NCT06244199 · VA Office of Research and Development
Transition to Cardiac Rehabilitation (T2CR) to Address Barriers of Multimorbidity and Frailty
(T2CR)
What this study is about
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.
View original scientific description
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.
Interventions
BEHAVIORAL
T2CR Intervention
The T2CR intervention entails two phases. T2CR Phase 1 (Assess and Plan) is a program that occurs during or shortly after hospital discharge that includes completion of a comprehensive risk assessment, development of strategies to address identified risks while restoring function through education regarding living a healthy lifestyle and familiarization and practice of exercise training techniques. T2CR Phase 2 (Implementation and Support) entails a HBCR program that is based on the Promising Practices HBCR but further enriched by insights and strategies developed in T2CR Phase 1 and which also incorporates techniques that maximize the effectiveness and efficiency of exercise training.
OTHER
Usual Care
Participants will receive usual care following an acute heart event that is recommended by their providers, which may include Promising Practices Home-Based Cardiac Rehabilitation (aka Usual HBCR) at both sites or site-based CR at VAPHS.
Primary outcome measures
PROMIS Physical Function SF 10a
Time frame: 3 months, i.e., baseline to 3-month change
The Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function V2.0 Short Form 10a is a standardized patient reported index of practical functional capacity. PROMIS physical function instruments measure self-reported capability and functioning of upper extremities (dexterity), lower extremities (walking or mobility), as well as instrumental activities of daily living. The PROMIS Physical Function Short Form 10a is a standardized questionnaire appropriate for comparing large groups. The Physical Function scaled score is applied as the primary outcome at 90 days.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Boston, Massachusetts
- Pittsburgh, Pennsylvania
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 22, 2025 · Source of record for eligibility and locations