Safety and Engagement in Cardiac Rehabilitation With the RecoveryPlus Telerehabilitation Platform: A Prospective, Single-arm, Pilot Study

1 BACKGROUND INFORMATION AND RATIONALE 1.1 Introduction Cardiac rehabilitation (CR) is an evidence-based program designed to help individuals with heart disease recover and improve their physical, psychological, and social functioning. CR is an important component in the management of patients with cardiovascular disease, which aims to reduce the risk of subsequent cardiovascular events and improve quality of life. However, traditional modes of CR delivery such as in-person sessions, have limitations, including low participation rates and inconvenience for patients. Telehealth technology may provide a viable alternative, and the RecoveryPlus platform has been developed specifically to deliver evidence-based CR content remotely.

1.2 Clinical Need Cardiovascular diseases (CVDs) are the leading cause of morbidity and mortality worldwide, and their incidence and prevalence have steadily risen over the past decades. Several common cardiovascular diseases include coronary heart disease, heart surgery cerebrovascular disease, rheumatic heart disease, deep vein thrombosis, congestive heart failure, and pulmonary embolism. The Million Hearts Cardiac Rehabilitation Collaborative, co-led by the Centers for Disease Control and Prevention (CDC) and the Centers for Medicare and Medicaid Services (CMS), aimed to prevent one million CVD events by 2027. However, there were only 2,300 CR programs in the U.S. in 2021.

1.3 Clinical Rationale This study will capture metrics that demonstrate the effectiveness and safety of RecoveryPlus in engaging participants in a 12-week, hybrid, synchronous/asynchronous remote CR program, thus contributing to study subjects' recovery from a precipitating cardiac health condition.

1.4 Design Rationale Given that RecoveryPlus is a remote CR platform that includes synchronous telehealth visits with a licensed Exercise Physiologist (EP) and a patient-facing mobile application offering tools for asynchronous exercise guidance, the study will be conducted entirely remotely. Study data, including clinical endpoints, will be collected per usual RecoveryPlus program participation.

1.5 Proposed Solution Safe, effective remote cardiac telerehabilitation (RCR) offers a scalable solution to the need for greater engagement of patients recovering from CVD events in evidence-based CR exercise programming. CR generally is a multi-faceted approach that combines exercise training, patient education, nutritional counseling, risk factor behavior modification (e.g., around management of lipids, blood pressure, weight, smoking) to improve outcomes of patients with CVD and reduce associated morbidity and mortality.4 In particular, physical activity has become a core component of CR programs as mortality risk is lower among patients who meet WHO recommendations for physical activity.5 Over the past decade, the use of home-based programs for CR has become more prevalent, as they expand access to rehabilitation for patients with limited mobility, and allow providers to manage a broader panel of patients.4 As with many healthcare services, the COVID-19 pandemic accelerated the transition of many CR programs to home-based care, also termed telerehabilitation or CTR.6 Status Quo: CR is a safe, effective, evidence-based intervention that remains severely underutilized by patients for a variety of reasons, including: inconvenience, lack of incorporation of patient input and capacity for personalization, and poorly designed, static content. Therefore, while proven effective, the lack of initiation and engagement of patients in CR programming means it falls short of its potential to widely impact patient outcomes.