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)患者参与动态心脏康复(CR) 很低。根据最近的估计，只有不到三分之二的合格患者得到了转诊，不到一半的患者得到了转诊 推荐参与。即使在提到的那些人中，参与的多重障碍也包括有限的设施， 相互竞争的时间需求、高额的自付成本和延长的等待时间。CR的障碍尤其是 老年人(≥70岁)高，由于身体残疾或交通障碍等因素，尽管 这些患者可能同时具有最大的受益潜力。支持移动健康的CR(mHealth- 用于国际HD的CR--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参与，但它在很大程度上仍未在 相对健康的年轻人。因此，尚不清楚患有IHD和障碍的老年人所占比例有多大 传统CR能够参与mHealth-CR，以及mHealth-CR是否会带来比 照常照看。因此，我们提出了弹性：老年人使用移动健康在家中进行康复 在因缺血性心脏病住院后。这是一项前瞻性、多中心、非盲法随机试验 临床试验(对主要终点进行盲法评估)，以评估参与情况和结果 MHealth-CR在急性心肌梗死(AMI)时发现的老年IHD患者中， 经皮冠状动脉介入治疗(PCI)或冠状动脉搭桥术(CABG)。审判将会进行 在两个学术医学中心：纽约大学医学院和耶鲁医学院，这两个中心共同 服务于不同的患者群体，并有在临床上成功招募老年人的记录 研究性研究。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)治疗3个月。我们的干预措施将通过平板设备提供的mHealth-CR软件与 超过3个月的基线咨询和每周由运动治疗师打来的电话。干预和惯常 护理小组还将按照指导方针接受标准的门诊CR转诊，以及 日常生活活动能力(ADLS)的动态评估。主要疗效终点是功能改变 容量，以6分钟步行距离评估。次要疗效终点是目标实现、健康 状态、ADLS、再次住院和死亡。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，而且 参与的模式将被辨别出来。该项目的PI(Dodson博士)是早期调查员 专注于老年人心血管结果的研究；其他研究人员有广泛的 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拥有广泛的专业知识。 研究结果可能导致新的可持续和资源高效的CR策略，适用于患有 IHD，为随后的大型多中心临床试验奠定了基础。

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.