Helping people with alcohol-related liver disease find and start alcohol treatment
Enhancing Alcohol Treatment Engagement in ALD Patients
This trial tests whether a tailored web app plus a follow-up coaching bundle can help people with alcohol-related liver disease start and stay in alcohol-use treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 268 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Henry Ford Health System Academic / other |
| Locations | 1 site (Detroit, Michigan) |
| Trial ID | NCT06269510 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults with a documented diagnosis of alcohol-related liver disease who have had any alcohol use within the past six months, are able to give consent, and receive care at a participating hepatology clinic are the ideal candidates.
Not a fit: People already receiving alcohol-focused treatment within the past month, those not receiving care at participating sites, or those unwilling/unable to use a web app or coaching are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, the approach could increase the number of people with alcohol-related liver disease who initiate and remain in alcohol-use treatment, potentially reducing alcohol-related liver harm.
How similar studies have performed: The ENGAGE-ALD app has been pilot-tested previously, and digital preference-matching and coaching approaches for alcohol use disorder have shown promising but mixed results in prior research.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Detroit, Michigan
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.