%0 Journal Article %@ 1929-0748 %I JMIR Publications %V 8 %N 1 %P e10935 %T A Web-Based Recovery Program (ICUTogether) for Intensive Care Survivors: Protocol for a Randomized Controlled Trial %A Ewens,Beverley %A Myers,Helen %A Whitehead,Lisa %A Seaman,Karla %A Sundin,Deborah %A Hendricks,Joyce %+ School of Nursing and Midwifery, Edith Cowan University, Building 21, 270 Joondlaup Drive, Joondalup, 6027, Australia, 61 86304 3542, b.ewens@ecu.edu.au %K intensive care %K survivorship %K survivor %K recovery program %D 2019 %7 17.01.2019 %9 Protocol %J JMIR Res Protoc %G English %X Background: Those who experience a critical illness or condition requiring admission to an intensive care unit (ICU) frequently experience physical and psychological complications as a direct result of their critical illness or condition and ICU experience. Complications, if left untreated, can affect the quality of life of survivors and impact health care resources. Explorations of potential interventions to reduce the negative impact of an ICU experience have failed to establish an evidence-based intervention. Objective: The aim of this study is to evaluate the impact of a Web-based intensive care recovery program on the mental well-being of intensive care survivors and to determine if it is a cost-effective approach. Methods: In total, 162 patients that survived an ICU experience will be recruited and randomized into 1 of 2 groups. The intervention group will receive access to the Web-based intensive care recovery program, ICUTogether, 2 weeks after discharge (n=81), and the control group will receive usual care (n=81). Mental well-being will be measured using the Hospital Anxiety and Depression Scale, The Impact of Events Scale-Revised and the 5-level 5-dimension EuroQoL at 3 time points (2 weeks, 6 months, and 12 months post discharge). Family support will be measured using the Multidimensional Scale of Perceived Social Support at 3 time points. Analysis will be conducted on an intention-to-treat basis using regression modeling. Covariates will include baseline outcome measures, study allocation (intervention or control), age, gender, length of ICU stay, APACHE III score, level of family support, and hospital readmissions. Participants’ evaluation of the mobile website will be sought at 12 months postdischarge. A cost utility analysis conducted at 12 months from a societal perspective will consider costs incurred by individuals as well as health care providers. Results: Participant recruitment is currently underway. Recruitment is anticipated to be completed by December 2020. Conclusions: This study will evaluate a novel intervention in a group of ICU survivors. The findings from this study will inform a larger study and wider debate about an appropriate intervention in this population. International Registered Report Identifier (IRRID): PRR1-10.2196/10935 %M 30664478 %R 10.2196/10935 %U http://www.researchprotocols.org/2019/1/e10935/ %U https://doi.org/10.2196/10935 %U http://www.ncbi.nlm.nih.gov/pubmed/30664478 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 8 %N 1 %P e12526 %T Understanding the Effect of Adding Automated and Human Coaching to a Mobile Health Physical Activity App for Afghanistan and Iraq Veterans: Protocol for a Randomized Controlled Trial of the Stay Strong Intervention %A Buis,Lorraine R %A McCant,Felicia A %A Gierisch,Jennifer M %A Bastian,Lori A %A Oddone,Eugene Z %A Richardson,Caroline R %A Kim,Hyungjin Myra %A Evans,Richard %A Hooks,Gwendolyn %A Kadri,Reema %A White-Clark,Courtney %A Damschroder,Laura J %+ VA Center for Clinical Management Research, VA Ann Arbor Healthcare System, PO Box 130170, Ann Arbor, MI, 48113, United States, 1 734 845 3603, laura.damschroder@va.gov %K exercise %K veterans %K cell phones %K mobile phone %K telemedicine %D 2019 %7 29.01.2019 %9 Protocol %J JMIR Res Protoc %G English %X Background: Although maintaining a healthy weight and physical conditioning are requirements of active military duty, many US veterans rapidly gain weight and lose conditioning when they separate from active-duty service. Mobile health (mHealth) interventions that incorporate wearables for activity monitoring have become common, but it is unclear how to optimize engagement over time. Personalized health coaching, either through tailored automated messaging or by individual health coaches, has the potential to increase the efficacy of mHealth programs. In an attempt to preserve conditioning and ward off weight gain, we developed Stay Strong, a mobile app that is tailored to veterans of recent conflicts and tracks physical activity monitored by Fitbit Charge 2 devices and weight measured on a Bluetooth-enabled scale. Objective: The goal of this study is to determine the effect of activity monitoring plus health coaching compared with activity monitoring alone. Methods: In this randomized controlled trial, with Stay Strong, a mobile app designed specifically for veterans, we plan to enroll 350 veterans to engage in an mHealth lifestyle intervention that combines the use of a wearable physical activity tracker and a Bluetooth-enabled weight scale. The Stay Strong app displays physical activity and weight data trends over time. Enrolled participants are randomized to receive the Stay Strong app (active comparator arm) or Stay Strong + Coaching, an enhanced version of the program that adds coaching features (automated tailored messaging with weekly physical activity goals and up to 3 telephone calls with a health coach—intervention arm) for 1 year. Our primary outcome is change in physical activity at 12 months, with weight, pain, patient activation, and depression serving as secondary outcome measures. All processes related to recruitment, eligibility screening, informed consent, Health Insurance Portability and Accountability Act authorization, baseline assessment, randomization, the bulk of intervention delivery, and outcome assessment will be accomplished via the internet or smartphone app. Results: The study recruitment began in September 2017, and data collection is expected to conclude in 2019. A total of 465 participants consented to participate and 357 (357/465, 77%) provided baseline levels of physical activity and were randomized to 1 of the 2 interventions. Conclusions: This novel randomized controlled trial will provide much-needed findings about whether the addition of telephone-based human coaching and other automated supportive-coaching features will improve physical activity compared with using a smartphone app linked to a wearable device alone. Trial Registration: ClinicalTrials.gov NCT02360293; https://clinicaltrials.gov/ct2/show/NCT02360293 (Archived by WebCite at http://www.webcitation.org/75KQeIFwh) International Registered Report Identifier (IRRID): DERR1-10.2196/12526 %M 30694208 %R 10.2196/12526 %U http://www.researchprotocols.org/2019/1/e12526/ %U https://doi.org/10.2196/12526 %U http://www.ncbi.nlm.nih.gov/pubmed/30694208 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 8 %N 1 %P e11560 %T Recruitment and Baseline Characteristics of Participants in the Social, Emotional, and Economic Empowerment Through Knowledge of Group Support Psychotherapy Study (SEEK-GSP): Cluster Randomized Controlled Trial %A Nakimuli-Mpungu,Etheldreda %A Musisi,Seggane %A Wamala,Kizito %A Okello,James %A Ndyanabangi,Sheila %A Birungi,Josephine %A Nanfuka,Mastula %A Etukoit,Michael %A Mojtabai,Ramin %A Nachega,Jean %A Harari,Ofir %A Mills,Edward %+ Department of Psychiatry, College of Health Sciences, Makerere University, Old Mulago Hospital Complex, Mulago Hill Road, Kampala, 256, Uganda, 256 788994050, ethelmpungu@yahoo.com %K cluster randomized trial %K group support psychotherapy %K lay health workers %K depression %K recruitment %K psychosocial stressors %K persons living with HIV/AIDS %K Uganda %D 2019 %7 03.01.2019 %9 Original Paper %J JMIR Res Protoc %G English %X Background: Psychosocial characteristics, including self-esteem, perceived social support, coping skills, stigma, discrimination, and poverty, are strongly correlated with depression symptoms. However, data on the extent of these correlations among persons living with HIV and the associations between psychosocial characteristics and HIV treatment outcomes are limited in sub-Saharan Africa. Objective: This paper aims to describe the recruitment process and baseline characteristics associated with depression in a sample of HIV-positive people in a cluster randomized trial of group support psychotherapy (GSP) for depression delivered by trained lay health workers (LHWs). Methods: Thirty eligible primary care health centers across three districts in Uganda were randomly allocated to have their LHWs trained to deliver GSP (intervention arm) or group HIV education and treatment as usual (control arm) to persons living with HIV comorbid with depression. Baseline demographic, socioeconomic, and psychosocial characteristics were collected via interviewer-administered questionnaires. Among eligible participants, differences between those enrolled versus those who refused enrollment were assessed using chi square for categorical variables and t tests for continuous variables. Spearman rank order correlation analyses were conducted to determine associations between baseline depression symptoms and adherence to antiretroviral therapy (ART), viral load suppression, and other psychosocial variables. Results: The study screened 1473 people and 1140 were found to be eligible and enrolled over 14 weeks. Participants recruited comprised 95% of the target sample size of 1200. The sample’s mean age was 38.5 (SD 10.9) years and both genders were well represented (males: 46.32%, 528/1140). Most participants met the diagnostic criteria for major depressive disorder (96.92%, 1105/1140), had significant posttraumatic stress symptoms (72.46%, 826/1140), reported moderate suicide risk (52.54%, 599/1140), had primary or no formal education (86.22%, 983/1140), and reported no income-generating activity (72.63%, 828/1140) and no food insecurity (81.67%, 931/1140). Among eligible participants, 48 of 1140 (4.21%) refused to participate in the interventions; these participants were more likely to be males (χ21=4.0, P=.045) and have significantly lower depression symptoms scores (t2=2.36, P=.01) than those who participated in the interventions. There was a significant positive correlation between viral load and number of traumatic experiences (ρ=.12, P=.05). Adherence to ART was positively correlated with perceived social support (ρ=.15, P<.001), but negatively correlated with depression symptoms (ρ=–.11, P=.05) and stigma (ρ=–.14, P<.001). Conclusions: Men and women with HIV and depression experience multiple social and economic vulnerabilities and disadvantages. Culturally tailored psychological interventions aimed at these individuals should address these socioeconomic disadvantages in addition to addressing their mental health care needs. Trial Registration: Pan African Clinical Trials Registry PACTR201608001738234; https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=1738 (Archived by WebCite at http://www.webcitation.org/74NtMphom) %M 30609989 %R 10.2196/11560 %U http://www.researchprotocols.org/2019/1/e11560/ %U https://doi.org/10.2196/11560 %U http://www.ncbi.nlm.nih.gov/pubmed/30609989 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 8 %N 1 %P e11911 %T Treatment of Atopic Dermatitis Using a Full-Body Blue Light Device (AD-Blue): Protocol of a Randomized Controlled Trial %A Kromer,Christian %A Nühnen,Viktoria P %A Pfützner,Wolfgang %A Pfeiffer,Sebastian %A Laubach,Hans-Joachim %A Boehncke,Wolf-Henning %A Liebmann,Joerg %A Born,Matthias %A Schön,Michael P %A Buhl,Timo %+ Department of Dermatology, Venereology, and Allergology, University Medical Centre Göttingen, Robert-Koch-Strasse 40, Göttingen,, Germany, 49 55139 ext 66402, timo.buhl@med.uni-goettingen.de %K atopic dermatitis %K atopic eczema %K blue light %K irradiation %K ultraviolet light %D 2019 %7 08.01.2019 %9 Protocol %J JMIR Res Protoc %G English %X Background: Irradiation with visible blue light (wavelength 400-495 nm) is a promising, effective, and safe new treatment option for chronic inflammatory skin diseases such as psoriasis and atopic dermatitis. Objective: We will perform a multicenter, placebo-controlled, double-blinded, 3-armed, prospective, randomized controlled trial to investigate the efficacy and safety of full-body blue light devices (wavelengths: 415 nm and 450 nm) compared with that of placebo irradiation for the treatment of atopic dermatitis. Methods: We are planning to enroll a total of 150 patients at the University hospitals in Göttingen (Germany), Marburg (Germany), and Geneva (Switzerland). Results: The trial was approved by the lead ethics committee of the medical faculty of the University of Göttingen (21/11/16). Further approvals were obtained from local and federal authorities (ethics committee Marburg, Cantonal Commission for Research Ethics Geneva, Suisse Medic, and Bundesinstitut für Arzneimittel und Medizinprodukte). Conclusions: We will disseminate the results in a peer-reviewed journal. Trial Registration: ClinicalTrials.gov NCT03085303; https://clinicaltrials.gov/ct2/show/NCT03085303 (Archived by WebCite at http://www.webcitation.org/73ucqkkA1) International Registered Report Identifier (IRRID): DERR1-10.2196/11911 %M 30622089 %R 10.2196/11911 %U http://www.researchprotocols.org/2019/1/e11911/ %U https://doi.org/10.2196/11911 %U http://www.ncbi.nlm.nih.gov/pubmed/30622089 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 8 %N 1 %P e11470 %T Rehabilitation for Children With Dystonic Cerebral Palsy Using Haptic Feedback in Virtual Reality: Protocol for a Randomized Controlled Trial %A McNish,Reika Nicole %A Chembrammel,Pramod %A Speidel,Nathaniel Christopher %A Lin,Julian Jwchun %A López-Ortiz,Citlali %+ Department of Kinesiology and Community Health, Department of Dance, Neuroscience Program, Illinois Informatics Institute, Beckman Institute for Advanced Science and Technology, University of Illinois at Urbana-Champaign, 906 South Goodwin Avenue, Urbana, IL, 61801, United States, 1 2173001022, lopezort@illinois.edu %K cerebral palsy %K child %K dystonia %K motor skills %K muscle spasticity %K randomized controlled trial %K rehabilitation %K robotics %K sensory feedback %K virtual reality %D 2019 %7 14.01.2019 %9 Protocol %J JMIR Res Protoc %G English %X Background: Cerebral palsy (CP) is the most common developmental motor disorder in children. Individuals with CP demonstrate abnormal muscle tone and motor control. Within the population of children with CP, between 4% and 17% present dystonic symptoms that may manifest as large errors in movement tasks, high variability in movement trajectories, and undesired movements at rest. These symptoms of dystonia typically worsen with physical intervention exercises. Objective: The aim of this study is to establish the effect of haptic feedback in a virtual reality (VR) game intervention on movement outcomes of children with dystonic CP. Methods: The protocol describes a randomized controlled trial that uses a VR game-based intervention incorporating fully automated robotic haptic feedback. The study consists of face-to-face assessments of movement before, after, and 1 month following the completion of the 6-session game-based intervention. Children with dystonic CP, aged between 7 and 17 years, will be recruited for this study through posted fliers and laboratory websites along with a group of typically developing (TD) children in the same age range. We anticipate to recruit a total of 68 participants, 34 each with CP and TD. Both groups of children will be randomly allocated into an intervention or control group using a blocked randomization method. The primary outcome measure will be the smoothness index of the interaction force with the robot and of the accelerometry signals of sensors placed on the upper limb segments. Secondary outcomes include a battery of clinical tests and a quantitative measure of spasticity. Assessors administering clinical measures will be blinded. All sessions will be administered on-site by research personnel. Results: The trial has not started and is pending local institutional review board approval. Conclusions: Movement outcomes will be examined for changes in muscle activation and clinical measures in children with dystonic CP and TD children. Paired t tests will be conducted on movement outcomes for both groups of children independently. Positive and negative results will be reported and addressed. Trial Registration: ClinicalTrials.gov NCT03744884; https://clinicaltrials.gov/ct2/show/NCT03744884 (Archived by WebCite at http://www.webcitation.org/74RSvmbZP) International Registered Report Identifier (IRRID): PRR1-10.2196/11470 %M 31344678 %R 10.2196/11470 %U https://www.researchprotocols.org/2019/1/e11470/ %U https://doi.org/10.2196/11470 %U http://www.ncbi.nlm.nih.gov/pubmed/31344678 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 8 %N 1 %P e11545 %T TheraSphere Yttrium-90 Glass Microspheres Combined With Chemotherapy Versus Chemotherapy Alone in Second-Line Treatment of Patients With Metastatic Colorectal Carcinoma of the Liver: Protocol for the EPOCH Phase 3 Randomized Clinical Trial %A Chauhan,Nikhil %A Mulcahy,Mary F %A Salem,Riad %A Benson III,Al B %A Boucher,Eveline %A Bukovcan,Janet %A Cosgrove,David %A Laframboise,Chantal %A Lewandowski,Robert J %A Master,Fayaz %A El-Rayes,Bassel %A Strosberg,Jonathan R %A Sze,Daniel Y %A Sharma,Ricky A %+ Research and Development, BTG International group companies, 5 Fleet Place, London, EC4M 7RD, United Kingdom, 44 20 7575 0000, Nikhil.Chauhan@btgplc.com %K colorectal neoplasms %K neoplasm metastasis %K microspheres %K yttrium radioisotopes %K research design %K clinical trial, phase III %K randomized controlled trial %K metastatic colorectal cancer %K mCRC %D 2019 %7 17.01.2019 %9 Protocol %J JMIR Res Protoc %G English %X Background: Colorectal cancer is one of the most common cancers and causes of cancer-related death. Up to approximately 70% of patients with metastatic colorectal cancer (mCRC) have metastases to the liver at initial diagnosis. Second-line systemic treatment in mCRC can prolong survival after development of disease progression during or after first-line treatment and in those who are intolerant to first-line treatment. Objective: The objective of this study is to evaluate the efficacy and safety of transarterial radioembolization (TARE) with TheraSphere yttrium-90 (90Y) glass microspheres combined with second-line therapy in patients with mCRC of the liver who had disease progression during or after first-line chemotherapy. Methods: EPOCH is an open-label, prospective, multicenter, randomized, phase 3 trial being conducted at up to 100 sites in the United States, Canada, Europe, and Asia. Eligible patients have mCRC of the liver and disease progression after first-line chemotherapy with either an oxaliplatin-based or irinotecan-based regimen and are eligible for second-line chemotherapy with the alternate regimen. Patients were randomized 1:1 to the TARE group (chemotherapy with TARE in place of the second chemotherapy infusion and subsequent resumption of chemotherapy) or the control group (chemotherapy alone). The addition of targeted agents is permitted. The primary end points are progression-free survival and hepatic progression-free survival. The study objective will be considered achieved if at least one primary end point is statistically significant. Secondary end points are overall survival, time to symptomatic progression defined as Eastern Cooperative Oncology Group Performance Status score of 2 or higher, objective response rate, disease control rate, quality-of-life assessment by the Functional Assessment of Cancer Therapy-Colorectal Cancer questionnaire, and adverse events. The study is an adaptive trial, comprising a group sequential design with 2 interim analyses with a planned maximum of 420 patients. The study is designed to detect a 2.5-month increase in median progression-free survival, from 6 months in the control group to 8.5 months in the TARE group (hazard ratio [HR] 0.71), and a 3.5-month increase in median hepatic progression-free survival time, from 6.5 months in the control group to 10 months in the TARE group (HR 0.65). On the basis of simulations, the power to detect the target difference in either progression-free survival or hepatic progression-free survival is >90%, and the power to detect the target difference in each end point alone is >80%. Results: Patient enrollment ended in October 2018. The first interim analysis in June 2018 resulted in continuation of the study without any changes. Conclusions: The EPOCH study may contribute toward the establishment of