Usability Study for SOBERLINK System
Condition: Alcoholism; Alcohol Dependence
MeSH terms: Alcoholism
Study type: Interventional

Summary: 
      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: 
      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.
    

Intervention name(s): Soberlink Cellular Device
Intervention type(s): Device
Intervention description(s): Alcohol Breath Analyzer
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Rehabilitation