Trial Outcomes & Findings for Alcohol Biosensor Monitoring for Alcoholic Liver Disease (NCT NCT03533660)
NCT ID: NCT03533660
Last Updated: 2022-11-07
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
33 participants
Primary outcome timeframe
continuous for up to 3 months
Results posted on
2022-11-07
Participant Flow
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
18
|
|
Overall Study
COMPLETED
|
11
|
10
|
|
Overall Study
NOT COMPLETED
|
4
|
8
|
Reasons for withdrawal
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
|
Overall Study
Death
|
2
|
4
|
|
Overall Study
Adverse Event
|
0
|
2
|
Baseline Characteristics
Alcohol Biosensor Monitoring for Alcoholic Liver Disease
Baseline characteristics by cohort
| Measure |
Feedback
n=14 Participants
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
|
Enhanced Usual Care
n=13 Participants
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
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
43 years
STANDARD_DEVIATION 10 • n=5 Participants
|
47 years
STANDARD_DEVIATION 10 • n=7 Participants
|
45 years
STANDARD_DEVIATION 10 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: continuous for up to 3 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Feedback
These data are only on those in the feedback group who drank
|
Enhanced Usual Care
n=6 Participants
These data are only on those in the EUC group who drank
|
|---|---|---|
|
Alcohol Use
Average drinks per drinking episode for first interval (month) of device wear
|
—
|
7.4 drinks per episode
Standard Deviation 3.7
|
|
Alcohol Use
Average drinks per drinking episode for second interval (one month) of device wear
|
—
|
5.3 drinks per episode
Standard Deviation 3.9
|
|
Alcohol Use
Average drinks per drinking episode for third interval (one month) of device wear
|
—
|
4.4 drinks per episode
Standard Deviation 3.5
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: 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
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
Outcome measures
| Measure |
Feedback
These data are only on those in the feedback group who drank
|
Enhanced Usual Care
n=6 Participants
These data are only on those in the EUC group who drank
|
|---|---|---|
|
Percent of Days Drinking Per Interval of Device Wear
% Days of drinking per first interval of device wear
|
—
|
0.48 percentage of days drinking
Standard Deviation 0.48
|
|
Percent of Days Drinking Per Interval of Device Wear
% Days of drinking per second interval of device wear
|
—
|
0.74 percentage of days drinking
Standard Deviation 0.16
|
|
Percent of Days Drinking Per Interval of Device Wear
% Days of drinking per third interval of device wear
|
—
|
0.42 percentage of days drinking
Standard Deviation 0.34
|
SECONDARY outcome
Timeframe: Scores determined at initiation, 6 weeks and 3 months of participationPopulation: numbers at follow up assessments are different than initially enrolled due to drop out
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)
Outcome measures
| Measure |
Feedback
n=14 Participants
These data are only on those in the feedback group who drank
|
Enhanced Usual Care
n=13 Participants
These data are only on those in the EUC group who drank
|
|---|---|---|
|
Improved Readiness for Alcohol Abstinence and Initiation of Change
SOCRATES Total Score: Intake assessment
|
82 score on a scale
Standard Deviation 7
|
79 score on a scale
Standard Deviation 14
|
|
Improved Readiness for Alcohol Abstinence and Initiation of Change
Subscale Recognition: intake
|
32 score on a scale
Standard Deviation 3
|
31 score on a scale
Standard Deviation 6
|
|
Improved Readiness for Alcohol Abstinence and Initiation of Change
Subscale Ambivalence: intake
|
14 score on a scale
Standard Deviation 5
|
13 score on a scale
Standard Deviation 4
|
|
Improved Readiness for Alcohol Abstinence and Initiation of Change
Subscale Taking Steps: intake
|
35 score on a scale
Standard Deviation 3
|
34 score on a scale
Standard Deviation 5
|
|
Improved Readiness for Alcohol Abstinence and Initiation of Change
SOCRATES Total Score: 6 week assessment
|
72 score on a scale
Standard Deviation 9
|
77 score on a scale
Standard Deviation 13
|
|
Improved Readiness for Alcohol Abstinence and Initiation of Change
Subscale Recognition: 6 weeks
|
27 score on a scale
Standard Deviation 5
|
31 score on a scale
Standard Deviation 6
|
|
Improved Readiness for Alcohol Abstinence and Initiation of Change
Subscale Ambivalence: 6 weeks
|
9 score on a scale
Standard Deviation 4
|
13 score on a scale
Standard Deviation 4
|
|
Improved Readiness for Alcohol Abstinence and Initiation of Change
Subscale Taking Steps: 6 weeks
|
28 score on a scale
Standard Deviation 5
|
33 score on a scale
Standard Deviation 4
|
|
Improved Readiness for Alcohol Abstinence and Initiation of Change
SOCRATES Total Score: 3 Month assessment
|
70 score on a scale
Standard Deviation 6
|
73 score on a scale
Standard Deviation 15
|
|
Improved Readiness for Alcohol Abstinence and Initiation of Change
Subscale Recognition: 3 months
|
24 score on a scale
Standard Deviation 5
|
28 score on a scale
Standard Deviation 7
|
|
Improved Readiness for Alcohol Abstinence and Initiation of Change
Subscale Ambivalence: 3 months
|
9 score on a scale
Standard Deviation 4
|
13 score on a scale
Standard Deviation 5
|
|
Improved Readiness for Alcohol Abstinence and Initiation of Change
Subscale Taking Steps: 3 months
|
28 score on a scale
Standard Deviation 4
|
31 score on a scale
Standard Deviation 5
|
SECONDARY outcome
Timeframe: Scores determined at initiation, 6 weeks and 3 months of participationPopulation: numbers at follow up assessments are different than initially enrolled due to drop out
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)
Outcome measures
| Measure |
Feedback
n=14 Participants
These data are only on those in the feedback group who drank
|
Enhanced Usual Care
n=13 Participants
These data are only on those in the EUC group who drank
|
|---|---|---|
|
Self Efficacy to Remain Abstinent
Alcohol Self Efficacy Scale: Intake assessment
|
82 score on a scale
Standard Deviation 15
|
85 score on a scale
Standard Deviation 25
|
|
Self Efficacy to Remain Abstinent
Subscale Negative Affect: intake
|
20 score on a scale
Standard Deviation 5
|
21 score on a scale
Standard Deviation 7
|
|
Self Efficacy to Remain Abstinent
Subscale Social Positive: intake
|
21 score on a scale
Standard Deviation 4
|
21 score on a scale
Standard Deviation 7
|
|
Self Efficacy to Remain Abstinent
Subscale Physical Concern: intake
|
22 score on a scale
Standard Deviation 3
|
22 score on a scale
Standard Deviation 6
|
|
Self Efficacy to Remain Abstinent
Subscale Withdrawal Urges: intake
|
19 score on a scale
Standard Deviation 5
|
22 score on a scale
Standard Deviation 6
|
|
Self Efficacy to Remain Abstinent
Alcohol Self Efficacy Scale: 6 week assessment
|
88 score on a scale
Standard Deviation 10
|
83 score on a scale
Standard Deviation 26
|
|
Self Efficacy to Remain Abstinent
Subscale Negative Affect: 6 weeks
|
21 score on a scale
Standard Deviation 3
|
20 score on a scale
Standard Deviation 7
|
|
Self Efficacy to Remain Abstinent
Subscale Social Positive: 6 weeks
|
23 score on a scale
Standard Deviation 3
|
20 score on a scale
Standard Deviation 7
|
|
Self Efficacy to Remain Abstinent
Subscale Physical Concern: 6 weeks
|
23 score on a scale
Standard Deviation 2
|
21 score on a scale
Standard Deviation 6
|
|
Self Efficacy to Remain Abstinent
Subscale Withdrawal Urges: 6 weeks
|
21 score on a scale
Standard Deviation 3
|
21 score on a scale
Standard Deviation 6
|
|
Self Efficacy to Remain Abstinent
Alcohol Self Efficacy Scale: 3 month assessment
|
91 score on a scale
Standard Deviation 11
|
77 score on a scale
Standard Deviation 30
|
|
Self Efficacy to Remain Abstinent
Subscale Negative Affect: 3 months
|
22 score on a scale
Standard Deviation 4
|
20 score on a scale
Standard Deviation 7
|
|
Self Efficacy to Remain Abstinent
Subscale Social Positive: 3 months
|
23 score on a scale
Standard Deviation 3
|
18 score on a scale
Standard Deviation 9
|
|
Self Efficacy to Remain Abstinent
Subscale Physical Concern: 3 months
|
24 score on a scale
Standard Deviation 2
|
20 score on a scale
Standard Deviation 6
|
|
Self Efficacy to Remain Abstinent
