Mayo Clinic
Rochester, Minnesota, 55905, United States
NCT Number: NCT05897710
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Rochester, Minnesota, 55905, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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: Destination Cardiac Rehab
Traditional 12-week in-person cardiac rehabilitation program; standard of care at participant's cardiac rehabilitation facility
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
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
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
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).
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
Time frame: Baseline, 3 months, and 6 months post-randomization
Changes from baseline in Non-HDL Cholesterol levels reported as mg/dL
Time frame: Baseline, 3 months, and 6 months post-randomization
Changes from baseline in Hemoglobin A1c (percent) and fasting blood glucose (mg/dL)
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
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).
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.
Time frame: 3 months and 6 months post-randomization
MACE (Major Adverse Cardiovascular Events): CV-related hospital readmissions; CV and all-cause mortality
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Mayo Clinic
Other
Virtual World-Based Cardiac Rehabilitation to Improve Cardiovascular Health and Outcomes Among Cardiac Patients
Acronym: VWCR
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