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

Part of paid clinical trials in Detroit, Michigan.

Sponsor
Henry Ford Health System
Study ID
NCT06269510
Status
Recruiting
Apply to this trial

Conditions

  • Alcohol-related Liver Disease
  • Liver Diseases

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ENGAGE-ALD Application (APP) — BEHAVIORAL
    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.
  • Treatment Facilitation bundle — BEHAVIORAL
    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.
  • Enhanced Usual Care — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Jan 28, 2026
Status verified
Jan 2026
Primary completion
Aug 1, 2029
Completion
Feb 28, 2030

Study Design

Enrollment
268 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Enhanced usual care (EUC)
    Eligible participants randomized will be given this for stage 1 of treatment (three months) and stage 2 (three months) if participants engaged in alcohol treatment during the first stage of treatment.
  • Experimental: ENGAGE-ALD application (app)
    Eligible participants randomized to this arm will be given this for stage 1 (three months) of treatment and stage 2 (three months) if participants engaged in alcohol treatment during the first stage of treatment.
  • Experimental: ENGAGE-ALD app then Treatment Facilitation Bundle
    Eligible participants randomized to this arm will be given this for stage 1 of treatment (three months). Participants that are non-responders (did not engage in alcohol treatment) will be re-randomized and assigned to the Treatment Facilitation bundle for stage 2 (three months).
  • Experimental: Enhanced usual care then Treatment Facilitation Bundle
    Eligible participants randomized to this arm will be given this for stage 1 of treatment (three months). Participants that are non-responders (did not engage in alcohol treatment) will be re-randomized and assigned to the Treatment Facilitation bundle for stage 2 (three months).
  • Experimental: ENGAGE-ALD app then Enhanced usual care
    Eligible participants randomized to this arm will be given this for stage 1 (three months) of treatment. Participants that are non-responders (did not engage in alcohol treatment) will be re-randomized to the EUC arm stage 2 (three months).
  • Experimental: Enhanced usual care then Enhanced usual care
    Eligible participants randomized to this arm will be given this for stage 1 of treatment (three months). Participants that are non-responders (did not engage in alcohol treatment) will be rerandomized to the Enhanced usual care arm stage 2 (three months).

Primary Outcome Measure

Alcohol treatment engagement [ Time Frame: Baseline and six months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Henry Ford HealthDetroitMichigan48202
Matthew Melican
[email protected]
3138744656
Jessica Mellinger
[email protected]
Jessica Mellinger, MD, MSc (PRINCIPAL_INVESTIGATOR)

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By research site
Henry Ford Health· Detroit, MI

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