Subscale Withdrawal Urges: 3 months
|
23 score on a scale
Standard Deviation 3
|
19 score on a scale
Standard Deviation 8
|
SECONDARY outcome
Timeframe: Counts determined at initiation, 6 weeks and 3 months of participationPopulation: Two participants in the EUC arm had died by the 3 month assessment
AALD related hospitalizations and ER visits - total count of participants in each arm who experienced these outcomes
Outcome measures
| Measure |
Feedback
n=14 Participants
These data are only on those in the feedback group who drank
|
Enhanced Usual Care
n=13 Participants
These data are only on those in the EUC group who drank
|
|---|---|---|
|
Medical Outcomes
Intake assessment: Count of participants hospitalized in prior 90 days
|
14 Participants
|
12 Participants
|
|
Medical Outcomes
Intake assessment: Count of participants in emergency room in prior 90 days
|
5 Participants
|
2 Participants
|
|
Medical Outcomes
6 week assessment: Count of participants hospitalized between intake and 6 week assessment
|
6 Participants
|
6 Participants
|
|
Medical Outcomes
6 week assessment: Count of participants in emergency room between intake and 6 week assessment
|
4 Participants
|
5 Participants
|
|
Medical Outcomes
3 month assessment: Count of participants hospitalized between 6 week and 3 month assessment
|
2 Participants
|
2 Participants
|
|
Medical Outcomes
3 month assessment: Count of participants in emergency room between 6 week and 3 month assessment
|
2 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Feedback
n=23 Participants
These data are only on those in the feedback group who drank
|
Enhanced Usual Care
These data are only on those in the EUC group who drank
|
|---|---|---|
|
Qualitative Interviews
Positive Usability examples: comfortable, no interference activities/lifestyle/sleep, easy to wear
|
6 Themes
|
—
|
|
Qualitative Interviews
Positive Acceptability example: looks didn't bother, didn't feel self-conscious, didn't hide purpose
|
8 Themes
|
—
|
|
Qualitative Interviews
Positive Feasibility examples: willing to wear, didn't take off, wouldn't change dr relationship
|
7 Themes
|
—
|
|
Qualitative Interviews
Positive Efficiency examples: benefit if prescribed, improve honesty, more data/ better/ accurate
|
6 Themes
|
—
|
|
Qualitative Interviews
Positive Impact of device on behavior examples: visual deterrent, accountability, therapeutic value
|
10 Themes
|
—
|
|
Qualitative Interviews
Positive Preferences, Facilitators, or Barriers: helpful if dr prescribed, gives proof not drinking
|
9 Themes
|
—
|
|
Qualitative Interviews
Negative Usability examples: uncomfortable/cumbersome/annoying, interfered with sleep
|
7 Themes
|
—
|
|
Qualitative Interviews
Negative Acceptability examples: conspicuous, felt self-conscious, appearance not optimal
|
4 Themes
|
—
|
|
Qualitative Interviews
Negative Feasibility examples: had to take off for a lot of activities/ to avoid damaging
|
6 Themes
|
—
|
|
Qualitative Interviews
Negative Efficiency examples: Wouldn't improve medical care, already honest about alcohol use
|
2 Themes
|
—
|
|
Qualitative Interviews
Negative Impact of device on behavior examples: can't prevent drinking, have to buy into concept
|
5 Themes
|
—
|
|
Qualitative Interviews
Negative Preferences, Facilitators, or Barriers: potential negative feelings/stigma/reminder
|
8 Themes
|
—
|
Adverse Events
Feedback
Serious events: 0 serious events
Other events: 7 other events
Deaths: 2 deaths
Enhanced Usual Care
Serious events: 0 serious events
Other events: 7 other events
Deaths: 2 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Feedback
n=14 participants at risk
Feedback: Participant will receive a brief feedback on alcohol use data downloaded from the ABM and information about treatment resources
|
Enhanced Usual Care
n=13 participants at risk
Participant will receive information about remaining abstinent and about treatment resources
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
skin irritation/indentation
|
50.0%
7/14 • Number of events 7 • Data was collected over the three month period that the participants participated in the study.
