords="qualitative research", keywords="VerifyMed", abstract="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. ", doi="10.2196/33113", url="https://formative.jmir.org/2021/10/e33113", url="http://www.ncbi.nlm.nih.gov/pubmed/34677137" } @Article{info:doi/10.2196/29273, author="Livanou, Maria and Lane, Rebecca", title="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", journal="JMIR Res Protoc", year="2021", month="Oct", day="22", volume="10", number="10", pages="e29273", keywords="transition", keywords="intervention", keywords="young people", keywords="feasibility cluster randomized trial", keywords="cluster randomized controlled trial", keywords="secure hospitals", keywords="outcomes", keywords="adolescents", keywords="patients", abstract="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 ", doi="10.2196/29273", url="https://www.researchprotocols.org/2021/10/e29273", url="http://www.ncbi.nlm.nih.gov/pubmed/34677140" } @Article{info:doi/10.2196/21405, author="Malik, S. Faisal and Lind, Cara and Duncan, Sarah and Mitrovich, Connor and Pascual, Michael and Yi-Frazier, P. Joyce", title="Augmenting Traditional Support Groups for Adolescents With Type 1 Diabetes Using Instagram: Mixed Methods Feasibility Study", journal="JMIR Diabetes", year="2021", month="Oct", day="21", volume="6", number="4", pages="e21405", keywords="diabetes mellitus, type 1", keywords="self-help groups", keywords="social media", keywords="adolescent", abstract="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. ", doi="10.2196/21405", url="https://diabetes.jmir.org/2021/4/e21405", url="http://www.ncbi.nlm.nih.gov/pubmed/34673527" } @Article{info:doi/10.2196/25217, author="Kelly, J. Peter and Beck, K. Alison and Deane, P. Frank and Larance, Briony and Baker, L. Amanda and Hides, Leanne and Manning, Victoria and Shakeshaft, Anthony and Neale, Joanne and Kelly, F. John and Oldmeadow, Christopher and Searles, Andrew and Palazzi, Kerrin and Lawson, Kenny and Treloar, Carla and Gray, M. Rebecca and Argent, Angela and McGlaughlin, Ryan", title="Feasibility of a Mobile Health App for Routine Outcome Monitoring and Feedback in SMART Recovery Mutual Support Groups: Stage 1 Mixed Methods Pilot Study", journal="J Med Internet Res", year="2021", month="Oct", day="6", volume="23", number="10", pages="e25217", keywords="mHealth", keywords="SMART Recovery", keywords="mutual support group", keywords="mutual aid", keywords="routine outcome monitoring", keywords="treatment progress feedback", keywords="addiction", keywords="mobile phone", abstract="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 ", doi="10.2196/25217", url="https://www.jmir.org/2021/10/e25217", url="http://www.ncbi.nlm.nih.gov/pubmed/34612829" } @Article{info:doi/10.2196/15519, author="Anthoine, Emmanuelle and Caillon, Julie and Deparis, Xavier and Blanche, Michel and Lebeaupin, Maxime and Brochard, Marc-Antoine and Venisse, Jean-Luc and Moret, Le{\"i}la", title="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", journal="JMIR Form Res", year="2021", month="Oct", day="1", volume="5", number="10", pages="e15519", keywords="feasibility study", keywords="preventive medicine", keywords="addiction", keywords="screening and brief intervention", keywords="web-based app", abstract="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 Sant{\'e}, 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 Sant{\'e} 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 Sant{\'e} app by users and HCWs. There is a need for further studies more directly focused on the limitations highlighted by the qualitative results. ", doi="10.2196/15519", url="https://formative.jmir.org/2021/10/e15519", url="http://www.ncbi.nlm.nih.gov/pubmed/34596571" } @Article{info:doi/10.2196/30990, author="Betz, E. Marian and Polzer, Evan and Nearing, Kathryn and Knoepke, E. Christopher and Johnson, L. Rachel and Meador, Lauren and Matlock, D. Daniel", title="Feasibility and Acceptability of a Web-Based Caregiver Decision Aid (Safety in Dementia) for Firearm Access: Pilot Randomized Controlled Trial", journal="JMIR Form Res", year="2021", month="Sep", day="22", volume="5", number="9", pages="e30990", keywords="dementia", keywords="cognitive impairment", keywords="firearm", keywords="decision aid", keywords="caregivers", keywords="safety", keywords="feasibility", keywords="pilot trial", keywords="Alzheimer disease", keywords="caregiver