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

NCT06244199 | Recruiting DMC

• 1 other identifier: IIR 21-177
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 2

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

Keywords

cardiovascular diseases; cardiac rehabilitation; transition of care

Outcome Measures

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.

  3 months, i.e., baseline to 3-month change

Secondary Outcomes (13)

• PROMIS Physical Function SF 10a

  Baseline to 6-month and 12-month change

• 5-Times Sit-to-Stand

  Baseline to 3-, 6-, and 12-month change

• Mini-Cog

  Baseline to 3-, 6-, and 12-month change

• Veterans Specific Activity Questionnaire (VSAQ)

  Baseline to 3-, 6-, and 12-month change

• Morley Frailty Scale

  Baseline to 3-, 6-, and 12-month change

Study Arms (2)

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.

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.

Other: Usual Care

Interventions

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.

T2CR Intervention

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.

Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (2)

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

Boston, Massachusetts, 02130-4817, United States

RECRUITING

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Pittsburgh, Pennsylvania, 15240, United States

RECRUITING

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

• Daniel E Forman, MD

  VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel E Forman, MD

CONTACT

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

Greg A Owens, BA

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Key investigators and outcomes assessors at each site will remain blinded to participant group placement. Quantitative study endpoints are assessed by blinded study personnel (i.e., separate from the clinical and study exercise physiologists who treat the patients in the T2CR intervention or usual HBCR).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 26, 2024
• First Posted: February 6, 2024
• Study Start: November 1, 2024
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: October 22, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)