Usability Study for SOBERLINK System

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02650180
Study type	Interventional
Source	Soberlink Healthcare LLC
Contact
Status	Completed
Phase	N/A
Start date	December 2015
Completion date	March 2016

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.