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

Not Applicable

Not yet recruiting

• Conditions: Alcohol-related Liver Disease; Liver Diseases

• Registration Number: NCT06269510
• Lead Sponsor: University of Michigan

Brief Summary

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.

Detailed Description

Eligible participants will be randomized to stage 1 of treatment which consists of a previously pilot-tested behavioral application (app), the ENGAGE-ALD app, consisting of a knowledge improvement module and a preference-sensitive treatment matching module. Those who do not engage in AUD treatment after randomization ('non-responders') will be re-randomized at 3-months and continue on this in stage two if considered a responder (met treatment engagement). Participants that were not considered to have met "treatment engagement" will be re-randomized at 3-months to a Treatment Facilitation bundle consisting of a barriers to treatment survey followed by a health coaching session.

Study Timeline

• Study First Submitted: 2024-02-13
• Study First Submitted QC: 2024-02-13
• Study First Posted: 2024-02-21
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-25
• Last Update Posted: 2024-03-26
• Study Start: 2025-04
• Primary Completion: 2027-07
• Study Completion: 2027-07

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 268

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
Alcohol treatment engagement	Baseline and six months	Measured using self-report and defined as any single session (in-person or virtual) of the following: * Professional mental health counselor led 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, Self-Management and Recovery Training (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

Secondary Outcome Measures

Name	Time	Method
Percent heavy drinking days (PHDD)	Six months	A heavy drinking day is defined as 5 or more drinks for men and 4 or more drinks for women.
Change in Liver health based on liver laboratory values (aspartate transaminase (AST), alanine transaminase (ALT), alkaline phosphatase) for all participants	Baseline and six months
Alcohol Use Frequency as Measured by a 30-day alcohol recall calendar method	Baseline and six months
Change in Liver health based on The Model for End-Stage Liver Disease (MELD) score in participants with cirrhosis or alcoholic hepatitis	Baseline and six months	Minimum MELD score: 6 points. Maximum MELD score: 40 points. Higher scores is considered a worse result.
Change in Liver health based on liver laboratory values (total bilirubin) for all participants	Baseline and six months

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States