Implementation of Mobile-based Programs for Alcohol Cessation in Treatment of Alcohol-associated Liver Disease

NCT06305624 | Recruiting

• 4 other identifiers: 2024-01301R01AA030470-01A1A532000Protocol Version 2/8/26
• Study Type: interventional
• Target: 298
• Locations: 1 country
• Sites: 3

Brief Summary

This protocol describes a randomized controlled trial testing the effectiveness and implementability of the CHESS Health Connections smartphone application among patients with alcohol-associated liver disease (ALD) at two medical centers in Michigan and Wisconsin, in two types of clinics: general hepatology and multidisciplinary that offers care for advanced ALD alongside co-located, integrated mental health and substance abuse treatment. The long-term goal of this and future work is to prevent disease progression and promote healthy behaviors by improving the rate of abstinence among patients with ALD earlier in the course of their disease. 298 participants will be enrolled and can expect to be on study for up to 6 months.

Conditions

Alcohol Use Disorder; Alcohol-related Liver Disease

Outcome Measures

Primary Outcomes (2)

• Days of Alcohol Abstinence in ALD Participants

  Alcohol consumption outcomes will be collected monthly and include whether or not alcohol was consumed on each of the past 30 days. Alcohol consumption outcomes will be compared between the usual care condition and the usual care plus the Connections app condition.

  data collected monthly, up to 6 months

• Number of Standard Drinks Consumed in ALD Participants

  Alcohol consumption outcomes will be collected monthly and include whether or not alcohol was consumed on each of the past 30 days, if yes, participant's will also be asked the number of standard drinks for each day alcohol was consumed. Alcohol consumption outcomes will be compared between the usual care condition and the usual care plus the Connections app condition.

  data collected monthly, up to 6 months

Secondary Outcomes (9)

• Change in Patient Health Questionnaire (PHQ-8) Score

  baseline, 3 months, 6 months

• Change in PROMIS Global Health Score

  baseline, 3 months, 6 months

• Change in Generalized Anxiety Disorder (GAD-7) Score

  baseline, 3 months, 6 months

• Change in Insomnia Severity Index (ISI) Score

  baseline, 3 months, 6 months

• Change in Pain Interference (PEG) Score

  baseline, 3 months, 6 months

Study Arms (2)

Connections App

EXPERIMENTAL

The Connections app is based on principles of effective care for substance use disorders, such as sustained duration, peer support, improving coping skills in high-risk situations, assertive outreach, self- monitoring, prompts, and action planning. The theoretical foundation of CHESS Health is self-determination theory, which holds that an individual's adaptive functioning can be improved if the patient feels (1) competent, (2) related to others, and (3) internally motivated rather than coerced in one's actions.

Device: Connections App

Treatment as Usual

NO INTERVENTION

Interventions

Connections App DEVICE

mobile application, a place where participants can find community and support to help them manage their ALD, learn liver health self-care, coping skills, and alcohol abstinence strategies.

Connections App

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of ALD (any stage)
• Alcoholic liver disease (ALD) encompasses a spectrum of hepatic injuries caused by long-term alcohol abuse. For this study, participants will have a diagnosis of ALD or evidence of the combination of liver disease and alcohol misuse in electronic health record.
• Alcohol use within the last 6 months
• Receiving care at UW or Henry Ford Health + MSU
• Either the general hepatology clinic or the multidisciplinary ALD clinic
• Able to read and write proficiently in English
• Willing and able to use a smartphone app

You may not qualify if:

• Actively listed for liver transplant or history of liver transplant before being enrolled in the study. Participants added to a liver transplant list after being enrolled in the study will be allowed to continue their participation
• In hospice care
• Has severe cognitive impairment (as described in electronic health record including dementia, delirium, and/or unable to maintain cognitive alertness during screening--as determined by study staff.)

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (3)

Henry Ford + Michigan State University Health Center

Lansing, Michigan, 48824, United States

RECRUITING

UW General Hepatology Clinic

Madison, Wisconsin, 53705, United States

RECRUITING

UW Multidisciplinary ALD Clinic

Madison, Wisconsin, 53705, United States

RECRUITING

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Andrew Quanbeck, PhD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jared P McDonald, MBA

CONTACT

608-263-4022; jared.mcdonald@fammed.wisc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, controlled, Type 1 hybrid implementation-effectiveness trial.

Study Record Dates

• First Submitted: March 5, 2024
• First Posted: March 12, 2024
• Study Start: June 1, 2024
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): October 31, 2027
• Last Updated: April 14, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be shared with the general research community at the time of an associated outcomes publication, or the end of the award/support period, whichever comes first. Data will be retained in NIAAA-DA for the life of the repository.

Locations

US (3)