Virtual World-based Cardiac Rehabilitation to Promote Data-Powered Cardiovascular Health Among Cardiac Patients: A Multicenter Randomized Clinical Trial - Despite well-established benefits of reduced mortality and improved quality of life, <25% of eligible patients participate in cardiac rehabilitation (CR). Disparities in CR participation are particularly worse among patients most affected by cardiovascular (CV) disease including those of lower socioeconomic status and those living in rural and dense urban areas. Participation barriers include inflexible CR hours and considerable distances to CR centers. In the post-COVID-19 pandemic era, novel CR delivery methods to mitigate barriers to care are crucial. Data-driven telehealth models using virtual technologies have emerged to expand CR access through home-based delivery. One such modality, virtual worlds (VWs), are 3-D, immersive computer-based environments allowing users to interact via online personas (avatars), simulate in-person experiences, and social network. VWs are applied for physical rehabilitation, health education, and chronic disease management and could address CR participation barriers. Our major project goal is to use a Hybrid Type 1 implementation trial design to rigorously test the efficacy of a behavioral theory-informed, 12-week, VW-based CR (VWCR) intervention compared to center-based CR (CBCR) for improving CV health and CR participation among cardiac patients. CV health will be measured by the American Heart Association Life’s Essential 8 (LE8) composite score, an evidence-based metric of 8 health-promoting behaviors/clinical factors (e.g., diet, blood pressure) that improves CV outcomes. We will conduct a multiphase, multicenter, 2-arm, randomized controlled non-inferiority trial with 150 adult cardiac patients. We hypothesize that patients randomized to our patient-centric VWCR intervention will have noninferior CV health profiles and higher adherence rates than those randomized to CBCR. This R01 proposal aligns with the NLM’s focus on next-generation technologies to “reach more people in more ways through enhanced dissemination and engagement.” Building on our patient informed VWCR preliminary work, we propose 2 aims. Aim 1 will determine the effect of VWCR on CV health among cardiac patients compared to CBCR. Primary outcome is the LE8 score. Aim 2 will determine whether patients randomized to VWCR will have improved participation in and adherence to CR compared to those in CBCR. Primary outcome is adherence (attendance of ≥70% of sessions prescribed). We will use mixed methods to assess adherence and sustainability/scalability potential. Secondary outcomes include major adverse CV events, psychosocial measures (quality of life, self-efficacy, self-regulation, social support), cost effectiveness and implementation outcomes according to the RE-AIM framework. A Patient/Community/Stakeholder Advisory Board will provide input for all activities. Our innovative, reproducible VWCR intervention integrates theory-informed and empirically supported components to influence the LE8. If successful, our results can pave the way for scalable, broad implementation of VWCR to increase CR accessibility and improve CV health outcomes among cardiac patients.
