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State the scientific aim(s) of the study, or the hypotheses to be tested. The purpose of the current study is to evaluate the usage and acceptability of the Soberlink's blood alcohol concentration (BAC) unit in collaboration with Aware treatment to assess increased sobriety within patients suffering from alcohol use disorder (AUD).
The specific AIMS will be:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sb+Aware | Experimental | Patients will access to the Soberlink device and receive treatment with Aware Recovery Care |
|
| Aware | No Intervention | Patients will only have access to Aware Recovery Care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Soberlink | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Alcohol Time Line Follow Back (TLFB) | 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). | up to 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life Survey | the 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. | up to 24 weeks |
| Mean Positive BAC Response With Soberlink |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aware Recovery Care | North Haven | Connecticut | 06517 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35029534 | Derived | Buono FD, Gleed C, Boldin M, Aviles A, Wheeler N. Preliminary Effectiveness of a Remotely Monitored Blood Alcohol Concentration Device as Treatment Modality: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2022 Jan 14;11(1):e30186. doi: 10.2196/30186. |
| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Aware | Patients will only have access to Aware Recovery Care |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| 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 Time Line Follow Back (TLFB) | 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). | Posted | Mean | Standard Deviation | drinks per month | up to 24 weeks |
|
up to 24 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Frank Buono | Yale University | 2037795799 | frank.buono@yale.edu |
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| 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 9, 2020 | Apr 24, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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|
sensor 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. |
| up to 24 weeks |
| Alcohol Abstinence Self-efficacy Scale for Temptation. | Alcohol 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 | up to 24 weeks |
| Alcohol Abstinence Self-efficacy Scale for Confidence | Alcohol 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. | up to 24 weeks |
| BG001 | Aware | Patients will only have access to Aware Recovery Care |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Marital Status | Count of Participants | Participants |
|
| Highest Level of Education Completed | Count of Participants | Participants |
|
| Work Status | Count of Participants | Participants |
|
| Generalized Anxiety Disorder-7 questionnaire | Generalized Anxiety Disorder-7 questionnaire is a 7-item validated questionnaire used to screen for anxiety with a range of scores from 0-3. A cumulative score of ≥8 is considered positive for anxiety with lower scores indicating no or mild anxiety. Minimum score is 0 and the maximum score 21. Total score was provided. | Mean | Standard Deviation | score on a scale |
|
| Patient Health Questionnaire-9 (PHQ-9) | PHQ-9 is a 9-item validated questionnaire used to screen for depression with a range of scores from 0-45. A cumulative score of ≥10 is considered positive with lower scores indicating no or mild anxiety. | Mean | Standard Deviation | units on a scale |
|
| Previous Alcohol Treatments | Mean number of participants that have had previous treatment for Alcohol. Data was extracted from self-reported demographic information by the participant. | Mean | Standard Deviation | mean number of participants |
|
| OG001 | Aware | Patients will only have access to Aware Recovery Care |
|
|
| Secondary | Quality of Life Survey | the 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. | Posted | Mean | Standard Deviation | score on a scale | up to 24 weeks |
|
|
|
|
| Secondary | Mean Positive BAC Response With Soberlink | sensor 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. | Posted | Mean | Standard Deviation | Positive responses | up to 24 weeks |
|
|
|
| Secondary | Alcohol Abstinence Self-efficacy Scale for Temptation. | Alcohol 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 | Posted | Mean | Standard Deviation | score on a scale | up to 24 weeks |
|
|
|
| Secondary | Alcohol Abstinence Self-efficacy Scale for Confidence | Alcohol 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. | Posted | Mean | Standard Deviation | score on a scale | up to 24 weeks |
|
|
|
| 0 |
| 43 |
| 0 |
| 43 |
| 0 |
| 43 |
| EG001 | Aware | Patients will only have access to Aware Recovery Care | 0 | 32 | 0 | 32 | 0 | 32 |
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