Phase II year
2023
(last award dollars: 2024)
Phase II Amount
$1,676,046
Few interventions have proven to be successful in promoting medication adherence and impacting short- and long-term posttransplant outcomes in adolescent heart transplant (HT) recipients. Improving adherence is a persistent challenge with youth experiencing chronic health conditions, especially among adolescent transplant recipients. Adolescent organ transplant recipients experience unique challenges remaining adherent to the complex posttransplant regimen, with rates of nonadherence as high as 40% to 60%. In this population, medication nonadherence remains a primary cause of late acute rejection (LAR) episodes, increased number of hospitalizations, graft failure, and patient mortality. A mobile health application developed by emocha Health Inc. facilitates asynchronous mobile video directly observed therapy (DOT) intervention, empowering users to track dose-by-dose medication adherence. The intervention has been successfully implemented with adolescent HT patients at University of Florida (UF) Health, wherein patients and their caregivers reported high levels of intervention acceptability. In the proposed SBIR Direct to Phase II (R44) project, we will examine several newly implemented technological and practical innovations within emocha's DOT app (and intervention). In this randomized controlled trial, we will assign adolescent HT recipients to either the 12-week DOT intervention or to a control group involving enhanced goal-setting sessions with transplant team members. Specifically, we seek to advance the DOT approach to allow for greater patient engagement and interaction through novel video feedback and simplify delivery of the intervention through centralized medication and dosing review at a single transplant center for the entire study population: three pediatric HT centers representing a significant proportion of pediatric HT patients in the state of Florida. Together with emocha, our small business partner, the proposed study will examine differences in patient- and caregiver-reported measures, factors related to scalability and potential of translation of the DOT intervention into routine clinical care, and long-term health and adherence patient outcomes. This study will expand on recent results from pilot research using the emocha DOT intervention with adolescent HT recipients. Implementing the DOT intervention with pediatric HT recipients with improved video feedback capabilities and use of centralized adherence and participant monitoring are both programmatic innovations. Our long-term goals are to provide evidence-based tools and support for pediatric HT recipients while improving their medication-taking behaviors and to reduce barriers to delivery of DOT for pediatric solid organ transplant teams. Such efforts are central to their care, the treatment efforts of transplant teams, and to the research priorities of NHLBI.
Public Health Relevance Statement: Narrative / Public Health Relevance Few interventions have proven to be successful in promoting medication adherence and impacting short- and long-term posttransplant outcomes in adolescent heart transplant recipients. In the proposed SBIR Direct to Phase II (R44) project, we will examine several newly implemented technological and practical innovations within emocha Health Inc.'s DOT app (and intervention) designed to help adolescent patients track their medication-taking and feel supported by their transplant care team. Together with emocha, the proposed study will examine differences in patient- and caregiver-reported measures, factors related to scalability and potential of translation of the DOT intervention into routine clinical care, and long-term health and adherence patient outcomes. Terms:
