Clinical trial NCT03533660: Alcohol Biosensor Monitoring for Alcoholic Liver Disease
Official title: Alcohol Biosensor Monitoring for Alcoholic Liver Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Use, Unspecified
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2018-05-23
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: RCT feedback vs. enhanced usual care
Primary purpose: PREVENTION

Brief 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.

Eligibility 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).

Primary outcomes:
measure: Alcohol Use
timeFrame: continuous for up to 3 months
measure: Percent of Days Drinking Per Interval of Device Wear
timeFrame: 3 months
Secondary outcomes:
measure: Improved Readiness for Alcohol Abstinence and Initiation of Change
timeFrame: Scores determined at initiation, 6 weeks and 3 months of participation
measure: Self Efficacy to Remain Abstinent
timeFrame: Scores determined at initiation, 6 weeks and 3 months of participation
measure: Medical Outcomes
timeFrame: Counts determined at initiation, 6 weeks and 3 months of participation
measure: Qualitative Interviews
timeFrame: measured at three months (completion of the participants use of ABM)
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Andrea DiMartini, MD
role: PRINCIPAL_INVESTIGATOR
References: