Enhancing Alcohol Treatment Engagement in Associated Liver Disease (ALD) Patients
NCT ID: NCT06269510
Last Updated: 2024-03-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
268 participants
INTERVENTIONAL
2025-04-30
2027-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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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.
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.
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.
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.
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).
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 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).
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.
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).
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.
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).
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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National Institute on Alcohol Abuse and Alcoholism (NIAAA)
NIH
University of Michigan
OTHER
Responsible Party
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Jessica Mellinger
Assistant Professor of Internal Medicine
Principal Investigators
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Jessica Mellinger, MD, MSc
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Locations
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University of Michigan
Ann Arbor, Michigan, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HUM00242997
Identifier Type: -
Identifier Source: org_study_id
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