the role of combination therapy with TARE and oxaliplatin- or irinotecan-based chemotherapy in the second-line treatment of mCRC of the liver. Trial Registration: ClinicalTrials.gov NCT01483027; https://clinicaltrials.gov/ct2/show/NCT01483027 (Archived by WebCite at http://www.webcitation.org/734A6PAYW) International Registered Report Identifier (IRRID): RR1-10.2196/11545 %M 30664496 %R 10.2196/11545 %U https://www.researchprotocols.org/2019/1/e11545/ %U https://doi.org/10.2196/11545 %U http://www.ncbi.nlm.nih.gov/pubmed/30664496 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 8 %N 1 %P e12322 %T Delivery of Peer Support Through a Self-Management mHealth Intervention (Healing Circles) in Patients With Cardiovascular Disease: Protocol for a Randomized Controlled Trial %A Sakakibara,Brodie M %A Chakrabarti,Santabhanu %A Krahn,Andrew %A Mackay,Martha H %A Sedlak,Tara %A Singer,Joel %A Whitehurst,David GT %A Lear,Scott A %+ Faculty of Health Sciences, Simon Fraser University, 180-1081 Burrard Street, Vancouver, BC,, Canada, 1 604 682 2344 ext 62778, slear@providencehealth.bc.ca %K cardiovascular disease %K eHealth %K mhealth %K mobile phone %K peer support %K self-management %D 2019 %7 11.01.2019 %9 Protocol %J JMIR Res Protoc %G English %X Background: Cardiovascular disease (CVD) is a leading cause of hospitalization and death around the world. The prevalence of CVD is increasing and, therefore, development and investigation of effective programs to help people better self-manage their CVD and prevent secondary complications are needed. Objective: In this paper, we report on a protocol to evaluate Healing Circles—an evidence-based and patient-informed peer support mobile health program designed to facilitate self-management and support patients in their recovery from and management of CVD. We hypothesize that individuals with CVD who use Healing Circles will experience greater improvements to their self-management ability than individuals receiving usual care. Methods: In this single-blinded (assessor) randomized controlled trial, 250 community-living individuals with CVD will be randomized on a 1:1 basis to either Healing Circles or Usual Care. The primary outcome of self-management will be measured using the Health Education Impact Questionnaire version 3.0. Secondary outcomes include self-efficacy with chronic disease management, health-related quality of life, health resource use and costs, and electronic health literacy. Measurements will be taken at the baseline and every 6 months for 24 months. Results: The study started recruitment in September 2017. Individuals are currently being recruited for participation, and existing participants are currently on follow-up. Measurements will be taken every 6 months until the study end, which is anticipated in December 2019. Conclusions: Healing Circles is a novel program aimed toward improving self-management through peer support. Given our real-world study design, our findings will be readily translatable into practice. If the results support our hypothesis, it will indicate that Healing Circles is an effective intervention for improving self-management and reducing health care use. Trial Registration: ClinicalTrials.gov NCT03159325; https://clinicaltrials.gov/ct2/show/NCT03159325 (Archived by WebCite at http://www.webcitation.org/74DvxVKUd) International Registered Report Identifier (IRRID): DERR1-10.2196/12322 %M 30635261 %R 10.2196/12322 %U http://www.researchprotocols.org/2019/1/e12322/ %U https://doi.org/10.2196/12322 %U http://www.ncbi.nlm.nih.gov/pubmed/30635261 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 8 %N 1 %P e11000 %T The Impact of the mKidney mHealth System on Live Donor Follow-Up Compliance: Protocol for a Randomized Controlled Trial %A Henderson,Macey L %A Thomas,Alvin G %A Eno,Ann K %A Waldram,Madeleine M %A Bannon,Jaclyn %A Massie,Allan B %A Levan,Michael A %A Segev,Dorry L %A Bingaman,Adam W %+ Department of Surgery, Johns Hopkins University School of Medicine, 2000 East Monument Street, Baltimore, MD, 21205, United States, 1 443 287 6649, macey@jhmi.edu %K app %K follow-up %K health care %K kidney transplantation %K mHealth %K mobile phone %K randomized controlled trial %K protocol %D 2019 %7 15.01.2019 %9 Protocol %J JMIR Res Protoc %G English %X Background: Every year, more than 5500 healthy people in the United States donate a kidney for the medical benefit of another person. The Organ Procurement and Transplantation Network (OPTN) requires transplant hospitals to monitor living kidney donors (LKDs) for 2 years postdonation. However, the majority (115/202, 57%) of transplant hospitals in the United States continue to fail to meet nationally mandated requirements for LKD follow-up. A novel method for collecting LKD follow-up is needed to ease both the transplant hospital-level and patient-level burden. We built mKidney—a mobile health (mHealth) system designed specifically to facilitate the collection and reporting of OPTN-required LKD follow-up data. The mKidney mobile app was developed on the basis of input elicited from LKDs, transplant providers, and thought leaders. Objective: The primary objective of this study is to evaluate the impact of the mKidney smartphone app on LKD follow-up rates. Methods: We will conduct a two-arm randomized controlled trial (RCT) with LKDs who undergo LKD transplantation at Methodist Specialty and Transplant Hospital in San Antonio, Texas. Eligible participants will be recruited in-person by a study team member at their 1-week postdonation clinical visit and randomly assigned to the intervention or control arm (1:1). Participants in the intervention arm will receive the mHealth intervention (mKidney), and participants in the control arm will receive the current standard of follow-up care. Our primary outcome will be policy-defined complete (all components addressed) and timely (60 days before or after the expected visit date) submission of LKD follow-up data at required 6-month, 1-year, and 2-year visits. Our secondary outcome will be hospital-level compliance with OPTN reporting requirements at each visit. Data analysis will follow the intention-to-treat principle. Additionally, we will collect quantitative and qualitative process data regarding the implementation of the mKidney system. Results: We began recruitment for this RCT in May 2018. We plan to enroll 400 LKDs over 2 years and follow participants for the 2-year mandated follow-up period. Conclusions: This pilot RCT will evaluate the impact of the mKidney system on rates of LKD and hospital compliance with OPTN-mandated LKD follow-up at a large LKD transplant hospital. It will provide valuable information on strategies for implementing such a system in a clinical setting and inform effect sizes for future RCT sample size calculations. International Registered Report Identifier (IRRID): DERR1-10.2196/11000 %M 30664485 %R 10.2196/11000 %U http://www.researchprotocols.org/2019/1/e11000/ %U https://doi.org/10.2196/11000 %U http://www.ncbi.nlm.nih.gov/pubmed/30664485 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 8 %N 1 %P e10938 %T Effect of a Mobile App on Preoperative Patient Preparation for Major Ambulatory Surgery: Protocol for a Randomized Controlled Trial %A Herrera-Usagre,Manuel %A Santana,Vicente %A Burgos-Pol,Ramon %A Oliva,Juan Pedro %A Sabater,Eliazar %A Rita-Acosta,Maria %A Casado,Miguel Angel %A Cruces,Susana %A Pacheco,Manuel %A Solorzano Perez,Carlos %+ Andalusian Agency for Healthcare Quality, Science and Technology Park, Italian Pavillion, 3rd Floor, 4 Isaac Newton Street, Sevilla, 41092, Spain, 34 645539726, manuel.herrera.usagre@juntadeandalucia.es %K ambulatory surgical procedures %K cost-benefit analysis %K mobile phone %K patient compliance %K patient safety %K preoperative care %K telemedicine %D 2019 %7 16.01.2019 %9 Protocol %J JMIR Res Protoc %G English %X Background: Inadequate preoperative patient preparation causes organizational, economic, and emotional problems to patients and professionals. In Spain, no current evidence is available on either the rate of compliance or the impact of good compliance with preoperative recommendations by patients in the ambulatory setting. However, it is known that around 25% of surgical cancellations in the major ambulatory surgery (MAS) are due to poor compliance with these recommendations and, therefore, avoidable. Introducing innovative tools based on mobile health (mHealth) apps may help patients meet the preoperative recommendations and, consequently, reduce the rate of cancellations in the ambulatory setting. Objective: The objective of this study was to evaluate the effectiveness of the Listeo+ mHealth app as a tool for improving compliance with preoperative recommendations in MAS versus standard of care (SOC). Methods: A multicenter, randomized, open-label clinical trial that compares SOC with the additional use of Listeo+, a specific mHealth app for MAS preoperative patient monitoring, is being conducted. The study will include patients aged ≥18 years with surgical indication for MAS who meet the necessary technological and connectivity requirements. Patients in the control group will receive written preoperative recommendations, while those in the intervention group will additionally use the Listeo+ mHealth app. There will be a competitive recruitment of 790 patients during 6 months in 4 hospitals in Andalusia (Spain) that belong to the National Health System. The primary efficacy outcome is the level of compliance with preoperative recommendations. Secondary outcomes include the rate of cancellations, associated resource consumption, and perceived usability and utility with Listeo+ by participants of the intervention group. Simple randomization 1:1 procedure will be used to allocate patients to each study group. Results: The technological development of Listeo+ and the integration and interoperability of information systems was completed in September 2017. Subsequently, simulation tests were performed with Listeo+, and a pilot study was initiated with real patients that concluded successfully in October 2017. Patient recruitment began in December 2017 in the 4 participating centers. After an intermediate analysis performed 10 months after the start of the recruitment phase, the data collection and cleaning phases are estimated to be completed in April 2019, and the analysis with the final results will be conducted in July 2019. Conclusions: Progress in the integration and interoperability of information systems represents a major step forward in the field of mHealth. The app will allow health professionals to monitor in real-time patients’ preparation and critical preoperative recommendations fulfillment. We expect a reduction in avoidable preoperative cancellations due to a lack of or a poor patient preparation. Self-assessed Web-based questionnaires and focus group will provide important information about the perceived usability and utility of Listeo+ app among patients and health care professionals. International Registered Report Identifier (IRRID): DERR1-10.2196/10938 %M 30664480 %R 10.2196/10938 %U http://www.researchprotocols.org/2019/1/e10938/ %U https://doi.org/10.2196/10938 %U http://www.ncbi.nlm.nih.gov/pubmed/30664480 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 8 %N 1 %P e11549 %T Evaluating the Effectiveness of an App-Based Nurse-Moderated Program for New Mothers With Depression and Parenting Problems (eMums Plus): Protocol for a Pragmatic Randomized Controlled Trial %A Sawyer,Alyssa CP %A Kaim,Amy L %A Reece,Christy E %A McDonald,Denise %A Le,Huynh-Nhu %A Clark,Jennifer %A Lynch,John W %A Sawyer,Michael G %+ School of Public Health, University of Adelaide, Adelaide Health & Medical Sciences Building, 57 North Terrace, Mail Drop DX 650 550, Adelaide, 5005, Australia, 61 8 8161 7207, alyssa.sawyer@adelaide.edu.au %K app %K infant %K mobile phone %K mother-child relations %K mother-child nursing %K postnatal depression %K protocol %K randomized controlled trial %D 2019 %7 16.01.2019 %9 Protocol %J JMIR Res Protoc %G English %X Background: Postnatal depression adversely affects many mothers and infants with good evidence that caregiving difficulties associated with depressive symptoms play a key role in later adverse childhood outcomes. In many countries, there is only limited support available for women who experience symptoms of depression during the postnatal period, particularly those experiencing subthreshold symptom levels. Furthermore, mental health services and community family health services in many countries tend to focus primarily on providing help for depressive symptoms or maternal caregiving, respectively, despite these problems commonly being comorbid. Group-based nurse-led interventions delivered over the Web through mobile phone “apps” have the potential to be a cost-effective method of providing a large number of mothers with easy access to integrated support for both maternal depressive symptoms and caregiving difficulties. Objective: This paper describes the protocol for a pragmatic randomized controlled trial of a 4-month group-based nurse-led intervention delivered over the Web when infants were 2-6 months. The primary aims of the trial are to determine whether the intervention (1) reduces levels of maternal depressive symptoms and (2) improves the quality of maternal caregiving when infants are 8-12 months of age. Methods: The trial aimed to recruit and randomize 160 mothers of infants aged 2-8 weeks to either the intervention (eMums plus) or standard care. Assessments were completed when infants were aged 1-2 (preintervention), 8, and 12 months. The primary outcomes were the level of maternal depressive symptoms and the quality of maternal caregiving assessed when infants were aged 12 months. The intervention provided specific support for problems with mood and problems with caregiving. The intervention was delivered by community health nurses as a part of routine service delivery to mothers via a mobile phone app. Results: Participant recruitment was carried out from March to July 2017. Follow-up data collection was completed in mid-2018. Data analysis has commenced. Conclusions: In the past, many mothers participated in nurse-led face-to-face groups postnatally. However, mothers’ groups held in clinics can be difficult for busy mothers to attend. The eMums intervention was delivered over the Web by nurses, allowing easy access by mothers early in an infant’s life. The intervention was evaluated while delivered as part of the routine service practice by community child health nurses. The advantage of evaluating the effectiveness of the intervention in the routine service practice is that if it is found to be effective, it can be more easily adopted by the service provider than if it had been assessed in an efficacy trial. International Registered Report Identifier (IRRID): RR1-10.2196/11549 %M 30664487 %R 10.2196/11549 %U http://www.researchprotocols.org/2019/1/e11549/ %U https://doi.org/10.2196/11549 %U http://www.ncbi.nlm.nih.gov/pubmed/30664487 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 8 %N 1 %P e10238 %T Collecting Symptoms and Sensor Data With Consumer Smartwatches (the Knee OsteoArthritis, Linking Activity and Pain Study): Protocol for a Longitudinal, Observational Feasibility Study %A Beukenhorst,Anna L %A Parkes,Matthew J %A Cook,Louise %A Barnard,Rebecca %A van der Veer,Sabine N %A Little,Max A %A Howells,Kelly %A Sanders,Caroline %A Sergeant,Jamie C %A O'Neill,Terence W %A McBeth,John %A Dixon,William G %+ Arthritis Research United Kingdom Centre for Epidemiology, Centre for Musculoskeletal Research, University of Manchester, Manchester Academic Health Science Centre, Oxford Rd, Manchester, M13 9PT, United Kingdom, 44 0 161 275 1642, Will.Dixon@manchester.ac.uk %K medical informatics computing %K mHealth %K patient-reported outcomes %K musculoskeletal diseases %K mobile phone %D 2019 %7 23.01.2019 %9 Protocol %J JMIR Res Protoc %G English %X Background: The Knee OsteoArthritis, Linking Activity and Pain (KOALAP) study is the first to test the feasibility of using consumer-grade cellular smartwatches for health care research. Objective: The overall aim was to investigate the feasibility of using consumer-grade cellular smartwatches as a novel tool to capture data on pain (multiple times a day) and physical activity (continuously) in patients with knee osteoarthritis. Additionally, KOALAP aimed to investigate smartwatch sensor data quality and assess whether engagement, acceptability, and user experience are sufficient for future large-scale observational and interventional studies. Methods: A total of 26 participants with self-diagnosed knee osteoarthritis were recruited in September 2017. All participants were aged 50 years or over and either lived in or were willing to travel to the Greater Manchester area. Participants received a smartwatch (Huawei Watch 2) with a bespoke app that collected patient-reported outcomes via questionnaires and continuous watch sensor data. All data were collected daily for 90 days. Additional data were collected through interviews (at baseline and follow-up) and baseline and end-of-study questionnaires. This study underwent full review by the University of Manchester Research Ethics Committee (#0165) and University Information Governance (#IGRR000060). For qualitative data analysis, a system-level security policy was developed in collaboration with the University Information Governance Office. Additionally, the project underwent an internal review process at Google, including separate reviews of accessibility, product engineering, privacy, security, legal, and protection regulation compliance. Results: Participants were recruited in September 2017. Data collection via the watches was completed in January 2018. Collection of qualitative data through patient interviews is still ongoing. Data analysis will commence when all data are collected; results are expected in 2019. Conclusions: KOALAP is the first health study to use consumer cellular smartwatches to collect self-reported symptoms alongside sensor data for musculoskeletal disorders. The results of this study will be used to inform the design of future mobile health studies. Results for feasibility and participant motivations will inform future researchers whether or under which conditions cellular smartwatches are a useful tool to collect patient-reported outcomes alongside passively measured patient behavior. The exploration of associations between self-reported symptoms at different moments will contribute to our understanding of whether it may be valuable to collect symptom data more frequently. Sensor data–quality measurements will indicate whether cellular smartwatch usage is feasible for obtaining sensor data. Methods for data-quality assessment and data-processing methods may be reusable, although generalizability to other clinical areas should be further investigated. International Registered Report Identifier (IRRID): DERR1-10.2196/10238 %M 30672745 %R 10.2196/10238 %U http://www.researchprotocols.org/2019/1/e10238/ %U https://doi.org/10.2196/10238 %U http://www.ncbi.nlm.nih.gov/pubmed/30672745 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 8 %N 1 %P e12601 %T Improving Blood Pressure Among African Americans With Hypertension Using a Mobile Health Approach (the MI-BP App): Protocol for a Randomized Controlled Trial %A Buis,Lorraine R %A Dawood,Katee %A Kadri,Reema %A Dawood,Rachelle %A Richardson,Caroline R %A Djuric,Zora %A Sen,Ananda %A Plegue,Melissa %A Hutton,David %A Brody,Aaron %A McNaughton,Candace D %A Brook,Robert D %A Levy,Phillip %+ Department of Family Medicine, University of Michigan, 1018 Fuller Street, Ann Arbor, MI, 48104, United States, 1 734 998 7120, buisl@umich.edu %K hypertension %K mHealth %K blood pressure %K smartphone %K mobile phone %D 2019 %7 25.01.2019 %9 Protocol %J JMIR Res Protoc %G English %X Background: African Americans shoulder significant disparities related to hypertension (HTN), which is a serious public health problem in the city of Detroit, Michigan, where more than 80% of the population is African American. Connectivity through smartphones, use of home blood pressure (BP) monitoring, and newly developed mobile health (mHealth) interventions can facilitate behavioral changes and may improve long-term self-care for chronic conditions, but implementation of a combined approach utilizing these methods has not been tested among African American patients with uncontrolled HTN. Since African Americans are more likely than other racial or ethnic subgroups to utilize the emergency department (ED) for ambulatory care, this presents an opportunity to intervene on a population that is otherwise difficult to reach. Objective: The MI-BP app aims to reduce