A Study of Cardiac Rehabilitation Intervention to Improve Cardiovascular Health and Outcomes
Purpose
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.
Condition
- Cardiovascular Health
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible 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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Other
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Subject enrolled in a cardiac rehab program |
|
Recruiting Locations
Mayo Clinic
Rochester 5043473, Minnesota 5037779 55905
Rochester 5043473, Minnesota 5037779 55905
More Details
- Status
- Recruiting
- Sponsor
- Mayo Clinic