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Alcohol Biosensor Monitoring for Alcoholic Liver Disease

Alcohol Biosensor Monitoring for Alcoholic Liver Disease

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03533660
Enrollment
33
Registered
2018-05-23
Start date
2018-09-13
Completion date
2021-06-28
Last updated
2022-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcohol Use, Unspecified

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.

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.

Interventions

BEHAVIORALFeedback

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

BEHAVIORALEnhanced Usual Care

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

Sponsors

National Institute on Alcohol Abuse and Alcoholism (NIAAA)
CollaboratorNIH
University of Pittsburgh
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Intervention model description

RCT feedback vs. enhanced usual care

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Percent of Days Drinking Per Interval of Device Wear3 monthsPercent 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
Alcohol Usecontinuous for up to 3 monthsAverage 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.

Secondary

MeasureTime frameDescription
Improved Readiness for Alcohol Abstinence and Initiation of ChangeScores determined at initiation, 6 weeks and 3 months of participationStages 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)
Self Efficacy to Remain AbstinentScores determined at initiation, 6 weeks and 3 months of participationAlcohol 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)
Medical OutcomesCounts determined at initiation, 6 weeks and 3 months of participationAALD related hospitalizations and ER visits - total count of participants in each arm who experienced these outcomes
Qualitative Interviewsmeasured 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
Feedback
Participant will receive a brief feedback on data downloaded from the ABM and information about treatment resources Feedback: Participant will receive a brief feedback on alcohol use data downloaded from the ABM and information about treatment resources
14
Enhanced Usual Care
Participant will receive information about remaining abstinent and about treatment resources Enhanced Usual Care: Participant will receive information on self reported alcohol use and information about remaining abstinent and about treatment resources
13
Total27

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyAdverse Event02
Overall StudyDeath24
Overall StudyWithdrawal by Subject22

Baseline characteristics

CharacteristicEnhanced Usual CareTotalFeedback
Age, Continuous47 years
STANDARD_DEVIATION 10
45 years
STANDARD_DEVIATION 10
43 years
STANDARD_DEVIATION 10
Ethnicity (NIH/OMB)
Hispanic or Latino
1 Participants1 Participants0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
12 Participants26 Participants14 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
1 Participants1 Participants0 Participants
Race (NIH/OMB)
More than one race
1 Participants1 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
11 Participants25 Participants14 Participants
Sex: Female, Male
Female
7 Participants16 Participants9 Participants
Sex: Female, Male
Male
6 Participants11 Participants5 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
2 / 142 / 13
other
Total, other adverse events
7 / 147 / 13
serious
Total, serious adverse events
0 / 140 / 13

Outcome results

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.

Time frame: continuous for up to 3 months

Population: We analyzed data for all 27 participants. Only 6 participants drank alcohol and their data is shown below. The remaining 21 participants had no alcohol use data to present.

ArmMeasureGroupValue (MEAN)Dispersion
Enhanced Usual CareAlcohol UseAverage drinks per drinking episode for first interval (month) of device wear7.4 drinks per episodeStandard Deviation 3.7
Enhanced Usual CareAlcohol UseAverage drinks per drinking episode for second interval (one month) of device wear5.3 drinks per episodeStandard Deviation 3.9
Enhanced Usual CareAlcohol UseAverage drinks per drinking episode for third interval (one month) of device wear4.4 drinks per episodeStandard Deviation 3.5
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

Time frame: 3 months

Population: We analyzed all 27 participants but only 6 participants were found to be drinking. Thus only participants who drank (n=6) were analyzed for drinking outcomes. The numbers at follow up assessments are different than initially enrolled due to drop out

ArmMeasureGroupValue (MEAN)Dispersion
Enhanced Usual CarePercent of Days Drinking Per Interval of Device Wear% Days of drinking per first interval of device wear0.48 percentage of days drinkingStandard Deviation 0.48
Enhanced Usual CarePercent of Days Drinking Per Interval of Device Wear% Days of drinking per second interval of device wear0.74 percentage of days drinkingStandard Deviation 0.16
Enhanced Usual CarePercent of Days Drinking Per Interval of Device Wear% Days of drinking per third interval of device wear0.42 percentage of days drinkingStandard Deviation 0.34
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)