health disparities related to HTN in the community by employing a user-centered intervention focused on self-BP monitoring, physical activity, reduced sodium intake, and medication adherence. We seek to test the efficacy of MI-BP, an mHealth app for HTN self-management, on BP control (primary aim), physical activity, sodium intake, and medication adherence (secondary aim) in African Americans with HTN. This study also seeks to evaluate the cost-effectiveness of MI-BP when compared with usual care methods. Methods: This is a 1-year randomized controlled trial that will recruit individuals who have uncontrolled HTN from 2 EDs in the city of Detroit, with a planned sample size of 396 randomized participants. To be eligible for inclusion, potential participants must be African American, 25 to 70 years old, previously diagnosed with HTN, have a smartphone compatible with MI-BP, and have uncontrolled BP at triage and on repeat measurement at least 1-hour post triage vitals. Once a participant is deemed eligible, all study procedures and subsequent follow-up visits (8 in total) are conducted at the Wayne State University Clinical Research Service Center. We seek to determine the effect of MI-BP on BP for 1 year (using BP control and mean systolic BP as coprimary outcomes and physical activity, sodium intake, and medication adherence as secondary outcomes) compared with usual care controls. Results: Recruitment for this study began in January 2018. The study will continue through 2021. Conclusions: As the first of its kind conducted in an ED setting, MI-BP was designed to document the efficacy and acceptability of a multicomponent mHealth approach to help African Americans with uncontrolled BP modify their lifestyle to better manage their HTN. We expect to lay the foundation to sustainably reduce HTN-related health disparities through better integration of multiple behavior self-monitoring and improve outcomes for those who traditionally rely on the ED for chronic disease care. Trial Registration: ClinicalTrials.gov NCT02360293; http://clinicaltrials.gov/ct2/show/NCT02360293 International Registered Report Identifier (IRRID): RR1-10.2196/12601 %M 30681965 %R 10.2196/12601 %U http://www.researchprotocols.org/2019/1/e12601/ %U https://doi.org/10.2196/12601 %U http://www.ncbi.nlm.nih.gov/pubmed/30681965 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 8 %N 1 %P e12459 %T The Feasibility of Examining the Effects of Gastric Bypass Surgery on Intestinal Metabolism: Prospective, Longitudinal Mechanistic Clinical Trial %A Courcoulas,Anita P %A Stefater,Margaret A %A Shirley,Eleanor %A Gourash,William F %A Stylopoulos,Nicholas %+ University of Pittsburgh Medical Center, 3380 Boulevard of the Allies, Suite 390, Pittsburgh, PA, 15213, United States, 1 412 641 3678, courcoulasap@upmc.edu %K bariatric surgery %K obesity %K diabetes mellitus %K metabolism %K gastric bypass %K intestine %K research subject recruitment %K feasibility studies %D 2019 %7 24.01.2019 %9 Original Paper %J JMIR Res Protoc %G English %X Background: Bariatric surgery, especially Roux-en-Y gastric bypass (RYGB), is the best treatment for severe obesity and its complications including type 2 diabetes mellitus (T2DM). Understanding the mechanisms responsible for the beneficial metabolic effects will help to engineer ways to improve the procedure or produce these effects without surgery. Objective: The aim is to present data on recruitment and feasibility of a translational study designed to collect intestinal samples before and after bariatric surgery. The goal of biobanking is to allow future studies to test the hypothesis that the mechanism of action of RYGB involves specific changes in the postsurgical short- and long-term metabolism and morphology of the jejunum (Roux limb). Specifically, to test whether the intestine enhances its metabolism and activity after RYGB and increases its fuel utilization, we designed a prospective, longitudinal study, which involved the recruitment of candidates for RYGB with and without T2DM. We describe the tissue bank that we have generated, and our experience, hoping to further facilitate the performance of longitudinal mechanistic studies in human patients undergoing bariatric surgery and especially those involving post-RYGB intestinal biology. Methods: We conducted a trial to characterize the effects of RYGB on intestinal metabolism. Intestinal tissue samples were collected from the jejunum at surgery, 1, 6, and 12 months postoperatively for the analysis of intestinal gene expression and metabolomic and morphologic changes. The target number of patients who completed at least the 6-month follow-up was 26, and we included a 20% attrition rate, increasing the total number to 32. Results: To enroll 26 patients, we had to approach 79 potential participants. A total of 37 agreed to participate and started the study; 33, 30, and 26 active participants completed their 1-month, 6-month, and 12-month studies, respectively. Three participants withdrew, and 30 participants are still active. Altruism and interest in research were the most common reasons for participation. Important factors for feasibility and successful retention included (1) large volume case flow, (2) inclusion and exclusion criteria broad enough to capture a large segment of the patient population but narrow enough to ensure the completion of study aims and protection of safety concerns, (3) accurate assessment of willingness and motivation to participate in a study, (4) seamless integration of the recruitment process into normal clinical flow, (5) financial reimbursement and nonfinancial rewards and gestures of appreciation, and (6) nonburdensome follow-up visits and measures and reasonable time allotted. Conclusions: Human translational studies of the intestinal mechanisms of metabolic and weight changes after bariatric surgery are important and feasible. A tissue bank with unique samples has been established that could be used by investigators in many research fields, further enabling mechanistic studies on the effects of bariatric surgery. Trial Registration: ClinicalTrials.gov NCT02710370; https://clinicaltrials.gov/ct2/show/NCT02710370 (Archived by WebCite at http://www.webcitation.org/75HrQT8Dl) %M 30679147 %R 10.2196/12459 %U http://www.researchprotocols.org/2019/1/e12459/ %U https://doi.org/10.2196/12459 %U http://www.ncbi.nlm.nih.gov/pubmed/30679147 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 8 %N 1 %P e11654 %T Magnesium for the Management of Chronic Noncancer Pain in Adults: Protocol for a Systematic Review %A Park,Rex %A Ho,Anthony M-H %A Pickering,Gisèle %A Arendt-Nielsen,Lars %A Mohiuddin,Mohammed %A Gilron,Ian %+ Department of Anesthesiology and Perioperative Medicine, Queen's University, Victory 2, Kingston General Hospital, 76 Stuart Street, Kingston, ON, K7L 2V7, Canada, 1 613 549 6666 ext 3963, gilroni@queensu.ca %K chronic pain %K magnesium %K noncancer pain %K pain management %K placebo %D 2019 %7 11.01.2019 %9 Protocol %J JMIR Res Protoc %G English %X Background: Chronic pain is a highly prevalent and complex health problem that is associated with a severe symptom burden, as well as substantial economic and social impact. Many patients with chronic pain still suffer from unrelieved or undertreated pain due to the incomplete efficacy and dose-limiting adverse effects of current therapies. Long-term and high-dose opioid use has considerably increased in the past 20 years despite limited evidence supporting its effectiveness in several chronic pain conditions, and serious concerns have emerged regarding adverse effects and potential misuse. Until recently, the steady increase in opioid prescribing rates has been associated with rising opioid-related mortality and other serious problems, emphasizing the need for better nonopioid therapies. Emerging evidence supports the safe use of magnesium in controlling chronic pain, but its overall efficacy and safety is still unclear. Objective: This paper aims to assess the efficacy and safety of magnesium compared with a placebo for the treatment of chronic noncancer pain. Methods: We will conduct a detailed search on Cochrane Central Register of Controlled Trials, MEDLINE, and EMBASE from their inception until the date the searches are run to identify relevant randomized controlled trials. The reference lists of retrieved studies as well as Web-based trial registries will also be searched. We will include randomized double-blind trials comparing magnesium (at any dose, frequency, or route of administration) with placebo using participant-reported pain assessment. Two reviewers will independently evaluate studies for eligibility, extract data, and assess trial quality and potential bias. Risk of bias will be assessed using criteria outlined in the Cochrane Handbook for Systematic Review of Interventions. Primary outcomes for this review will include any validated measure of pain intensity or pain relief. Dichotomous data will be used to calculate the risk ratio and number needed to treat or harm. The quality of evidence will be assessed using the Grading of Recommendations Assessment, Development and Evaluation approach. Results: This protocol is grant-funded and has undergone a peer-review process through the Queen’s University Department of Anesthesiology and Perioperative Medicine Vandewater Endowed Studentship. This project is also supported, in part, by the Chronic Pain Network of the Canadian Institutes of Health Research Strategy for Patient-Oriented Research. The electronic database search strategies are currently being developed and modified. The entire review is expected to be completed by January 1, 2019. Conclusions: The completion of this review is expected to identify available high-quality evidence describing the efficacy and safety of magnesium for the treatment of chronic noncancer pain. International Registered Report Identifier (IRRID): PRR1-10.2196/11654 %M 30635260 %R 10.2196/11654 %U http://www.researchprotocols.org/2019/1/e11654/ %U https://doi.org/10.2196/11654 %U http://www.ncbi.nlm.nih.gov/pubmed/30635260 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 8 %N 1 %P e11637 %T Adherence to Consolidated Standards of Reporting Trials (CONSORT) Guidelines for Reporting Safety Outcomes in Trials of Cannabinoids for Chronic Pain: Protocol for a Systematic Review %A Mohiuddin,Mohammed M %A Mizubuti,Glenio %A Haroutounian,Simon %A Smith,Shannon %A Campbell,Fiona %A Park,Rex %A Gilron,Ian %+ Department of Anesthesiology & Perioperative Medicine, Queen's University, Anesthesiology, Victory 2 Kingston Health Sciences Centre, 76 Stuart Street, Kingston, ON, K7L 2V7, Canada, 1 613 549 666 ext 3963, gilroni@queensu.ca %K adverse events %K adverse event reporting %K cannabis %K cannabinoids %K cannabidiol %K chronic pain %K clinical trial %K systematic review %K marijuana %K safety %K tetrahydrocannabinol %D 2019 %7 28.01.2019 %9 Protocol %J JMIR Res Protoc %G English %X Background: Chronic pain affects a significant proportion of the population and presents a major challenge to clinicians and pain specialists. Despite the availability of pharmacologic treatment options such as opioids, many patients continue to experience persistent pain. Cannabinoids present an alternative option with some data on efficacy; however, to date, a systematic review of adverse events (AEs) assessment and reporting in randomized clinical trials (RCTs) involving cannabinoids has not been performed. As a result, it is unclear whether a clear profile of cannabinoid-associated AEs has been accurately detailed in the literature. As cannabinoids are likely to become readily available for patients in the near future, it is important to study how well AEs have been reported in trials so that the safety profile of cannabinoids can be better understood. Objective: With a potentially enormous shift toward cannabinoid use for managing chronic pain and spasticity, this study aims to reveal the adequacy of AE reporting and cannabinoid-specific AEs in this setting. Spasticity is a major contributor to chronic pain in patients with multiple sclerosis (MS), with a comorbidity of 75%. Many cannabinoid studies have been performed in MS-related painful spasticity with relevant pain outcomes, and these studies will be included in this review for comprehensiveness. The primary outcome will be the quality of AE assessment and reporting by adherence to the Consolidated Standards of Reporting Trials (CONSORT) guidelines. Secondary outcomes will include the type of AE, method of AE reporting, severity of AE, frequency of AEs, patient withdrawals, and reasons for withdrawals. Methods: We will perform a systematic review by searching for primary reports of double-blind, randomized controlled trials of cannabinoids compared with placebo and any active comparator treatments for chronic pain, with a primary outcome directly related to pain (eg, pain intensity, pain relief, and pain-related interference). We will search the following databases: MEDLINE, Embase, Cochrane Library, and PsycINFO. RevMan software will be used for meta-analysis. Results: The protocol has been registered on the International Prospective Register of Systematic Reviews (CRD42018100401). The project was funded in 2018 and screening has been completed. Data extraction is under way and the first results are expected to be submitted for publication in January or February 2019. Conclusions: This review will better elucidate the safety of cannabinoids for the treatment of chronic pain and spasticity through identifying gaps in the literature for AE reporting. Like in any new therapy, it is essential that accurate information surrounding the safety and efficacy of cannabinoids be clearly outlined and identified to balance the benefit and harm described for patients. Trial Registration: PROSPERO CRD42018100401; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=100401 International Registered Report Identifier (IRRID): DERR1-10.2196/11637 %M 30688655 %R 10.2196/11637 %U http://www.researchprotocols.org/2019/1/e11637/ %U https://doi.org/10.2196/11637 %U http://www.ncbi.nlm.nih.gov/pubmed/30688655 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 8 %N 1 %P e12510 %T The Integration of Interlinkages Between Nature and Human Health in Primary Health Care: Protocol for a Scoping Review %A Lauwers,Laura %A Bastiaens,Hilde %A Remmen,Roy %A Keune,Hans %+ Department of Primary and Interdisciplinary Care, Faculty of Medicine and Health Sciences, University of Antwerp, Gouverneur Kinsbergencentrum 00.58., Doornstraat 331, Antwerp, 2610, Belgium, 32 489097822, laura.lauwers@uantwerpen.be %K primary health care %K nature %K health %K human microbiome %K infectious diseases %K natural disasters %K medicinal plants %K nutrition %K nature-based care %D 2019 %7 18.01.2019 %9 Protocol %J JMIR Res Protoc %G English %X Background: International overview reports and the majority of scientific publications on interlinkages between nature and human health (NHI) do not seem to focus on the role of the health care sector. Primary health care (PHC) is often the first point of contact people have with the health care system and provides comprehensive, accessible, and community-based care that meets the health needs of individuals throughout their life. PHC is a vital backbone for linking knowledge and practice within the organization of health care. This scoping review aims to focus on the potential role of PHC in relation to NHI. Objective: The objective of this protocol is to present the method used to scope international overview reports and scientific publications on what is mentioned on the integration of NHI in PHC. Methods: The international overview reports have been screened for keywords relating to PHC. We developed a specific search strategy to scope scientific literature on NHI in relation to PHC. The scientific literature search ran in Web of Science (WOS) and PubMed from inception to May 2017. The scientific publications are screened by 2 independent reviewers, which will result in a list of relevant publications that meet eligibility and inclusion criteria. Results: On the basis of a first screen on the title of the first 200 results in both search engines, we decided to restrict to WOS. First insights in the international overview reports and the quantitative overview of the results in WOS give a first impression of a missing link between NHI and PHC. The findings are expected to identify knowledge gaps in the translation of evidence on NHI in PHC practices and the role of PHC regarding the application of that evidence in health care practice. Conclusions: This is, to our knowledge, the first study that seeks to relate existing knowledge on NHI to PHC. The presentation of our method through this protocol allows researchers to build upon and improve our work in future research on the practical implementation of NIH. The findings of the scoping review are expected to guide future scientific research, international policy directives, and PHC workers to fill the gaps in the integration of NHI in PHC. International Registered Report Identifier (IRRID): DERR1-10.2196/12510 %M 30664484 %R 10.2196/12510 %U http://www.researchprotocols.org/2019/1/e12510/ %U https://doi.org/10.2196/12510 %U http://www.ncbi.nlm.nih.gov/pubmed/30664484 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 8 %N 1 %P e10678 %T Data Quality and Cost-Effectiveness Analyses of Electronic and Paper-Based Interviewer-Administered Public Health Surveys: Protocol for a Systematic Review %A Zeleke,Atinkut Alamirrew %A Naziyok,Tolga %A Fritz,Fleur %A Röhrig,Rainer %+ Division of Medical Informatics, Department of Health Services Research, Carl von Ossietzky University of Oldenburg, Bldg V04-1-133, Ammerländer Heerstraße 140, Oldenburg, 26129, Germany, 49 441 798 2871, atinkut.alamirrew.zeleke@uni-oldenburg.de %K data collection %K demographic and health surveys %K tablet computers %K smartphone %K mobile phone %K data quality %K cost comparison %D 2019 %7 30.01.2019 %9 Protocol %J JMIR Res Protoc %G English %X Background: Population-level survey is an essential standard method used in public health research to quantify sociodemographic events and support public health policy development and intervention designs with evidence. Although all steps in the survey can contribute to the data quality parameters, data collection mechanisms seem the most determinant, as they can avoid mistakes before they happen. The use of electronic devices such as smartphones and tablet computers improve the quality and cost-effectiveness of public health surveys. However, there is lack of systematically analyzed evidence to show the potential impact on data quality and cost reduction of electronic-based data collection tools in interviewer-administered surveys. Objective: This systematic review aims to evaluate the impact of interviewer-administered electronic device data collection methods concerning data quality and cost reduction in population-level surveys compared with the traditional paper-based methods. Methods: We will conduct a systematic search on Medical Literature Analysis and Retrieval System Online, PubMed, CINAHL, PsycINFO, Global Health, Trip, ISI Web of Science, and Cochrane Library for studies from 2007 to 2018 to identify relevant studies. The review will include randomized and nonrandomized studies that examine data quality and cost reduction outcomes. Moreover, usability, user experience, and usage parameters from the same study will be summarized. Two independent authors will screen the title and abstract. A third author will mediate in cases of disagreement. If the studies are considered to be combinable with minimal heterogeneity, we will perform a meta-analysis. Results: The preliminary search in PubMed and Web of Science showed 1491 and 979 resulting hits of articles, respectively. The review protocol is registered in the International Prospective Register of Systematic Reviews (CRD42018092259). We anticipate January 30, 2019, to be the finishing date. Conclusions: This systematic review will inform policymakers, investors, researchers, and technologists about the impact of an electronic-based data collection system on data quality, work efficiency, and cost reduction. Trial Registration: PROSPERO CRD42018092259; http://www.crd.york.ac.uk/PROSPERO/display_record.php?ID= CRD42018092259 International Registered Report Identifier (IRRID): PRR1-10.2196/10678 %M 30698530 %R 10.2196/10678 %U http://www.researchprotocols.org/2019/1/e10678/ %U https://doi.org/10.2196/10678 %U http://www.ncbi.nlm.nih.gov/pubmed/30698530 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 8 %N 1 %P e8055 %T Integrating Taxonomies Into Theory-Based Digital Health Interventions for Behavior Change: A Holistic Framework %A