Status:
ACTIVE_NOT_RECRUITING
Telehealth Treatment of Veterans With Alcohol Misuse at Risk for Cardiovascular Disease
Lead Sponsor:
VA Office of Research and Development
Conditions:
Alcohol Misuse
Hypertension
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
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 ba...
Eligibility Criteria
Inclusion
- Enrolled in 1 of 3 primary care clinics associated with the Durham VAHCS, as evidenced by at least one outpatient PCP visit recorded in Managerial Cost Accounting (MCA) system.
- Diagnosis of hypertension, hyperlipidemia, and/or diabetes mellitus in EHR (ICD-10 codes I10, E78.xx, and E11.xxxx) for at least one year.
- Uncontrolled BP (indicated by average outpatient past year systolic BP of \>140/100mmHg). \> 1 measurement required.
- Currently prescribed at least one oral medication for hypertension, hyperlipidemia, and/or diabetes mellitus as evidenced by at least one pharmacy refill within the previous year.
- Most recent EHR AUDIT-C 5 (suggestive of alcohol misuse).
- Self-reported access to any SMS text-capable phone.
- Appropriate medication regimen for CVD prevention, screened by research coordinator and reviewed by Matt Crowley, MD (Mentor).
Exclusion
- Current enrollment in another trial for CVD risk reduction or medication adherence specifically.
- Current participation in other alcohol misuse treatment programming.
- EHR AUDIT-C suggestive of severe alcohol dependence requiring medical treatment, defined as 10-12 for both men and women.
- Any recent or impending procedures that would warrant inpatient hospital stays or considerable changes to current medications (e.g., any changes other than altered doses).
- Current palliative care or care through a nursing/hospice home.
- History of clinically significant alcohol withdrawal symptoms, as evidenced by a score 10 on the CIWA.
- Contraindicated medication regimen for CVD prevention, screened by research coordinator and reviewed by Matt Crowley, MD (Mentor).
Key Trial Info
Start Date :
December 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 30 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04838457
Start Date
December 1 2021
End Date
May 30 2026
Last Update
June 15 2025
Active Locations (1)
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1
Durham VA Medical Center, Durham, NC
Durham, North Carolina, United States, 27705-3875