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

Alcohol Use Disorder Clinical Trial

— IMPACT-ALD  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06305624
• Other study ID #: 2024-0130
• Secondary ID: 1R01AA030470-01A
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2024
• Est. completion date: October 2027

Study information

• Verified date: April 2024
• Source: University of Wisconsin, Madison
• Contact: Mary M Checovich, MS CCRC
• Phone: 608-263-2653
• Email: mary.checovich[@]fammed.wisc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 298
• Est. completion date: October 2027
• Est. primary completion date: October 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of ALD (any stage)
• Alcohol use within the last 6 months
• Receiving care at UW or UM
• 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
• 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.)

Related Conditions & MeSH terms

• Alcohol Use Disorder
• Alcohol-related Liver Disease
• Alcoholism
• Liver Diseases

Intervention

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.

Locations

Country	Name	City	State
United States	UM General Hepatology Clinic	Ann Arbor	Michigan
United States	UM Multidisciplinary ALD Clinic	Ann Arbor	Michigan
United States	UW General Hepatology Clinic	Madison	Wisconsin
United States	UW Multidisciplinary ALD Clinic	Madison	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	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	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
Primary	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	Change in Patient Health Questionnaire (PHQ-8) Score	The PHQ-8 score is a measure of depressive symptoms that ranges from 0 to 24 where higher scores indicate increase depression.	baseline, 3 months, 6 months
Secondary	Change in PROMIS Global Health Score	Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health Score is a measure of quality of life. It is a 10-item patient-reported questionnaire in which the response options are presented as 5-point (as well as a single 11-point) rating scales. The results of the questions are used to calculate two summary scores: a Global Physical Health Score and a Global Mental Health Score. These scores are then standardized to the general population, using the "T-Score". The average "T-Score" for the United States population is 50 points, with a standard deviation of 10 points. Higher scores indicate a healthier patient.	baseline, 3 months, 6 months
Secondary	Change in Generalized Anxiety Disorder (GAD-7) Score	GAD-7 is a measure of anxiety and has a range of scores from 0-21 where higher scores indicate increased anxiety.	baseline, 3 months, 6 months
Secondary	Change in Insomnia Severity Index (ISI) Score	ISI is a measure of insomnia and has a range of scores from 0-28 where higher scores indicate increased insomnia.	baseline, 3 months, 6 months
Secondary	Change in Pain Interference (PEG) Score	PEG is a pain measure scored from 0 (no pain or interference) to 10 (worst pain and complete interference).	baseline, 3 months, 6 months
Secondary	Change in Drinking Motivations Questionnaire - Adult (DMQ-A) Score	DMQ-A is a measure of drinking motivations, scored from 1-5 in each of 5 domains: social, coping, confidence, taste, enhancement. Higher scores indicate higher motivation to drink.	baseline, 3 months, 6 months
Secondary	Change in CHESS Bonding Scale Score	The CHESS Bonding Scale is an adapted measure developed to "capture the concept of universality, group cohesiveness, and informational and emotional support". Score from 0 to 20 where higher scores indicates increased bonding.	baseline, 3 months, 6 months
Secondary	Change in Drug-Taking Confidence Questionnaire (DTCQ-8A) Score	DTCQ-8A is a measure of self-efficacy scored from 0-100 where higher scores indicate greater self-efficacy.	baseline, 3 months, 6 months
Secondary	Change in Treatment Self-Regulation Questionnaire (TSRQ) Score	TSRQ is a measure of self-regulation scored from 1 to 7 in each of 4 domains: autonomous motivation, introjected regulation, external regulation, amotivation. Higher scores indicate more self-regulation.	baseline, 3 months, 6 months