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

Population: numbers at follow up assessments are different than initially enrolled due to drop out

ArmMeasureGroupValue (MEAN)Dispersion
FeedbackImproved Readiness for Alcohol Abstinence and Initiation of ChangeSOCRATES Total Score: Intake assessment82 score on a scaleStandard Deviation 7
FeedbackImproved Readiness for Alcohol Abstinence and Initiation of ChangeSubscale Recognition: intake32 score on a scaleStandard Deviation 3
FeedbackImproved Readiness for Alcohol Abstinence and Initiation of ChangeSubscale Ambivalence: intake14 score on a scaleStandard Deviation 5
FeedbackImproved Readiness for Alcohol Abstinence and Initiation of ChangeSubscale Taking Steps: intake35 score on a scaleStandard Deviation 3
FeedbackImproved Readiness for Alcohol Abstinence and Initiation of ChangeSOCRATES Total Score: 6 week assessment72 score on a scaleStandard Deviation 9
FeedbackImproved Readiness for Alcohol Abstinence and Initiation of ChangeSubscale Recognition: 6 weeks27 score on a scaleStandard Deviation 5
FeedbackImproved Readiness for Alcohol Abstinence and Initiation of ChangeSubscale Ambivalence: 6 weeks9 score on a scaleStandard Deviation 4
FeedbackImproved Readiness for Alcohol Abstinence and Initiation of ChangeSubscale Taking Steps: 6 weeks28 score on a scaleStandard Deviation 5
FeedbackImproved Readiness for Alcohol Abstinence and Initiation of ChangeSOCRATES Total Score: 3 Month assessment70 score on a scaleStandard Deviation 6
FeedbackImproved Readiness for Alcohol Abstinence and Initiation of ChangeSubscale Recognition: 3 months24 score on a scaleStandard Deviation 5
FeedbackImproved Readiness for Alcohol Abstinence and Initiation of ChangeSubscale Ambivalence: 3 months9 score on a scaleStandard Deviation 4
FeedbackImproved Readiness for Alcohol Abstinence and Initiation of ChangeSubscale Taking Steps: 3 months28 score on a scaleStandard Deviation 4
Enhanced Usual CareImproved Readiness for Alcohol Abstinence and Initiation of ChangeSubscale Ambivalence: 3 months13 score on a scaleStandard Deviation 5
Enhanced Usual CareImproved Readiness for Alcohol Abstinence and Initiation of ChangeSOCRATES Total Score: Intake assessment79 score on a scaleStandard Deviation 14
Enhanced Usual CareImproved Readiness for Alcohol Abstinence and Initiation of ChangeSubscale Ambivalence: 6 weeks13 score on a scaleStandard Deviation 4
Enhanced Usual CareImproved Readiness for Alcohol Abstinence and Initiation of ChangeSubscale Recognition: intake31 score on a scaleStandard Deviation 6
Enhanced Usual CareImproved Readiness for Alcohol Abstinence and Initiation of ChangeSubscale Recognition: 3 months28 score on a scaleStandard Deviation 7
Enhanced Usual CareImproved Readiness for Alcohol Abstinence and Initiation of ChangeSubscale Ambivalence: intake13 score on a scaleStandard Deviation 4
Enhanced Usual CareImproved Readiness for Alcohol Abstinence and Initiation of ChangeSubscale Taking Steps: 6 weeks33 score on a scaleStandard Deviation 4
Enhanced Usual CareImproved Readiness for Alcohol Abstinence and Initiation of ChangeSubscale Taking Steps: intake34 score on a scaleStandard Deviation 5
Enhanced Usual CareImproved Readiness for Alcohol Abstinence and Initiation of ChangeSubscale Taking Steps: 3 months31 score on a scaleStandard Deviation 5
Enhanced Usual CareImproved Readiness for Alcohol Abstinence and Initiation of ChangeSOCRATES Total Score: 6 week assessment77 score on a scaleStandard Deviation 13
Enhanced Usual CareImproved Readiness for Alcohol Abstinence and Initiation of ChangeSOCRATES Total Score: 3 Month assessment73 score on a scaleStandard Deviation 15
Enhanced Usual CareImproved Readiness for Alcohol Abstinence and Initiation of ChangeSubscale Recognition: 6 weeks31 score on a scaleStandard Deviation 6
p-value: <0.05t-test, 2 sided
p-value: >0.05t-test, 2 sided
Secondary

