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

基于移动应用程序的视频直接观察治疗（视频 DOT）干预对儿童心脏移植患者药物依从性的评估

• 批准号: 10603790
• 负责人: Dipankar Gupta
• 金额: $ 83.86万
• 依托单位: EMOCHA MOBILE HEALTH, INC.
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-04-01 至 2025-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10603790
• 关键词: Acute; Adherence; Adolescent; Behavior; Businesses; COVID-19; Caregivers; Caring; Childhood; Chronic; Clinical; Collaborations; Complex; Consent; Control Groups; Directly Observed Therapy; Dose; Evaluation; Exhibits; Feedback; Florida; Goals; Health; Health Personnel; Heart; Heart Transplantation; Hospitalization; Intervention; Measurement; Measures; Mobile Health Application; Monitor; National Heart, Lung, and Blood Institute; Organ Transplantation; Outcome; Participant; Patient Monitoring; Patient-Focused Outcomes; Patients; Perception; Pharmaceutical Preparations; Phase; Population; Positioning Attribute; Process; Quality of Care; Randomized; Randomized, Controlled Trials; Regimen; Reporting; Research; Research Priority; Safety; Sampling; Small Business Innovation Research Grant; Solid; Technology; Therapeutic Intervention; Time; Transplant Recipients; Transplantation; Universities; Youth; adolescent patient; aged; care coordination; clinical care; compliance behavior; design; empowerment; evidence base; experience; graft failure; group intervention; health related quality of life; high risk; improved; indexing; innovation; intervention delivery; mHealth; medication compliance; medication nonadherence; member; mobile application; mortality; novel; organ transplant recipient; participant enrollment; patient engagement; post intervention; post-transplant; public health relevance; recruit; study population; tool; translational potential; transplant centers; trend; virtual

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.

很少有干预措施被证明能够成功地促进药物依从性和影响短期和 改善青少年心脏移植（HT）接受者的长期移植后结果是一个重要因素。 患有慢性健康问题的青少年，尤其是青少年移植者面临的持续挑战 青少年器官移植接受者在坚持遵守规则方面面临着独特的挑战。 复杂的移植后治疗方案，在该人群中不依从率高达 40% 至 60%。 药物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 emocha 开发的移动健康应用程序。 Health Inc. 促进异步移动视频直接观察治疗 (DOT) 干预， 使用户能够跟踪逐次服药的依从性。该干预措施已取得成功。 佛罗里达大学 (UF) 健康中心对青少年 HT 患者实施了治疗，因此患者及其患者 在拟议的 SBIR Direct to Phase II (R44) 中，护理人员报告了高水平的干预可接受性。 项目中，我们将研究几项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，我们将分配青少年 HT。 接受为期 12 周 DOT 干预或涉及强化目标设定的对照组 具体来说，我们寻求推进 DOT 方法以允许移植团队成员参加会议。 通过新颖的视频反馈提高患者参与度和互动，并简化交付 通过在单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 中心代表了该地区儿科 HT 患者的很大一部分 拟议的研究将与我们的小型企业合作伙伴 emocha 一起研究佛罗里达州的差异。 在患者和护理人员报告的测量中，与可扩展性和转化潜力相关的因素 DOT 干预常规临床护理以及长期健康和依从性患者结果。 将扩展使用 emocha DOT 干预青少年 HT 的试点研究的最新结果 通过改进的视频反馈对儿科 HT 接受者实施 DOT 干预。 集中遵守和参与者监控的能力和使用都是程序性创新。 我们的长期目标是为儿科 HT 接受者提供基于证据的工具和支持，同时 改善他们的服药行为并减少为儿科实体器官提供 DOT 的障碍 这些努力对于他们的护理、移植团队的治疗工作以及移植团队的治疗工作至关重要。 NHLBI 的研究重点。