Telehealth Treatment of Veterans With Alcohol Misuse at Risk for Cardiovascular Disease
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.
Conditions:
🦠 Alcohol Misuse 🦠 Hypertension 🦠 Elevated Cardiovascular Risk
🗓️ Study Start (Actual) 1 December 2021
🗓️ Primary Completion (Estimated) 30 September 2024
✅ Study Completion (Estimated) 9 May 2026
👥 Enrollment (Estimated) 40
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Durham, North Carolina, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * 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 Criteria:

    • * 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).
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 6 April 2021
  • First Submitted that Met QC Criteria 6 April 2021
  • First Posted 9 April 2021

Study Record Updates

  • Last Update Submitted that Met QC Criteria 9 November 2023
  • Last Update Posted 14 November 2023
  • Last Verified November 2023