N/A N=33 Randomized Single-blind Prevention

Alcohol Biosensor Monitoring for Alcoholic Liver Disease

Alcohol Use, Unspecified

Bottom Line

View on ClinicalTrials.gov: NCT03533660 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2022

Primary outcome: Primary: Alcohol Use — 7.4; 5.3; 4.4 drinks per episode

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Feedback (Behavioral); Enhanced Usual Care (Behavioral)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Pittsburgh
Primary completion: Feb 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Alcohol Use	7.4; 5.3; 4.4	—
PRIMARY Percent of Days Drinking Per Interval of Device Wear	0.48; 0.74; 0.42	—
SECONDARY Improved Readiness for Alcohol Abstinence and Initiation of Change	82; 79; 32; 31; 14; 13	<.05 sig
SECONDARY Self Efficacy to Remain Abstinent	82; 85; 20; 21; 21; 21	>.05
SECONDARY Medical Outcomes	14; 12; 5; 2; 6; 6	—
SECONDARY Qualitative Interviews	6; 8; 7; 6; 10; 9	—

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.

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).

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03533660). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.