ACTIVE_NOT_RECRUITING

Telehealth Treatment of Veterans With Alcohol Misuse at Risk for Cardiovascular Disease

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Telehealth Treatment of Veterans With Alcohol Misuse at Risk for Cardiovascular Disease (CDA 19-035)

Quick Facts

Study Start:2021-12-01
Study Completion:2026-05-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04838457

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * Diagnosis of hypertension, hyperlipidemia, and/or diabetes mellitus in EHR (ICD-10 codes I10, E78.xx, and E11.xxxx) for at least one year.
  3. * Uncontrolled BP (indicated by average outpatient past year systolic BP of \>140/100mmHg). \> 1 measurement required.
  4. * 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.
  5. * Most recent EHR AUDIT-C 5 (suggestive of alcohol misuse).
  6. * Self-reported access to any SMS text-capable phone.
  7. * Appropriate medication regimen for CVD prevention, screened by research coordinator and reviewed by Matt Crowley, MD (Mentor).
  1. * Current enrollment in another trial for CVD risk reduction or medication adherence specifically.
  2. * Current participation in other alcohol misuse treatment programming.
  3. * EHR AUDIT-C suggestive of severe alcohol dependence requiring medical treatment, defined as 10-12 for both men and women.
  4. * 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).
  5. * Current palliative care or care through a nursing/hospice home.
  6. * History of clinically significant alcohol withdrawal symptoms, as evidenced by a score 10 on the CIWA.
  7. * Contraindicated medication regimen for CVD prevention, screened by research coordinator and reviewed by Matt Crowley, MD (Mentor).

Contacts and Locations

Principal Investigator

Daniel Blalock, PhD
PRINCIPAL_INVESTIGATOR
Durham VA Medical Center, Durham, NC

Study Locations (Sites)

Durham VA Medical Center, Durham, NC
Durham, North Carolina, 27705-3875
United States

Collaborators and Investigators

Sponsor: VA Office of Research and Development

  • Daniel Blalock, PhD, PRINCIPAL_INVESTIGATOR, Durham VA Medical Center, Durham, NC

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

Study Start Date2021-12-01
Study Completion Date2026-05-30

Study Record Updates

Study Start Date2021-12-01
Study Completion Date2026-05-30

Terms related to this study

Keywords Provided by Researchers

  • Alcohol
  • Cardiovascular Disease
  • Telehealth
  • Cognitive Behavioral Therapy
  • SMS Text

Additional Relevant MeSH Terms

  • Alcohol Misuse
  • Hypertension
  • Elevated Cardiovascular Risk