Leveraging Technology to Improve Medication Adherence in Adolescent and Young Adult Kidney or Liver Transplant Recipients

利用技术提高青少年和年轻肾移植或肝移植受者的药物依从性

• 批准号: 10487516
• 负责人: Cyd Kumiko Eaton
• 金额: $ 17.59万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-15 至 2026-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10487516
• 关键词: Address; Adherence; Adolescent; Adolescent and Young Adult; American; Biological; Blood; Cessation of life; Chronic Disease; Chronic Kidney Failure; Clinical; Data; Databases; Dose; Experimental Designs; Goals; Health; Immunosuppressive Agents; Ingestion; Intervention; Investigation; Kidney Transplantation; Knowledge; Link; Measures; Medicine; Methodology; Methods; Monitor; Patients; Persons; Pharmaceutical Preparations; Phase; Population; Provider; Public Health; Qualitative Methods; Quality of life; Randomized; Reporting; Research; Research Methodology; Research Personnel; Risk; Signal Transduction; Societies; Tacrolimus; Technology; Time; Training; Training Activity; Transplant Recipients; Transplantation; adaptive intervention; base; behavioral adherence; career development; design; dose information; efficacious intervention; electronic data; graft failure; health related quality of life; improved; indexing; innovation; instrument; intervention effect; liver transplantation; mHealth; medication compliance; medication nonadherence; novel; organ transplant rejection; pilot test; post intervention; randomized trial; research and development; therapy design; tool; uptake; young adult

Over 1/3 of adolescents and young adults (AYAs) who have undergone kidney or liver transplantation are nonadherent to immunosuppressant medicine, a leading cause of organ rejection, graft failure, and death. Despite the American Society of Transplantation's calls for real-time approaches to address immunosuppressant nonadherence, there are no validated metrics using real-time adherence data (e.g., electronic pillboxes) to identify those at risk for rejection and no efficacious interventions that leverage these data to improve adherence. Hence, we will fill these critical gaps in nonadherence management by validating the new “Real-Time Adherence Measure,” a novel instrument that could revolutionize how nonadherence is detected by linking the precision of non-invasive, easily downloaded, timestamped electronic pillbox data to tacrolimus blood level standard deviations (biological index of drug ingestion) to direct in the moment when immunosuppressant nonadherence leads to rejection. We will harness this real-time daily dosing information in an adherence-promoting just-in-time adaptive intervention (JITAI), a cutting-edge mobile health approach capable of fully incorporating AYAs' daily electronically-monitored adherence to deliver tailored intervention content exactly when the AYA needs it most. Currently, there are no JITAIs for this purpose. We will conduct this vital research, which involves using a micro- randomized trial, a state-of-the-art experimental design for creating successful JITAIs. To develop our JITAI, we will modify a promising existing intervention for promoting AYA adherence (sent adherence support messages when dose was due) by triggering adherence support messages only when medicine is missed and providing praise messages when medicine is taken. A JITAI-version of this intervention will be piloted with AYA kidney or liver transplant recipients in a 12-week micro-randomized trial to identify intervention content and timing that maximize the JITAI's impact on adherence. AYAs will be randomized after each electronically-monitored missed tacrolimus dose to receive (1) an adherence support message or (2) no message. After each on time dose, AYAs will be randomized to receive (1) a praise message or (2) no message. AYAs' engagement in the JITAI will be qualitatively characterized to support long-term uptake. Our findings will address significant knowledge gaps in how to optimally leverage technology to effectively measure and improve medication adherence for AYA kidney or liver transplant recipients, reduce nonadherence-related rejection, graft loss, and death, and improve people's health and quality of life. Dr. Eaton's study and training activities will prepare her to use advanced methodologies to validate novel clinical metrics, design JITAIs, conduct micro-randomized trials, and improve mobile health engagement. It is critical for Dr. Eaton to have support from this K23 to attain expertise in these innovative methods and to achieve her important scientific aims. Dr. Eaton's career development activities will occur at Johns Hopkins. Results of this study will provide essential preliminary data for Dr. Eaton's R01-supported full- scale RCT of her JITAI and support her successful transition to become an independent investigator.

超过三分之一的青少年和年轻人（AYAs）接受了肾脏或肝脏移植， 免疫抑制剂药物的不依从性，这是器官排斥、移植失败和死亡的主要原因。 尽管美国移植学会呼吁采用实时方法来解决免疫抑制剂 不遵守，不存在使用实时遵守数据的经验证的度量（例如，电子碉堡）， 识别那些有拒绝风险的患者，以及没有有效的干预措施来利用这些数据来提高依从性的患者。 因此，我们将通过验证新的“实时依从性”， 测量，”一种新颖的仪器，可以彻底改变如何通过连接的精度不遵守检测 非侵入性、易于下载、时间戳的电子药盒数据与他克莫司血液水平标准 偏差（药物摄入的生物学指数），以指导免疫抑制剂不依从的时刻 导致拒绝。我们将利用这一实时每日剂量信息， 适应性干预（JITAI），一种尖端的移动的健康方法，能够完全融入AYA的日常生活， 电子监控的依从性，以便在AYA最需要的时候提供定制的干预内容。 目前，没有用于这一目的的综合技术援助机构。我们将进行这项重要的研究，其中涉及使用一个微型- 随机试验，一个最先进的实验设计，创造成功的JITAI。为了发展吉泰，我们 我将修改有希望的现有干预措施，以促进AYA依从性（发送依从性支持消息 当剂量到期时）通过仅在药物遗漏时触发依从性支持消息并提供 吃药时的赞美信息。JITAI版本的这种干预将与AYA肾脏或 在一项为期12周的微随机试验中， 最大限度地发挥JITAI对坚持的影响。每次电子监测缺失后，将对AYA进行随机化 他克莫司剂量以接收（1）依从性支持消息或（2）无消息。每次按时给药后，AYA 将被随机分配以接收（1）表扬消息或（2）没有消息。AYA在JITAI的参与将是 定性特征，以支持长期吸收。我们的研究结果将解决重大的知识差距， 如何最佳地利用技术来有效地测量和改善AYA肾脏的药物依从性 或肝移植受者，减少非粘附性相关排斥反应，移植物丢失和死亡，并改善人们的 健康和生活质量。伊顿博士的学习和培训活动将使她能够使用先进的方法 验证新的临床指标，设计JITAI，进行微观随机试验，并改善移动的健康 订婚伊顿博士必须得到K23的支持，以获得这些创新领域的专业知识。 方法和实现其重要的科学目标。伊顿博士的职业发展活动将在 约翰·霍普金斯大学。这项研究的结果将为伊顿博士的R 01支持的全面研究提供必要的初步数据， 扩展其JITAI的RCT，并支持其成功转型为独立研究者。