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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and six months for reporting.

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

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

~8400

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