support", abstract="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. ", doi="10.2196/30990", url="https://formative.jmir.org/2021/9/e30990", url="http://www.ncbi.nlm.nih.gov/pubmed/34550082" } @Article{info:doi/10.2196/29642, author="Shin, In-Soo and Rim, Hong Chai", title="Stepwise-Hierarchical Pooled Analysis for Synergistic Interpretation of Meta-analyses Involving Randomized and Observational Studies: Methodology Development", journal="J Med Internet Res", year="2021", month="Sep", day="2", volume="23", number="9", pages="e29642", keywords="meta-analysis", keywords="observational study", keywords="randomized study", keywords="interpretation", keywords="combination", keywords="statistics", keywords="synergy", keywords="methodology", keywords="hypothesis", keywords="validity", abstract="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. ", doi="10.2196/29642", url="https://www.jmir.org/2021/9/e29642", url="http://www.ncbi.nlm.nih.gov/pubmed/34315697" } @Article{info:doi/10.2196/23360, author="Ashrafi, Agaah and Tabatabaee, Maryam and Sharifi, Vandad", title="Development and Evaluation of Acceptability and Feasibility of a Web-Based Intervention for Patients With Bipolar Disorder in Iran: Implementation Study", journal="JMIR Form Res", year="2021", month="Aug", day="17", volume="5", number="8", pages="e23360", keywords="bipolar disorder", keywords="psychoeducation", keywords="web-based intervention", keywords="feasibility", keywords="acceptability", abstract="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. ", doi="10.2196/23360", url="https://formative.jmir.org/2021/8/e23360", url="http://www.ncbi.nlm.nih.gov/pubmed/34402794" } @Article{info:doi/10.2196/31588, author="Pine, Russell and Mbinta, James and Te Morenga, Lisa and Fleming, Theresa", title="A Casual Video Game With Psychological Well-being Concepts for Young Adolescents: Protocol for an Acceptability and Feasibility Study", journal="JMIR Res Protoc", year="2021", month="Aug", day="12", volume="10", number="8", pages="e31588", keywords="digital mental health tools", keywords="casual video games", keywords="young people", abstract="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 ", doi="10.2196/31588", url="https://www.researchprotocols.org/2021/8/e31588", url="http://www.ncbi.nlm.nih.gov/pubmed/34387558" } @Article{info:doi/10.2196/25569, author="Lambert, Genevieve and Alos, Nathalie and Bernier, Pascal and Laverdi{\`e}re, Caroline and Kairy, Dahlia and Drummond, Kenneth and Dahan-Oliel, No{\'e}mi and Lemay, Martin and Veilleux, Louis-Nicolas", title="Home-Based Telehealth Exercise Intervention in Early-On Survivors of Childhood Acute Lymphoblastic Leukemia: Feasibility Study", journal="JMIR Cancer", year="2021", month="Jun", day="16", volume="7", number="2", pages="e25569", keywords="exercise therapy", keywords="rehabilitation", keywords="acute lymphoblastic leukemia", keywords="intervention study", keywords="telehealth", keywords="mobile phone", abstract="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. ", doi="10.2196/25569", url="https://cancer.jmir.org/2021/2/e25569", url="http://www.ncbi.nlm.nih.gov/pubmed/34132645" } @Article{info:doi/10.2196/24808, author="Lecomte, Fabienne and Thecua, Elise and Ziane, Laurine and Deleporte, Pascal and Duhamel, Alain and Vamour, Cl{\'e}mence and Mordon, Serge and Rakza, Thameur", title="Phototherapy Using a Light-Emitting Fabric (BUBOLight) Device in the Treatment of Newborn Jaundice: Protocol for an Interventional Feasibility and Safety Study", journal="JMIR Res Protoc", year="2021", month="May", day="25", volume="10", number="5", pages="e24808", keywords="jaundice", keywords="light emitting fabrics", keywords="light", keywords="neonate", keywords="newborn jaundice", keywords="perinatal", keywords="phototherapy", abstract="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, signi?cant 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 {\textmu}W/cm{\texttwosuperior}/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 ", doi="10.2196/24808", url="https://www.researchprotocols.org/2021/5/e24808", url="http://www.ncbi.nlm.nih.gov/pubmed/34032584" } @Article{info:doi/10.2196/21357, author="St{\o}me, Nathalie Linn and Wilhelmsen, Ringnes Christian and Kv{\ae}rner, Jorunn Kari", title="Enabling Guidelines for the Adoption of eHealth Solutions: Scoping Review", journal="JMIR Form Res", year="2021", month="Apr", day="30", volume="5", number="4", pages="e21357", keywords="eHealth", keywords="feasibility", keywords="global health", keywords="implementation", abstract="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. ", doi="10.2196/21357", url="https://formative.jmir.org/2021/4/e21357", url="http://www.ncbi.nlm.nih.gov/pubmed/33929330" } @Article{info:doi/10.2196/24704, author="Kuula, Liisa and Pesonen, Anu-Katriina", title="Heart Rate Variability and Firstbeat Method for Detecting Sleep Stages in Healthy Young Adults: Feasibility Study", journal="JMIR Mhealth Uhealth", year="2021", month="Feb", day="3", volume="9", number="2", pages="e24704", keywords="electroencephalogram", keywords="actigraphy", keywords="polysomnography", keywords="sleep", keywords="heart rate", keywords="rapid eye movements", abstract="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. ", doi="10.2196/24704", url="http://mhealth.jmir.org/2021/2/e24704/", url="http://www.ncbi.nlm.nih.gov/pubmed/33533726" } @Article{info:doi/10.2196/14494, author="Katzan, Irene and Schuster, Andrew and Kinzy, Tyler", title="Physical Activity Monitoring Using a Fitbit Device in Ischemic Stroke Patients: Prospective Cohort Feasibility Study", journal="JMIR Mhealth Uhealth", year="2021", month="Jan", day="19", volume="9", number="1", pages="e14494", keywords="physical activity", keywords="accelerometer", keywords="ischemic stroke", keywords="step activity monitor", abstract="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. ", doi="10.2196/14494", url="http://mhealth.jmir.org/2021/1/e14494/", url="http://www.ncbi.nlm.nih.gov/pubmed/33464213" } @Article{info:doi/10.2196/20410, author="Larsen, Hoekjaer Lisbeth and Lauritzen, Hedegaard Maja and Gangstad, Wilhelmsen Sirin and Kjaer, Wesenberg Troels", title="The Use of Small Electronic Devices and Health: Feasibility of Interventions for a Forthcoming Crossover Design", journal="JMIR Form Res", year="2021", month="Jan", day="4", volume="5", number="1", pages="e20410", keywords="accelerometer", keywords="activity trackers", keywords="aerobic capacity", keywords="insufficient sleep", keywords="media use", keywords="screen time", keywords="sleep problems", keywords="smartphones", keywords="wearable tracking devices", abstract="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. ", doi="10.2196/20410", url="https://formative.jmir.org/2021/1/e20410", url="http://www.ncbi.nlm.nih.gov/pubmed/33393907" } @Article{info:doi/10.2196/23414, author="Kapoor, Akshat and Nambisan, Priya", title="Exploring Interactive Survivorship Care Plans to Support Breast Cancer Survivors: Protocol for a Randomized Controlled Trial", journal="JMIR Res Protoc", year="2020", month="Dec", day="4", volume="9", number="12", pages="e23414", keywords="breast cancer", keywords="cancer survivorship", keywords="self-management", keywords="patient education", abstract="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 ", doi="10.2196/23414", url="https://www.researchprotocols.org/2020/12/e23414", url="http://www.ncbi.nlm.nih.gov/pubmed/33274725" } @Article{info:doi/10.2196/21964, author="Choi, K. Yong and Thompson, J. Hilaire and Demiris, George", title="Use of an Internet-of-Things Smart Home System for Healthy Aging in Older Adults in Residential Settings: Pilot Feasibility Study", journal="JMIR Aging", year="2020", month="Nov", day="10", volume="3", number="2", pages="e21964", keywords="Internet of Things", keywords="smart home", keywords="independent living", keywords="aging", keywords="healthy aging", abstract="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. ", doi="10.2196/21964", url="http://aging.jmir.org/2020/2/e21964/", url="http://www.ncbi.nlm.nih.gov/pubmed/33170128" } @Article{info:doi/10.2196/21816, author="Lim, Tara Brittany and Chhina, Harpreet and Pike, Ian and Brussoni, Mariana and Cooper, Anthony", title="Methodological Challenges in Investigating Supracondylar Fractures of the Humerus From a Child's Viewpoint: Evolution of Study Protocol", journal="JMIR Res Protoc", year="2020", month="Nov", day="2", volume="9", number="11", pages="e21816", keywords="supracondylar fracture", keywords="pediatrics", keywords="trauma", keywords="protocol", keywords="injury prevention", keywords="child's viewpoint", abstract="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 ", doi="10.2196/21816", url="https://www.researchprotocols.org/2020/11/e21816", url="http://www.ncbi.nlm.nih.gov/pubmed/33136061" } @Article{info:doi/10.2196/23893, author="Bostr{\o}m, Katrine and B{\o}r{\o}sund, Elin and Varsi, Cecilie and Eide, Hilde and Flakk Nordang, Elise and Schreurs, MG Karlein and Waxenberg, B. Lori and Weiss, E. Karen and Morrison, J. Eleshia and Cvancarova Sm{\aa}stuen, Milada and