Recruiting

Observational Study

Sponsor:

VA Office of Research and Development

Code:

NCT06244199

Conditions

Cardiovascular Diseases

Cardiac Rehabilitation

Transition of Care

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

T2CR Intervention

Usual Care

Study Details

Brief 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. 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.

Conditions

Cardiovascular Diseases

Cardiac Rehabilitation

Transition of Care

Study ID

NCT06244199

Start date

Nov 1, 2024

Status verified date

Oct, 2025

Completion date

Aug 31, 2027

Anticipated

Primary completion date

Mar 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

250 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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.

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 measure

  • PROMIS Physical Function SF 10a [ Time Frame: 3 months, i.e., baseline to 3-month change ]

Central Contacts and Locations

Central contacts

Daniel E Forman, MD

(412) 360-2917Daniel.Forman@va.gov

Greg A Owens, BA

(412) 360-1792gregory.owens@va.gov

Locations

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Recruiting

Boston, Massachusetts, United States, 02130-4817

Contacts

Sonya Vaziri, MD

617-323-7700Sonya.Vaziri@va.gov

Jane Driver, MD

(857) 364-2560Jane.Driver@va.gov

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Recruiting

Pittsburgh, Pennsylvania, United States, 15240

Contacts

Daniel E Forman, MD

412-360-2917Daniel.Forman@va.gov

Principal Investigator:

Daniel E Forman, MD

More Information

Sponsor

VA Office of Research and Development

Last update posted

Oct 22, 2025

Last verified

Oct, 2025

Keywords

  • cardiovascular diseases
  • cardiac rehabilitation
  • transition of care

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2025-10-22.