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NCT Number: NCT06244199

Transition to Cardiac Rehabilitation (T2CR) to Address Barriers of Multimorbidity and Frailty

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA, Boston, Massachusetts, United States

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About this study

Cardiac rehabilitation (CR) is an evidence-based secondary prevention program for patients with cardiovascular disease (CVD) that aims to stabilize patients clinically and to restore physical function and health after a CVD event. It is well-suited to the needs of the aging Veterans Health Administration's (VHA) aging population which is prone to CVD in a context of comorbidity, frailty, and associated functional decline. Unfortunately, few eligible Veterans participate. Logistic challenges are a key barrier as few VHA site-based CR programs are available. The Promising Practice home-based CR (HBCR) is a VHA initiative that was designed to improve CR participation using a novel home-based approach. While HBCR has been demonstrated to be effective for Veterans who attend, only few participate. Many Veterans eligible for HBCR remain encumbered by comorbidity and frailty, and often lack confidence and/or perceived capacity for home-based formats of care. The Transition to CR (T2CR) intervention is a 2-phase program that aims to improve the process of HBCR and to thereby better respond to Veterans' needs. T2CR Phase 1 is a ~2 day face-to-face program between the initial CVD hospitalization and home that includes comprehensive assessment of holistic risks (CVD and non-CVD), functional limitations, and psychosocial circumstances. Individualized pragmatic plans are formulated to ensure HBCR is feasible, safe, and practical despite aggregate complexity. Goal setting, adherence reinforcements, and education are integrated; exercise practice is emphasized; and consultations for comorbid issues and telemedicine video facilitation are arranged. T2CR Phase 2 is HBCR that is enriched by the orientation, practice, consultations, supports, and goal setting that were initiated in T2CR Phase 1, as well as innovative exercise training techniques for patients who are frail and/or functionally impaired. T2CR is aligned with the already existing Coordinated Transitional Care (C-TraC) Program. C-TraC nurse practitioners currently hone medication management, medical follow-up, and education as hospitalized Veterans transition to home, but do little to guide recovery of physical function. By facilitating referral to the T2CR intervention, C-TraC care will be enhanced. Using a hybrid efficacy-implementation (type 1) design, the Transition to Cardiac Rehabilitation to Address Barriers of Multimorbidity and Frailty study is a randomized controlled trial to study T2CR versus usual HBCR in the VA Pittsburgh and Boston Healthcare Systems. Quantitative endpoints include functional gains (assessed using the Patient Reported Outcomes Measurement Information System [PROMIS] Physical Function measure) over 365 days as well as a 5-Times Sit-To-Stand performance measure. The number of CR sessions attended, rehospitalizations, and Healthy Days at Home will be assessed. Patients' perceptions of feasibility and acceptability of T2CR will also be evaluated. Providers' perceptions of T2CR will be evaluated as well; the Consolidated Framework for Implementation Research (CFIR) framework will be used to structure their insights. Patient and provider feedback will be applied to refine implementation strategies with the goal to ultimately extend T2CR throughout the entire ORH Promising Practices network.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

T2CR Intervention

Behavioral

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.

Usual Care

Other

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 outcomes

  1. 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.

Secondary outcomes

  1. PROMIS Physical Function SF 10a

    Time frame: Baseline to 6-month and 12-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.

  2. 5-Times Sit-to-Stand

    Time frame: Baseline to 3-, 6-, and 12-month change

    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.

  3. Mini-Cog

    Time frame: Baseline to 3-, 6-, and 12-month change

    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.

  4. Veterans Specific Activity Questionnaire (VSAQ)

    Time frame: Baseline to 3-, 6-, and 12-month change

    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).

  5. Morley Frailty Scale

    Time frame: Baseline to 3-, 6-, and 12-month change

    The Frail Scale is a 5-item assessment of fatigue, resistance, ambulation, illnesses, and loss of weight. Scores range from 0-5 with a higher number indicating greater frailty.

  6. Cardiac Self-Efficacy Scale

    Time frame: Baseline to 3-, 6-, and 12-month change

    An assessment of a cardiac patient's confidence and coping capacities after a cardiac event. Scored on a scale of 0 to 52, with a higher score indicating higher confidence.

  7. Patient Health Questionnaire 9-item (PHQ-9)

    Time frame: Baseline to 3-, 6-, and 12-month change

    PHQ-9 is a 9 item depression scale. Scores range from 0-27 with a higher score showing the greater possibility of depression.

  8. Pain, Enjoyment, General Activity (PEG)

    Time frame: Baseline to 3-, 6-, and 12-month change

    A 3-item scale to assess pain intensity and interference, and tracking changes in pain over time. The PEG scale includes individual scales in which participants rate their pain level in different areas on a scale of 0-10. The average of the 3 items is the PEG final score, with higher scores representing higher levels of pain.

  9. Rehospitalizations and Emergency Room Visits

    Time frame: 3-months, 6-months, and 12-months

    The number of rehospitalizations and emergency room visits will be assessed at 3-month, 6-month, and 12-month follow-up time points.

  10. Healthy Days at Home

    Time frame: 12-months

    Independent living is assessed as Healthy Days at Home time. This is a summary quality measure that is used for community-living older Veterans, particularly those at higher risk of death of institutionalization.

  11. Cardiac Rehabilitation Participatory Metrics

    Time frame: 3-months, 6-months, 12-months

    Based on established VA Coordinated Transitional Care (C-TraC) metrics, the number of cardiac rehabilitation sessions attended and number of cardiac rehabilitation program completions will be tracked at follow-up time points.

  12. Perception Metrics

    Time frame: 3-months, 6-months, 12-months

    Perceived value of HBCR as a program of education, nutrition, and support versus its value as a program of exercise-training program (each graded 1 [very little] to 5 [very substantial]).

  13. Veterans RAND 12 Item Health Survey (VR-12)

    Time frame: Baseline to 3-, 6-, and 12-month change

    The Veterans RAND 12-Item Health Survey (VR-12) is a standardized questionnaire which evaluates self-reported quality of life. The score is summarized in two parts, a "Physical Health Summary Measure {PCS-physical component score}" and a "Mental Health Summary Measure {MCS-mental component score}." Scoring includes a standardized t-score with a mean of 50 and standard deviation of 10.

Study contacts

Contact information is provided by the study sponsor or research team.

Daniel E Forman, MD

CONTACT

[email protected]

(412) 360-2917

Greg A Owens, BA

CONTACT

[email protected]

(412) 360-1792

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Acronym: T2CR

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Feb 6, 2024
Registry last updated
Oct 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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