Ignite Creation Date:
2024-05-06 @ 5:10 PM
Last Modification Date:
2024-10-26 @ 2:23 PM
Study NCT ID:
NCT05214989
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-01-29
First Post:
2022-01-18
Brief Title:
Tailored Interventions to Increase Cardiac Rehabilitation Enrollment
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Development of a Tailored Intervention to Increase Veteran Enrollment in Cardiac Rehabilitation CDA 19-391
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
SignificanceImpact 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 interventions 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 interventions effect on perceived barriers to CR enrollment as measured by the BACRS summary score
ImplementationNext 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
SignificanceImpact 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 interventions 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 interventions effect on perceived barriers to CR enrollment as measured by the BACRS summary score
ImplementationNext 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None