Stubhaug, Audun and Solberg Nes, Lise", title="Digital Self-Management in Support of Patients Living With Chronic Pain: Feasibility Pilot Study", journal="JMIR Form Res", year="2020", month="Oct", day="23", volume="4", number="10", pages="e23893", keywords="chronic pain", keywords="feasibility", keywords="acceptability", keywords="self-management", keywords="eHealth", keywords="digital", keywords="cognitive-behavioral pain", keywords="usability", keywords="user centered", abstract="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 ", doi="10.2196/23893", url="http://formative.jmir.org/2020/10/e23893/", url="http://www.ncbi.nlm.nih.gov/pubmed/33094734" } @Article{info:doi/10.2196/14322, author="Gonze, Barros B{\'a}rbara De and Padovani, Costa Ricardo Da and Simoes, Socorro Maria Do and Lauria, Vinicius and Proen{\c{c}}a, Leite Neli and Sperandio, Fornias Evandro and Ostolin, Paschoale Thatiane Lopes Valentim Di and Gomes, Oliveira Grace Ang{\'e}lica De and Castro, Costa Paula and Romiti, Marcello and Gagliardi, Antonio and Arantes, Leite Rodolfo and Dourado, Zuniga Victor", title="Use of a Smartphone App to Increase Physical Activity Levels in Insufficiently Active Adults: Feasibility Sequential Multiple Assignment Randomized Trial (SMART)", journal="JMIR Res Protoc", year="2020", month="Oct", day="23", volume="9", number="10", pages="e14322", keywords="tailored messages", keywords="gamification", keywords="steps per day", abstract="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/. ", doi="10.2196/14322", url="https://www.researchprotocols.org/2020/10/e14322", url="http://www.ncbi.nlm.nih.gov/pubmed/33094733" } @Article{info:doi/10.2196/15623, author="Stens, Oleg and Weisman, H. Michael and Simard, Julia and Reuter, Katja", title="Insights From Twitter Conversations on Lupus and Reproductive Health: Protocol for a Content Analysis", journal="JMIR Res Protoc", year="2020", month="Aug", day="26", volume="9", number="8", pages="e15623", keywords="fertility", keywords="infodemiology", keywords="infoveillance", keywords="listening", keywords="lupus", keywords="monitoring", keywords="patient opinion", keywords="reproductive health", keywords="surveillance", keywords="Twitter", keywords="social media", keywords="social network", abstract="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 ", doi="10.2196/15623", url="http://www.researchprotocols.org/2020/8/e15623/", url="http://www.ncbi.nlm.nih.gov/pubmed/32844753" } @Article{info:doi/10.2196/18178, author="D'Haeseleer, Miguel and Eelen, Piet and Sadeghi, Nima and D'Hooghe, B. Marie and Van Schependom, Jeroen and Nagels, Guy", title="Feasibility of Real Time Internet-Based Teleconsultation in Patients With Multiple Sclerosis: Interventional Pilot Study", journal="J Med Internet Res", year="2020", month="Aug", day="13", volume="22", number="8", pages="e18178", keywords="multiple sclerosis", keywords="teleconsultation", keywords="internet", keywords="feasibility", keywords="eHealth", abstract="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. ", doi="10.2196/18178", url="https://www.jmir.org/2020/8/e18178", url="http://www.ncbi.nlm.nih.gov/pubmed/32447274" } @Article{info:doi/10.2196/15690, author="Eisenhut, Michael", title="The Identification of Native Epitopes Eliciting a Protective High-Affinity Immunoglobulin Subclass Response to Blood Stages of Plasmodium falciparum: Protocol for Observational Studies", journal="JMIR Res Protoc", year="2020", month="Jul", day="17", volume="9", number="7", pages="e15690", keywords="proteome", keywords="immunome", keywords="2D electrophoresis", keywords="Plasmodium falciparum", keywords="immunoglobulin", keywords="affinity", keywords="avidity", keywords="western blot", keywords="conformational epitope", keywords="nonlinear epitope", abstract="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 ", doi="10.2196/15690", url="https://www.researchprotocols.org/2020/7/e15690", url="http://www.ncbi.nlm.nih.gov/pubmed/32706743" } @Article{info:doi/10.2196/14536, author="Bevan Jones, Rhys and Thapar, Anita and Rice, Frances and Mars, Becky and Agha, Shameem Sharifah and Smith, Daniel and Merry, Sally and Stallard, Paul and Thapar, K. Ajay and Jones, Ian and Simpson, A. Sharon", title="A Digital Intervention for Adolescent Depression (MoodHwb): Mixed Methods Feasibility Evaluation", journal="JMIR Ment Health", year="2020", month="Jul", day="17", volume="7", number="7", pages="e14536", keywords="adolescent", keywords="depression", keywords="internet", keywords="education", keywords="early