Helping people with alcohol-related liver disease find and start alcohol treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Participants with alcohol-related liver disease are randomized to use the ENGAGE-ALD app, which includes a knowledge module and a preference-sensitive treatment-matching tool, or to enhanced usual care. Those who do not meet a predefined treatment engagement threshold at 3 months are re-randomized to either continue their assigned approach or receive a Treatment Facilitation bundle consisting of a barriers-to-treatment survey and a health coaching session. The trial uses this staged randomization design to target non-responders with more intensive support. The main outcome is engagement with alcohol-use disorder treatment over follow-up.

Why it matters

Who can join: the full rules

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

Where it's running

• Henry Ford Health
  Detroit, Michigan, United States Recruiting

Study contacts

• Principal investigator: Jessica Mellinger, MD, MSc — Henry Ford Health System
• Study coordinator: Matthew Melican
• Email: mmelica1@hfhs.org
• Phone: 3138744656

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.