We collected data only on those who completed the intake interview and participated in the study (n=27). Data was collected from medical record review and information on device wearing issues was collected during monthly assessments. We tracked mortality, and number of hospitalizations and emergency room visits but our protocol was not to identify the causes/reasons for ER visit/hospitalizations. There were no serious adverse events related to the study.
|
53.8%
7/13 • Number of events 7 • Data was collected over the three month period that the participants participated in the study.
We collected data only on those who completed the intake interview and participated in the study (n=27). Data was collected from medical record review and information on device wearing issues was collected during monthly assessments. We tracked mortality, and number of hospitalizations and emergency room visits but our protocol was not to identify the causes/reasons for ER visit/hospitalizations. There were no serious adverse events related to the study.
|
|
Skin and subcutaneous tissue disorders
strap being itchy/scratchy
|
14.3%
2/14 • Number of events 2 • Data was collected over the three month period that the participants participated in the study.
We collected data only on those who completed the intake interview and participated in the study (n=27). Data was collected from medical record review and information on device wearing issues was collected during monthly assessments. We tracked mortality, and number of hospitalizations and emergency room visits but our protocol was not to identify the causes/reasons for ER visit/hospitalizations. There were no serious adverse events related to the study.
|
30.8%
4/13 • Number of events 4 • Data was collected over the three month period that the participants participated in the study.
We collected data only on those who completed the intake interview and participated in the study (n=27). Data was collected from medical record review and information on device wearing issues was collected during monthly assessments. We tracked mortality, and number of hospitalizations and emergency room visits but our protocol was not to identify the causes/reasons for ER visit/hospitalizations. There were no serious adverse events related to the study.
|
|
Skin and subcutaneous tissue disorders
Uncomfortable
|
28.6%
4/14 • Number of events 4 • Data was collected over the three month period that the participants participated in the study.
We collected data only on those who completed the intake interview and participated in the study (n=27). Data was collected from medical record review and information on device wearing issues was collected during monthly assessments. We tracked mortality, and number of hospitalizations and emergency room visits but our protocol was not to identify the causes/reasons for ER visit/hospitalizations. There were no serious adverse events related to the study.
|
15.4%
2/13 • Number of events 2 • Data was collected over the three month period that the participants participated in the study.
We collected data only on those who completed the intake interview and participated in the study (n=27). Data was collected from medical record review and information on device wearing issues was collected during monthly assessments. We tracked mortality, and number of hospitalizations and emergency room visits but our protocol was not to identify the causes/reasons for ER visit/hospitalizations. There were no serious adverse events related to the study.
|
|
Product Issues
Participants uncomfortable with device appearance
|
7.1%
1/14 • Number of events 1 • Data was collected over the three month period that the participants participated in the study.
We collected data only on those who completed the intake interview and participated in the study (n=27). Data was collected from medical record review and information on device wearing issues was collected during monthly assessments. We tracked mortality, and number of hospitalizations and emergency room visits but our protocol was not to identify the causes/reasons for ER visit/hospitalizations. There were no serious adverse events related to the study.
|
15.4%
2/13 • Number of events 2 • Data was collected over the three month period that the participants participated in the study.
We collected data only on those who completed the intake interview and participated in the study (n=27). Data was collected from medical record review and information on device wearing issues was collected during monthly assessments. We tracked mortality, and number of hospitalizations and emergency room visits but our protocol was not to identify the causes/reasons for ER visit/hospitalizations. There were no serious adverse events related to the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place