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Virtual World-Based Cardiac Rehabilitation
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.
Conditions:
🦠 Cardiac Event 🦠 Telemedicine 🦠 Cardiovascular Diseases
🗓️ Study Start (Actual) 1 September 2024
🗓️ Primary Completion (Estimated) 1 September 2027
✅ Study Completion (Estimated) 1 September 2028
👥 Enrollment (Estimated) 150
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Rochester, Minnesota, United States

📋 Eligibility Criteria

Description

    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: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 5 May 2023
  • First Submitted that Met QC Criteria 1 June 2023
  • First Posted 9 June 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 23 July 2024
  • Last Update Posted 25 July 2024
  • Last Verified February 2024
I'm interested ...!!