Alcohol Biosensor Monitoring for Alcoholic Liver Disease

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 Overview

• Status: Completed
• Conditions: Alcohol Use, Unspecified
• Intervention / Treatment: Behavioral: Feedback; Behavioral: Enhanced Usual Care

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.

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Feedback; Participant will receive a brief feedback on data downloaded from the ABM and information about treatment resources	Behavioral: Feedback; Participant will receive a brief feedback on alcohol use data downloaded from the ABM and information about treatment resources
Active Comparator: Enhanced usual care; Participant will receive information about remaining abstinent and about treatment resources	Behavioral: Enhanced Usual Care; Participant will receive information on self reported alcohol use and information about remaining abstinent and about treatment resources

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improved Readiness for Alcohol Abstinence and Initiation of Change	Stages of Change Readiness & Treatment Eagerness Scale (SOCRATES) is a 19-item instrument that measures readiness for change assessing three areas; ambivalence, recognition, and taking steps with change scores assessing the impact of an intervention on these areas. Three subscale scores are produced with total scores ranging 19-95 and higher score indicating greater readiness: 7 items for recognition of an alcohol problem (scores range from low of 7 to highest of 35); 4 items for ambivalence (range from low of 4 to highest of 20); 8 items for taking steps to make a positive change in drinking (range from low of 8 to highest of 40)	Scores determined at initiation, 6 weeks and 3 months of participation
Self Efficacy to Remain Abstinent	Alcohol Abstinence Self-efficacy (AASE) evaluates confidence in ability to abstain from drinking in situations that represent typical drinking cues. Four subscales with 5 specific situations each are rated on confidence not to drink in each situations on a 5-point Likert scale from 1=not at all confident to 5=extremely confident. Total scores range from 20-100 with higher scores reflecting greater self confidence not to drink.; negative affect situations (range from low confidence of 5 to highest confidence of 25); social/positive situations (range from low confidence of 5 to highest confidence of 25); physical and other concerns situations (range from low confidence of 5 to highest confidence of 25); cravings and urges situations (range from low confidence of 5 to highest confidence of 25)	Scores determined at initiation, 6 weeks and 3 months of participation
Medical Outcomes	AALD related hospitalizations and ER visits - total count of participants in each arm who experienced these outcomes	Counts determined at initiation, 6 weeks and 3 months of participation
Qualitative Interviews	Qualitative interviews of participants will use a semi-structured script of open-ended stem questions with prompts. The qualitative assessment will cover such topics as patients' perceived need/psychologic barriers (e.g., beliefs in value of ABM in their clinical care and for their relationship with clinicians) and experience with ABM (e.g., wearability, satisfaction, and barriers to monitoring). Transcribed interviews will be thematically coded. The constant comparison method will be used, and subsequent interviews may be modified/informed by findings from previous interviews to explore emerging themes as the analysis proceeds.	measured at three months (completion of the participants use of ABM)

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Investigators: Principal Investigator: Andrea DiMartini, MD, University of Pittsburgh

Study record dates

Study Major Dates

• Study Start (Actual): September 13, 2018
• Primary Completion (Actual): February 28, 2021
• Study Completion (Actual): June 28, 2021

Study Registration Dates

• First Submitted: April 13, 2018
• First Submitted That Met QC Criteria: May 10, 2018
• First Posted (Actual): May 23, 2018

Study Record Updates

• Last Update Posted (Actual): November 7, 2022
• Last Update Submitted That Met QC Criteria: November 4, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Digestive System Diseases; Alcohol-Related Disorders; Substance-Related Disorders; Alcohol-Induced Disorders; Liver Diseases; Liver Diseases, Alcoholic
• Other Study ID Numbers: R21AA025730 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing 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.
• IPD Sharing Access Criteria: Access can be requested from PI following plan description and time frame noted above

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No