Alcohol Biosensor Monitoring for Alcoholic Liver Disease
1 other identifier
interventional
33
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2018
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 13, 2018
CompletedFirst Posted
Study publicly available on registry
May 23, 2018
CompletedStudy Start
First participant enrolled
September 13, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 28, 2021
CompletedResults Posted
Study results publicly available
November 7, 2022
CompletedNovember 7, 2022
November 1, 2022
2.5 years
April 13, 2018
July 1, 2022
November 4, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
Alcohol Use
Average number of drinks per drinking episode per interval (month) of device wear. We analyzed the number of drinks per drinking episode and present the group average per month interval of assessment.
continuous for up to 3 months
Percent of Days Drinking Per Interval of Device Wear
Percent of days drinking per interval of device wear: We analyzed the data by number of drinking episodes per individual per days of device wear and present the mean percent days drinking per assessment interval
3 months
Secondary Outcomes (4)
Improved Readiness for Alcohol Abstinence and Initiation of Change
Scores determined at initiation, 6 weeks and 3 months of participation
Self Efficacy to Remain Abstinent
Scores determined at initiation, 6 weeks and 3 months of participation
Medical Outcomes
Counts determined at initiation, 6 weeks and 3 months of participation
Qualitative Interviews
measured at three months (completion of the participants use of ABM)
Study Arms (2)
Feedback
ACTIVE COMPARATORParticipant will receive a brief feedback on data downloaded from the ABM and information about treatment resources
Enhanced usual care
ACTIVE COMPARATORParticipant will receive information about remaining abstinent and about treatment resources
Interventions
Participant will receive a brief feedback on alcohol use data downloaded from the ABM and information about treatment resources
Participant will receive information on self reported alcohol use and information about remaining abstinent and about treatment resources
Eligibility Criteria
You may qualify if:
- Patients with AALD followed at our liver disease clinic,
- 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).
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
Related Publications (1)
DiMartini A, Behari J, Dunn M, Bataller RA, Jakicic JM, McNulty M, Young RC, Dew MA. Challenges and Solutions for Monitoring Alcohol Use in Patients With Alcohol-Related Liver Disease: Pilot Study of a Wearable Alcohol Biosensor. Psychosom Med. 2023 Sep 1;85(7):596-604. doi: 10.1097/PSY.0000000000001203. Epub 2023 Apr 17.
PMID: 37097109DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Andrea DiMartini
- Organization
- University of Pittsburgh
Study Officials
- PRINCIPAL INVESTIGATOR
Andrea DiMartini, MD
University of Pittsburgh
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Psychiatry and Surgery
Study Record Dates
First Submitted
April 13, 2018
First Posted
May 23, 2018
Study Start
September 13, 2018
Primary Completion
February 28, 2021
Study Completion
June 28, 2021
Last Updated
November 7, 2022
Results First Posted
November 7, 2022
Record last verified: 2022-11
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- To provide the investigators adequate time to prepare and submit the majority of publications likely to result from the research, data obtained from the study will be made publicly available no sooner than 18 months after the conclusion of the study.
- Access Criteria
- Access can be requested from PI following plan description and time frame noted above
The study database will be reviewed to ensure that no identifying information of any type is contained therein. A downloadable, de-identified data set and data dictionary will be made available electronically from the PI after the request is reviewed by the research team for scientific merit and requestors provide evidence to the PI that (a) their plan for the use of such data has been approved by their institution's Institutional Review Board or its equivalent, and (b) they have completed NIH requirements for training in research integrity and human subjects protection.