Medical Outcomes

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

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

Population: Two participants in the EUC arm had died by the 3 month assessment

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
FeedbackMedical OutcomesIntake assessment: Count of participants in emergency room in prior 90 days5 Participants
FeedbackMedical Outcomes6 week assessment: Count of participants in emergency room between intake and 6 week assessment4 Participants
FeedbackMedical OutcomesIntake assessment: Count of participants hospitalized in prior 90 days14 Participants
FeedbackMedical Outcomes6 week assessment: Count of participants hospitalized between intake and 6 week assessment6 Participants
FeedbackMedical Outcomes3 month assessment: Count of participants in emergency room between 6 week and 3 month assessment2 Participants
FeedbackMedical Outcomes3 month assessment: Count of participants hospitalized between 6 week and 3 month assessment2 Participants
Enhanced Usual CareMedical Outcomes3 month assessment: Count of participants in emergency room between 6 week and 3 month assessment3 Participants
Enhanced Usual CareMedical OutcomesIntake assessment: Count of participants hospitalized in prior 90 days12 Participants
Enhanced Usual CareMedical OutcomesIntake assessment: Count of participants in emergency room in prior 90 days2 Participants
Enhanced Usual CareMedical Outcomes6 week assessment: Count of participants hospitalized between intake and 6 week assessment6 Participants
Enhanced Usual CareMedical Outcomes6 week assessment: Count of participants in emergency room between intake and 6 week assessment5 Participants
Enhanced Usual CareMedical Outcomes3 month assessment: Count of participants hospitalized between 6 week and 3 month assessment2 Participants
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.

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

Population: Includes 21 participants who completed the study and 2 additional participants who had to withdraw prior to completing the full study but were able to complete the qualitative interview. The purpose of qualitative interviews was to determine themes across both groups not between groups. We assigned qualitative data its own separate purpose within the larger project. We did not plan to quantitatively analyze the qualitative data.

ArmMeasureGroupValue (NUMBER)
FeedbackQualitative InterviewsPositive Usability examples: comfortable, no interference activities/lifestyle/sleep, easy to wear6 Themes
FeedbackQualitative InterviewsPositive Acceptability example: looks didn't bother, didn't feel self-conscious, didn't hide purpose8 Themes
FeedbackQualitative InterviewsPositive Feasibility examples: willing to wear, didn't take off, wouldn't change dr relationship7 Themes
FeedbackQualitative InterviewsPositive Efficiency examples: benefit if prescribed, improve honesty, more data/ better/ accurate6 Themes
FeedbackQualitative InterviewsPositive Impact of device on behavior examples: visual deterrent, accountability, therapeutic value10 Themes
FeedbackQualitative InterviewsPositive Preferences, Facilitators, or Barriers: helpful if dr prescribed, gives proof not drinking9 Themes
FeedbackQualitative InterviewsNegative Usability examples: uncomfortable/cumbersome/annoying, interfered with sleep7 Themes
FeedbackQualitative InterviewsNegative Acceptability examples: conspicuous, felt self-conscious, appearance not optimal4 Themes
FeedbackQualitative InterviewsNegative Feasibility examples: had to take off for a lot of activities/ to avoid damaging6 Themes
FeedbackQualitative InterviewsNegative Efficiency examples: Wouldn't improve medical care, already honest about alcohol use2 Themes
FeedbackQualitative InterviewsNegative Impact of device on behavior examples: can't prevent drinking, have to buy into concept5 Themes
FeedbackQualitative InterviewsNegative Preferences, Facilitators, or Barriers: potential negative feelings/stigma/reminder8 Themes
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)

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

Population: numbers at follow up assessments are different than initially enrolled due to drop out

