Telehealth treatment for veterans with alcohol misuse and cardiovascular risk
Telehealth Treatment of Veterans With Alcohol Misuse at Risk for Cardiovascular Disease (CDA 19-035)
This study is testing a new telehealth program that helps veterans who struggle with alcohol use and heart health by providing therapy, text reminders, and coaching calls to see if it works well for them.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | VA Office of Research and Development Federal |
| Locations | 1 site (Durham, North Carolina) |
| Trial ID | NCT04838457 on ClinicalTrials.gov |
What this trial studies
This project aims to refine a cognitive-behavioral intervention targeting veterans who misuse alcohol and are at risk for cardiovascular disease (CVD). The intervention includes telehealth cognitive behavioral therapy (CBT), tailored text messages for CVD risk reduction, and coaching calls to help transition treatment focus. The study will assess the feasibility and acceptability of this intervention while characterizing the cohort of veterans and identifying barriers to treatment. The methodology involves utilizing electronic health records and qualitative interviews to gather comprehensive data and feedback from participants.
Who should consider this trial
Good fit: Ideal candidates are veterans enrolled in specific primary care clinics with a diagnosis of hypertension, hyperlipidemia, or diabetes, and evidence of alcohol misuse.
Not a fit: Patients currently enrolled in another trial for CVD risk reduction or medication adherence may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly reduce alcohol misuse and improve cardiovascular health among veterans.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in addressing comorbid conditions through integrated interventions.
Eligibility criteria
Show full inclusion / exclusion criteria
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).
Where this trial is running
Durham, North Carolina
- Durham VA Medical Center, Durham, NC — Durham, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Daniel Blalock, PhD — Durham VA Medical Center, Durham, NC
- Study coordinator: Daniel Blalock, PhD
- Email: daniel.blalock@va.gov
- Phone: (919) 286-0411
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.