Alcohol Biosensor Monitoring for Alcoholic Liver Disease

Alcohol Use, Unspecified Clinical Trial

Official title:

Alcohol Biosensor Monitoring for Alcoholic Liver Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03533660
• Other study ID #: R21AA025730
• Secondary ID: R21AA025730
• Status: Completed
• Phase: N/A
• Start date: September 13, 2018
• Est. completion date: June 28, 2021

Study information

• Verified date: November 2022
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: June 28, 2021
• Est. primary completion date: February 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Alcohol Use, Unspecified
• Liver Diseases
• Liver Diseases, Alcoholic

Intervention

Behavioral:
• Feedback
Participant will receive a brief feedback on alcohol use data downloaded from the ABM and information about treatment resources
• Enhanced Usual Care
Participant will receive information on self reported alcohol use and information about remaining abstinent and about treatment resources

Locations

Country	Name	City	State
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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)