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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Virtual World-Based Cardiac Rehab | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual World-based Cardiac Rehabilitation (VWCR) program | Behavioral | 24 Virtual World-based Cardiac Rehabilitation sessions over the course of 8 weeks (3 sessions/week). Weekly visits include 1:1 video visit with Exercise Physiologist, 1:1 video visit with Nurse Coach, and virtual group education session followed by social discussion. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Cardiovascular health score | 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. | Baseline, 2 Months, 5 Months |
| Percent of Virtual world-based cardiac rehabilitation attended | 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). | Baseline, 6 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of cardiovascular hospital readmissions | Cardiovascular Hospital readmissions will be determined by the number of times a patient is admitted to the hospital after initial admission. | Baseline, 6 Months |
| All-cause mortality |
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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:
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
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
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| Name | Affiliation | Role |
|---|---|---|
| LaPrincess Brewer, M.P.H. | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California (UCI), Irvine | Irvine | California | 92617 | United States | ||
| Mayo Clinic |
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All-cause mortality will be determined by the number of patient deaths no matter the cause.
| 6 Months |
| Jacksonville |
| Florida |
| 32224 |
| United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |