Trial Outcomes & Findings for Preliminary Effectiveness of Remotely Monitored Blood Alcohol Concentration Device as Treatment Modality (NCT NCT04380116)
NCT ID: NCT04380116
Last Updated: 2023-05-26
Results Overview
The Alcohol TLFB is a drinking assessment method that obtains estimates of daily drinking and has been evaluated with clinical and nonclinical populations. Using a calendar, people provide retrospective estimates of their daily drinking over a specified time (previous month). The Alcohol TLFB allows several dimensions of a person's drinking to be separately examined: (a) variability (i.e., scatter); (b) pattern (i.e., shape); and (c) extent of drinking (i.e., elevation; how much).
COMPLETED
NA
96 participants
up to 24 weeks
2023-05-26
Participant Flow
Participant milestones
| Measure |
Sb+Aware
Patients will access to the Soberlink device and receive treatment with Aware Recovery Care
Soberlink: Soberlink is a comprehensive alcohol monitoring system designed to remotely monitor a person's Blood Alcohol Concentration (BAC). Combining a professional grade handheld breathalyzer with wireless connectivity, the technology includes real-time facial recognition, robust tamper detection and real-time alerting.
|
Aware
Patients will only have access to Aware Recovery Care
|
|---|---|---|
|
Overall Study
STARTED
|
48
|
48
|
|
Overall Study
COMPLETED
|
43
|
32
|
|
Overall Study
NOT COMPLETED
|
5
|
16
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Preliminary Effectiveness of Remotely Monitored Blood Alcohol Concentration Device as Treatment Modality
Baseline characteristics by cohort
| Measure |
Sb+Aware
n=43 Participants
Patients will access to the Soberlink device and receive treatment with Aware Recovery Care
Soberlink: Soberlink is a comprehensive alcohol monitoring system designed to remotely monitor a person's Blood Alcohol Concentration (BAC). Combining a professional grade handheld breathalyzer with wireless connectivity, the technology includes real-time facial recognition, robust tamper detection and real-time alerting.
|
Aware
n=32 Participants
Patients will only have access to Aware Recovery Care
|
Total
n=75 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
48.6 years
STANDARD_DEVIATION 10.5 • n=99 Participants
|
44.1 years
STANDARD_DEVIATION 11.8 • n=107 Participants
|
45.04 years
STANDARD_DEVIATION 11.7 • n=206 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
57 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
34 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
56 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
6 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
43 participants
n=99 Participants
|
32 participants
n=107 Participants
|
75 participants
n=206 Participants
|
|
Marital Status
Single
|
5 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Marital Status
Married
|
26 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
45 Participants
n=206 Participants
|
|
Marital Status
Divorced
|
10 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Marital Status
Separated
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Marital Status
Widowed
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Highest Level of Education Completed
High School
|
11 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Highest Level of Education Completed
Some College
|
5 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Highest Level of Education Completed
Associates
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Highest Level of Education Completed
Bachelors
|
12 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Highest Level of Education Completed
Advanced Degree
|
14 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Work Status
Employed
|
33 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
60 Participants
n=206 Participants
|
|
Work Status
Student
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Work Status
Retired
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Work Status
Unemployed
|
6 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Generalized Anxiety Disorder-7 questionnaire
|
14.8 score on a scale
STANDARD_DEVIATION 4.3 • n=99 Participants
|
15.3 score on a scale
STANDARD_DEVIATION 6.1 • n=107 Participants
|
15.1 score on a scale
STANDARD_DEVIATION 5.8 • n=206 Participants
|
|
Patient Health Questionnaire-9 (PHQ-9)
|
13.3 units on a scale
STANDARD_DEVIATION 5.5 • n=99 Participants
|
12.6 units on a scale
STANDARD_DEVIATION 4.8 • n=107 Participants
|
12.9 units on a scale
STANDARD_DEVIATION 5.8 • n=206 Participants
|
|
Previous Alcohol Treatments
|
3.1 mean number of participants
STANDARD_DEVIATION 2.2 • n=99 Participants
|
2.9 mean number of participants
STANDARD_DEVIATION 1.8 • n=107 Participants
|
3.02 mean number of participants
STANDARD_DEVIATION 1.1 • n=206 Participants
|
PRIMARY outcome
Timeframe: up to 24 weeksThe Alcohol TLFB is a drinking assessment method that obtains estimates of daily drinking and has been evaluated with clinical and nonclinical populations. Using a calendar, people provide retrospective estimates of their daily drinking over a specified time (previous month). The Alcohol TLFB allows several dimensions of a person's drinking to be separately examined: (a) variability (i.e., scatter); (b) pattern (i.e., shape); and (c) extent of drinking (i.e., elevation; how much).
