Evaluation of a mobile app-based video Directly Observed Therapy (video DOT) intervention for medication adherence in pediatric heart transplant patients

很少有干预措施已被证明是成功的，在促进药物依从性和影响短期和长期的， 青少年心脏移植（HT）受者的长期移植后结局。提高依从性是 患有慢性健康状况的青少年面临的持续挑战，特别是在青少年移植中 受惠人士青少年器官移植接受者经历独特的挑战， 复杂的移植后方案，不依从率高达40%至60%。在这个群体中， 药物不依从仍然是晚期急性排斥反应（LAR）发作的主要原因， 住院、移植失败和患者死亡率。一款由emocha开发的移动的健康应用 Health Inc.便于异步移动的视频直接观察治疗（DOT）干预， 使用户能够跟踪逐剂量的药物依从性。干预已成功 在佛罗里达大学（UF）健康部对青少年HT患者实施，其中患者及其 护理人员报告说，干预措施的可接受程度很高。在拟议的SBIR中，直接进入第二阶段（R44） 项目，我们将研究几个新实施的技术和实践创新， emocha的DOT应用程序（和干预）。在这项随机对照试验中，我们将青少年HT 接受12周DOT干预或涉及增强目标设定的对照组 与移植团队成员的会议。具体而言，我们寻求推进DOT方法， 通过新颖的视频反馈提高患者参与度和互动度， 通过在单个移植中心集中药物和剂量审查进行干预， 研究人群：三家儿科HT中心代表了本研究中儿科HT患者的显著比例。 佛罗里达州。与我们的小企业合作伙伴emocha一起，这项拟议中的研究将研究 在患者和患者报告的测量中，与可扩展性和翻译潜力相关的因素 DOT干预常规临床护理，以及长期健康和依从性患者结局。本研究 将扩大最近的结果，从试点研究使用emocha DOT干预青少年HT 受惠人士通过改进的视频反馈对儿科HT接受者实施DOT干预 集中式遵守和参与者监控的能力和使用都是方案创新。 我们的长期目标是为儿童HT接受者提供基于证据的工具和支持， 改善他们的服药行为，减少DOT在儿科实体器官中的传递障碍 移植团队这些努力对于他们的护理、移植团队的治疗努力以及移植手术的成功都是至关重要的。 NHLBI的研究重点。

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.