medical intervention", keywords="feasibility study", abstract="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. ", doi="10.2196/14536", url="https://mental.jmir.org/2020/7/e14536", url="http://www.ncbi.nlm.nih.gov/pubmed/32384053" } @Article{info:doi/10.2196/15448, author="Staite, Emily and Bayley, Adam and Al-Ozairi, Ebaa and Stewart, Kurtis and Hopkins, David and Rundle, Jennifer and Basudev, Neel and Mohamedali, Zahra and Ismail, Khalida", title="A Wearable Technology Delivering a Web-Based Diabetes Prevention Program to People at High Risk of Type 2 Diabetes: Randomized Controlled Trial", journal="JMIR Mhealth Uhealth", year="2020", month="Jul", day="15", volume="8", number="7", pages="e15448", keywords="motivational interviewing", keywords="lifestyle", keywords="diabetes prevention program", keywords="theory of planned behavior", keywords="type 2 diabetes mellitus", keywords="wearable technology", keywords="mobile phone", abstract="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 ", doi="10.2196/15448", url="https://mhealth.jmir.org/2020/7/e15448", url="http://www.ncbi.nlm.nih.gov/pubmed/32459651" } @Article{info:doi/10.2196/16543, author="Zepecki, Anne and Guendelman, Sylvia and DeNero, John and Prata, Ndola", title="Using Application Programming Interfaces to Access Google Data for Health Research: Protocol for a Methodological Framework", journal="JMIR Res Protoc", year="2020", month="Jul", day="6", volume="9", number="7", pages="e16543", keywords="Google", keywords="search data", keywords="infodemiology", keywords="infoveillance", keywords="infodemic", keywords="reproductive health", keywords="abortion", keywords="birth control", keywords="Google Trends", keywords="APIs", abstract="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 ", doi="10.2196/16543", url="https://www.researchprotocols.org/2020/7/e16543", url="http://www.ncbi.nlm.nih.gov/pubmed/32442159" } @Article{info:doi/10.2196/18204, author="van Beek, Willemijn Judith Jantine and van Wegen, Henri Erwin Everardus and Rietberg, Berend Marc and Nyffeler, Thomas and Bohlhalter, Stephan and Kamm, Philipp Christian and Nef, Tobias and Vanbellingen, Tim", title="Feasibility of a Home-Based Tablet App for Dexterity Training in Multiple Sclerosis: Usability Study", journal="JMIR Mhealth Uhealth", year="2020", month="Jun", day="9", volume="8", number="6", pages="e18204", keywords="dexterity", keywords="feasibility", keywords="multiple sclerosis", keywords="rehabilitation", keywords="app", keywords="home-based training", abstract="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. ", doi="10.2196/18204", url="http://mhealth.jmir.org/2020/6/e18204/", url="http://www.ncbi.nlm.nih.gov/pubmed/32515747" } @Article{info:doi/10.2196/16371, author="Seelye, Adriana and Leese, Isabelle Mira and Dorociak, Katherine and Bouranis, Nicole and Mattek, Nora and Sharma, Nicole and Beattie, Zachary and Riley, Thomas and Lee, Jonathan and Cosgrove, Kevin and Fleming, Nicole and Klinger, Jessica and Ferguson, John and Lamberty, John Greg and Kaye, Jeffrey", title="Feasibility of In-Home Sensor Monitoring to Detect Mild Cognitive Impairment in Aging Military Veterans: Prospective Observational Study", journal="JMIR Form Res", year="2020", month="Jun", day="8", volume="4", number="6", pages="e16371", keywords="aging", keywords="mild cognitive impairment", keywords="activities of daily living", keywords="technology", abstract="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. ", doi="10.2196/16371", url="https://formative.jmir.org/2020/6/e16371", url="http://www.ncbi.nlm.nih.gov/pubmed/32310138" } @Article{info:doi/10.2196/16203, author="Bentley, L. Claire and Powell, Lauren and Potter, Stephen and Parker, Jack and Mountain, A. Gail and Bartlett, Kiera Yvonne and Farwer, Jochen and O'Connor, Cath and Burns, Jennifer and Cresswell, L. Rachel and Dunn, D. Heather and Hawley, S. Mark", title="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", journal="JMIR Mhealth Uhealth", year="2020", month="Jun", day="3", volume="8", number="6", pages="e16203", keywords="mobile health", keywords="mHealth", keywords="chronic obstructive pulmonary disease", keywords="feasibility", keywords="physical activity", keywords="activity tracker", keywords="Fitbit", keywords="self-management", keywords="health behavior change", keywords="pulmonary rehabilitation", abstract="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. ", doi="10.2196/16203", url="https://mhealth.jmir.org/2020/6/e16203", url="http://www.ncbi.nlm.nih.gov/pubmed/32490838" } @Article{info:doi/10.2196/17603, author="Thomas, Douglas