Outcome measures
| Measure |
Sb+Aware
n=43 Participants
Patients will access to the Soberlink device and receive treatment with Aware Recovery Care
Soberlink: Soberlink is a comprehensive alcohol monitoring system designed to remotely monitor a person's Blood Alcohol Concentration (BAC). Combining a professional grade handheld breathalyzer with wireless connectivity, the technology includes real-time facial recognition, robust tamper detection and real-time alerting.
|
Aware
n=32 Participants
Patients will only have access to Aware Recovery Care
|
|---|---|---|
|
Alcohol Time Line Follow Back (TLFB)
|
27.1 drinks per month
Standard Deviation 2.2
|
21 drinks per month
Standard Deviation 3.1
|
SECONDARY outcome
Timeframe: up to 24 weeksthe quality of life survey (QLS) is a 16 question self-directed 7-point likert based survey (7-delighted; 1-terrible. The total score is 112, and the lowest is 16. Generally higher score indicate better QLS.
Outcome measures
| Measure |
Sb+Aware
n=43 Participants
Patients will access to the Soberlink device and receive treatment with Aware Recovery Care
Soberlink: Soberlink is a comprehensive alcohol monitoring system designed to remotely monitor a person's Blood Alcohol Concentration (BAC). Combining a professional grade handheld breathalyzer with wireless connectivity, the technology includes real-time facial recognition, robust tamper detection and real-time alerting.
|
Aware
n=32 Participants
Patients will only have access to Aware Recovery Care
|
|---|---|---|
|
Quality of Life Survey
|
73.53 score on a scale
Standard Deviation 26.3
|
75.9 score on a scale
Standard Deviation 23.2
|
SECONDARY outcome
Timeframe: up to 24 weekssensor to detect alcohol levels at an accuracy of +/-.005 BAC. BAC is established by the manufacturer based on predetermined cut off points. Mean number of positive responses, recorded using Soberlink sensor.
Outcome measures
| Measure |
Sb+Aware
n=43 Participants
Patients will access to the Soberlink device and receive treatment with Aware Recovery Care
Soberlink: Soberlink is a comprehensive alcohol monitoring system designed to remotely monitor a person's Blood Alcohol Concentration (BAC). Combining a professional grade handheld breathalyzer with wireless connectivity, the technology includes real-time facial recognition, robust tamper detection and real-time alerting.
|
Aware
Patients will only have access to Aware Recovery Care
|
|---|---|---|
|
Mean Positive BAC Response With Soberlink
|
1.09 Positive responses
Standard Deviation 1.4
|
—
|
SECONDARY outcome
Timeframe: up to 24 weeksAlcohol Abstinence Self-Efficacy Scale for Temptation is a 5 item 5 point Likert scale questionnaire where 0 indicates not at all, and 4 indicates extremely, total score has a range between 0-80. Lower scores indicate that participants do not believe they can resist the temptation to drink alcohol
Outcome measures
| Measure |
Sb+Aware
n=43 Participants
Patients will access to the Soberlink device and receive treatment with Aware Recovery Care
Soberlink: Soberlink is a comprehensive alcohol monitoring system designed to remotely monitor a person's Blood Alcohol Concentration (BAC). Combining a professional grade handheld breathalyzer with wireless connectivity, the technology includes real-time facial recognition, robust tamper detection and real-time alerting.
|
Aware
n=32 Participants
Patients will only have access to Aware Recovery Care
|
|---|---|---|
|
Alcohol Abstinence Self-efficacy Scale for Temptation.
|
20.5 score on a scale
Standard Deviation 18.5
|
20.1 score on a scale
Standard Deviation 19.4
|
SECONDARY outcome
Timeframe: up to 24 weeksAlcohol Abstinence Self-Efficacy Scale for Confidence is a 5 item 5 point Likert scale questionnaire where 0 indicates not at all, and 4 indicates extremely, total score has a range between 0-80. Higher scores indicate higher confidence in abstaining from alcohol.
Outcome measures
| Measure |
Sb+Aware
n=43 Participants
Patients will access to the Soberlink device and receive treatment with Aware Recovery Care
Soberlink: Soberlink is a comprehensive alcohol monitoring system designed to remotely monitor a person's Blood Alcohol Concentration (BAC). Combining a professional grade handheld breathalyzer with wireless connectivity, the technology includes real-time facial recognition, robust tamper detection and real-time alerting.
|
Aware
n=32 Participants
Patients will only have access to Aware Recovery Care
|
|---|---|---|
|
Alcohol Abstinence Self-efficacy Scale for Confidence
|
50.2 score on a scale
Standard Deviation 27.5
|
46.3 score on a scale
Standard Deviation 27.1
|
Adverse Events
Sb+Aware
Aware
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place