Clinical trial NCT02650180: Usability Study for SOBERLINK System
Official title: Usability Study for SOBERLINK System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcoholism
Alcohol Dependence
Keywords: Rehabilitation
Lead sponsor: Soberlink Healthcare LLC
Sponsor class: INDUSTRY
First posted: 2016-01-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Operating the Soberlink Cellular device
timeFrame: 30 minutes
Secondary outcomes:
measure: Participants' level of success in recollecting tasks related to the use of the Soberlink Cellular device and application.
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Fullerton
country: United States
facility: Private Practice
state: California
city: Los Angeles
country: United States
facility: Addiction Alternatives
state: California
city: Center City
country: United States
facility: Hazelden Betty Ford
state: Minnesota
Study officials:
affiliation: Soberlink Healthcare LLC
name: Jenna Costa, BA
role: STUDY_DIRECTOR
References: