Recruiting

Alcohol Use Treatment

Sponsor:

Henry Ford Health System

Code:

NCT06269510

Conditions

Alcohol-related Liver Disease

Liver Diseases

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

ENGAGE-ALD Application (APP)

Treatment Facilitation bundle

Enhanced Usual Care

Study Details

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.

Conditions

Alcohol-related Liver Disease

Liver Diseases

Study ID

NCT06269510

Start date

Jan 28, 2026

Status verified date

Jan, 2026

Completion date

Feb, 2030

Anticipated

Primary completion date

Aug 1, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

268 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

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).

Interventions

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.

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.

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Matthew Melican

3138744656mmelica1@hfhs.org

Jessica Mellinger, MD

3134281536jmellin2@hfhs.org

Locations

Henry Ford Health

Recruiting

Detroit, Michigan, United States, 48202

Contacts

Matthew Melican

3138744656mmelica1@hfhs.org

Jessica Mellinger

jmellin2@hfhs.org

Principal Investigator:

Jessica Mellinger, MD, MSc

More Information

Sponsor

Henry Ford Health System

Last update posted

Feb 3, 2026

Last verified

Jan, 2026

Keywords

  • Online web application
  • Engagement
  • Alcohol use disorder (AUD) treatment
  • Alcohol-related cirrhosis
  • SMART trial
  • Behavioral treatment

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Henry Ford Health System on 2026-02-03.