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Completed

NCT Number: NCT03533660

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.

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Key information

Conditions

Alcohol Use, Unspecified Alcohol Drinking Behavior Drinking Behavior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Feedback

Behavioral

Participant will receive a brief feedback on alcohol use data downloaded from the ABM and information about treatment resources

Enhanced Usual Care

Behavioral

Participant will receive information on self reported alcohol use and information about remaining abstinent and about treatment resources

Primary outcomes

  1. Alcohol Use

    Time frame: continuous for up to 3 months

    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.

  2. Percent of Days Drinking Per Interval of Device Wear

    Time frame: 3 months

    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

Secondary outcomes

  1. Improved Readiness for Alcohol Abstinence and Initiation of Change

    Time frame: Scores determined at initiation, 6 weeks and 3 months of participation

    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)

  2. Self Efficacy to Remain Abstinent

    Time frame: Scores determined at initiation, 6 weeks and 3 months of participation

    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)

  3. Medical Outcomes

    Time frame: Counts determined at initiation, 6 weeks and 3 months of participation

    AALD related hospitalizations and ER visits - total count of participants in each arm who experienced these outcomes

  4. Qualitative Interviews

    Time frame: measured at three months (completion of the participants use of ABM)

    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.

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
May 23, 2018
Registry last updated
Nov 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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