Wang,Yunlong %A Fadhil,Ahmed %A Lange,Jan-Philipp %A Reiterer,Harald %+ HCI Group, Department of Computer and Information Science, University of Konstanz, PZ 908, Universitätsstraße 10, Konstanz, 78457, Germany, 49 07531 88 2869, yunlong.wang@uni-konstanz.de %K behavior change technique %K behavior change technique taxonomy %K digital health interventions %K persuasive technology %K persuasive system design %D 2019 %7 15.01.2019 %9 Viewpoint %J JMIR Res Protoc %G English %X Digital health interventions (DHIs) have been emerging in the last decade. Due to their interdisciplinary nature, DHIs are guided and influenced by theories (eg, behavioral theories, behavior change technologies, and persuasive technology) from different research communities. However, DHIs are always coded using various taxonomies and reported in insufficient perspectives. This inconsistency and incomprehensiveness will cause difficulty in conducting systematic reviews and sharing contributions among communities. Therefore, based on existing related work, we propose a holistic framework that embeds behavioral theories, behavior change technique taxonomy, and persuasive system design principles. Including four development steps, two toolboxes, and one workflow, our framework aims to guide DHI developers to design, evaluate, and report their work in a formative and comprehensive way. %M 30664477 %R 10.2196/resprot.8055 %U https://www.researchprotocols.org/2019/1/e8055/ %U https://doi.org/10.2196/resprot.8055 %U http://www.ncbi.nlm.nih.gov/pubmed/30664477 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 8 %N 1 %P e2 %T Testing MD-Link, a Low-Cost Mobile Electrocardiography Monitoring Device, in Patients With Irregular Heartbeat: Protocol for a Cross-Sectional Study %A Kilimo,Precious J %A Le,Tai %A Phan,Ngoc T %A Han,Huy-Dung %A Hoang,Hoc T %A Vu,Nguyen C %A Pham,Nga TT %A Cao,Hung %A Nguyen,Cuong K %+ Institute of Population, Health and Development, 14th Floor, Icon4 Tower, 243A De La Thanh St, Dong Da, Hanoi, 117222, Viet Nam, 84 247 300 0988, cuong.kieu.nguyen@phad.org %K cardiac arrhythmia %K cardiovascular diseases %K ECG %K electrocardiography %K irregular heartbeat %K mHealth %K mobile devices %K mobile phone %D 2019 %7 31.01.2019 %9 Protocol %J JMIR Res Protoc %G English %X Background: Having mobile devices that provide patients with the ability to record and monitor the electrical activity of their heart enhances patient self-care and the early detection of irregular heartbeat (cardiac arrhythmia), yet few such devices exist in Vietnam. Challenges exist for introducing mobile electrocardiography (ECG) monitoring devices in Vietnam, including patient accessibility and affordability. A low-cost mobile ECG monitoring device designed and developed in Vietnam, which allows patients to easily measure their heart’s electrical activity and navigate recordings, may be a solution. Objective: The aim of this project is to assess the usability of the MD-Link system, a newly developed mobile handheld 1-lead ECG device, in detecting patients with irregular heartbeat. We will compare its outputs to the standard printed outputs of a 12-lead electrocardiogram generated by the Nihon Kohden Cardiofax S Electrocardiograph Model ECG-1250K. Methods: We will conduct a cross-sectional study in two stages, including the measurement of ECG signals of patients using the MD-Link and the Nihon Kohden Cardiofax S and analysis of the selected standard outputs collected from the ECG recordings of the MD-Link and the Nihon Kohden Cardiofax S. The MD-Link consists of (1) a mobile device (eg, a smartphone); (2) a lead wire with 2 disposable electrodes; and (3) an easy-to-use mobile app interface enabling the upload and accurate display of ECG recordings to patients and their clinicians. Our research team, consisting of members from Dartmouth College; the Institute of Health, Population and Development; Hanoi University of Science and Technology; and physicians and nurses from Thanh Chan Clinic, will assist in carrying out this project. Results: We will proceed with a publication plan that includes a project report and, ultimately, articles for peer-reviewed journals. We also hope to disseminate our work at relevant conferences to provide more coverage and exposure to the MD-Link mobile device. Recruitment and data collection were completed in January 2018. Data analysis started in February 2018 and is ongoing. Results are expected mid-2019. Conclusions: At the end of this project, we will have developed and tested the MD-Link, a low-cost mobile ECG monitoring device, with some supportive comparisons to standard ECG devices commonly used in heart clinics or hospitals in Vietnam. Our long-term goal is for the MD-Link to be easily accessible, affordable, and to fit into a patient’s daily routine, thus improving the care and treatment of patients with cardiovascular diseases (CVDs). International Registered Report Identifier (IRRID): RR1-10.2196/8762 %M 30702440 %R 10.2196/resprot.8762 %U http://www.researchprotocols.org/2019/1/e2/ %U https://doi.org/10.2196/resprot.8762 %U http://www.ncbi.nlm.nih.gov/pubmed/30702440 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 8 %N 1 %P e12108 %T YouthCHAT as a Primary Care E-Screening Tool for Mental Health Issues Among Te Tai Tokerau Youth: Protocol for a Co-Design Study %A Martel,Rhiannon Mary %A Darragh,Margot Louise %A Lawrence,Aniva Joanne %A Shepherd,Matthew John %A Wihongi,Tracey %A Goodyear-Smith,Felicity Anne %+ Department of General Practice and Primary Health Care, Faculty of Medical and Health Science, The University of Auckland, University of Auckland Tamaki Campus, 261 Morrin Road, Auckland, 1072, New Zealand, 64 274461683, rhiannonmartel@xtra.co.nz %K adolescents %K brief intervention %K co-design %K mental health %K primary health care %K protocol %K risk behavior %K YouthCHAT %D 2019 %7 09.01.2019 %9 Protocol %J JMIR Res Protoc %G English %X Background: In New Zealand (NZ), 1 in 4 adolescents is affected by mental health issues (eg, depression and anxiety) and engages in risk behaviors (eg, harmful drinking and substance abuse), with rates among Māori youth being significantly higher. The majority of NZ secondary school students visit their local primary health care providers (PHPs) at least annually, yet most do not seek help for mental health and risk behavior (MHB) concerns. While youth think it acceptable to discuss sensitive issues during a consultation with their PHPs, unless problems are severe, such conversations are not initiated by PHPs. Early intervention for MHB concerns can prevent long-term health and well-being issues. However, this relies on the early identification of developing problems and youth being offered and accepting help. YouthCHAT is an electronic, multi-item screening tool developed in 2016 to assess MHB concerns among youth. YouthCHAT is completed before a consultation with the PHP, who can access a summary report straight away. A help question allows young people to identify issues that need addressing. A resource pack uses stepped care pathways to guide providers to use appropriate brief interventions. Objective: This study aimed to explore the utility, feasibility, and acceptability of YouthCHAT when tailored for use with youth in primary care settings with large Māori populations. Objectives of the study are to evaluate the implementation of YouthCHAT in nurse-led youth clinics, school-based clinics, and general practice in Te Tai Tokerau (Northland, NZ); to develop a framework for the scaling up of YouthCHAT across further settings; to assess health provider and youth acceptability of the tool; to improve screening rates for mental health and help-seeking behavior; to enable early identification of emerging problems; and to improve brief intervention delivery. Methods: Using a bicultural mixed-methods co-design approach, 3 phases over a 3-year period will provide an iterative evaluation of the utility, feasibility, and acceptability of YouthCHAT, aiming to create a framework for wider-scale rollout and implementation. Results: Recruitment for the first phase began in September 2018. YouthCHAT was implemented at the first site in October 2018 and is expected to be at a further two sites in late January to early February 2019. The study is due for completion at the end of 2021. Conclusions: YouthCHAT has potential as a user-friendly, time efficient, and culturally safe screening tool for early detection of MHB issues in NZ youth. The resource pack assists the clinician to provide appropriate interventions for emerging and developed youth mental health and lifestyle issues. Involving input from community providers, users, and stakeholders will ensure that modifiable elements of YouthCHAT are tailored to meet the health needs specific to each context and will have a positive influence on future mental, physical, and social outcomes for NZ youth. International Registered Report Identifier (IRRID): PRR1-10.2196/12108 %M 30626568 %R 10.2196/12108 %U http://www.researchprotocols.org/2019/1/e12108/ %U https://doi.org/10.2196/12108 %U http://www.ncbi.nlm.nih.gov/pubmed/30626568 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 8 %N 1 %P e11674 %T Using an Electronic Tablet to Assess Patients’ Home Environment by Videoconferencing Prior to Hospital Discharge: Protocol for a Mixed-Methods Feasibility and Comparative Study %A Latulippe,Karine %A Provencher,Véronique %A Boivin,Katia %A Vincent,Claude %A Guay,Manon %A Kairy,Dahlia %A Morales,Ernesto %A Pellerin,Marc-André %A Giroux,Dominique %+ Center of Excellence on Aging Quebec, 1050 chemin Sainte-Foy, Quebec, QC, G1S 4L8, Canada, 1 418 435 8541, karine.latulippe.3@ulaval.ca %K caregivers %K feasibility %K mixed-methods %K mobile videoconferencing %K mobile phone %K occupational therapists %D 2019 %7 14.01.2019 %9 Protocol %J JMIR Res Protoc %G English %X Background: Occupational therapists working in hospitals are usually involved in discharge planning to assess patients’ safety and autonomy upon returning home. However, their assessment is usually done at the hospital due to organizational and financial constraints. The lack of visual data about the patients’ home may thus reduce the appropriateness and applicability of the support recommended upon discharge. Although various technological tools such as mobile devices (mobile health) are promising methods for home-based distance assessment, their application in hospital settings may raise several feasibility issues. To our knowledge, their usefulness and added value compared to standard procedure have not been addressed yet in previous studies. Moreover, several feasibility issues need to be explored. Objective: This paper aims to (1) document the clinical feasibility of using an electronic tablet to assess the patient's home environment by mobile videoconferencing and (2) explore the added value of using mobile videoconferencing, compared to the standard procedure. Methods: A feasibility and comparative study using a mixed-methods (convergent) design is currently undergoing. Six occupational therapists will assess the home environment of their patients in the hospital setting: they will first perform a semistructured interview (a) and then use mobile videoconferencing (b) to compare “a versus a+b.” Interviews with occupational therapists and patients and their caregivers will further explore the advantages and disadvantages of mobile videoconferencing. Two valid tools are used (the Canadian Measure of Occupational Performance and the telehealth responsivity questionnaire). Direct and indirect time is also collected. Results: The project was funded in the spring of 2016 and authorized by the ethics committee in February 2017. Enrollment started in April 2017. Five triads (n=4 occupational therapists, n=5 clients, n=5 caregivers) have been recruited until now. The experiment is expected to be completed by April 2019 and analysis of the results by June 2019. Conclusions: Mobile videoconferencing may be a familiar and easy solution for visualizing environmental barriers in the home by caregivers and clinicians, thus providing a promising and inexpensive option to promote a safe return home upon hospital discharge, but clinical feasibility and obstacles to the use of mobile videoconferencing must be understood. International Registered Report Identifier (IRRID): DERR1-10.2196/11674 %M 31344677 %R 10.2196/11674 %U http://www.researchprotocols.org/2019/1/e11674/ %U https://doi.org/10.2196/11674 %U http://www.ncbi.nlm.nih.gov/pubmed/31344677 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 8 %N 1 %P e11493 %T Web-Based Stress Management Program for University Students in Indonesia: Systematic Cultural Adaptation and Protocol for a Feasibility Study %A Juniar,Dilfa %A van Ballegooijen,Wouter %A Karyotaki,Eirini %A van Schaik,Anneke %A Passchier,Jan %A Heber,Elena %A Lehr,Dirk %A Sadarjoen,Sawitri Supardi %A Riper,Heleen %+ VU Amsterdam, Van der Boechorststraat 7, Amsterdam,, Netherlands, 31 20 5988800, d.juniar@vu.nl %K internet intervention %K stress management %K cultural adaptation %K feasibility study %K low and middle income countries (LMICs) %K university student %K Indonesia %D 2019 %7 25.01.2019 %9 Protocol %J JMIR Res Protoc %G English %X Background: The number of university students experiencing stress is increasing, which often leads to adverse effects such as poor grades, academic probation, and emotional problems. Unfortunately, most of these problems remain untreated because of limited professional resources and fear of stigma. Several Web-based stress management interventions are now available for student populations, but these treatments are not yet available in Indonesia. To make treatment for stress more acceptable in Indonesia, a cultural adaptation process is needed, and part of the process is assessing the feasibility of the adapted intervention. Objective: This paper describes the first two stages of a cultural adaptation process and the protocol of a feasibility study that will assess the acceptability of a culturally adapted stress management intervention for university students in Indonesia. Methods: Focus group discussions with Indonesian university students were held, and input from Indonesian psychologists was gathered for developing the adapted intervention. A single-group feasibility study with a pre-post design will be conducted. We will recruit at minimum 50 university students who have an elevated level of stress (Depression, Anxiety, and Stress Scales–42 stress subscale score ≥15), identify themselves as being of Indonesian culture (eg, able to speak Bahasa Indonesia fluently), and are studying at a university in Indonesia. The primary endpoints of this study will be rates of participant satisfaction, system usability, dropout rates, and level of adherence. We will also use qualitative data to assess the adapted intervention more thoroughly. Secondary study endpoints will be quality of life, stress, anxiety, and depression levels. Feasibility parameters (eg, participant satisfaction, system usability, and level of adherence) will be summarized with descriptive statistics. Two-tailed paired within-group t tests will be used to analyze stress, anxiety, depression, and quality of life. Results: The enrollment of pilot study is currently ongoing. First results are expected to be ready for analysis in the second half of 2019. The project was funded as part of a PhD trajectory in 2015 by the Indonesian Endowment Fund for Education. Conclusions: This is one of the first studies to assess the feasibility of a culturally adapted Web-based stress management intervention for university students in Indonesia. Strengths and limitations of the study are discussed. International Registered Report Identifier (IRRID): DERR1-10.2196/11493 %M 30681970 %R 10.2196/11493 %U http://www.researchprotocols.org/2019/1/e11493/ %U https://doi.org/10.2196/11493 %U http://www.ncbi.nlm.nih.gov/pubmed/30681970 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 8 %N 1 %P e10854 %T Determining the Cause of Death Among Children Hospitalized With Respiratory Illness in Kenya: Protocol for Pediatric Respiratory Etiology Surveillance Study (PRESS) %A Njuguna,Henry N %A Zaki,Sherif R %A Roberts,Drucilla J %A Fligner,Corinne L %A Keating,M Kelly %A Rogena,Emily %A Walong,Edwin %A Gachii,Andrew K %A Maleche-Obimbo,Elizabeth %A Irimu,Grace %A Mathaiya,John %A Orata,Noelle %A Lopokoiyit,Rosemarie %A Maina,Jackson %A Emukule,Gideon O %A Onyango,Clayton O %A Gikunju,Stella %A Owuor,Collins %A Kinuthia,Peter %A Bunei,Milka %A Fields,Barry %A Widdowson,Marc-Alain %A Mott,Joshua A %A Chaves,Sandra S %+ Influenza Division, Centers for Disease Control and Prevention, 1600 Clifton Road NE, Atlanta, GA, 30333, United States, +254 710 602 748, bev8@cdc.gov %K cause of death %K pneumonia %K etiology %K infectious disease %K postmortem %K mortality %K respiratory illness %D 2019 %7 10.01.2019 %9 Protocol %J JMIR Res Protoc %G English %X Background: In sub-Saharan Africa, where the burden of respiratory disease–related deaths is the highest, information on the cause of death remains inadequate because of poor access to health care and limited availability of diagnostic tools. Postmortem examination can aid in the ascertainment of causes of death. This manuscript describes the study protocol for the Pediatric Respiratory Etiology Surveillance Study (PRESS). Objective: This study protocol aims to identify causes and etiologies associated with respiratory disease–related deaths among children (age 1-59 months) with respiratory illness admitted to the Kenyatta National Hospital (KNH), the largest public hospital in Kenya, through postmortem examination coupled with innovative approaches to laboratory investigation. Methods: We prospectively followed children hospitalized with respiratory illness until the end of clinical care or death. In case of death, parents or guardians were offered grief counseling, and postmortem examination was offered. Lung tissue specimens were collected using minimally invasive tissue sampling and conventional autopsy where other tissues were collected. Tissues were tested using histopathology, immunohistochemistry, and multipathogen molecular-based assays to identify pathogens. For each case, clinical and laboratory data were reviewed by a team of pathologists, clinicians, laboratorians, and epidemiologists to assign a cause of and etiology associated with death. Results: We have enrolled pediatric cases of respiratory illness hospitalized at the KNH at the time of this submission; of those, 14.8% (140/945) died while in the hospital. Both analysis and interpretation of laboratory results and writing up of findings are expected in 2019-2020. Conclusions: Postmortem studies can help identify major pathogens contributing to respiratory-associated deaths in children. This information is needed to develop evidence-based prevention and treatment policies that target important causes of pediatric respiratory mortality and assist with the prioritization of local resources. Furthermore, PRESS can provide insights into the interpretation of results using multipathogen testing platforms in resource-limited settings. International Registered Report Identifier (IRRID): DERR1-10.2196/10854 %M 30632968 %R 10.2196/10854 %U http://www.researchprotocols.org/2019/1/e10854/ %U https://doi.org/10.2196/10854 %U http://www.ncbi.nlm.nih.gov/pubmed/30632968 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 8 %N 1 %P e12112 %T Investigating Health Risk Environments in Housing Programs for Young Adults: Protocol for a Geographically Explicit Ecological Momentary Assessment Study %A Henwood,Benjamin F %A Redline,Brian %A Dzubur,Eldin %A Madden,Danielle R %A Rhoades,Harmony %A Dunton,Genevieve F %A Rice,Eric %A Semborski,Sara %A Tang,Qu %A Intille,Stephen S %+ Suzanne Dworak-Peck School of Social Work, University of Southern California, 1150 S Olive Street, Suite 1429, Los Angeles, CA, 90039, United States, 1 6107316872, bhenwood@usc.edu %K homelessness %K ecological momentary assessment %K experience sampling %K social environment %K qualitative research %K geography %D 2019 %7 10.01.2019 %9 Protocol %J JMIR Res Protoc %G English %X Background: Young adults who experience homelessness are exposed to environments that contribute to risk behavior. However, few studies have examined how access to housing may affect the health risk behaviors of young adults experiencing homelessness. Objective: This paper describes the Log My Life study that uses an innovative, mixed-methods approach based on geographically explicit ecological momentary assessment (EMA) through cell phone technology to understand the risk environment of young adults who have either enrolled in housing programs or are currently