Virtual World-Based Cardiac Rehabilitation

Study Overview
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Brief Summary
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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
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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.

Official Title
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Virtual World-Based Cardiac Rehabilitation to Improve Cardiovascular Health and Outcomes Among Cardiac Patients

Conditions
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Cardiac Event, Telemedicine, Cardiovascular Diseases

Intervention / Treatment
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* Other: Virtual World-Based Cardiac Rehabilitation (VWCR)
* Other: Center-Based Cardiac Rehabilitation (CBCR)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Center-Based Cardiac Rehab (CBCR)<br>Standard of care for participants' center-based cardiac rehabilitation program. Traditional 12-week, in-person program. | Other: Center-Based Cardiac Rehabilitation (CBCR)<br>* Traditional 12-week in-person cardiac rehabilitation program; standard of care at participant's cardiac rehabilitation facility<br>|
| Experimental: Virtual World-Based Cardiac Rehab (VWCR)<br>Telehealth delivery of cardiac rehabilitation via Second Life virtual world platform. 12-week, home-based program. | Other: Virtual World-Based Cardiac Rehabilitation (VWCR)<br>* 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.<br>* Other names: Destination Cardiac Rehab;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Life's Essential 8 component: Self-reported healthy diet | 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 | Baseline, 3 months, and 6 months post-randomization | 
| Life's Essential 8 component: Self-reported physical activity | 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 | Baseline, 3 months, and 6 months post-randomization | 
| Life's Essential 8 component: Self-Reported smoking status | 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 | Baseline, 3 months, and 6 months post-randomization | 
| Life's Essential 8 component: Sleep Quality | Changes from baseline in sleep quality (number of hours of sleep nightly) using the Pittsburg Sleep Quality Index (PSQI). | Baseline, 3 months, and 6 months post-randomization | 
| Life's Essential 8 component: Body Mass Index (BMI) | Changes from baseline in BMI as calculated with weight (kg) and height (m), reported as kg/m^2 | Baseline, 3 months, and 6 months post-randomization | 
| Life's Essential 8 component: Cholesterol | Changes from baseline in Non-HDL Cholesterol levels reported as mg/dL | Baseline, 3 months, and 6 months post-randomization | 
| Life's Essential 8 component: Blood Glucose | Changes from baseline in Hemoglobin A1c (percent) and fasting blood glucose (mg/dL) | Baseline, 3 months, and 6 months post-randomization | 
| Life's Essential 8 component: Blood Pressure | Changes from baseline in systolic and diastolic blood pressure measurements; average of three sitting readings in mmHg | Baseline, 3 months, and 6 months post-randomization | 
| Life's Essential 8 composite score: Cardiovascular health | 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). | Baseline, 3 months, and 6 months post-randomization | 
| Number of sessions attended by participants | 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. | Baseline through 12-week program | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MACE (Major Adverse Cardiovascular Events) 3 months post-randomization | MACE (Major Adverse Cardiovascular Events): CV-related hospital readmissions; CV and all-cause mortality | 3 months and 6 months post-randomization | 
| Exercise Sessions | Self-reported number of self-directed exercise sessions per week, confirmed by Fitbit activity tracker data. | Baseline through 12-week (36 session) cardiac rehabilitation program | 
| Functional Capacity | Six-Minute walk test, evaluating blood pressure, oxygen saturation, and pulse after walking for 6 minutes at a normal pace | Baseline, 3 months, and 6 months post-randomization | 
| Health-related quality of life | 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. | Baseline, 3 months, and 6 months post-randomization | 
| Physical Activity Self-efficacy | 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. | Baseline, 3 months, and 6 months post-randomization | 
| Physical Activity Self-regulation | 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. | Baseline, 3 months, and 6 months post-randomization | 
| Physical Activity Social Support | 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. | Baseline, 3 months, and 6 months post-randomization | 
| Diet Self-efficacy | 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. | Baseline, 3 months, and 6 months post-randomization | 
| Diet Self-regulation | 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. | Baseline, 3 months, and 6 months post-randomization | 
| Diet Social Support | 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. | Baseline, 3 months, and 6 months post-randomization |