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Not yet recruiting NCT07745894

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

No phase Interventional Heart Diseases

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Virtual Cardiac Rehabilitation, In-Person Cardiac Rehabilitation.
Who it may be relevant to
Registry conditions: Heart Diseases. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Virtual World-based Cardiac Rehabilitation to Improve Cardiovascular Health and Outcomes Among Cardiac Patients: A Multicenter Randomized Clinical Trial Protocol (Destination Cardiac Rehab Study)

Overview

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.

Interventions

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

Primary outcome measures

  • Change in LE8 composite score [Time frame: Baseline, 3 Months, 6 Months]
Secondary outcome measures (3)
  • Number of CV-related hospital readmissions [Time frame: 3 Months, 6 Months]
  • Number of Deaths [Time frame: 3 Months, 6 Months]
  • Number of CV Deaths [Time frame: 3 Months, 6 Months]

Eligibility criteria

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 stratification103 given safety concern of unsupervised exercise:
  • 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)
  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Single group
Masking
Open label
Primary purpose
Health services research

Study locations

United States · 3 centers
  • University of California — Irvine
  • Mayo Clinic — Rochester
  • University of Mississippi Medical Center — Jackson

Identifiers

NCT: NCT07745894 · 25-008267 · 1R01LM014760-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