Trial Summary
What is the purpose of this trial?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.
Eligibility Criteria
This trial is for individuals with alcohol-related liver disease. It's aimed at those who may benefit from tailored treatment options to help them engage more effectively with their treatment and address any misunderstandings about their condition.Inclusion Criteria
I haven't received any alcohol use treatment in the last month.
I am willing and able to follow all study rules and attend all appointments.
Willing and able to provide informed consent
+5 more
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
Any other medical condition or circumstance that precludes safe and meaningful participation in the study
Unable to provide voluntary informed consent for any reason
+4 more
Participant Groups
The study is testing three approaches: an ENGAGE-ALD Application (APP) designed to support patients, a Treatment Facilitation bundle that provides additional resources, and Enhanced Usual Care which represents the standard approach to care.
6Treatment groups
Experimental Treatment
Group I: Enhanced usual care then Treatment Facilitation BundleExperimental Treatment2 Interventions
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).
Group II: Enhanced usual care then Enhanced usual careExperimental Treatment1 Intervention
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).
Group III: Enhanced usual care (EUC)Experimental Treatment1 Intervention
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.
Group IV: ENGAGE-ALD application (app)Experimental Treatment1 Intervention
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.
Group V: ENGAGE-ALD app then Treatment Facilitation BundleExperimental Treatment2 Interventions
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).
Group VI: ENGAGE-ALD app then Enhanced usual careExperimental Treatment1 Intervention
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).
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of MichiganAnn Arbor, MI
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Who Is Running the Clinical Trial?
University of MichiganLead Sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)Collaborator