Tailored Interventions to Increase Cardiac Rehabilitation Enrollment

NCT05214989 | Withdrawn

• 1 other identifier: CDX 22-003
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cardiovascular Disease

Keywords

Cardiac Rehabilitation; Cardiovascular Disease

Outcome Measures

Primary Outcomes (1)

• Qualitative interviews

  Qualitative interviews will evaluate the effectiveness of the intervention in changing attitudes towards cardiac rehabilitation participation.

  1-2 days after intervention

Study Arms (1)

Tailored intervention

EXPERIMENTAL

Tailored intervention designed to address individual barriers to cardiac rehabilitation participation

Behavioral: Tailored intervention

Interventions

Tailored intervention BEHAVIORAL

Tailored intervention designed to address individual barriers to cardiac rehabilitation participation

Tailored intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Tennessee Valley Healthcare System Nashville Campus, Nashville, TN

Nashville, Tennessee, 37212-2637, United States

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

• Justin M Bachmann, MD MPH

  Tennessee Valley Healthcare System Nashville Campus, Nashville, TN

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: This is a single group proof of concept study of an intervention involving tailored counseling.

Study Record Dates

• First Submitted: January 18, 2022
• First Posted: January 31, 2022
• Study Start: January 1, 2025
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: January 8, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)