Cardiovascular DiseaseNCT05214989
Tailored Interventions to Increase Cardiac Rehabilitation Enrollment
A study testing Tailored intervention in people with Cardiovascular Disease, run by VA Office of Research and Development at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- Tailored intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2025to 1 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Inpatients undergoing coronary artery bypass grafting or percutaneous coronary intervention.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
Nashville, Tennessee, 37212-2637
About this study
Official title: Development of a Tailored Intervention to Increase Veteran Enrollment in Cardiac Rehabilitation (CDA 19-391)
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.
Read the 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.
- Conditions
- Cardiovascular Disease
- Being tested
- Tailored intervention
- Keywords
- Cardiac Rehabilitation, Cardiovascular Disease
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tailored interventionBehavioural
Tailored intervention designed to address individual barriers to cardiac rehabilitation participation
| Study group | Role | What they receive |
|---|---|---|
| Tailored intervention | Experimental | Tailored intervention designed to address individual barriers to cardiac rehabilitation participation Receives: Behavioral: Tailored intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Qualitative interviews
Qualitative interviews will evaluate the effectiveness of the intervention in changing attitudes towards cardiac rehabilitation participation.
Measured: 1-2 days after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2022
- Study start1 Jan 2025
- Primary completion1 Jan 2025
- Study completion1 Jan 2025
Why it stopped: We obtained information that referral rates are very low across the VA system for cardiac rehabilitation services, rendering the proposed clinical trial obsolete. Further information is detailed in the RPPR for the associated Career Development Award
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single group proof of concept study of an intervention involving tailored counseling.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Justin M Bachmann, MD MPH, Principal investigator, Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05214989
- Sponsor's protocol ID
- CDX 22-003
- Status last verified
- Jan 2025
- First submitted
- 18 Jan 2022
- Last updated
- 8 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Tailored Intervention to Increase Veteran Enrollment in Cardiac Rehabilitation (CDA 19-391)
- ClinicalTrials.gov ID
- NCT05214989
- Acronym / sponsor ID
- CDX 22-003
- Conditions
- Cardiovascular Disease
- Keywords
- Cardiac Rehabilitation, Cardiovascular Disease
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: We obtained information that referral rates are very low across the VA system for cardiac rehabilitation services, rendering the proposed clinical trial obsolete. Further information is detailed in the RPPR for the associated Career Development Award
- Enrolment
- 0 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 31 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single group proof of concept study of an intervention involving tailored counseling.
| Arm | Type | Receives |
|---|---|---|
| Tailored intervention | Experimental | Behavioral: Tailored interventionTailored intervention designed to address individual barriers to cardiac rehabilitation participation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Inpatients undergoing coronary artery bypass grafting or percutaneous coronary intervention.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tailored interventionTailored intervention designed to address individual barriers to cardiac rehabilitation participation | Behavioural | Tailored intervention |
Primary outcome
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2025.
- Individual participant dataSharing planned: No
Related trials for Cardiovascular Disease
Active, not recruitingObservational study
Gulf Long-Term Follow-Up Study
Cardiovascular Disease, Hematologic Diseases
Active, not recruitingObservational study
The CoPenHagen PREeClampsia and cardIOvascUlar diSease Study
Pre-Eclampsia, Atherosclerosis
Recruiting
CT Stress Myocardial Perfusion, Fractional Flow Reserve and Angiography in Patients With Stable Chest Pain Syndromes
Coronary Artery Disease, Chest Syndrome
Enrolling by invitation
The DANE-HEART Trial - Computed Tomography Coronary Angiography for Primary Prevention
Coronary Atherosclerosis and Other Heart Disease, Cardiovascular Diseases
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Justin M Bachmann, MD MPH principal investigator
Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tailored intervention in people with Cardiovascular Disease, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 8 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Qualitative interviews (time frame: 1-2 days after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2025; AzTrials last refreshed its copy on 6 Nov 2026.