Tailored Interventions for Cardiovascular Disease

Overseen By Rachel L Jones, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Dementia, Psychosis, Mania, others

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

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assist Veterans with heart disease (cardiovascular disease) by facilitating their participation in cardiac rehabilitation programs. Cardiac rehab, which includes exercise and education to improve heart health, often sees low attendance among Veterans. The trial will identify personal challenges Veterans face and develop a tailored intervention to encourage participation, using surveys and interviews. Veterans who have had recent heart surgery or procedures may qualify for this study if they haven't participated in a rehab program in the past year. The goal is to enhance their health and quality of life by increasing participation in these valuable programs. As an unphased trial, this study provides Veterans with a unique opportunity to contribute to research that seeks to improve their access to life-enhancing cardiac rehabilitation programs.

Do I need to stop my current medications for this trial?

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 doctor.

What prior data suggests that this tailored intervention is safe for Veterans with cardiovascular disease?

Research has shown that cardiac rehab programs are generally safe and can improve the quality of life for people with heart disease. These programs typically include exercise and education about heart health and have been proven to reduce the risk of heart attacks and hospital visits.

The study tests a new approach designed to help Veterans overcome personal challenges in joining cardiac rehab programs. Although specific safety data on this new approach is limited, existing cardiac rehab programs have a strong safety record.

The research aims to create a more personalized plan without introducing significant safety concerns compared to regular cardiac rehab practices. Overall, the new approach seeks to safely encourage more Veterans to join these beneficial programs. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a personalized approach to cardiac rehabilitation, which is different from the usual one-size-fits-all programs. Unlike standard treatments that often provide the same regimen to all patients, this tailored intervention identifies and addresses individual barriers that might prevent someone from participating in cardiac rehabilitation. This means that patients could receive support and resources specifically designed to overcome their unique challenges, potentially leading to better participation and outcomes. By focusing on personalized care, this approach has the potential to significantly improve recovery rates for individuals with cardiovascular disease.

What evidence suggests that this tailored intervention is effective for increasing cardiac rehabilitation enrollment in Veterans?

Research has shown that cardiac rehabilitation (CR) can greatly benefit people with heart disease. Studies have found that participating in CR programs can lower the risk of complications and encourage adherence to healthy habits. This trial tests a tailored intervention designed to address individual barriers to CR participation. This personalized approach aims to increase enrollment and retention in the program, which is expected to reduce mortality rates and enhance quality of life. Overall, CR supports heart health and promotes lasting healthy behaviors. ^{2 5 6 7 8}

Who Is on the Research Team?

Justin M Bachmann, MD MPH

Principal Investigator

Tennessee Valley Healthcare System Nashville Campus, Nashville, TN

Are You a Good Fit for This Trial?

This trial is for Veterans hospitalized with cardiovascular disease who are undergoing specific heart procedures and have not been in a cardiac rehab program recently. It's not for those with certain mental conditions, near end of life, under police custody, uncooperative, or with severe hearing or vision impairments.

Inclusion Criteria

I am in the hospital for a procedure to improve blood flow to my heart.

Exclusion Criteria

I cannot communicate in English.

Hearing impairment

I have been in a heart rehab program in the last year or am in another study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Barrier Evaluation

Quantify barriers to cardiac rehabilitation in Veterans using the Beliefs About Cardiac Rehabilitation Scale (BACRS)

Varies

1 visit (in-person)

Intervention Development

Iterative development of a tailored intervention to increase outpatient cardiac rehabilitation enrollment

Varies

Proof-of-Concept Testing

Testing the tailored intervention in a non-randomized group of Veterans

1-2 days

1 visit (in-person)

Follow-up

Participants are monitored for changes in attitudes towards cardiac rehabilitation participation

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Tailored intervention

Trial Overview The study tests a personalized behavioral intervention to encourage these Veterans to enroll in outpatient cardiac rehabilitation programs. The approach uses surveys and interviews to tailor the support based on individual barriers and motivation theories.

How Is the Trial Designed?

Group I: Tailored intervention Experimental Treatment 1 Intervention

Tailored intervention designed to address individual barriers to cardiac rehabilitation participation

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2995341/

The Effects of a Cardiac Rehabilitation Program Tailored ... This RCT showed that a tailored CR intervention designed for women improved global QOL. Improving QOL may positively influence adherence to healthy behaviors.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12128146/

Effectiveness of Cardiac Rehabilitation in Enhancing ... Cardiac rehabilitation significantly enhances adherence to medical and lifestyle recommendations, reduces complications, and improves outcomes in ACS patients.

3. sciencedirect.com sciencedirect.com/science/article/pii/S2772374725004454

Long-Term Outcomes of Digital Cardiac Rehabilitation Several studies suggest that patients participating in home-based cardiac rehabilitation (HBCR) report higher satisfaction, better exercise adherence, and ...

4. thelancet.com thelancet.com/journals/landig/article/PIIS2589-7500(25)00012-3/fulltext

Effectiveness of home-based cardiac rehabilitation ... This study aims to assess the effects of mHealth HBCR interventions compared with usual care and CBCR in patients with heart disease.

5. ahajournals.org ahajournals.org/doi/10.1161/CIR.0000000000001289

Core Components of Cardiac Rehabilitation Programs Cardiac rehabilitation (CR) reduces mortality rates and improves the quality of life of patients with cardiovascular disease (CVD), and its use ...

6. 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 ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8445013/

The role of cardiac rehabilitation in improving cardiovascular ... Participation in cardiac rehabilitation resulted in reductions in the risk of fatal or non-fatal MI and all-cause hospitalization. Although 29 ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S0147956322000978

Safety of home-based cardiac rehabilitation: A systematic ... Previous research has shown that HBCR programs are feasible and effective. However, there is a lack of evidence on safety issues in different cardiac ...