TY - JOUR AU - Tam, Chi Cheuk AU - Young, D. Sean AU - Harrison, Sayward AU - Li, Xiaoming AU - Litwin, H. Alain PY - 2025/3/26 TI - Theory-Based Social Media Intervention for Nonmedical Use of Prescription Opioids in Young Adults: Protocol for a Randomized Controlled Trial JO - JMIR Res Protoc SP - e65847 VL - 14 KW - nonmedical use of prescription opioids KW - opioid misuse KW - young adults KW - social media KW - psychosocial intervention KW - randomized controlled trial KW - mixed methods N2 - Background: The nonmedical use of prescription opioids (NMUPO) in young adults in the United States is concerning and is robustly influenced by many psychosocial factors. Given the advantages of flexibility, wide coverage, and real-time responses and assessment, using social media appears to be a promising and innovative approach to delivering psychosocial intervention to young adults. However, few theory-based social media interventions are available for NMUPO targeting this at-risk population. Objective: Guided by the information-motivation-behavioral skills model, the proposed research aims to address critical gaps by theoretically exploring psychosocial content associated with NMUPO among young adults via formative assessment. These findings will then be used to develop and evaluate the feasibility and preliminary efficacy of a peer-led social media intervention to reduce NMUPO among young adults. Methods: The proposed study will comprise serial research activities. First, formative research will be conducted through semistructured interviews among 30 young adults engaged in NMUPO. Qualitative data will be synthesized using a pragmatic approach for identifying psychosocial content associated with NMUPO. Second, qualitative findings will be used for developing a peer-led social media intervention to reduce NMUPO among young adults by integrating promising psychotherapy principles and incorporating them with well-trained recovery coaches. Third, the social media intervention will be evaluated through a 12-week randomized controlled trial among 70 young adults (n=35, 50% in the intervention group and control group) engaged in NMUPO via mixed methods, including pre- and postintervention surveys, social media paradata (eg, time-series reactions to posts) collection, and ecological momentary assessment during the intervention. The control group will not receive an intervention but will complete the pre- and postintervention surveys. The primary outcomes will be feasibility, usability, and acceptability, while the secondary outcomes will be psychosocial and behavioral measures, such as past?3-month NMUPO, intention, psychological distress, self-efficacy, resilience, and coping strategies. Results: The proposed study was funded in May 2024. Social media campaigns have received responses from a total of 379 individuals, with 24 (6.3%) identified as eligible. As of February 10, 2025, we have completed formative interviews with 8 eligible participants. Conclusions: The proposed study will be one of the first efforts to develop and deliver a theory-based peer-led intervention on social media, incorporating empirical findings on the psychosocial mechanism of NMUPO. The findings of the proposed study will provide valuable insights into opioid risk reduction for young adults through an innovative approach. If the tested trial is found to be feasible, the proposed study will contribute to future scaled-up and fully powered psychosocial interventions among young adults and other key populations at risk for NMUPO. Trial Registration: ClincialTrials.gov NCT06469749; https://clinicaltrials.gov/study/NCT06469749 International Registered Report Identifier (IRRID): DERR1-10.2196/65847 UR - https://www.researchprotocols.org/2025/1/e65847 UR - http://dx.doi.org/10.2196/65847 UR - http://www.ncbi.nlm.nih.gov/pubmed/ ID - info:doi/10.2196/65847 ER - TY - JOUR AU - Kariuki, Jacob AU - Burke, Lora AU - Erickson, Kirk AU - Sereika, Susan AU - Paul, Sudeshna AU - Cheng, Jessica AU - Biza, Heran AU - Abdirahman, Amjad AU - Wilbraham, Katherine AU - Milton, Heather AU - Brown, Cornelius AU - Sells, Matthew AU - Osei Baah, Foster AU - Wells, Jessica AU - Chandler, Rasheeta AU - Barone Gibbs, Bethany PY - 2025/3/18 TI - Acceptability and Preliminary Efficacy of a Novel Web-Based Physical Activity for the Heart (PATH) Intervention Designed to Promote Physical Activity in Adults With Obesity: Protocol for a Pilot Randomized Controlled Trial JO - JMIR Res Protoc SP - e67972 VL - 14 KW - obesity KW - physical activity KW - cardiometabolic risk, body positivity, cardiovascular fitness, self-efficacy N2 - Background: Even in the absence of weight loss, any level of physical activity (PA) can reduce the risk of cardiovascular disease among individuals with obesity. However, these individuals face multifaceted barriers that reduce their motivation and engagement in PA. They prefer programs that are convenient, fun to engage in, and feature people who they can relate to. Yet, there is a paucity of PA interventions that are designed to incorporate these preferences. We designed the web-based PA for The Heart (PATH) intervention to address this gap. Objective: This study aimed to describe the protocol of a study that aims to examine the acceptability and preliminary efficacy of PATH intervention among insufficiently active adults with obesity aged at least 18 years. Methods: This is a 6-month pilot randomized controlled trial (RCT), using a parallel design with 1:1 allocation to intervention or control group. The PATH intervention group is given access to the PATH platform, but the resources each participant can access are tailored according to their baseline fitness level. Control group receives a self-help PA handout. Both groups self-monitor their PA using Fitbit (Google) and have Zoom (Zoom Video Communications) meetings twice a month with either the health coach (intervention) or study coordinator (control). The outcomes at 6-months include acceptability, changes in PA, and cardiometabolic risk from baseline to 6-months. Results: We screened 763 individuals for eligibility and 89 participants were enrolled and randomized to the intervention (45/504, 50.6%) and control arms (44/504, 49.4%). The average age was 48.7 (SD 12.17) years, and most participants were female (81/504, 90.1%), Black (45/504, 50.6%), and non-Hispanic (83/504, 93.3%). No systematic differences in baseline characteristics were observed between the study arms. The 6-month intervention is currently underway, and the completion of follow-up data collection is expected in February 2025, with results to be published soon after. Conclusions: The PATH intervention offers a promising, evidence-based approach to overcoming the barriers that have hindered previous PA programs for adults with obesity. It can support new and existing programs to foster long-term maintenance of health-enhancing PA. Trial Registration: ClinicalTrials.gov NCT05803304; https://clinicaltrials.gov/study/NCT05803304 International Registered Report Identifier (IRRID): DERR1-10.2196/67972 UR - https://www.researchprotocols.org/2025/1/e67972 UR - http://dx.doi.org/10.2196/67972 UR - http://www.ncbi.nlm.nih.gov/pubmed/ ID - info:doi/10.2196/67972 ER - TY - JOUR AU - Downs, Symons Danielle AU - Pauley, M. Abigail AU - Rivera, E. Daniel AU - Savage, S. Jennifer AU - Moore, M. Amy AU - Shao, Danying AU - Chow, Sy-Miin AU - Lagoa, Constantino AU - Pauli, M. Jaimey AU - Khan, Owais AU - Kunselman, Allen PY - 2025/3/13 TI - Healthy Mom Zone Adaptive Intervention With a Novel Control System and Digital Platform to Manage Gestational Weight Gain in Pregnant Women With Overweight or Obesity: Study Design and Protocol for a Randomized Controlled Trial JO - JMIR Res Protoc SP - e66637 VL - 14 KW - pregnancy KW - gestational weight gain KW - physical activity KW - healthy eating KW - overweight KW - obesity KW - intervention N2 - Background: Regulating gestational weight gain (GWG) in pregnant women with overweight or obesity is difficult, particularly because of the narrow range of recommended GWG for optimal health outcomes. Given that many pregnant women show excessive GWG and considering the lack of a ?gold standard? intervention to manage GWG, there is a timely need for effective and efficient approaches to regulate GWG. We have enhanced the Healthy Mom Zone (HMZ) 2.0 intervention with a novel digital platform, automated dosage changes, and personalized strategies to regulate GWG, and our pilot study demonstrated successful recruitment, compliance, and utility of our new control system and digital platform. Objective: The goal of this paper is to describe the study protocol for a randomized controlled optimization trial to examine the efficacy of the enhanced HMZ 2.0 intervention with the new automated control system and digital platform to regulate GWG and influence secondary maternal and infant outcomes while collecting implementation data to inform future scalability. Methods: This is an efficacy study using a randomized controlled trial design. HMZ 2.0 is a multidosage, theoretically based, and individually tailored adaptive intervention that is delivered through a novel digital platform with an automated link of participant data to a new model-based predictive control algorithm to predict GWG. Our new control system computes individual dosage changes and produces personalized physical activity (PA) and energy intake (EI) strategies to deliver just-in-time dosage change recommendations to regulate GWG. Participants are 144 pregnant women with overweight or obesity randomized to an intervention (n=72) or attention control (n=72) group, stratified by prepregnancy BMI (<29.9 vs ?30 kg/m2), and they will participate from approximately 8 to 36 weeks of gestation. The sample size is based on GWG (primary outcome) and informed by our feasibility trial showing a 21% reduction in GWG in the intervention group compared to the control group, with 3% dropout. Secondary outcomes include PA, EI, sedentary and sleep behaviors, social cognitive determinants, adverse pregnancy and delivery outcomes, infant birth weight, and implementation outcomes. Analyses will include descriptive statistics, time series and fixed effects meta-analytic approaches, and mixed effects models. Results: Recruitment started in April 2024, and enrollment will continue through May 2027. The primary (GWG) and secondary (eg, maternal and infant health) outcome results will be analyzed, posted on ClinicalTrials.gov, and published after January 2028. Conclusions: Examining the efficacy of the novel HMZ 2.0 intervention in terms of GWG and secondary outcomes expands the boundaries of current GWG interventions and has high clinical and public health impact. There is excellent potential to further refine HMZ 2.0 to scale-up use of the novel digital platform by clinicians as an adjunct treatment in prenatal care to regulate GWG in all pregnant women. International Registered Report Identifier (IRRID): DERR1-10.2196/66637 UR - https://www.researchprotocols.org/2025/1/e66637 UR - http://dx.doi.org/10.2196/66637 UR - http://www.ncbi.nlm.nih.gov/pubmed/ ID - info:doi/10.2196/66637 ER - TY - JOUR AU - Lindhiem, Oliver AU - Tomlinson, S. Claire AU - Kolko, J. David AU - Silk, S. Jennifer AU - Hafeman, Danella AU - Wallace, Meredith AU - Setiawan, Agus I. Made AU - Parmanto, Bambang PY - 2025/3/11 TI - Novel Smartphone App and Supportive Accountability for the Treatment of Childhood Disruptive Behavior Problems: Protocol for a Randomized Controlled Trial JO - JMIR Res Protoc SP - e67051 VL - 14 KW - mobile health KW - disruptive behaviors KW - parent management training KW - randomized controlled trial KW - externalizing behavior N2 - Background: Although evidence-based treatments have been developed for childhood behavior problems, many families encounter barriers to treatment access and completion (eg, local availability of services, transportation, cost, and perceived stigma). Smartphone apps offer a cost-efficient method to deliver content to families. Objective: The aim of this study is to evaluate the effectiveness of the UseIt! mobile health system as both stand-alone and coach-assisted interventions via a randomized controlled trial. The UseIt! System is designed to reduce disruptive behaviors in young children. Methods: A nationwide sample of parents of children aged 5 years to 8 years with disruptive behaviors (N=324 dyads) are randomly assigned to the stand-alone app (UseIt!; n=108), the coach-assisted app (UseIt! plus supportive accountability; n=108), or the control app (mindfulness app; n=108). The UseIt! App provides parents with tools and troubleshooting to address disruptive behaviors, along with a behavior diary to track behaviors and strategies over time. The coach-assisted condition includes a bachelor?s level paraprofessional who provides weekly phone calls to promote engagement with the app. The control condition is composed of a mindfulness app. The web-based, self-assessed outcome measures (post treatment and 6-month follow-up) include measures of app usage, parenting knowledge (eg, knowledge of parent management training and cognitive behavioral therapy skills), and strategies (use of evidence-based parenting strategies), symptom reduction (eg, behavior problems), and parent mental health (eg, anxiety, stress, and depression). We hypothesize that both intervention conditions will show greater parent knowledge and use of skills along with greater symptom reduction relative to the control condition. Further, we hypothesize that those assigned to the coach assisted condition will report greater knowledge, skill use, and symptom reduction than the stand-alone app. We will use intent-to-treat analyses to regress outcomes on study conditions to evaluate for differences across conditions. Results: Recruitment of study participants began in December of 2022 and is ongoing. We have recruited over half of our intended sample of 324 parent-child dyads (n=214) as of December 2024. These dyads have been randomly allocated to each of the intervention conditions, with 71 assigned to the coach-assisted condition, 72 assigned to the stand-alone app, and 71 assigned to the control app condition. Data collection is projected to be completed by late 2026. Conclusions: The current study aims to address a gap in the literature regarding the feasibility, effectiveness, and utility of a smartphone app that includes a coach-assisted arm. Digital therapeutics have the potential to enhance the reach and scalability of skills-based psychosocial interventions. Findings from this study will advance scientific knowledge and have implications for clinical practice. Trial Registration: ClinicalTrials.gov NCT05647772; https://clinicaltrials.gov/study/NCT05647772 International Registered Report Identifier (IRRID): DERR1-10.2196/67051 UR - https://www.researchprotocols.org/2025/1/e67051 UR - http://dx.doi.org/10.2196/67051 UR - http://www.ncbi.nlm.nih.gov/pubmed/ ID - info:doi/10.2196/67051 ER - TY - JOUR AU - Dunleavy, Kim AU - Radunovich, Liss Heidi AU - Beneciuk, M. Jason AU - Hu, Boyi AU - Yang, Yang AU - Blythe, McCormick Janeen AU - Gurka, K. Kelly PY - 2025/1/28 TI - Self-Management Strategies for Low Back Pain Among Horticulture Workers: Protocol for a Type II Hybrid Effectiveness-Implementation Study JO - JMIR Res Protoc SP - e64817 VL - 14 KW - low back pain KW - self-management KW - implementation KW - horticulture workers KW - video training KW - video feedback KW - text message reminders KW - agriculture KW - ergonomic KW - nonpharmacological N2 - Background: Low back pain (LBP) is highly prevalent and disabling, especially in agriculture sectors. However, there is a gap in LBP prevention and intervention studies in these physically demanding occupations, and to date, no studies have focused on horticulture workers. Given the challenges of implementing interventions for those working in small businesses, self-management offers an attractive and feasible option to address work-related risk factors and manage LBP. Objective: This study will (1) investigate the effectiveness of self-management strategies for nursery and landscape workers by comparing within-subject control and intervention periods and (2) determine if adoption and effectiveness differs between participants randomly assigned to review self-management videos only and those who also receive multimodal implementation support. We will also identify contextual factors impacting effectiveness and implementation. Methods: A pragmatic, mixed methods, hybrid effectiveness and implementation design will be used to compare back pain with work tasks, disability, medication and substance use, and psychological factors between a baseline control and intervention periods. We aim to recruit 122 English- and Spanish-speaking horticulture workers with back pain, 30 supervisors, and 12 focus group participants. Participants will review short video modules designed to increase awareness of opioid risk and introduce self-management and ergonomic choices and use 1 self-management and 1 ergonomic strategy for 10 weeks. They will be randomly assigned to 2 implementation groups: video modules only or video + multimodal personalized support (checklist guidance, review of video feedback for ergonomic problem-solving, and text message reminders). Questionnaires will be administered at 3-month time points: baseline, pre- and postintervention, and at 3 and 6 months. Qualitative analysis of field notes, open-ended comments, and focus groups will expand understanding of results with comprehensive documentation of the context, barriers and facilitators, and reasons for adoption. Results: The project was funded on September 29, 2023 (Centers for Disease Control and Prevention National Institute of Occupational Health and Safety, CDC NIOSH; U54OH011230-07S1), as a core research grant for the Southeast Coastal Center for Agricultural Health and Safety. The design, creation, and editing of English and Spanish videos was completed in June 2024 after comprehensive formative evaluation. Enrollment began in June 2024 with anticipated completion in 2027. Conclusions: We hypothesize that both self-management interventions will result in reductions in work task pain and disability and that the video enhanced with multimodal personalized support will result in greater reductions than the video alone. If self-management is effective, mitigating pain positively impacts quality of life, productivity, and retention, while increasing the use of nonpharmacological alternatives to opioids addresses an important public health issue. Implementation aims will help inform reasons for results, barriers and facilitators, and potential for similar interventions in these and similar industries with physically challenging outdoor work. Trial Registration: ClinicalTrials.gov NCT06153199; http://clinicaltrials.gov/study/NCT06153199 International Registered Report Identifier (IRRID): DERR1-10.2196/64817 UR - https://www.researchprotocols.org/2025/1/e64817 UR - http://dx.doi.org/10.2196/64817 UR - http://www.ncbi.nlm.nih.gov/pubmed/ ID - info:doi/10.2196/64817 ER - TY - JOUR AU - Reback, J. Cathy AU - Blue, Thomas AU - Jalali, Ali AU - Landovitz, Raphael AU - Li, J. Michael AU - Mata, P. Raymond AU - Ryan, Danielle AU - Jeng, J. Philip AU - Murphy, M. Sean PY - 2025/1/23 TI - Comparative- and Cost-Effectiveness Research Determining the Optimal Intervention for Advancing Transgender Women With HIV to Full Viral Suppression (Text Me, Alexis!): Protocol for a Randomized Controlled Trial JO - JMIR Res Protoc SP - e65313 VL - 14 KW - HIV/AIDS KW - transgender women KW - SMS text messaging KW - peer health navigation KW - HIV Care Continuum N2 - Background: Many transgender women with HIV achieve suboptimal advancement through the HIV Care Continuum, including poor HIV health care usage, retention in HIV medical care, and rates of viral suppression. These issues are exacerbated by comorbid conditions, such as substance use disorder, which is also associated with reduced quality of life, increased overdose deaths, usage of high-cost health care services, engagement in a street economy, and cycles of incarceration. Thus, it is critical that efforts to End the HIV Epidemic include effective interventions to link and retain transgender women in HIV care through full viral suppression. Objective: This study builds on the promising findings from our two Health Resources and Services Administration-funded demonstration projects, The Alexis Project and Text Me, Girl!, which used peer health navigation (PHN) and SMS text messaging, respectively, for advancing transgender women with HIV to full viral suppression. Though the effectiveness of both interventions has been established, their comparative effectiveness, required resources or costs, cost-effectiveness, and heterogeneous effects on subgroups, including those with substance use disorder, have not been evaluated. Given the many negative personal and public health consequences of untreated or undertreated HIV, and that HIV services for transgender women are frequently delivered in resource-limited, community-based settings, a comprehensive economic evaluation is critical to inform decisions of stakeholders, such as providers, insurers, and policy makers. Methods: Text Me, Alexis! is a 3-arm randomized controlled trial. Participants (N=195) will be randomized (1:1:1) into: PHN alone (n=65), SMS text messaging alone (n=65), or PHN+SMS text messaging (n=65). Using the same time points as the Health Resources and Services Administration demonstration projects, the repeated-measures design will assess participants at baseline, 3, 6, 12, and 18 months post randomization. Over the course of the 90 days, participants in the PHN arm will receive unlimited navigation sessions; participants in the SMS text messaging arm will receive 270 theory-based SMS text messages (3 messages daily) that are targeted, tailored, and personalized specifically for transgender women with HIV; and participants in the PHN+SMS text messaging arm will receive a combined PHN and SMS text message intervention. The desired outcome of Text Me, Alexis! is viral suppression and cost-effectiveness. Results: Recruitment began on April 10, 2024, and the first participant was enrolled on April 11, 2024. Data collection is expected to be completed in July 2027. Primary outcome analyses will begin immediately following the conclusion of the follow-up evaluations. Conclusions: Transgender women are a high-priority population for reaching End the HIV Epidemic goals. Findings have the potential to improve individual and population health outcomes by generating significant improvements in viral suppression among transgender women and guiding service provision and public policy. International Registered Report Identifier (IRRID): DERR1-10.2196/65313 UR - https://www.researchprotocols.org/2025/1/e65313 UR - http://dx.doi.org/10.2196/65313 UR - http://www.ncbi.nlm.nih.gov/pubmed/39847410 ID - info:doi/10.2196/65313 ER - TY - JOUR AU - Johnson, A. Jillian AU - Zawadzki, J. Matthew AU - Sliwinski, J. Martin AU - Almeida, M. David AU - Buxton, M. Orfeu AU - Conroy, E. David AU - Marcusson-Clavertz, David AU - Kim, Jinhyuk AU - Stawski, S. Robert AU - Scott, B. Stacey AU - Sciamanna, N. Christopher AU - Green, A. Paige AU - Repka, M. Emily AU - Toledo, L. Meynard John AU - Sturges, L. Nicole AU - Smyth, M. Joshua PY - 2025/1/22 TI - Adaptive Just-in-Time Intervention to Reduce Everyday Stress Responses: Protocol for a Randomized Controlled Trial JO - JMIR Res Protoc SP - e58985 VL - 14 KW - stress KW - stress responses KW - stress management KW - just-in-time adaptive intervention KW - sleep KW - physical activity KW - behavior change KW - experimental medicine approach N2 - Background: Personalized approaches to behavior change to improve mental and physical health outcomes are needed. Reducing the intensity, duration, and frequency of stress responses is a mechanism for interventions to improve health behaviors. We developed an ambulatory, dynamic stress measurement approach that can identify personalized stress responses in the moments and contexts in which they occur; we propose that intervening in these stress responses as they arise (ie, just in time; JIT) will result in positive impacts on health behaviors. Objective: This study aims to (1) use an experimental medicine approach to evaluate the impact of a smartphone-delivered JIT stress management intervention on the frequency and intensity of person-specific stress responses (ie, stress reactivity, nonrecovery, and pileup); (2) evaluate the impact of the JIT intervention on the enactment of health behaviors in everyday life (physical activity and sleep); and (3) explore whether changes in stress responses mediate the interventions? effects on health behaviors. Methods: In a 2-arm phase 2 clinical trial, we will enroll 210 adults in either a JIT stress management intervention or an active control condition. For 4 weeks, participants will complete 8 brief smartphone surveys each day and wear devices to assess sleep and physical activity. After a 1-week run-in period, participants will be randomized into the JIT intervention or an active control condition for 2 weeks. Participants in the JIT intervention will receive very brief stress management activities when reporting greater than typical stress responses, whereas control participants will receive no personalized stress management activities. Participants enrolled in both conditions will engage in self-monitoring for the entire study period and have access to a general stress management education module. Self-report outcomes will be assessed again 1 month after the intervention. We will use mixed-effects models to evaluate differences in person-specific stress responses between the intervention and control groups. We will conduct parallel analyses to evaluate whether the intervention is associated with improvement in health behavior enactment (ie, sleep and physical activity). The Pennsylvania State University Institutional Review Board approved all study procedures (STUDY00012740). Results: Initial participant recruitment for the trial was initiated on August 15, 2022, and enrollment was completed on June 9, 2023. A total of 213 participants were enrolled in this period. Data are currently being processed; analyses have not yet begun. Conclusions: We anticipate that this research will contribute to advancing stress measurement, thereby enhancing understanding of health behavior change mechanisms and, more broadly, providing a conceptual roadmap to advance JIT interventions aimed at improving stress management and health behaviors. Trial Registration: Clinicaltrials.gov NCT05502575; https://clinicaltrials.gov/study/NCT05502575 International Registered Report Identifier (IRRID): DERR1-10.2196/58985 UR - https://www.researchprotocols.org/2025/1/e58985 UR - http://dx.doi.org/10.2196/58985 UR - http://www.ncbi.nlm.nih.gov/pubmed/ ID - info:doi/10.2196/58985 ER - TY - JOUR AU - Martin, M. Lindsay AU - McKinney, D. Christine AU - Escobar Acosta, Lia AU - Coughlin, W. Janelle AU - Jeffers, K. Noelene AU - Solano-Umaņa, Alexandra AU - Carson, A. Kathryn AU - Wang, Nae-Yuh AU - Bennett, L. Wendy AU - Bower, M. Kelly PY - 2025/1/7 TI - Remote Lifestyle Intervention to Reduce Postpartum Weight Retention: Protocol for a Community-Engaged Hybrid Type I Effectiveness-Implementation Randomized Controlled Trial JO - JMIR Res Protoc SP - e62847 VL - 14 KW - pregnancy KW - obesity KW - postpartum weight retention KW - remote lifestyle intervention KW - home visiting KW - mobile health KW - mHealth app KW - community-engaged research KW - implementation science KW - health disparities KW - maternal health N2 - Background: Maternal obesity is associated with significant racial disparities. People who identify as non-Hispanic Black and Latinx are at the highest risk related adverse short- and long-term health outcomes (eg, hypertension in pregnancy and postpartum weight retention). Remote lifestyle interventions delivered during and after pregnancy hold promise for supporting healthy weight outcomes; however, few are tested in groups of people who self-identify as non-Hispanic Black and Latinx or address the neighborhood-level and psychosocial factors driving maternal health disparities. Implementing remote lifestyle interventions within community-based programs that serve birthing people may optimize trust and engagement, promote scalability and sustainability, and have the broadest public health impact. Objective: The goal of this trial is to test the effectiveness of a culturally adapted remote lifestyle intervention (Healthy for Two?Home Visiting) implemented within home visiting compared to usual home visiting services on postpartum weight retention among pregnant or postpartum individuals, in particular those who identify as non-Hispanic Black and Latinx. Facilitators and barriers to implementation of the intervention within home visiting will be examined. Methods: We describe the rationale and protocol for this hybrid type I effectiveness-implementation randomized controlled trial. In this paper, we highlight the community-engaged approach and trial design features that enable the implementation of the intervention within home visiting and demonstrate its applicability to the target population. Participants will be 360 pregnant individuals with overweight or obesity enrolled between 20 and 33 weeks of gestation and randomized 1:1 to Healthy for Two?Home Visiting or usual home visiting services. The primary outcome is weight retention at 6 months post partum, calculated as 6-month postpartum weight minus earliest pregnancy weight (?18 wk of gestation). The measures of implementation include intervention feasibility, acceptability, reach, adoption, and fidelity. Throughout the paper, we highlight the community input used to improve intervention effectiveness and study implementation and as a strategy to promote maternal health equity. Results: This study was funded in June 2021, and recruitment began in April 2023. As of November 2024, we enrolled 90 participants. Data collection to assess the intervention?s effectiveness is expected to end in June 2026. Implementation evaluation is expected to conclude in December 2026. Conclusions: This hybrid type I effectiveness-implementation randomized controlled trial integrates a culturally adapted remote lifestyle intervention into early home visiting services to examine its effectiveness on postpartum weight retention compared to usual home visiting. We anticipate that the study results will enable an understanding of the drivers of successful implementation within a community-based setting to maximize the future sustainability and dissemination of a strategy for reducing long-term obesity and other maternal health disparities. Trial Registration: Clinicaltrials.gov NCT05619705; https://clinicaltrials.gov/study/NCT05619705 International Registered Report Identifier (IRRID): DERR1-10.2196/62847 UR - https://www.researchprotocols.org/2025/1/e62847 UR - http://dx.doi.org/10.2196/62847 UR - http://www.ncbi.nlm.nih.gov/pubmed/ ID - info:doi/10.2196/62847 ER - TY - JOUR AU - Normann, J. Amber AU - Mo, C. Clifton AU - Wilson, L. Rebekah AU - Perez, Michelle AU - Cutler, Corey AU - Uno, Hajime AU - Thompson, V. LaDora AU - Skinner, L. Tina AU - Richardson, G. Paul AU - Marinac, R. Catherine AU - Dieli-Conwright, M. Christina PY - 2024/12/19 TI - Prehabilitation Exercise Training to Target Improved Muscle Strength in Pretransplant Patients Diagnosed With Multiple Myeloma: Protocol for a Pilot Randomized Controlled Trial JO - JMIR Res Protoc SP - e64905 VL - 13 KW - multiple myeloma KW - stem cell transplantation KW - exercise training KW - aerobic exercise KW - resistance exercise KW - preoperative exercise KW - muscle strength KW - physical fitness N2 - Background: Muscle mass and strength are severely compromised in patients diagnosed with multiple myeloma, such that the risk of poor overall survival increases as the prevalence of low muscle mass, also known as sarcopenia, increases. Additionally, at the time of autologous stem cell transplant (ASCT), 51% of patients experience low muscle mass and strength, which can prolong hospitalization and lead to increased risk of obesity, insulin resistance, lowered physical function, and poor quality of life. Objective: The PROTECT (Prehabilitation Exercise Training in Multiple Myeloma Patients Undergoing Autologous Stem Cell Transplantation) trial will examine the preliminary effects of digitally supervised prehabilitative aerobic and resistance exercise on muscle strength in patients with multiple myeloma scheduled for ASCT. Methods: This prospective, 2-armed single-center randomized controlled trial will recruit 30 patients with multiple myeloma, aged 18 years and older, planning to receive ASCT. Individuals will be assigned to either the exercise or the waitlist control group. The 8-week exercise intervention is home-based and digitally supervised by a clinical exercise trainer. The frequency of the exercise intervention is 3 times per week consisting of aerobic exercise on a cycle ergometer and resistance exercises, which are individually tailored based on patient health status. The waitlist control group maintains normal daily activities of living and is offered the intervention within 6 months from ASCT. The primary outcome is lower limb muscle strength, measured using the 10-repetition maximum leg press or extensor strength. Additional outcomes include physical and cardiorespiratory function, patient-reported outcomes, cardiometabolic health outcomes, and clinical outcomes. Results: The trial was funded in the fall of 2022 and recruitment began in June 2023. As of August 2024, a total of 3 participants have consented and been randomized (n=1, exercise group; n=2, waitlist control group). Trial completion and start of data analysis is expected in July 2025 with expected results to be published in early winter of 2026. Conclusions: We expect exercise to improve lower limb muscle strength and overall health outcomes compared to the waitlist control group. Results will contribute foundational knowledge needed to conduct larger-phase clinical trials testing the clinical benefits of prehabilitation exercise in this patient population. This study will provide insight into a prehabilitative exercise intervention designed to support patient prognosis. Trial Registration: ClinicalTrials.gov NCT05706766; https://clinicaltrials.gov/study/NCT05706766 International Registered Report Identifier (IRRID): DERR1-10.2196/64905 UR - https://www.researchprotocols.org/2024/1/e64905 UR - http://dx.doi.org/10.2196/64905 UR - http://www.ncbi.nlm.nih.gov/pubmed/ ID - info:doi/10.2196/64905 ER - TY - JOUR AU - Pagoto, Sherry AU - Xu, Ran AU - Bannor, Richard AU - Idiong, Christie AU - Goetz, Jared AU - Fernandes, Denise PY - 2024/12/19 TI - Comparing Synchronous and Asynchronous Remotely Delivered Lifestyle Interventions: Protocol for a Randomized Noninferiority Trial JO - JMIR Res Protoc SP - e65323 VL - 13 KW - obesity KW - lifestyle intervention KW - digital health KW - weight loss maintenance KW - engagement KW - mobile phone N2 - Background: Remotely delivered lifestyle interventions have emerged to increase the reach and accessibility of traditional interventions that involve numerous in-person visits. Remote interventions can be delivered synchronously via videoconference software or phone or asynchronously via online platforms. Asynchronously delivered interventions are convenient and flexible in that they allow people to participate at any time and as such, they may be more sustainable. Evidence for asynchronous interventions is needed given their potential for convenience and sustainability, which may have implications for weight loss maintenance. Objective: This is a randomized noninferiority trial comparing 2 remotely delivered lifestyle interventions: one that is delivered synchronously via videoconference meetings and one that is delivered asynchronously through private Facebook (Meta) groups. We hypothesize that the percent weight loss difference between conditions at 6 and 12 months will be less than 2% and that the asynchronous condition will cost less to deliver per pound lost. We also hypothesize that engagement will be higher in the asynchronous condition at 12, 18, and 24 months and that the asynchronous condition will have greater weight loss at 24 months. Methods: We will randomize 328 participants with overweight or obesity to a remotely delivered lifestyle intervention that is delivered either synchronously or asynchronously. Delivery of the synchronous lifestyle intervention will be via videoconference group sessions, whereas the delivery of the asynchronous lifestyle intervention will be via private Facebook groups. The lifestyle intervention in both conditions is based on the Diabetes Prevention Program. The intervention goals are to lose 5%-10% of baseline weight and to work toward 300 minutes per week of moderate intensity physical activity. The core intervention will last for 12 months and be led by counselors in each group. This will be followed by a 12-month maintenance phase to be led by participant volunteers from each group. Participant engagement and weight loss maintenance will be assessed during this phase. The primary outcome is mean percent weight loss at 6 and 12 months. The noninferiority margin for differences in weight loss between conditions is 2% at both 6 and 12 months. We will model percent weight loss at 6 and 12 months using general linear regression models with the intent-to-treat sample. Secondary outcomes include engagement, collective efficacy, cost, and weight loss at 18 and 24 months. Results: The funding period began on August 17, 2023, and the study was approved by the University of Connecticut Institutional Review Board on August 17, 2023. Participant recruitment will begin December 2024 and the intervention will begin February 2024. Conclusions: If hypotheses are confirmed, this work will provide evidence that asynchronously delivered remote interventions are as efficacious as synchronously delivered ones and more sustainable such that people will engage in them longer and retain more weight loss for less cost. Trial Registration: ClinicalTrials.gov NCT06393725; https://tinyurl.com/4kzzwkc9 International Registered Report Identifier (IRRID): PRR1-10.2196/65323 UR - https://www.researchprotocols.org/2024/1/e65323 UR - http://dx.doi.org/10.2196/65323 UR - http://www.ncbi.nlm.nih.gov/pubmed/ ID - info:doi/10.2196/65323 ER - TY - JOUR AU - Levey, Nadine AU - Chen, Neal AU - Ditre, Joseph AU - Sylvia, Louisa AU - Mudgal, Chaitanya AU - Bhashyam, Abhiram AU - Garg, Rohit AU - Ring, David AU - Vranceanu, Ana-Maria AU - Bakhshaie, Jafar PY - 2024/12/9 TI - A Web-Based Mind-Body Intervention to Improve Resilience Among Patients With Nontraumatic Painful Upper-Extremity Conditions and Comorbid Risky Substance Use: Protocol for a Mixed Methods Study JO - JMIR Res Protoc SP - e64547 VL - 13 KW - chronic pain KW - upper-extremity conditions KW - psychiatry KW - mindfulness KW - mind-body KW - substance use KW - web-based intervention development N2 - Background: Nontraumatic painful upper-extremity conditions (NPUCs) are largely age-related degenerations that affect the majority of adults. Most patients with NPUCs do not seek medical care and adjust on their own. Among those who do seek care, approximately 20% report risky substance use, defined as a consumption pattern that increases the risk of harm to physical or psychosocial health. In the context of NPUC, risky substance use is associated with more intense pain, emotional distress, disability, and opioid or other substance misuse (ie, cross-tolerance). Consequently, risky substance use is a significant modifiable risk factor for the progression and maintenance of chronic pain-related disability and comorbid psychopathology among patients with NPUCs. Objective: This study aims to develop, adapt, and test the feasibility of the Web-Based Toolkit for Resilient Life Beyond Pain and Substance Use (Web-TIRELESS), a novel, asynchronous, and web-based mind-body intervention aimed at modifying maladaptive pain-coping behaviors in patients with NPUC and comorbid risky substance use. This study illustrates the proposed study design, methodology, and intervention content. Methods: In aim 1, we will conduct live video qualitative interviews (n=20) with care-seeking adult patients with NPUC and comorbid risky substance use to inform the development and refinement of Web-TIRELESS and study procedures. In aim 2, we propose an open pilot study (n=12) of Web-TIRELESS with exit interviews and pre- and postintervention assessments to evaluate the feasibility, credibility, and acceptability of Web-TIRELESS and refine study procedures. Aim 3 consists of a pilot feasibility randomized controlled trial of Web-TIRELESS versus minimally enhanced usual care (n=50), both of which follow a web-based modality, to demonstrate the feasibility of recruitment procedures and data collection, as well as the feasibility, credibility, and acceptability of Web-TIRELESS and the control condition (adherence, retention, fidelity, and satisfaction), following prespecified benchmarks. Results: Patient interviews (aim 1) concluded in May 2024 and qualitative analysis is expected to be completed in September 2024. Completion of aim 2 (data collection and analysis) is expected by June 2025. The completion of aim 3 and other study-related operations is anticipated by June 2027. Conclusions: We will develop and test Web-TIRELESS, the first asynchronous mind-body intervention specifically adapted to enhance resilience in response to chronic pain among individuals with NPUCs and comorbid risky substance use. Results from this 3-aim study (feasibility, acceptability, and satisfaction of Web-TIRELESS) will be leveraged to inform a future efficacy randomized controlled trial of Web-TIRELESS versus the minimally enhanced usual care. Trial Registration: ClinicalTrials.gov NCT06366633; https://clinicaltrials.gov/study/NCT06366633 International Registered Report Identifier (IRRID): DERR1-10.2196/64547 UR - https://www.researchprotocols.org/2024/1/e64547 UR - http://dx.doi.org/10.2196/64547 UR - http://www.ncbi.nlm.nih.gov/pubmed/ ID - info:doi/10.2196/64547 ER - TY - JOUR AU - Bice, L. Briana AU - Michaud, L. Alexis AU - McCormick, G. Katherine AU - Miklos, M. Eva AU - Descombes, D. Indiana AU - Medeiros-Nancarrow, Cheryl AU - Zhou, S. Eric AU - Recklitis, J. Christopher PY - 2024/11/28 TI - Sleep Treatment Education Program for Cancer Survivors: Protocol for an Efficacy Trial JO - JMIR Res Protoc SP - e60762 VL - 13 KW - insomnia KW - mood KW - cancer survivors KW - online interventions KW - protocol KW - cognitive behavioral therapy KW - CBT KW - cognitive behavioral therapy for insomnia KW - CBTI KW - digital health KW - sleep disorders KW - sleep treatment education program KW - STEP-1 N2 - Background: Cancer survivors are at increased risk for chronic insomnia, even years after treatment completion. As insomnia is associated with a variety of long-term health consequences, access to insomnia treatment is critically important for the survivor population. Cognitive behavioral therapy for insomnia (CBTI) is the recommended first-line treatment for insomnia but remains largely unavailable to survivors. Treatment barriers include geographic limitations, a shortage of trained providers, and demanding treatment regimens. Designed with these limitations in mind, the Sleep Treatment Education Program (STEP-1) delivers components of CBTI in a low-intensity educational intervention delivered online. Objective: This is a phase II pilot randomized controlled trial. The primary aims are to test the efficacy of STEP-1 to improve (1) insomnia symptoms and (2) mood in cancer survivors compared to a control condition. The secondary aims will (1) explore participant factors associated with clinically significant response, (2) evaluate acceptability of the control intervention, (3) explore feasibility of delivering individualized coaching sessions for participants who do not have a significant response to STEP-1, and (4) describe participants? satisfaction with STEP-1 and suggestions for improvement. Methods: This 2-arm randomized controlled trial enrolled 70 off-treatment cancer survivors aged 40-89 years with clinically significant insomnia. Participants are randomized to receive either the STEP-1 intervention or control condition (relaxation education); interventions are delivered in one-on-one, synchronous, virtual videoconference sessions by trained interventionists. The STEP-1 intervention presents educational information on the development of insomnia after cancer and offers suggestions for improving insomnia symptoms based on the CBTI elements of sleep hygiene, stimulus control, and cognitive restructuring. With the interventionist, participants review the suggestions and develop a personalized sleep action plan for implementation. The relaxation education session provides information on the potential benefits of relaxation and how to independently access online relaxation exercises. The Insomnia Severity Index is used to measure insomnia symptoms, and the Profile of Mood States Short Form is used to measure mood at baseline and 4 and 8 weeks after intervention. The primary end point is change in the Insomnia Severity Index score at 8 weeks, and the secondary end point is change in mood symptoms (Profile of Mood States Short Form) at 8 weeks. Results: This trial was funded in July 2022. Enrollment and data collection began in February 2023 and concluded in October 2024, with 70 participants enrolled. The analysis will begin in fall 2024, and the results are expected in winter 2025. Conclusions: Trial results will determine if STEP-1 effects go beyond those that could be attributed to placebo and other nonspecific treatment factors. Should results support the efficacy of STEP-1 to improve mood and insomnia symptoms, we anticipate developing efficacy and implementation trials of STEP-1 in larger and more diverse samples. Trial Registration: ClinicalTrials.gov NCT05519982; https://clinicaltrials.gov/study/NCT05519982 International Registered Report Identifier (IRRID): DERR1-10.2196/60762 UR - https://www.researchprotocols.org/2024/1/e60762 UR - http://dx.doi.org/10.2196/60762 UR - http://www.ncbi.nlm.nih.gov/pubmed/ ID - info:doi/10.2196/60762 ER - TY - JOUR AU - Danielson, C. Elizabeth AU - Saturday, Mystie AU - Leonard, Sarah AU - Levit, Alexandra AU - Graham, K. Andrea AU - Marquez, Melissa AU - Alperin, Keith AU - Shankman, A. Stewart AU - Griffith, W. James PY - 2024/11/26 TI - Efficacy of a Mobile App?Based Behavioral Intervention (DRIVEN) to Help Individuals With Unemployment-Related Emotional Distress Return to Work: Protocol for a Randomized Controlled Trial JO - JMIR Res Protoc SP - e62715 VL - 13 KW - unemployment KW - wellness KW - depression KW - job stress KW - job distress KW - career coaching KW - coaching KW - mhealth KW - ehealth KW - job-seeking KW - mobile app KW - behavioral intervention KW - N2 - Background: Employment plays an important role in the maintenance of mental and physical health. Losing a job creates emotional distress, which can, in turn, interfere with effective job seeking. Thus, a program for job seekers that provides support for both the logistics of job seeking as well as emotional distress may help people find employment and improve emotional well-being. Objective: This study aims to test the efficacy of the 6-week intervention for job seekers in a randomized controlled trial. Methods: This is a parallel-assignment randomized control trial comparing a 6-week return-to-work intervention versus job seeking as usual for a stratified sample of job seekers (n=150). The intervention will be delivered through a mobile phone app and scheduled video counseling sessions with a job coach. Assessments will be taken weekly during the intervention as well as 8 and 16 weeks later. The intervention and control group procedures will be administered remotely, allowing the study to take place in several regions of the United States. Eligible participants will be adults aged 18 to 65 years, currently unemployed, and actively searching for work. Participants will be recruited from 7 major metropolitan areas in the United States using online advertisements on Craigslist. The primary outcome measure is the Job Search Behavior Scale, which has 2 subscales, preparatory job search behavior and active job search behavior. Employment status will also be assessed throughout the trial. A mixed-model regression analysis will be used to compare job searching behavior in the intervention group versus the control group. A time-to-event analysis (ie, survival analysis) will be used to compare employment status in the 2 experimental groups. Secondary outcomes will also be evaluated, including job search self-efficacy and mental health-related outcomes such as anxiety and depression. Results: This study started on August 7, 2023, and as of June 2024, we have enrolled 140 participants. Enrollment began in August 2023 and will conclude by October 2024. Half of the participants (75/150, 50%) will be assigned to the intervention arm while the other half (75/150, 50%) will be assigned to the control arm, job seeking as usual. Conclusions: The findings from this study will determine the efficacy of a mobile app?based intervention that uses both job training and psychological techniques on job seeking and employment outcomes. This first trial of Distress Return-to-Work Intervention (DRIVEN) will provide important information about blended support techniques for unemployed individuals, determine the usefulness of mobile apps to address large-scale mental health outcomes, and improve our understanding of the relationship between depression and unemployment status. Trial Registration: ClinicalTrials.gov NCT06026280; https://clinicaltrials.gov/study/NCT06026280 International Registered Report Identifier (IRRID): DERR1-10.2196/62715 UR - https://www.researchprotocols.org/2024/1/e62715 UR - http://dx.doi.org/10.2196/62715 UR - http://www.ncbi.nlm.nih.gov/pubmed/39589786 ID - info:doi/10.2196/62715 ER - TY - JOUR AU - Mace, A. Ryan AU - Law, E. Makenna AU - Cohen, E. Joshua AU - Ritchie, S. Christine AU - Okereke, I. Olivia AU - Hoeppner, B. Bettina AU - Brewer, A. Judson AU - Bartels, J. Stephen AU - Vranceanu, Ana-Maria AU - PY - 2024/11/21 TI - A Mindfulness-Based Lifestyle Intervention for Dementia Risk Reduction: Protocol for the My Healthy Brain Feasibility Randomized Controlled Trial JO - JMIR Res Protoc SP - e64149 VL - 13 KW - lifestyle KW - cognitive decline KW - brain health KW - mindfulness KW - mind-body therapies KW - telemedicine KW - digital health KW - randomized clinical trial N2 - Background: Lifestyle behavior change and mindfulness have direct and synergistic effects on cognitive functioning and may prevent Alzheimer disease and Alzheimer disease?related dementias (AD/ADRD). We are iteratively developing and testing My Healthy Brain (MHB), the first mindfulness-based lifestyle group program targeting AD/ADRD risk factors in older adults with subjective cognitive decline. Our pilot studies (National Institutes of Health [NIH] stage 1A) have shown that MHB is feasible, acceptable, and associated with improvement in lifestyle behavior and cognitive outcomes. Objective: We will compare the feasibility of MHB versus an education control (health enhancement program [HEP]) in 50 older adults (aged ?60 y) with subjective cognitive decline and AD/ADRD risk factors. In an NIH stage 1B randomized controlled trial (RCT), we will evaluate feasibility benchmarks, improvements in cognitive and lifestyle outcomes, and engagement of hypothesized mechanisms. Methods: We are recruiting through clinics, flyers, web-based research platforms, and community partnerships. Participants are randomized to MHB or the HEP, both delivered in telehealth groups over 8 weeks. MHB participants learn behavior modification and mindfulness skills to achieve individualized lifestyle goals. HEP participants receive lifestyle education and group support. Assessments are repeated after the intervention and at a 6-month follow-up. Our primary outcomes are feasibility, acceptability, appropriateness, credibility, satisfaction, and fidelity benchmarks. The secondary outcomes are cognitive function and lifestyle (physical activity, sleep, nutrition, alcohol and tobacco use, and mental and social activity) behaviors. Data analyses will include the proportion of MHB and HEP participants who meet each benchmark (primary outcome) and paired samples 2-tailed t tests, Cohen d effect sizes, and the minimal clinically important difference for each measure (secondary outcomes). Results: Recruitment began in January 2024. We received 225 inquiries. Of these 225 individuals, 40 (17.8%) were eligible. Of the 40 eligible participants, 21 (52.5%) were enrolled in 2 group cohorts, 17 (42.5%) were on hold for future group cohorts, and 2 (5%) withdrew before enrollment. All participants have completed before the intervention assessments. All cohort 1 participants (9/21, 43%) have completed either MHB or the HEP (?6 of 8 sessions) and after the intervention assessments. The intervention for cohort 2 (12/21, 57%) is ongoing. Adherence rates for the Garmin Vivosmart 5 (128/147, 87.1% weeks) and daily surveys (105/122, 86.1% weeks) are high. No enrolled participants have dropped out. Enrollment is projected to be completed by December 2024. Conclusions: The RCT will inform the development of a larger efficacy RCT (NIH stage 2) of MHB versus the HEP in a more diverse sample of older adults, testing mechanisms of improvements through theoretically driven mediators and moderators. The integration of mindfulness with lifestyle behavior change in MHB has the potential to be an effective and sustainable approach for increasing the uptake of AD/ADRD risk reduction strategies among older adults. Trial Registration: ClinicalTrials.gov NCT05934136; https://www.clinicaltrials.gov/study/NCT05934136 International Registered Report Identifier (IRRID): DERR1-10.2196/64149 UR - https://www.researchprotocols.org/2024/1/e64149 UR - http://dx.doi.org/10.2196/64149 UR - http://www.ncbi.nlm.nih.gov/pubmed/ ID - info:doi/10.2196/64149 ER - TY - JOUR AU - Cauley, Elaine Christy AU - Rubio, Atziri AU - Brindle, Mary AU - Cooper, Zara AU - Vranceanu, Ana-Maria AU - Ritchie, S. Christine PY - 2024/11/15 TI - A Video-Based Communication Intervention for Fecal Ostomy Surgery (CI-oSurg): Protocol for Open Pilot Testing to Improve Intervention Acceptability and Feasibility JO - JMIR Res Protoc SP - e60575 VL - 13 KW - fecal ostomy KW - distress KW - open pilot KW - fecal ostomy surgeryl CI-oSurg KW - intervention acceptability KW - biopsychosocial outcomes KW - psychosocial support KW - ostomy care N2 - Background: Approximately 100,000 patients undergo fecal ostomy operations annually across the United States. This patient population experiences high surgical complication rates and poor biopsychosocial outcomes. Surgical teams are not trained to address the psychosocial needs that often arise during recovery after fecal ostomy surgery. Objective: This study aims to refine and establish the acceptability and usability of the Communication Intervention for fecal ostomy Surgery (CI-oSurg), a web-based communication intervention aimed at reducing distress among patients recovering from ostomy surgery. Methods: We describe the proposed study design, methodology, and training protocol. We will conduct an open pilot (n=24 patients and n=8 clinicians) of video-based training to first identify the level and types of distress patients are experiencing. Next, patients will view web videos that address frequent challenges faced by ostomy patients, considering practical management and emotional and adaptation concerns. Qualitative one-to-one semistructured interviews will be conducted with participants to explore the acceptability and feasibility of the program and refine the intervention and study procedures. Results: This study has been approved by the Mass General Brigham Institutional Review Board. Study funding has been obtained, and recruitment is planned for the fall of 2024. Conclusions: Through this study, we will refine CI-oSurg, a web-based communication intervention focused on reducing distress after ostomy surgery, to improve intervention acceptability and usability. These improvements will allow us to establish the usability and acceptability of the intervention before efficacy testing to determine the ability of this intervention to reduce distress after fecal ostomy surgery. Trial Registration: ClinicalTrials.gov NCT06320002; https://clinicaltrials.gov/study/NCT06320002 International Registered Report Identifier (IRRID): PRR1-10.2196/60575 UR - https://www.researchprotocols.org/2024/1/e60575 UR - http://dx.doi.org/10.2196/60575 UR - http://www.ncbi.nlm.nih.gov/pubmed/ ID - info:doi/10.2196/60575 ER - TY - JOUR AU - Chaudary, Jatin AU - Rawat, Shruta AU - Dange, Alpana AU - Golub, A. Sarit AU - Kim, S. Ryung AU - Chakrapani, Venkatesan AU - Mayer, H. Kenneth AU - Arnsten, Julia AU - Patel, V. Viraj PY - 2024/11/5 TI - The CHALO! 2.0 mHealth-Based Multilevel Intervention to Promote HIV Testing and Linkage-to-Care Among Men Who Have Sex with Men in Mumbai, India: Protocol for a Randomized Controlled Trial JO - JMIR Res Protoc SP - e59873 VL - 13 KW - Keywords: digital health KW - HIV prevention KW - social media KW - stigma KW - gay KW - men who have sex with men KW - MSM N2 - Background: Current programs to engage marginalized populations such as gay and bisexual individuals and other men who have sex with men (MSM) in HIV prevention interventions do not often reach all MSM who may benefit from them. To reduce the global burden of HIV, far-reaching strategies are needed to engage MSM in HIV prevention and treatment. Globally, including low- and middle-income countries, MSM are now widely using internet-based social and mobile technologies (SMTs; eg, dating apps, social media, and WhatsApp [Meta]), which provides an unprecedented opportunity to engage unreached and underserved groups, such as MSM for HIV prevention and care. Objective: This study aimed to assess the effectiveness of a multilevel mobile health (mHealth)?based intervention to improve HIV testing uptake and status neutral linkage-to-care among sexually active MSM reached through internet-based platforms in Mumbai, India. Methods: In this randomized controlled trial, we will determine whether CHALO! 2.0 (a theory-based multilevel intervention delivered in part through WhatsApp) results in increased HIV testing and linkage-to-care (prevention or treatment). This study is being conducted among 1000 sexually active MSM who are unaware of their HIV status (never tested or tested >6 months ago) and are recruited through SMTs in Mumbai, India. We will conduct a 12-week, 3-arm randomized trial comparing CHALO! 2.0 to 2 control conditions?an attention-matched SMT-based control (also including a digital coupon for free HIV testing) and a digital coupon?only control. The primary outcomes will be HIV testing and status neutral linkage-to-care by 6 months post enrollment. Participants will be followed up for a total of 18 months to evaluate the long-term impact. Results: The study was funded in 2020, with recruitment having started in April 2022 due to delays from the COVID-19 pandemic. Baseline survey data collection began in April 2022, with follow-up surveys starting in July 2022. As of April 2022, we enrolled 1004 participants in the study. The completion of follow-up data collection is expected in January 2025, with results to be published thereafter. Conclusions: While global health agencies have called for internet-based interventions to engage populations vulnerable to HIV who are not being reached, few proven effective and scalable models exist and none is in India, which has one of the world?s largest HIV epidemics. This study will address this gap by testing a multicomponent mHealth intervention to reach and engage MSM at high priority for HIV interventions and link them to HIV testing and prevention or treatment. Trial Registration: ClinicalTrials.gov NCT04814654; https://clinicaltrials.gov/study/NCT04814654. Clinical Trial Registry of India CTRI/2021/03/032280 International Registered Report Identifier (IRRID): DERR1-10.2196/59873 UR - https://www.researchprotocols.org/2024/1/e59873 UR - http://dx.doi.org/10.2196/59873 UR - http://www.ncbi.nlm.nih.gov/pubmed/ ID - info:doi/10.2196/59873 ER - TY - JOUR AU - Khati, Antoine AU - Wickersham, A. Jeffrey AU - Gautam, Kamal AU - Paudel, Kiran AU - Phiphatkhunarnon, Panyaphon AU - Lim, How Sin AU - Puniamurthy, Kirthana AU - Altice, L. Frederick AU - Phanuphak, Nittaya AU - Azwa, Iskandar AU - Shrestha, Roman PY - 2024/10/23 TI - Integrated Online-to-Offline Model of Care for HIV Prevention and Treatment Among Men Who Have Sex With Men in Malaysia: Protocol for an Intervention Development and a Multiphase Trial JO - JMIR Res Protoc SP - e60962 VL - 13 KW - HIV KW - HIV testing KW - pre-exposure prophylaxis KW - antiretroviral therapy KW - CINTAI KW - men who have sex with men KW - online-to-offline model KW - eHealth N2 - Background: HIV continues to have a disproportionate impact on specific populations in Malaysia, particularly men who have sex with men (MSM). HIV self-testing (HIVST) is a strategy that has been shown to scale up HIV testing rates. However, it faces shortcomings because of concerns about self-efficacy, result interpretation, and lack of counseling and linkage to care. This underscores the need for an innovative approach that integrates HIVST with timely counseling, expert guidance, and referrals to enhance engagement in relevant HIV prevention or treatment. Objective: This study aims to describe the protocol used in developing and testing a web-based platform (ie, CINTAI) providing an HIVST kit and real-time e-counseling to support online-to-offline linkage to HIV care services for MSM in Malaysia. Methods: The methods are reported according to the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013 guidelines. In phase I, we will adapt existing HIVST web-based platforms to create a new online-to-offline HIVST and counseling platform called ?CINTAI? for Malaysian MSM. In phase II, we will use a type 1 hybrid implementation trial design to determine the feasibility, acceptability, and preliminary efficacy of ?CINTAI? compared with treatment as usual among Malaysian MSM, with assessments conducted over 6 months. Multilevel implementation factors will also be collected to guide future adoption and scale-up. We will enroll 78 MSM in the pilot randomized controlled trial. Baseline characteristics will be tested for homogeneity between groups using appropriate statistical tests. A generalized linear mixed model with random subject effects will account for within-subject correlation. Treatment assignment, time, interaction, and confounders will be included. The proportion of MSM tested for HIV over 6 months and other outcomes (pre-exposure prophylaxis for HIV or antiretroviral therapy linkage, HIV risk behaviors, and chemsex harm reduction) will be compared using linear contrasts. Results: We completed phase I of the proposed study in April 2024 and started phase II in May 2024, with 15 participants recruited (7 in the CINTAI and 8 in the treatment-as-usual groups). On the basis of a series of formative works completed during phase I, we developed a fully functional, web-based platform that provides a digital platform for MSM in Malaysia to order HIVST kits for free and to receive HIV counseling, followed by offline linkage to HIV prevention services (if HIV negative) or HIV treatment services (if HIV positive). Conclusions: Despite being at high risk for HIV transmission, MSM in Malaysia have alarmingly low testing and linkage to HIV care services, prompting the need for innovative approaches to support HIV prevention efforts. If found to be feasible and acceptable, CINTAI can be easily adapted for a range of health outcomes and health care delivery services for MSM, including adaptation to other low- and middle-income countries. International Registered Report Identifier (IRRID): DERR1-10.2196/60962 UR - https://www.researchprotocols.org/2024/1/e60962 UR - http://dx.doi.org/10.2196/60962 UR - http://www.ncbi.nlm.nih.gov/pubmed/39441624 ID - info:doi/10.2196/60962 ER - TY - JOUR AU - Berube, T. Lauren AU - Shrestha, Archana AU - Shrestha, Abha AU - Daneault, Jean-Francois AU - Shakya, Raj Prabin AU - Dhimal, Meghnath AU - Shrestha, Roman AU - Rawal, Shristi PY - 2024/10/21 TI - Development and Testing of a Mobile App for Management of Gestational Diabetes in Nepal: Protocol for a User-Centered Design Study and Exploratory Randomized Controlled Trial JO - JMIR Res Protoc SP - e59423 VL - 13 KW - gestational diabetes mellitus KW - mobile health KW - mHealth KW - self-management KW - pregnancy KW - maternal and child health KW - South Asia KW - Nepal KW - low- and middle-income country KW - mobile phone N2 - Background: The prevalence of gestational diabetes mellitus (GDM) is increasing, particularly in low- and middle-income countries (LMICs) like Nepal. GDM self-management, including intensive dietary and lifestyle modifications and blood glucose monitoring, is critical to maintain glycemic control and prevent adverse outcomes. However, in resource-limited settings, several barriers hinder optimal self-management. Mobile health (mHealth) technology holds promise as a strategy to augment GDM treatment by promoting healthy behaviors and supporting self-management, but this approach has not yet been tested in any LMIC. Objective: This report describes the protocol to develop a culturally tailored mHealth app that supports self-management and treatment of GDM (GDM?Dhulikhel Hospital [GDM-DH] app, phase 1) and test its usability and preliminary efficacy (phase 2) among patients with GDM in a periurban hospital setting in Nepal. Methods: The study will be conducted at Dhulikhel Hospital in Dhulikhel, Nepal. In the development phase (phase 1), a prototype of the GDM-DH app will be developed based on expert reviews and a user-centered design approach. To understand facilitators and barriers to GDM self-management and to gather feedback on the prototype, focus groups and in-depth interviews will be conducted with patients with GDM (n=12), health care providers (n=5), and family members (n=3), with plans to recruit further if saturation is not achieved. Feedback will be used to build a minimum viable product, which will undergo user testing with 18 patients with GDM using a think-aloud protocol. The final GDM-DH app will be developed based on user feedback and following an iterative product design and user testing process. In the randomized controlled trial phase (phase 2), newly diagnosed patients with GDM (n=120) will be recruited and randomized to either standard care alone or standard care plus the GDM-DH app from 24-30 weeks gestation until delivery. In this proof-of-concept trial, feasibility outcomes will be app usage, self-monitoring adherence, and app usability and acceptability. Exploratory treatment outcomes will be maternal glycemic control at 6 weeks post partum, birth weight, and rates of labor induction and cesarean delivery. Qualitative data obtained from phase 1 will be analyzed using thematic analysis. In phase 2, independent 2-tailed t tests or chi-square analyses will examine differences in outcomes between the 2 treatment conditions. Results: As of July 2024, we have completed phase 1. Phase 2 is underway. The first participant was enrolled in October 2021, with 99 participants enrolled as of July 2024. We anticipate completing recruitment by December 2024 and disseminating findings by December 2025. Conclusions: App-based lifestyle interventions for GDM management are not common in LMICs, where GDM prevalence is rapidly increasing. This proof-of-concept trial will provide valuable insights into the potential of leveraging mHealth app?based platforms for GDM self-management in LMICs. Trial Registration: ClinicalTrials.gov NCT04198857; https://clinicaltrials.gov/study/NCT04198857 International Registered Report Identifier (IRRID): DERR1-10.2196/59423 UR - https://www.researchprotocols.org/2024/1/e59423 UR - http://dx.doi.org/10.2196/59423 UR - http://www.ncbi.nlm.nih.gov/pubmed/ ID - info:doi/10.2196/59423 ER - TY - JOUR AU - Zeidan, S. Rola AU - Ohama, K. Margaret AU - Evripidou, Natalia AU - Anton, D. Stephen AU - Hamed, L. Laith AU - Lin, Yi AU - Leeuwenburgh, Christiaan AU - Guirguis, W. Faheem AU - Efron, A. Philip AU - Flynn, Sheryl AU - Smith, Barbara AU - Bacher, Rhonda AU - Bakarasan, Naveen AU - Sarmiento Delgado, Juan AU - Mankowski, T. Robert PY - 2024/10/17 TI - Home-Based Digital Exercise Training Program to Improve Physical Function of Older Sepsis Survivors: Protocol of the HEAL Sepsis Randomized Clinical Trial JO - JMIR Res Protoc SP - e60270 VL - 13 KW - sepsis KW - physical function KW - exercise KW - rehabilitation KW - remotely delivered KW - aging N2 - Background: While sepsis, an exaggerated response to infection, can affect people of all age groups, it is more prevalent in middle-aged and older adults. Older adults suffer worse short-term and long-term outcomes than younger patients. Older sepsis survivors are commonly discharged to long-term acute care facilities, where they often die within 1 year. Those who return home from the hospital lose the momentum of physical function improvement after early inpatient rehabilitation, and often face exacerbation of comorbidities and decline in physical function. Additionally, patients who are discharged home often live at distant locations and are not able to commute to rehabilitation centers due to their poor health status. Therefore, remotely delivered exercise interventions tailored to this population hold promise to improve physical function safely and effectively after sepsis. However, this type of intervention has yet to be tested in this population. Objective: This study aims to assess the safety, feasibility, and ease of recruitment and retention of participants for a remotely delivered physical activity intervention for improving physical function in middle-aged and older sepsis survivors. Methods: The proposed intervention will be delivered through a digital health platform that comprises a patient-facing mobile app and a 12-week physical activity program specifically designed for middle-aged and older sepsis survivors with poor health status who may face challenges participating in traditional out-patient or community-based exercise interventions. This study is ongoing and plans to enroll 40 sepsis survivors aged 55 years and older who will be randomized to either a remotely delivered exercise intervention group or a control group (electronic health diary). Both groups will use a tablet containing the Health in Motion app (Blue Marble Health). The intervention group will receive a clinician-designed personalized avatar-guided home exercise program and reminders while the control group will self-report daily activities using the in-app health diary feature. Results: This study is the first to use a home-based, remotely monitored 12-week exercise program to improve physical function in sepsis survivors. This study will evaluate the safety, feasibility, and efficacy, providing the necessary knowledge to design and calculate power for future larger trials. Conclusions: This study will provide important information for planning a future randomized clinical trial to test the efficacy of a remotely delivered exercise intervention in this high-risk population. Trial Registration: ClinicalTrials.gov NCT05568511; https://clinicaltrials.gov/study/NCT05568511 International Registered Report Identifier (IRRID): DERR1-10.2196/60270 UR - https://www.researchprotocols.org/2024/1/e60270 UR - http://dx.doi.org/10.2196/60270 UR - http://www.ncbi.nlm.nih.gov/pubmed/39418096 ID - info:doi/10.2196/60270 ER - TY - JOUR AU - Mitchell, W. Jason AU - Bursac, Zoran AU - Diaz, David AU - Reyes Diaz, Michael Edward AU - Silva-Santisteban, Alfonso AU - Konda, A. Kelika PY - 2024/10/10 TI - Assessing a Couples-Based, Digital HIV Serostatus-Neutral Intervention (Para Ti, Para Mí, Para Nosotros) for Adult Cisgender Sexual Minority Male Couples in Lima, Peru: Protocol for a 6-Month Pilot Randomized Controlled Trial JO - JMIR Res Protoc SP - e63106 VL - 13 KW - digital health intervention KW - HIV prevention care KW - sexually transmitted infection KW - cisgender, sexual minority male couples KW - randomized controlled trial KW - Peru KW - mobile phone N2 - Background: HIV disproportionately affects sexual minority men (SMM; eg, gay, bisexual, and other men who have sex with men) in Lima, Peru; epidemiological data estimate that 32% to 39% of new HIV infections occur among adult cisgender SMM within primary partnerships (ie, male couples). Most HIV prevention-care research in Lima, Peru, has focused on SMM as individuals and not couples. To help address this critical gap in prevention care, we developed Para Ti, Para Mí, Para Nosotros (P3): a couples-based, digital HIV serostatus-neutral intervention (DHI) for adult cisgender SMM couples in Lima, Peru. The P3 DHI is designed to facilitate couples with skill-building, communication, decision-making, and working together to form and adhere to a detailed prevention care plan that aligns with their explicit sexual agreement. The P3 DHI is theoretically informed, self-guided, directed, sequential, and fully automated. Objective: This pilot randomized controlled trial (RCT) aims to examine the preliminary effects of P3 on couples? formation and adherence to a detailed prevention care plan containing evidence-based strategies that also aligns with their explicit sexual agreement over time. In addition, the feasibility of enrollment and retention and couples? acceptability of P3 will be assessed. Methods: The research implements a prospective, 6-month pilot RCT with a 3-month delayed control condition. After baseline, 60 enrolled SMM couples will be randomized to 1 of 2 conditions. Couples randomized to the unmatched, delayed control condition will receive access to the P3 DHI to use during the last 3 months of the trial after the 3-month assessment. Couples randomized to the immediate intervention condition will immediately receive access to the P3 DHI for 6 months. Study assessments will occur at baseline and months 3 and 6. Descriptive, comparative, qualitative, and longitudinal analyses using generalized linear mixed-effect, multilevel, and actor-partner interdependence models will be conducted to address the specific aims. Results: The 6-month pilot RCT is ongoing. Recruitment, enrollment, and data collection began in January 2023 and ended in April 2024. A total of 74 adult cisgender SMM couples met all inclusion criteria, provided consent, and were enrolled in the pilot RCT. Retention was 92% (68/74) at month 6. Data are currently being analyzed to address the 3 specific aims regarding feasibility, acceptability, and preliminary efficacy. Conclusions: Findings from this research will reveal whether couples deemed the P3 DHI to be acceptable. Findings will also highlight the preliminary efficacy of the P3 DHI on couples managing their vulnerability to HIV and other sexually transmitted infections (STIs) over time via alignment of their prevention-care plan and sexual agreement. Trial findings will help shape the future direction of the P3 DHI while addressing the existing gap in prevention and care services for couples in the local context. Trial Registration: ClinicalTrials.gov NCT05873855; https://clinicaltrials.gov/study/NCT05873855 International Registered Report Identifier (IRRID): DERR1-10.2196/63106 UR - https://www.researchprotocols.org/2024/1/e63106 UR - http://dx.doi.org/10.2196/63106 UR - http://www.ncbi.nlm.nih.gov/pubmed/ ID - info:doi/10.2196/63106 ER - TY - JOUR AU - Loerzel, Victoria AU - Alamian, Arsham AU - Clochesy, John AU - Geddie, I. Patricia PY - 2024/10/2 TI - Serious Gaming for Chemotherapy-Induced Nausea and Vomiting in Older Adults With Cancer: Protocol for a Randomized Clinical Trial JO - JMIR Res Protoc SP - e64673 VL - 13 KW - chemotherapy-induced nausea and vomiting KW - aged KW - serious game KW - symptom self-management KW - mobile phone KW - neoplasms KW - self-care N2 - Background: Older adults are at high risk for toxicity due to cancer treatment and increased risk for adverse events related to chemotherapy-induced nausea and vomiting (CINV). Unfortunately, older adults report multiple treatment-related symptoms but use few strategies to self-manage these symptoms due to erroneous beliefs related to the effectiveness of commonly taught self-management strategies. We developed a novel serious game, Managing at Home (MAH), to help older adults learn how to effectively self-manage CINV at home. Objective: This study has 2 aims. Aim 1 is to examine changes in CINV severity, self-management behaviors, functioning, quality of life, cognitive representation, and health care use within the intervention group from baseline (T1) to completion of the study (T6). Aim 2 is to determine the efficacy of the MAH intervention by comparing differences in primary outcomes (CINV severity and health care use) and secondary outcomes (self-management behaviors, functioning, and quality of life) between the intervention and control groups at each follow-up visit (T2-T6) and completion of the study (T6). Methods: This is a longitudinal randomized clinical trial. We will collect data from 500 older adults receiving cancer-related chemotherapy at baseline (T1) and at each treatment cycle until cycle 6 (T6). Participants will be enrolled if they are 60 years or older of age, are newly diagnosed with cancer, being treated with any chemotherapy agent with moderate or high emetic potential, are on a 2-, 3-, or 4-week treatment cycle, are proficient in English, and have a telephone. Previous diagnosis or treatment for cancer, end-stage disease with less than 6 months to live, and uncorrected visual or hearing impairment are exclusion criteria. Results: This study was funded in September 2022 and received institutional review board approval in October 2022. As of July 2023, the enrollment of participants is ongoing and currently has 130 enrolled participants. Data collection and analysis will be complete in 2027. Conclusions: This study addresses self-management of CINV in older adults using an innovative serious game. The MAH intervention uses simulation and gaming technology to engage older adults in active learning in order to reframe erroneous perceptions about symptom self-management. If shown to be effective, it can easily be adapted to include other cancer-related symptoms or other chronic illnesses. Trial Registration: ClinicalTrials.gov NCT05838638; https://clinicaltrials.gov/study/NCT05838638 International Registered Report Identifier (IRRID): DERR1-10.2196/64673 UR - https://www.researchprotocols.org/2024/1/e64673 UR - http://dx.doi.org/10.2196/64673 UR - http://www.ncbi.nlm.nih.gov/pubmed/ ID - info:doi/10.2196/64673 ER - TY - JOUR AU - Chung, H. Kaitlin AU - Youngblood, M. Shari AU - Clingan, L. Carin AU - Deighton, C. Dana AU - Jump, A. Virginia AU - Manuweera, Thushini AU - McGeorge, M. Nicolette AU - Renn, L. Cynthia AU - Rosenblatt, Y. Paula AU - Winder, T. Aaron AU - Zhu, Shijun AU - Kleckner, R. Ian AU - Kleckner, S. Amber PY - 2024/9/5 TI - Digitizing Survivorship Care Plans Through the POST-Treatment Health Outcomes of Cancer Survivors (POSTHOC) Mobile App: Protocol for a Phase II Randomized Controlled Trial JO - JMIR Res Protoc SP - e59222 VL - 13 KW - mobile health KW - mHealth KW - symptoms KW - clinical trial KW - posttreatment KW - oncology KW - mobile phone N2 - Background: Survivorship care plans (SCPs) are provided at the completion of cancer treatment to aid in the transition from active treatment to long-term survivorship. They describe the details of a patient?s diagnosis and treatment and offer recommendations for follow-up appointments, referrals, and healthy behaviors. The plans are currently paper-based and become outdated as soon as a patient?s health status changes. There is a need to digitize these plans to improve their accessibility, modifiability, and longevity. With current technology, SCPs can be linked to mobile devices and activity trackers so that patients can track health behaviors and compare them to their clinical goals, taking charge of their own health. Objective: A mobile app, POSTHOC (POST-Treatment Health Outcomes of Cancer Survivors), that digitizes the SCP was developed, with goals of integrating it with wearable technologies and electronic medical records. Herein, we are conducting a randomized controlled trial that evaluates the POSTHOC app versus the traditional SCP on total symptom burden in the early posttreatment period. Methods: We will recruit 54 patients who have recently completed curative therapy for cancer (any type) in person and remotely. They will be randomized 2:1, POSTHOC:usual care (unblinded). Those randomized to the POSTHOC group will receive their SCP via the app and will choose to focus on nutrition or exercise for the duration of the study based on their individual plan and personal preferences. Those randomized to the control group will get a paper-based plan. At baseline, 6 weeks, and 12 weeks, we will evaluate patient-reported outcomes, including total symptom burden (web-based questionnaire), diet (24-hour Automated Self-Administered [ASA24]), and physical activity (Fitbit Charge 6 [Google LLC]). We will also collect quantitative and qualitative feedback on the usability of the app from those in the POSTHOC arm to improve the app for future implementation studies, with a specific focus on patient-provider communication. For feasibility, we will calculate the percentage of patients who used the POSTHOC app at least 3 times per week. We will use linear mixed models to evaluate the effects of the POSTHOC app versus those of usual care on other outcomes at weeks 6 and 12. Results: This trial is open to accrual in the University of Maryland Medical System as of March 2024, and as of July 3, 2024, a total of 20 participants have consented. Conclusions: This study is among the first to digitize the SCP in a mobile app and test the effects of a mobile health?delivered behavioral health intervention on symptom burden in cancer survivors. Our results will provide evidence about the effects of health self-management on symptoms. This knowledge will be integral to larger randomized controlled studies, integration with the electronic medical record, and nationwide implementation. Trial Registration: ClinicalTrials.gov NCT05499663; https://clinicaltrials.gov/ct2/show/NCT05499663 International Registered Report Identifier (IRRID): DERR1-10.2196/59222 UR - https://www.researchprotocols.org/2024/1/e59222 UR - http://dx.doi.org/10.2196/59222 UR - http://www.ncbi.nlm.nih.gov/pubmed/39235855 ID - info:doi/10.2196/59222 ER - TY - JOUR AU - Wirtz, L. Andrea AU - Poteat, Tonia AU - Borquez, Annick AU - Linton, Sabriya AU - Stevenson, Megan AU - Case, James AU - Brown, Carter AU - Lint, Arianna AU - Miller, Marissa AU - Radix, Asa AU - Althoff, N. Keri AU - Schneider, S. Jason AU - Haw, Sonya J. AU - Wawrzyniak, J. Andrew AU - Rodriguez, Allan AU - Cooney, Erin AU - Humes, Elizabeth AU - Pontes, Ceza AU - Seopaul, Shannon AU - White, Camille AU - Beyrer, Chris AU - Reisner, L. Sari AU - PY - 2024/8/27 TI - Enhanced Cohort Methods for HIV Research and Epidemiology (ENCORE): Protocol for a Nationwide Hybrid Cohort for Transgender Women in the United States JO - JMIR Res Protoc SP - e59846 VL - 13 KW - transgender women KW - cohort KW - United States KW - HIV KW - digital methods N2 - Background: In the United States, transgender women are disproportionately impacted by HIV and prioritized in the national strategy to end the epidemic. Individual, interpersonal, and structural vulnerabilities underlie HIV acquisition among transgender women and fuel syndemic conditions, yet no nationwide cohort monitors their HIV and other health outcomes. Objective: Our objective is to develop a nationwide cohort to estimate HIV incidence, identify risk factors, and investigate syndemic conditions co-occurring with HIV vulnerability or acquisition among US transgender women. The study is informed by the Syndemics Framework and the Social Ecological Model, positing that stigma-related conditions are synergistically driven by shared multilevel vulnerabilities. Methods: To address logistical and cost challenges while minimizing technology barriers and research distrust, we aim to establish a novel, hybrid community hub?supported digital cohort (N=3000). The digital cohort is the backbone of the study and is enhanced by hubs strategically located across the United States for increased engagement and in-person support. Study participants are English or Spanish speakers, are aged ?18 years, identify as transgender women or along the transfeminine spectrum, reside in 1 of the 50 states or Puerto Rico, and do not have HIV (laboratory confirmed). Participants are followed for 24 months, with semiannual assessments. These include a questionnaire and laboratory-based HIV testing using self-collected specimens. Using residential zip codes, person-level data will be merged with contextual geolocated data, including population health measures and economic, housing, and other social and structural factors. Analyses will (1) evaluate the contribution of hub support to the digital cohort using descriptive statistics; (2) estimate and characterize syndemic patterns among transgender women using latent class analysis; (3) examine the role of contextual factors in driving syndemics and HIV prevention over time using multilevel regression models; (4) estimate HIV incidence in transgender women and examine the effect of syndemics and contextual factors on HIV incidence using Poisson regression models; and (5) develop dynamic, compartmental models of multilevel combination HIV prevention interventions among transgender women to simulate their impact on HIV incidence through 2030. Results: Enrollment launched on March 15, 2023, with data collection phases occurring in spring and fall. As of February 24, 2024, a total of 3084 individuals were screened, and 996 (32.3%) met the inclusion criteria and enrolled into the cohort: 2.3% (23/996) enrolled at a hub, and 53.6% (534/996) enrolled through a community hub?supported strategy. Recruitment through purely digital methods contributed 61.5% (1895/3084) of those screened and 42.7% (425/996) of those enrolled in the cohort. Conclusions: Study findings will inform the development of evidence-based interventions to reduce HIV acquisition and syndemic conditions among US transgender women and advance efforts to end the US HIV epidemic. Methodological findings will also have critical implications for the design of future innovative approaches to HIV research. International Registered Report Identifier (IRRID): DERR1-10.2196/59846 UR - https://www.researchprotocols.org/2024/1/e59846 UR - http://dx.doi.org/10.2196/59846 UR - http://www.ncbi.nlm.nih.gov/pubmed/ ID - info:doi/10.2196/59846 ER - TY - JOUR AU - Shaffer, M. Kelly AU - Reese, Barsky Jennifer AU - Dressler, V. Emily AU - Glazer, V. Jillian AU - Cohn, Wendy AU - Showalter, L. Shayna AU - Clayton, H. Anita AU - Danhauer, C. Suzanne AU - Loch, Michelle AU - Kadi, Mai AU - Smith, Caleigh AU - Weaver, E. Kathryn AU - Lesser, J. Glenn AU - Ritterband, M. Lee PY - 2024/8/19 TI - Factorial Trial to Optimize an Internet-Delivered Intervention for Sexual Health After Breast Cancer: Protocol for the WF-2202 Sexual Health and Intimacy Enhancement (SHINE) Trial JO - JMIR Res Protoc SP - e57781 VL - 13 KW - breast neoplasms KW - cancer survivorship KW - clinical trial KW - communication skills KW - factorial trial KW - internet interventions KW - intimacy KW - mobile phone KW - multiphase optimization strategy KW - sexual distress KW - sexual functioning KW - sexual health N2 - Background: Although most survivors of breast cancer report substantial sexual concerns following treatment, few receive support for these concerns. Delivering sexual health care to survivors of breast cancer via the internet could overcome many of the barriers to in-person treatment. Even when delivered remotely, survivor time constraints remain a leading barrier to sexual health intervention uptake. Objective: Guided by the multiphase optimization strategy methodological framework, the primary objective of this study is to identify the most efficient internet-delivered sexual health intervention package that is expected to provide survivors of breast cancer the greatest benefit with the fewest (and least-intensive) intervention components. This study aims to determine how intervention components work (mediators) and for whom they work best (moderators). Methods: Partnered, posttreatment adult female survivors of breast cancer (N=320) experiencing at least 1 bothersome sexual symptom (ie, pain with sex, vaginal dryness, low sexual desire, and difficulty with orgasm) related to their breast cancer treatment will be enrolled. Clinic-based recruitment will be conducted via the Wake Forest National Cancer Institute Community Oncology Research Program (NCORP) Research Base. Participants will be randomly assigned to 1 of 16 combinations of four intervention components with two levels each in this factorial trial: (1) psychoeducation about cancer-related sexual morbidity (receive either enhanced vs standard versions); (2) communication skills training for discussing concerns with health care providers (received vs not received); (3) communication skills training for discussing concerns with a partner (received vs not received); and (4) intimacy promotion skills training (received vs not received). Cores will be fully automated and implemented using a robust internet intervention platform with highly engaging elements such as animation, video, and automated email prompts. Survivors will complete web-based assessments at baseline (prerandomization time point) and again at 12 and 24 weeks later. The primary study aim will be achieved through a decision-making process based on systematically evaluating the main and interaction effects of components on sexual distress (Female Sexual Distress Scale?Desire, Arousal, Orgasm) and sexual functioning (Female Sexual Function Index) using a generalized linear model approach to ANOVA with effect coding. Mediation analyses will be conducted through a structural equation modeling approach, and moderation analyses will be conducted by extending the generalized linear model to include interaction effects. Results: This protocol has been reviewed and approved by the National Cancer Institute Central Institutional Review Board. Data collection is planned to begin in March 2024 and conclude in 2027. Conclusions: By identifying the combination of the fewest and least-intensive intervention components likely to provide survivors of breast cancer the greatest sexual health benefit, this study will result in the first internet intervention that is optimized for maximum impact on the undertreated, prevalent, and distressing problem of breast cancer?related sexual morbidity. Trial Registration: ClinicalTrials.gov NCT06216574; https://clinicaltrials.gov/study/NCT06216574 International Registered Report Identifier (IRRID): PRR1-10.2196/57781 UR - https://www.researchprotocols.org/2024/1/e57781 UR - http://dx.doi.org/10.2196/57781 UR - http://www.ncbi.nlm.nih.gov/pubmed/ ID - info:doi/10.2196/57781 ER - TY - JOUR AU - El-Toukhy, Sherine AU - Hegeman, Phillip AU - Zuckerman, Gabrielle AU - Das, Roy Anirban AU - Moses, Nia AU - Troendle, James AU - Powell-Wiley, M. Tiffany PY - 2024/8/16 TI - Study of Postacute Sequelae of COVID-19 Using Digital Wearables: Protocol for a Prospective Longitudinal Observational Study JO - JMIR Res Protoc SP - e57382 VL - 13 KW - postacute sequelae of COVID-19 KW - wearable devices KW - physiological parameters KW - prospective observational study KW - mobile phone N2 - Background: Postacute sequelae of COVID-19 (PASC) remain understudied in nonhospitalized patients. Digital wearables allow for a continuous collection of physiological parameters such as respiratory rate and oxygen saturation that have been predictive of disease trajectories in hospitalized patients. Objective: This protocol outlines the design and procedures of a prospective, longitudinal, observational study of PASC that aims to identify wearables-collected physiological parameters that are associated with PASC in patients with a positive diagnosis. Methods: This is a single-arm, prospective, observational study of a cohort of 550 patients, aged 18 to 65 years, male or female, who own a smartphone or a tablet that meets predetermined Bluetooth version and operating system requirements, speak English, and provide documentation of a positive COVID-19 test issued by a health care professional within 5 days before enrollment. The primary end point is long COVID-19, defined as ?1 symptom at 3 weeks beyond the first symptom onset or positive diagnosis, whichever comes first. The secondary end point is chronic COVID-19, defined as ?1 symptom at 12 weeks beyond the first symptom onset or positive diagnosis. Participants must be willing and able to consent to participate in the study and adhere to study procedures for 6 months. Results: The first patient was enrolled in October 2021. The estimated year for publishing the study results is 2025. Conclusions: This is a fully decentralized study investigating PASC using wearable devices to collect physiological parameters and patient-reported outcomes. The study will shed light on the duration and symptom manifestation of PASC in nonhospitalized patient subgroups and is an exemplar of the use of wearables as population-level monitoring health tools for communicable diseases. Trial Registration: ClinicalTrials.gov NCT04927442; https://clinicaltrials.gov/study/NCT04927442 International Registered Report Identifier (IRRID): DERR1-10.2196/57382 UR - https://www.researchprotocols.org/2024/1/e57382 UR - http://dx.doi.org/10.2196/57382 UR - http://www.ncbi.nlm.nih.gov/pubmed/ ID - info:doi/10.2196/57382 ER - TY - JOUR AU - Sibley, L. Adams AU - Noar, M. Seth AU - Muessig, E. Kathryn AU - O'Shea, G. Nisha AU - Paquette, E. Catherine AU - Spears, G. Abby AU - Miller, C. William AU - Go, F. Vivian PY - 2024/8/9 TI - An Automated Text Messaging Intervention to Reduce Substance Use Self-Stigma (Project RESTART): Protocol for a Feasibility and Acceptability Pilot Study JO - JMIR Res Protoc SP - e59224 VL - 13 KW - substance use KW - harm reduction KW - stigma KW - self-stigma KW - stigma resistance KW - mobile health KW - mHealth KW - SMS text messaging KW - mobile phone N2 - Background: Stigma is a barrier to treatment and harm reduction seeking in people who use drugs. Most stigma reduction interventions offer psychotherapy or psychoeducation in group-based clinical settings, failing to reach people who are not in treatment. SMS text messaging is an effective and acceptable modality for delivering health information to people who use drugs and may be a suitable conduit for providing information and advice to understand and cope with stigma. Objective: This paper presents the protocol for a study that aims to determine the feasibility, acceptability, and preliminary effectiveness of a 4-week automated SMS text message intervention to increase stigma resistance and reduce self-stigma in people who use drugs. Methods: We designed a novel automated SMS text message intervention to address the four personal-level constructs of stigma resistance: (1) not believing stigma and catching and challenging stigmatizing thoughts, (2) empowering oneself through learning about substance use and one?s recovery, (3) maintaining one?s recovery and proving stigma wrong, and (4) developing a meaningful identity and purpose apart from one?s substance use. Theory-based messages were developed and pilot-tested in qualitative elicitation interviews with 22 people who use drugs, resulting in a library of 56 messages. In a single-group, within-subjects, community-based pilot trial, we will enroll 30 participants in the Resisting Stigma and Revaluating Your Thoughts (RESTART) intervention. Participants will receive 2 daily SMS text messages for 4 weeks. Implementation feasibility will be assessed through recruitment, enrollment, retention, and message delivery statistics. User feasibility and acceptability will be assessed at follow-up using 23 survey items informed by the Theoretical Framework of Acceptability. Primary effectiveness outcomes are changes in self-stigma (Substance Abuse Self-Stigma Scale) and stigma resistance (Stigma Resistance Scale) from baseline to follow-up measured via a self-administered survey. Secondary outcomes are changes in hope (Adult Dispositional Hope Scale) and self-esteem (Rosenberg Self-Esteem Scale). Feasibility and acceptability will be assessed with descriptive statistics; effectiveness outcomes will be assessed with paired 2-tailed t tests, and group differences will be explored using ANOVA. Overall, 12 participants will also be selected to complete acceptability interviews. Results: This pilot study was funded by the National Institute on Drug Abuse in April 2023 and received regulatory approval in January 2024 by the University of North Carolina-Chapel Hill Institutional Review Board. Recruitment and enrollment began in March 2024. Follow-up visits are expected to conclude by May 2024. Results will be disseminated in relevant peer-reviewed journals. Conclusions: To the best of our knowledge, this is the first study to address substance use stigma via a self-help SMS text messaging program. Results will add to the nascent literature on stigma reduction in people who use drugs. This protocol may interest researchers who are considering text messaging to address psychosocial needs in hard-to-reach populations. Trial Registration: ClinicalTrials.gov NCT06281548; https://clinicaltrials.gov/ct2/show/NCT06281548 International Registered Report Identifier (IRRID): DERR1-10.2196/59224 UR - https://www.researchprotocols.org/2024/1/e59224 UR - http://dx.doi.org/10.2196/59224 UR - http://www.ncbi.nlm.nih.gov/pubmed/ ID - info:doi/10.2196/59224 ER - TY - JOUR AU - Mollard, Elizabeth AU - Cooper Owens, Deirdre AU - Bach, Christina AU - Gaines, Cydney AU - Maloney, Shannon AU - Moore, Tiffany AU - Wichman, Christopher AU - Shah, Neel AU - Balas, Michele PY - 2024/8/8 TI - Protective Assets Reinforced With Integrated Care and Technology (PARITY): Protocol for a Randomized Controlled Trial JO - JMIR Res Protoc SP - e58580 VL - 13 KW - maternal health KW - health disparities KW - doula KW - African American KW - mobile phone N2 - Background: Black women are significantly more likely to experience severe maternal morbidity and are 3 times as likely to die from pregnancy-related causes compared to White women. Using a strengths-based wellness approach within an integrated supportive care program provided by a community doula could offer pragmatic solutions for Black maternal disparities. The Protective Assets Reinforced with Integrated Care and Technology (PARITY) program consists of a wellness technology platform, including informational links to wellness content and reinforcing motivational SMS text messages, as well as community-based doula support delivered both in person and through the technology platform to improve Black maternal wellness. Objective: This pilot randomized controlled trial (RCT) and mixed methods evaluation aims to (1) determine the feasibility and acceptability of the PARITY intervention; (2) investigate the preliminary efficacy of the PARITY intervention on clinical outcomes (maternal blood pressure, gestational weight gain, and cesarean birth); and (3) investigate changes to wellness behavioral outcomes (nutrition, physical activity, sleep, and health care adherence) and empowered strengths (self-efficacy, social support, motivation, resilience, problem-solving, and self-regulation) in the intervention group compared to a control group. Methods: A 2-arm RCT and mixed methods evaluation will be conducted. Overall, 60 Black pregnant individuals will be randomized in a ratio of 1:1 to either the intervention or informational control group. Participants in the intervention group will receive access to the technology platform over a 12-week period that ends before birth. Intervention participants will be assigned a doula interventionist, who will meet with them 4 times during the intervention. All participants (intervention and control) will receive a referral for a birth doula at no cost, printed materials about having a healthy pregnancy, and community resources. Feasibility and acceptability will be assessed at the end of the program. Measures will be obtained at baseline (20-28 weeks), the 36th week of pregnancy, birth, and 6-12 weeks post partum. Summary statistics and distribution plots will be used to describe measured variables at each time point. A generalized linear mixed model with a shared random component will be used to analyze the effects of PARITY on clinical, wellness behavioral, and empowered strength outcomes, including baseline nutrition, physical activity, and sleep measures as covariates. For significant effects, post hoc contrasts will be adjusted using the Holm method to maintain comparison-wise error at or <.05. Missing data will be addressed using a pattern-mixture model. Results: The National Institute of Nursing Research funded this pilot RCT. Recruitment, enrollment, and data collection are ongoing, and the estimated study completion date is October 2024. Conclusions: The expected results of this study will provide the feasibility and preliminary efficacy of the PARITY intervention, to be used in a larger trial with a 12-month PARITY program intervention. Trial Registration: ClinicalTrials.gov NCT05802615; https://clinicaltrials.gov/study/NCT05802615 International Registered Report Identifier (IRRID): DERR1-10.2196/58580 UR - https://www.researchprotocols.org/2024/1/e58580 UR - http://dx.doi.org/10.2196/58580 UR - http://www.ncbi.nlm.nih.gov/pubmed/ ID - info:doi/10.2196/58580 ER - TY - JOUR AU - Attarha, Mouna AU - de Figueiredo Pelegrino, Carolina Ana AU - Toussaint, Paule-Joanne AU - Grant, Sarah-Jane AU - Van Vleet, Thomas AU - de Villers-Sidani, Etienne PY - 2024/8/8 TI - Improving Neurological Health in Aging Via Neuroplasticity-Based Computerized Exercise: Protocol for a Randomized Controlled Trial JO - JMIR Res Protoc SP - e59705 VL - 13 KW - brain training KW - cognitive training KW - healthy aging KW - neuroplasticity KW - acetylcholine KW - FEOBV KW - randomized controlled trial KW - aging KW - ageing KW - elderly KW - elder KW - older adults KW - older adult KW - neurological health KW - cognitive KW - computerized brain training KW - computerize KW - cognition KW - cognitive decline KW - Canada N2 - Background: Our current understanding of how computerized brain training drives cognitive and functional benefits remains incomplete. This paper describes the protocol for Improving Neurological Health in Aging via Neuroplasticity-based Computerized Exercise (INHANCE), a randomized controlled trial in healthy older adults designed to evaluate whether brain training improves cholinergic signaling. Objective: INHANCE evaluates whether 2 computerized training programs alter acetylcholine binding using the vesicular acetylcholine transporter ligand [18F] fluoroethoxybenzovesamicol ([18F] FEOBV) and positron emission tomography (PET). Methods: In this phase IIb, prospective, double-blind, parallel-arm, active-controlled randomized trial, a minimum of 92 community-dwelling healthy adults aged 65 years and older are randomly assigned to a brain training program designed using the principles of neuroplasticity (BrainHQ by Posit Science) or to an active control program of computer games designed for entertainment (eg, Solitaire). Both programs consist of 30-minute sessions, 7 times per week for 10 weeks (35 total hours), completed remotely at home using either loaned or personal devices. The primary outcome is the change in FEOBV binding in the anterior cingulate cortex, assessed at baseline and posttest. Exploratory cognitive and behavioral outcomes sensitive to acetylcholine are evaluated before, immediately after, and 3 months following the intervention to assess the maintenance of observed effects. Results: The trial was funded in September 2019. The study received approval from the Western Institutional Review Board in October 2020 with Research Ethics Board of McGill University Health Centre and Health Canada approvals in June 2021. The trial is currently ongoing. The first participant was enrolled in July 2021, enrollment closed when 93 participants were randomized in December 2023, and the trial will conclude in June 2024. The study team will be unblinded to conduct analyses after the final participant exits the study. We expect to publish the results in the fourth quarter of 2024. Conclusions: There remains a critical need to identify effective and scalable nonpharmaceutical interventions to enhance cognition in older adults. This trial contributes to our understanding of brain training by providing a potential neurochemical explanation of cognitive benefit. Trial Registration: ClinicalTrials.gov NCT04149457; https://clinicaltrials.gov/ct2/show/NCT04149457 International Registered Report Identifier (IRRID): DERR1-10.2196/59705 UR - https://www.researchprotocols.org/2024/1/e59705 UR - http://dx.doi.org/10.2196/59705 UR - http://www.ncbi.nlm.nih.gov/pubmed/ ID - info:doi/10.2196/59705 ER - TY - JOUR AU - Lau, Nancy AU - Palermo, M. Tonya AU - Zhou, Chuan AU - Badillo, Isabel AU - Hong, Shannon AU - Aalfs, Homer AU - Yi-Frazier, P. Joyce AU - McCauley, Elizabeth AU - Chow, J. Eric AU - Weiner, J. Bryan AU - Ben-Zeev, Dror AU - Rosenberg, R. Abby PY - 2024/7/30 TI - Mobile App Promoting Resilience in Stress Management for Adolescents and Young Adults With Cancer: Protocol for a Pilot Randomized Controlled Trial JO - JMIR Res Protoc SP - e57950 VL - 13 KW - adolescents KW - young adult KW - cancer KW - mHealth KW - psychosocial intervention KW - stress management KW - coping KW - resilience KW - health-related quality of life KW - randomized controlled trial KW - mobile phone N2 - Background: Adolescents and young adults (AYAs) with cancer are at risk of poor psychosocial outcomes. AYAs grew up with the internet and digital technology, and mobile Health (mHealth) psychosocial interventions have the potential to overcome care access barriers. Objective: This pilot randomized controlled trial (RCT) aimed to establish the feasibility, acceptability, and preliminary efficacy of a fully automated mobile app version of the Promoting Resilience in Stress Management intervention (mPRISM). Promoting Resilience in Stress Management is an evidence-based intervention developed in collaboration with AYAs, based on stress and coping theory, resilience theory, and evidence-based coping strategies. We hypothesized that mPRISM would be feasible, acceptable, and appropriate. Methods: This is a parallel, 2-arm, single-site pilot RCT with a waitlist control design. The study will recruit 80 AYAs with cancer from a clinic. Eligible AYAs are aged 12 to 25 years, within 12 months of a new cancer diagnosis, receiving chemotherapy or radiation therapy, speak, read, or write in English, and are cognitively able to participate in study procedures. Recruitment by clinical research coordinators will occur remotely by phone, video, or text. Participants will be randomized to psychosocial usual care (UC) alone or UC plus mPRISM for an 8-week intervention period, and will remain unblinded to study condition. Enrolled participants will complete surveys at baseline before randomization, 8 weeks, and 3-month follow-up. Using a waitlist design, the UC arm will receive mPRISM upon completion of 3-month follow-up surveys. Those in the UC arm will complete 2 additional measurement points at immediate posttreatment and 3 months later. The primary outcomes of interest are feasibility, defined as ?60% enrollment and ?70% retention (ie, percentage of participants who completed the study), and ?feasibility, acceptability, and appropriateness? as defined by cut-off scores ?4/5 on 3 brief validated implementation outcome measures (feasibility of implementation measure, acceptability of intervention measure [AIM], intervention appropriateness measure [IAM]). We will apply top-box scoring for the implementation measures. Exploratory outcomes of interest include patient-reported health-related quality of life, resilience, distress, anxiety, depression, pain, and sleep. We will conduct an intention-to-treat analysis to compare the outcomes of the mPRISM arm versus the control arm with covariate-adjusted regression models. We will summarize individual digital usage metrics using descriptive statistics. Results: Since September 2023, we have enrolled 20 participants and recruitment is ongoing. Conclusions: Although our previous work suggests AYAs with cancer are interested in mHealth psychosocial interventions, such interventions have not yet been sufficiently evaluated or implemented among AYA oncology patients. mPRISM may serve as a potential mHealth intervention to fill this gap. In this study, we will test the feasibility, acceptability, and preliminary efficacy of mPRISM. This work will inform future larger-scale RCTs powered for efficacy outcomes. Trial Registration: ClinicalTrials.gov NCT05842902; https://clinicaltrials.gov/study/NCT05842902 International Registered Report Identifier (IRRID): DERR1-10.2196/57950 UR - https://www.researchprotocols.org/2024/1/e57950 UR - http://dx.doi.org/10.2196/57950 UR - http://www.ncbi.nlm.nih.gov/pubmed/ ID - info:doi/10.2196/57950 ER - TY - JOUR AU - Xu, Jie AU - Talankar, Sankalp AU - Pan, Jinqian AU - Harmon, Ira AU - Wu, Yonghui AU - Fedele, A. David AU - Brailsford, Jennifer AU - Fishe, Noel Jennifer PY - 2024/7/8 TI - Combining Federated Machine Learning and Qualitative Methods to Investigate Novel Pediatric Asthma Subtypes: Protocol for a Mixed Methods Study JO - JMIR Res Protoc SP - e57981 VL - 13 KW - pediatric asthma KW - machine learning KW - federated learning KW - qualitative research N2 - Background: Pediatric asthma is a heterogeneous disease; however, current characterizations of its subtypes are limited. Machine learning (ML) methods are well-suited for identifying subtypes. In particular, deep neural networks can learn patient representations by leveraging longitudinal information captured in electronic health records (EHRs) while considering future outcomes. However, the traditional approach for subtype analysis requires large amounts of EHR data, which may contain protected health information causing potential concerns regarding patient privacy. Federated learning is the key technology to address privacy concerns while preserving the accuracy and performance of ML algorithms. Federated learning could enable multisite development and implementation of ML algorithms to facilitate the translation of artificial intelligence into clinical practice. Objective: The aim of this study is to develop a research protocol for implementation of federated ML across a large clinical research network to identify and discover pediatric asthma subtypes and their progression over time. Methods: This mixed methods study uses data and clinicians from the OneFlorida+ clinical research network, which is a large regional network covering linked and longitudinal patient-level real-world data (RWD) of over 20 million patients from Florida, Georgia, and Alabama in the United States. To characterize the subtypes, we will use OneFlorida+ data from 2011 to 2023 and develop a research-grade pediatric asthma computable phenotype and clinical natural language processing pipeline to identify pediatric patients with asthma aged 2-18 years. We will then apply federated learning to characterize pediatric asthma subtypes and their temporal progression. Using the Promoting Action on Research Implementation in Health Services framework, we will conduct focus groups with practicing pediatric asthma clinicians within the OneFlorida+ network to investigate the clinical utility of the subtypes. With a user-centered design, we will create prototypes to visualize the subtypes in the EHR to best assist with the clinical management of children with asthma. Results: OneFlorida+ data from 2011 to 2023 have been collected for 411,628 patients aged 2-18 years along with 11,156,148 clinical notes. We expect to complete the computable phenotyping within the first year of the project, followed by subtyping during the second and third years, and then will perform the focus groups and establish the user-centered design in the fourth and fifth years of the project. Conclusions: Pediatric asthma subtypes incorporating RWD from diverse populations could improve patient outcomes by moving the field closer to precision pediatric asthma care. Our privacy-preserving federated learning methodology and qualitative implementation work will address several challenges of applying ML to large, multicenter RWD data. International Registered Report Identifier (IRRID): DERR1-10.2196/57981 UR - https://www.researchprotocols.org/2024/1/e57981 UR - http://dx.doi.org/10.2196/57981 UR - http://www.ncbi.nlm.nih.gov/pubmed/38976313 ID - info:doi/10.2196/57981 ER - TY - JOUR AU - Carey, L. Rachel AU - Le, Ha AU - Coffman, L. Donna AU - Nahum-Shani, Inbal AU - Thirumalai, Mohanraj AU - Hagen, Cole AU - Baehr, A. Laura AU - Schmidt-Read, Mary AU - Lamboy, R. Marlyn S. AU - Kolakowsky-Hayner, A. Stephanie AU - Marino, J. Ralph AU - Intille, S. Stephen AU - Hiremath, V. Shivayogi PY - 2024/6/28 TI - mHealth-Based Just-in-Time Adaptive Intervention to Improve the Physical Activity Levels of Individuals With Spinal Cord Injury: Protocol for a Randomized Controlled Trial JO - JMIR Res Protoc SP - e57699 VL - 13 KW - spinal cord injury KW - physical activity KW - just-in-time adaptive intervention KW - mobile health KW - randomized controlled trial KW - microrandomized trial KW - wearable sensors KW - ecological momentary assessment KW - community KW - mobile phone N2 - Background: The lack of regular physical activity (PA) in individuals with spinal cord injury (SCI) in the United States is an ongoing health crisis. Regular PA and exercise-based interventions have been linked with improved outcomes and healthier lifestyles among those with SCI. Providing people with an accurate estimate of their everyday PA level can promote PA. Furthermore, PA tracking can be combined with mobile health technology such as smartphones and smartwatches to provide a just-in-time adaptive intervention (JITAI) for individuals with SCI as they go about everyday life. A JITAI can prompt an individual to set a PA goal or provide feedback about their PA levels. Objective: The primary aim of this study is to investigate whether minutes of moderate-intensity PA among individuals with SCI can be increased by integrating a JITAI with a web-based PA intervention (WI) program. The WI program is a 14-week web-based PA program widely recommended for individuals with disabilities. A secondary aim is to investigate the benefit of a JITAI on proximal PA, defined as minutes of moderate-intensity PA within 120 minutes of a PA feedback prompt. Methods: Individuals with SCI (N=196) will be randomized to a WI arm or a WI+JITAI arm. Within the WI+JITAI arm, a microrandomized trial will be used to randomize participants several times a day to different tailored feedback and PA recommendations. Participants will take part in the 24-week study from their home environment in the community. The study has three phases: (1) baseline, (2) WI program with or without JITAI, and (3) PA sustainability. Participants will provide survey-based information at the initial meeting and at the end of weeks 2, 8, 16, and 24. Participants will be asked to wear a smartwatch every day for ?12 hours for the duration of the study. Results: Recruitment and enrollment began in May 2023. Data analysis is expected to be completed within 6 months of finishing participant data collection. Conclusions: The JITAI has the potential to achieve long-term PA performance by delivering tailored, just-in-time feedback based on the person?s actual PA behavior rather than a generic PA recommendation. New insights from this study may guide intervention designers to develop engaging PA interventions for individuals with disability. Trial Registration: ClinicalTrials.gov NCT05317832; https://clinicaltrials.gov/study/NCT05317832 International Registered Report Identifier (IRRID): DERR1-10.2196/57699 UR - https://www.researchprotocols.org/2024/1/e57699 UR - http://dx.doi.org/10.2196/57699 UR - http://www.ncbi.nlm.nih.gov/pubmed/38941145 ID - info:doi/10.2196/57699 ER - TY - JOUR AU - Toure, Mahamoudou AU - Shaffer, G. Jeffrey AU - Sanogo, Daouda AU - Keita, Soumba AU - Keita, Moussa AU - Kane, Fousseyni AU - Traore, Bourama AU - Dabitao, Djeneba AU - Kone, Aissata AU - Doumbia, Oumar Cheick AU - Keating, Joseph AU - Yukich, Joshua AU - Hansson, H. Helle AU - Barry, E. Alyssa AU - Diakité, Mahamadou AU - Alifrangis, Michael AU - Doumbia, Seydou PY - 2024/1/22 TI - Seasonal Malaria Chemoprevention Therapy in Children Up To 9 Years of Age: Protocol for a Cluster-Randomized Trial Study JO - JMIR Res Protoc SP - e51660 VL - 13 KW - malaria KW - seasonal malaria chemoprevention KW - RCT KW - randomized KW - controlled trial KW - controlled trials KW - parasite KW - parasites KW - mosquito KW - mosquitoes KW - vector-borne KW - malarial KW - antimalarial KW - age KW - Plasmodium falciparum, protocol, cluster-randomized trial KW - child KW - children KW - infant KW - infants KW - pediatric KW - pediatrics KW - clinical trial KW - clinical trials KW - drug KW - drugs KW - pharmacy KW - pharmacology KW - pharmaceutic KW - pharmaceutics KW - pharmaceuticals KW - pharmaceutical KW - medication KW - medications N2 - Background: Seasonal malaria chemoprevention (SMC) is recommended by the World Health Organization for the sub-Sahel region in sub-Saharan Africa for preventing malaria in children 3 months old to younger than 5 years. Since 2016, the Malian National Malaria Control Program has deployed SMC countrywide during its high malaria transmission season at a rate of 4 monthly cycles annually. The standard SMC regimen includes sulfadoxine-pyrimethamine (SP) plus amodiaquine (AQ). Resistance against SP is suspected to be rising across West Africa; therefore, assessing the effectiveness of an alternative antimalarial drug for SMC is needed to provide a second-line regimen when it is ultimately needed. It is not well understood whether SMC effectively prevents malaria in children aged 5 years or older. Objective: The primary goal of the study is to compare 2 SMC regimens (SP-AQ and dihydroartemisinin-piperaquine [DHA-PQ]) in preventing uncomplicated Plasmodium falciparum malaria in children 3 months to 9 years old. Secondly, we will assess the possible use of DHA-PQ as an alternative SMC drug in areas where resistance to SP or AQ may increase following intensive use. Methods: The study design is a 3-arm cluster-randomized design comparing the SP-AQ and DHA-PQ arms in 2 age groups (younger than 5 years and 5-9 years) and a control group for children aged 5-9 years. Standard SMC (SP-AQ) for children younger than 5 years was provided to the control arm, while SMC with SP-AQ was delivered to children aged 3 months to 9 years (arm 2), and SMC with DHA-PQ will be implemented in study arm 3 for children up to 9 years of age. The study was performed in Mali?s Koulikoro District, a rural area in southwest Mali with historically high malaria transmission rates. The study?s primary outcome is P falciparum incidence for 2 SMC regimens in children up to 9 years of age. Should DHA-PQ provide an acceptable alternative to SP-AQ, a plausible second-line prevention option would be available in the event of SP resistance or drug supply shortages. A significant byproduct of this effort included bolstering district health information systems for rapid identification of severe malaria cases. Results: The study began on July 1, 2019. Through November 2022, a total of 4556 children 3 months old to younger than 5 years were enrolled. Data collection ended in spring 2023, and the findings are expected to be published later in early 2024. Conclusions: Routine evaluation of antimalarial drugs is needed to establish appropriate SMC age targets. The study goals here may impact public health policy and provide alternative therapies in the event of drug shortages or resistance. Trial Registration: ClinicalTrials.gov NCT04149106, https://clinicaltrials.gov/ct2/show/NCT04149106 International Registered Report Identifier (IRRID): DERR1-10.2196/51660 UR - https://www.researchprotocols.org/2024/1/e51660 UR - http://dx.doi.org/10.2196/51660 UR - http://www.ncbi.nlm.nih.gov/pubmed/38252481 ID - info:doi/10.2196/51660 ER - TY - JOUR AU - Vranceanu, Ana-Maria AU - Choukas, R. Nathaniel AU - Rochon, A. Elizabeth AU - Duarte, Brooke AU - Pietrzykowski, O. Malvina AU - McDermott, Katherine AU - Hooker, E. Julia AU - Kulich, Ronald AU - Quiroz, T. Yakeel AU - Parker, A. Robert AU - Macklin, A. Eric AU - Ritchie, Christine AU - AU - Mace, A. Ryan PY - 2023/9/28 TI - Addressing the Chronic Pain?Early Cognitive Decline Comorbidity Among Older Adults: Protocol for the Active Brains Remote Efficacy Trial JO - JMIR Res Protoc SP - e47319 VL - 12 KW - chronic pain KW - cognitive decline KW - physical activity KW - mind-body therapies KW - aged KW - telemedicine KW - randomized clinical trial KW - mobile phone N2 - Background: Chronic pain and early cognitive decline, which are costly to treat and highly prevalent among older adults, commonly co-occur, exacerbate one another over time, and can accelerate the development and progression of Alzheimer disease and related dementias. We developed the first mind-body activity program (Active Brains [AB]) tailored to the needs of older adults with chronic pain and early cognitive decline. Results from our previous study strongly supported the feasibility of conducting AB remotely and provided evidence for improvements in outcomes. Objective: We are conducting a single-blinded, National Institutes of Health stage-2, randomized clinical trial to establish the efficacy of AB versus a time-matched and dose-matched education control (Health Enhancement Program [HEP]) in improving self-reported and objective outcomes of physical, cognitive, and emotional functions in 260 participants. The methodology described in this paper was informed by the lessons learned from the first year of the trial. Methods: Participants are identified and recruited through multidisciplinary clinician?referred individuals (eg, pain psychologists and geriatricians), the Rally Research platform, social media, and community partnerships. Interested participants complete eligibility screening and electronic informed consent. Baseline assessments include self-report, performance-based measures (eg, 6-min walk test) and objective measures (eg, Repeatable Battery for the Assessment of Neuropsychological Status). Participants are mailed a wrist-worn ActiGraph device (ActiGraph LLC) to passively monitor objective function (eg, steps) during the week between the baseline assessment and the beginning of the programs, which they continue to wear throughout the programs. After baseline assessments, participants are randomized to either AB or HEP and complete 8 weekly, remote, group sessions with a Massachusetts General Hospital psychologist. The AB group receives a Fitbit (Fitbit Inc) to help reinforce increased activity. Assessments are repeated after the intervention and at the 6-month follow-up. Coprimary outcomes include multimodal physical function (self-report, performance based, and objective). Secondary outcomes are cognitive function (self-report and objective), emotional function, and pain. Results: We began recruitment in July 2022 and recruited 37 participants across 4 cohorts. Of them, all (n=37, 100%) have completed the baseline assessment, 26 (70%) have completed the posttest assessment, and 9 (24%) are actively enrolled in the intervention (total dropout: n=2, 5%). In the three cohorts (26/37, 70%) that have completed the AB or HEP, 26 (100%) participants completed all 8 group sessions (including minimal makeups), and watch adherence (1937/2072, 93.48%, average across ActiGraph and Fitbit devices) has been excellent. The fourth cohort is ongoing (9/37, 24%), and we plan to complete enrollment by March 2026. Conclusions: We aim to establish the efficacy of the AB program over a time-matched and dose-matched control in a live video-based trial and test the mechanisms through theoretically driven mediators and moderators. Findings will inform the development of a future multisite effectiveness-implementation trial. Trial Registration: ClinicalTrials.gov NCT05373745; https://classic.clinicaltrials.gov/ct2/show/NCT05373745 International Registered Report Identifier (IRRID): DERR1-10.2196/47319 UR - https://www.researchprotocols.org/2023/1/e47319 UR - http://dx.doi.org/10.2196/47319 UR - http://www.ncbi.nlm.nih.gov/pubmed/37768713 ID - info:doi/10.2196/47319 ER - TY - JOUR AU - Wang, Bo AU - Janamnuaysook, Rena AU - MacDonell, Karen AU - Rongkavilit, Chokechai AU - Schieber, Elizabeth AU - Naar, Sylvie AU - Phanuphak, Nittaya PY - 2023/9/4 TI - Adapting Effective mHealth Interventions to Improve Uptake and Adherence to HIV Pre-Exposure Prophylaxis Among Thai Young Men Who Have Sex With Men: Protocol for a Randomized Controlled Trial JO - JMIR Res Protoc SP - e46435 VL - 12 KW - young men who have sex with men KW - pre-exposure prophylaxis KW - PrEP KW - HIV prevention KW - mHealth KW - motivational interviewing KW - motivational text messaging KW - Thailand N2 - Background: Young men who have sex with men (YMSM) are the fastest-growing HIV-positive population worldwide. Thailand has the highest adult HIV seroprevalence in Asia; over 25% of men having sex with men in Bangkok are HIV positive. Pre-exposure prophylaxis (PrEP) is an efficacious HIV prevention strategy recommended for all at-risk individuals. PrEP is highly effective when taken as prescribed, but PrEP utilization rate has been low, and adherence is often inadequate. Objective: We propose to develop and pilot a multicomponent, technology-based intervention to promote motivation to begin PrEP (?uptake?) and sustained adherence to PrEP among HIV-negative Thai YMSM. We will adapt an existing 2-session technology-delivered, motivational interviewing?based intervention to focus on PrEP use in YMSM in Thailand. The resulting intervention is called the Motivational Enhancement System for PrEP Uptake and Adherence (MES-PrEP). We will also develop motivational text messaging (MTM) to send two-way motivational messages to promote PrEP use. Methods: The proposed study includes 3 phases. Phase 1 includes in-depth interviews with HIV-negative Thai YMSM and providers to explore barriers and facilitators of PrEP initiation and adherence, aiming to inform intervention content. Phase 2 consists of adapting and beta-testing MES-PrEP and MTM for functionality and feasibility using a youth advisory board of Thai YMSM. In Phase 3, we will conduct a pilot randomized controlled trial to evaluate the feasibility, acceptability, and preliminary efficacy of MES-PrEP and MTM to increase PrEP uptake and adherence among Thai YMSM. A total of 60 HIV-negative Thai YMSM who have not started PrEP and 60 YMSM who are on PrEP but not adherent to it will be randomized 2:1 to receive MES-PrEP and MTM (n=40) or standard PrEP counseling (n=20). The feasibility and acceptability of the intervention will be assessed through usage patterns and the System Usability Scale. The preliminary impact will be assessed by evaluating the proportion of PrEP initiation and level of adherence to PrEP. Participants will complete the assessments at baseline and at 1-, 3-, and 6-month postintervention. Biomarkers of adherence to PrEP and biomarkers of HIV and sexually transmitted infections will be collected. Results: Recruitment for this study began in January 2022 for phase 1. Qualitative interviews were completed with 30 YMSM and 5 clinical providers in May 2022. Phase 3, the pilot feasibility and acceptability trial, began in July 2023. Upon project completion, we shall have developed a highly innovative mobile health intervention to support YMSM using PrEP, which will be ready for testing in a larger efficacy trial. Conclusions: This study addresses a critical problem (ie, high HIV incidence and low PrEP use) among Thai YMSM. We are developing 2 potentially synergistic technology-based, theory-driven interventions aimed at maximizing PrEP use. The proposed project has the potential to make significant contributions to advancing HIV prevention research and implementation science. Trial Registration: ClinicalTrials.gov NCT05243030; https://clinicaltrials.gov/ct2/show/NCT05243030 International Registered Report Identifier (IRRID): DERR1-10.2196/46435 UR - https://www.researchprotocols.org/2023/1/e46435 UR - http://dx.doi.org/10.2196/46435 UR - http://www.ncbi.nlm.nih.gov/pubmed/37665622 ID - info:doi/10.2196/46435 ER - TY - JOUR AU - Maher, P. Jaclyn AU - Hevel, J. Derek AU - Bittel, M. Kelsey AU - Hudgins, L. Brynn AU - Labban, D. Jeffery AU - Kennedy-Malone, Laurie PY - 2023/7/28 TI - Studying Movement-Related Behavioral Maintenance and Adoption in Real Time: Protocol for an Intensive Ecological Momentary Assessment Study Among Older Adults JO - JMIR Res Protoc SP - e47320 VL - 12 KW - physical activity KW - sedentary behavior KW - aging KW - multiburst design KW - ambulatory assessment KW - experience sampling method KW - accelerometers KW - stage of change KW - dual process KW - motivation KW - mobile phone N2 - Background: Older adults struggle to maintain newly initiated levels of physical activity (PA) or sedentary behavior (SB) and often regress to baseline levels over time. This is partly because health behavior theories that inform interventions rarely address how the changing contexts of daily life influence the processes regulating PA and SB or how those processes differ across the behavior change continuum. Few studies have focused on motivational processes that regulate the dynamic nature of PA and SB adoption and maintenance on microtimescales (ie, across minutes, hours, or days). Objective: The overarching goal of Project Studying Maintenance and Adoption in Real Time (SMART) is to determine the motivational processes that regulate behavioral adoption versus maintenance over microtimescales, using a dual process framework combined with ecological momentary assessment and sensor-based monitoring of behavior. This paper describes the recruitment, enrollment, data collection, and analytics protocols for Project SMART. Methods: In Project SMART, older adults engaging in at least 30 minutes of moderate-to-vigorous intensity PA per week complete 3 data collection periods over 1 year, with each data collection period lasting 14 days. Across each data collection period, participants wear an ActiGraph GT3X accelerometer (ActiGraph, LLC) on their nondominant waist and an ActivPAL micro4 accelerometer (PAL Technologies, Ltd) on their anterior thigh to measure PA and SB, respectively. Ecological momentary assessment questionnaires are randomly delivered via smartphone 10 times per day on 4 selected days in each data collection period and assess reflective processes (eg, evaluating one?s efficacy and exerting self-control) and reactive processes (eg, contextual cues) within the dual process framework. At the beginning and end of each data collection period, participants complete a computer-based questionnaire to learn more about their typical motivation for PA and SB, physical and mental health, and life events over the course of the study. Results: Recruitment and enrollment began in January 2021; enrollment in the first data collection period was completed by February 2022; and all participants completed their second and third data collection by July 2022 and December 2022, respectively. Data were collected from 202 older adults during the first data collection period, with approximate retention rates of 90.1% (n=182) during the second data collection period and 88.1% (n=178) during the third data collection period. Multilevel models and mixed-effects location scale modeling will be used to evaluate the study aims. Conclusions: Project SMART seeks to predict and model the adoption and maintenance of optimal levels of PA and SB among older adults. In turn, this will inform the future delivery of personalized intervention content under conditions where the content will be most effective to promote sustained behavior change among older adults. International Registered Report Identifier (IRRID): DERR1-10.2196/47320 UR - https://www.researchprotocols.org/2023/1/e47320 UR - http://dx.doi.org/10.2196/47320 UR - http://www.ncbi.nlm.nih.gov/pubmed/37505805 ID - info:doi/10.2196/47320 ER - TY - JOUR AU - Skolarus, Lesli AU - Thrash-Sall, Erica AU - Hellem, Katherine Abby AU - Giacalone Jr, Michael AU - Burke, James AU - Lin, Chieh Chun AU - Bailey, Sarah AU - Corches, Casey AU - Dinh, Mackenzie AU - Casetti, Amanda AU - Mansour, Maria AU - Bowie, Kaitlyn AU - Roth, Rylyn AU - Whitfield, Candace AU - Sales, Anne PY - 2023/6/29 TI - Community-Led, Cross-Sector Partnership of Housing and Health Care to Promote Aging in Place (Unite Health Project): Protocol for a Prospective Observational Study JO - JMIR Res Protoc SP - e47855 VL - 12 KW - aging in place KW - stroke prevention KW - hypertension KW - blood pressure KW - social determinants of health KW - affordable housing KW - older adults KW - community-based participatory research KW - implementation evaluation N2 - Background: For many older Americans, aging in place is their preferred living arrangement. Minoritized and socioeconomically disadvantaged older adults are up to 3 times more likely to experience disability than other groups, which increases their likelihood of being unable to age in place. Bold ideas to facilitate aging in place, particularly among vulnerable populations, are needed. One such idea is the Unite care model, a community-initiated, academic-supported, cross-sector initiative that combines 2 sectors: housing and health care. The Unite care model colocates a federally qualified health center clinic on an older adult affordable housing campus in Flint, Michigan. Objective: There are two aims to this study. Aim 1 is to evaluate the implementation of the Unite care model in terms of acceptability, adoption, and penetration. Aim 2 is to determine which older adults use the care model and whether the care model promotes aging in place through risk factor reduction and improvement in the physical and social environment. Methods: We will assess the care model using a concurrent, exploratory mixed methods design. For aim 1, acceptability will be assessed through semistructured interviews with key stakeholder groups; adoption and penetration will be assessed using housing and health care records. For aim 2, residents residing in the Unite clinic building will participate in structured outcome assessments at 6 and 12 months. Risk factor reduction will be measured by change in systolic blood pressure from baseline to 12 months and change in the physical and social environment (item counts) will also be assessed from baseline to 12 months. Results: Data collection for aim 1 began in July 2021 and is anticipated to end in April 2023. Data collection for aim 2 began in June 2021 and concluded in November 2022. Data analysis for aim 1 is anticipated to begin in the summer of 2023 and analysis for aim 2 will begin in the spring of 2023. Conclusions: If successful, the Unite care model could serve as a new care model to promote aging in place among older adults living in poverty and older Black Americans. The results of this proposal will inform whether larger scale testing of this new model of care is warranted. International Registered Report Identifier (IRRID): DERR1-10.2196/47855 UR - https://www.researchprotocols.org/2023/1/e47855 UR - http://dx.doi.org/10.2196/47855 UR - http://www.ncbi.nlm.nih.gov/pubmed/37384383 ID - info:doi/10.2196/47855 ER - TY - JOUR AU - Palermo, H. Emma AU - Young, V. Amanda AU - Deswert, Sky AU - Brown, Alyssa AU - Goldberg, Miranda AU - Sultanik, Evan AU - Tan, Jessica AU - Mazefsky, A. Carla AU - Brookman-Frazee, Lauren AU - McPartland, C. James AU - Goodwin, S. Matthew AU - Pennington, Jeffrey AU - Marcus, C. Steven AU - Beidas, S. Rinad AU - Mandell, S. David AU - Nuske, J. Heather PY - 2023/6/26 TI - A Digital Mental Health App Incorporating Wearable Biosensing for Teachers of Children on the Autism Spectrum to Support Emotion Regulation: Protocol for a Pilot Randomized Controlled Trial JO - JMIR Res Protoc SP - e45852 VL - 12 KW - digital mental health KW - just-in-time adaptive intervention augmentation KW - JITAI KW - autism KW - heart rate tracking KW - emotion dysregulation KW - challenging behavior KW - evidence-based strategies KW - student progress monitoring KW - mobile phone N2 - Background: As much as 80% of children on the autism spectrum exhibit challenging behaviors (ie, behaviors dangerous to the self or others, behaviors that interfere with learning and development, and behaviors that interfere with socialization) that can have a devastating impact on personal and family well-being, contribute to teacher burnout, and even require hospitalization. Evidence-based practices to reduce these behaviors emphasize identifying triggers (events or antecedents that lead to challenging behaviors); however, parents and teachers often report that challenging behaviors surface with little warning. Exciting recent advances in biometric sensing and mobile computing technology allow the measurement of momentary emotion dysregulation using physiological indexes. Objective: We present the framework and protocol for a pilot trial that will test a mobile digital mental health app, the KeepCalm app. School-based approaches to managing challenging behaviors in children on the autism spectrum are limited by 3 key factors: children on the autism spectrum often have difficulties in communicating their emotions; it is challenging to implement evidence-based, personalized strategies for individual children in group settings; and it is difficult for teachers to track which strategies are successful for each child. KeepCalm aims to address those barriers by communicating children?s stress to their teachers using physiological signaling (emotion dysregulation detection), supporting the implementation of emotion regulation strategies via smartphone pop-up notifications of top strategies for each child according to their behavior (emotion regulation strategy implementation), and easing the task of tracking outcomes by providing the child?s educational team with a tool to track the most effective emotion regulation strategies for that child based on physiological stress reduction data (emotion regulation strategy evaluation). Methods: We will test KeepCalm with 20 educational teams of students on the autism spectrum with challenging behaviors (no exclusion based on IQ or speaking ability) in a pilot randomized waitlist-controlled field trial over a 3-month period. We will examine the usability, acceptability, feasibility, and appropriateness of KeepCalm as primary outcomes. Secondary preliminary efficacy outcomes include clinical decision support success, false positives or false negatives of stress alerts, and the reduction of challenging behaviors and emotion dysregulation. We will also examine technical outcomes, including the number of artifacts and the proportion of time children are engaged in high physical movement based on accelerometry data; test the feasibility of our recruitment strategies; and test the response rate and sensitivity to change of our measures, in preparation for a future fully powered large-scale randomized controlled trial. Results: The pilot trial will begin by September 2023. Conclusions: Results will provide key data about important aspects of implementing KeepCalm in preschools and elementary schools and will provide preliminary data about its efficacy to reduce challenging behaviors and support emotion regulation in children on the autism spectrum. Trial Registration: ClinicalTrials.gov NCT05277194; https://www.clinicaltrials.gov/ct2/show/NCT05277194 International Registered Report Identifier (IRRID): PRR1-10.2196/45852 UR - https://www.researchprotocols.org/2023/1/e45852 UR - http://dx.doi.org/10.2196/45852 UR - http://www.ncbi.nlm.nih.gov/pubmed/37358908 ID - info:doi/10.2196/45852 ER - TY - JOUR AU - Canter, S. Kimberly AU - Ritterband, Lee AU - Freyer, R. David AU - Askins, A. Martha AU - Bava, Laura AU - Loucas, Caitlyn AU - Arasteh, Kamyar AU - You, Wen AU - Kazak, E. Anne PY - 2023/6/2 TI - The Electronic Surviving Cancer Competently Intervention Program?a Psychosocial Digital Health Intervention for English- and Spanish-Speaking Parents of Children With Cancer: Protocol for Randomized Controlled Trial JO - JMIR Res Protoc SP - e46339 VL - 12 KW - pediatric cancer KW - digital health KW - parents KW - caregivers KW - psychosocial intervention KW - family systems KW - cultural and linguistic adaptation N2 - Background: The psychosocial needs and risks of children with cancer and their families are well-documented including increased risk of parental distress, posttraumatic stress, and anxiety. There is a critical need to provide evidence-based psychosocial care to parents and caregivers of children with cancer. Digital health interventions are important to address many barriers to in-person intervention delivery but are not widely used in pediatric psychosocial cancer care. The COVID-19 pandemic has reinforced the need for flexible, acceptable, and accessible psychosocial digital health interventions. The Electronic Surviving Cancer Competently Intervention Program (eSCCIP) is an innovative digital health intervention for parents and caregivers of children with cancer, delivered through a combination of self-guided web-based content and supplemented by 3 telehealth follow-up sessions with a trained telehealth guide. A Spanish language adaptation of eSCCIP, El Programa Electronico de Intervencion para Superar Cancer Competentemente (eSCCIP-SP), has been developed. The self-guided web-based cores of eSCCIP/eSCCIP-SP are a mix of didactic video content, multifamily video discussion groups featuring parents of children with cancer, and hands-on web-based activities. Objective: The objective of this study is to test eSCCIP/eSCCIP-SP in a multisite randomized controlled trial, compared to an internet-based education control condition consisting of information specifically focused on concerns relevant to parents and caregivers of children with cancer. Methods: Using a randomized controlled clinical trial design, 350 eligible parents and caregivers of children with cancer will be randomly assigned to the intervention (eSCCIP/eSCCIP-SP) or an education control condition. Data will be collected at 3 time points: preintervention (prior to randomization), immediately post intervention (after 6 weeks), and at a 3-month follow-up (from baseline). Participants randomized to either condition will receive study material (eSCCIP/eSCCIP-SP intervention or education control website) in English or Spanish, based on the primary language spoken in the home and participant preference. Results: The primary study end point is a reduction in acute distress from baseline to postintervention, with secondary end points focused on reductions in symptoms of posttraumatic stress and anxiety, and improvements in coping self-efficacy and cognitive coping. An additional exploratory aim will be focused on implementation strategies and potential costs and cost-savings of eSCCIP/eSCCIP-SP, laying the groundwork for future trials focused on dissemination and implementation, stepped-care models, and intervention refinement. Conclusions: This trial will provide necessary data to evaluate the efficacy of eSCCIP/eSCCIP-SP. This intervention has the potential to be an easily scalable and highly impactful psychosocial treatment option for parents and caregivers of children with cancer. Trial Registration: ClinicalTrials.gov NCT05294302; https://clinicaltrials.gov/ct2/show/NCT05294302 International Registered Report Identifier (IRRID): PRR1-10.2196/46339 UR - https://www.researchprotocols.org/2023/1/e46339 UR - http://dx.doi.org/10.2196/46339 UR - http://www.ncbi.nlm.nih.gov/pubmed/37267038 ID - info:doi/10.2196/46339 ER - TY - JOUR AU - Bannon, Sarah AU - Brewer, Julie AU - Cornelius, Talea AU - Jackson, Jonathan AU - Parker, A. Robert AU - Dams-O'Connor, Kristen AU - Dickerson, Bradford AU - Ritchie, Christine AU - Vranceanu, Ana-Maria PY - 2023/5/29 TI - Focus Group Study of Medical Stakeholders to Inform the Development of Resilient Together for Dementia: Protocol for a Postdiagnosis Live Video Dyadic Resiliency Intervention JO - JMIR Res Protoc SP - e45533 VL - 12 KW - dementia KW - stakeholders KW - focus group KW - intervention KW - video KW - telehealth N2 - Background: Alzheimer disease and related dementias (ADRD) are increasingly common conditions that disrupt the lives of persons living with dementia and their spousal care partners. At the time of ADRD diagnoses, many couples experience challenges that produce emotional distress and relationship strain. At present, there are no interventions to address these challenges early after diagnoses to promote positive adjustment. Objective: The study protocol described here is part of the first phase of a larger program of research that aims to develop, adapt, and establish the feasibility of Resilient Together for Dementia (RT-ADRD), a novel dyadic skills-based intervention to be delivered over live video early after diagnosis, with the goal of preventing chronic emotional distress. This study will elicit and systematically summarize perspectives of ADRD medical stakeholders to inform the procedures (eg, recruitment and screening methods, eligibility, timing of intervention, and intervention delivery) of the first iteration of RT-ADRD prior to pilot-testing. Methods: We will recruit interdisciplinary medical stakeholders (eg, neurologists, social workers, neuropsychologists, care coordinators, and speech language pathologists) from academic medical center clinics in the departments treating persons living with dementia such as neurology, psychiatry, and geriatric medicine via flyers and word-of-mouth referrals from clinic directors and members of relevant organizations (eg, dementia care collaboratives and Alzheimer disease research centers). The participants will complete electronic screening and consent procedures. Consenting individuals will then participate in a 30- to 60-minute qualitative virtual focus group, held either via telephone or Zoom, using an interview guide designed to assess provider experiences with postdiagnosis clinical care and to gather feedback on the proposed RT-ADRD protocol. The participants will also have the opportunity to participate in an optional exit interview and web-based survey to gather additional feedback. Qualitative data will be analyzed using a hybrid inductive-deductive approach and the framework method for thematic synthesis. We will conduct approximately 6 focus groups with 4-6 individuals in each group (maximum N=30 individuals; until saturation is reached). Results: Data collection began in November 2022 and will continue through June 2023. We anticipate that the study will be completed by late 2023. Conclusions: The results from this study will inform the procedures of the first live video RT-ADRD dyadic resiliency intervention focused on the prevention of chronic emotional and relational distress in couples shortly after ADRD diagnoses. Our study will allow us to gather comprehensive information from stakeholders on ways to best deliver our early prevention?focused intervention and gain detailed feedback on study procedures prior to further testing. International Registered Report Identifier (IRRID): DERR1-10.2196/45533 UR - https://www.researchprotocols.org/2023/1/e45533 UR - http://dx.doi.org/10.2196/45533 UR - http://www.ncbi.nlm.nih.gov/pubmed/37247224 ID - info:doi/10.2196/45533 ER - TY - JOUR AU - Reilly, D. Erin AU - Kathawalla, Ummul-Kiram AU - Robins, E. Hannah AU - Heapy, A. Alicia AU - Hogan, P. Timothy AU - Waring, E. Molly AU - Quigley, S. Karen AU - Drebing, E. Charles AU - Bickmore, Timothy AU - Volonte, Matias AU - Kelly, M. Megan PY - 2023/3/7 TI - An Online Acceptance and Mindfulness Intervention for Chronic Pain in Veterans: Development and Protocol for a Pilot Feasibility Randomized Controlled Trial JO - JMIR Res Protoc SP - e45887 VL - 12 KW - chronic pain KW - randomized controlled trial KW - usability KW - acceptance and commitment therapy KW - embodied conversational agent N2 - Background: In the veteran community, chronic pain is particularly prevalent and often debilitating. Until recently, veterans with chronic pain were offered primarily pharmacological intervention options, which rarely suffice and can also have negative health consequences. To better address chronic pain in veterans, the Veterans Health Administration has invested in novel, nonpharmacological behavior interventions that target both pain management and chronic pain?related functional issues. One approach, acceptance and commitment therapy (ACT) for chronic pain, is supported by decades of efficacy evidence for improving pain outcomes; however, ACT can be difficult to obtain owing to issues such as a lack of trained therapists or veterans having difficulty committing to the time and resources needed for the full clinician-led ACT protocol. Given the strong ACT evidence base combined with access limitations, we set out to develop and evaluate Veteran ACT for Chronic Pain (VACT-CP), an online program guided by an embodied conversational agent to improve pain management and functioning. Objective: The aims of this study are to develop, iteratively refine, and then conduct a pilot feasibility randomized controlled trial (RCT) of a VACT-CP group (n=20) versus a waitlist and treatment-as-usual control group (n=20). Methods: This research project includes 3 phases. In phase 1, our research team consulted with pain and virtual care experts, developed the preliminary VACT-CP online program, and conducted interviews with providers to obtain their feedback on the intervention. In phase 2, we incorporated feedback from phase 1 into the VACT-CP program and completed initial usability testing with veterans with chronic pain. In phase 3, we are conducting a small pilot feasibility RCT, with the primary outcome being assessment of usability of the VACT-CP system. Results: This study is currently in phase 3; recruitment for the RCT began in April 2022 and is expected to continue through April 2023. Data collection is expected to be completed by October 2023, with full data analysis completed by late 2023. Conclusions: The findings from this research project will provide information on the usability of the VACT-CP intervention, as well as secondary outcomes related to treatment satisfaction, pain outcomes (pain-related daily functioning and pain severity), ACT processes (pain acceptance, behavioral avoidance, and valued living), and mental and physical functioning. Trial Registration: ClinicalTrials.gov NCT03655132; https://clinicaltrials.gov/ct2/show/NCT03655132 International Registered Report Identifier (IRRID): DERR1-10.2196/45887 UR - https://www.researchprotocols.org/2023/1/e45887 UR - http://dx.doi.org/10.2196/45887 UR - http://www.ncbi.nlm.nih.gov/pubmed/36881446 ID - info:doi/10.2196/45887 ER - TY - JOUR AU - Jin, Haomiao AU - Junghaenel, U. Doerte AU - Orriens, Bart AU - Lee, Pey-Jiuan AU - Schneider, Stefan PY - 2023/2/21 TI - Developing Early Markers of Cognitive Decline and Dementia Derived From Survey Response Behaviors: Protocol for Analyses of Preexisting Large-scale Longitudinal Data JO - JMIR Res Protoc SP - e44627 VL - 12 KW - dementia KW - mild cognitive impairment KW - early markers KW - survey response behaviors KW - epidemiology N2 - Background: Accumulating evidence shows that subtle alterations in daily functioning are among the earliest and strongest signals that predict cognitive decline and dementia. A survey is a small slice of everyday functioning; nevertheless, completing a survey is a complex and cognitively demanding task that requires attention, working memory, executive functioning, and short- and long-term memory. Examining older people?s survey response behaviors, which focus on how respondents complete surveys irrespective of the content being sought by the questions, may represent a valuable but often neglected resource that can be leveraged to develop behavior-based early markers of cognitive decline and dementia that are cost-effective, unobtrusive, and scalable for use in large population samples. Objective: This paper describes the protocol of a multiyear research project funded by the US National Institute on Aging to develop early markers of cognitive decline and dementia derived from survey response behaviors at older ages. Methods: Two types of indices summarizing different aspects of older adults? survey response behaviors are created. Indices of subtle reporting mistakes are derived from questionnaire answer patterns in a number of population-based longitudinal aging studies. In parallel, para-data indices are generated from computer use behaviors recorded on the backend server of a large web-based panel study known as the Understanding America Study (UAS). In-depth examinations of the properties of the created questionnaire answer pattern and para-data indices will be conducted for the purpose of evaluating their concurrent validity, sensitivity to change, and predictive validity. We will synthesize the indices using individual participant data meta-analysis and conduct feature selection to identify the optimal combination of indices for predicting cognitive decline and dementia. Results: As of October 2022, we have identified 15 longitudinal ageing studies as eligible data sources for creating questionnaire answer pattern indices and obtained para-data from 15 UAS surveys that were fielded from mid-2014 to 2015. A total of 20 questionnaire answer pattern indices and 20 para-data indices have also been identified. We have conducted a preliminary investigation to test the utility of the questionnaire answer patterns and para-data indices for the prediction of cognitive decline and dementia. These early results are based on only a subset of indices but are suggestive of the findings that we anticipate will emerge from the planned analyses of multiple behavioral indices derived from many diverse studies. Conclusions: Survey response behaviors are a relatively inexpensive data source, but they are seldom used directly for epidemiological research on cognitive impairment at older ages. This study is anticipated to develop an innovative yet unconventional approach that may complement existing approaches aimed at the early detection of cognitive decline and dementia. International Registered Report Identifier (IRRID): DERR1-10.2196/44627 UR - https://www.researchprotocols.org/2023/1/e44627 UR - http://dx.doi.org/10.2196/44627 UR - http://www.ncbi.nlm.nih.gov/pubmed/36809337 ID - info:doi/10.2196/44627 ER - TY - JOUR AU - Weser, Veronica AU - Opara, Ijeoma AU - Budge, Mariana AU - Duncan, Lindsay AU - Fernandes, F. Claudia-Santi AU - Hussett-Richardson, Sydney AU - Sands, Brandon AU - Hieftje, Kimberly PY - 2023/1/23 TI - Pilot-testing a Multiplayer HIV and Sexually Transmitted Infection Prevention Video Game Intervention for Black Adolescent Girls: Protocol for a Randomized Controlled Trial JO - JMIR Res Protoc SP - e43666 VL - 12 KW - black KW - adolescent KW - female KW - video games KW - feasibility studies KW - HIV prevention KW - randomized controlled trial KW - sexual health KW - condom use KW - self-efficacy KW - pre-exposure prophylaxis KW - PrEP N2 - Background: Black adolescent girls aged between 14 and 19 years are more likely than White girls to be diagnosed with a sexually transmitted infection (STI). As STI diagnosis is associated with an increase in the risk for HIV acquisition, an early intervention specifically tailored to Black adolescent girls is warranted. A web-based video game intervention has the potential to reach this demographic. Because studies of social and behavioral determinants of disease demonstrate the protective role of peer group structures on individual outcomes, a multiplayer game can facilitate opportunities to exchange and evaluate information, learn social norms, develop behavioral skills, and allow peers to influence attitudes and behavior. No prior research has examined the feasibility of a web-based multiplayer game intervention for this population. Objective: This study describes the protocol for a randomized controlled trial (RCT) pilot-testing the feasibility, acceptability, and limited efficacy of a multiplayer game?based intervention for increasing HIV and STI testing and condom use in Black adolescent girls. Methods: We enrolled 79 Black adolescent girls aged 14 to 19 years residing in the United States into a 2-arm parallel RCT. The intervention is a theory-based, community-informed, multiplayer game that can be played with peers on the web using videoconferencing software. The goal of the game is to empower Black adolescent girls to make healthy decisions regarding dating, relationships, and sex, thus reducing HIV and STI infection. Control condition participants received a list of resources after playing a time and attention control game. All study procedures were conducted via the internet. We conveniently sampled Black adolescent girls using web-based advertisements. Study assessments occurred at enrollment, 1 week, 1 month, and 4 months after enrollment. The primary outcome of this study is increased HIV and STI testing by Black adolescent girls. Secondary outcomes include increased condom use, self-efficacy to use condoms, positive attitudes toward condom use, intentions, harm perceptions, HIV and STI and pre-exposure prophylaxis knowledge, positive sexual norms, sexual communication with partners, and reduced incidence of sexual risk behaviors associated with HIV and STI transmission. Secondary outcomes also included assessment of intervention feasibility and acceptability. Results: From February to April 2022, a total of 79 Black adolescent girls were enrolled, with 40 (51%) having been randomized into the intervention condition and 39 (49%) into the control condition. At baseline, participant ages ranged from 14 to 19 (mean 16.4, SD 1.23) years. Conclusions: Web-accessible game interventions overcome common impediments of face-to-face interventions presenting a unique opportunity to reach Black adolescent girls and improve their sexual health and self-efficacy. Trial data will provide information about the limited efficacy of the intervention and inform future web-based studies and a larger RCT aimed at improving the sexual health of Black adolescent girls. Trial Registration: ClinicalTrials.gov NCT04108988; https://clinicaltrials.gov/ct2/show/NCT04108988 International Registered Report Identifier (IRRID): DERR1-10.2196/43666 UR - https://www.researchprotocols.org/2023/1/e43666 UR - http://dx.doi.org/10.2196/43666 UR - http://www.ncbi.nlm.nih.gov/pubmed/36689272 ID - info:doi/10.2196/43666 ER - TY - JOUR AU - Shrestha, Roman AU - Wickersham, A. Jeffrey AU - Khati, Antoine AU - Azwa, Iskandar AU - Ni, Zhao AU - Kamarulzaman, Adeeba AU - Sullivan, Sean Patrick AU - Jadkarim, Luzan AU - Eger, H. William AU - Gautam, Kamal AU - Altice, L. Frederick PY - 2022/12/21 TI - Clinic-Integrated Mobile Health Intervention (?JomPrEP? App) to Improve Uptake of HIV Testing and Pre-exposure Prophylaxis Among Men Who Have Sex With Men in Malaysia: Protocol for an Intervention Development and Multiphase Trial JO - JMIR Res Protoc SP - e43318 VL - 11 IS - 12 KW - men who have sex with men KW - mHealth KW - HIV prevention KW - pre-exposure prophylaxis KW - smartphone app KW - Malaysia N2 - Background: Men who have sex with men (MSM) are disproportionately affected by the HIV epidemic in Malaysia and globally. Cross-cutting prevention strategies such as mobile health (mHealth), particularly smartphone apps, hold great promise for HIV prevention efforts among Malaysian MSM, especially when linked to HIV testing and pre-exposure prophylaxis (PrEP). Objective: This study aims to adapt an existing app to create and test a clinic-integrated app (JomPrEP), a virtual platform to deliver HIV testing and PrEP services for MSM in Malaysia. Methods: The JomPrEP project involves developing and testing an app-based platform for HIV prevention among Malaysian MSM and will be conducted in 2 phases. In phase I (development phase), we will adapt an existing mHealth app (HealthMindr) to create a new clinic-integrated app called ?JomPrEP? to deliver holistic HIV prevention services (eg, HIV testing, PrEP, support services for mental health and substance use) among MSM in Malaysia. During phase II (testing phase), we will use a type I hybrid implementation science trial design to test the efficacy of JomPrEP while gathering information on implementation factors to guide future scale-up in real-world settings. Results: As of September 2022, we have completed phase I of the proposed study. Based on a series of formative work completed during phase I, we