homeless. Methods: For the quantitative arm, study participants age 18-27 respond to momentary surveys via a smartphone app that collects geospatial information repeatedly during a 1-week period. Both EMAs (up to 8 per day) and daily diaries are prompted to explore within-day and daily variations in emotional affect, context, and health risk behavior, while also capturing infrequent risk behaviors such as sex in exchange for goods or services. For the qualitative arm, a purposive subsample of participants who indicated engaging in risky behaviors are asked to complete an in-depth qualitative interview using an interactive, personalized geospatial map rendering of EMA responses. Results: Recruitment began in June of 2017. To date, 170 participants enrolled in the study. Compliance with EMA and daily diary surveys was generally high. In-depth qualitative follow-ups have been conducted with 15 participants. We expect to recruit 50 additional participants and complete analyses by September of 2019. Conclusions: Mixing the quantitative and qualitative arms in this study will provide a more complete understanding of differences in risk environments between homeless and housed young adults. Furthermore, this approach can improve recall bias and enhance ecological validity. International Registered Report Identifier (IRRID): DERR1-10.2196/12112 %M 30632969 %R 10.2196/12112 %U http://www.researchprotocols.org/2019/1/e12112/ %U https://doi.org/10.2196/12112 %U http://www.ncbi.nlm.nih.gov/pubmed/30632969 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 8 %N 1 %P e11452 %T Use of Mental Health Apps by Breast Cancer Patients and Their Caregivers in the United States: Protocol for a Pilot Pre-Post Study %A Chow,Philip I %A Showalter,Shayna L %A Gerber,Matthew S %A Kennedy,Erin %A Brenin,David R %A Schroen,Anneke T %A Mohr,David C %A Lattie,Emily G %A Cohn,Wendy F %+ Center for Behavioral Health and Technology, Department of Psychiatry and Neurobehavioral Sciences, University of Virginia, 560 Ray C Hunt Drive, Charlottesville, VA, 22903, United States, 1 924 5401, philip.i.chow@gmail.com %K cancer %K caregivers %K mental health %K mHealth %D 2019 %7 14.01.2019 %9 Protocol %J JMIR Res Protoc %G English %X Background: Over one-third of cancer patients experience clinically significant mental distress, and distress in caregivers can exceed that of the cancer patients for whom they care. There is an urgent need to identify scalable and cost-efficient ways of delivering mental health interventions to cancer patients and their loved ones. Objective: The aim of this study is to describe the protocol to pilot a mobile app–based mental health intervention in breast cancer patients and caregivers. Methods: The IntelliCare mental health apps are grounded in evidence-based research in psychology. They have not been examined in cancer populations. This pilot study will adopt a within-subject, pre-post study design to inform a potential phase III randomized controlled trial. A target sample of 50 individuals (with roughly equal numbers of patients and caregivers) at least 18 years of age and fluent in English will be recruited at a US National Cancer Institute designated clinical cancer center. Consent will be obtained in writing and a mobile phone will be provided if needed. Self-report surveys assessing mental health outcomes will be administered at a baseline session and after a 7-week intervention. Before using the apps, participants will receive a 30-min coaching call to explain their purpose and function. A 10-min coaching call 3 weeks later will check on user progress and address questions or barriers to use. Self-report and semistructured interviews with participants at the end of the study period will focus on user experience and suggestions for improving the apps and coaching in future studies. Results: This study is ongoing, and recruitment will be completed by the end of 2018. Conclusions: Results from this study will inform how scalable mobile phone-delivered programs can be used to support breast cancer patients and their loved ones. Trial Registration: ClinicalTrials.gov NCT03488745; https://clinicaltrials.gov/ct2/show/NCT03488745 International Registered Report Identifier (IRRID): DERR1-10.2196/11452 %M 31344674 %R 10.2196/11452 %U http://www.researchprotocols.org/2019/1/e11452/ %U https://doi.org/10.2196/11452 %U http://www.ncbi.nlm.nih.gov/pubmed/31344674 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 8 %N 1 %P e9017 %T American Heart Association’s Cholesterol CarePlan as a Smartphone-Delivered Web App for Patients Prescribed Cholesterol-Lowering Medication: Protocol for an Observational Feasibility Study %A Woringer,Maria %A Dharmayat,Kanika I %A Greenfield,Geva %A Bottle,Alex %A Ray,Kausik K %+ Imperial College London, Department of Primary Care and Public Health, Reynolds Building, St Dunstan's Road, London, W6 8RP, United Kingdom, 44 02075940789, m.woringer@imperial.ac.uk %K behavioral change %K cholesterol %K lifestyle %K mHealth %K medication adherence %D 2019 %7 24.01.2019 %9 Protocol %J JMIR Res Protoc %G English %X Background: Adoption of healthy lifestyle and compliance with cholesterol-lowering medication reduces the risk of cardiovascular disease (CVD). The use of digital tools and mobile technology may be important for sustaining positive behavioral change. Objective: The primary objective of this study is to evaluate the feasibility and acceptability of administering the Cholesterol CarePlan Web app developed by the American Heart Association aimed at improving lifestyle and medication adherence among patients prescribed cholesterol-lowering medication. The secondary objective is to assess the Web app’s efficacy. Methods: A prospective, observational feasibility study will be conducted to demonstrate whether the Web app may be successfully taken up by patients and will be associated with improved clinical and behavioral outcomes. The study will aim to recruit 180 study participants being prescribed cholesterol-lowering medication for at least 30 days across 14 general practices in London, England. Potentially eligible patients will be invited to use the Web app on a smartphone and visit general practice for three 20-minute clinical assessments of blood pressure, height, weight, smoking, and nonfasting cholesterol over 24 weeks. The feasibility of administering the Web app will be judged by recruitment and dropout statistics and the sociodemographic and comorbidity profile of consenting study participants, consenting nonparticipants, and all potentially eligible patients. Acceptability will be assessed using patients’ readiness to embrace new technologies, the usability of the Web app, and patient satisfaction. The efficacy of the Web app will be assessed by changes in medication adherence and clinical risk factors by levels of the Web app compliance. Results: This study is currently funded by the American Heart Association. Initial study recruitment will take place between February and July 2018 followed by patient follow-up. Patient level data will be obtained in January 2019. Data analysis will be completed by February 2019. Results will be submitted for publication in March 2019. Conclusions: The potential of an app to improve patients’ lifestyle and management of cholesterol may inform the design of a randomized controlled trial and the delivery of more effective CVD prevention programs. International Registered Report Identifier (IRRID): PRR1-10.2196/9017 %M 30679150 %R 10.2196/resprot.9017 %U https://www.researchprotocols.org/2019/1/e9017/ %U https://doi.org/10.2196/resprot.9017 %U http://www.ncbi.nlm.nih.gov/pubmed/30679150 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 8 %N 1 %P e10952 %T User-Driven Living Lab for Assistive Technology to Support People With Dementia Living at Home: Protocol for Developing Co-Creation–Based Innovations %A van den Kieboom,Robin CP %A Bongers,Inge MB %A Mark,Ruth E %A Snaphaan,Liselore JAE %+ Tranzo, Tilburg School of Social and Behavioral Sciences, Tilburg University, Reitse Poort, 2nd Floor, Professor Cobbenhagenlaan 125, Tilburg, 5037 DB, Netherlands, 31 0683669336, r.c.p.vdnkieboom@tilburguniversity.edu %K dementia %K family caregivers %K longitudinal studies %K technology %D 2019 %7 28.01.2019 %9 Protocol %J JMIR Res Protoc %G English %X Background: Owing to no cure for dementia currently, there is an urgent need to look for alternative ways to support these people and their informal caregivers. Carefully designed interventions can answer the unmet needs of both people with dementia and their informal caregivers in the community. However, existing products, systems, and services are often too complex or unsuitable. Objective: This study aims to identify, longitudinally, the changing needs (as dementia progresses) of people with dementia living at home and their informal caregivers. By developing co-creation-based innovations, these changing needs will hopefully be met. Methods: A user-driven Living Lab design is used to structurally explore the needs over time of people with dementia (and their informal caregivers) living in the community in the North Brabant region of the Netherlands. In addition, co-creation-based innovations will be developed, tested, and evaluated by these people and their caregivers at home. All participants will complete complaints-oriented questionnaires at 3 time-points—at the baseline, 1 year, and 2 years after they start participating. Home interviews are scheduled to explore if and how these complaints translate into participants’ specific needs or wishes. Focus groups meet on a monthly basis to further identify the needs of people with dementia and their informal caregivers and provide feedback to the stakeholders. In the context field, participants have an opportunity to actually test the products at home and provide feedback. Quantitative outcome measurements include neuropsychiatric symptoms, cognitive decline, independence in activities of daily living, safety, and caregiver burden. Qualitative outcome measurements include feedback to the stakeholders regarding the needs of people with dementia and their informal caregivers and how these needs change over time, as well as user experiences about the specific innovations. Results: Participant recruitment will start in September 2018 and is ongoing. The first results of data analyses are expected in the spring of 2019. Conclusions: The overall aim of Innovate Dementia 2.0 is to facilitate person-centered innovations developed for people with dementia and their informal caregivers at all stages as dementia progresses. This should lead to newly designed concepts and innovations, which are better able to answer the needs of people with dementia and their caregivers in the community. International Registered Report Identifier (IRRID): DERR1-10.2196/10952 %M 30688653 %R 10.2196/10952 %U http://www.researchprotocols.org/2019/1/e10952/ %U https://doi.org/10.2196/10952 %U http://www.ncbi.nlm.nih.gov/pubmed/30688653 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 8 %N 1 %P e10681 %T Promising Approaches for Engaging Youth and Young Adults Living with HIV in HIV Primary Care Using Social Media and Mobile Technology Interventions: Protocol for the SPNS Social Media Initiative %A Medich,Melissa %A Swendeman,Dallas T %A Comulada,W Scott %A Kao,Uyen H %A Myers,Janet J %A Brooks,Ronald A %A , %+ Department of Family Medicine, University of California, Los Angeles, Suite 1800, 10880 Wilshire Boulevard, Los Angeles, CA, 90024, United States, 1 3107940773, rabrooks@mednet.ucla.edu %K HIV %K health outcomes %K mobile technology %K social media %K youth %K young adult %K mobile phone %D 2019 %7 31.01.2019 %9 Protocol %J JMIR Res Protoc %G English %X Background: In the United States, disparities in the rates of HIV care among youth and young adults result from the intersections of factors that include stigma, substance use, homelessness or marginal housing, institutional neglect, and mental health issues. Novel interventions are needed that are geared to youth and young adults. Objective: In this paper, we aim to describe the interventions used by participating sites for Using Social Media initiative, the process for classifying the intervention components, and the methods for conducting a comprehensive evaluation of the interventions. Methods: In 2015, the Health Resources and Services Administration (HRSA) HIV/AIDS Bureau, Special Projects of National Significance (SPNS) funded the Evaluation and Technical Assistance Center (ETAC) at the University of California, Los Angeles and 10 demonstration projects at sites across the United States that incorporated innovative approaches using a variety of social media and mobile technology strategies designed specifically for youth and young adults living with HIV. The ETAC developed a typology, or a classification system, that systematically summarizes the principal components of the interventions into broader groups and developed a multisite, mixed-methods approach to evaluate them based on the Department of Health and Human Services HIV health outcomes along the HIV care continuum. The mixed-methods approach is key to remove potential biases in assessing the effectiveness of demonstration projects. Results: This SPNS project was funded in September 2015, and enrollment was completed on May 31, 2018. A total of 984 participants have been enrolled in the multisite evaluation. Data collection will continue until August 2019. However, data analysis is currently underway, and the first results are expected to be submitted for publication in 2019. Conclusions: This HRSA-funded initiative seeks to increase engagement in HIV medical care, improve health outcomes for people living with HIV, and reduce HIV-related health disparities and health inequities that affect HIV-positive youth and young adults. International Registered Report Identifier (IRRID): DERR1-10.2196/10681 %M 30702434 %R 10.2196/10681 %U http://www.researchprotocols.org/2019/1/e10681/ %U https://doi.org/10.2196/10681 %U http://www.ncbi.nlm.nih.gov/pubmed/30702434 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 8 %N 1 %P e11540 %T Investigating Intervention Components and Exploring States of Receptivity for a Smartphone App to Promote Physical Activity: Protocol of a Microrandomized Trial %A Kramer,Jan-Niklas %A Künzler,Florian %A Mishra,Varun %A Presset,Bastien %A Kotz,David %A Smith,Shawna %A Scholz,Urte %A Kowatsch,Tobias %+ Center for Digital Health Interventions, Institute of Technology Management, University of St. Gallen, Dufourstrasse 40a, St. Gallen, 9000, Switzerland, 41 71224 ext 7249, jan-niklas.kramer@unisg.ch %K physical activity %K mHealth %K walking %K smartphone %K incentives %K self-regulation %D 2019 %7 31.01.2019 %9 Protocol %J JMIR Res Protoc %G English %X Background: Smartphones enable the implementation of just-in-time adaptive interventions (JITAIs) that tailor the delivery of health interventions over time to user- and time-varying context characteristics. Ideally, JITAIs include effective intervention components, and delivery tailoring is based on effective moderators of intervention effects. Using machine learning techniques to infer each user’s context from smartphone sensor data is a promising approach to further enhance tailoring. Objective: The primary objective of this study is to quantify main effects, interactions, and moderators of 3 intervention components of a smartphone-based intervention for physical activity. The secondary objective is the exploration of participants’ states of receptivity, that is, situations in which participants are more likely to react to intervention notifications through collection of smartphone sensor data. Methods: In 2017, we developed the Assistant to Lift your Level of activitY (Ally), a chatbot-based mobile health intervention for increasing physical activity that utilizes incentives, planning, and self-monitoring prompts to help participants meet personalized step goals. We used a microrandomized trial design to meet the study objectives. Insurees of a large Swiss insurance company were invited to use the Ally app over a 12-day baseline and a 6-week intervention period. Upon enrollment, participants were randomly allocated to either a financial incentive, a charity incentive, or a no incentive condition. Over the course of the intervention period, participants were repeatedly randomized on a daily basis to either receive prompts that support self-monitoring or not and on a weekly basis to receive 1 of 2 planning interventions or no planning. Participants completed a Web-based questionnaire at baseline and postintervention follow-up. Results: Data collection was completed in January 2018. In total, 274 insurees (mean age 41.73 years; 57.7% [158/274] female) enrolled in the study and installed the Ally app on their smartphones. Main reasons for declining participation were having an incompatible smartphone (37/191, 19.4%) and collection of sensor data (35/191, 18.3%). Step data are available for 227 (82.8%, 227/274) participants, and smartphone sensor data are available for 247 (90.1%, 247/274) participants. Conclusions: This study describes the evidence-based development of a JITAI for increasing physical activity. If components prove to be efficacious, they will be included in a revised version of the app that offers scalable promotion of physical activity at low cost. Trial Registration: ClinicalTrials.gov NCT03384550; https://clinicaltrials.gov/ct2/show/NCT03384550 (Archived by WebCite at http://www.webcitation.org/74IgCiK3d) International Registered Report Identifier (IRRID): DERR1-10.2196/11540 %M 30702430 %R 10.2196/11540 %U http://www.researchprotocols.org/2019/1/e11540/ %U https://doi.org/10.2196/11540 %U http://www.ncbi.nlm.nih.gov/pubmed/30702430 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 8 %N 1 %P e11284 %T Human Papillomavirus Infection and Transmission Among Couples Through Heterosexual Activity (HITCH) Cohort Study: Protocol Describing Design, Methods, and Research Goals %A El-Zein,Mariam %A Coutlée,François %A Tellier,Pierre-Paul %A Roger,Michel %A Franco,Eduardo L %A Burchell,Ann N %A , %+ Li Ka Shing Knowledge Intitute, Department of Family and Community Medicine and Centre for Urban Health Solutions, St. Michael’s Hospital, 30 Bond Street, Toronto, ON,, Canada, 1 416 864 6060 ext 77498, burchella@smh.ca %K human papillomavirus %K HPV transmission %K longitudinal study %K sex partners %K young adults %D 2019 %7 16.01.2019 %9 Protocol %J JMIR Res Protoc %G English %X Background: Human papillomavirus (HPV) epidemiological research has generally been individual based, typically focusing on women, with couple-based research mostly consisting of cross-sectional assessment of prevalent HPV infection in both partners. Objective: The HPV Infection and Transmission among Couples through Heterosexual activity (HITCH) study was set up to investigate the transmissibility of HPV among young, recently formed couples in Montreal, Canada. This paper provides an overview of the HITCH cohort study design and procedures as well as a narrative summary of the most important findings. Methods: HITCH is a longitudinal investigation of HPV transmission in recently formed heterosexual partnerships initiated within 6-month pre-enrollment, a time at which considerable transmission is believed to occur. A total of 549 newly formed dyads were recruited (2005-2011) from postsecondary institutions, including 502 young women and their male partners. An additional 46 males were enrolled at follow-up, as some women enrolled a subsequent partner at follow-up. Women aged 18-24 years were followed for 24 months for acquisition of HPV types not present at enrollment, whereas men returned for a single follow-up visit at month 4, for a sum total of 3361 clinic visits. The last follow-up visit occurred in January 2014. Extensive sociodemographic, sexual behavioral, and medical history data were collected every 2-4 months using computer-assisted, self-administered questionnaires. Furthermore, participants provided genital, blood, oral, and hand specimens for HPV assessment. Results: Although in its early analysis stage, HITCH has produced important publications. Findings from HITCH have increased the available knowledge about the natural history of HPV transmission and its determinants, provided further evidence regarding oral-oral and oral-genital routes of HPV transmission, and supplied empirically valid epidemiological parameters of HPV transmission to assist mathematical modelers in health economic assessments. In addition, HITCH data were made available to several multistudy collaborations evaluating new HPV detection assays and evidence for-or-against HPV type replacement following the introduction of HPV