ArmMeasureGroupValue (MEAN)Dispersion
FeedbackSelf Efficacy to Remain AbstinentSubscale Withdrawal Urges: intake19 score on a scaleStandard Deviation 5
FeedbackSelf Efficacy to Remain AbstinentSubscale Physical Concern: 6 weeks23 score on a scaleStandard Deviation 2
FeedbackSelf Efficacy to Remain AbstinentSubscale Negative Affect: intake20 score on a scaleStandard Deviation 5
FeedbackSelf Efficacy to Remain AbstinentSubscale Withdrawal Urges: 6 weeks21 score on a scaleStandard Deviation 3
FeedbackSelf Efficacy to Remain AbstinentAlcohol Self Efficacy Scale: 6 week assessment88 score on a scaleStandard Deviation 10
FeedbackSelf Efficacy to Remain AbstinentAlcohol Self Efficacy Scale: 3 month assessment91 score on a scaleStandard Deviation 11
FeedbackSelf Efficacy to Remain AbstinentSubscale Physical Concern: intake22 score on a scaleStandard Deviation 3
FeedbackSelf Efficacy to Remain AbstinentSubscale Negative Affect: 3 months22 score on a scaleStandard Deviation 4
FeedbackSelf Efficacy to Remain AbstinentSubscale Negative Affect: 6 weeks21 score on a scaleStandard Deviation 3
FeedbackSelf Efficacy to Remain AbstinentSubscale Social Positive: 3 months23 score on a scaleStandard Deviation 3
FeedbackSelf Efficacy to Remain AbstinentSubscale Social Positive: intake21 score on a scaleStandard Deviation 4
FeedbackSelf Efficacy to Remain AbstinentSubscale Physical Concern: 3 months24 score on a scaleStandard Deviation 2
FeedbackSelf Efficacy to Remain AbstinentSubscale Social Positive: 6 weeks23 score on a scaleStandard Deviation 3
FeedbackSelf Efficacy to Remain AbstinentSubscale Withdrawal Urges: 3 months23 score on a scaleStandard Deviation 3
FeedbackSelf Efficacy to Remain AbstinentAlcohol Self Efficacy Scale: Intake assessment82 score on a scaleStandard Deviation 15
Enhanced Usual CareSelf Efficacy to Remain AbstinentSubscale Withdrawal Urges: 3 months19 score on a scaleStandard Deviation 8
Enhanced Usual CareSelf Efficacy to Remain AbstinentAlcohol Self Efficacy Scale: Intake assessment85 score on a scaleStandard Deviation 25
Enhanced Usual CareSelf Efficacy to Remain AbstinentSubscale Negative Affect: intake21 score on a scaleStandard Deviation 7
Enhanced Usual CareSelf Efficacy to Remain AbstinentSubscale Social Positive: intake21 score on a scaleStandard Deviation 7
Enhanced Usual CareSelf Efficacy to Remain AbstinentSubscale Physical Concern: intake22 score on a scaleStandard Deviation 6
Enhanced Usual CareSelf Efficacy to Remain AbstinentSubscale Withdrawal Urges: intake22 score on a scaleStandard Deviation 6
Enhanced Usual CareSelf Efficacy to Remain AbstinentAlcohol Self Efficacy Scale: 6 week assessment83 score on a scaleStandard Deviation 26
Enhanced Usual CareSelf Efficacy to Remain AbstinentSubscale Negative Affect: 6 weeks20 score on a scaleStandard Deviation 7
Enhanced Usual CareSelf Efficacy to Remain AbstinentSubscale Social Positive: 6 weeks20 score on a scaleStandard Deviation 7
Enhanced Usual CareSelf Efficacy to Remain AbstinentSubscale Physical Concern: 6 weeks21 score on a scaleStandard Deviation 6
Enhanced Usual CareSelf Efficacy to Remain AbstinentSubscale Withdrawal Urges: 6 weeks21 score on a scaleStandard Deviation 6
Enhanced Usual CareSelf Efficacy to Remain AbstinentAlcohol Self Efficacy Scale: 3 month assessment77 score on a scaleStandard Deviation 30
Enhanced Usual CareSelf Efficacy to Remain AbstinentSubscale Negative Affect: 3 months20 score on a scaleStandard Deviation 7
Enhanced Usual CareSelf Efficacy to Remain AbstinentSubscale Social Positive: 3 months18 score on a scaleStandard Deviation 9
Enhanced Usual CareSelf Efficacy to Remain AbstinentSubscale Physical Concern: 3 months20 score on a scaleStandard Deviation 6
p-value: >0.05t-test, 2 sided

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026