NCT04838457

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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 6, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 9, 2021

Completed
8 months until next milestone

Study Start

First participant enrolled

December 1, 2021

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2025

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 12, 2026

Completed
Last Updated

May 29, 2026

Status Verified

May 1, 2026

Enrollment Period

3.5 years

First QC Date

April 6, 2021

Last Update Submit

May 26, 2026

Conditions

Alcohol MisuseHypertensionElevated Cardiovascular Risk

Keywords

AlcoholCardiovascular DiseaseTelehealthCognitive Behavioral TherapySMS Text

Outcome Measures

Primary Outcomes (5)

  • Enrollment Feasibility

    Intervention and trial feasibility will be evaluated by tracking patient recruitment (feasibility of enrollment; proportion contacted/proportion enrolled and consented).

    Baseline Only

  • Treatment Feasibility

    Intervention and trial feasibility will be evaluated by tracking patient adherence/retention during treatment (feasibility of treatment; adherence cutoff of 75% of sessions).

    10 Weeks Post-Baseline

  • Treatment Acceptability

    Acceptability will be measured by the Treatment Acceptability and Preferences (TAP). Post-treatment, patients will complete the TAP measure and open-ended questions to assess their knowledge about their conditions, experiences with treatment, and satisfaction.

    10 Weeks Post-Baseline

  • Therapist Fidelity

    Therapist fidelity will be measured by structured independent ratings of a random sample of 20% of recordings using the Yale Adherence and Competence Scale (YACS).

    6 Weeks Post-Baseline

  • SMS Text Acceptability

    SMS text utilization metrics (read reports on 75% of texts, or affirmative responses to receipt of 75% of texts) and open-ended post-treatment responses will be used to measure SMS text acceptability.

    10 Weeks Post-Baseline

Secondary Outcomes (3)

  • Systolic Blood Pressure

    6 months Post-Baseline

  • Past-Month Self-Reported Heavy Drinking Days

    6 months Post-Baseline

  • ReComp Pharmacy Refill Compliance Estimate for CVD medications

    6 months Post-Baseline

Study Arms (1)

ACME-TM

EXPERIMENTAL

Participants will obtain 4 sessions of telehealth cognitive behavioral therapy (CBT) focused on reducing alcohol misuse. Participants will receive a 5th telehealth coaching call to develop a plan for ensuing treatment regarding their elevated cardiovascular risk factors. Participants will then receive daily texts for one month aimed at helping them decrease these cardiovascular risk factors.

Behavioral: Alcohol and CVD Management and Engagement through Telehealth and mHealth (ACME-TM)

Interventions

Alcohol and CVD Management and Engagement through Telehealth and mHealth (ACME-TM)BEHAVIORAL

Participants will obtain 4 sessions of telehealth cognitive behavioral therapy (CBT) focused on reducing alcohol misuse. Participants will receive a 5th telehealth coaching call to develop a plan for ensuing treatment regarding their elevated cardiovascular risk factors. Participants will then receive daily texts for one month aimed at helping them decrease these cardiovascular risk factors.

ACME-TM

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Durham VA Medical Center, Durham, NC

Durham, North Carolina, 27705-3875, United States

Location

MeSH Terms

Conditions

HypertensionCardiovascular Diseases

Interventions

EthanolTelemedicine

Condition Hierarchy (Ancestors)

Vascular Diseases

Intervention Hierarchy (Ancestors)

AlcoholsOrganic ChemicalsDelivery of Health CarePatient Care ManagementHealth Services Administration

Study Officials

  • Daniel Blalock, PhD

    Durham VA Medical Center, Durham, NC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: The interventional model takes place in two parts. Part 1 is a successive cohort design in which a small cohort of participants complete the treatment, and provide qualitative and quantitative feedback on the treatment. The treatment process is then revised accordingly. A second and third cohort of participants complete treatment, followed by the same revision process. Part 2 involves a single-arm pilot trial of acceptability and feasibility of recruiting methods, treatment, and measurement of outcomes for participants.
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 6, 2021

First Posted

April 9, 2021

Study Start

December 1, 2021

Primary Completion

May 30, 2025

Study Completion

March 12, 2026

Last Updated

May 29, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)