vaccination. Conclusions: HITCH will continue to offer a unique resource for research on HPV transmission. International Registered Report Identifier (IRRID): RR1-10.2196/11284 %M 30650383 %R 10.2196/11284 %U http://www.researchprotocols.org/2019/1/e11284/ %U https://doi.org/10.2196/11284 %U http://www.ncbi.nlm.nih.gov/pubmed/30650383 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 8 %N 1 %P e11022 %T Access to Resources in the Community Through Navigation: Protocol for a Mixed-Methods Feasibility Study %A Dahrouge,Simone %A Gauthier,Alain %A Chiocchio,Francois %A Presseau,Justin %A Kendall,Claire %A Lemonde,Manon %A Chomienne,Marie-Hélène %A Perna,Andrea %A Toal-Sullivan,Darene %A Devlin,Rose A %A Timony,Patrick %A Prud'homme,Denis %+ Bruyere Research Institute, Department of Family Medicine, University of Ottawa, Annex E, 113-43 Bruyère Street, Ottawa, ON, K1N 5C8, Canada, 1 613 562 6262 ext 2913, sdahrouge@bruyere.org %K access %K community resources %K feasibility study %K navigation %K primary health care %D 2019 %7 24.01.2019 %9 Protocol %J JMIR Res Protoc %G English %X Background: Community-based health and social resources can help individuals with complex health and social needs achieve their health goals. However, there is often inadequate access to these resources due to a lack of physician and patient awareness of available resources and the presence of social barriers that limit an individual’s ability to reach these services. Navigation services, where a person is tasked with helping connect patients to community resources, embedded within primary care may facilitate access and strengthen the continuity of care for patients. Objective: This study aims to describe the protocol to assess whether the implementation of the Access to Resources in the Community (ARC) navigation model (an innovative approach to navigation services) is feasible, including its potential to achieve its intended outcomes, and to assess the viability of the evaluation approach. Methods: The study consists of a single-arm, prospective, explanatory, mixed-methods, pre-post design feasibility study focusing on primary care practice settings with vulnerable populations. Participants include primary care providers and patients. Results: Enrollment is closed with 82 patients. Navigation services have ended for 69 patients. Conclusions: The study of an innovative complex intervention requires an adequate assessment of the feasibility of the intended approach during which the potential challenges of the planned intervention and need for its adaptation may be uncovered. Undertaking a feasibility study of the ARC navigation model from a conceptually clear and methodologically solid protocol will inform on the practicality and acceptability of the approach, demand for the services, ease of implementation, quality of integration of the new services within primary care, and practicality and potential for efficacy prior to initiating a randomized controlled trial. Trial Registration: ClinicalTrials.gov NCT03105635; https://clinicaltrials.gov/ct2/show/NCT03105635 (Archived by WebCite at hhttp://www.webcitation.org/75FrwXORl) International Registered Report Identifier (IRRID): RR1-10.2196/11022 %M 30679151 %R 10.2196/11022 %U http://www.researchprotocols.org/2019/1/e11022/ %U https://doi.org/10.2196/11022 %U http://www.ncbi.nlm.nih.gov/pubmed/30679151 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 8 %N 1 %P e10914 %T Exposure to Pesticides and Health Effects on Farm Owners and Workers From Conventional and Organic Agricultural Farms in Costa Rica: Protocol for a Cross-Sectional Study %A Fuhrimann,Samuel %A Winkler,Mirko S %A Staudacher,Philipp %A Weiss,Frederik T %A Stamm,Christian %A Eggen,Rik IL %A Lindh,Christian H %A Menezes-Filho,José A %A Baker,Joseph M %A Ramírez-Muñoz,Fernando %A Gutiérrez-Vargas,Randall %A Mora,Ana M %+ Central American Institute for Studies on Toxic Substances, Universidad Nacional, PO Box 86, Heredia, 3000, Costa Rica, 506 22773677, ana.mora.mora@una.cr %K acetylcholinesterase %K agriculture %K Costa Rica %K farm workers %K near-infrared spectroscopy %K neurobehavioral outcomes %K pesticides %K pesticide exposure assessment %K respiratory outcomes %D 2019 %7 25.1.2019 %9 Protocol %J JMIR Res Protoc %G English %X Background: Pesticide use is increasing in low- and middle-income countries (LMICs) including Costa Rica. This increase poses health risks to farm owners, farm workers, and communities living near agricultural farms. Objective: We aimed to examine the health effects associated with occupational pesticide exposure in farm owners and workers from conventional and organic smallholder farms in Costa Rica. Methods: We conducted a cross-sectional study involving 300 owners and workers from organic and conventional horticultural smallholder farms in Zarcero County, Costa Rica. During the baseline study visit, we administered a structured, tablet-based questionnaire to collect data on sociodemographic characteristics, pesticide exposure, and health conditions (eg, respiratory and allergic outcomes and acute pesticide intoxication symptoms) and administered a neurobehavioral test battery (eg, Finger Tapping Test and Purdue Pegboard); we measured blood pressure, anthropometry (height, weight, and waist circumference), and erythrocytic acetylcholinesterase activity and also collected urine samples. In addition, a functional neuroimaging assessment using near-infrared spectroscopy was conducted with a subset of 50 study participants. During the follow-up study visit (~2-4 weeks after the baseline), we administered participants a short questionnaire on recent pesticide exposure and farming practices and collected hair, toenail, and urine samples. Urine samples will be analyzed for various pesticide metabolites, whereas toenails and hair will be analyzed for manganese (Mn), a biomarker of exposure to Mn-containing fungicides. Self-reported pesticide exposure data will be used to develop exposure intensity scores using an exposure algorithm. Furthermore, exposure-outcome associations will be examined using linear and logistic mixed-effects regression models. Results: Fieldwork for our study was conducted between May 2016 and August 2016. In total, 113 farm owners and 187 workers from 9 organic and 83 conventional horticultural smallholder farms were enrolled. Data analyses are ongoing and expected to be published between 2019 and 2020. Conclusions: This study is one of the first to examine differences in health effects due to pesticide exposure between farm owners and workers from organic and conventional smallholder farms in an LMIC. We expect that this study will provide critical data on farming practices, exposure pathways, and how occupational exposure to pesticides may affect farm owners and workers’ health. Finally, we hope that this study will allow us to identify strategies to reduce pesticide exposure in farm owners and workers and will potentially lay the groundwork for a future longitudinal study of health outcomes in farm owners and workers exposed to pesticides. International Registered Report Identifier (IRRID): DERR1-10.2196/10914 %M 30681969 %R 10.2196/10914 %U http://www.researchprotocols.org/2019/1/e10914/ %U https://doi.org/10.2196/10914 %U http://www.ncbi.nlm.nih.gov/pubmed/30681969 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 8 %N 1 %P e11596 %T The Table to Tablet (T2T) Speech and Language Therapy Software Development Roadmap %A Jesus,Luis MT %A Santos,Joaquim %A Martinez,Joana %+ University of Aveiro, Campus Universitário de Santiago, Aveiro, 3810-193 Aveiro, Portugal, 351 234372458 ext 22117, lmtj@ua.pt %K software %K tablets %K children %K speech sound disorders %K design-based research %D 2019 %7 30.01.2019 %9 Original Paper %J JMIR Res Protoc %G English %X Background: Few studies have analyzed gains in using computers in speech and language therapy interventions for children with speech and/or language disorders when compared to a control group, but virtual tutors and computer-based visual feedback have been gaining interest in the literature. Previous systematic reviews mainly focused on development technological details of computer-based speech training systems or the potential of integrating mobile technology into education and rehabilitation, but recent systematic reviews have also evaluated the efficacy of computer-based speech and language therapy for children and how digital technology can support different activities, at school or elsewhere. Objective: This study aimed to analyze a continuous communication and joint team approach to develop solutions focused on the real needs of end users, which digitally emulate reliable and validated physical intervention materials for children with speech sound disorders (SSD). Methods: The Table to Tablet (T2T) software was developed using a design-based research methodology, which included four phases: activities development; ethnographic pretesting with a sample from the target population; software development; and beta-testing. The technology used to develop the software, the method used to ensure satisfaction and replay ability of the intervention materials, and results from the ethnographic and beta-testing phases are presented. Results: Nineteen activities were developed during the first phase, which were then tested, with 7 service users, using a physical prototype. The beta-test approach included extensive testing and reformulation, supported by direct, nonparticipant observation and data collection using a questionnaire designed for children. Feedback was used to improve the software and interaction with users. Conclusions: The use of T2T-based intervention programmes by speech and language therapists (SLTs) will allow these professionals to make a better and more effective communication intervention, based on proven methodologies, that coexists in a structured physical and a digital version. These versions provide a full, 6-week intervention program, with minimal effort in preparing the session by the SLTs while delivering a very consistent intervention, with high replay value. A continuous communication and joint team approach was beneficial to the project and to the development of a solution focused on the real needs of SLTs and children with SSD. All problems were approached as a team with different skills and expertise, which minimized errors (eg, the developer making choices that would save him from spending time doing something that would not be used) and time spent. To add to this, the importance of integrating the end users as testers and collecting their opinions and actions per session allowed the production of better-targeted activities. Trial Registration: ClinicalTrials.gov NCT02490826; https://clinicaltrials.gov/ct2/show/NCT02490826 %M 30698534 %R 10.2196/11596 %U http://www.researchprotocols.org/2019/1/e11596/ %U https://doi.org/10.2196/11596 %U http://www.ncbi.nlm.nih.gov/pubmed/30698534 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 8 %N 1 %P e12006 %T Development of the Gambling Disorder Identification Test (G-DIT): Protocol for a Delphi Method Study %A Molander,Olof %A Volberg,Rachel %A Sundqvist,Kristina %A Wennberg,Peter %A Månsson,Viktor %A Berman,Anne H %+ Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, Norra Stationsgatan 69, 7th floor, Stockholm, 113 64, Sweden, 46 700011241, olof.molander@ki.se %K consensus methods %K Delphi technique %K DSM-5 %K gambling %K Gambling Disorder Identification Test %K measurement %K psychometrics %K screening %D 2019 %7 08.01.2019 %9 Protocol %J JMIR Res Protoc %G English %X Background: Research on the identification and treatment of problem gambling has been characterized by a wide range of outcome measures and instruments. However, a single instrument measuring gambling behavior, severity, and specific deleterious effects is lacking. Objective: This protocol describes the development of the Gambling Disorder Identification Test (G-DIT), which is a 9- to 12-item multiple-choice scale with three domains: gambling consumption, symptom severity, and negative consequences. The scale is analogous to the widely used Alcohol Use Disorders Identification Test (AUDIT) and the Drug Use Disorders Identification Test (DUDIT). Methods: The G-DIT is developed in four steps: (1) identification of items eligible for the G-DIT from a pool of existing gambling measures; (2) presentation of items proposed for evaluation by invited expert researchers through an online Delphi process and subsequent consensus meetings; (3) pilot testing of a draft of the 9- to 12-item version in a small group of participants with problem gambling behavior (n=12); and (4) evaluation of the psychometric properties of the final G-DIT measure in relation to the existing instruments and self-reported criteria of the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5), among individuals with problem gambling and nonproblematic recreational gambling behaviors (n=600). This protocol article summarizes step 1 and describes steps 2 and 3 in detail. Results: As of October 2018, steps 1-3 are complete, and step 4 is underway. Conclusions: Implementation of this online Delphi study early in the psychometric development process will contribute to the face and construct validity of the G-DIT. We believe the G-DIT will be useful as a standard outcome measure in the field of problem gambling research and serve as a problem-identification tool in clinical settings. International Registered Report Identifier (IRRID): RR1-10.2196/12006 %M 30622097 %R 10.2196/12006 %U http://www.researchprotocols.org/2019/1/e12006/ %U https://doi.org/10.2196/12006 %U http://www.ncbi.nlm.nih.gov/pubmed/30622097 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 8 %N 1 %P e12270 %T Association Between Residual Inhibition and Neural Activity in Patients with Tinnitus: Protocol for a Controlled Within- and Between-Subject Comparison Study %A Hu,Suyi %A Anschuetz,Lukas %A Huth,Markus E %A Sznitman,Raphael %A Blaser,Daniela %A Kompis,Martin %A Hall,Deborah A %A Caversaccio,Marco %A Wimmer,Wilhelm %+ Hearing Research Laboratory, ARTORG Center for Biomedical Engineering Research, University of Bern, Murtenstrasse 50, Bern,, Switzerland, 41 316238789, wilhelm.wimmer@artorg.unibe.ch %K electroencephalography %K heterogeneity %K high-frequency audiometry %K neural activity %K tinnitus %K tinnitometry %D 2019 %7 09.01.2019 %9 Protocol %J JMIR Res Protoc %G English %X Background: Electroencephalography (EEG) studies indicate possible associations between tinnitus and changes in the neural activity. However, inconsistent results require further investigation to better understand such heterogeneity and inform the interpretation of previous findings. Objective: This study aims to investigate the feasibility of EEG measurements as an objective indicator for the identification of tinnitus-associated neural activities. Methods: To reduce heterogeneity, participants served as their own control using residual inhibition (RI) to modulate the tinnitus perception in a within-subject EEG study design with a tinnitus group. In addition, comparison with a nontinnitus control group allowed for a between-subjects comparison. We will apply RI stimulation to generate tinnitus and nontinnitus conditions in the same subject. Furthermore, high-frequency audiometry (up to 13 kHz) and tinnitometry will be performed. Results: This work was funded by the Infrastructure Grant of the University of Bern, Bern, Switzerland and Bernafon AG, Bern, Switzerland. Enrollment for the study described in this protocol commenced in February 2018. Data analysis is currently under way and the first results are expected to be submitted for publication in 2019. Conclusions: This study design helps in comparing the neural activity between conditions in the same individual, thereby addressing a notable limitation of previous EEG tinnitus studies. In addition, the high-frequency assessment will help to analyze and classify tinnitus symptoms beyond the conventional clinical standard. International Registered Report Identifier (IRRID): RR1-10.2196/12270 %M 30626571 %R 10.2196/12270 %U http://www.researchprotocols.org/2019/1/e12270/ %U https://doi.org/10.2196/12270 %U http://www.ncbi.nlm.nih.gov/pubmed/30626571 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 8 %N 1 %P e11333 %T Estimating Vaccine Effectiveness Against Hospitalized Influenza During Pregnancy: Multicountry Protocol for a Retrospective Cohort Study %A Naleway,Allison L %A Ball,Sarah %A Kwong,Jeffrey C %A Wyant,Brandy E %A Katz,Mark A %A Regan,Annette K %A Russell,Margaret L %A Klein,Nicola P %A Chung,Hannah %A Simmonds,Kimberley A %A Azziz-Baumgartner,Eduardo %A Feldman,Becca S %A Levy,Avram %A Fell,Deshayne B %A Drews,Steven J %A Garg,Shikha %A Effler,Paul %A Barda,Noam %A Irving,Stephanie A %A Shifflett,Patricia %A Jackson,Michael L %A Thompson,Mark G %+ Kaiser Permanente Northwest, Center for Health Research, 3800 North Interstate Avenue, Portland, OR, 97005, United States, 1 503 335 6352, allison.naleway@kpchr.org %K influenza %K pregnancy %K hospitalization %K epidemiology %K vaccines %D 2019 %7 21.01.2019 %9 Protocol %J JMIR Res Protoc %G English %X Background: Although pregnant women are believed to have elevated risks of severe influenza infection and are targeted for influenza vaccination, no study to date has examined influenza vaccine effectiveness (IVE) against laboratory-confirmed influenza-associated hospitalizations during pregnancy, primarily because this outcome poses many methodological challenges. Objective: The Pregnancy Influenza Vaccine Effectiveness Network (PREVENT) was formed in 2016 as an international collaboration with the Centers for Disease Control and Prevention; Abt Associates; and study sites in Australia, Canada, Israel, and the United States. The primary goal of this collaboration is to estimate IVE in preventing acute respiratory or febrile illness (ARFI) hospitalizations associated with laboratory-confirmed influenza virus infection during pregnancy. Secondary aims include (1) describing the incidence, clinical course, and severity of influenza-associated ARFI hospitalization during pregnancy; (2) comparing the characteristics of ARFI-hospitalized pregnant women who were tested for influenza with those who were not tested; (3) describing influenza vaccination coverage in pregnant women; and (4) comparing birth outcomes among women with laboratory-confirmed influenza-associated hospitalization versus other noninfluenza ARFI hospitalizations. Methods: For an initial assessment of IVE, sites identified a retrospective cohort of pregnant women aged from 18 to 50 years whose pregnancies overlapped with local influenza seasons from 2010 to 2016. Pregnancies were defined as those that ended in a live birth or stillbirth of at least 20 weeks gestation. The analytic sample for the primary IVE analysis was restricted to pregnant women who were hospitalized for ARFI during site-specific influenza seasons and clinically tested for influenza virus infection using real-time reverse transcription polymerase chain reaction. Results: We identified approximately 2 million women whose pregnancies overlapped with influenza seasons; 550,344 had at least one hospitalization during this time. After restricting to women who were hospitalized for ARFI and tested for influenza, the IVE analytic sample included 1005 women. Conclusions: In addition to addressing the primary question about the effectiveness of influenza vaccination, PREVENT data will address other important knowledge gaps including understanding the incidence, clinical course, and severity of influenza-related hospitalizations during pregnancy. The data infrastructure and international partnerships created for these analyses may be useful and informative for future influenza studies. International Registered Report Identifier (IRRID): DERR1-10.2196/11333 %M 30664495 %R 10.2196/11333 %U http://www.researchprotocols.org/2019/1/e11333/ %U https://doi.org/10.2196/11333 %U http://www.ncbi.nlm.nih.gov/pubmed/30664495 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 8 %N 1 %P e10738 %T A Focus on the HIV Care Continuum Through the Healthy Young Men’s Cohort Study: Protocol for a Mixed-Methods Study %A Kipke,Michele D %A Kubicek,Katrina %A Wong,Carolyn F %A Robinson,Yolo Akili %A Akinyemi,Ifedayo C %A Beyer,William J %A Hawkins,Wendy %A Rice,Cara E %A Layland,Eric %A Bray,Bethany C %A Belzer,Marvin %+ Division of Research on Children, Youth and Families, The Saban Research Institute, Children's Hospital Los Angeles, 4650 Sunset Blvd, MS #30, Los Angeles, CA, 90027, United States, 1 3104976295, mkipke@chla.usc.edu %K acquired immune deficiency syndrome virus %K HIV %K cohort study %K men who have sex with men %D 2019 %7 24.01.2019 %9 