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.

项目概要 缺血性心脏病（IHD）患者仍然参与门诊心脏康复（CR） 根据最近的估计，转诊的合格患者不到三分之二，而且不到一半。 即使在那些被推荐的人中，参与的多重障碍包括设施有限、 竞争性的时间需求、高昂的自付费用和漫长的等待时间尤其是 CR 的障碍。 由于身体缺陷或交通障碍等因素，老年人（年龄≥70岁）的患病率较高，尽管 这些患者可能同时具有最大的受益潜力，即移动健康 CR（mHealth-）。 CR）用于 IHD——涉及通过便携式电子设备提供 CR——有可能增加 通过减少参与障碍来提高参与度，但除了小型研究之外，它在很大程度上尚未经过测试 因此，尚不清楚患有 IHD 和障碍的老年人比例有多少。 传统 CR 能够与 mHealth-CR 结合，以及 mHealth-CR 是否会比传统 CR 带来更好的结果 因此，我们建议弹性：使用移动医疗对老年人进行家庭康复。 这是一项前瞻性、多中心、非盲随机研究。 临床试验（对主要终点进行盲法评估）评估参与度和结果 患有 IHD 的老年人中的 mHealth-CR，在急性心肌梗塞 (AMI) 时被识别， 将进行经皮冠状动脉介入治疗（PCI）或冠状动脉旁路移植术（CABG）。 在两个学术医学中心：纽约大学医学院和耶鲁大学医学院，它们统称为 为不同的患者群体提供服务，并拥有成功招募老年人参与临床的记录 我们将随机抽取 400 名患有 IHD 的老年人接受 mHealth-CR (n=300) 或常规护理。 (n=100) 3 个月，我们的干预结合了通过平板电脑设备提供的 mHealth-CR 软件。 3 个月内，运动治疗师每周进行基线咨询和电话干预。 护理小组还将根据指南收到标准转诊至门诊 CR 的信息，以及 日常生活活动（ADL）的动态评估主要疗效终点是功能的变化。 能力，通过 6 分钟步行距离进行评估 次要功效终点是目标实现情况、健康状况。 参与终点由每周完成情况来定义。 我们认为 mHealth-CR 任务将改善一系列结果，并且具有独特的意义。 该项目的 PI（Dodson 博士）是一名早期研究员。 重点关注老年人的心血管结果研究； 老年病学、生物统计学、行为科学、心脏康复和计算机科学等领域的专业知识。 研究结果可能会为患有老年痴呆症的老年人制定新的可持续且资源高效的 CR 策略 IHD，为后续大型多中心临床试验奠定基础。