250 Participants Needed

Cardiac Rehabilitation for Cardiovascular Disease

(T2CR Trial)

Recruiting at 1 trial location
DE
MH
GA
Overseen ByGreg A Owens, BA
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: VA Office of Research and Development
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.

Is cardiac rehabilitation safe for people with cardiovascular disease?

Research indicates that cardiac rehabilitation is generally safe for people with cardiovascular disease, including those at high risk. It is an important part of treatment and has been shown to reduce mortality rates.12345

How is the T2CR treatment different from other treatments for cardiovascular disease?

The T2CR Program is unique because it focuses on transitioning patients to cardiac rehabilitation, which is often underutilized, especially among the elderly. Unlike traditional center-based programs, T2CR may incorporate innovative delivery models like telehealth to improve accessibility and adherence.678910

What data supports the effectiveness of the T2CR Program treatment for cardiovascular disease?

Research shows that cardiac rehabilitation (CR) is effective for patients with coronary artery disease and heart failure, reducing hospital readmissions and mortality risk. Telehealth interventions, similar to the T2CR Program, can effectively deliver CR, making it more accessible and potentially improving outcomes.711121314

Who Is on the Research Team?

Dr. Daniel E. Forman, MD - Pittsburgh ...

Daniel Forman, MD

Principal Investigator

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Are You a Good Fit for This Trial?

This trial is for Veterans with cardiovascular disease who may also be dealing with other health conditions and frailty, making it hard for them to attend traditional cardiac rehabilitation programs. Participants should be eligible for cardiac rehab but find it challenging due to their complex health needs.

Inclusion Criteria

Study candidates must be English speaking and able to provide written informed consent
I am a veteran hospitalized for a serious heart condition.
I am open to considering cardiac rehabilitation, even if it extends my hospital stay by up to 2 days.

Exclusion Criteria

Living in a long-term care living situation prior to hospitalization with no plans to return to independent living after hospitalization
Veterans with unstable medical condition likely to be fatal within 12 months
Severe cognitive impairment (MiniCog score 0-2)
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

T2CR Phase 1

A 2-day face-to-face program that includes comprehensive assessment of holistic risks, functional limitations, and psychosocial circumstances. Individualized plans are formulated, and exercise practice is emphasized.

2 days
1 visit (in-person)

T2CR Phase 2

Home-based cardiac rehabilitation enriched by the orientation, practice, consultations, supports, and goal setting initiated in T2CR Phase 1.

12 months

Follow-up

Participants are monitored for functional gains, rehospitalizations, and Healthy Days at Home over 12 months.

12 months

What Are the Treatments Tested in This Trial?

Interventions

  • T2CR Intervention
Trial Overview The study is testing a new program called T2CR Intervention against the usual care given to patients. T2CR aims to help patients transition into home-based cardiac rehab by providing skills, education, and support needed for success in the program.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: T2CR InterventionExperimental Treatment1 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.
Group II: Usual CareActive Control1 Intervention
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials
1,691
Recruited
3,759,000+

Published Research Related to This Trial

Data from 24,644 patients in the UK National Audit of Cardiac Rehabilitation showed that achieving optimal risk factor status during phase II CR significantly increases the likelihood of maintaining that status at 12 months, particularly for BMI.
Patients who reached optimal risk factors during CR had a higher chance of being assessed at 12 months, suggesting that monitoring and supporting these factors during rehabilitation can improve long-term health outcomes.
Optimal outcomes from cardiac rehabilitation are associated with longer-term follow-up and risk factor status at 12 months: An observational registry-based study.Tang, LH., Doherty, P., Skou, ST., et al.[2023]
Telehealth interventions for cardiac rehabilitation (CR) show similar effectiveness to traditional center-based supervised CR in patients with coronary artery disease, with no significant differences in key health outcomes such as exercise capacity, weight, and blood pressure.
This review of nine trials involving patients primarily with myocardial infarction or revascularization suggests that telehealth CR can be a viable alternative for those who may have difficulty accessing traditional rehabilitation programs.
Telehealth interventions versus center-based cardiac rehabilitation of coronary artery disease: A systematic review and meta-analysis.Huang, K., Liu, W., He, D., et al.[2022]
A study of 425 patients undergoing a phase II cardiac rehabilitation program showed an average improvement of 20.1% in their 6-minute walk test (6MWT), indicating significant physical benefits from the program.
Patients with lower initial walking ability experienced greater improvements, and those attending 25 or more sessions had better outcomes in walking ability and weight loss, highlighting the importance of session attendance for maximizing benefits.
Who is likely to benefit from phase II cardiac rehabilitation?Araya-Ramรญrez, F., Briggs, KK., Bishop, SR., et al.[2010]

Citations

Optimal outcomes from cardiac rehabilitation are associated with longer-term follow-up and risk factor status at 12 months: An observational registry-based study. [2023]
Telehealth interventions versus center-based cardiac rehabilitation of coronary artery disease: A systematic review and meta-analysis. [2022]
Who is likely to benefit from phase II cardiac rehabilitation? [2010]
Cardiac rehabilitation for patients with heart failure: association with readmission and mortality risk. [2022]
Patient-Selected Strategies for Post Cardiac Rehabilitation Exercise Adherence in Heart Failure. [2019]
PATHway I: design and rationale for the investigation of the feasibility, clinical effectiveness and cost-effectiveness of a technology-enabled cardiac rehabilitation platform. [2022]
Novel advances in cardiac rehabilitation : Position paper from the Working Group on Preventive Cardiology and Cardiac Rehabilitation of the Netherlands Society of Cardiology. [2021]
Using the CHANGE intervention to enhance long-term exercise. [2019]
Development of standardised programme content for phase II cardiac rehabilitation programmes in Australia using a modified Delphi process. [2020]
10.Korea (South)pubmed.ncbi.nlm.nih.gov
Cardiac Rehabilitation Exercise Training for High-Risk Cardiac Patients. [2020]
A EUropean study on effectiveness and sustainability of current Cardiac Rehabilitation programmes in the Elderly: Design of the EU-CaRE randomised controlled trial. [2022]
Effects of the Strong Hearts program after a major cardiovascular event in patients with cardiovascular disease. [2023]
13.United Statespubmed.ncbi.nlm.nih.gov
Changing clinical profile of patients entering cardiac rehabilitation/secondary prevention programs: 1996 to 2006. [2008]
14.United Statespubmed.ncbi.nlm.nih.gov
Effect of cardiac rehabilitation referral strategies on utilization rates: a prospective, controlled study. [2018]
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