Alcohol-related Liver DiseaseENGAGE-ALDNCT06269510
Enhancing Alcohol Treatment Engagement in Associated Liver Disease (ALD) Patients
A study testing ENGAGE-ALD Application (APP) and Treatment Facilitation bundle in people with Alcohol-related Liver Disease and Liver Diseases, run by Henry Ford Health System at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol-related Liver Disease, Liver Diseases
- What is being tested?
- ENGAGE-ALD Application (APP) and Treatment Facilitation bundle
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 268 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jan 2026to Feb 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Henry Ford Health
Detroit, Michigan, 48202
Matthew Melican, 3138744656, mmelica1@hfhs.org
Jessica Mellinger, jmellin2@hfhs.org
About this study
Official title: Enhancing Alcohol Treatment Engagement in 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.
Read the detailed description
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.
- Conditions
- Alcohol-related Liver Disease, Liver Diseases
- Being tested
- ENGAGE-ALD Application (APP), Treatment Facilitation bundle, Enhanced Usual Care
- Keywords
- Online web application, Engagement, Alcohol use disorder (AUD) treatment, Alcohol-related cirrhosis, SMART trial, Behavioral treatment
- Medical subject headings
- Liver Diseases, Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ENGAGE-ALD Application (APP)Behavioural
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 bundleBehavioural
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 CareBehavioural
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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). Receives: 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). Receives: Behavioral: Treatment Facilitation bundle; Behavioral: 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). Receives: 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). Receives: Behavioral: Enhanced Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline and six months
Secondary outcomes (5)
Alcohol Use Frequency as Measured by a 30-day alcohol recall calendar method
Measured: Baseline and six months
Percent heavy drinking days (PHDD)
A heavy drinking day is defined as 5 or more drinks for men and 4 or more drinks for women.
Measured: Six months
Change in Liver health based on liver laboratory values (aspartate transaminase (AST), alanine transaminase (ALT), alkaline phosphatase) for all participants
Measured: Baseline and six months
Change in Liver health based on liver laboratory values (total bilirubin) for all participants
Measured: 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
Minimum MELD score: 6 points. Maximum MELD score: 40 points. Higher scores is considered a worse result.
Measured: Baseline and six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2024
- Study start28 Jan 2026
- Primary completion1 Aug 2029 (estimated)
- Study completionFeb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol-related Liver DiseaseStudies of the same condition, open and under way.
- More trials run by Henry Ford Health SystemThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 268 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Jessica Mellinger, Henry Ford Health System
- Investigators
- Jessica Mellinger, MD, MSc, Principal investigator, Henry Ford Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06269510
- Sponsor's protocol ID
- 17705
- Other IDs
- 1R01AA030748-01
- Acronym
- ENGAGE-ALD
- Status last verified
- Jan 2026
- First submitted
- 13 Feb 2024
- Last updated
- 3 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Alcohol Treatment Engagement in ALD Patients
- ClinicalTrials.gov ID
- NCT06269510
- Acronym / sponsor ID
- ENGAGE-ALD / 17705
- Conditions
- Alcohol-related Liver Disease, Liver Diseases
- Keywords
- Online web application, Engagement, Alcohol use disorder (AUD) treatment, Alcohol-related cirrhosis, SMART trial, Behavioral treatment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 268 participants (estimated)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 28 Jan 2026 (actual)
- Primary completion
- 1 Aug 2029 (estimated)
- Study completion
- Feb 2030 (estimated)
- First posted
- 21 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Enhanced usual care (EUC) | Experimental | Behavioral: Enhanced Usual CareEligible 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. |
| ENGAGE-ALD application (app) | Experimental | Behavioral: 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 app then Treatment Facilitation Bundle | Experimental | Behavioral: ENGAGE-ALD Application (APP), Behavioral: Treatment Facilitation bundleEligible 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). |
| Enhanced usual care then Treatment Facilitation Bundle | Experimental | Behavioral: Treatment Facilitation bundle, Behavioral: Enhanced Usual CareEligible 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 app then Enhanced usual care | Experimental | Behavioral: ENGAGE-ALD Application (APP)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). |
| Enhanced usual care then Enhanced usual care | Experimental | Behavioral: Enhanced Usual CareEligible 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | ENGAGE-ALD app then Enhanced usual care, ENGAGE-ALD app then Treatment Facilitation Bundle, ENGAGE-ALD application (app) |
| Treatment Facilitation bundleParticipants 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. | Behavioural | ENGAGE-ALD app then Treatment Facilitation Bundle, Enhanced usual care then Treatment Facilitation Bundle |
| Enhanced Usual CareThis 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. | Behavioural | Enhanced usual care (EUC), Enhanced usual care then Enhanced usual care, Enhanced usual care then Treatment Facilitation Bundle |
Primary outcome
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
5 secondary outcomes
Alcohol Use Frequency as Measured by a 30-day alcohol recall calendar method
Time frame: Baseline and six months
Percent heavy drinking days (PHDD)
Time frame: Six months
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
Change in Liver health based on liver laboratory values (total bilirubin) for all participants
Time frame: 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
Time frame: Baseline and six months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jessica Mellinger, MD, MSc principal investigator
Henry Ford Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ENGAGE-ALD Application (APP) and Treatment Facilitation bundle in people with Alcohol-related Liver Disease and Liver Diseases, run by Henry Ford Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Matthew Melican (3138744656, mmelica1@hfhs.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alcohol treatment engagement (time frame: Baseline and six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2026.