Neil William and Beattie, Zachary and Marcoe, Jennifer and Wright, Kirsten and Sharma, Nicole and Mattek, Nora and Dodge, Hiroko and Wild, Katherine and Kaye, Jeffrey", title="An Ecologically Valid, Longitudinal, and Unbiased Assessment of Treatment Efficacy in Alzheimer Disease (the EVALUATE-AD Trial): Proof-of-Concept Study", journal="JMIR Res Protoc", year="2020", month="May", day="27", volume="9", number="5", pages="e17603", keywords="mild cognitive impairment", keywords="Alzheimer disease", keywords="mobile health", keywords="clinical trial", keywords="health information technology", abstract="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 ", doi="10.2196/17603", url="http://www.researchprotocols.org/2020/5/e17603/", url="http://www.ncbi.nlm.nih.gov/pubmed/32459184" } @Article{info:doi/10.2196/14747, author="Zeisler, Marie-Luise and Bilgic, Leman and Schumann, Maria and Wengler, Annelene and Lemcke, Johannes and G{\"o}{\ss}wald, Antje and Lampert, Thomas and Santos-H{\"o}vener, Claudia and Schmich, Patrick", title="Interventions to Increase the Reachability of Migrants in Germany With Health Interview Surveys: Mixed-Mode Feasibility Study", journal="JMIR Form Res", year="2020", month="Apr", day="15", volume="4", number="4", pages="e14747", keywords="transients and migrants", keywords="surveys and questionnaires", keywords="cross-sectional studies", keywords="feasibility studies", keywords="multilingualism and health monitoring", abstract="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. ", doi="10.2196/14747", url="https://formative.jmir.org/2020/4/e14747", url="http://www.ncbi.nlm.nih.gov/pubmed/32305950" } @Article{info:doi/10.2196/16142, author="Lancaster, Claire and Koychev, Ivan and Blane, Jasmine and Chinner, Amy and Wolters, Leona and Hinds, Chris", title="Evaluating the Feasibility of Frequent Cognitive Assessment Using the Mezurio Smartphone App: Observational and Interview Study in Adults With Elevated Dementia Risk", journal="JMIR Mhealth Uhealth", year="2020", month="Apr", day="2", volume="8", number="4", pages="e16142", keywords="technology assessment", keywords="cognition", keywords="smartphone", keywords="mhealth", keywords="mobile phone", keywords="Alzheimer disease", keywords="early diagnosis", keywords="feasibility study", keywords="ecological momentary assessment", abstract="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. ", doi="10.2196/16142", url="https://mhealth.jmir.org/2020/4/e16142", url="http://www.ncbi.nlm.nih.gov/pubmed/32238339" } @Article{info:doi/10.2196/16336, author="Tzilos Wernette, Golfo and Countryman, Kristina and Khatibi, Kristie and Riley, Erin and Stephenson, Rob", title="Love My Body: Pilot Study to Understand Reproductive Health Vulnerabilities in Adolescent Girls", journal="J Med Internet Res", year="2020", month="Mar", day="30", volume="22", number="3", pages="e16336", keywords="adolescent", keywords="alcohol", keywords="sexually transmitted infections", keywords="risky sex", keywords="pregnancy", abstract="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. ", doi="10.2196/16336", url="http://www.jmir.org/2020/3/e16336/", url="http://www.ncbi.nlm.nih.gov/pubmed/32224484" } @Article{info:doi/10.2196/16683, author="Yin, Zenong and Lesser, Janna and Paiva, A. Kristi and Zapata Jr, Jose and Moreno-Vasquez, Andrea and Grigsby, J. Timothy and Ryan-Pettes, R. Stacy and Parra-Medina, Deborah and Estrada, Vanessa and Li, Shiyu and Wang, Jing", title="Using Mobile Health Tools to Engage Rural Underserved Individuals in a Diabetes Education Program in South Texas: Feasibility Study", journal="JMIR Mhealth Uhealth", year="2020", month="Mar", day="24", volume="8", number="3", pages="e16683", keywords="Screening, Brief Intervention, and Referral to Treatment (SBIRT)", keywords="Hispanic Americans", keywords="behavioral economics", keywords="rural population", keywords="diabetes", keywords="screening", abstract="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. ", doi="10.2196/16683", url="http://mhealth.jmir.org/2020/3/e16683/", url="http://www.ncbi.nlm.nih.gov/pubmed/32207694" } @Article{info:doi/10.2196/15424, author="Agarwal, Payal and Kithulegoda, Natasha and Bouck, Zachary and Bosiak, Beth and Birnbaum, Ilana and Reddeman, Lindsay and Steiner, Liane and Altman, Liora and Mawson, Robin and Propp, Roni and Thornton, Jane and Ivers, Noah", title="Feasibility of an