Alcohol Biosensor Monitoring for Alcoholic Liver Disease
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- alcohol use [continuous for up to 3 months]
The data from the ABM will produce a continuous profile of drinking and changes in drinking. The AMB can create a complete picture of the distribution of drinking days. The temporal pattern, variability, and level of drinking will be determined.
Secondary Outcome Measures
- improved readiness for alcohol abstinence and initiation of change [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 for; 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)
- self efficacy to remain abstinent [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. 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)
- medical outcomes [Scores determined at initiation, 6 weeks and 3 months of participation]
AALD related hospitalizations and ER visits - total count of these events for each participant
- Qualitative interviews [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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients with AALD followed at our liver disease clinic,
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18 years or older,
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willing to accept randomization,
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and agree to wear device for 3 months,
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SOCRATES problem recognition subscale score >26 (scores <26 indicate very low recognition of an alcohol problem).
Exclusion Criteria:
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Non-English speaking,
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Montreal Cognitive Assessment (MOCA) scores <21 (moderate cognitive impairment) or neurologic diseases (e.g. Parkinson's),
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patients with unresponsive acute alcoholic hepatitis, multi-organ failure, fulminant hepatic failure,
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cancer/terminal illness;
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those unable to wear a wrist monitor (e.g., edema);
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lacking a residence, or unable to identify a contact person (if lost to follow-up).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | United States | 15213 |
Sponsors and Collaborators
- University of Pittsburgh
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators
- Principal Investigator: Andrea DiMartini, MD, University of Pittsburgh
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- R21AA025730
- R21AA025730