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Transition to Cardiac Rehabilitation (T2CR) to Address Barriers of Multimorbidity and Frailty
Cardiac rehabilitation (CR) is a secondary prevention program for patients with cardiovascular disease (CVD). It is especially valuable as CVD increasingly occurs in combination with comorbidity, frailty, and complexities of care that predispose patients to functional decline, disability, and high costs. Still, few Veterans participate in CR, in part because of the difficult logistics to attend. Promising Practice home-based CR (HBCR) was developed to increase CR participation, but many Veterans remain too limited by comorbidity and frailty for participation. A Transition to CR (T2CR) intervention is a face-to-face program that fosters vital skills, education, insights, motivation, and patient-provider relationships conducive to successful HBCR thereafter. This study compares Veterans eligible for CR who are randomized to T2CR intervention versus usual care. Differences in functional capacity, HBCR participation, and healthy days at home are compared over one year. Patients' experiences and providers' perspectives of barriers and facilitators to T2CR are also compared.
Conditions:
🦠 Cardiovascular Diseases 🦠 Cardiac Rehabilitation 🦠 Transition of Care
🗓️ Study Start (Actual) 15 July 2024
🗓️ Primary Completion (Estimated) 31 March 2027
✅ Study Completion (Estimated) 31 August 2027
👥 Enrollment (Estimated) 250
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE2
Locations:
📍 Boston, Massachusetts, United States
📍 Pittsburgh, Pennsylvania, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Eligible candidates will consist of male and female Veterans hospitalized with:
    • * ischemic heart disease (acute myocardial infarction or stable ischemia)
    • * revascularization (coronary artery bypass grafting or percutaneous coronary intervention)
    • * valvular heart disease (surgical or percutaneous intervention for mitral regurgitation or aortic stenosis)
    • * or heart failure (with reduced or preserved ejection fraction)
    • * All will be recruited while initially hospitalized and must express willingness to consider cardiac rehabilitation as a treatment option, including the possibility of the intervention which could possibly extend the length of their hospitalization (for 2 days maximum).
    • * Study candidates must also be English speaking and able to provide written informed consent

    Exclusion Criteria:

    • * Veterans with unstable medical condition as indicated by history, physical exam, and/or laboratory findings end-stage disease likely to be fatal within 12 months
    • * severe cognitive impairment (MiniCog score 0-2)
    • * history of addictive or behavioral issues that confound safe administration of HBCR
    • * hearing loss that interferes with participation in the trial
    • * living in a long-term care living situation prior to the time of hospitalization, no plans to return to independent living after the hospitalization
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ 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 26 January 2024
  • First Submitted that Met QC Criteria 29 January 2024
  • First Posted 6 February 2024

Study Record Updates

  • Last Update Submitted that Met QC Criteria 17 June 2024
  • Last Update Posted 20 June 2024
  • Last Verified June 2024
I'm interested ...!!