Transition to Cardiac Rehabilitation (T2CR) to Address Barriers of Multimorbidity and Frailty
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVA Office of Research and Development
About this trial
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
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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 home-based cardiac rehabilitation (HBCR)
Hearing loss that interferes with participation in the trial
Trial design
Design model
Parallel
Treatments tested in this trial
T2CR Intervention
BehavioralThe 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.
Usual Care
Other interventionParticipants 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.
Treatment groups
250 Participants
are divided into 2 treatment groupsGroup A: T2CR InterventionExperimental treatment 1 intervention
Group B: Usual CareActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
PROMIS Physical Function SF 10a
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.
Time frame
3 months, i.e., baseline to 3-month changeSecondary outcomes
1
PROMIS Physical Function SF 10a
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.
Time frame
Baseline to 6-month and 12-month change2
5-Times Sit-to-Stand
The 5-Times Sit-to-Stand is a performance measure of strength and balance that is applied as an index of capacity and disability risk. This is assessed at baseline and 90 days in all participants and to the extent possible, at 180 and 365 days.
Time frame
Baseline to 3-, 6-, and 12-month change3
Mini-Cog
A brief assessment of cognition which tests visuospatial representation, recall, and executive function. It is scored on a scale of 0-5, with higher scores suggesting better cognitive performance.
Time frame
Baseline to 3-, 6-, and 12-month change4
Veterans Specific Activity Questionnaire (VSAQ)
Patient reported 13-item assessment of daily activity that estimates functional capacity and also correlates to cardiorespiratory fitness. Scores range from 1-13 metabolic equivalents (METs).
Time frame
Baseline to 3-, 6-, and 12-month changeSponsors and contacts
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Source ClinicalTrials.gov