VWCR to Improve Cardiovascular Health and Outcomes Among Cardiac Patients: A Multicenter Randomized Clinical Trial Protocol (Destination Cardiac Rehab Study)

Mayo Clinic

Status: Not yet enrolling

Conditions: Heart Diseases

Treatments: Other: Virtual Cardiac Rehabilitation; Other: In-Person Cardiac Rehabilitation

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07745894

1R01LM014760-01 (U.S. NIH Grant/Contract)

25-008267

Details and patient eligibility

About

The purpose of this research is to compare health outcomes and participation between a virtual world cardiac rehabilitation (Destination Cardiac Rehab) program and the standard of care Center-based Cardiac Rehabilitation program. Destination Cardiac Rehab, developed with input from patients with heart disease and their caregivers, is a 3-D, interactive program offering an affordable telehealth option for cardiac rehabilitation (cardiac rehab) that can be done from home or any place that you can access the Internet with a computer.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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 stratification103 given safety concern of unsupervised exercise:

  • 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)

• 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: Single Group Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

Virtual World-based Cardiac Rehabilitation

Experimental group

Treatment:

Other: Virtual Cardiac Rehabilitation

Control Arm

Active Comparator group

Treatment:

Other: In-Person Cardiac Rehabilitation