Recruiting

Mobile-based Programs

Sponsor:

University of Wisconsin, Madison

Code:

NCT06305624

Conditions

Alcohol Use Disorder

Alcohol-related Liver Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Connections App

Study Details

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

Study ID

NCT06305624

Start date

Jun 1, 2024

Status verified date

Jul, 2026

Completion date

Oct 31, 2027

Anticipated

Primary completion date

Oct 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria (Aim 1):

  • 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

Exclusion Criteria:

  • 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.)

Study Design

Enrollment

298 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: Connections App

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.

no intervention: Treatment as Usual

Interventions

Connections App

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.

Primary outcome measure

  • Days of Alcohol Abstinence in ALD Participants [ Time Frame: data collected monthly, up to 6 months ]
  • Number of Standard Drinks Consumed in ALD Participants [ Time Frame: data collected monthly, up to 6 months ]

Central Contacts and Locations

Central contacts

Jared P McDonald, MBA

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

Locations

Henry Ford + Michigan State University Health Center

Recruiting

Lansing, Michigan, United States, 48824

UW General Hepatology Clinic

Recruiting

Madison, Wisconsin, United States, 53705

UW Multidisciplinary ALD Clinic

Recruiting

Madison, Wisconsin, United States, 53705

More Information

Sponsor

University of Wisconsin, Madison

Last update posted

Jul 31, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Wisconsin, Madison on 2026-07-31.