VWCR: Virtual World-Based Cardiac Rehabilitation
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Center-Based Cardiac Rehab (CBCR) Standard of care for participants' center-based cardiac rehabilitation program. Traditional 12-week, in-person program. |
Other: Center-Based Cardiac Rehabilitation (CBCR)
Traditional 12-week in-person cardiac rehabilitation program; standard of care at participant's cardiac rehabilitation facility
|
| Experimental: Virtual World-Based Cardiac Rehab (VWCR) Telehealth delivery of cardiac rehabilitation via Second Life virtual world platform. 12-week, home-based program. |
Other: Virtual World-Based Cardiac Rehabilitation (VWCR)
12-week virtual world technology-based program via Second Life platform. Weekly virtual visits with nurse coach and exercise physiologist, weekly education sessions, and social support group discussions within the virtual world environment.
Other Names:
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Outcome Measures
Primary Outcome Measures
- Life's Essential 8 component: Self-reported healthy diet [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: Self-reported physical activity [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 component: Self-Reported smoking status [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: Sleep Quality [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) [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: Cholesterol [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: Blood Glucose [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 [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 composite score: Cardiovascular health [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 [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 Outcome Measures
- MACE (Major Adverse Cardiovascular Events) 3 months post-randomization [3 months and 6 months post-randomization]
MACE (Major Adverse Cardiovascular Events): CV-related hospital readmissions; CV and all-cause mortality
- Exercise Sessions [Baseline through 12-week (36 session) cardiac rehabilitation program]
Self-reported number of self-directed exercise sessions per week, confirmed by Fitbit activity tracker data.
- Functional Capacity [Baseline, 3 months, and 6 months post-randomization]
Six-Minute walk test, evaluating blood pressure, oxygen saturation, and pulse after walking for 6 minutes at a normal pace
- Health-related quality of life [Baseline, 3 months, and 6 months post-randomization]
Changes from baseline in health-related quality of life using the Short Form [SF]-12 Health Survey, a self-reported outcome measure assessing the impact of health on an individual's everyday life. The SF-12 consists of 12-items and 8 subdomains. Each item of the questionnaire has response categories which vary from 2- to 6-point scales and raw scores for items ranging from 1 to 6. The raw scores are summated and linearly transformed into 0-100 scale with a higher score indicating better health status.
- Physical Activity Self-efficacy [Baseline, 3 months, and 6 months post-randomization]
Changes from baseline in physical activity self-efficacy measured by the Exercise Confidence Survey scale to assess the participant's confidence in their ability to exercise when faced with common barriers. 12 items are assessed, each on a 5-point scale ranging from 1 to 5. A higher total sum indicates higher self-efficacy for physical activity.
- Physical Activity Self-regulation [Baseline, 3 months, and 6 months post-randomization]
Changes from baseline in physical activity self-regulation measured by the Health Beliefs Survey to assess strategies used in the past 3 months to increase their step count or physical activity levels. Items are measured on a five-point scale from 1 (never) to 5 (repeatedly). Higher scores indicate more self-regulation.
- Physical Activity Social Support [Baseline, 3 months, and 6 months post-randomization]
Changes from baseline in physical activity social support using the Social Support for Exercise Survey scale that asks participants how much encouragement they received to increase physical activity on a five-point scale from 1 (never) to 5 (very often). Higher scores indicate more social support for physical activity.
- Diet Self-efficacy [Baseline, 3 months, and 6 months post-randomization]
Changes from baseline in diet self-efficacy measured the Diet Confidence Survey scale to assess the participant's confidence in their ability to maintain a healthy diet when faced with common barriers. 12 items are assessed, each on a 5-point scale ranging from 1 to 5. A higher total sum indicates higher self-efficacy for healthy eating.
- Diet Self-regulation [Baseline, 3 months, and 6 months post-randomization]
Changes from baseline in diet self-regulation measured by the Health Beliefs Survey to assess strategies used in the past 3 months to eat healthier foods. Items are measured on a five-point scale from 1 (never) to 5 (repeatedly). Higher scores indicate more use of self-regulation strategies to promote healthy eating.
- Diet Social Support [Baseline, 3 months, and 6 months post-randomization]
Changes from baseline in diet social support using the Social Support for Eating Habits Survey scale that asks participants how much encouragement they received to eat healthier on a five-point scale from 1 (never) to 5 (very often). Higher scores indicate more social support for healthy eating.
Eligibility Criteria
Criteria
Inclusion Criteria:
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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
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Aged ≥18 years
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Basic Internet navigation skills
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Active email address
Exclusion Criteria:
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High risk patients according to the American Association of Cardiovascular and Pulmonary Rehabilitation (AACVPR) risk stratification (e.g., sudden cardiac arrest survivor)
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Receiving continuous inotropic support
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Presence of a mechanical circulatory support device
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Decompensated heart failure
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Symptomatic valvular heart disease
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Uncontrolled angina
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Presence of hemodynamically unstable dysrhythmias (e.g., ventricular tachycardia) given safety concern of unsupervised exercise20
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Pregnant (due to associated hormonal and weight changes)
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Non-English-speaking
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Visual/hearing impairment or mental disability that would preclude independent use of the VW platform
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Mayo Clinic | Rochester | Minnesota | United States | 55905 |
Sponsors and Collaborators
- Mayo Clinic
- Johns Hopkins University
- University of California, Irvine
- University of Mississippi Medical Center
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 22-011357