Clinical trial NCT05897710: Virtual World-Based Cardiac Rehabilitation
Official title: Virtual World-Based Cardiac Rehabilitation to Improve Cardiovascular Health and Outcomes Among Cardiac Patients
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cardiac Event
Telemedicine
Cardiovascular Diseases
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Johns Hopkins University
name: University of California, Irvine
name: University of Mississippi Medical Center
First posted: 2023-06-09
Enrollment: 2881
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The proposed trial is a multiphase, multicenter, non-inferiority, hybrid type 1 effectiveness, randomized controlled trial to test an innovative virtual world-based cardiac rehabilitation (CR) program, "Destination Cardiac Rehab". The primary objectives of this study are to assess the efficacy and adherence of "Destination Cardiac Rehab" compared to traditional center-based CR.

Detailed description: The proposed virtual world-based cardiac rehabilitation (VWCR) program provides a novel home-based delivery method of a CR program to address several barriers to care associated with traditional center-based CR (CBCR). This 2-arm, randomized controlled trial (RCT) will rigorously assess adherence and efficacy of VWCR compared to CBCR in a 12-week (36-session) intervention that includes patient education, self-monitoring of physical activity and blood pressure, social support, and weekly telehealth visits with a CR nurse and exercise physiologist. Patients with a CR eligible cardiovascular event will be recruited from 6 geographically diverse CR centers across the United States. We hypothesize that the VWCR, known as "Destination Cardiac Rehab" will be non-inferior to CBCR as assessed by improvement in cardiovascular health and adherence to CR sessions.

Eligibility criteria: 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 stratification (e.g., 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) given safety concern of unsupervised exercise20
* 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

Primary outcomes:
measure: Life's Essential 8 component: Self-reported healthy diet
timeFrame: Baseline, 3 months, and 6 months post-randomization
measure: Life's Essential 8 component: Self-reported physical activity
timeFrame: Baseline, 3 months, and 6 months post-randomization
measure: Life's Essential 8 component: Self-Reported smoking status
timeFrame: Baseline, 3 months, and 6 months post-randomization
measure: Life's Essential 8 component: Sleep Quality
timeFrame: Baseline, 3 months, and 6 months post-randomization
measure: Life's Essential 8 component: Body Mass Index (BMI)
timeFrame: Baseline, 3 months, and 6 months post-randomization
measure: Life's Essential 8 component: Cholesterol
timeFrame: Baseline, 3 months, and 6 months post-randomization
measure: Life's Essential 8 component: Blood Glucose
timeFrame: Baseline, 3 months, and 6 months post-randomization
measure: Life's Essential 8 component: Blood Pressure
timeFrame: Baseline, 3 months, and 6 months post-randomization
measure: Life's Essential 8 composite score: Cardiovascular health
timeFrame: Baseline, 3 months, and 6 months post-randomization
measure: Number of sessions attended by participants
timeFrame: Baseline through 12-week program
Secondary outcomes:
measure: MACE (Major Adverse Cardiovascular Events) 3 months post-randomization
timeFrame: 3 months and 6 months post-randomization
measure: Exercise Sessions
timeFrame: Baseline through 12-week (36 session) cardiac rehabilitation program
measure: Functional Capacity
timeFrame: Baseline, 3 months, and 6 months post-randomization
measure: Health-related quality of life
timeFrame: Baseline, 3 months, and 6 months post-randomization
measure: Physical Activity Self-efficacy
timeFrame: Baseline, 3 months, and 6 months post-randomization
measure: Physical Activity Self-regulation
timeFrame: Baseline, 3 months, and 6 months post-randomization
measure: Physical Activity Social Support
timeFrame: Baseline, 3 months, and 6 months post-randomization
measure: Diet Self-efficacy
timeFrame: Baseline, 3 months, and 6 months post-randomization
measure: Diet Self-regulation
timeFrame: Baseline, 3 months, and 6 months post-randomization
measure: Diet Social Support
timeFrame: Baseline, 3 months, and 6 months post-randomization
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: LaPrincess Brewer, M.D., M.P.H.
role: PRINCIPAL_INVESTIGATOR
References: