Transition to Cardiac Rehabilitation (T2CR) to Address Barriers of Multimorbidity and Frailty (NCT06244199) | Clinical Trial Compass
RecruitingNot Applicable
Transition to Cardiac Rehabilitation (T2CR) to Address Barriers of Multimorbidity and Frailty
United States250 participantsStarted 2024-11-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
PROMIS Physical Function SF 10a
Timeframe: 3 months, i.e., baseline to 3-month change