Usability Study for SOBERLINK System

Study Overview
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Brief Summary
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The Soberlink Cellular device, in its original packaging, along with the QuickStart guide will be provided to the end user in a simulated home use environment or by Rx in clinic. The patient labeling will be in the format intended for distribution. Ten (10) Rx subjects will be provided instruction for use in clinic for the Soberlink Cellular device while an additional ten (10) Rx subjects will be provided instruction for use in clinic for the Soberlink Cellular device and Sober Sky web portal. An additional ten (10) simulated home use subjects will be provided instruction for use for the Soberlink Cellular device while an additional ten (10) simulated home use subjects will be provided instruction for use in clinic for the Soberlink Cellular device and Sober Sky web portal. All subjects will be provided with a post-test questionnaire on how to operate the device. The post-test questionnaire will collect information regarding device use. The device's use will be compared with identified risks to determine if the percentage of failures is within the study protocol success criteria. Additionally, measurable usability criteria for specific, critical steps will be evaluated.

Detailed Description
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Forty (40) subjects identified as potential end users of the device will be recruited to the study and screened according to the study inclusion and exclusion criteria. Subjects will be asked to sign informed consent. The Soberlink Cellular device, in its original packaging, along with the QuickStart guide will be provided to the patient in a simulated home-use environment and Rx clinical setting. The patient labeling will be in the format intended for distribution. Ten (10) Rx subjects will be provided instruction for use in clinic for the Soberlink Cellular device while an additional ten (10) Rx subjects will be provided instruction for use in clinic for the Soberlink Cellular device and Sober Sky web portal. An additional ten (10) simulated home use subjects will be provided instruction for use for the Soberlink Cellular device while an additional ten (10) simulated home use subjects will be provided instruction for use in clinic for the Soberlink Cellular device and Sober Sky web portal. All subjects will be provided with a post-test questionnaire on how to operate the device. The post-test questionnaire will collect information regarding device use. The device's use will be compared with identified risks to determine if the percentage of failures is within the study protocol success criteria. Additionally, measurable usability criteria for specific, critical steps will be evaluated.

Official Title
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Usability Study for SOBERLINK System

Conditions
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Alcoholism, Alcohol Dependence

Intervention / Treatment
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* Device: Soberlink Cellular Device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female participants between the ages of 18-99 years old in a clinical setting under the care of a healthcare provider. Male and female participants between the ages of 18-99 years old in an over-the-counter setting (home use setting). Exclusion Criteria: Participants with lung disease unable to exhale for 4 seconds.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Soberlink Cellular Device<br>Soberlink Cellular Device: a Breath Alcohol Analyzer | Device: Soberlink Cellular Device<br>* Alcohol Breath Analyzer<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operating the Soberlink Cellular device | Using the device with the Quick Start Guide, all 40 subjects tested are expected to be able to complete device related tasks, including starting the application, operating the Soberlink Cellular device and obtaining a breath reading and recording the results, in a timeframe of up to 30 minutes and with minimal attempts to ask for assistance; and using the device and the Quick Start Guide. Considering that the Soberlink Cellular device is a low risk device, and the probability of an occurrence and the severity of a failure are low, a success rate of 100% potential end user subjects passing may be considered acceptable for the over the counter use of the device. Any failures to complete the device related tasks and/or self-exclude from use of the device must be explained. | 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participants' level of success in recollecting tasks related to the use of the Soberlink Cellular device and application. | Numerical ratings describing the participants' level of success in recollecting tasks will be collected through user post-test questionnaire responses and will be analyzed. | 30 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rehabilitation