Cardiovascular DiseasesT2CRNCT06244199
Transition to Cardiac Rehabilitation (T2CR) to Address Barriers of Multimorbidity and Frailty
A study testing T2CR Intervention in people with Cardiovascular Diseases and Cardiac Rehabilitation, run by VA Office of Research and Development at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Diseases, Cardiac Rehabilitation, Transition of Care
- What is being tested?
- T2CR Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Nov 2024to 31 Dec 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
- Living in a long-term care living situation prior to the time of hospitalization, no plans to return to independent living after the hospitalization
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, Massachusetts, 02130-4817
Sonya Vaziri, MD, (617) 323-7700, Sonya.Vaziri@va.gov
Jane Driver, MD, (857) 364-2560, Jane.Driver@va.gov
- Recruiting
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Pittsburgh, Pennsylvania, 15240
Daniel E Forman, MD, (412) 360-2917, Daniel.Forman@va.gov
Daniel E Forman, MD
About this study
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.
Read the detailed description
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.
- Being tested
- T2CR Intervention, Usual Care
- Keywords
- cardiovascular diseases, cardiac rehabilitation, transition of care
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T2CR InterventionBehavioural
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 CareOther
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.
| Study group | Role | What they receive |
|---|---|---|
| T2CR Intervention | Experimental | Participants randomized to the T2CR intervention arm will receive a transitional care program designed to supplement usual care following an acute heart event. Study personnel will follow T2CR Intervention participants for the course of the 12-month study period to assess endpoints in comparison to the Usual Care arm. Receives: Behavioral: T2CR Intervention |
| Usual Care | Active comparator | Participants randomized to the Usual Care are will receive usual care at the discretion of their clinical providers. Study personnel will follow Usual Care participants for the course of the 12-month study period to assess endpoints in comparison to the T2CR intervention arm. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months, i.e., baseline to 3-month change
Secondary outcomes (13)
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.
Measured: Baseline to 6-month and 12-month change
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.
Measured: Baseline to 3-, 6-, and 12-month change
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.
Measured: Baseline to 3-, 6-, and 12-month change
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).
Measured: Baseline to 3-, 6-, and 12-month change
Morley Frailty Scale
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.
Measured: Baseline to 3-, 6-, and 12-month change
Cardiac Self-Efficacy Scale
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.
Measured: Baseline to 3-, 6-, and 12-month change
Patient Health Questionnaire 9-item (PHQ-9)
PHQ-9 is a 9 item depression scale. Scores range from 0-27 with a higher score showing the greater possibility of depression.
Measured: Baseline to 3-, 6-, and 12-month change
Pain, Enjoyment, General Activity (PEG)
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.
Measured: Baseline to 3-, 6-, and 12-month change
Rehospitalizations and Emergency Room Visits
The number of rehospitalizations and emergency room visits will be assessed at 3-month, 6-month, and 12-month follow-up time points.
Measured: 3-months, 6-months, and 12-months
Healthy Days at Home
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.
Measured: 12-months
Cardiac Rehabilitation Participatory Metrics
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.
Measured: 3-months, 6-months, 12-months
Perception Metrics
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]).
Measured: 3-months, 6-months, 12-months
Veterans RAND 12 Item Health Survey (VR-12)
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.
Measured: Baseline to 3-, 6-, and 12-month change
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2024
- Study start1 Nov 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a 4-year, 2-site, type 1 hybrid-effectiveness-implementation trial using a randomized controlled design to compare T2CR-facilitated HBCR to Usual Care, an option that can include Promising Practice HBCR (henceforth called "usual HBCR") but without a transition to HBCR.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Daniel E Forman, MD, Principal investigator, VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06244199
- Sponsor's protocol ID
- IIR 21-177
- Other IDs
- 1I01HX003518-01A1
- Acronym
- T2CR
- Status last verified
- Sep 2026
- First submitted
- 26 Jan 2024
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
VanSwearingen JM, Tighe CA, Perera S, Forman DE, Buysse DJ, Brach JS. Association of Sleep Quality With Activity and Participation in Older Adults. Arch Phys Med Rehabil. 2026 Feb;107(2):207-214. doi: 10.1016/j.apmr.2025.05.010. Epub 2025 May 23.
PubMed 40414548Hung A, Glynn NW, Garcia RE, Hetherington-Rauth M, Cawthon PM, Forman DE, Johnson E, Rubin DS. Determining reduced functional capacity in older adults using research-grade wearable accelerometers: a secondary analysis of the study of muscle, mobility, and aging. BJA Open. 2025 Nov 24;16:100510. doi: 10.1016/j.bjao.2025.100510. eCollection 2025 Dec.
PubMed 41377949Sattui SE, Bertolet M, Forman DE, Danielson ME, Yao S, Lopez OL, Glynn NW, Nadkarni NK, Sekikawa A, Bruno TC, Finkel T, Newman AB. The "Reducing Inflammation for Greater Health Trial (RIGHT)" Study-Concept, Rationale, and Design. J Am Geriatr Soc. 2026 Mar;74(3):636-647. doi: 10.1111/jgs.70272. Epub 2026 Jan 10.
PubMed 41518612