Alcohol Biosensor Monitoring for Alcoholic Liver Disease

Study Overview
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Brief Summary
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Successful treatment of alcohol associated liver disease (AALD) depends primarily on abstinence from alcohol. The investigators propose a randomized clinical trial of alcohol biosensor monitoring for patients with alcohol associated liver disease to determine if monitoring with feedback on alcohol use patterns reduces alcohol consumption and improves outcomes.

Detailed Description
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The investigators propose a 3 month randomized controlled trial (RCT) pilot of alcohol biosensor monitoring (ABM)(WrisTAS) for patients with Alcohol Associated Liver Disease (AALD) who intend to stop drinking. All participants will wear the ABM device but participants will be randomized to receive either personalized feedback on the data recorded on the device (n=30) or enhanced usual care without feedback on device data (n=30). The investigators will determine whether ABM plus feedback improves outcomes for AALD patients compared to enhanced usual care and hypothesize ABM feedback will reduce alcohol consumption, improve motivation and self-efficacy for abstinence and improve engagement in treatment. The investigators will also conduct research including qualitative data collected from participants who will provide opinions on ABM feasibility, acceptability, and usability. Qualitative methods are especially useful for understanding the perceived needs, barriers, and preferences for monitoring alcohol use and are especially required for future translation of this technology into clinical practice.

Official Title
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Alcohol Biosensor Monitoring for Alcoholic Liver Disease

Conditions
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Alcohol Use, Unspecified

Intervention / Treatment
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* Behavioral: Feedback
* Behavioral: Enhanced Usual Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with AALD followed at our liver disease clinic, 18 years or older, willing to accept randomization, and agree to wear device for 3 months, SOCRATES problem recognition subscale score >26 (scores <26 indicate very low recognition of an alcohol problem). Exclusion Criteria: Non-English speaking, Montreal Cognitive Assessment (MOCA) scores <21 (moderate cognitive impairment) or neurologic diseases (e.g. Parkinson's), patients with unresponsive acute alcoholic hepatitis, multi-organ failure, fulminant hepatic failure, cancer/terminal illness; those unable to wear a wrist monitor (e.g., edema); lacking a residence, or unable to identify a contact person (if lost to follow-up).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: RCT feedback vs. enhanced usual care
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Feedback<br>Participant will receive a brief feedback on data downloaded from the ABM and information about treatment resources | Behavioral: Feedback<br>* Participant will receive a brief feedback on alcohol use data downloaded from the ABM and information about treatment resources<br>|
| Active Comparator: Enhanced usual care<br>Participant will receive information about remaining abstinent and about treatment resources | Behavioral: Enhanced Usual Care<br>* Participant will receive information on self reported alcohol use and information about remaining abstinent and about treatment resources<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alcohol Use | Average number of drinks per drinking episode per interval (month) of device wear. We analyzed the number of drinks per drinking episode and present the group average per month interval of assessment. | continuous for up to 3 months | 
| Percent of Days Drinking Per Interval of Device Wear | Percent of days drinking per interval of device wear: We analyzed the data by number of drinking episodes per individual per days of device wear and present the mean percent days drinking per assessment interval | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improved Readiness for Alcohol Abstinence and Initiation of Change | Stages of Change Readiness & Treatment Eagerness Scale (SOCRATES) is a 19-item instrument that measures readiness for change assessing three areas; ambivalence, recognition, and taking steps with change scores assessing the impact of an intervention on these areas. Three subscale scores are produced with total scores ranging 19-95 and higher score indicating greater readiness: 7 items for recognition of an alcohol problem (scores range from low of 7 to highest of 35) 4 items for ambivalence (range from low of 4 to highest of 20) 8 items for taking steps to make a positive change in drinking (range from low of 8 to highest of 40) | Scores determined at initiation, 6 weeks and 3 months of participation | 
| Self Efficacy to Remain Abstinent | Alcohol Abstinence Self-efficacy (AASE) evaluates confidence in ability to abstain from drinking in situations that represent typical drinking cues. Four subscales with 5 specific situations each are rated on confidence not to drink in each situations on a 5-point Likert scale from 1=not at all confident to 5=extremely confident. Total scores range from 20-100 with higher scores reflecting greater self confidence not to drink. negative affect situations (range from low confidence of 5 to highest confidence of 25) social/positive situations (range from low confidence of 5 to highest confidence of 25) physical and other concerns situations (range from low confidence of 5 to highest confidence of 25) cravings and urges situations (range from low confidence of 5 to highest confidence of 25) | Scores determined at initiation, 6 weeks and 3 months of participation | 
| Medical Outcomes | AALD related hospitalizations and ER visits - total count of participants in each arm who experienced these outcomes | Counts determined at initiation, 6 weeks and 3 months of participation | 
| Qualitative Interviews | Qualitative interviews of participants will use a semi-structured script of open-ended stem questions with prompts. The qualitative assessment will cover such topics as patients' perceived need/psychologic barriers (e.g., beliefs in value of ABM in their clinical care and for their relationship with clinicians) and experience with ABM (e.g., wearability, satisfaction, and barriers to monitoring). Transcribed interviews will be thematically coded. The constant comparison method will be used, and subsequent interviews may be modified/informed by findings from previous interviews to explore emerging themes as the analysis proceeds. | measured at three months (completion of the participants use of ABM) |