Rehabilitation at home using mobile health in older adults after hospitalization for ischemic heart disease (RESILIENT)

使用移动医疗对因缺血性心脏病住院的老年人进行家庭康复（RESILIENT）

• 批准号: 10450751
• 负责人: John A Dodson
• 金额: $ 62.87万
• 依托单位: NEW YORK UNIVERSITY SCHOOL OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-07-15 至 2024-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10450751
• 关键词: Academic Medical Centers; Activities of Daily Living; Acute myocardial infarction; Aerobic; Age; Behavioral Sciences; Biometry; Blinded; Cardiac rehabilitation; Cardiology; Cardiovascular system; Cessation of life; Clinical Research; Computer software; Control Groups; Coronary Artery Bypass; Counseling; Data; Disease; Documentation; Education; Elderly; Electronic Mail; Electronics; Enrollment; Ethnic Origin; Exercise; Face; Foundations; General Population; Geriatrics; Goals; Guidelines; Health; Health Status; Heart Block; Home; Hospitalization; Impaired cognition; Impairment; Intervention; Lead; Measures; Modification; Multi-Institutional Clinical Trial; Myocardial Ischemia; Outcome; Outcomes Research; Participant; Patients; Pattern; Persons; Physical Function; Physical Medicine; Population; Proliferating; Race; Randomized; Randomized Clinical Trials; Rehabilitation therapy; Research Personnel; Risk Factors; Social support; Supervision; Tablet Computer; Technology; Telephone; Testing; Time; Transportation; Wait Time; Walking; behavioral clinical trial; comorbidity; computer science; cost; depressive symptoms; experience; frailty; hemodynamics; high risk; hospital readmission; improved; improved functioning; instrumental activity of daily living; mHealth; medical schools; multidisciplinary; older patient; patient population; percutaneous coronary intervention; portability; preservation; primary endpoint; programs; prospective; randomized effectiveness trial; readmission rates; recruit; rehabilitation paradigm; rehabilitation science; rehabilitation strategy; research study; sex; sustainable resource; treatment as usual

Project Summary Participation in ambulatory cardiac rehabilitation (CR) by patients with ischemic heart disease (IHD) remains low. By recent estimates, fewer than two thirds of eligible patients are referred, and fewer than half of those referred participate. Even among those referred, multiple barriers to participation include limited facilities, competing time demands, high out-of-pocket costs, and prolonged wait time. Barriers to CR are particularly high in older adults (age ≥70), due to factors such as physical impairments or transportation barriers, although these patients may simultaneously have the greatest potential to benefit. Mobile health-enabled CR (mHealth- CR) for IHD – which involves delivery of CR via portable electronic devices – has the potential to increase engagement by reducing participation barriers, but it remains largely untested outside of small studies in relatively healthy young persons. It is therefore unclear what proportion of older adults with IHD and barriers to traditional CR are able to engage with mHealth-CR, and whether mHealth-CR leads to better outcomes than usual care. Therefore, we propose RESILIENT: Rehabilitation at home using mobile health in older adults after hospitalization for ischemic heart disease. This is a prospective, multicenter, non-blinded randomized clinical trial (with blinded assessment of primary endpoint) to evaluate engagement and outcomes with mHealth-CR among older adults with IHD, identified at the time of acute myocardial infarction (AMI), percutaneous coronary intervention (PCI), or coronary artery bypass graft (CABG). The trial will be conducted at two academic medical centers: NYU School of Medicine and Yale School of Medicine, which collectively serve a diverse patient population and have a track record of successfully recruiting older adults in clinical research studies. We will randomize 400 older adults with IHD to receive mHealth-CR (n=300) or usual care (n=100) for 3 months. Our intervention combines mHealth-CR software, delivered via a tablet device, with baseline counseling and weekly phone calls by an exercise therapist over 3 months. Intervention and usual care groups will also receive a standard referral to ambulatory CR in accordance with guidelines, as well as dynamic assessment of activities of daily living (ADLs). The primary efficacy endpoint is change in functional capacity, assessed by 6 minute walk distance. Secondary efficacy endpoints are goal attainment, health status, ADLs, hospital readmission, and death. The engagement endpoint is defined by weekly completion of mHealth-CR tasks. We hypothesize that mHealth-CR will improve a range of outcomes, and that distinct patterns of engagement will be discerned. The PI for this project (Dr. Dodson) is an Early Stage Investigator with a focus on cardiovascular outcomes research among older adults; additional investigators have a wide range of expertise in geriatrics, biostatistics, behavioral science, cardiac rehabilitation, and computer science. The study results could lead to new sustainable and resource-efficient CR strategies among older adults with IHD, and lay the groundwork for a subsequent large multi-center clinical trial.

项目摘要 缺血性心脏病（IHD）的患者参与门诊心脏康复（CR） 低的。根据最近的估计，参考合格患者中不到三分之二，其中不到一半 参与参与。即使在被提及的人中，参与的多个障碍也包括有限的设施， 竞争时间的需求，高昂的自付成本以及延长的等待时间。 CR的障碍特别是 由于身体障碍或运输障碍等因素，老年人高（年龄≥70岁）高（年龄≥70） 这些患者可能只有最大的受益潜力。移动健康支持CR（MHealth- CR）对于IHD（涉及通过便携式电子设备传递CR）的IHD可能会增加 通过减少参与障碍来参与，但在很大程度上未经测试。 相关健康的年轻人。因此，尚不清楚具有IHD和障碍的老年人比例 传统的CR能够与MHealth-CR互动，MHealth-CR是否会带来更好的结果 通常的护理。因此，我们提出弹性：在家中使用移动健康的老年人康复 缺血性心脏病住院后。这是一个预期的，多中心的，非盲的随机分组 临床试验（对主要端点的盲评估），以评估参与度和结果 IHD老年人中的MHealth-CR，在急性心肌梗塞（AMI）时被确定 经皮冠状动脉干预（PCI）或冠状动脉搭桥移植物（CABG）。试验将进行 在两个学术医学中心：纽约大学医学院和耶鲁大学医学院，共同 为潜水员的患者群体服务，并在临床上成功招募老年人的记录 研究。我们将与IHD的400名老年人随机接收MHealth-CR（n = 300）或通常的护理 （n = 100）3个月。我们的干预组合MHealth-CR软件，通过平板电脑设备提供，并带有 运动治疗师3个月内的基线咨询和每周电话。干预和通常 护理小组还将根据指南以及 日常生活活动（ADL）的动态评估。主要效率终点是功能的变化 容量，通过6分钟步行距离进行评估。次要效率终点是目标实现，健康 身份，ADL，医院再入院和死亡。参与终点是通过每周完成的定义 MHealth-CR任务。我们假设MHealth-Cr将改善一定范围的结果，而这种不同 参与模式将被辨别。该项目的PI（Dodson博士）是早期的调查员 重点是老年人的心血管结局研究；其他调查员有很大的 老年医学，生物统计学，行为科学，心脏康复和计算机科学方面的专业知识范围。 该研究结果可能会导致具有新的可持续和资源效率的CR策略 IHD，为随后的大型多中心临床试验奠定了基础。