Usability Study for SOBERLINK System
Primary Purpose
Alcoholism, Alcohol Dependence
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Soberlink Cellular Device
Sponsored by
About this trial
This is an interventional supportive care trial for Alcoholism focused on measuring Rehabilitation
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.
Sites / Locations
- Private Practice
- Addiction Alternatives
- Hazelden Betty Ford
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Soberlink Cellular Device
Arm Description
Soberlink Cellular Device: a Breath Alcohol Analyzer
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT02650180
First Posted
December 29, 2015
Last Updated
March 8, 2016
Sponsor
Soberlink Healthcare LLC
1. Study Identification
Unique Protocol Identification Number
NCT02650180
Brief Title
Usability Study for SOBERLINK System
Official Title
Usability Study for SOBERLINK System
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
December 2015 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Soberlink Healthcare LLC
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcoholism, Alcohol Dependence
Keywords
Rehabilitation
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Soberlink Cellular Device
Arm Type
Other
Arm Description
Soberlink Cellular Device: a Breath Alcohol Analyzer
Intervention Type
Device
Intervention Name(s)
Soberlink Cellular Device
Intervention Description
Alcohol Breath Analyzer
Primary Outcome Measure Information:
Title
Operating the Soberlink Cellular device
Description
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.
Time Frame
30 minutes
Secondary Outcome Measure Information:
Title
Participants' level of success in recollecting tasks related to the use of the Soberlink Cellular device and application.
Description
Numerical ratings describing the participants' level of success in recollecting tasks will be collected through user post-test questionnaire responses and will be analyzed.
Time Frame
30 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jenna Costa, BA
Organizational Affiliation
Soberlink Healthcare LLC
Official's Role
Study Director
Facility Information:
Facility Name
Private Practice
City
Fullerton
State/Province
California
ZIP/Postal Code
92832
Country
United States
Facility Name
Addiction Alternatives
City
Los Angeles
State/Province
California
ZIP/Postal Code
90035
Country
United States
Facility Name
Hazelden Betty Ford
City
Center City
State/Province
Minnesota
ZIP/Postal Code
55012
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Usability Study for SOBERLINK System
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