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.
Traditional cardiac rehabilitation for patients with ischemic heart disease (blocked heart vessels) involves supervised exercise and counseling to improve health. Despite the many known benefits of cardiac rehabilitation, many patients don?t use it because of multiple barriers (such as transportation, physical limitations, and cost) which are especially high in older adults (age ?70). Our study will test whether delivering cardiac rehabilitation through a portable electronic device at home (called ?mobile health cardiac rehabilitation?) improves function and other outcomes in older adults with ischemic heart disease, and also will evaluate whether these patients continue to use the technology over a period of 3 months.
