Virtual World-Based Cardiac Rehabilitation

NCT ID: NCT05897710

Last Updated: 2025-01-16

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 2881 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-07
• Study Completion Date: 2028-09-01

Brief Summary

The proposed trial is a multiphase, multicenter, non-inferiority, hybrid type 1 effectiveness, randomized controlled trial to test an innovative virtual world-based cardiac rehabilitation (CR) program, "Destination Cardiac Rehab". The primary objectives of this study are to assess the efficacy and adherence of "Destination Cardiac Rehab" compared to traditional center-based CR.

Detailed Description

The proposed virtual world-based cardiac rehabilitation (VWCR) program provides a novel home-based delivery method of a CR program to address several barriers to care associated with traditional center-based CR (CBCR). This 2-arm, randomized controlled trial (RCT) will rigorously assess adherence and efficacy of VWCR compared to CBCR in a 12-week (36-session) intervention that includes patient education, self-monitoring of physical activity and blood pressure, social support, and weekly telehealth visits with a CR nurse and exercise physiologist. Patients with a CR eligible cardiovascular event will be recruited from 6 geographically diverse CR centers across the United States. We hypothesize that the VWCR, known as "Destination Cardiac Rehab" will be non-inferior to CBCR as assessed by improvement in cardiovascular health and adherence to CR sessions.

Conditions

Cardiac Event; Telemedicine; Cardiovascular Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Center-Based Cardiac Rehab (CBCR)

Standard of care for participants' center-based cardiac rehabilitation program. Traditional 12-week, in-person program.

Group Type: ACTIVE_COMPARATOR

Center-Based Cardiac Rehabilitation (CBCR)

Intervention Type: OTHER

Traditional 12-week in-person cardiac rehabilitation program; standard of care at participant's cardiac rehabilitation facility

Virtual World-Based Cardiac Rehab (VWCR)

Telehealth delivery of cardiac rehabilitation via Second Life virtual world platform. 12-week, home-based program.

Group Type: EXPERIMENTAL

Virtual World-Based Cardiac Rehabilitation (VWCR)

Intervention Type: OTHER

12-week virtual world technology-based program via Second Life platform. Weekly virtual visits with nurse coach and exercise physiologist, weekly education sessions, and social support group discussions within the virtual world environment.

Interventions

Virtual World-Based Cardiac Rehabilitation (VWCR)

12-week virtual world technology-based program via Second Life platform. Weekly virtual visits with nurse coach and exercise physiologist, weekly education sessions, and social support group discussions within the virtual world environment.

Intervention Type: OTHER

Center-Based Cardiac Rehabilitation (CBCR)

Traditional 12-week in-person cardiac rehabilitation program; standard of care at participant's cardiac rehabilitation facility

Intervention Type: OTHER

Other Intervention Names

Destination Cardiac Rehab

Eligibility Criteria

Inclusion Criteria

• Indication for CR according to Centers for Medicare & Medicaid Services (CMS) guidelines: Myocardial infarction within the preceding 12 months; Coronary artery bypass surgery; Current stable angina (chest pain); Heart valve repair or replacement; Percutaneous transluminal coronary angioplasty (PTCA) or coronary stenting; Heart or heart-lung transplant; Stable chronic heart failure
• Aged ≥18 years
• Basic Internet navigation skills
• Active email address

Exclusion Criteria

• High risk patients according to the American Association of Cardiovascular and Pulmonary Rehabilitation (AACVPR) risk stratification (e.g., sudden cardiac arrest survivor)
• Receiving continuous inotropic support
• Presence of a mechanical circulatory support device
• Decompensated heart failure
• Symptomatic valvular heart disease
• Uncontrolled angina
• Presence of hemodynamically unstable dysrhythmias (e.g., ventricular tachycardia) given safety concern of unsupervised exercise20
• Pregnant (due to associated hormonal and weight changes)
• Non-English-speaking
• Visual/hearing impairment or mental disability that would preclude independent use of the VW platform

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Johns Hopkins University

OTHER

Sponsor Role: collaborator

University of California, Irvine

OTHER

Sponsor Role: collaborator

University of Mississippi Medical Center

OTHER

Sponsor Role: collaborator

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

LaPrincess C. Brewer

Associate Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

LaPrincess Brewer, M.D., M.P.H.

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic

Rochester, Minnesota, United States

Countries

United States

References

Brewer LC, Abraham H, Clark D 3rd, Echols M, Hall M, Hodgman K, Kaihoi B, Kopecky S, Krogman A, Leth S, Malik S, Marsteller J, Mathews L, Scales R, Schulte P, Shultz A, Taylor B, Thomas R, Wong N, Olson T. Efficacy and Adherence Rates of a Novel Community-Informed Virtual World-Based Cardiac Rehabilitation Program: Protocol for the Destination Cardiac Rehab Randomized Controlled Trial. J Am Heart Assoc. 2023 Dec 5;12(23):e030883. doi: 10.1161/JAHA.123.030883. Epub 2023 Nov 28.

Reference Type: DERIVED

PMID: 38014699 (View on PubMed)

Other Identifiers

22-011357

Identifier Type: -

Identifier Source: org_study_id