NCT06244199 Transition to Cardiac Rehabilitation (T2CR) to Address Barriers of Multimorbidity and Frailty
| NCT ID | NCT06244199 |
| Status | Recruiting |
| Phase | — |
| Sponsor | VA Office of Research and Development |
| Condition | Cardiovascular Diseases |
| Study Type | INTERVENTIONAL |
| Enrollment | 250 participants |
| Start Date | 2024-11-01 |
| Primary Completion | 2027-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 250 participants in total. It began in 2024-11-01 with a primary completion date of 2027-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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
Contact & Investigator
Daniel E Forman, MD
PRINCIPAL INVESTIGATOR
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Frequently Asked Questions
Who can join the NCT06244199 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cardiovascular Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06244199 currently recruiting?
Yes, NCT06244199 is actively recruiting participants. Contact the research team at Daniel.Forman@va.gov for enrollment information.
Where is the NCT06244199 trial being conducted?
This trial is being conducted at Boston, United States, Pittsburgh, United States.
Who is sponsoring the NCT06244199 clinical trial?
NCT06244199 is sponsored by VA Office of Research and Development. The principal investigator is Daniel E Forman, MD at VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA. The trial plans to enroll 250 participants.