Pittsburgh, Pennsylvania 15213

  • Alcohol Use, Unspecified

Purpose:

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.


Study summary:

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.


Criteria:

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).


NCT ID:

NCT03533660


Primary Contact:

Principal Investigator
Andrea DiMartini, MD
University of Pittsburgh

Andrea DiMartini, MD
Phone: 412-692-4797
Email: dimartiniaf@upmc.edu


Backup Contact:

N/A


Location Contact:

Pittsburgh, Pennsylvania 15213
United States

Andrea DiMartini, MD
Phone: 412-647-7627

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: June 20, 2021

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