Virtual World-Based Cardiac Rehabilitation to Improve Cardiovascular Health and Outcomes Among Cardiac Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Mayo Clinic
- Enrollment
- 2,881
- Locations
- 1
- Primary Endpoint
- Life's Essential 8 component: Self-Reported smoking status
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Center-Based Cardiac Rehab (CBCR)
Standard of care for participants' center-based cardiac rehabilitation program. Traditional 12-week, in-person program.
Intervention: Center-Based Cardiac Rehabilitation (CBCR) (Other)
Virtual World-Based Cardiac Rehab (VWCR)
Telehealth delivery of cardiac rehabilitation via Second Life virtual world platform. 12-week, home-based program.
Intervention: Virtual World-Based Cardiac Rehabilitation (VWCR) (Other)
Outcomes
Primary Outcomes
Life's Essential 8 component: Self-Reported smoking status
Time Frame: Baseline, 3 months, and 6 months post-randomization
Changes from baseline in smoking status using the National Health and Nutrition Examination Survey-Smoking-Cigarette Use Questionnaire (NHANES-SMQ), evaluating current and past smoking habits
Life's Essential 8 component: Cholesterol
Time Frame: Baseline, 3 months, and 6 months post-randomization
Changes from baseline in Non-HDL Cholesterol levels reported as mg/dL
Life's Essential 8 component: Self-reported healthy diet
Time Frame: Baseline, 3 months, and 6 months post-randomization
Changes from baseline in healthy diet using the Mediterranean Eating Patterns for Americans (MEPA), a 16-item questionnaire evaluating accordance with a Mediterranean-like diet pattern
Life's Essential 8 component: Sleep Quality
Time Frame: Baseline, 3 months, and 6 months post-randomization
Changes from baseline in sleep quality (number of hours of sleep nightly) using the Pittsburg Sleep Quality Index (PSQI).
Life's Essential 8 component: Body Mass Index (BMI)
Time Frame: Baseline, 3 months, and 6 months post-randomization
Changes from baseline in BMI as calculated with weight (kg) and height (m), reported as kg/m\^2
Life's Essential 8 component: Blood Glucose
Time Frame: Baseline, 3 months, and 6 months post-randomization
Changes from baseline in Hemoglobin A1c (percent) and fasting blood glucose (mg/dL)
Life's Essential 8 component: Blood Pressure
Time Frame: Baseline, 3 months, and 6 months post-randomization
Changes from baseline in systolic and diastolic blood pressure measurements; average of three sitting readings in mmHg
Life's Essential 8 component: Self-reported physical activity
Time Frame: Baseline, 3 months, and 6 months post-randomization
Changes from baseline in physical activity using the International Physical Activity Questionnaire (IPAQ), a 12-item questionnaire classifying physical activity as "low," "moderate," or "high" intensity physical activity (minutes/day) over the prior week
Life's Essential 8 composite score: Cardiovascular health
Time Frame: Baseline, 3 months, and 6 months post-randomization
Changes from baseline in Life's Essential 8 score. Life's Essential 8 composite score is determined as a composite of all components by calculating an unweighted average score on a scale of 0 to 100 points. An overall cardiovascular health score (Life's Essential 8 score) will be considered high (80 to 100 points), moderate (50 to 79 points) or low for (0 to 49 points).
Number of sessions attended by participants
Time Frame: Baseline through 12-week program
Optimal adherence defined as completion of 70% or more of weekly visits (in-person or virtual). Attendance measured by CR staff for control group, and by VWCR web administrators, Exercise Physiologists, and Nurse Coaches in the VWCR arm.
Secondary Outcomes
- Physical Activity Social Support(Baseline, 3 months, and 6 months post-randomization)
- MACE (Major Adverse Cardiovascular Events) 3 months post-randomization(3 months and 6 months post-randomization)
- Functional Capacity(Baseline, 3 months, and 6 months post-randomization)
- Physical Activity Self-efficacy(Baseline, 3 months, and 6 months post-randomization)
- Diet Self-efficacy(Baseline, 3 months, and 6 months post-randomization)
- Exercise Sessions(Baseline through 12-week (36 session) cardiac rehabilitation program)
- Physical Activity Self-regulation(Baseline, 3 months, and 6 months post-randomization)
- Diet Self-regulation(Baseline, 3 months, and 6 months post-randomization)
- Health-related quality of life(Baseline, 3 months, and 6 months post-randomization)
- Diet Social Support(Baseline, 3 months, and 6 months post-randomization)
Investigators
LaPrincess C. Brewer
Associate Professor of Medicine
Mayo Clinic