developed a fully functional, clinic-integrated JomPrEP app, which provides a virtual platform for MSM in Malaysia to facilitate their engagement in HIV prevention in a fast and convenient manner. Based on participant feedback provided during phase I, we are currently optimizing JomPrEP and the research protocols for a large-scale efficacy trial (phase II), which will commence in January 2023. Conclusions: Scant HIV prevention resources coupled with entrenched stigma, discrimination, and criminalization of same-sex sexual behavior and substance use hamper access to HIV prevention services in Malaysia. If found efficacious, JomPrEP can be easily adapted for a range of health outcomes and health care delivery services for MSM, including adaptation to other low- and middle-income countries. Trial Registration: ClinicalTrials.gov NCT05325476; https://clinicaltrials.gov/ct2/show/NCT05325476 International Registered Report Identifier (IRRID): DERR1-10.2196/43318 UR - https://www.researchprotocols.org/2022/12/e43318 UR - http://dx.doi.org/10.2196/43318 UR - http://www.ncbi.nlm.nih.gov/pubmed/36542425 ID - info:doi/10.2196/43318 ER - TY - JOUR AU - Simons, E. Laura AU - Hess, W. Courtney AU - Choate, S. Ellison AU - Van Orden, R. Amanda AU - Tremblay-McGaw, G. Alexandra AU - Menendez, Maria AU - Boothroyd, B. Derek AU - Parvathinathan, Gomathy AU - Griffin, Anya AU - Caruso, J. Thomas AU - Stinson, Jennifer AU - Weisman, Amy AU - Liu, Timothy AU - Koeppen, Kurt PY - 2022/12/12 TI - Virtual Reality?Augmented Physiotherapy for Chronic Pain in Youth: Protocol for a Randomized Controlled Trial Enhanced With a Single-Case Experimental Design JO - JMIR Res Protoc SP - e40705 VL - 11 IS - 12 KW - chronic pain KW - adolescents KW - physiotherapy KW - virtual reality KW - single-case experimental design KW - mobile phone N2 - Background: Chronic musculoskeletal (MSK) pain is a prominent health concern, resulting in pain-related disability, loss of functioning, and high health care costs. Physiotherapy rehabilitation is a gold-standard treatment for improving functioning in youth with chronic MSK pain. However, increasing physical activity can feel unattainable for many adolescents because of pain-related fear and movement avoidance. Virtual reality (VR) offers an immersive experience that can interrupt the fear-avoidance cycle and improve engagement in physiotherapy. Despite promising initial findings, data are limited and often lack the rigor required to establish VR as an evidence-based treatment for MSK pain. Objective: This trial evaluates physiorehabilitation with VR in adolescents with MSK pain. This protocol outlines the rationale, design, and implementation of a randomized controlled trial enhanced with a single-case experimental design. Methods: This study is a 2-group randomized controlled trial assessing the use of physiorehabilitation with VR in adolescents with MSK pain. The authors will collaborate with physical therapists to integrate VR into their standard clinical care. For participants enrolled in standard physiotherapy, there will be no VR integrated into their physical therapy program. Primary outcomes include physical function and engagement in VR. Secondary outcomes include pain-related fear and treatment adherence. Moreover, we will obtain clinician perspectives regarding the feasibility of integrating the intervention into the flow of clinical practice. Results: The pilot study implementing physiorehabilitation with VR demonstrated that high engagement and use of physiorehabilitation with VR were associated with improvements in pain, fear, avoidance, and function. Coupled with qualitative feedback from patients, families, and clinicians, the pilot study results provide support for this trial to evaluate physiorehabilitation with VR for youth with chronic MSK pain. Analysis of results from the main clinical trial will begin as recruitment progresses, and results are expected in early 2024. Conclusions: Significant breakthroughs for treating MSK pain require mechanistically informed innovative approaches. Physiorehabilitation with VR provides exposure to progressive challenges, real-time feedback, and reinforcement for movement and can include activities that are difficult to achieve in the real world. It has the added benefit of sustaining patient motivation and adherence while enabling clinicians to use objective benchmarks to influence progression. These findings will inform the decision of whether to proceed with a hybrid effectiveness-dissemination trial of physiorehabilitation with VR, serving as the basis for potential large-scale implementation of physiorehabilitation with VR. Trial Registration: ClinicalTrials.gov NCT04636177; https://clinicaltrials.gov/ct2/show/NCT04636177 International Registered Report Identifier (IRRID): DERR1-10.2196/40705 UR - https://www.researchprotocols.org/2022/12/e40705 UR - http://dx.doi.org/10.2196/40705 UR - http://www.ncbi.nlm.nih.gov/pubmed/36508251 ID - info:doi/10.2196/40705 ER - TY - JOUR AU - Stecher, Chad AU - Ghai, Ishita AU - Lunkuse, Lillian AU - Wabukala, Peter AU - Odiit, Mary AU - Nakanwagi, Agnes AU - Linnemayr, Sebastian PY - 2022/10/31 TI - Incentives and Reminders to Improve Long-term Medication Adherence (INMIND): Protocol for a Pilot Randomized Controlled Trial JO - JMIR Res Protoc SP - e42216 VL - 11 IS - 10 KW - medication adherence KW - HIV KW - antiretroviral therapy KW - habit formation KW - routines KW - behavioral economics N2 - Background: Nonadherence to antiretroviral therapy (ART) among people living with HIV is a crucial barrier to attaining viral suppression globally. Existing behavioral interventions have successfully increased ART adherence, but typically show only short-term impact that dissipates after the interventions are withdrawn. Objective: This study aims to test the feasibility, acceptability, and preliminary efficacy of a novel intervention that uses SMS text messages and conditional incentives to support ART initiators in establishing pill-taking habits. Methods: A sample of 150 participants aged ?18 years who have initiated ART in the preceding 3 months will be recruited from Mildmay Uganda in Kampala, Uganda. All (150/150, 100%) participants will be educated on the anchoring strategy and will choose an existing routine to pair with their daily ART adherence from a set of 3 suggested routines: getting dressed in the morning, eating breakfast, or eating dinner. Then, participants will be randomized to receive either usual care (control group: 50/150, 33.3%) or 1 of the 2 interventions delivered over 3 months: daily SMS text message reminders to follow their chosen anchoring plan (messages group; treatment group 1: 50/150, 33.3%) or daily SMS text messages and incentives conditional on taking their ART medication around the time of their chosen anchor (incentives group; treatment group 2: 50/150, 33.3%). Long-term ART adherence will be evaluated for 6 months after the intervention, and survey assessments will be conducted at baseline, 3 months, and 9 months. Outcomes include feasibility and acceptability measures and intervention efficacy outcomes defined by electronically measured mean medication adherence during the intervention and during the 6 months after the intervention, along with a measure of routine ART adherence based on taking medications around the time of participants? anchor during the intervention and during the 6 months after intervention. Results: As of February 18, 2022, recruitment was completed. A total of 150 participants were recruited, and data collection is expected to end in December of 2022. Final results are expected to be submitted for publication by April 2023. Conclusions: This study is the first to use behavioral economics?based interventions in combination with the anchoring strategy to improve long-term ART adherence among treatment initiators. We hypothesize that the combination of SMS text message reminders and incentives will increase participants? use of their anchoring strategy, and thus medication adherence will be better maintained after the intervention ends in our intervention groups relative to the control group that uses only the anchoring strategy. Results of this pilot study will help to refine this combined intervention approach for testing at scale and broaden our understanding of the habit formation process. Trial Registration: ClinicalTrials.gov NCT05131165; https://clinicaltrials.gov/ct2/show/NCT05131165 International Registered Report Identifier (IRRID): DERR1-10.2196/42216 UR - https://www.researchprotocols.org/2022/10/e42216 UR - http://dx.doi.org/10.2196/42216 UR - http://www.ncbi.nlm.nih.gov/pubmed/36315224 ID - info:doi/10.2196/42216 ER - TY - JOUR AU - Hu, Lu AU - Islam, Nadia AU - Zhang, Yiyang AU - Shi, Yun AU - Li, Huilin AU - Wang, Chan AU - Sevick, Ann Mary PY - 2022/10/28 TI - Leveraging Social Media to Increase Access to an Evidence-Based Diabetes Intervention Among Low-Income Chinese Immigrants: Protocol for a Pilot Randomized Controlled Trial JO - JMIR Res Protoc SP - e42554 VL - 11 IS - 10 KW - diabetes KW - health equity KW - immigrant health KW - mobile health KW - social media KW - messaging app KW - health education KW - education video KW - diabetes education KW - self-management N2 - Background: Type 2 diabetes (T2D) in Chinese Americans is a rising public health concern for the US health care system. The majority of Chinese Americans with T2D are foreign-born older immigrants and report limited English proficiency and health literacy. Multiple social determinants of health limit access to evidence-based diabetes interventions for underserved Chinese immigrants. A social media?based diabetes intervention may be feasible to reach this community. Objective: The purpose of the Chinese American Research and Education (CARE) study was to examine the potential efficacy of a social media?based intervention on glycemic control in Chinese Americans with T2D. Additionally, the study aimed to explore the potential effects of the intervention on psychosocial and behavioral factors involved in successful T2D management. In this report, we describe the design and protocol of the CARE trial. Methods: CARE was a pilot randomized controlled trial (RCT; n=60) of a 3-month intervention. Participants were randomized to one of two arms (n=30 each): wait-list control or CARE intervention. Each week, CARE intervention participants received two culturally and linguistically tailored diabetes self-management videos for a total of 12 weeks. Video links were delivered to participants via WeChat, a free and popular social media app among Chinese immigrants. In addition, CARE intervention participants received biweekly phone calls from the study?s community health workers to set goals related to T2D self-management and work on addressing goal-achievement barriers. Hemoglobin A1c (HbA1c), self-efficacy, diabetes self-management behaviors, dietary intake, and physical activity were measured at baseline, 3 months, and 6 months. Piecewise linear mixed-effects modeling will be performed to examine intergroup differences in HbA1c and psychosocial and behavioral outcomes. Results: This pilot RCT study was approved by the Institutional Review Board at NYU Grossman School of Medicine in March 2021. The first participant was enrolled in March 2021, and the recruitment goal (n=60) was met in March 2022. All data collection is expected to conclude by November 2022, with data analysis and study results ready for reporting by December 2023. Findings from this pilot RCT will further guide the team in planning a future large-scale study. Conclusions: This study will serve as an important first step in exploring scalable interventions to increase access to evidence-based diabetes interventions among underserved, low-income, immigrant populations. This has significant implications for chronic care in other high-risk immigrant groups, such as low-income Hispanic immigrants, who also bear a high T2D burden, face similar barriers to accessing diabetes programs, and report frequent social media use (eg, WhatsApp). Trial Registration: ClinicalTrials.gov NCT03557697; https://clinicaltrials.gov/ct2/show/NCT03557697 International Registered Report Identifier (IRRID): DERR1-10.2196/42554 UR - https://www.researchprotocols.org/2022/10/e42554 UR - http://dx.doi.org/10.2196/42554 UR - http://www.ncbi.nlm.nih.gov/pubmed/36306161 ID - info:doi/10.2196/42554 ER - TY - JOUR AU - Braitman, L. Abby AU - Shipley, L. Jennifer AU - Strowger, Megan AU - Ayala Guzman, Rachel AU - Whiteside, Alina AU - Bravo, J. Adrian AU - Carey, B. Kate PY - 2022/10/28 TI - Examining Emailed Feedback as Boosters After a College Drinking Intervention Among Fraternities and Sororities: Rationale and Protocol for a Remote Controlled Trial (Project Greek) JO - JMIR Res Protoc SP - e42535 VL - 11 IS - 10 KW - college drinking KW - fraternities KW - sororities KW - web-based intervention KW - boosters N2 - Background: College students involved in Greek life (ie, members of fraternities and sororities) tend to engage in more high-risk alcohol use and experience more negative consequences than those not involved in Greek life. Web-based alcohol interventions, such as Alcohol eCHECKUP TO GO, have been successful in reducing alcohol use and consequences among the general college student population, but interventions targeting alcohol reduction among those involved in Greek life have had limited success. Booster emails including personalized feedback regarding descriptive norms and protective behavioral strategies have shown potential in increasing the effectiveness of web-based interventions among college drinkers. Studies are needed to determine the efficacy of these boosters among those involved in Greek life. Objective: The primary objective of this study is to assess the efficacy of booster emails sent to Greek life students who complete Alcohol eCHECKUP TO GO. Specifically, we expect that participants who receive the booster emails will reduce their alcohol consumption and related problems (primary aim 1), reduce perceived peer drinking, and increase the number of protective behavioral strategies they use over time (primary aim 2) relative to those who do not receive boosters. Contingent upon finding the emailed booster efficacious and sufficient enrollment of members from each organization, an exploratory aim is to examine social mechanisms of change (ie, through selection vs socialization). Methods: This study is a remote, controlled intervention trial following participants for up to 6 months. Participants must be aged at least 18 years, undergraduate students, and members of a participating fraternity or sorority. Eligible participants complete a web-based baseline survey to assess their alcohol consumption behaviors and beliefs, including norms and protective behavioral strategies, and information about their social networks. After completing the baseline survey, they participate in the web-based intervention. Follow-up surveys are sent 1, 3, and 6 months after the intervention. Those in the booster condition also receive emails containing personalized feedback at 2 weeks and 14 weeks after the intervention. Latent growth models and R-Simulation Investigation for Empirical Network Analysis will be used to analyze the data. Results: As of September 2022, we have enrolled 18 participants from 2 fraternities and 2 sororities, and they have completed the baseline survey. Overall, 72% (13/18) of participants have completed the 1-month follow-up. Enrollment will continue through December 2022. Conclusions: This study aims to examine the effectiveness of personalized feedback booster emails sent after an alcohol intervention among members of college Greek life. A secondary, exploratory aim is to provide information about social mechanisms of change (if possible). The current methodology targets whole network recruitment, with chapter presidents serving as gatekeepers and facilitators. Unique challenges of recruiting whole networks and working with campus administrators are discussed. Trial Registration: ClinicalTrials.gov NCT05107284; https://clinicaltrials.gov/ct2/show/NCT05107284 International Registered Report Identifier (IRRID): DERR1-10.2196/42535 UR - https://www.researchprotocols.org/2022/10/e42535 UR - http://dx.doi.org/10.2196/42535 UR - http://www.ncbi.nlm.nih.gov/pubmed/36306162 ID - info:doi/10.2196/42535 ER - TY - JOUR AU - Lori, R. Jody AU - Williams, O. John E. AU - Kukula, A. Vida AU - Apetorgbor, A. Veronica E. AU - Awini, A. Elizabeth AU - Amankwah, Georgina AU - Zielinski, Ruth AU - Lockhart, Nancy AU - James, H. Katherine AU - Moyer, A. Cheryl PY - 2022/9/9 TI - Group Antenatal Care in Ghana: Protocol for a Cluster Randomized Controlled Trial JO - JMIR Res Protoc SP - e40828 VL - 11 IS - 9 KW - group care KW - antenatal care KW - group antenatal care KW - health literacy KW - maternal health literacy KW - Ghana KW - sub-Saharan Africa KW - care seeking KW - maternal outcomes KW - neonatal outcomes N2 - Background: While group antenatal care (ANC) has been delivered and studied in high-income countries for over a decade, it has only recently been introduced as an alternative to individual care in sub-Saharan Africa. Although the experimental design of the studies from high-resource countries have been scientifically rigorous, findings cannot be generalized to low-resource countries with low literacy rates and high rates of maternal and newborn morbidity and mortality. The Group Antenatal Care Delivery Project (GRAND) is a collaboration between the University of Michigan in the United States and the Dodowa Health Research Centre in Ghana. GRAND is a 5-year, cluster randomized controlled trial (RCT). Our intervention?group ANC?consists of grouping women by similar gestational ages of pregnancy into small groups at the first ANC visit. They then meet with the same group and the same midwife at the recommended intervals for care. Objective: This study aims to improve health literacy, increase birth preparedness and complication readiness, and optimize maternal and newborn outcomes among women attending ANC at seven rural health facilities in the Eastern Region of Ghana. Methods: Quantitative data will be collected at four time points using a secure web application for data collection and a database management tool. Data will be analyzed on an intention-to-treat basis to test the differences between the two arms: women randomized to group-based ANC and women randomized to routine individual ANC. We will conduct a process evaluation concurrently to identify and document patient, provider, and system barriers and facilitators to program implementation. Results: The study was funded in September 2018. Recruitment and enrollment of participants and data collection started in July 2019. In November 2021, we completed participant enrollment in the study (n=1761), and we completed data collection at the third trimester in May 2022 (n=1284). Data collection at the additional three time points is ongoing: 6 weeks postpartum, 6 months postpartum, and 1 year postpartum. Conclusions: This study is significant and timely because it is among the first RCTs to be conducted to examine the effects of group ANC among low-literacy and nonliterate participants. Our findings have the potential to impact how clinical care is delivered to low-literacy populations, both globally and domestically, to improve maternal and newborn outcomes. Trial Registration: ClinicalTrials.gov NCT04033003; https://clinicaltrials.gov/ct2/show/NCT04033003 International Registered Report Identifier (IRRID): DERR1-10.2196/40828 UR - https://www.researchprotocols.org/2022/9/e40828 UR - http://dx.doi.org/10.2196/40828 UR - http://www.ncbi.nlm.nih.gov/pubmed/36083608 ID - info:doi/10.2196/40828 ER - TY - JOUR AU - Lai, Byron AU - Davis, Drew AU - Young, Raven AU - Kimani-Swanson, Erin AU - Wozow, Cynthia AU - Wen, Huacong AU - Kim, Yumi AU - Wilroy, Jereme AU - Rimmer, James PY - 2022/8/17 TI - The Effects of Virtual Reality Tele-exergaming on Cardiometabolic Indicators of Health Among Youth With Cerebral Palsy: Protocol for a Pilot Randomized Controlled Trial JO - JMIR Res Protoc SP - e40708 VL - 11 IS - 8 KW - disability KW - physical therapy KW - adapted physical activity KW - physical activity KW - active video gaming N2 - Background: Youth with cerebral palsy do not have enjoyable, accessible, and scalable exercise options that can empower them to independently maintain their cardiometabolic health. Objective: The primary aim is to examine the preliminary efficacy of a 12-week home-based virtual reality tele-exergaming intervention on several indicators of cardiometabolic health in youth with cerebral palsy compared to the wait list control. A secondary aim is to describe feasibility metrics, namely, recruitment, retention, and adherence rates; perceived enjoyment; intervention safety; and management issues. The tertiary aim is to generate a theory that reveals critical behavioral mechanisms of adherence to tele-exergaming. Methods: In this parallel group design randomized controlled trial, 34 inactive youths with cerebral palsy are randomly allocated to one of two groups: a group that immediately receives 12 weeks of virtual reality exergaming with tele?physical education or a wait list control group that undergoes their habitual activity for 12 weeks. Participants are recruited from a Children?s Hospital and community network. At baseline (week 0), week 6, and week 12, high sensitivity C-reactive protein and blood insulin, hemoglobin A1c, triglycerides, cholesterol, and pressure are measured by the youth and a caregiver at home using a blood spot test kit and blood pressure cuff. They will also self-measure their lung function and body weight using a peak flow meter and bathroom scale, respectively. Collections are supervised by research staff via videoconference. Changes in outcomes are compared between and within groups using exploratory statistical analyses and descriptive statistics. At postintervention or dropout, participants will undergo semistructured interviews to identify behavioral mechanisms that underly participation. Results: Recruitment procedures started in June 2022. All data are expected to be collected by October 2023. Full trial results are expected to be published by February 2024. Secondary analyses of data will be subsequently published. Conclusions: This trial tests an innovative serious exergaming virtual reality program that includes a completely remote enrollment, assessment, and intervention tele-protocol. The knowledge obtained will inform the development of a larger effectiveness trial for improving the health and well-being of youth with cerebral palsy. Trial Registration: ClinicalTrials.gov NCT05336227; https://clinicaltrials.gov/ct2/show/NCT05336227 International Registered Report Identifier (IRRID): PRR1-10.2196/40708 UR - https://www.researchprotocols.org/2022/8/e40708 UR - http://dx.doi.org/10.2196/40708 UR - http://www.ncbi.nlm.nih.gov/pubmed/35976192 ID - info:doi/10.2196/40708 ER - TY - JOUR AU - Waselewski, Marika AU - Plegue, Melissa AU - Sonneville, Kendrin AU - Resnicow, Ken AU - Ghumman, Aisha AU - Ebbeling, Cara AU - Mahmoudi, Elham AU - Sen, Ananda AU - Wolfson, A. Julia AU - Chang, Tammy PY - 2022/8/5 TI - Grocery Delivery to Support Healthy Weight Gain Among Pregnant Young Women With Low Income: Protocol for a Randomized Controlled Trial JO - JMIR Res Protoc SP - e40568 VL - 11 IS - 8 KW - pregnancy KW - weight KW - diet KW - grocery delivery N2 - Background: Excessive weight gain during pregnancy is associated with complications for both the mother and her infant including gestational diabetes, hypertensive disorders, operative delivery, and long-term obesity. A healthy diet during pregnancy promotes healthy gestational weight gain and determines fetal epigenetic programming in infants that impacts risk for future chronic disease. Objective: This project will examine the impact of grocery delivery during pregnancy on the weight, diet, and health outcomes of young pregnant women and their infants. Methods: A three-arm randomized controlled trial design will be performed. A total of 855 young pregnant women, aged 14-24 years, from across the state of Michigan will be enrolled and randomized equally into the three study arms. Participants in arm one (control) will receive usual care from the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC); arm two will receive WIC plus biweekly grocery delivery; and arm three will receive WIC plus biweekly grocery and unsweetened beverage delivery. Weight will be assessed weekly during pregnancy, and total pregnancy weight gain will be categorized as above, below, or within guidelines. Additionally, dietary intake will be assessed at three time points (baseline, second trimester, and third trimester), and pregnancy outcomes will be extracted from medical records. The appropriateness of pregnancy weight gain, diet quality, and occurrence of poor outcomes will be compared between groups using standard practices for multinomial regression and confounder adjustment. Results: This study was funded in April 2021, data collection started in December 2021, and data collection is expected to be concluded in 2026. Conclusions: This study will test whether grocery delivery of healthy foods improves weight, diet, and pregnancy outcomes of young moms with low income. The findings will inform policies and practices that promote a healthy diet during pregnancy, which has multigenerational impacts on health. Trial Registration: ClinicalTrials.gov NCT05000645; https://clinicaltrials.gov/ct2/show/NCT05000645 International Registered Report Identifier (IRRID): DERR1-10.2196/40568 UR - https://www.researchprotocols.org/2022/8/e40568 UR - http://dx.doi.org/10.2196/40568 UR - http://www.ncbi.nlm.nih.gov/pubmed/35930351 ID - info:doi/10.2196/40568 ER - TY - JOUR AU - Skeens, Micah AU - Sezgin, Emre AU - Stevens, Jack AU - Landier, Wendy AU - Pai, Ahna AU - Gerhardt, Cynthia PY - 2022/7/21 TI - An mHealth App to Promote Adherence to Immunosuppressant Medication and Track Symptoms in Children After Hematopoietic Stem Cell Transplant: Protocol for a Mixed Methods Usability Study JO - JMIR Res Protoc SP - e39098 VL - 11 IS - 7 KW - medication adherence KW - digital health KW - mHealth KW - pediatrics KW - app KW - bone marrow transplant KW - adherence KW - usability KW - feasibility KW - caregivers KW - children KW - hematopoietic stem cell transplant KW - HSCT N2 - Background: In the United States, poor adherence accounts for up to 70% of all medication-related hospital admissions, resulting in $100 billion in health care costs annually. In pediatrics, adherence is largely dependent on caregivers. In a high-risk hematopoietic stem cell transplant (HSCT) population, caregivers are isolated with their child due to infection risk and must manage challenging treatment regimens at home, often with limited time and support. Complex behavioral interventions, typically employed to address adherence, are