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Behavioral Intervention
Alcohol Treatment Engagement for Liver Disease
N/A
Waitlist Available
Led By Jessica Mellinger, MD, MSc
Research Sponsored by University of Michigan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and six months
Awards & highlights
No Placebo-Only Group
Summary
"This trial aims to determine if offering personalized alcohol treatment options to patients with alcohol-related liver disease will help them to better engage with treatment and address any misunderstandings they may have."
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since this trial involves non-medical interventions like apps and resource bundles, traditional side effects associated with medications are not applicable. However, there might be indirect effects on stress or anxiety levels due to changes in treatment engagement.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ six months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~six months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Alcohol treatment engagement
Secondary study objectives
Change in Liver health based on The Model for End-Stage Liver Disease (MELD) score in participants with cirrhosis or alcoholic hepatitis
Percent heavy drinking days (PHDD)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
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).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Enhanced Usual Care
2019
Completed Phase 3
~8490
Find a Location
Who is running the clinical trial?
University of MichiganLead Sponsor
1,860 Previous Clinical Trials
6,437,652 Total Patients Enrolled
National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH
837 Previous Clinical Trials
1,082,766 Total Patients Enrolled
Jessica Mellinger, MD, MScPrincipal InvestigatorUniversity of Michigan
1 Previous Clinical Trials
60 Total Patients Enrolled