Despite center based cardiac rehabilitation (CBCR) representing guideline-based care for patients with cardiovascular disease, most patients do not complete the maximum number of sessions allowed by third party insurance payers. As such, many patients may not be receiving the full clinical benefit ascribed to CR. Several studies suggest that the number of CR sessions completed is directly and independently associated with lower mortality (an ~1% to 2% observed decrease in risk for each additional session of CR completed). The barriers to attendance in CBCR include those at the patient, program, policy, and system-levels. Among African Americans, participation and attendance to CR and adoption of healthier lifestyle changes are less likely. The iATTEND (improving ATTENDance to cardiac rehabilitation) Trial will assess the efficacy of an innovative approach to CR delivery on attendance. The intervention group combines CBCR and remote-/home-based CR (i.e., Hybrid CR, HYCR) and is tailored to the individual needs of each patient, accomplished with the assistance of an easy-to-access telecommunications methodology (telemedicine). iATTEND is also unique because it focuses on patients residing within (or proximal to) Detroit, MI., representing a predominately at-risk cohort (e.g., 79% African American) that often cannot regularly attend CR due to social (e.g., dependent care) and economic challenges. In addition to being understudied and likely associated with disparity in CR utilization, our cohort provides an opportunity to examine the adoption and efficacy of an innovative model to deliver CR, one that otherwise mimics traditional CBCR in terms of delivered content and expected outcomes. For the R61 start-up phase of iATTEND (year one), the primary aims will be to prepare and operationalize a clinical trial, including finalizing protocol, developing and finalizing the manual of operations, establishing data safety monitoring board, confirming partnerships, and demonstrating the ability to screen and enroll patients in to the trial. The primary aim for the R33 clinical trial phase (years 2-5) of iATTEND will be to assess the effect of a HYCR program on patient attendance [Primary Hypothesis: The number of CR sessions completed within 6 months will be significantly greater among patients randomized to HYCR than patients randomized to CBCR]. The secondary aim is to assess the effect of HYCR on exercise capacity and quality of life. The design of iATTEND is a single-site, prospective, controlled Phase II clinical trial that will randomize 270 urban patients to CBCR only or HYCR. Both groups will be scheduled to attend 36 CR sessions within 6 months. Patient assessments will be conducted at baseline, within 10 days after completing CR, and 6 months after completing CR. To strengthen the generalizability of iATTEND, for both study groups we plan to (a) deliver the same secondary prevention elements and (b) measure the common program outcomes expected of traditional CR. We plan to revise operations at our Detroit-based site in a manner that allows the unit to simultaneously offer both CBCR only and HYCR, using only existing CR staff (not additional research staff).
The benefits of cardiac rehabilitation are well known; however, many patients that participate do not derive all of the ascribed benefits because of less than optimal attendance. Using an innovative, generalizable hybrid model that integrates both traditional center-based and remote-/home-based services (the latter delivered via telemedicine), the overarching goal of this trial is to increase clinical knowledge to improve cardiac rehabilitation attendance as a potential means to further improve program outcomes (functional capacity, quality of life, reduce re-hospitalizations and mortality). Such benefits, although patient-specific, when scaled to a national perspective across other cardiac programs can then be viewed as also favorably influencing general public health and health care utilization.
