THE HEALERS: A PATIENT, COMMUNITY, AND STAKEHOLDER ADVISORY BOARD FOCUS GROUP SERIES TO REFINE A NOVEL VIRTUAL-WORLD CARDIAC REHABILITATION INTERVENTION AND CLINICAL TRIAL

Therapeutic Area

Rehabilitation

Background

Cardiac rehabilitation (CR) is a widely underutilized secondary cardiovascular disease prevention strategy, due to a variety of barriers to participation that disproportionately impact women, racial and ethnic minority groups, and patients with low socioeconomic status. Destination Cardiac Rehab, a virtual world-based CR (VWCR) program was designed by our team in collaboration with patients and community members to mitigate the barriers to CR participation. Prior proof-of-concept and pilot studies demonstrated feasibility and acceptability of this novel intervention and a trend toward improvement in cardiovascular health behaviors. In anticipation of a randomized-controlled trial planned to further validate the intervention as an alternative to tradition center-based CR, utilizing a community engaged research (CER) approach, a patient/community/stakeholder-advisory board (PCS-AB), self-coined, the HEALERS was created to inform iterative refinements to the VWCR intervention, and the trial recruitment/retention plans to better meet patients’ needs.

Methods

Patients who previously completed CR, patients who enrolled but did not complete CR, CR eligible patients, and representatives from key stakeholder/advocacy groups were recruited to the PCS-AB from six academic medical centers. Following recruitment of a diverse group, the HEALERS participated in five 90-minute virtual focus group sessions to provide feedback on various aspects of the VWCR intervention and the recruitment/retention plans. Feedback was analyzed to identify major themes to inform revisions to the trial protocol. Illustrative quotes were selected to represent each theme.

Results

Twenty-two members were recruited with diverse sociodemographic and personal/professional backgrounds (mean age 59 years, 50% female). Emerging themes were identified and classified into subgroups. Regarding trial recruitment, members recommended effective communication strategies, suggestions for the recruitment video, and expansion of recruitment settings. The HEALERS emphasized the importance of feeling safe during exercise and social support in designing an effective VWCR intervention. They also provided recommendations to optimize various components of the CR sessions and the VWCR platform. Lastly, they identified reminder messages, tangible incentives, and garnering positive relationships with the CR staff as important retention tools.

Conclusions

A diverse PCS-AB was convened to better understand the community needs and improve Destination Cardiac Rehab in meeting patient needs in anticipation of an upcoming RCT. The HEALERS offered valuable insights that informed actionable changes to the RCT protocol. They also expressed concerns inherent to a VW intervention and potential solutions to mitigate their concerns. The PCS-AB will continue to meet throughout the RCT implementation phase to continue to offer insight into the trial implementation strategy.