difficult to deliver and manage in the context of these daily tasks. The most successful adherence interventions, and thus improved clinical outcomes, have included mobile health (mHealth) reminder approaches and a direct measure of adherence. Objective: This is a 3-phase project, with this protocol describing phase 2, to determine the usability and feasibility of an mHealth app (BMT4me) designed to promote adherence to immunosuppressant medication and to track symptoms among children who received HSCT. Methods: This study uses an iterative convergent mixed methods design to develop and assess the usability and feasibility of an adherence digital health intervention. We will recruit 15 caregivers of pediatric patients receiving HSCT to complete user testing. Qualitative and quantitative data will be integrated to enhance and expand upon study findings. Results: Enrollment began in September 2021 and is ongoing. A total of 7 caregivers have enrolled. We anticipate completion by fall 2022. We anticipate high usability scores and a better understanding of unique features within the app that are needed for HSCT families post transplant. To date, usability scores among enrolled participants are greater than 70%. Feedback from qualitative interviews is being used to further adapt the app by adding specific weekly logs, call provider options, and voice to text. Conclusions: This protocol describes a mixed methods usability and feasibility study to develop and implement a smartphone app for caregivers of children receiving HSCT. The app was designed to improve immunosuppressant adherence and to track symptoms in the acute phase post discharge. Study findings will inform further refinement of the app and the feasibility of a pilot randomized controlled trial examining efficacy on clinical outcomes. Trial Registration: ClinicalTrials.gov NCT04976933; https://clinicaltrials.gov/ct2/show/NCT04976933 International Registered Report Identifier (IRRID): DERR1-10.2196/39098 UR - https://www.researchprotocols.org/2022/7/e39098 UR - http://dx.doi.org/10.2196/39098 UR - http://www.ncbi.nlm.nih.gov/pubmed/35862184 ID - info:doi/10.2196/39098 ER - TY - JOUR AU - MacDonell, Kolmodin Karen AU - Wang, Bo AU - Phanuphak, Nittaya AU - Janamnuaysook, Rena AU - Srimanus, Peevara AU - Rongkavilit, Chokechai AU - Naar, Sylvie PY - 2022/5/19 TI - Optimizing an mHealth Intervention to Improve Uptake and Adherence to HIV Pre-exposure Prophylaxis in Young Transgender Women: Protocol for a Multi-Phase Trial JO - JMIR Res Protoc SP - e37659 VL - 11 IS - 5 KW - transgender women KW - PrEP KW - HIV prevention KW - mHealth KW - motivational interviewing KW - Thailand KW - mobile phone N2 - Background: Vulnerable adolescents and emerging adults (aged 18-29 years), particularly young transgender women, are among the fastest-growing HIV positive populations worldwide. Thailand has the highest adult HIV seroprevalence in Asia, with a rate of infection among this population of 18%. Widespread technology offers opportunities for innovative mobile health (mHealth) interventions. Pre-exposure prophylaxis (PrEP) is an efficacious HIV prevention strategy recommended for at-risk individuals. PrEP is highly effective when taken as prescribed, but uptake and adherence have been low, with high discontinuation rates among youth. Objective: We propose to develop and pilot a multi-component, technology-based intervention to promote PrEP usage. We will adapt an existing 2-session, technology-delivered, motivational interviewing-based intervention to focus on PrEP use in transgender women in Thailand. We call this the Motivational Enhancement System for PrEP Uptake and Adherence (MES-PrEP). We will also refine and enhance YaCool, a mobile app with integrated text messaging developed and used clinically by our Thai team. The new version of the app is called Enhanced YaCool, and it enables self-management of gender and sexual health (including PrEP). Our primary aim is to develop and assess the preliminary efficacy of this mHealth intervention. Methods: We will utilize a multiphase optimization strategy (MOST) to identify the most effective intervention component or combination of components to improve PrEP usage in Thai transgender women. The study includes two phases: phase I (R21) includes qualitative interviews with key stakeholders to explore barriers and facilitators of PrEP usage through thematic analysis to inform intervention adaptation. Following this, we will adapt and beta-test MES-PrEP and Enhanced YaCool for functionality and feasibility using a community advisory board of HIV-negative Thai transgender women. In phase II (R33), we will conduct a MOST design-based trial to evaluate the feasibility, acceptability, and preliminary efficacy of MES-PrEP and Enhanced YaCool. Eighty HIV-negative participants who are currently taking PrEP and 80 participants who are not will be randomized to four conditions: (1) standard PrEP counseling (the control condition); (2) MES-PrEP and standard PrEP counseling; (3) Enhanced YaCool and standard PrEP counseling; and (4) MES-PrEP, Enhanced YaCool, and standard PrEP counseling. Feasibility and acceptability of the intervention will be assessed through usage patterns and the System Usability Scale. Preliminary impact will be assessed by evaluating the proportion of participants who initiate PrEP and their level of adherence to PrEP. Assessments will be at baseline and 1, 3, 6, 9, and 12 months postintervention. Biomarkers of adherence to PrEP, HIV, and other sexually transmitted infections will be collected. Results: Upon project completion, we will have an optimized mHealth intervention to support the use of PrEP by transgender women that will be ready for testing in a larger efficacy trial. Conclusions: Even though transgender women in Thailand face increasing risks of HIV, few interventions have targeted them. Effective developmentally and culturally tailored interventions are needed to prevent HIV transmission in this high-risk population. Trial Registration: ClinicalTrials.gov NCT05262426; https://clinicaltrials.gov/ct2/show/NCT05262426 International Registered Report Identifier (IRRID): PRR1-10.2196/37659 UR - https://www.researchprotocols.org/2022/5/e37659 UR - http://dx.doi.org/10.2196/37659 UR - http://www.ncbi.nlm.nih.gov/pubmed/35587370 ID - info:doi/10.2196/37659 ER - TY - JOUR AU - Ramos, Raquel S. AU - Johnson, Constance AU - Melkus, Gail AU - Kershaw, Trace AU - Gwadz, Marya AU - Reynolds, Harmony AU - Vorderstrasse, Allison PY - 2022/5/17 TI - Cardiovascular Disease Prevention Education Using a Virtual Environment in Sexual-Minority Men of Color With HIV: Protocol for a Sequential, Mixed Method, Waitlist Randomized Controlled Trial JO - JMIR Res Protoc SP - e38348 VL - 11 IS - 5 KW - virtual environment KW - behavioral intervention KW - consumer health informatics KW - HIV KW - cardiovascular disease KW - sexual minority men KW - prevention education KW - gamification KW - health communication N2 - Background: It is estimated that 70% of all deaths each year in the United States are due to chronic conditions. Cardiovascular disease (CVD), a chronic condition, is the leading cause of death in ethnic and racial minority males. It has been identified as the second most common cause of death in persons with HIV. By the year 2030, it is estimated that 78% of persons with HIV will be diagnosed with CVD. Objective: We propose the first technology-based virtual environment intervention to address behavioral, modifiable risk factors associated with cardiovascular and metabolic comorbidities in sexual-minority men of color with HIV. Methods: This study will be guided using social cognitive theory and the Technology Acceptance Model. A sequential, mixed method, waitlist controlled randomized control feasibility trial will be conducted. Aim 1 is to qualitatively explore perceptions of cardiovascular risk in 15 participants. Aim 2 is to conduct a waitlist controlled comparison to test if a virtual environment is feasible and acceptable for CVD prevention, based on web-based, self-assessed, behavioral, and psychosocial outcomes in 80 sexual-minority men of color with HIV. Results: The study was approved by the New York University Institutional Review Board in 2019, University of Texas Health Science Center at Houston in 2020, and by the Yale University Institutional Review Board in February 2022. As of April 2022, aim 1 data collection is 87% completed. We expect to complete data collection for aim 1 by April 30, 2022. Recruitment for aim 2 will begin mid-May 2022. Conclusions: This study will be the first online virtual environment intervention for CVD prevention in sexual-minority men of color with HIV. We anticipate that the intervention will be beneficial for CVD prevention education and building peer social supports, resulting in change or modification over time in risk behaviors for CVD. Trial Registration: ClinicalTrials.gov NCT05242952; https://clinicaltrials.gov/ct2/show/NCT05242952 International Registered Report Identifier (IRRID): PRR1-10.2196/38348 UR - https://www.researchprotocols.org/2022/5/e38348 UR - http://dx.doi.org/10.2196/38348 UR - http://www.ncbi.nlm.nih.gov/pubmed/35579928 ID - info:doi/10.2196/38348 ER - TY - JOUR AU - Moreno, P. Jennette AU - Dadabhoy, Hafza AU - Musaad, Salma AU - Baranowski, Tom AU - Thompson, Debbe AU - Alfano, A. Candice AU - Crowley, J. Stephanie PY - 2022/5/16 TI - Evaluation of a Circadian Rhythm and Sleep-Focused Mobile Health Intervention for the Prevention of Accelerated Summer Weight Gain Among Elementary School?Age Children: Protocol for a Randomized Controlled Feasibility Study JO - JMIR Res Protoc SP - e37002 VL - 11 IS - 5 KW - summer KW - circadian rhythms KW - sleep KW - child obesity KW - elementary school N2 - Background: The i?rhythm project is a mobile health adaptation of interpersonal and social rhythm therapy designed to promote healthy sleep and behavioral rhythms among 5-8-year olds during summer for the prevention of accelerated summer weight gain. Objective: This pilot study will examine the feasibility, acceptability, and preliminary efficacy of the i?rhythm intervention. This will ensure that the research protocol and procedures work as desired and are acceptable to families in preparation for the fully powered randomized controlled trial. The proposed study will examine the willingness of participants to participate in the intervention and determine whether modifications to the intervention, procedures, and measures are needed before conducting a fully powered study. We will assess our ability to (1) recruit, consent, and retain participants; (2) deliver the intervention; (3) implement the study and assessment procedures; (4) assess the reliability of the proposed measures; and (5) assess the acceptability of the intervention and assessment protocol. Methods: This study will employ a single-blinded 2-group randomized control design (treatment and no-treatment control) with randomization occurring after baseline (Time 0) and 3 additional evaluation periods (postintervention [Time 1], and 9 months [Time 2] and 12 months after intervention [Time 3]). A sample of 40 parent-child dyads will be recruited. Results: This study was approved by the institutional review board of Baylor College of Medicine (H-47369). Recruitment began in March 2021. As of March 2022, data collection and recruitment are ongoing. Conclusions: This study will address the role of sleep and circadian rhythms in the prevention of accelerated summer weight gain and assess the intervention?s effects on the long-term prevention of child obesity. Trial Registration: ClinicalTrials.gov NCT04445740; https://clinicaltrials.gov/ct2/show/NCT04445740. International Registered Report Identifier (IRRID): DERR1-10.2196/37002 UR - https://www.researchprotocols.org/2022/5/e37002 UR - http://dx.doi.org/10.2196/37002 UR - http://www.ncbi.nlm.nih.gov/pubmed/35576573 ID - info:doi/10.2196/37002 ER - TY - JOUR AU - Baptist, Alan AU - Gibson-Scipio, Wanda AU - Carcone, Idalski April AU - Ghosh, Samiran AU - Jacques-Tiura, J. Angela AU - Hall, Amy AU - MacDonell, Kolmodin Karen PY - 2022/5/10 TI - Asthma and Technology in Emerging African American Adults (The ATHENA Project): Protocol for a Trial Using the Multiphase Optimization Strategy Framework JO - JMIR Res Protoc SP - e37946 VL - 11 IS - 5 KW - African American emerging adults KW - asthma management KW - mHealth KW - mobile health KW - motivational interviewing KW - asthma control KW - physical activity N2 - Background: Asthma causes substantial morbidity and mortality in the United States, particularly among African American emerging adults (AAEAs; aged 18-30 years), but very few asthma programs have targeted this population. Interventions that provide education and address underlying motivation for managing asthma may be the most effective. However, intensive face-to-face interventions are often difficult to implement in this population. Objective: The purpose of this study is to develop an effective mobile asthma management intervention to improve control among AAEAs. Methods: We will assess the ability of multiple technologic components to assist and improve traditional asthma education. The first component is the Motivational Enhancement System for asthma management. It is a mobile 4-session intervention using supported self-regulation and motivational interviewing. Personalized content is based on each participant?s activity level, daily experiences, and goals. The second component is supportive accountability. It is administered by asthma nurses using targeted mobile support (Skype/voice calls) to provide education, promote self-efficacy, and overcome barriers through a motivational interviewing?based framework. The third component is SMS text messaging. It provides reminders for asthma education, medication adherence, and physical activity. The fourth component is physical activity tracking. It uses wearable technology to help meet user-defined physical activity goals. Using a multiphase optimization strategy (MOST) framework, we will test intervention components and combinations of components to identify the most effective mobile intervention. The MOST framework is an innovative, and cost- and time-effective framework that uses engineering principles to produce effective behavioral interventions. We will conduct a component selection experiment using a factorial research design to build an intervention that has been optimized for maximum efficacy, using a clinically significant improvement in asthma. Participants (N=180) will be randomized to 1 of 6 intervention arms. Participants will be recruited from multiple sites of the American Lung Association-Airway Clinical Research Centers network and ambulatory care clinics at the Detroit Medical Center. Data collections will occur at baseline, and 3, 6, and 12 months. Results: At study completion, we will have an empirically supported optimized mobile asthma management intervention to improve asthma control for AAEAs. We hypothesize that postintervention (3, 6, and 12 months), participants with uncontrolled asthma will show a clinically significant improvement in asthma control. We also hypothesize that improvements in asthma management behaviors (including physical activity), quality of life, symptoms, adherence, and exacerbation (secondary outcomes) will be observed. Conclusions: AAEAs are disproportionately impacted by asthma, but have been underrepresented in research. Mobile asthma management interventions may help improve asthma control and allow people to live healthier lives. During this project, we will use an innovative strategy to develop an optimized mobile asthma management intervention using the most effective combination of nurse-delivered asthma education, a smartphone app, and text messaging. International Registered Report Identifier (IRRID): PRR1-10.2196/37946 UR - https://www.researchprotocols.org/2022/5/e37946 UR - http://dx.doi.org/10.2196/37946 UR - http://www.ncbi.nlm.nih.gov/pubmed/35536642 ID - info:doi/10.2196/37946 ER - TY - JOUR AU - Hodges, Jacqueline AU - Caldwell, Sylvia AU - Cohn, Wendy AU - Flickinger, Tabor AU - Waldman, Lena Ava AU - Dillingham, Rebecca AU - Castel, Amanda AU - Ingersoll, Karen PY - 2022/4/22 TI - Evaluation of the Implementation and Effectiveness of a Mobile Health Intervention to Improve Outcomes for People With HIV in the Washington, DC Cohort: Study Protocol for a Cluster Randomized Controlled Trial JO - JMIR Res Protoc SP - e37748 VL - 11 IS - 4 KW - human immunodeficiency virus KW - HIV KW - mobile health KW - mHealth KW - implementation science KW - cluster randomized controlled trial KW - smartphone N2 - Background: Gaps remain in achieving retention in care and durable HIV viral load suppression for people with HIV in Washington, DC (hereafter DC). Although people with HIV seeking care in DC have access to a range of supportive services, innovative strategies are needed to enhance patient engagement in this setting. Mobile health (mHealth) interventions have shown promise in reaching previously underengaged groups and improving HIV-related outcomes in various settings. Objective: This study will evaluate the implementation and effectiveness of a clinic-deployed, multifeature mHealth intervention called PositiveLinks (PL) among people with HIV enrolled in the DC Cohort, a longitudinal cohort of people with HIV receiving care in DC. A cluster randomized controlled trial will be conducted using a hybrid effectiveness-implementation design and will compare HIV-related outcomes between clinics randomized to PL versus usual care. Methods: The study aims are threefold: (1) We will perform a formative evaluation of PL in the context of DC Cohort clinics to test the feasibility, acceptability, and usability of PL and tailor the platform for use in this context. (2) We will conduct a cluster randomized controlled trial with 12 DC Cohort clinics randomized to PL or usual care (n=6 [50%] per arm) and measure the effectiveness of PL by the primary outcomes of patient visit constancy, retention in care, and HIV viral load suppression. We aim to enroll a total of 482 participants from DC Cohort clinic sites, specifically including people with HIV who show evidence of inconsistent retention in care or lack of viral suppression. (3) We will use the Consolidated Framework for Implementation Research (CFIR) and the Reach Effectiveness Adoption Implementation Maintenance (RE-AIM) framework to measure implementation success and identify site, patient, provider, and system factors associated with successful implementation. Evaluation activities will occur pre-, mid-, and postimplementation. Results: Formative data collection was completed between April 2021 and January 2022. Preliminary mHealth platform modifications have been performed, and the first round of user testing has been completed. A preimplementation evaluation was performed to identify relevant implementation outcomes and design a suite of instruments to guide data collection for evaluation of PL implementation throughout the trial period. Instruments include those already developed to support DC Cohort Study activities and PL implementation in other cohorts, which required modification for use in the study, as well as novel instruments designed to complete data collection, as guided by the CFIR and RE-AIM frameworks. Conclusions: Formative and preimplementation evaluations will be completed in spring 2022 when the trial is planned to launch. Specifically, comprehensive formative data analysis will be completed following data collection, coding, preliminary review, and synthesis. Corresponding platform modifications are ready for beta testing within the DC Cohort. Finalization of the platform for use in the trial will follow beta testing. Trial Registration: ClinicalTrials.gov NCT04998019; https://clinicaltrials.gov/ct2/show/NCT04998019 International Registered Report Identifier (IRRID): PRR1-10.2196/37748 UR - https://www.researchprotocols.org/2022/4/e37748 UR - http://dx.doi.org/10.2196/37748 UR - http://www.ncbi.nlm.nih.gov/pubmed/35349466 ID - info:doi/10.2196/37748 ER - TY - JOUR AU - Becker, J. Sara AU - Helseth, A. Sarah AU - Kelly, M. Lourah AU - Janssen, Tim AU - Wolff, C. Jennifer AU - Spirito, Anthony AU - Wright, Thomas PY - 2022/2/28 TI - Parent SMART (Substance Misuse in Adolescents in Residential Treatment): Protocol of a Randomized Effectiveness Trial of a Technology-Assisted Parenting Intervention JO - JMIR Res Protoc SP - e35934 VL - 11 IS - 2 KW - adolescent KW - residential KW - technology-assisted KW - substance use KW - parent KW - randomized controlled trial KW - RCT KW - intervention KW - eHealth KW - problem behaviour KW - problem behavior N2 - Background: Adolescents in residential substance use treatment are at extremely high risk for relapse following discharge to the community. Parenting practices, including parental monitoring and parent-adolescent communication, have been established as key predictors of adolescent substance use outcomes and relapse. However, traditional office-based therapy may not be feasible for parents who face structural and systemic barriers. There is a clear need for effective, accessible, and scalable interventions for parents of adolescents receiving residential substance use treatment. In a prior pilot randomized controlled trial, we tested Parent SMART (Substance Misuse among Adolescents in Residential Treatment)?a technology-assisted parenting intervention informed by extensive formative research?as an adjunct to residential treatment as usual (TAU). Parent SMART demonstrated high feasibility and acceptability, as well as evidence of effectiveness in improving parental monitoring and communication. Objective: This protocol paper describes a fully-powered randomized controlled pragmatic effectiveness trial of Parent SMART as an adjunct to residential TAU. We hypothesize that families who receive Parent SMART will demonstrate greater improvements in parenting skills, reductions in adolescent substance use, and reductions in adolescent problem behaviors relative to families that receive residential TAU. We will test the exploratory hypothesis that reductions in adolescent substance use will be partially mediated by improvements in parenting skills. Methods: Adolescent-parent dyads (n = 220 dyads; 440 total) will be randomized to either residential TAU only or Parent SMART+TAU. Parents randomized to Parent SMART will receive access to a networking forum, an off-the-shelf computer program called Parenting Wisely, and up to four telehealth coaching calls. Multimethod follow-up assessments consisting of self-reported parent and adolescent measures, a parent-adolescent in vivo interaction task, and 8-panel urine screens will be conducted 6, 12, and 24 weeks postdischarge from residential care. Measures will assess parenting skills, adolescent substance use, and adolescent problem behaviors. Analyses will be conducted using latent change score structural equation modeling. Results: The trial was funded in August 2021; ethics approval was obtained in August 2020, prior to funding. Due to concerns with the administrative interface in the pilot trial, the Parent SMART networking forum is currently being rebuilt by a different vendor. The programming is scheduled to be completed by December 2021, with recruitment beginning in February 2022. Conclusions: The proposed research has the potential to advance the field by serving a high-need, underserved population during a vital treatment juncture; targeting parenting practices (putative mediators) that have been shown to predict adolescent substance use outcomes; addressing barriers to accessing continuing care; and testing a highly scalable intervention model. Trial Registration: ClinicalTrials.gov NCT05169385; https://clinicaltrials.gov/ct2/show/NCT05169385 International Registered Report Identifier (IRRID): PRR1-10.2196/35934 UR - https://www.researchprotocols.org/2022/2/e35934 UR - http://dx.doi.org/10.2196/35934 UR - http://www.ncbi.nlm.nih.gov/pubmed/35225821 ID - info:doi/10.2196/35934 ER - TY - JOUR AU - Ezeanolue, Edozie Echezona AU - Gbadamosi, Olatunde Semiu AU - Olawepo, Olajide John AU - Iwelunmor, Juliet AU - Sarpong, Daniel AU - Eze, Chuka AU - Ogidi, Amaka AU - Patel, Dina AU - Onoka, Chima PY - 2017/05/26 TI - An mHealth Framework to Improve Birth Outcomes in Benue State, Nigeria: A Study Protocol JO - JMIR Res Protoc SP - e100 VL - 6 IS - 5 KW - mHealth KW - smart card KW - HIV KW - hepatitis B KW - sickle cell disease KW - mobile health technology KW - Nigeria N2 - Background: The unprecedented coverage of mobile technology across the globe has led to an increase in the use of mobile health apps and related strategies to make health information available at the point of care. These strategies have the potential to improve birth outcomes, but are limited by the availability of Internet services, especially in resource-limited settings such as Nigeria. Objective: Our primary objective is to determine the feasibility of developing an integrated mobile health platform that is able to collect data from community-based programs, embed collected data into a smart card, and read the smart card using a mobile phone-based app without the need for Internet access. Our secondary objectives are to determine (1) the acceptability of the smart card among pregnant women and (2) the usability of the smart card by pregnant women and health facilities in rural Nigeria. Methods: We will leverage existing technology to develop a platform that integrates a database, smart card technology, and a mobile phone-based app to read the smart cards. We will recruit 300 pregnant women with one of the three conditions?HIV, hepatitis B virus infection, and sickle cell trait or disease?and four health facilities in their community. We will use Glasgow?s Reach, Effectiveness, Adoption, Implementation, and Maintenance framework as a guide to assess the implementation, acceptability, and usability of the mHealth platform. Results: We have recruited four health facilities and 300 pregnant women with at least one of the eligible conditions. Over the course of 3 months, we will complete the development of the mobile health platform and each participant will be offered a smart card; staff in each health facility will receive training on the use of the mobile health platform. Conclusions: Findings from this study could offer a new approach to making health data from pregnant women available at the point of delivery without the need for an Internet connection. This would allow clinicians to implement evidence-based interventions in real time to improve health outcomes. Trial Registration: ClinicalTrials.gov NCT03027258; https://clinicaltrials.gov/ct2/show/NCT03027258 (Archived by WebCite at http://www.webcitation.org/6owR2D0kE) UR - http://www.researchprotocols.org/2017/5/e100/ UR - http://dx.doi.org/10.2196/resprot.7743 UR - http://www.ncbi.nlm.nih.gov/pubmed/28550003 ID - info:doi/10.2196/resprot.7743 ER -