Program to help Veterans transition to cardiac rehabilitation
Transition to Cardiac Rehabilitation (T2CR) to Address Barriers of Multimorbidity and Frailty
This study tests a new program designed to help Veterans with heart issues join and stick with home-based rehabilitation to see if it improves their health and daily living.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 250 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | VA Office of Research and Development Federal |
| Locations | 2 sites (Boston, Massachusetts and 1 other locations) |
| Trial ID | NCT06244199 on ClinicalTrials.gov |
What this trial studies
This intervention focuses on improving participation in cardiac rehabilitation (CR) for Veterans with cardiovascular disease (CVD) who face barriers due to comorbidity and frailty. The Transition to CR (T2CR) program includes a two-day face-to-face assessment and planning phase that addresses individual risks and limitations, aiming to enhance the feasibility of home-based CR. Participants are randomized to receive either the T2CR intervention or usual care, with outcomes measured over one year in terms of functional capacity, participation in home-based CR, and overall health days at home.
Who should consider this trial
Good fit: Ideal candidates are male and female Veterans hospitalized with conditions such as ischemic heart disease, heart failure, or valvular heart disease who are willing to consider cardiac rehabilitation.
Not a fit: Patients with unstable medical conditions or end-stage diseases likely to be fatal within 12 months may not benefit from this intervention.
Why it matters
Potential benefit: If successful, this program could significantly increase participation in cardiac rehabilitation among Veterans, leading to improved health outcomes and quality of life.
How similar studies have performed: Other studies have shown promise in improving cardiac rehabilitation participation through tailored interventions, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Boston, Massachusetts and 1 other locations
- VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA — Boston, Massachusetts, United States (Recruiting)
- VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA — Pittsburgh, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Daniel E Forman, MD — VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
- Study coordinator: Daniel E Forman, MD
- Email: Daniel.Forman@va.gov
- Phone: (412) 360-2917
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.