Cardiac Rehabilitation for Cardiovascular Disease

(T2CR Trial)

Recruiting at 1 trial location

Overseen By Greg A Owens, BA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

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

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

250 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how the Transition to Cardiac Rehabilitation (T2CR) program can help Veterans with heart conditions improve their health and stay active. It compares two groups: one receiving the T2CR program and another receiving usual care, to determine which leads to better participation in home-based cardiac rehab and more healthy days at home. Veterans who might be suitable candidates are those recently hospitalized with certain heart issues, such as heart attacks or heart surgery, and who are open to trying cardiac rehab. As an unphased trial, this study offers Veterans the opportunity to contribute to research that could enhance cardiac rehabilitation programs for others.

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 prior data suggests that the T2CR intervention is safe for Veterans with cardiovascular disease?

Research shows that cardiac rehabilitation (CR) is generally safe for people with heart conditions. Studies have found that home-based cardiac rehab (HBCR) programs, such as the Transition to Cardiac Rehabilitation (T2CR) intervention, rarely cause serious side effects. Most participants do not experience severe health issues from participating.

The T2CR program assists veterans in transitioning to home-based rehab after a heart event. Research suggests these programs are well-tolerated, with few reports of negative effects. Participants usually find the program easy to follow and beneficial, with minimal health risks.

In summary, joining the T2CR program is likely safe and should not cause major health problems for most people. As always, consulting a healthcare provider about personal risks before starting any new program is advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the T2CR intervention for cardiovascular disease because it offers a comprehensive transitional care program that goes beyond standard post-heart event care. Unlike typical treatments that primarily focus on medication and lifestyle advice, T2CR integrates personalized support throughout the recovery period. This approach aims to provide continuous guidance and monitoring, potentially improving long-term outcomes by addressing both medical and lifestyle factors. By supplementing usual care with this holistic method, T2CR could pave the way for more effective rehabilitation and reduced risk of future heart events.

What evidence suggests that the T2CR intervention is effective for cardiac rehabilitation?

Research has shown that cardiac rehabilitation (CR) can reduce the risk of death and enhance heart health in individuals with heart disease. Studies have found that home-based cardiac rehabilitation (HBCR) is as effective as traditional, in-person programs. In this trial, participants in the T2CR Intervention arm will follow a program designed to help Veterans initiate and maintain HBCR, promoting activity and health at home. This is particularly important for those with additional health issues or frailty. Overall, CR programs, including T2CR, provide significant benefits for heart health and daily life. ^{1 3 5 6 7}

Who Is on the Research Team?

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)

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?

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+

Published Research Related to This Trial

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]

A multicenter randomized controlled pilot trial involving 120 participants (ages 40-80) is evaluating the feasibility and clinical efficacy of the PATHway telerehabilitation platform, which offers personalized, internet-enabled home cardiac rehabilitation programs.

The primary outcome of the study is the change in active energy expenditure, with secondary outcomes including improvements in cardiopulmonary endurance, muscle strength, and overall health-related quality of life, aiming to enhance adherence to exercise post-cardiac rehabilitation.

NCBI (Pubmed)

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. Claes, J., Buys, R., Woods, C., et al.[2022]

The CHANGE intervention, consisting of five small-group sessions led by nurses, effectively improves long-term exercise habits in individuals completing Phase II Cardiac Rehabilitation, enhancing their problem-solving and self-efficacy skills.

Pilot data show that participants who underwent the CHANGE intervention increased their exercise frequency, duration, and time spent in the target heart rate zone for up to three months after completing cardiac rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using the CHANGE intervention to enhance long-term exercise. Moore, SM., Charvat, JM.[2019]

The EU-CaRE study aims to evaluate the effectiveness of cardiac rehabilitation (CR) in elderly patients, specifically focusing on 1760 participants aged 65 and older with heart conditions, to understand their adherence and outcomes in traditional CR programs.

The study will also investigate mobile telemonitoring guided cardiac rehabilitation (mCR) as a potential effective alternative for elderly patients who decline regular CR, assessing outcomes like VO2peak and overall sustainability after 12 months.

NCBI (Pubmed)

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. Prescott, E., Meindersma, EP., van der Velde, AE., et al.[2022]

Cardiac rehabilitation (CR) is crucial for patients with cardiovascular disease, but its potential is underutilized; new developments aim to improve participation and effectiveness for diverse patient groups, including those with atrial fibrillation, obesity, and chronic heart failure.

Innovative delivery methods like cardiac telerehabilitation and loyalty programs, along with integrated care pathways, can enhance CR programs, making them more accessible and effective for a broader range of patients.

NCBI (Pubmed)

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. Vromen, T., Brouwers, RWM., Jorstad, HT., et al.[2021]

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]

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.

NCBI (Pubmed)

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. Tang, LH., Doherty, P., Skou, ST., et al.[2023]

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]

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]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Who is likely to benefit from phase II cardiac rehabilitation? Araya-Ramírez, F., Briggs, KK., Bishop, SR., et al.[2010]

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]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

High-risk cardiac patients showed significant improvements in exercise capacity (VO2peak) and heart function (LVEF) after participating in a 6 to 8 week cardiac rehabilitation program, with no serious cardiovascular events reported during the training.

The improvements in both VO2peak and LVEF in high-risk patients were comparable to those seen in control participants, indicating that cardiac rehabilitation is safe and effective for high-risk individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiac Rehabilitation Exercise Training for High-Risk Cardiac Patients. Choi, HE., Kim, C., Sohn, Y.[2020]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06244199

NCT06244199 | Transition to Cardiac Rehabilitation (T2CR ... The Transition to CR (T2CR) intervention is a 2-phase program that aims to improve the process of HBCR and to thereby better respond to Veterans' needs. T2CR ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11588675/

The Effectiveness of Cardiac Rehabilitation Programs in ... The findings show a reduction of all-cause and cardiovascular mortality and an improvement in functional class in patients enrolled in CR ...

3. withpower.com withpower.com/trial/phase-2-cardiac-rehabilitation-3-2024-26201

Cardiac Rehabilitation for Cardiovascular Disease (T2CR Trial) Telehealth interventions for cardiac rehabilitation (CR) show similar effectiveness to traditional center-based supervised CR in patients with coronary artery ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10066431/

Comparing the Effectiveness of 2 Cardiac Rehabilitation ... This study evaluates the impact of 2 CR programs implemented by the Northern Alberta Cardiac Rehabilitation Program, by comparing peak metabolic equivalents.

5. ahajournals.org ahajournals.org/doi/10.1161/JAHA.123.033568

Mortality Benefits of Cardiac Rehabilitation in Coronary ... Cardiac rehabilitation (CR) is a multicomponent intervention to reduce adverse outcomes from coronary artery disease, but its mechanisms are ...

6. trialx.com trialx.com/clinical-trials/listings/314222/transition-to-cardiac-rehabilitation-t2cr-to-address-barriers-of-multimorbidity-and-frailty/

Transition to Cardiac Rehabilitation (T2CR) to Address ... This study compares Veterans eligible for CR who are randomized to T2CR intervention versus usual care. Differences in functional capacity, HBCR ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10964460/

Safety and long-term outcomes of remote cardiac ... To systematically review the safety and the long-term mortality and morbidity risk-rates of the remotely-delivered cardiac rehabilitation ...