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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
VA Office of Research and Development
Study ID
NCT06244199
Status
Recruiting
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Conditions

  • Cardiac Rehabilitation
  • Cardiovascular Diseases
  • Transition of Care

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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.

Key Dates

Start date
Nov 1, 2024
Status verified
Oct 2025
Primary completion
Mar 31, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
250 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MABostonMassachusetts02130-4817
Sonya Vaziri, MD
[email protected]
617-323-7700
Jane Driver, MD
[email protected]
(857) 364-2560
Sonya Vaziri, MD (SUB_INVESTIGATOR)
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PAPittsburghPennsylvania15240
Daniel E Forman, MD
[email protected]
412-360-2917
Daniel E Forman, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Boston, MA

By research site
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA· Boston, MAVA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA· Pittsburgh, PA

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