Implementation of Mobile-based Programs for Alcohol Cessation in Treatment of Alcohol-associated Liver Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Wisconsin, Madison
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.)
Trial design
Design model
Parallel
Treatments tested in this trial
Connections App
Devicemobile 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.
Treatment groups
298 Participants
are divided into 2 treatment groupsGroup A: Connections AppExperimental treatment 1 intervention
Group B: Treatment as UsualNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
data collected monthly, up to 6 months2
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.
Time frame
data collected monthly, up to 6 monthsSecondary outcomes
1
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.
Time frame
baseline, 3 months, 6 months2
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.
Time frame
baseline, 3 months, 6 months3
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.
Time frame
baseline, 3 months, 6 months4
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.
Time frame
baseline, 3 months, 6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Wisconsin, Madison
Lead sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborator
Source ClinicalTrials.gov