- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05214989
Tailored Interventions to Increase Cardiac Rehabilitation Enrollment
Development of a Tailored Intervention to Increase Veteran Enrollment in Cardiac Rehabilitation (CDA 19-391)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Justin M Bachmann, MD MPH
- Phone Number: (615) 327-4751
- Email: justin.bachmann2@va.gov
Study Contact Backup
- Name: Rachel L Jones, MS
- Phone Number: (615) 421-8235
- Email: Rachel.Jones4@va.gov
Study Locations
-
-
Tennessee
-
Nashville, Tennessee, United States, 37212-2637
- Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
-
Contact:
- Justin M Bachmann, MD MPH
- Phone Number: (615) 327-4751
- Email: justin.bachmann2@va.gov
-
Principal Investigator:
- Justin M Bachmann, MD MPH
-
Contact:
- Rachel L Jones, MS
- Phone Number: 615-421-8235
- Email: Rachel.Jones4@va.gov
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Tailored intervention
Tailored intervention designed to address individual barriers to cardiac rehabilitation participation
|
Tailored intervention designed to address individual barriers to cardiac rehabilitation participation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Qualitative interviews
Time Frame: 1-2 days after intervention
|
Qualitative interviews will evaluate the effectiveness of the intervention in changing attitudes towards cardiac rehabilitation participation.
|
1-2 days after intervention
|
Collaborators and Investigators
Investigators
- Principal Investigator: Justin M Bachmann, MD MPH, Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDX 22-003
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cardiovascular Disease
-
University of FloridaUniversity of Alabama at Birmingham; Brown UniversityCompletedCardiovascular Disease | Psychosocial Influence on Cardiovascular DiseaseUnited States
-
National Heart, Lung, and Blood Institute (NHLBI)CompletedCardiovascular Disease | Inflammatory DiseaseUnited States
-
Morehouse School of MedicineNot yet recruiting
-
Yonsei UniversityRecruitingCardiovascular DiseaseKorea, Republic of
-
Nanjing Medical UniversityNot yet recruitingCardiovascular Disease
-
National Human Genome Research Institute (NHGRI)Active, not recruiting
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruiting
-
AmgenCompletedCardiovascular DiseaseUnited States, Australia
-
VA Office of Research and DevelopmentEnrolling by invitationCardiovascular DiseaseUnited States
Clinical Trials on Tailored intervention
-
Memorial Sloan Kettering Cancer CenterNational Cancer Institute (NCI); Massachusetts General Hospital; Fox Chase Cancer... and other collaboratorsCompletedCancer | Colorectal | Intervention | ScreeningUnited States
-
University of California, San DiegoNational Institute of Nursing Research (NINR)CompletedInactivityUnited States
-
Duke UniversityNational Cancer Institute (NCI)Completed
-
Rabin Medical CenterAcademic College of Tel Aviv-Jaffa; Israel Cancer AssociationUnknownOvarian Cancer | Cancer of Cervix | Cancer of EndometriumIsrael
-
Nova Southeastern UniversityEmory UniversityCompletedDepression | Pain | Sleep Wake Disorders | Fatigue | Chronic DiseaseUnited States
-
University of Colorado, DenverWashington State University; Missouri Breaks Industries Research, Inc.RecruitingAlzheimer DiseaseUnited States
-
Poriya Medical CenterRecruiting
-
Icahn School of Medicine at Mount SinaiRutgers UniversityRecruitingDiabetes Mellitus, Type 2 | Alzheimer DiseaseUnited States
-
Indiana UniversityCompletedAttitude to Health | Human Papilloma Virus VaccinesUnited States
-
Icahn School of Medicine at Mount SinaiNational Institute on Aging (NIA)RecruitingDepression | Sleep DisturbancesUnited States