- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04177524
Distracted Driving App Study for Teens and Parents/Caregivers (IDD)
November 11, 2021 updated by: Children's Hospital of Philadelphia
An Informatics Approach to Preventing Distracted Driving
The purpose of this research study is to determine if a new smartphone application helps to decrease distracted driving, and to learn about parent and teen perspectives about the application
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This 3-group randomized controlled trial aims to (1) evaluate the frequency of smartphone use among young drivers and their parents/caregivers while driving; and (2) determine if the LifeSaver mobile app reduces the rate of smartphone use while driving.
Eligible participants will be licensed teenage drivers between the ages of 16 and 18 years, and a parent/caregiver.
The app will be downloaded and installed on both parent/caregivers' and teens' phones to monitor phone use while in a vehicle for 8 weeks.
Study Type
Interventional
Enrollment (Actual)
134
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19146
- Children's Hospital of Philadelphia Roberts Center for Pediatric Research
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Licensed teen drivers 16 years to 18 years and one parent/caregiver
- Teen and parent/caregiver are both Android smartphone users
- Teen and parent/caregiver both drive a minimum of 2 days per week
Exclusion Criteria:
- Non-fluency in written or spoken English
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm 1
Participants alternate between using the Manual Mode of the app for 2 weeks and Auto-Detect Mode of the app for 2 weeks, for a total of 4 periods (8 weeks).
|
In addition to the features in the Background Mode, the LifeSaver app locks the participants' phone while they are in a moving vehicle unless they actively press an "Emergency Unlock" or "Passenger Unlock" button.
Other Names:
In addition to the features in Manual Mode, the LifeSaver app's "Passenger Unlock" feature can only be used if the app, via the smartphone's camera, confirms that the participant is not the driver of the vehicle.
Other Names:
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Experimental: Arm 2
Participants use the Auto-Detect Mode of the app for 4 weeks, followed by the Manual Mode for 4 weeks.
|
In addition to the features in the Background Mode, the LifeSaver app locks the participants' phone while they are in a moving vehicle unless they actively press an "Emergency Unlock" or "Passenger Unlock" button.
Other Names:
In addition to the features in Manual Mode, the LifeSaver app's "Passenger Unlock" feature can only be used if the app, via the smartphone's camera, confirms that the participant is not the driver of the vehicle.
Other Names:
|
Experimental: Arm 3
Participants use the Background Mode of the app for 4 weeks, followed by the Auto-Detect Mode of the app for 4 weeks.
|
In addition to the features in Manual Mode, the LifeSaver app's "Passenger Unlock" feature can only be used if the app, via the smartphone's camera, confirms that the participant is not the driver of the vehicle.
Other Names:
The LifeSaver app tracks the date, time, and global positioning system (GPS) location of each trip that the participant takes in a moving vehicle, along with a list of apps used during the trip, but does not contain any anti-distracted driving features.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in frequency of smartphone use while driving
Time Frame: Week 2, 4, 6, and post-intervention at Week 8
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Frequency of smartphone use is recorded by the LifeSaver app among the three app modes.
Within-driver smartphone use over the 8-week study period is compared as the app modes change.
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Week 2, 4, 6, and post-intervention at Week 8
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in frequency of self-reported smartphone use while driving
Time Frame: Weeks 2, 4, 6, and Post-Intervention at Week 8
|
The change in self-reported smartphone use while driving will be assessed using the same within-driver and between-driver comparisons as the primary outcome measure.
Self-reported smartphone use is collected through 10 items on a participant survey that is completed at enrollment, Weeks 2, 4, 6 and post-intervention at Week 8. Participants report how many days during the previous 2 weeks (0-14) that they drove, and talked on a hands-held smartphone, talked on a hands-free smartphone, sent a text, and read a text while driving.
Participants also report how many times per day (free text, any number greater than or equal to 0) that they drove, and talked on a hands-held smartphone, talked on a hands-free smartphone, sent a text, and read a text while driving.
There is no overall self-reported smartphone use score for these survey items.
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Weeks 2, 4, 6, and Post-Intervention at Week 8
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Participant acceptability of the smartphone App: survey
Time Frame: Post-Intervention at Week 8
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Participant assessment of accessibility will be collected, and Manual Mode and Auto-Detect Mode of the LifeSaver app will be compared.
Participants complete a survey at Week 8, post-intervention.
8 items in the survey ask participants about accessibility of the app through Likert scales (range from Not at all to Extremely). 3 items in the survey ask participants about accessibility of the app through open-ended questions, where participants are able to enter free text.
There is no overall score for these survey items.
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Post-Intervention at Week 8
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Participant usability of the smartphone app: survey
Time Frame: Post-Intervention at Week 8
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Participant assessment of usability will be collected, and Manual Mode and Auto-Detect Mode of the LifeSaver app will be compared.
Participants complete a survey at Week 8, post-intervention.
8 items in the survey ask participants about usability of the app through Likert scales (range from Not at all to Extremely). 3 items in the survey ask participants about usability of the app through open-ended questions, where participants are able to enter free text.
There is no overall score for these survey items.
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Post-Intervention at Week 8
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Sara Seifert, MPH, Minnesota HealthSolutions
- Principal Investigator: Allison Curry, PhD, MPH, Children's Hospital of Philadelphia
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 23, 2020
Primary Completion (Actual)
August 31, 2021
Study Completion (Actual)
August 31, 2021
Study Registration Dates
First Submitted
November 22, 2019
First Submitted That Met QC Criteria
November 25, 2019
First Posted (Actual)
November 26, 2019
Study Record Updates
Last Update Posted (Actual)
November 19, 2021
Last Update Submitted That Met QC Criteria
November 11, 2021
Last Verified
November 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- 19-016717
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Data and study documents will be shared with Minnesota HealthSolutions (the sponsor).
No identifiable data will be used for future studies without first obtaining CHOP Institutional Review Board (IRB) approval.
The investigator will obtain a data use agreement between the provider (the PI) of the data and any recipient researchers (including others at CHOP) before sharing a limited dataset (PHI limited to dates and zip codes).
IPD Sharing Time Frame
The study will comply with CHOP's data retention policy.
All study data will be maintained for at least 6 years following study completion.
There is no set timeline for the destruction of the study's de-identified data.
IPD Sharing Access Criteria
IRB approval, data use agreement
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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