Alcohol Biosensor Monitoring for Alcoholic Liver Disease



Status:Recruiting
Conditions:Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - Any
Updated:9/19/2018
Start Date:September 13, 2018
End Date:February 2020
Contact:Andrea DiMartini, MD
Email:dimartiniaf@upmc.edu
Phone:412-692-4797

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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.

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.

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).
We found this trial at
1
site
200 Lothrop St
Pittsburgh, Pennsylvania 15213
Phone: 412-647-7627
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