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

很少有干预措施被证明能成功地促进服药依从性并影响短期和 青少年心脏移植(HT)受者移植后的长期结果。提高遵从性是一项 对经历慢性健康状况的年轻人，特别是青少年器官移植患者，提出持续的挑战 收件人。青少年器官移植受者经历了独特的挑战，继续遵守 复杂的移植后方案，不粘附率高达40%至60%。在这群人中， 药物不依从性仍然是晚期急性排斥反应(LAR)发作的主要原因，数量增加 住院、移植物衰竭和病人死亡率。由emocha开发的移动健康应用程序 Health Inc.促进了异步移动视频直接观察治疗(DOT)干预， 使用户能够跟踪逐个剂量的用药依从性。干预成功了 在佛罗里达大学(UF)健康中心对青少年高血压患者实施，其中患者和他们的 照顾者报告了高水平的干预可接受性。在建议的SBIR中直接进入第二阶段(R44) 项目中，我们将检查几个新实施的技术和实践创新 Emocha的DOT应用程序(以及干预)。在这项随机对照试验中，我们将青少年羟色胺 接受为期12周的DOT干预的受试者或接受包含强化目标设定的对照组 与移植团队成员进行会谈。具体地说，我们寻求推进DOT方法，以允许 通过新颖的视频反馈提高患者参与度和互动性，并简化 通过在整个移植中心集中用药和剂量审查进行干预 研究人群：三个儿科HT中心占儿童HT患者的很大比例 佛罗里达州。与我们的小企业合作伙伴emocha一起，这项拟议的研究将考察差异 在患者和护理人员报告的测量中，与可扩展性和翻译的潜力相关的因素 DOT对常规临床护理的干预，以及长期健康和患者依从性的结果。本研究 我将扩展使用emocha DOT对青少年HT进行干预的试点研究的最新结果 收件人。用改进的视频反馈对儿童高血压病患者实施DOT干预 集中遵守和参与者监测的能力和使用都是方案创新。 我们的长期目标是为儿童移植受者提供循证工具和支持，同时 改善儿童用药行为，降低儿童实体器官DOT给药障碍 移植团队。这样的努力对他们的护理、移植团队的治疗努力以及 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.