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NCT Number: NCT06269510

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

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.

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Key information

Conditions

Alcohol-related Liver Disease Alcohol-Related Disorders Alcoholism Chemically-Induced Disorders Digestive System Diseases Liver Diseases Mental Disorders Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Henry Ford Health

Detroit, Michigan, 48202, United States

Location status: Recruiting

Location contact

Jessica Mellinger

CONTACT

[email protected]

Jessica Mellinger, MD, MSc

PRINCIPAL_INVESTIGATOR

Matthew Melican

CONTACT

[email protected]

3138744656

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Alcohol treatment engagement

    Time frame: Baseline and six months

    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

Secondary outcomes

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

    Time frame: Baseline and six months

  2. Percent heavy drinking days (PHDD)

    Time frame: Six months

    A heavy drinking day is defined as 5 or more drinks for men and 4 or more drinks for women.

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

    Time frame: Baseline and six months

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

    Time frame: Baseline and six months

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

    Time frame: Baseline and six months

    Minimum MELD score: 6 points. Maximum MELD score: 40 points. Higher scores is considered a worse result.

Study contacts

Contact information is provided by the study sponsor or research team.

Jessica Mellinger, MD

CONTACT

[email protected]

3134281536

Matthew Melican

CONTACT

[email protected]

3138744656

Sponsors and collaborators

Lead sponsor

Henry Ford Health System

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Official study title

Enhancing Alcohol Treatment Engagement in ALD Patients

Acronym: ENGAGE-ALD

Important dates

Study start
2026
Primary completion
2029
Study completion
2030
First posted
Feb 21, 2024
Registry last updated
Feb 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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