Virtual World-Based Cardiac Rehabilitation (VWCR)

Mayo Clinic

Status: Active, not recruiting

Conditions: Cardiovascular Diseases; Telemedicine; Cardiac Event

Treatments: Other: Virtual World-Based Cardiac Rehabilitation (VWCR); Other: Center-Based Cardiac Rehabilitation (CBCR)

Study type: Interventional

Funder types: Other

Identifiers

NCT05897710

22-011357

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,881 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,881 participants in 2 patient groups

Center-Based Cardiac Rehab (CBCR)

Active Comparator group

Description:

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

Treatment:

Other: Center-Based Cardiac Rehabilitation (CBCR)

Virtual World-Based Cardiac Rehab (VWCR)

Experimental group

Description:

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

Treatment:

Other: Virtual World-Based Cardiac Rehabilitation (VWCR)