NCT06269510

Brief 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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
268

participants targeted

Target at P75+ for not_applicable

Timeline
46mo left

Started Jan 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress7%
Jan 2026Feb 2030

First Submitted

Initial submission to the registry

February 13, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 21, 2024

Completed
1.9 years until next milestone

Study Start

First participant enrolled

January 28, 2026

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2029

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2030

Last Updated

February 3, 2026

Status Verified

January 1, 2026

Enrollment Period

3.5 years

First QC Date

February 13, 2024

Last Update Submit

January 30, 2026

Conditions

Alcohol-related Liver DiseaseLiver Diseases

Keywords

Online web applicationEngagementAlcohol use disorder (AUD) treatmentAlcohol-related cirrhosisSMART trialBehavioral treatment

Outcome Measures

Primary Outcomes (1)

  • Alcohol treatment engagement

    Measured using self-report and defined as any single session (in-person or virtual) of the following: * Professional mental health counselor led one-on-one therapy, group therapy, couples, or family therapy with a primary aim of alcohol abstinence or reduction in alcohol use. * Community-based alcohol recovery groups (such as Alcoholics Anonymous, Self-Management and Recovery Training (SMART) Recovery, Celebrate Recovery, Refuge Recovery) * Community-based church support groups primarily focused on alcohol abstinence or reduction in use * Residential (inpatient) alcohol treatment * Intensive outpatient programs * Any telehealth version of the above options

    Baseline and six months

Secondary Outcomes (5)

  • Alcohol Use Frequency as Measured by a 30-day alcohol recall calendar method

    Baseline and six months

  • Percent heavy drinking days (PHDD)

    Six months

  • Change in Liver health based on liver laboratory values (aspartate transaminase (AST), alanine transaminase (ALT), alkaline phosphatase) for all participants

    Baseline and six months

  • Change in Liver health based on liver laboratory values (total bilirubin) for all participants

    Baseline and six months

  • Change in Liver health based on The Model for End-Stage Liver Disease (MELD) score in participants with cirrhosis or alcoholic hepatitis

    Baseline and six months

Study Arms (6)

Enhanced usual care (EUC)

EXPERIMENTAL

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.

Behavioral: Enhanced Usual Care

ENGAGE-ALD application (app)

EXPERIMENTAL

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.

Behavioral: ENGAGE-ALD Application (APP)

ENGAGE-ALD app then Treatment Facilitation Bundle

EXPERIMENTAL

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).

Behavioral: ENGAGE-ALD Application (APP)Behavioral: Treatment Facilitation bundle

Enhanced usual care then Treatment Facilitation Bundle

EXPERIMENTAL

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).

Behavioral: Treatment Facilitation bundleBehavioral: Enhanced Usual Care

ENGAGE-ALD app then Enhanced usual care

EXPERIMENTAL

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).

Behavioral: ENGAGE-ALD Application (APP)

Enhanced usual care then Enhanced usual care

EXPERIMENTAL

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).

Behavioral: Enhanced Usual Care

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.

ENGAGE-ALD app then Enhanced usual careENGAGE-ALD app then Treatment Facilitation BundleENGAGE-ALD application (app)
Treatment Facilitation bundleBEHAVIORAL

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.

ENGAGE-ALD app then Treatment Facilitation BundleEnhanced usual care then Treatment Facilitation Bundle
Enhanced Usual CareBEHAVIORAL

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.

Enhanced usual care (EUC)Enhanced usual care then Enhanced usual careEnhanced usual care then Treatment Facilitation Bundle

Eligibility Criteria

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

You may qualify if:

  • Willingness to comply with all study procedures and availability for the duration of the study
  • Willing and able to provide informed consent
  • Enrolled at University of Michigan (UM) hepatology clinics or inpatients at UM Hospitals
  • Documented diagnosis of alcohol-related liver disease (ALD) (per protocol)
  • Recent alcohol use of any amount within the past 6 months as assessed by either patient interview, medical chart review, or positive alcohol biomarker (e.g. blood alcohol level, urinary ethyl glucuronide, urinary ethyl sulfate, or phosphatidylethanol) in the medical record.
  • No alcohol use treatment within the past 1 month including, but not limited to:
  • Any professionally lead therapy with a mental health counselor (such as, one-on-one therapy, group therapy, couples or family therapy) with a primary aim of alcohol abstinence or reduction in alcohol use.
  • Community-based alcohol recovery groups (such as, Alcoholics Anonymous, SMART Recovery, Celebrate Recovery, Refuge Recovery)
  • Community-based church support groups primarily focused on alcohol abstinence or reduction in use.
  • Residential (inpatient) alcohol treatment
  • Intensive outpatient programs
  • Any telehealth version of the above options
  • Access to a Smartphone or computer for purposes of follow-up. Those who do not have a Smartphone will be provided one along with a calling/data plan at no cost to subject by the study team for the duration of the research stud.
  • Ability to speak and comprehend English

You may not qualify if:

  • Unable to provide voluntary informed consent for any reason
  • Substantially cognitively impaired as evidenced by Westhaven grade 2 or higher hepatic encephalopathy or a score \>=10 on the Short Blessed Test for cognitive impairment.
  • Unable to read or understand English
  • Undergoing active evaluation for liver transplantation, is listed for liver transplant, or is post-transplantation
  • Is enrolled in the multidisciplinary ALD clinic at Michigan Medicine
  • Any other medical condition or circumstance that precludes safe and meaningful participation in the study
  • History of nonadherence to previous clinical or research studies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Henry Ford Health

Detroit, Michigan, 48202, United States

RECRUITING

MeSH Terms

Conditions

Liver DiseasesAlcoholism

Condition Hierarchy (Ancestors)

Digestive System DiseasesAlcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Jessica Mellinger, MD, MSc

    Henry Ford Health System

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Matthew Melican

CONTACT

3138744656mmelica1@hfhs.org

Jessica Mellinger, MD

CONTACT

3134281536jmellin2@hfhs.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Model Details: Computer-generated urn randomization will ensure balanced groups based on stage of ALD (advanced ALD and non-advanced ALD) and inpatient versus outpatient status at time of recruitment. Second stage randomization to 3-month intervention conditions will be stratified based on response and non-response status. Urn randomization using stage of ALD and inpatient versus outpatient recruitment will also be used at the second stage randomization. Re-randomization of non-responders will be computerized and stratified by stage of ALD and inpatient vs outpatient status.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 13, 2024

First Posted

February 21, 2024

Study Start

January 28, 2026

Primary Completion (Estimated)

August 1, 2029

Study Completion (Estimated)

February 1, 2030

Last Updated

February 3, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)