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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Alcohol Use Disorder; Alcohol-related Liver Disease
• Intervention / Treatment: Device: Connections App

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.

• Study Type: Interventional
• Enrollment (Estimated): 298
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mary M Checovich, MS CCRC; Phone Number: 608-263-2653; Email: mary.checovich@fammed.wisc.edu

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • UM General Hepatology Clinic
    • Ann Arbor, Michigan, United States, 48109
      • UM Multidisciplinary ALD Clinic
  • Wisconsin
    • Madison, Wisconsin, United States, 53705
      • UW General Hepatology Clinic
    • Madison, Wisconsin, United States, 53705
      • UW Multidisciplinary ALD Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Treatment as Usual
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Investigators: Principal Investigator: Andrew Quanbeck, PhD, University of Wisconsin, Madison

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027

Study Registration Dates

• First Submitted: March 5, 2024
• First Submitted That Met QC Criteria: March 5, 2024
• First Posted (Actual): March 12, 2024

Study Record Updates

• Last Update Posted (Actual): April 30, 2024
• Last Update Submitted That Met QC Criteria: April 26, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Digestive System Diseases; Alcohol-Related Disorders; Substance-Related Disorders; Liver Diseases; Alcoholism
• Other Study ID Numbers: 2024-0130; A532000 (Other Identifier: UW Madison); Protocol Version 2/21/2024 (Other Identifier: UW Madison); 1R01AA030470-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Participant-level data that have been de-identified will be deposited and made available in a data repository maintained by NIAAA and referenced as NIAAA-DA. The National Institute on Alcohol Abuse and Alcoholism Data Archive (NIAAADA) is a data repository that houses and shares human subjects' data generated by NIAAA-funded research.

Data released through NIAAA-DA are assigned a citation that includes a Global Unique Identifier (GUID). The GUID is a unique persistent identifier maintained by NIAAA-DA to ensure the data can be permanently identified. The citation and GUID are available on the study page and are provided with each download.

• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No