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

Author:

Brewer LaPrincess C.12ORCID,Abraham Helayna3ORCID,Clark Donald4ORCID,Echols Melvin5ORCID,Hall Michael4ORCID,Hodgman Karen1,Kaihoi Brian6,Kopecky Stephen1ORCID,Krogman Ashton1ORCID,Leth Shawn1ORCID,Malik Shaista7,Marsteller Jill8ORCID,Mathews Lena9ORCID,Scales Robert10ORCID,Schulte Phillip11ORCID,Shultz Adam1ORCID,Taylor Bryan12,Thomas Randal1ORCID,Wong Nathan7ORCID,Olson Thomas1ORCID

Affiliation:

1. Department of Cardiovascular Medicine Mayo Clinic College of Medicine Rochester MN

2. Center for Health Equity and Community Engagement Research Mayo Clinic Rochester MN

3. Department of Internal Medicine Mayo Clinic College of Medicine Rochester MN

4. Division of Cardiology University of Mississippi Medical Center Jackson MS

5. Department of Cardiovascular Medicine Morehouse School of Medicine Atlanta GA

6. Global Products and Services Mayo Clinic Center for Innovation Rochester MN

7. Division of Cardiology, Department of Medicine University of California Irvine CA

8. Center for Health Services and Outcomes Research Johns Hopkins Bloomberg School of Public Health Baltimore MD

9. Division of Cardiology Johns Hopkins School of Medicine Baltimore MD

10. Department of Cardiovascular Medicine Mayo Clinic College of Medicine Phoenix AZ

11. Division of Clinical Trials and Biostatistics Mayo Clinic Rochester MN

12. Department of Cardiovascular Medicine Mayo Clinic College of Medicine Jacksonville FL

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.

Publisher

Ovid Technologies (Wolters Kluwer Health)

Subject

Cardiology and Cardiovascular Medicine

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