Protocol %J JMIR Res Protoc %G English %X Background: No group is at greater risk for acquiring HIV than young men who have sex with men (YMSM), particularly black or African American (AA) and Hispanic or Latino (L) YMSM living in inner cities, who account for the largest number of new HIV infections each year. Although pre-exposure prophylaxis (PrEP), postexposure prophylaxis (PEP), and treatment as prevention hold enormous promise for changing the course of the epidemic, AA/L-YMSM are the least likely population to be receiving primary health care and HIV prevention/care and are the least likely to be using PrEP and PEP. Objective: The overarching aim of the Healthy Young Men’s (HYM) cohort study is to conduct longitudinal research with a cohort of AA/L-YMSM to prevent new HIV infections, reduce transmission, and reduce HIV/AIDS-related disparities by focusing on successful engagement in care. Findings from this research will be used to inform the development of new interventions designed to engage AA/L-YMSM in the HIV prevention and care continua. Methods: Longitudinal research (baseline and follow-up assessments every 6 months for a total of 8 waves of data collection) is ongoing with a new cohort of 450 high-risk AA/L-YMSM in Los Angeles. Participants were recruited using a venue-based and social media sampling design. In addition to self-report surveys, the study protocol includes the collection of urine to assess recent use of illicit drugs and the collection of blood and rectal/throat swabs to test for current sexually transmitted infection (STI)/HIV infection. An additional sample of blood/plasma (10 mL for 4 aliquots and 1 pellet) is also collected and stored in the HYM cohort study biorepository for future research. By design, we recruited 400 HIV-negative participants and 50 HIV-positive (HIV+) participants. This mixed-methods study design includes collection and triangulated analysis of quantitative, qualitative, and biological measures (ie, drug use, STI/HIV testing, and adherence to antiretroviral therapy among HIV+ participants) at baseline and every 6 months. The HYM cohort study will provide a platform from which new and emerging biomedical prevention strategies (eg, PrEP, rectal microbicides, and PEP) and other HIV prevention and care engagement interventions can be developed and evaluated with AA/L-YMSM. Results: To date, all participants in the HYM cohort study have been recruited and baseline assessment has been conducted. Conclusions: The findings from this research will be used to inform the development of new and/or adaptation of existing evidence-based HIV prevention interventions and interventions designed to engage this population in the HIV prevention and care continua. International Registered Report Identifier (IRRID): DERR1-10.2196/10738 %M 30679146 %R 10.2196/10738 %U http://www.researchprotocols.org/2019/1/e10738/ %U https://doi.org/10.2196/10738 %U http://www.ncbi.nlm.nih.gov/pubmed/30679146 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 8 %N 1 %P e10753 %T Role or Synergistic Interaction of Adenosine and Vitamin D3 Alongside High-Intensity Interval Training and Isocaloric Moderate Intensity Training on Metabolic Parameters: Protocol for an Experimental Study %A Mirghani,Seyed Javad %A Peeri,Maghsoud %A Yaghoobpour Yekani,Omid %A Zamani,Masoud %A Feizolahi,Foad %A Nikbin,Sina %A Derakhshideh,Armin %A Mousavi,Niloufar %A Khojasteh,Zohreh %A Nasrollahi,Zeynab %A Khorasani,Elya %A Ghodousi Johari,Elham %A Afshar,Tayebeh %A Azarbayjani,Mohammad Ali %+ Department of Exercise Physiology, Faculty of Physical Education and Sports Science, Islamic Azad University, Central Tehran Branch, , Tehran,, Islamic Republic of Iran, 98 9120747177, seyedgavadmirghani@yahoo.com %K high-fat, diet-induced obesity %K high-intensity interval training %K isocaloric moderate-intensity training %K vitamin D3 %K adenosine %K metabolic parameters %K weight loss %D 2019 %7 30.01.2019 %9 Protocol %J JMIR Res Protoc %G English %X Background: Obesity is known as one of the major causes of epidemiologic diseases worldwide; therefore, the introduction of treatment strategies by medical professionals, such as the use of various medicines and exercise programs to reduce fat or prevent obesity, is on the rise. Recently, researchers have shown special interest in assessing the effect of lipolytic adenosine and vitamin D deficiency, as well as the effect of exercise, on decreasing body fat percentage. Objective: This study has been designed to examine the effect of adenosine and vitamin D3 injections, in conjunction with high-intensity interval training and isocaloric moderate-intensity training, on the metabolic parameters of obesity induced by a high-fat diet. Methods: This is an experimental study using 92 Wistar rats. At 6 weeks of age, the rats' weights will be recorded, after which they will have 1 week to adapt to their new environment before being divided into 12 groups. The rats will participate in a 2-stage experimental intervention, including a 13-week fattening diet phase followed by a 12-week exercise training phase consisting of an exercise program and the injection of adenosine and vitamin D3. Groups 1 and 2 will have a normal diet, and the other groups will have a diet of 40% fat, with free access to food and water up to the second half of the second stage of the study (end of the sixth week of training). After termination of the interventions, tissue collection and molecular assessments (blood for biochemical, tissues for gene expression analyses, and anthropometrical indexes) will be performed. Results: The project was initiated in April 2017 and completed in December 2017. Data analysis is under way, and the first results are expected to be submitted for publication in November 2018. Conclusions: We hypothesize that weight loss–induced molecular changes and upregulation will be observed in line with an increase in lipolysis and beta oxidation in muscle and fat tissue as a result of performing isocaloric training in drug-receiving rats and groups on a high-fat diet. International Registered Report Identifier (IRRID): RR1-10.2196/10753 %M 30698527 %R 10.2196/10753 %U http://www.researchprotocols.org/2019/1/e10753/ %U https://doi.org/10.2196/10753 %U http://www.ncbi.nlm.nih.gov/pubmed/30698527 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 8 %N 1 %P e10941 %T Neurological Disorders in Central Spain, Second Survey: Feasibility Pilot Observational Study %A Hernández-Gallego,Jesús %A Llamas-Velasco,Sara %A Bermejo-Pareja,Felix %A Vega,Saturio %A Tapias-Merino,Ester %A Rodríguez-Sánchez,Emiliano %A Boycheva,Elina %A Serrano,José Ignacio %A Gil-García,Juan-Francisco %A Trincado,Rocio %A Sánchez-Rodrigo,José-María Vizcaino %A Cacho,Jesús %A Contador,Israel %A Garcia-Ptacek,Sara %A Sierra-Hidalgo,Fernando %A Cubo,Esther %A Carro,Eva %A Villarejo-Galende,Alberto %A García García-Patino,Rosalía %A Benito-León,Julián %+ Department of Neurology, University Hospital “12 de Octubre”, Av de Córdoba km 5400, Madrid, ES-28041, Spain, 34 34 913908000, jbenitol67@gmail.com %K dementia %K essential tremor %K headache %K longitudinal study %K mild cognitive impairment %K NEDICES %K observational study %K Parkinson’s disease %K pilot study %K population-based study %K stroke %D 2019 %7 10.01.2019 %9 Original Paper %J JMIR Res Protoc %G English %X Background: The Neurological Disorders in Central Spain, second survey (NEDICES-2) is a population-based, closed-cohort study that will include over 8000 subjects aged ≥55 years. It will also include a biobank. Objective: The objective of this study was to evaluate all major aspects of the NEDICES-2 (methods, database, screening instruments, and questionnaires, as well as interexpert rating of the neurological diagnoses) in each one of the planned areas (all of them in central Spain) and to test the possibility of obtaining biological samples from each participant. Methods: A selection of patients and participants of the planned NEDICES-2 underwent face-to-face interviews including a comprehensive questionnaire on demographics, current medications, medical conditions, and lifestyle habits. Biological samples (blood, saliva, urine, and hair) were also obtained. Furthermore, every participant was examined by a neurologist. Results: In this pilot study, 567 study participants were enrolled (196 from hospitals and 371 from primary care physician lists). Of these 567, 310 completed all study procedures (questionnaires and the neurological evaluation). The study was time-consuming for several primary care physicians. Hence, a few primary care physicians from some areas refused to participate, which led to a reconfiguration of study areas. In addition, the central biobank needed to be supplemented by the biobanks of local Spanish National Health System hospitals. Conclusions: Population-based epidemiological surveys, such as the NEDICES-2, require a pilot study to evaluate the feasibility of all aspects of a future field study (population selection, methods and instruments to be used, neurological diagnosis agreement, and data collection). %M 30632964 %R 10.2196/10941 %U http://www.researchprotocols.org/2019/1/e10941/ %U https://doi.org/10.2196/10941 %U http://www.ncbi.nlm.nih.gov/pubmed/30632964 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 8 %N 1 %P e10974 %T Accelerating Research With Technology: Rapid Recruitment for a Large-Scale Web-Based Sleep Study %A Deering,Sean %A Grade,Madeline M %A Uppal,Jaspreet K %A Foschini,Luca %A Juusola,Jessie L %A Amdur,Adam M %A Stepnowsky,Carl J %+ Evidation Health, 167 2nd Avenue, San Mateo, CA, 94401, United States, 1 6502798855, jjuusola@evidation.com %K connected health %K engagement %K health %K mHealth %K mobile health %K mobile phone %K recruitment %K sleep %K sleep quality %K wearables %D 2019 %7 21.01.2019 %9 Original Paper %J JMIR Res Protoc %G English %X Background: Participant recruitment can be a significant bottleneck in carrying out research studies. Connected health and mobile health platforms allow for the development of Web-based studies that can offer improvement in this domain. Sleep is of vital importance to the mental and physical health of all individuals, yet is understudied on a large scale or beyond the focus of sleep disorders. For this reason and owing to the availability of digital sleep tracking tools, sleep is well suited to being studied in a Web-based environment. Objective: The aim of this study was to investigate a method for speeding up the recruitment process and maximizing participant engagement using a novel approach, the Achievement Studies platform (Evidation Health, Inc, San Mateo, CA, USA), while carrying out a study that examined the relationship between participant sleep and daytime function. Methods: Participants could access the Web-based study platform at any time from any computer or Web-enabled device to complete study procedures and track study progress. Achievement community members were invited to the study and assessed for eligibility. Eligible participants completed an electronic informed consent process to enroll in the study and were subsequently invited to complete an electronic baseline questionnaire. Then, they were asked to connect a wearable device account through their study dashboard, which shared their device data with the research team. The data were used to provide objective sleep and activity metrics for the study. Participants who completed the baseline questionnaires were subsequently sent a daily single-item Sleepiness Checker activity for 7 consecutive days at baseline and every 3 months thereafter for 1 year. Results: Overall, 1156 participants enrolled in the study within a 5-day recruitment window. In the 1st hour, the enrollment rate was 6.6 participants per minute (394 per hour). In the first 24 hours, the enrollment rate was 0.8 participants per minute (47 participants per hour). Overall, 1132 participants completed the baseline questionnaires (1132/1156, 97.9%) and 1047 participants completed the initial Sleepiness Checker activity (1047/1156, 90.6%). Furthermore, 1000 participants provided activity-specific wearable data (1000/1156, 86.5%) and 982 provided sleep-specific wearable data (982/1156, 84.9%). Conclusions: The Achievement Studies platform allowed for rapid recruitment and high study engagement (survey completion and device data sharing). This approach to carrying out research appears promising. However, conducting research in this way requires that participants have internet access and own and use a wearable device. As such, our sample may not be representative of the general population. %M 30664491 %R 10.2196/10974 %U http://www.researchprotocols.org/2019/1/e10974/ %U https://doi.org/10.2196/10974 %U http://www.ncbi.nlm.nih.gov/pubmed/30664491 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 8 %N 1 %P e12180 %T Metadata Correction: A Decision Support System to Enhance Self-Management of Low Back Pain: Protocol for the selfBACK Project %A Mork,Paul Jarle %A Bach,Kerstin %A , %+ Department of Public Health and Nursing, Norwegian University of Science and Technology, Håkon Jarls Gate 1, Trondheim, N-7491, Norway, 47 73597577, paul.mork@ntnu.no %D 2019 %7 03.01.2019 %9 Corrigenda and Addenda %J JMIR Res Protoc %G English %X %M 30609979 %R 10.2196/12180 %U https://www.researchprotocols.org/2019/1/e12180/ %U https://doi.org/10.2196/12180 %U http://www.ncbi.nlm.nih.gov/pubmed/30609979 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 8 %N 1 %P e10712 %T Metadata Correction: Epidemiology of Surgical Site Infections With Staphylococcus aureus in Europe: Protocol for a Retrospective, Multicenter Study %A Mellinghoff,Sibylle C %A Vehreschild,Jörg Janne %A Liss,Blasius J %A Cornely,Oliver A %+ Department I of Internal Medicine, University Hospital of Cologne, University of Cologne, Kerpener St 62, Cologne, 50937, Germany, 49 22147832884, sibylle.mellinghoff@uk-koeln.de %D 2019 %7 07.01.2019 %9 Corrigenda and Addenda %J JMIR Res Protoc %G English %X %M 30617045 %R 10.2196/10712 %U http://www.researchprotocols.org/2019/1/e10712/ %U https://doi.org/10.2196/10712 %U http://www.ncbi.nlm.nih.gov/pubmed/30617045 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 8 %N 1 %P e12117 %T A Social Media Website (Supporting Our Valued Adolescents) to Support Treatment Uptake for Adolescents With Depression and/or Anxiety and Their Parents: Protocol for a Pilot Randomized Controlled Trial %A Radovic,Ana %A Li,Yaming %A Landsittel,Douglas %A Stein,Bradley D %A Miller,Elizabeth %+ Division of Adolescent and Young Adult Medicine, Department of Pediatrics, University of Pittsburgh School of Medicine, 120 Lytton Avenue, Pittsburgh, PA, 15213, United States, 1 412 692 7227, ana.radovic@chp.edu %K adolescent %K adolescent health services %K anxiety %K depression %K technology %D 2019 %7 23.01.2019 %9 Protocol %J JMIR Res Protoc %G English %X Background: Few adolescents who experience depression or anxiety connect to mental health treatment. Supporting Our Valued Adolescents (SOVA) is a stakeholder-informed technology intervention that consists of 2 blog-format websites—one for adolescents and another for parents. SOVA is designed to intervene on targets, which may increase the mental health treatment uptake when adolescents with depression or anxiety are identified in primary care settings. Objective: This study aims to describe the protocol for a pilot randomized controlled trial designed to refine recruitment and retention strategies, document intervention fidelity and implementation outcomes, and assess changes in health beliefs and knowledge, emotional or informational support, and parent-adolescent communication quality in adolescents and their parents. Methods: Adolescents identified with symptoms of depression or anxiety, for which a health care provider recommends treatment, and their parents will be recruited from clinics where adolescents are seen for primary care. Adolescent-parent dyads will be randomized at 1:1 to both receive the SOVA websites and enhanced usual care or enhanced usual care alone. Baseline measures and 6-week and 3-month outcomes will be collected by Web-based self-report surveys and electronic health record review. The main pilot outcome is the 6-week study retention rate. Analyses will also assess changes in health beliefs and knowledge, emotional support, and parent-adolescent communication in both adolescents and their parents. Results: The project was funded in 2017. Recruitment commenced in April 2018 and enrollment is ongoing, with completion anticipated at the end of 2019 with subsequent plans for data analysis and publication submission in early 2020. Conclusions: The findings of this research will inform the design of a multisite hybrid effectiveness-implementation randomized controlled trial examining the effectiveness and optimal implementation strategies for using SOVA in community primary care settings. Trial Registration: ClinicalTrials.gov NCT03318666; https://clinicaltrials.gov/ct2/show/NCT03318666 International Registered Report Identifier (IRRID): PRR1-10.2196/12117 %M 30672741 %R 10.2196/12117 %U http://www.researchprotocols.org/2019/1/e12117/ %U https://doi.org/10.2196/12117 %U http://www.ncbi.nlm.nih.gov/pubmed/30672741 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 8 %N 1 %P e10370 %T The Development and Testing of a Relationship Skills Intervention to Improve HIV Prevention Uptake Among Young Gay, Bisexual, and Other Men Who Have Sex With Men and Their Primary Partners (We Prevent): Protocol for a Randomized Controlled Trial %A Gamarel,Kristi E %A Darbes,Lynae A %A Hightow-Weidman,Lisa %A Sullivan,Patrick %A Stephenson,Rob %+ Center for Sexuality and Health Disparities, University of Michigan, Room 2236, 400 North Ingalls Street, Ann Arbor, MI, 48109, United States, 1 734 615 0149, rbsteph@umich.edu %K HIV %K telehealth %K men who have sex with men %K adolescents %K couples %D 2019 %7 02.01.2019 %9 Original Paper %J JMIR Res Protoc %G English %X Background: Young gay, bisexual, and other men who have sex with men (YMSM) continue to be the group most heavily impacted by HIV in the United States. Substantial evidence indicates that up to two-thirds of new HIV infections occur in the context of a main partnership. Couples HIV testing and counseling (CHTC) has been shown to be a promising and effective strategy for increasing HIV prevention uptake among male couples; however, YMSM who are new to relationships may not have yet developed the efficacy, negotiation, and communication skills to navigate HIV testing in their relationship and communicate around developing a prevention plan. Objective: This study aims to develop and test a relationship skills–focused HIV prevention intervention for YMSM and their partners. The intervention consists of two telehealth-delivered sessions: the first focuses on relationship skills and the second consists of CHTC and prevention planning. Both sessions are attended by both members of the dyad. Methods: This protocol describes the development of the proposed intervention (We Prevent) and pilot test to examine its feasibility and preliminary efficacy. The intervention will include two motivational interviewing–based sessions: session one is a relationship skills–building session, focused on techniques to explore and build communication skills in a relationship, to help YMSM develop and enhance necessary skills for their current and future relationships; the second session is a CHTC session with YMSM and their partners, to help them develop an HIV prevention plan. Through qualitative data collection and a one-arm pilot with YMSM, we will develop and refine a developmentally appropriate relationship skills session as an addition to the current CHTC intervention. We will then conduct a pilot randomized controlled trial (RCT), comparing the acceptability, feasibility, and preliminary efficacy of the adapted two-session telehealth intervention for YMSM versus a control group receiving one session only—a CHTC session delivered via telehealth. Results: The We Prevent intervention is designed to increase uptake of HIV prevention, shown through self-reported reductions in condomless sex and increases in knowledge and uptake of pre-exposure prophylaxis. In addition, the intervention is designed to increase HIV and sexually transmitted infection (STI) testing. STI incidence is examined as a secondary outcome. A cost-input analysis will examine the costs associated with intervention delivery to inform future scale-up of the intervention. Conclusions: Drawing on theory and existing CHTC protocols delivered with video-based counseling, this proposed intervention affords the opportunity to empower YMSM with the skills necessary to communicate with their partners and protect