VWCR to Improve Cardiovascular Health and Outcomes Among Cardiac Patients: A Multicenter Randomized Clinical Trial Protocol (Destination Cardiac Rehab Study)

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMayo Clinic

About this trial

The purpose of this research is to compare health outcomes and participation between a virtual world cardiac rehabilitation (Destination Cardiac Rehab) program and the standard of care Center-based Cardiac Rehabilitation program. Destination Cardiac Rehab, developed with input from patients with heart disease and their caregivers, is a 3-D, interactive program offering an affordable telehealth option for cardiac rehabilitation (cardiac rehab) that can be done from home or any place that you can access the Internet with a computer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Myocardial infarction within the preceding 12 months

Coronary artery bypass surgery

Current stable angina (chest pain)

Heart valve repair or replacement

Disqualifiers

Sudden cardiac arrest survivor

Receiving continuous inotropic support

Presence of a mechanical circulatory support device

Decompensated heart failure

Trial design

Design model

Single group

Treatments tested in this trial

  • Virtual Cardiac Rehabilitation

    Other intervention

    * Weekly Virtual Cardiac Rehabilitation Session * Virtual Nurse Coaching Visit (frequency: weekly) * Virtual Exercise Physiologist Visit (frequency: weekly) * Self-Directed Exercise: 3 sessions per week

  • In-Person Cardiac Rehabilitation

    Other intervention

    Participants will attend three in-person cardiac rehabilitation sessions per week, each including: * Supervised exercise under the guidance of an Exercise Physiologist * Educational components related to cardiac health and lifestyle

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: Virtual World-based Cardiac RehabilitationExperimental treatment 1 intervention
Group B: Control ArmActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in LE8 composite score

Life's Essential 8 score is a composite cardiovascular health (CVH) score developed by the American Heart Association (AHA) to quantify and track an individual's heart- and brain-health based on eight key lifestyle behaviors and clinical health factors (healthy diet, physical activity, nicotine exposure, sleep health, body mass index, lipids, glucose and blood pressure). The score ranges from 0 to 100 points, with higher scores indicating better overall cardiovascular health. Interpretation of the composite score usually follows these general categories: 0-49: Low cardiovascular health 50-79: Moderate cardiovascular health 80-100: High (optimal) cardiovascular health

Time frame
Baseline, 3 Months, 6 Months

Secondary outcomes

1

Number of CV-related hospital readmissions

Number of CV-related hospital readmissions will be defined as the total number of participants readmitted to the hospital for a cardiovascular-related issue.

Time frame
3 Months, 6 Months
2

Number of Deaths

Number of deaths will be defined as the total number of participants who die, regardless of cause

Time frame
3 Months, 6 Months
3

Number of CV Deaths

Number of CV deaths will be defined as the total number of participants who die due to cardiovascular (CV)-related causes.

Time frame
3 Months, 6 Months

Other outcomes

Sponsors and contacts

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Mayo Clinic

Lead sponsor

National Library of Medicine (NLM)

Collaborator

This trial is not recruiting at the moment. You can still explore other options: