NCT03533660

Alcohol Biosensor Monitoring for Alcoholic Liver Disease

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: University of Pittsburgh · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Alcohol Use, Unspecified

Interventions

Type	Name	Description
BEHAVIORAL	Feedback	Participant will receive a brief feedback on alcohol use data downloaded from the ABM and information about treatment resources
BEHAVIORAL	Enhanced Usual Care	Participant will receive information on self reported alcohol use and information about remaining abstinent and about treatment resources

Timeline

• Start date: 2018-09-13
• Primary completion: 2021-02-28
• Completion: 2021-06-28
• First posted: 2018-05-23
• Last updated: 2022-11-07
• Results posted: 2022-11-07

Locations

1 site across 1 country: United States