Destination Cardiac Rehab: A Multicenter Feasibility Clinical Trial of an Enhanced Virtual World-based Cardiac Rehabilitation Intervention to Improve Cardiovascular Health and Outcomes Among Cardiac Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Mayo Clinic
- Enrollment
- 8
- Locations
- 3
- Primary Endpoint
- Change in Cardiovascular health score
Study Overview
Brief Summary
A single-group, multi-center, non-randomized clinical trial will be conducted to assess the feasibility of implementing an enhanced virtual world-based cardiac rehabilitation (VWCR) program within a muti-site clinical trial.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Indication for CR according to Centers for Medicare & Medicaid Services (CMS) guidelines (diagnosed within the preceding 12 months) to include one or more of the following:
- •Myocardial infarction
- •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
- •Receiving care at one of the participating CR centers
- •Age ≥18 years
- •Basic Internet navigation skills
- •Active email address
- •Access to Internet at home or public access (church, library, etc) for 3 virtual visits per week
Exclusion Criteria
- •High risk patients according to the AACVPR risk stratification44 given safety concern of unsupervised exercise
- •Patients receiving continuous inotropic support
- •Recent receipt of a mechanical support device
- •Presence of hemodynamically unstable dysrhythmias (e.g., ventricular tachycardia)
- •Decompensated heart failure
- •Symptomatic valvular heart disease
- •Uncontrolled angina
- •Pregnancy (due to associated hormonal and weight changes) per patient report
- •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 exercise
- •Visual/hearing impairment or mental disability that would preclude independent use of the VW platform
- •Non-English-speaking patients due to logistical challenges with real time translation over a virtual platform
- •Currently participating in a cardiac rehab program
Arms & Interventions
Virtual World-Based Cardiac Rehab
Intervention: Virtual World-based Cardiac Rehabilitation (VWCR) program (Behavioral)
Outcomes
Primary Outcomes
Change in Cardiovascular health score
Time Frame: Baseline, 2 Months, 5 Months
Cardiovascular health score will be determined by the American Heart Association's (AHA) Life's Essential 8 (LS8). The scale is 0-100 pts (low to high), with LE8 categories as low (0-49), moderate (50-79) and high (80-100). A higher score indicates higher cardiovascular health.
Percent of Virtual world-based cardiac rehabilitation attended
Time Frame: Baseline, 6 Months
Virtual world-based cardiac rehabilitation attended will be determined by the number of sessions prescribed vs the number of sessions attended (reported as a percent).
Secondary Outcomes
- Number of cardiovascular hospital readmissions(Baseline, 6 Months)
- All-cause mortality(6 Months)
Investigators
LaPrincess C. Brewer
Principal Investigator
Mayo Clinic