Cardiac Rehabilitation for Cardiovascular Disease

(T2CR Trial)

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Daniel Forman, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: VA Office of Research and Development

Disqualifiers: Unstable condition, Cognitive impairment, Addictive issues, Hearing loss, Long-term care, others

No Placebo Group

Trial Summary

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.

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. ^{1 2 3 4 5}

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. ^{6 7 8 9 10}

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. ^{2 11 12 13 14}

Research Team

Daniel Forman, MD

Principal Investigator

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Eligibility Criteria

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)

Trial Timeline

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

Treatment Details

Interventions

• T2CR Intervention (Behavioural 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.

Participant Groups

Group I: T2CR Intervention Experimental Treatment 1 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 Care Active Control 1 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.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Dr. Grant Huang

VA Office of Research and Development

Acting Chief Research and Development Officer

PhD in Medical Psychology and Master of Public Health from the Uniformed Services University of Health Sciences

Dr. Erica M. Scavella

VA Office of Research and Development

Chief Medical Officer since 2022

MD from University of Massachusetts School of Medicine

Findings from Research

In Denmark, only 46.7% of heart failure patients were referred to cardiac rehabilitation (CR) in 2018, despite an increase from 31.7% in 2010, highlighting a need for improved referral strategies, especially for high-risk groups.

Patients referred to CR had a significantly lower risk of hospital readmission (odds ratio 0.92) and mortality (odds ratio 0.65) within one year, indicating that CR is an effective intervention for improving outcomes in heart failure patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiac rehabilitation for patients with heart failure: association with readmission and mortality risk. Thygesen, LC., Zinckernagel, L., Dalal, H., et al.[2022]

In a study involving 20 heart failure patients, those who used patient-selected exercise adherence strategies after cardiac rehabilitation showed significant improvements in walking distance and reduced heart failure symptoms over 12 weeks.

The use of personalized adherence strategies, such as logs and phone follow-ups, helped patients maintain recommended exercise levels, suggesting that tailored approaches can enhance long-term exercise adherence and support ongoing health improvements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-Selected Strategies for Post Cardiac Rehabilitation Exercise Adherence in Heart Failure. Nielsen, J., Duncan, K., Pozehl, B.[2019]

A standardized program content for phase II cardiac rehabilitation in Australia was developed through a comprehensive literature review and a modified Delphi process involving 16 multidisciplinary experts, resulting in 49 best practice statements.

Out of these, 29 statements were deemed essential for effective cardiac rehabilitation, ensuring that the program is evidence-based and can be reliably implemented by CR coordinators.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of standardised programme content for phase II cardiac rehabilitation programmes in Australia using a modified Delphi process. Cartledge, S., Thomas, E., Hollier, K., et al.[2020]

The Strong Hearts program, a 9-week structured intervention for cardiovascular patients, significantly reduced key cardiac risk factors such as weight, blood pressure, and triglycerides, indicating its efficacy in improving cardiovascular health.

Participants also experienced improvements in exercise capacity and quality of life, as evidenced by increased metabolic equivalents and better nutrition scores, highlighting the program's comprehensive benefits for patients recovering from major cardiovascular events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of the Strong Hearts program after a major cardiovascular event in patients with cardiovascular disease. Murphy, BE., Card, PD., Ramirez-Kelly, L., et al.[2023]

Over a 10-year period, patients entering cardiac rehabilitation have become older and less fit, with a significant increase in obesity, diabetes, and hypertension among participants.

Despite these challenges, the use of evidence-based cardiovascular medications, especially statins, has tripled, leading to notable improvements in cholesterol levels and overall lipid profiles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changing clinical profile of patients entering cardiac rehabilitation/secondary prevention programs: 1996 to 2006. Audelin, MC., Savage, PD., Ades, PA.[2008]

A study involving 2635 inpatients with coronary artery disease found that a combined referral strategy of automatic and healthcare provider liaison significantly increased cardiac rehabilitation (CR) referral and enrollment rates, achieving 85.8% referral and 73.5% enrollment compared to only 32.2% referral and 29.0% enrollment with usual care.

The research indicates that implementing automatic referrals along with patient discussions can enhance CR access, potentially allowing 45% more patients to benefit from this life-saving intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of cardiac rehabilitation referral strategies on utilization rates: a prospective, controlled study. Grace, SL., Russell, KL., Reid, RD., et al.[2018]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

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]

2. England pubmed.ncbi.nlm.nih.gov

Telehealth interventions versus center-based cardiac rehabilitation of coronary artery disease: A systematic review and meta-analysis. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Who is likely to benefit from phase II cardiac rehabilitation? [2010]

4. England pubmed.ncbi.nlm.nih.gov

Cardiac rehabilitation for patients with heart failure: association with readmission and mortality risk. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Patient-Selected Strategies for Post Cardiac Rehabilitation Exercise Adherence in Heart Failure. [2019]

6. England pubmed.ncbi.nlm.nih.gov

PATHway I: design and rationale for the investigation of the feasibility, clinical effectiveness and cost-effectiveness of a technology-enabled cardiac rehabilitation platform. [2022]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Novel advances in cardiac rehabilitation : Position paper from the Working Group on Preventive Cardiology and Cardiac Rehabilitation of the Netherlands Society of Cardiology. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Using the CHANGE intervention to enhance long-term exercise. [2019]

9. England pubmed.ncbi.nlm.nih.gov

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]

11. England pubmed.ncbi.nlm.nih.gov

A EUropean study on effectiveness and sustainability of current Cardiac Rehabilitation programmes in the Elderly: Design of the EU-CaRE randomised controlled trial. [2022]

12. Germany pubmed.ncbi.nlm.nih.gov

Effects of the Strong Hearts program after a major cardiovascular event in patients with cardiovascular disease. [2023]

13. United States pubmed.ncbi.nlm.nih.gov

Changing clinical profile of patients entering cardiac rehabilitation/secondary prevention programs: 1996 to 2006. [2008]

14. United States pubmed.ncbi.nlm.nih.gov

Effect of cardiac rehabilitation referral strategies on utilization rates: a prospective, controlled study. [2018]