Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2025-12-30 @ 3:07 AM
Study NCT ID:
NCT04838457
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-06-15
First Post:
2021-04-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Telehealth Treatment of Veterans With Alcohol Misuse at Risk for Cardiovascular Disease
Sponsor:
VA Office of Research and Development
Organization:
Study Overview
Official Title:
Telehealth Treatment of Veterans With Alcohol Misuse at Risk for Cardiovascular Disease (CDA 19-035)
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-06
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:
ACME-TM
Brief Summary:
The primary objective of this project is to refine a cognitive-behavioral intervention for comorbid alcohol misuse and modifiable CVD risk with diverse stakeholder input, so that the intervention can be deployed within existing VA systems. The intervention will deliver telehealth CBT for alcohol misuse, tailored and timely text messages facilitating clinical traction with CVD risk reduction, and a telehealth coaching call to transition focus of treatment targets. The primary hypotheses of this study are that the developed intervention will be feasible to deliver, acceptable to Veterans and clinicians, and show signs of reducing alcohol misuse and increasing behaviors associated with cardiovascular health.
Detailed Description:
Specific Aims: Aim 1 -Characterize a national cohort of Veterans with alcohol misuse and modifiable CVD risk, their alcohol services utilization, and clinical outcomes. Aim 2 - Qualitatively assess barriers to treatment for Veterans with alcohol misuse and CVD risk across multiple stakeholders. Aim 3 - Use a successive cohort design to iteratively develop an intervention based on patient feedback. Aim 4 - Test the acceptability and feasibility of an intervention to reduce alcohol misuse and CVD risk in Veterans.
Innovation: This application is highly innovative in its attempt to address for the first time: 1) perceptions of barriers to treatment in this population, 2) the utility of a combined intervention for alcohol misuse and CVD risk, 3) multimorbid patient preferences for timing of treatments for multiple different targets, and 4) the sustainability of health behavior habits in VA formed by an intervention using "implementation intentions." Methodology: Aim 1 will use electronic health records to examine the status of key health criteria and services utilization among Veterans with alcohol misuse, both with and without comorbid CVD risk. Aim 2 will use qualitative interviews of both Veterans with comorbid alcohol misuse and elevated modifiable CVD risk, their providers across different settings, and systems-level stakeholders to assess current treatment barriers. Aim 3 will employ a successive cohort design to iteratively test the proposed intervention with rapid and early feedback from multiple Veteran cohorts. Aim 4 will test a refined intervention based on feedback from Aims 2 and 3 to determine the acceptability to Veteran patients, as well as the feasibility of recruitment, randomization, and intervention.
Innovation: This application is highly innovative in its attempt to address for the first time: 1) perceptions of barriers to treatment in this population, 2) the utility of a combined intervention for alcohol misuse and CVD risk, 3) multimorbid patient preferences for timing of treatments for multiple different targets, and 4) the sustainability of health behavior habits in VA formed by an intervention using "implementation intentions." Methodology: Aim 1 will use electronic health records to examine the status of key health criteria and services utilization among Veterans with alcohol misuse, both with and without comorbid CVD risk. Aim 2 will use qualitative interviews of both Veterans with comorbid alcohol misuse and elevated modifiable CVD risk, their providers across different settings, and systems-level stakeholders to assess current treatment barriers. Aim 3 will employ a successive cohort design to iteratively test the proposed intervention with rapid and early feedback from multiple Veteran cohorts. Aim 4 will test a refined intervention based on feedback from Aims 2 and 3 to determine the acceptability to Veteran patients, as well as the feasibility of recruitment, randomization, and intervention.
Study Oversight
Has Oversight DMC:
False
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?: