NCT06305624

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

Implementation of Mobile-based Programs for Alcohol Cessation in Treatment of Alcohol-associated Liver Disease (IMPACT-ALD): Aim 1

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 298 (estimated)
• Sponsor: University of Wisconsin, Madison · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The goal of this project is to implement and evaluate an evidence-based mHealth system to help patients diagnosed with ALD with alcohol cessation. Connections is a mobile health app developed by CHESS Health to support patients with alcohol use disorders. Patients will be enrolled in both general hepatology and multidisciplinary ALD clinics (which include integrated alcohol use treatment professionals alongside hepatology providers) at two large tertiary care centers (University of Wisconsin (UW) and University of Michigan (UM)). The hypothesis is that the implementation of an adapted version of Connections for patients with ALD will improve rates of alcohol cessation and improve liver function. * Aim 1 (described in this record) will assess the effectiveness of the Connections app plus usual care (n=149) compared to usual care (n=149) on days of alcohol abstinence over 6 months. * Aim 2 will assess the implementation of the Connections app through qualitative interviews of key patient, provider, and clinic-level stakeholders using the Replicating Effective Programs framework. Aim 2 follows the study intervention phase and is not part of this record. Secondary analyses will examine use of the Connections app on health outcomes (including depression, anxiety, insomnia, liver health, and quality of life) and health behaviors (including engagement with alcohol use disorder (AUD) and/or ALD treatments and ongoing alcohol use). Key moderators (including age, sex, race, ethnicity, marital status, rurality, and ALD severity) and mediators (including relatedness, competence, autonomous motivation) on outcomes will be explored. The impact of the Connections app on measures of chronic liver impairment documented in the health record will be examined.

Conditions

• Alcohol Use Disorder
• Alcohol-related Liver Disease

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2024-06-01
• Primary completion: 2027-10-31
• Completion: 2027-10-31
• First posted: 2024-03-12
• Last updated: 2026-04-14

Locations

3 sites across 1 country: United States