Tailored Interventions to Increase Cardiac Rehabilitation Enrollment

Cardiovascular Disease Clinical Trial

Official title:

Development of a Tailored Intervention to Increase Veteran Enrollment in Cardiac Rehabilitation (CDA 19-391)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05214989
• Other study ID #: CDX 22-003
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2025
• Est. completion date: December 31, 2025

Study information

• Verified date: January 2024
• Source: VA Office of Research and Development
• Contact: Rachel L Jones, MS
• Phone: (615) 421-8235
• Email: Rachel.Jones4[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

Background: This Veterans Affairs (VA) Health Services Research & Development Career Development Award resubmission is a five-year plan that will enable the candidate, a staff cardiologist and specialist in cardiac rehabilitation (CR) at the VA Tennessee Valley Healthcare System, to develop and implement interventions to increase CR enrollment in Veterans. CR is an outpatient program including prescriptive exercise and cardiac risk factor education that is an essential therapy for patients with cardiovascular disease. This proposal will develop a tailored intervention to increase Veteran enrollment in CR.

Significance/Impact: CR is widely underutilized, with less than 20% of eligible patients enrolling in CR programs nationally. CR utilization is particularly low among Veterans, with only 10% of eligible Veterans enrolling in CR programs. Though CR referral rates have risen substantially over the past decade, CR enrollment has remained static. It is imperative to study barriers to CR enrollment among Veterans that have already been referred to CR and develop interventions tailored to these individual barriers.

Innovation: The applicant will develop a tailored intervention for increasing CR enrollment using the Obesity- Related Behavioral Intervention Trials model, a conceptual model for intervention development, as well as the information-motivation-behavioral skills model, a theory of behavior change that allows individual tailoring. Linking these models will produce new knowledge regarding behavioral intervention methodology as well as an innovative clinical intervention that can be delivered by nurses and other clinical staff at VA facilities. The proposed intervention aligns with current VA initiatives by supporting CR enrollment wherever is most convenient for Veterans (including VA CR programs, non-VA CR programs, and home-based CR programs).

Specific Aims: Aims 1 and 2 comprise a sequential explanatory mixed methods study to evaluate barriers to CR enrollment among Veterans. The purpose of Aim 1 is to quantify barriers to CR in 100 Veterans hospitalized with ischemic heart disease using the previously validated Beliefs About Cardiac Rehabilitation Scale (BACRS). The purpose of Aim 2 is to reveal additional barriers to outpatient CR enrollment through qualitative interviews in 30 Veterans from Aim 1 who did not enroll in CR. Aim 3 focuses on the iterative development of a tailored intervention to increase outpatient CR enrollment in 3 groups of 5 hospitalized Veterans, characterizing the intervention's feasibility and acceptability. In Aim 4, the tailored intervention will undergo proof-of-concept testing in a non-randomized group of 25 Veterans hospitalized with ischemic heart disease. The applicant hypothesizes that these Veterans will have a clinically significant improvement in BACRS summary scores after the intervention, representing a decrease in perceived barriers to CR.

Methodology: Aim 1 will quantitate the burden of CR barriers among Veterans by evaluating distributions of BACRS summary scores and subscales. In Aim 2, the applicant will use intensity sampling to purposefully select Veterans with the lowest individual BACRS subscale scores (and highest perceived barriers to CR) from the Aim 1 cohort for semi-structured qualitative interviews. Aim 3 will use mixed data from Aims 1 and 2 and serial formative evaluations to inform the iterative development of a tailored intervention. In Aim 4, the BACRS will be administered before and after the intervention, characterizing the intervention's effect on perceived barriers to CR enrollment as measured by the BACRS summary score.

Implementation/Next Steps: The applicant will align the study activities with the QUERI Implementation Roadmap and convene a Stakeholder Engagement Panel to ensure that the tailored intervention is developed with maximum generalizability to other VA facilities. Findings from the proposed study will inform a wide range of initiatives related to CR enrollment among Veterans and will be used to conduct a randomized clinical trial of the tailored intervention within the context of an Investigator Initiated Research application.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 25
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Inpatients undergoing coronary artery bypass grafting or percutaneous coronary intervention.

Exclusion Criteria:

• Inability to communicate in English

• Blindness

• Hearing impairment

• Conditions that would interfere with the validity of the questionnaire (e.g., significant dementia, active psychosis or mania), being near the end of life (hospice or home hospice)

• Lack of cooperation

• Police custody

• Participation in a cardiac rehabilitation program within the previous year, or enrollment in a conflicting study

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases

Intervention

Behavioral:
• Tailored intervention
Tailored intervention designed to address individual barriers to cardiac rehabilitation participation

Locations

Country	Name	City	State
United States	Tennessee Valley Healthcare System Nashville Campus, Nashville, TN	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Qualitative interviews	Qualitative interviews will evaluate the effectiveness of the intervention in changing attitudes towards cardiac rehabilitation participation.	1-2 days after intervention