Alcohol Biosensor Monitoring for Alcoholic Liver Disease

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-13

Study Completion Date

2021-06-28

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.

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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.

Conditions

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Alcohol Use, Unspecified

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

RCT feedback vs. enhanced usual care

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Feedback

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

Group Type ACTIVE_COMPARATOR

Feedback

Intervention Type BEHAVIORAL

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

Enhanced usual care

Participant will receive information about remaining abstinent and about treatment resources

Group Type ACTIVE_COMPARATOR

Enhanced Usual Care

Intervention Type BEHAVIORAL

Participant will receive information on self reported alcohol use and information about remaining abstinent and about treatment resources

Interventions

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Feedback

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

Intervention Type BEHAVIORAL

Enhanced Usual Care

Participant will receive information on self reported alcohol use and information about remaining abstinent and about treatment resources

Intervention Type BEHAVIORAL

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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No