Cardiovascular Health
Conditions
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.
Interventions
BEHAVIORALVirtual World-based Cardiac Rehabilitation (VWCR) program
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.
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Cardiovascular health score | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of cardiovascular hospital readmissions | Baseline, 6 Months | Cardiovascular Hospital readmissions will be determined by the number of times a patient is admitted to the hospital after initial admission. |
| All-cause mortality | 6 Months | All-cause mortality will be determined by the number of patient deaths no matter the cause. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORLaPrincess Brewer, M.P.H.
Mayo Clinic
Outcome results
None listed