Alcohol Use, UnspecifiedNCT03533660
Alcohol Biosensor Monitoring for Alcoholic Liver Disease
A study testing Feedback in people with Alcohol Use, Unspecified, run by University of Pittsburgh at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol Use, Unspecified
- What is being tested?
- Feedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Sep 2018to 28 Jun 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
About this study
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.
Read the 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.
- Conditions
- Alcohol Use, Unspecified
- Being tested
- Feedback, Enhanced Usual Care
- Medical subject headings
- Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FeedbackBehavioural
Participant will receive a brief feedback on alcohol use data downloaded from the ABM and information about treatment resources
Enhanced Usual CareBehavioural
Participant will receive information on self reported alcohol use and information about remaining abstinent and about treatment resources
| Study group | Role | What they receive |
|---|---|---|
| Feedback | Active comparator | Participant will receive a brief feedback on data downloaded from the ABM and information about treatment resources Receives: Behavioral: Feedback |
| Enhanced usual care | Active comparator | Participant will receive information about remaining abstinent and about treatment resources Receives: Behavioral: Enhanced Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 3 months
Secondary outcomes (4)
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)
Measured: 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)
Measured: 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
Measured: 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: measured at three months (completion of the participants use of ABM)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2018
- Study start13 Sep 2018
- Primary completion28 Feb 2021
- Study completion28 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Alcohol Use, UnspecifiedStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- RCT feedback vs. enhanced usual care
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Andrea DiMartini, University of Pittsburgh
- Investigators
- Andrea DiMartini, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03533660
- Sponsor's protocol ID
- R21AA025730
- Other IDs
- R21AA025730
- Status last verified
- Nov 2022
- First submitted
- 13 Apr 2018
- Last updated
- 7 Nov 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
DiMartini A, Behari J, Punzi J, Dunn M, Bataller R, Jakicic JM, McNulty M, Young RC, Dew MA. What hepatology clinicians and their patients with alcohol-related liver disease think of wearable alcohol biosensors to aid abstinence from alcohol: A qualitative study. Drug Alcohol Rev. 2025 Feb;44(2):532-554. doi: 10.1111/dar.13978. Epub 2024 Dec 9.
PubMed 39654280DiMartini 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.
PubMed 37097109
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alcohol Biosensor Monitoring for Alcoholic Liver Disease
- ClinicalTrials.gov ID
- NCT03533660
- Acronym / sponsor ID
- R21AA025730
- Conditions
- Alcohol Use, Unspecified
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 13 Sep 2018 (actual)
- Primary completion
- 28 Feb 2021 (actual)
- Study completion
- 28 Jun 2021 (actual)
- First posted
- 23 May 2018 (actual)
- Results
- Posted 7 Nov 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- RCT feedback vs. enhanced usual care
| Arm | Type | Receives |
|---|---|---|
| Feedback | Active comparator | Behavioral: FeedbackParticipant will receive a brief feedback on data downloaded from the ABM and information about treatment resources |
| Enhanced usual care | Active comparator | Behavioral: Enhanced Usual CareParticipant will receive information about remaining abstinent and about treatment resources |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (6 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FeedbackParticipant will receive a brief feedback on alcohol use data downloaded from the ABM and information about treatment resources | Behavioural | Feedback |
| Enhanced Usual CareParticipant will receive information on self reported alcohol use and information about remaining abstinent and about treatment resources | Behavioural | Enhanced usual care |
Primary outcome
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.
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
4 secondary outcomes
Improved Readiness for Alcohol Abstinence and Initiation of Change
Time frame: Scores determined at initiation, 6 weeks and 3 months of participation
Self Efficacy to Remain Abstinent
Time frame: Scores determined at initiation, 6 weeks and 3 months of participation
Medical Outcomes
Time frame: Counts determined at initiation, 6 weeks and 3 months of participation
Qualitative Interviews
Time frame: measured at three months (completion of the participants use of ABM)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39654280DiMartini A, Behari J, Punzi J, Dunn M, Bataller R, Jakicic JM, McNulty M, Young RC, Dew MA. What hepatology clinicians and their patients with alcohol-related liver disease think of wearable alcohol biosensors to aid abstinence from alcohol: A qualitative study. Drug Alcohol Rev. 2025 Feb;44(2):532-554. doi: 10.1111/dar.13978. Epub 2024 Dec 9.
- Derived from this study: PubMed 37097109DiMartini 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea DiMartini, MD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Feedback in people with Alcohol Use, Unspecified, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Nov 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alcohol Use (time frame: continuous for up to 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03533660, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2022.