Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2015-12-31
2016-03-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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Soberlink Cellular Device
Soberlink Cellular Device: a Breath Alcohol Analyzer
Soberlink Cellular Device
Alcohol Breath Analyzer
Interventions
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Soberlink Cellular Device
Alcohol Breath Analyzer
Eligibility Criteria
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Inclusion Criteria
* Male and female participants between the ages of 18-99 years old in an over-the-counter setting (home use setting).
Exclusion Criteria
18 Years
99 Years
ALL
No
Sponsors
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Soberlink Healthcare LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Jenna Costa, BA
Role: STUDY_DIRECTOR
Soberlink Healthcare LLC
Locations
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Private Practice
Fullerton, California, United States
Addiction Alternatives
Los Angeles, California, United States
Hazelden Betty Ford
Center City, Minnesota, United States
Countries
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Other Identifiers
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USPROT 2015-001
Identifier Type: -
Identifier Source: org_study_id
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