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

Liver Diseases Clinical Trial

Official title:

Enhancing Alcohol Treatment Engagement in ALD Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06269510
• Other study ID #: HUM00242997
• Secondary ID: 1R01AA030748-01
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2025
• Est. completion date: July 2027

Study information

• Verified date: March 2024
• Source: University of Michigan
• Contact: Haila Asefa
• Phone: 734-232-0284
• Email: asefah[@]umich.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 268
• Est. completion date: July 2027
• Est. primary completion date: July 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alcohol-related Liver Disease
• Liver Diseases

Intervention

Behavioral:
• ENGAGE-ALD Application (APP)
Participants randomized to this will complete the app at the time of enrollment. If in-person, will complete the app on a research laptop or iPad. The ENGAGE-ALD app consists of two modules developed based on preliminary data: 1) a misconception correction module and 2) a treatment matching module designed to match patients to participant's preferred form of alcohol treatment based on preferences for 19 different dimensions of alcohol treatment. The intervention will consist of administering a single session of the ENGAGE-ALD app.
• Treatment Facilitation bundle
Participants will complete a survey. The module includes motivational interviewing-informed content tailored to address and assist in overcoming barriers. After taking the survey, participants will receive a virtual coaching session (either via phone or online virtual platform). Sessions will focus on identifying participant goals with respect to alcohol use and liver health, providing education on risks of alcohol use to liver health and risks of relapse, reviewing participants individually identified barriers to alcohol treatment, exploring benefits of and these barriers to alcohol treatment, and performing collaborative goal-setting, among other topics.
• Enhanced Usual Care
This group will receive standard hepatology care, and an educational pamphlet defining alcohol treatment resources available within Michigan Medicine and giving information on how participants can access these resources. This information will be given directly to participants that enroll in person or e-mailed to participants or sent via postal mail for those that enroll remotely.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

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