themselves from HIV in their current and future relationships. Trial Registration: Clinicaltrials.gov NCT03551938; https://clinicaltrials.gov/ct2/show/NCT03551938 (Archived by WebCite at http://www.webcitation.org/73omJCz1a) International Registered Report Identifier (IRRID): RR1-10.2196/10370 %M 30602433 %R 10.2196/10370 %U http://www.researchprotocols.org/2019/1/e10370/ %U https://doi.org/10.2196/10370 %U http://www.ncbi.nlm.nih.gov/pubmed/30602433 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 8 %N 1 %P e10694 %T A Mobile-Based App (MyChoices) to Increase Uptake of HIV Testing and Pre-Exposure Prophylaxis by Young Men Who Have Sex With Men: Protocol for a Pilot Randomized Controlled Trial %A Biello,Katie B %A Marrow,Elliot %A Mimiaga,Matthew J %A Sullivan,Patrick %A Hightow-Weidman,Lisa %A Mayer,Kenneth H %+ Center for Health Equity Research, Brown University School of Public Health, Box G-S121-8, Providence, RI, 02912, United States, 1 401 863 3082, katie_biello@brown.edu %K adolescents %K HIV %K men who have sex with men %K mHealth %K mobile phone %K pre-exposure prophylaxis %D 2019 %7 07.01.2019 %9 Protocol %J JMIR Res Protoc %G English %X Background: HIV incidence is growing most rapidly in the United States among young men who have sex with men (YMSM). Overwhelming evidence demonstrates that routine testing and expanded use of pre-exposure prophylaxis (PrEP) would dramatically reduce the population burden of HIV; however, uptake of both interventions is suboptimal among young adults. The use of mobile phone apps by YMSM is ubiquitous and may offer unique opportunities for public health interventions. MyChoices is a theory-driven app to increase HIV testing and PrEP uptake. It was developed by an interdisciplinary team based on feedback from a diverse sample of YMSM. Objective: The aim of this paper is to describe the protocol for the refinement, beta testing, and pilot randomized controlled trial (RCT) to examine the acceptability and feasibility of the MyChoices app. Methods: This 3-phase study includes 4 theater testing groups for app refinement with a total of approximately 30 YMSM; for beta testing, including quantitative assessments and exit interviews, with approximately 15 YMSM over a 2-month period; and for a pilot RCT with 60 YMSM. The pilot will assess feasibility, acceptability, and preliminary efficacy of the MyChoices app, compared with referrals only, in increasing HIV testing and PrEP uptake. All participants will be recruited at iTech clinical research sites in Boston, MA, and Bronx, NY. Results: App refinement is underway. Enrollment for the pilot RCT began in October 2018. Conclusions: MyChoices is one of the first comprehensive, theory-driven HIV prevention apps designed specifically for YMSM. If MyChoices demonstrates acceptability and feasibility in this pilot RCT, a multicity, 3-arm randomized controlled efficacy trial of this app and another youth-optimized app (LYNX) versus standard of care is planned within iTech. If shown to be efficacious, the app will be scalable, with the ability to reach YMSM across the United States as well as be geographically individualized, with app content integrated with local prevention and testing activities. International Registered Report Identifier (IRRID): PRR1-10.2196/10694 %M 30617042 %R 10.2196/10694 %U http://www.researchprotocols.org/2019/1/e10694/ %U https://doi.org/10.2196/10694 %U http://www.ncbi.nlm.nih.gov/pubmed/30617042 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 8 %N 1 %P e10807 %T Acute HIV Infection in Youth: Protocol for the Adolescent Trials Network 147 (ATN147) Comprehensive Adolescent Research and Engagement Studies (CARES) Study %A Nielsen-Saines,Karin %A Mitchell,Kate %A Kerin,Tara %A Fournier,Jasmine %A Kozina,Leslie %A Andrews,Brenda %A Cortado,Ruth %A Bolan,Robert %A Flynn,Risa %A Rotheram,Mary Jane %A Abdalian,Sue Ellen %A Bryson,Yvonne %A , %+ Department of Pediatrics, David Geffen School of Medicine, University of California Los Angeles, 22-442 MDCC, 805 Tiverton Ave, Los Angeles, CA, 90095-1752, United States, 1 310 825 5235, knielsen@mednet.ucla.edu %K HIV %K youth %K adolescents %D 2019 %7 16.01.2019 %9 Protocol %J JMIR Res Protoc %G English %X Background: Early treatment studies have shown that prompt treatment of HIV with combination antiretroviral therapy (cART) can limit the size of latent viral reservoirs, thereby providing clinical and public health benefits. Studies have demonstrated that adolescents have a greater capacity for immune reconstitution than adults. Nevertheless, adolescents who acquired HIV through sexual transmission have not been included in early treatment studies because of challenges in identification and adherence to cART. Objective: This study aimed to identify and promptly treat with cART youth aged 12 to 24 years in Los Angeles and New Orleans who have acute, recent, or established HIV infection, as determined by Fiebig stages 1 to 6 determined by viral RNA polymerase chain reaction, p24 antigen presence, and HIV-1 antigen Western blot. The protocol recommends treatment on the day of diagnosis when feasible. Surveillance and dedicated behavioral strategies are used to retain them in care and optimize adherence. Through serial follow-up, HIV biomarkers and response to antiretroviral therapy (ART) are assessed. The study aims to assess viral dynamics, decay and persistence of viral reservoirs over time, and correlate these data with the duration of viral suppression. Methods: A total of 72 youth (36 acutely infected and 36 treatment naïve controls) are enrolled across clinical sites using a current community-based strategy and direct referrals. Youth are prescribed ART according to the standard of care HIV-1 management guidelines and followed for a period of 2 years. Assessments are conducted at specific time points throughout these 2 years of follow-up for monitoring of adherence to ART, viral load, magnitude of HIV reservoirs, and presence of coinfections. Results: The study began enrolling youth in July 2017 across study sites in Los Angeles and New Orleans. As of September 30, 2018, a total of 37 youth were enrolled, 12 with recently acquired, 16 with established HIV infection as determined by Fiebig staging, and 9 pending determination of Fiebig status. Recruitment and enrollment are ongoing. Conclusions: We hypothesize that the size of the HIV reservoir and immune activation markers will be different across groups treated with cART, that is, those with acute or recent HIV infection and those with established infection. Adolescents treated early who are virally suppressed will have diminished HIV reservoirs than those with established infection. These youth may be potential candidates for a possible HIV vaccine and additional HIV remission intervention trials. Our study will inform future studies of viral remission strategies. International Registered Report Identifier (IRRID): DERR1-10.2196/10807 %M 30650057 %R 10.2196/10807 %U http://www.researchprotocols.org/2019/1/e10807/ %U https://doi.org/10.2196/10807 %U http://www.ncbi.nlm.nih.gov/pubmed/30650057 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 8 %N 1 %P e10759 %T Strategies to Treat and Prevent HIV in the United States for Adolescents and Young Adults: Protocol for a Mixed-Methods Study %A Rotheram,Mary Jane %A Fernandez,Maria Isabel %A Lee,Sung-Jae %A Abdalian,Sue Ellen %A Kozina,Leslie %A Koussa,Maryann %A Comulada,Warren Scott %A Klausner,Jeffrey D %A Mayfield Arnold,Elizabeth %A Ocasio,Manuel A %A Swendeman,Dallas %A , %+ Department of Psychiatry & Biobehavioral Sciences, University of California Los Angeles, 10920 Wilshire Boulevard, Suite 350, Los Angeles, CA, 90024, United States, 1 310 794 8278, cchpublications@mednet.ucla.edu %K gay, bisexual, and transgender youth %K HIV/AIDS %K homelessness %K LGBTQ %K mobile phone %D 2019 %7 21.01.2019 %9 Protocol %J JMIR Res Protoc %G English %X Background: Over 20% of HIV diagnoses in the United States are among youth aged 12-24 years. Furthermore, youth have the lowest rates of uptake and adherence to antiretroviral (ARV) medications and are least aware of their HIV status. Objective: Our objective was to design a set of interrelated studies to promote completion of each step of the HIV Prevention Continuum by uninfected youth at high risk (YHR), as well as completion of steps in the Treatment Continuum by youth living with HIV (YLH). Methods: Gay, bisexual, and transgender youth; homeless youth; substance-abusing youth; youth with criminal justice contact; and youth with significant mental health challenges, particularly black and Latino individuals, are being recruited from 13 community-based organizations, clinics, drop-in centers, and shelters in Los Angeles and New Orleans. Youth are screened on the basis of self-reports and rapid diagnostic tests for HIV, drug use, and sexually transmitted infections and, then, triaged into one of 3 studies: (1) an observational cohort of YLH who have never received ARV medications and are then treated—half initially are in the acute infection period (n=36) and half with established HIV infection (n=36); (2) a randomized controlled trial (RCT) for YLH (N=220); and (3) an RCT for YHR (N=1340). Each study contrasts efficacy and costs of 3 interventions: an automated messaging and weekly monitoring program delivered via text messages (short message service, SMS); a peer support intervention delivered via social media forums; and coaching, delivered via text message (SMS), phone, and in-person or telehealth contacts. The primary outcomes are assessing youths’ uptake and retention of and adherence to the HIV Prevention or Treatment Continua. Repeat assessments are conducted every 4 months over 24 months to engage and retain youth and to monitor their status. Results: The project is funded from September 2016 through May 2021. Recruitment began in May 2017 and is expected to be completed by June 2019. We expect to submit the first results for publication by fall 2019. Conclusions: Using similar, flexible, and adaptable intervention approaches for YLH and YHR, this set of studies may provide a roadmap for communities to broadly address HIV risk among youth. We will evaluate whether the interventions are cost-efficient strategies that can be leveraged to help youth adhere to the actions in the HIV Prevention and Treatment Continua. International Registered Report Identifier (IRRID): DERR1-10.2196/10759 %M 30664482 %R 10.2196/10759 %U http://www.researchprotocols.org/2019/1/e10759/ %U https://doi.org/10.2196/10759 %U http://www.ncbi.nlm.nih.gov/pubmed/30664482 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 8 %N 1 %P e10659 %T Developing a Mobile App (LYNX) to Support Linkage to HIV/Sexually Transmitted Infection Testing and Pre-Exposure Prophylaxis for Young Men Who Have Sex With Men: Protocol for a Randomized Controlled Trial %A Liu,Albert %A Coleman,Kenneth %A Bojan,Kelly %A Serrano,Pedro Alonso %A Oyedele,Temitope %A Garcia,Amayvis %A Enriquez-Bruce,Elizabeth %A Emmanuel,Patricia %A Jones,Jeb %A Sullivan,Patrick %A Hightow-Weidman,Lisa %A Buchbinder,Susan %A Scott,Hyman %+ Bridge HIV, San Francisco Department of Public Health, 25 Van Ness Avenue, Suite 100, San Francisco, CA, 94102, United States, 1 415 437 7408, albert.liu@sfdph.org %K mobile app %K HIV testing %K sexually transmitted infections %K sexually transmitted diseases %K pre-exposure prophylaxis %K youth %K adolescent %K men who have sex with men %D 2019 %7 25.01.2019 %9 Protocol %J JMIR Res Protoc %G English %X Background: Young men who have sex with men (YMSM) in the United States have among the highest incidence of HIV and sexually transmitted infection (STI) and the lowest uptake of HIV and STI testing and pre-exposure prophylaxis (PrEP). Nearly universal mobile phone ownership among youth provides an opportunity to leverage mobile health apps to increase HIV/STI testing and PrEP uptake among YMSM. Objective: The goals of this project are to develop and refine LYNX, a novel mobile app to support linkage to HIV/STIs testing and PrEP services among YMSM in the United States, and to evaluate the acceptability and feasibility of LYNX in a pilot randomized controlled trial (RCT). Methods: This research protocol will be conducted in 3 phases: an iterative development phase with a series of 3 focus groups among 20 YMSM to refine the LYNX app; an open technical pilot among 15 YMSM to optimize usability of the app; and then a 6-month pilot RCT among 60 HIV-uninfected YMSM at risk for HIV acquisition. Developed using the Information, Motivation, and Behavioral skills theoretical model, the LYNX app includes an electronic diary to track sexual behaviors (information), a personalized risk score to promote accurate risk perception (information/motivation), testing reminders (motivation/behavioral skills), and access to home-based HIV/STI testing options and geospatial-based HIV/STI testing care sites (behavioral skills). Feasibility and acceptability will be assessed through app analytics of usage patterns and acceptability scales administered via computer-assisted self-interview at 3 and 6 months. We will also evaluate preliminary efficacy by comparing the proportion of YMSM who test at least once during the 6-month pilot and the proportion who successfully link to a PrEP provider in the intervention versus control groups. Results: Formative work is currently underway. The LYNX pilot RCT will begin enrollment in October 2018, with study results available in 2019. Conclusions: The LYNX app is one of the first mobile apps designed to increase HIV/STI testing and PrEP uptake among YMSM. As low-perceived risk is a barrier to HIV/STI testing and PrEP use among youth, the personalized risk assessment and interactive sexual diary in LYNX could assist YMSM in better understanding their HIV risk and providing motivation to test for HIV/STIs and initiate PrEP. Coupled with community-based recruitment, this novel mobile app has great potential to reach and engage YMSM not currently involved in care and increase rates of HIV/STI testing and PrEP uptake in this vulnerable population. Trial Registration: ClinicalTrials.gov NCT03177512; https://clinicaltrials.gov/ct2/show/NCT03177512 (Archived by WebCite at http://www.webcitation.org/73c917wAw) International Registered Report Identifier (IRRID): PRR1-10.2196/10659 %M 30681964 %R 10.2196/10659 %U http://www.researchprotocols.org/2019/1/e10659/ %U https://doi.org/10.2196/10659 %U http://www.ncbi.nlm.nih.gov/pubmed/30681964 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 8 %N 1 %P e10661 %T A Pre-Exposure Prophylaxis Adherence Intervention (LifeSteps) for Young Men Who Have Sex With Men: Protocol for a Pilot Randomized Controlled Trial %A Biello,Katie B %A Psaros,Christina %A Krakower,Douglas S %A Marrow,Elliot %A Safren,Steven A %A Mimiaga,Matthew J %A Hightow-Weidman,Lisa %A Sullivan,Patrick %A Mayer,Kenneth H %+ Center for Health Equity Research, Brown University School of Public Health, Box G-S121-8, Providence, RI, 02912, United States, 1 (401) 863 6651, katie_biello@brown.edu %K adolescents %K adherence %K antiretroviral pre-exposure prophylaxis %K HIV prevention %K men who have sex with men %D 2019 %7 29.01.2019 %9 Protocol %J JMIR Res Protoc %G English %X Background: New HIV infections occur at a disproportionately high rate among young men who have sex with men (YMSM). It is, therefore, essential that comprehensive HIV prevention strategies, specifically tailored to their needs and perceptions, are developed, tested, and disseminated. Antiretroviral pre-exposure prophylaxis (PrEP) is effective in decreasing HIV transmission among men who have sex with men; however, adherence is critical to its efficacy. In open-label studies among YMSM, adherence was suboptimal. Hence, behavioral approaches that address the unique challenges to YMSM PrEP adherence are needed. Objective: This study aims to describe the protocol for intervention refinement and a pilot randomized controlled trial (RCT) of a PrEP adherence intervention, LifeSteps for pre-exposure prophylaxis for young men who have sex with men (LSPY). Methods: This study includes the following 2 phases: formative qualitative interviews with approximately 20 YMSM and 10 key informants for intervention adaptation and refinement and a pilot RCT of up to 50 YMSM to assess the feasibility, acceptability, and preliminary efficacy of the LSPY, compared with the PrEP standard of care, to improve PrEP adherence. Participants will be recruited at 3 iTech subject recruitment venues in the United States. Results: Phase 1 is expected to begin in June 2018, and enrollment of phase 2 is anticipated to begin in early 2019. Conclusions: Few rigorously developed and tested interventions have been designed to increase PrEP adherence among YMSM in community settings, despite this population’s high HIV incidence. The long-term goal of this intervention is to develop scalable protocols to optimize at-risk YMSM’s PrEP uptake and adherence to decrease the HIV incidence. International Registered Report Identifier (IRRID): DERR1-10.2196/10661 %M 30694206 %R 10.2196/10661 %U http://www.researchprotocols.org/2019/1/e10661/ %U https://doi.org/10.2196/10661 %U http://www.ncbi.nlm.nih.gov/pubmed/30694206 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 8 %N 1 %P e11533 %T Primary Prevention of Intimate Partner Violence Among Recently Married Dyads Residing in the Slums of Pune, India: Development and Rationale for a Dyadic Intervention %A Kalokhe,Ameeta Shivdas %A Iyer,Sandhya %A Katendra,Tuman %A Gadhe,Keshav %A Kolhe,Ambika R %A Paranjape,Anuradha %A del Rio,Carlos %A Stephenson,Rob %A Sahay,Seema %+ Division of Infectious Diseases, Department of Medicine, Emory University School of Medicine, 1518 Clifton Road Office 6009, Atlanta, GA, 30322, United States, 1 4047121924, akalokh@emory.edu %K intimate partner violence %K prevention %K gender-based violence %K domestic violence %K intervention %D 2019 %7 18.01.2019 %9 Original Paper %J JMIR Res Protoc %G English %X Background: Intimate partner violence (IPV) is frequently experienced by women of low socioeconomic status in India. It is a human rights violation and associated with negative effects on physical and mental well-being, underscoring the need for effective prevention strategies. Objective: This study aimed to develop a dyadic intervention for the primary prevention of IPV among newly married couples residing in slum communities in India. Methods: The intervention was developed using a community-based, mixed-methods design rooted in couple-interdependence theory and guided by the intervention mapping (IM) framework. It used the six critical IM steps to inform the content and delivery of the intervention: (1) needs assessment, (2) preparation of matrices of change objectives, (3) selection of theory-based methods and practical applications, (4) production of intervention components and materials, (5) intervention adoption and implementation, and (6) evaluation planning. Results: The resulting Ghya Bharari Ekatra (Take a Flight Together) intervention is intended to be delivered in 6 weekly sessions by a trained pair of male and female lay community educators to groups of 3 to 5 newly married couples in the community in which they reside. It uses games, discussions, self-reflections, and skill-building exercises to cover the following topics: enhancing relationship quality time, self-esteem and resilience, communication and conflict management, goal setting and implementation, sexual communication and sexual health and reproductive health knowledge, and redefining and challenging norms surrounding IPV occurrence. The formative work guided the protocol, including module duration and timing (2-hour sessions of convenience to participants), ordering of modules (based on potential level of interest and sensitivity of the topics), content (ie, informed scripts of role plays and films), intervention delivery methods (ie, interactive activities), and selection of the interventionists (based on capacity to connect with participants) and venue (community-based, convenient, and safe spaces). Ghya Bharari Ekatra was piloted between January and May 2018, and evaluation is presently underway. Conclusions: Ghya Bharari Ekatra is evidence-based, grounded in intervention-mapping, and developed and iteratively refined using a community-based participatory research approach, suggesting it has great potential to be an acceptable and effective solution to preventing IPV among newly married couples. Trial Registration: ClinicalTrials.gov NCT03332134; https://clinicaltrials.gov/ct2/show/NCT03332134 %M 30664483 %R 10.2196/11533 %U http://www.researchprotocols.org/2019/1/e11533/ %U https://doi.org/10.2196/11533 %U http://www.ncbi.nlm.nih.gov/pubmed/30664483