Enhancing cardiac rehabilitation adherence through home-based rehabilitation and behavioral nudges: The ERA nudge study design and rationale

BACKGROUND: Cardiac rehabilitation (CR) continues to be under-utilized despite known benefits across the cardiovascular disease spectrum. Unfortunately, despite efforts to augment access, barriers persist in patient access to rehabilitation and ability to participate due to logistical challenges. A choice of home-based CR may present an appealing alternative that circumvents these known obstacles. Similarly, nudge reminders, or messages designed to elicit behavioral change, may improve adherence to CR. HYPOTHESIS: Providing a choice of home or hospital-based CR, and nudge reminders will improve adherence to CR in an urban safety net population. DESIGN: The Enhancing Cardiac Rehabilitation Adherence through Home-Based Rehabilitation and Behavioral Nudges (ERA-Nudge) study utilizes a 2 × 2 factorial design to randomize eligible CR patients to usual care versus choice of home or hospital-based CR, and tailored nudge messages versus generic reminders to encourage healthy behavior. The study assesses the effectiveness of choice of CR location (ie, home versus hospital) and nudge messages in improving CR adherence. The study also uses an implementation framework to understand reach, adoption, implementation, and maintenance of this approach within the context of real-world care delivery in a pragmatic trial design. The enrollment was completed in May 2023, with a total of 447 patients. SUMMARY: The ERA-Nudge trial assesses the implementation, effectiveness, and safety of choice in CR location and nudge messaging to improve CR adherence. If successful, this approach can be easily disseminated and may inform future implementations for rehabilitation and other behavioral therapies. TRIAL REGISTRATION: URL: https://clinicaltrials.gov; Unique identifier: NCT03834155.