NCT06269510

Enhancing Alcohol Treatment Engagement in Associated Liver Disease (ALD) Patients

Enhancing Alcohol Treatment Engagement in ALD Patients

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 268 (estimated)
• Sponsor: Henry Ford Health System · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this trial is to see if providing patients with alcohol-related liver disease with tailored alcohol use treatment options will increase engagement with treatment and correct possible misconceptions.

Detailed description

Eligible participants will be randomized to stage 1 of treatment which consists of a previously pilot-tested behavioral application (app), the ENGAGE-ALD app, consisting of a knowledge improvement module and a preference-sensitive treatment matching module. Those who do not engage in AUD treatment after randomization ('non-responders') will be re-randomized at 3-months and continue on this in stage two if considered a responder (met treatment engagement). Participants that were not considered to have met "treatment engagement" will be re-randomized at 3-months to a Treatment Facilitation bundle consisting of a barriers to treatment survey followed by a health coaching session.

Conditions

• Alcohol-related Liver Disease
• Liver Diseases

Interventions

Type	Name	Description
BEHAVIORAL	ENGAGE-ALD Application (APP)	Participants randomized to this will complete the app at the time of enrollment. If in-person, will complete the app on a research laptop or iPad. The ENGAGE-ALD app consists of two modules developed based on preliminary data: 1) a misconception correction module and 2) a treatment matching module designed to match patients to participant's preferred form of alcohol treatment based on preferences for 19 different dimensions of alcohol treatment. The intervention will consist of administering a single session of the ENGAGE-ALD app.
BEHAVIORAL	Treatment Facilitation bundle	Participants will complete a survey. The module includes motivational interviewing-informed content tailored to address and assist in overcoming barriers. After taking the survey, participants will receive a virtual coaching session (either via phone or online virtual platform). Sessions will focus on identifying participant goals with respect to alcohol use and liver health, providing education on risks of alcohol use to liver health and risks of relapse, reviewing participants individually identified barriers to alcohol treatment, exploring benefits of and these barriers to alcohol treatment, and performing collaborative goal-setting, among other topics.
BEHAVIORAL	Enhanced Usual Care	This group will receive standard hepatology care, and an educational pamphlet defining alcohol treatment resources available within Michigan Medicine and giving information on how participants can access these resources. This information will be given directly to participants that enroll in person or e-mailed to participants or sent via postal mail for those that enroll remotely.

Timeline

• Start date: 2026-01-28
• Primary completion: 2029-08-01
• Completion: 2030-02-01
• First posted: 2024-02-21
• Last updated: 2026-02-03

Locations

1 site across 1 country: United States