Electronic Health Tool to Promote Physical Activity in Primary Care: Pilot Cluster Randomized Controlled Trial", journal="J Med Internet Res", year="2020", month="Feb", day="14", volume="22", number="2", pages="e15424", keywords="eHealth", keywords="primary care", keywords="physical activity", keywords="patient-centered care", abstract="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 ", doi="10.2196/15424", url="https://www.jmir.org/2020/2/e15424", url="http://www.ncbi.nlm.nih.gov/pubmed/32130122" } @Article{info:doi/10.2196/14557, author="Escobar-Viera, C{\'e}sar and Zhou, Zhi and Morano, P. Jamie and Lucero, Robert and Lieb, Spencer and McIntosh, Sean and Clauson, A. Kevin and Cook, L. Robert", title="The Florida Mobile Health Adherence Project for People Living With HIV (FL-mAPP): Longitudinal Assessment of Feasibility, Acceptability, and Clinical Outcomes", journal="JMIR Mhealth Uhealth", year="2020", month="Jan", day="8", volume="8", number="1", pages="e14557", keywords="mHealth", keywords="HIV", keywords="ART adherence", keywords="feasibility", keywords="acceptability", abstract="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. ", doi="10.2196/14557", url="https://mhealth.jmir.org/2020/1/e14557", url="http://www.ncbi.nlm.nih.gov/pubmed/31913127" } @Article{info:doi/10.2196/15744, author="Poduval, Shoba and Marston, Louise and Hamilton, Fiona and Stevenson, Fiona and Murray, Elizabeth", title="Feasibility, Acceptability, and Impact of a Web-Based Structured Education Program for Type 2 Diabetes: Real-World Study", journal="JMIR Diabetes", year="2020", month="Jan", day="6", volume="5", number="1", pages="e15744", keywords="diabetes mellitus, type 2", keywords="self-management", keywords="patient education", keywords="internet", keywords="digital divide", keywords="social class", keywords="health literacy", keywords="computer literacy", abstract="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. ", doi="10.2196/15744", url="https://diabetes.jmir.org/2020/1/e15744", url="http://www.ncbi.nlm.nih.gov/pubmed/31904580" } @Article{info:doi/10.2196/13229, author="Guo, Xiaorong and Gu, Xiang and Jiang, Jiang and Li, Hongxiao and Duan, Ruoyu and Zhang, Yi and Sun, Lei and Bao, Zhengyu and Shen, Jianhua and Chen, Fukun", title="A Hospital-Community-Family--Based Telehealth Program for Patients With Chronic Heart Failure: Single-Arm, Prospective Feasibility Study", journal="JMIR Mhealth Uhealth", year="2019", month="Dec", day="13", volume="7", number="12", pages="e13229", keywords="telehealth", keywords="chronic heart failure", keywords="feasibility studies", keywords="precise follow-up", keywords="self-management", abstract="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. ", doi="10.2196/13229", url="https://mhealth.jmir.org/2019/12/e13229", url="http://www.ncbi.nlm.nih.gov/pubmed/31833835" } @Article{info:doi/10.2196/13671, author="Johnson, Amanda and Yang, Fan and Gollarahalli, Siddharth and Banerjee, Tanvi and Abrams, Daniel and Jonassaint, Jude and Jonassaint, Charles and Shah, Nirmish", title="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", journal="JMIR Mhealth Uhealth", year="2019", month="Dec", day="2", volume="7", number="12", pages="e13671", keywords="pain", keywords="sickle cell disease", keywords="SCD", keywords="machine learning", abstract="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. ", doi="10.2196/13671", url="https://mhealth.jmir.org/2019/12/e13671", url="http://www.ncbi.nlm.nih.gov/pubmed/31789599" } @Article{info:doi/10.2196/15539, author="Marthick, Michael and Janssen, Anna and Cheema, S. Birinder and Alison, Jennifer and Shaw, Tim and Dhillon, Haryana", title="Feasibility of an Interactive Patient Portal for Monitoring Physical Activity, Remote Symptom Reporting, and Patient Education in Oncology: Qualitative Study", journal="JMIR Cancer", year="2019", month="Nov", day="28", volume="5", number="2", pages="e15539", keywords="physical activity", keywords="patient Web portals", keywords="neoplasms", abstract="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 ", doi="10.2196/15539", url="http://cancer.jmir.org/2019/2/e15539/", url="http://www.ncbi.nlm.nih.gov/pubmed/31778123" } @Article{info:doi/10.2196/14776, author="Williamson, Heidi and Hamlet, Claire and White, Paul and Marques, R. Elsa M. and Paling, Thomas and Cadogan, Julia and Perera, Rohan and Rumsey, Nichola and Hayward, Leighton and Harcourt, Diana", title="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", journal="JMIR Ment