Reasons preventing enrollment into a randomized trial assessing center-based versus hybrid cardiac rehabilitation

Introduction: Despite the known benefits of cardiac rehabilitation (CR), a minority of eligible patients participate. With recent advances in technology and due to the COVID-19 pandemic, hybrid (i.e., combined center-based with home-/community-based) CR (HYCR) programs using synchronized telehealth have gained interest to improve access to care. Despite the availability of a HYCR program, some patients still choose not to (or are unable to) participate. Purpose: Describe patient reasons and barriers for not participating in a HYCR program. Design: This is a sub-study of the iATTEND (improving ATTENDance to cardiac rehabilitation) trial, an NHLBI funded study (NCT identifier: 03646760) currently randomizing subjects to standard center-based CR (CBCR) versus HYCR. This study used baseline data from the iATTEND trial. Methods: 3,708 patients receiving care from the Health System were referred and potentially eligible for CR between March 2019 through January 2021. One site for participation in CR was located within the City of Detroit and 2 sites in a suburban location. Eligibility criteria included: experienced a CR qualifying event, >18 yr of age, demonstrated connectivity to the internet via 'smart' device for telehealth CR sessions, and access to home- or community-based exercise equipment. Patients were excluded due to: a left ventricular assist device;receiving inotropic support or dialysis;angina at low functional capacity;or unable to exercise independently. Results: 887 of the 3708 (24%) of the potentially eligible patients attended a CR orientation (CRO) session and among these patients, 63% (554/887) were deemed ineligible per study criteria, 23% (205/887) declined participation in the trial, and 14% consented to participate. Three percent (29/887) of those ineligibles was due to lack of access to a smart device and 14% (128/887) due to lack of access to exercise equipment. Among the 157 patients unable to participate in iATTEND due to lack of access to either smart phone or exercise equipment, the percentage unable to participate was not significantly different (p =0.204) between those patients who attended their CRO within the City of Detroit (17% = 107/641) and those who attended CRO at a suburban location (20% = 50/246). The racial demographic for this subset of 157 patients includes a population that was 85% Black at the Detroit site versus a 32% Black population across the two suburban sites. Among all patients attending a CRO, 103 (12%) declined because they preferred CBCRover HYCR;two of the main reasons for preferring CBCR were the communal aspect of CBCR and fear of exercising independently. Conclusions: Lack of access to technology to participate in telehealth visits didn't represent a meaningful barrier (3%) to participate in a trial involving telehealth based CR, whereas access to home- or community-based exercise equipment was a barrier (14%). Additionally, a small (12%) group of patients declined trial participation in a project involving HYCR because they preferred attending CBCR only.