Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2025-12-24 @ 6:51 PM
NCT ID:
NCT04838457
Eligibility 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).
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04838457
Study Brief:
Protocol Section:
NCT04838457