Clinical trial NCT06305624: Implementation of Mobile-based Programs for Alcohol Cessation in Treatment of Alcohol-associated Liver Disease
Official title: Implementation of Mobile-based Programs for Alcohol Cessation in Treatment of Alcohol-associated Liver Disease (IMPACT-ALD): Aim 1
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alcohol Use Disorder
Alcohol-related Liver Disease
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2024-03-12
Enrollment: 298
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, controlled, Type 1 hybrid implementation-effectiveness trial.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.
* 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.)

Primary outcomes:
measure: Days of Alcohol Abstinence in ALD Participants
timeFrame: data collected monthly, up to 6 months
measure: Number of Standard Drinks Consumed in ALD Participants
timeFrame: data collected monthly, up to 6 months
Secondary outcomes:
measure: Change in Patient Health Questionnaire (PHQ-8) Score
timeFrame: baseline, 3 months, 6 months
measure: Change in PROMIS Global Health Score
timeFrame: baseline, 3 months, 6 months
measure: Change in Generalized Anxiety Disorder (GAD-7) Score
timeFrame: baseline, 3 months, 6 months
measure: Change in Insomnia Severity Index (ISI) Score
timeFrame: baseline, 3 months, 6 months
measure: Change in Pain Interference (PEG) Score
timeFrame: baseline, 3 months, 6 months
measure: Change in Drinking Motivations Questionnaire - Adult (DMQ-A) Score
timeFrame: baseline, 3 months, 6 months
measure: Change in CHESS Bonding Scale Score
timeFrame: baseline, 3 months, 6 months
measure: Change in Drug-Taking Confidence Questionnaire (DTCQ-8A) Score
timeFrame: baseline, 3 months, 6 months
measure: Change in Treatment Self-Regulation Questionnaire (TSRQ) Score
timeFrame: baseline, 3 months, 6 months
Other outcomes:
Locations:
city: Lansing
country: United States
facility: Henry Ford + Michigan State University Health Center
state: Michigan
city: Madison
country: United States
facility: UW General Hepatology Clinic
state: Wisconsin
city: Madison
country: United States
facility: UW Multidisciplinary ALD Clinic
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Andrew Quanbeck, PhD
role: PRINCIPAL_INVESTIGATOR
References: