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

Trial Summary

What is the purpose of this trial?

Cardiac rehabilitation, an outpatient program that includes supervised exercise and cardiovascular risk factor education, is one of the most important therapies for patients with cardiovascular disease. Unfortunately, very few Veterans with cardiovascular disease enroll in cardiac rehabilitation programs. This proposal will evaluate Veterans' individual barriers to attending cardiac rehabilitation with both surveys and interviews. Using this information, the investigators will develop a behavioral intervention to encourage Veterans to enroll in outpatient cardiac rehabilitation programs. This intervention will be individually tailored to Veterans with the information- motivation-behavioral skills model, a theory of behavior change. The investigators will test the tailored intervention with a proof-of-concept study in Veterans hospitalized with cardiovascular disease at the Veterans Affairs Tennessee Valley Healthcare System. This project is relevant to Veterans' health because increasing enrollment in cardiac rehabilitation will decrease mortality and increase quality of life in Veterans with cardiovascular disease.

Research Team

Justin M Bachmann, MD MPH

Principal Investigator

Tennessee Valley Healthcare System Nashville Campus, Nashville, TN

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+