N/A
Completed N=33
Alcohol Biosensor Monitoring for Alcoholic Liver Disease
Alcohol Use, Unspecified
Source: ClinicalTrials.gov NCT03533660 ↗
Enrolled (actual)
33
Serious AEs
0.0%
Results posted
Nov 2022
Primary outcomePrimary: Alcohol Use — 7.4; 5.3; 4.4 drinks per episode
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.
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 | — |
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).
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. Informational only — not medical advice.