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. 2023 Dec 5;12(23):e030883.
doi: 10.1161/JAHA.123.030883. Epub 2023 Nov 28.

Efficacy and Adherence Rates of a Novel Community-Informed Virtual World-Based Cardiac Rehabilitation Program: Protocol for the Destination Cardiac Rehab Randomized Controlled Trial

LaPrincess C Brewer  1   2 , Helayna Abraham  3 , Donald Clark 3rd  4 , Melvin Echols  5 , Michael Hall  4 , Karen Hodgman  1 , Brian Kaihoi  6 , Stephen Kopecky  1 , Ashton Krogman  1 , Shawn Leth  1 , Shaista Malik  7 , Jill Marsteller  8 , Lena Mathews  9 , Robert Scales  10 , Phillip Schulte  11 , Adam Shultz  1 , Bryan Taylor  12 , Randal Thomas  1 , Nathan Wong  7 , Thomas Olson  1
Affiliations

Efficacy and Adherence Rates of a Novel Community-Informed Virtual World-Based Cardiac Rehabilitation Program: Protocol for the Destination Cardiac Rehab Randomized Controlled Trial

LaPrincess C Brewer et al. J Am Heart Assoc. .

Abstract

Background: Innovative restructuring of cardiac rehabilitation (CR) delivery remains critical to reduce barriers and improve access to diverse populations. Destination Cardiac Rehab is a novel virtual world technology-based CR program delivered through the virtual world platform, Second Life, which previously demonstrated high acceptability as an extension of traditional center-based CR. This study aims to evaluate efficacy and adherence of the virtual world-based CR program compared with center-based CR within a community-informed, implementation science framework.

Methods: Using a noninferiority, hybrid type 1 effectiveness-implementation, randomized controlled trial, 150 patients with an eligible cardiovascular event will be recruited from 6 geographically diverse CR centers across the United States. Participants will be randomized 1:1 to either the 12-week Destination Cardiac Rehab or the center-based CR control groups. The primary efficacy outcome is a composite cardiovascular health score based on the American Heart Association Life's Essential 8 at 3 and 6 months. Adherence outcomes include CR session attendance and participation in exercise sessions. A diverse patient/caregiver/stakeholder advisory board was assembled to guide recruitment, implementation, and dissemination plans and to contextualize study findings. The institutional review board-approved randomized controlled trial will enroll and randomize patients to the intervention (or control group) in 3 consecutive waves/year over 3 years. The results will be published at data collection and analyses completion.

Conclusions: The Destination Cardiac Rehab randomized controlled trial tests an innovative and potentially scalable model to enhance CR participation and advance health equity. Our findings will inform the use of effective virtual CR programs to expand equitable access to diverse patient populations.

Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT05897710.

Keywords: cardiac rehabilitation; cardiovascular health; health disparities; home‐based programs; social determinants of health.

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Figures

Figure 1
Figure 1. Destination Cardiac Rehab logo.
Created with Adobe Illustrator.
Figure 2
Figure 2. Overview of study design and study arms.
Participants will be screened for eligibility following index cardiac event and randomized 1:1 following baseline assessment. Participants will undergo a 12‐week intervention. Postintervention assessments will occur at 3 and 6 months after randomization. CBCR indicates center‐based CR; CR, cardiac rehabilitation; CV, cardiovascular; EP, exercise physiologist; LE8, Life's Essential 8; NC, nurse coach; and VWCR, virtual world–based CR. Created with BioRender.com.
Figure 3
Figure 3. Summary of study timeline.
The study team will formulate and finalize recruitment plans in year (Y) 1. The intervention will occur in 3 waves per year over Y2 to Y4. Participant focus groups (FGs) will be conducted at the end of Y2 to Y4. Cardiac rehabilitation (CR) staff and stakeholder FGs will occur at the beginning of Y5. Data analysis will be complete by the end of Y5. PCS‐AB indicates patient/caregiver/stakeholder advisory board. Created with BioRender.com.
Figure 4
Figure 4. Cardiac rehabilitation program participant requirements by study arm.
Participants in the intervention arm will participate in 3 virtual sessions per week: a group education session, nurse coach (NC) visit, and exercise physiologist (EP) visit, in addition to ≥3 self‐directed exercise sessions per week. Participants in the control arm will participate in 3 in‐person sessions per week and will also be encouraged to exercise outside of cardiac rehabilitation (CR) sessions. CBCR indicates center‐based CR; and VWCR, virtual world–based CR. Created with BioRender.com.
Figure 5
Figure 5. Images of Destination Cardiac Rehab.
A, Peer support group. B, Patient using treadmill in fitness center. C, Patient at restaurant. D, Patient practicing yoga in fitness center. Created with BioRender.com.
See this image and copyright information in PMC

References

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