Alcohol Biosensor Monitoring for Alcoholic Liver Disease

University of Pittsburgh

Status: Completed

Conditions: Alcohol Use, Unspecified

Treatments: Behavioral: Enhanced Usual Care; Behavioral: Feedback

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03533660

R21AA025730 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 33 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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33 participants in 2 patient groups

Feedback

Active Comparator group

Description:

Participant will receive a brief feedback on data downloaded from the ABM and information about treatment resources

Treatment:

Behavioral: Feedback

Enhanced usual care

Active Comparator group

Description:

Participant will receive information about remaining abstinent and about treatment resources

Treatment:

Behavioral: Enhanced Usual Care