Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R21AA025730 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Feedback | Active Comparator | Participant will receive a brief feedback on data downloaded from the ABM and information about treatment resources |
|
| Enhanced usual care | Active Comparator | Participant will receive information about remaining abstinent and about treatment resources |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Feedback | Behavioral | Participant will receive a brief feedback on alcohol use data downloaded from the ABM and information about treatment resources |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
|
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Andrea DiMartini, MD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39654280 | Derived | 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. | |
| 37097109 | Derived | DiMartini 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. |
Not provided
Not provided
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.
Not provided
To provide the investigators adequate time to prepare and submit the majority of publications likely to result from the research, data obtained from the study will be made publicly available no sooner than 18 months after the conclusion of the study.
Access can be requested from PI following plan description and time frame noted above
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
These 27 participants are those that went through the initial intake assessment and thus are included in the analyses
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Enhanced Usual Care |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Mean | Standard Deviation | drinks per episode | continuous for up to 3 months |
|
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Feedback | Feedback: Participant will receive a brief feedback on alcohol use data downloaded from the ABM and information about treatment resources |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| skin irritation/indentation | Skin and subcutaneous tissue disorders | Systematic Assessment | Number of participants who reported skin irritation/indentation typically noted this was from wearing the device too tightly - strap was adjustable and most reported issues resolved with adjustment/removal |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Andrea DiMartini | University of Pittsburgh | 14122164550 | dimartiniaf@upmc.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 15, 2022 | Jun 20, 2022 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D000428 | Alcohol Drinking |
| ID | Term |
|---|---|
| D004327 | Drinking Behavior |
| D001519 | Behavior |
Not provided
Not provided
RCT feedback vs. enhanced usual care
Not provided
Not provided
Not provided
| Enhanced Usual Care | Behavioral | Participant will receive information on self reported alcohol use and information about remaining abstinent and about treatment resources |
|
| 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.
| 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 | 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 at three months (completion of the participants use of ABM) |
| Adverse Event |
|
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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
| 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 | 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 | Posted | Mean | Standard Deviation | percentage of days drinking | 3 months |
|
|
|
| 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:
| numbers at follow up assessments are different than initially enrolled due to drop out | Posted | Mean | Standard Deviation | score on a scale | Scores determined at initiation, 6 weeks and 3 months of participation |
|
|
|
|
| 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.
| numbers at follow up assessments are different than initially enrolled due to drop out | Posted | Mean | Standard Deviation | score on a scale | Scores determined at initiation, 6 weeks and 3 months of participation |
|
|
|
|
| Secondary | Medical Outcomes | AALD related hospitalizations and ER visits - total count of participants in each arm who experienced these outcomes | Two participants in the EUC arm had died by the 3 month assessment | Posted | Count of Participants | Participants | Counts determined at initiation, 6 weeks and 3 months of participation |
|
|
|
| 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. | 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. | Posted | Number | Themes | measured at three months (completion of the participants use of ABM) |
|
|
|
| 2 |
| 14 |
| 0 |
| 14 |
| 7 |
| 14 |
| EG001 | Enhanced Usual Care | Participant will receive information about remaining abstinent and about treatment resources | 2 | 13 | 0 | 13 | 7 | 13 |
|
| strap being itchy/scratchy | Skin and subcutaneous tissue disorders | Systematic Assessment | Number of participants who reported device strap was itchy/scratchy |
|
| Uncomfortable | Skin and subcutaneous tissue disorders | Systematic Assessment | Number of participants who reported wearing the device was uncomfortable (sleeping or otherwise) |
|
| Participants uncomfortable with device appearance | Product Issues | Systematic Assessment | Number of participants who commented that the device was unappealing in appearance |
|
Not provided
Not provided
| % Days of drinking per second interval of device wear |
|
|
| % Days of drinking per third interval of device wear |
|
|
| Subscale Recognition: intake |
|
|
| Subscale Ambivalence: intake |
|
|
| Subscale Taking Steps: intake |
|
|
| SOCRATES Total Score: 6 week assessment |
|
|
| Subscale Recognition: 6 weeks |
|
|
| Subscale Ambivalence: 6 weeks |
|
|
| Subscale Taking Steps: 6 weeks |
|
|
| SOCRATES Total Score: 3 Month assessment |
|
|
| Subscale Recognition: 3 months |
|
|
| Subscale Ambivalence: 3 months |
|
|
| Subscale Taking Steps: 3 months |
|
|
| >.05 |
Applies to SOCRATES total scores and subscales (recognition, ambivalence, and taking steps) at intake and 3 months |
| Superiority |
| Subscale Negative Affect: intake |
|
|
| Subscale Social Positive: intake |
|
|
| Subscale Physical Concern: intake |
|
|
| Subscale Withdrawal Urges: intake |
|
|
| Alcohol Self Efficacy Scale: 6 week assessment |
|
|
| Subscale Negative Affect: 6 weeks |
|
|
| Subscale Social Positive: 6 weeks |
|
|
| Subscale Physical Concern: 6 weeks |
|
|
| Subscale Withdrawal Urges: 6 weeks |
|
|
| Alcohol Self Efficacy Scale: 3 month assessment |
|
|
| Subscale Negative Affect: 3 months |
|
|
| Subscale Social Positive: 3 months |
|
|
| Subscale Physical Concern: 3 months |
|
|
| Subscale Withdrawal Urges: 3 months |
|
|
| Intake assessment: Count of participants in emergency room in prior 90 days |
|
|
| 6 week assessment: Count of participants hospitalized between intake and 6 week assessment |
|
|
| 6 week assessment: Count of participants in emergency room between intake and 6 week assessment |
|
|
| 3 month assessment: Count of participants hospitalized between 6 week and 3 month assessment |
|
|
| 3 month assessment: Count of participants in emergency room between 6 week and 3 month assessment |
|
|
|
| Positive Efficiency examples: benefit if prescribed, improve honesty, more data/ better/ accurate |
|
| Positive Impact of device on behavior examples: visual deterrent, accountability, therapeutic value |
|
| Positive Preferences, Facilitators, or Barriers: helpful if dr prescribed, gives proof not drinking |
|
| Negative Usability examples: uncomfortable/cumbersome/annoying, interfered with sleep |
|
| Negative Acceptability examples: conspicuous, felt self-conscious, appearance not optimal |
|
| Negative Feasibility examples: had to take off for a lot of activities/ to avoid damaging |
|
| Negative Efficiency examples: Wouldn't improve medical care, already honest about alcohol use |
|
| Negative Impact of device on behavior examples: can't prevent drinking, have to buy into concept |
|
| Negative Preferences, Facilitators, or Barriers: potential negative feelings/stigma/reminder |
|