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

October 21, 2025 updated by: VA Office of Research and Development
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
250

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02130-4817
        • Recruiting
        • VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Sonya Vaziri, MD
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15240
        • Recruiting
        • VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
        • Principal Investigator:
          • Daniel E Forman, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: T2CR Intervention
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.
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.
Active Comparator: Usual Care
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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
3 months, i.e., baseline to 3-month change

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Baseline to 3-, 6-, and 12-month change
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.
Baseline to 3-, 6-, and 12-month change
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.
Baseline to 3-, 6-, and 12-month change
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.
Baseline to 3-, 6-, and 12-month change
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.
Baseline to 3-, 6-, and 12-month change
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.
Baseline to 3-, 6-, and 12-month change
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.
3-months, 6-months, and 12-months
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.
12-months
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.
3-months, 6-months, 12-months
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]).
3-months, 6-months, 12-months
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.
Baseline to 6-month and 12-month change
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).
Baseline to 3-, 6-, and 12-month change
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.
Baseline to 3-, 6-, and 12-month change

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
VA Office of Research and Development

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Daniel E Forman, MD, VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 26, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 29, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 6, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 22, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 21, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IIR 21-177

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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