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

项目摘要 缺血性心脏病（IHD）患者参与非卧床心脏康复（CR）的情况仍然存在 低根据最近的估计，只有不到三分之二的符合条件的患者被转诊， 推荐参与。即使在提到的国家中，参与的多重障碍包括设施有限， 竞争时间要求、高自付成本和长等待时间。CR的障碍主要是 老年人（年龄≥70岁）高，由于身体障碍或交通障碍等因素，虽然 这些患者可能同时具有最大的受益潜力。支持移动的健康的CR（mHealth- CR）-涉及通过便携式电子设备输送CR-有可能增加 通过减少参与障碍来参与，但在小型研究之外， 相对健康的年轻人。因此，目前尚不清楚患有IHD的老年人的比例以及 传统CR能够与mHealth-CR进行互动，以及mHealth-CR是否会带来比 常规护理因此，我们提出RESILIENT：老年人使用移动的健康在家中进行康复 因缺血性心脏病住院治疗这是一项前瞻性、多中心、非盲随机研究 临床试验（对主要终点进行盲态评估），以评价 在急性心肌梗死（AMI）时确定的老年IHD患者中的mHealth-CR， 经皮冠状动脉介入治疗（PCI）或冠状动脉旁路移植术（CABG）。审判将在 在两个学术医疗中心：纽约大学医学院和耶鲁大学医学院， 服务于不同的患者人群，并有成功招募老年人临床研究的记录。 调查研究。我们将随机选择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。我们的干预措施结合了mHealth-CR软件，通过平板电脑设备提供， 基线咨询和每周电话由运动治疗师超过3个月。干预和常规 护理组还将根据指南接受标准的门诊CR转诊，以及 日常生活活动能力（ADL）的动态评估。主要疗效终点是功能性 容量，通过6分钟步行距离评估。次要疗效终点为目标实现、健康 状态、ADL、再入院和死亡。项目终点定义为每周完成 mHealth-CR任务。我们假设mHealth-CR将改善一系列结果， 交战模式将被识别。本项目的PI（Dr. Dodson）是一名早期研究者 重点是老年人的心血管结局研究;其他研究者有广泛的 在老年病学、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。 研究结果可能会为老年人带来新的可持续和资源有效的CR策略， IHD，并为后续大型多中心临床试验奠定基础。

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.