Alcoholism Clinical Trial
Official title:
Usability Study for SOBERLINK System
| Verified date | March 2016 |
| Source | Soberlink Healthcare LLC |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 40 |
| Est. completion date | March 2016 |
| Est. primary completion date | March 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 99 Years |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Hazelden Betty Ford | Center City | Minnesota |
| United States | Private Practice | Fullerton | California |
| United States | Addiction Alternatives | Los Angeles | California |
| Lead Sponsor | Collaborator |
|---|---|
| Soberlink Healthcare LLC |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 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 |
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