Health", year="2019", month="Nov", day="22", volume="6", number="11", pages="e14776", keywords="physical appearance, body image, disfigurement", keywords="visible difference", keywords="adolescents", keywords="young people", keywords="psychological support", keywords="online intervention.", abstract="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 ", doi="10.2196/14776", url="http://mental.jmir.org/2019/11/e14776/", url="http://www.ncbi.nlm.nih.gov/pubmed/31755870" } @Article{info:doi/10.2196/14406, author="Calaminus, Gabriele and Jenney, Meriel and Hjorth, Lars and Baust, Katja and Bernstein, Mark and Bielack, Stefan and Vos, De Patricia and Hogendoorn, W. Pancras C. and Jovic, Gordana and Krailo, Mark and Kreitz, Kiana and Marina, Neyssa and Popoola, O. Babasola and Sauerland, Cristina and Smeland, Sigbj{\o}rn and Teske, Carmen and Schweinitz, V. Clara and Whelan, Jeremy and Wiener, Andreas and Sydes, R. Matthew and Nagarajan, Rajaram", title="Quality of Life of Patients With Osteosarcoma in the European American Osteosarcoma Study-1 (EURAMOS-1): Development and Implementation of a Questionnaire Substudy", journal="JMIR Res Protoc", year="2019", month="Sep", day="26", volume="8", number="9", pages="e14406", keywords="osteosarcoma", keywords="quality of life", keywords="cancer", keywords="child", keywords="adolescent", keywords="young adult", keywords="observational study", keywords="sarcoma", keywords="survivors of childhood cancer", abstract="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. ", doi="10.2196/14406", url="https://www.researchprotocols.org/2019/9/e14406", url="http://www.ncbi.nlm.nih.gov/pubmed/31573951" } @Article{info:doi/10.2196/13725, author="Kleiman, Evan and Millner, J. Alexander and Joyce, W. Victoria and Nash, C. Carol and Buonopane, J. Ralph and Nock, K. Matthew", title="Using Wearable Physiological Monitors With Suicidal Adolescent Inpatients: Feasibility and Acceptability Study", journal="JMIR Mhealth Uhealth", year="2019", month="Sep", day="24", volume="7", number="9", pages="e13725", keywords="feasibility studies", keywords="wearable electronic devices", keywords="adolescent, hospitalized", keywords="self-injurious behavior", keywords="qualitative research", abstract="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. ", doi="10.2196/13725", url="http://mhealth.jmir.org/2019/9/e13725/", url="http://www.ncbi.nlm.nih.gov/pubmed/31586364" } @Article{info:doi/10.2196/13887, author="Ijaz, Kiran and Ahmadpour, Naseem and Naismith, L. Sharon and Calvo, A. Rafael", title="An Immersive Virtual Reality Platform for Assessing Spatial Navigation Memory in Predementia Screening: Feasibility and Usability Study", journal="JMIR Ment Health", year="2019", month="Sep", day="03", volume="6", number="9", pages="e13887", keywords="virtual reality", keywords="healthy aging", keywords="memory", keywords="cognition", keywords="dementia", abstract="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. ", doi="10.2196/13887", url="https://mental.jmir.org/2019/9/e13887/", url="http://www.ncbi.nlm.nih.gov/pubmed/31482851" } @Article{info:doi/10.2196/13400, author="Gibson, Kim and Al-Naji, Ali and Fleet, Julie-Anne and Steen, Mary and Chahl, Javaan and Huynh, Jasmine and Morris, Scott", title="Noncontact Heart and Respiratory Rate Monitoring of Preterm Infants Based on a Computer Vision System: Protocol for a Method Comparison Study", journal="JMIR Res Protoc", year="2019", month="Aug", day="29", volume="8", number="8", pages="e13400", keywords="heart rate", keywords="respiratory rate", keywords="infant", keywords="electrocardiography", keywords="computers", abstract="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 ", doi="10.2196/13400", url="https://www.researchprotocols.org/2019/8/e13400", url="http://www.ncbi.nlm.nih.gov/pubmed/31469077" } @Article{info:doi/10.2196/14021, author="Shaver, Garrett Lance and Khawer, Ahmed and Yi, Yanqing and Aubrey-Bassler, Kris and Etchegary, Holly and Roebothan, Barbara and Asghari, Shabnam and Wang, Peter Peizhong", title="Using Facebook Advertising to Recruit Representative Samples: Feasibility Assessment of a Cross-Sectional Survey", journal="J Med Internet Res", year="2019", month="Aug", day="19", volume="21", number="8", pages="e14021", keywords="Facebook", keywords="health surveys", keywords="Canada", keywords="research subject recruitment", keywords="social media", keywords="internet", keywords="online recruitment", abstract="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