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Behavioral Intervention

Enhanced usual care then Treatment Facilitation Bundle for Alcoholic 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

Study 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.Check my eligibility

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.See study design

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 ~ baseline and six months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and six months

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Alcohol treatment engagement

Secondary outcome measures

Alcohol Use Frequency as Measured by a 30-day alcohol recall calendar method

Change in Liver health based on The Model for End-Stage Liver Disease (MELD) score in participants with cirrhosis or alcoholic hepatitis

Change in Liver health based on liver laboratory values (aspartate transaminase (AST), alanine transaminase (ALT), alkaline phosphatase) for all participants

+2 more

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

~8530

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of MichiganLead Sponsor

1,799 Previous Clinical Trials

6,378,370 Total Patients Enrolled

National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH

805 Previous Clinical Trials

1,365,644 Total Patients Enrolled

Jessica Mellinger, MD, MScPrincipal InvestigatorUniversity of Michigan

1 Previous Clinical Trials

60 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are eligible patients able to enroll in this ongoing trial at the present time?

"As per details on clinicaltrials.gov, this particular research endeavor is no longer in the process of actively seeking participants. The trial's initial posting date was 2/1/2024 with the latest edit made on 2/13/2024. Despite its closure to applicants, there are currently 267 other trials actively looking for suitable candidates at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Enhancing Alcohol Treatment Engagement in Associated Liver Disease (ALD) Patients

Jessica Mellinger 2025. "Enhancing Alcohol Treatment Engagement in Associated Liver Disease (ALD) Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06269510.

All > Liver Disease

~179 spots leftby Jul 2027

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