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| Name | Class |
|---|---|
| Minnesota HealthSolutions | INDUSTRY |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | 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). |
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| Arm 2 | Experimental | Participants use the Auto-Detect Mode of the app for 4 weeks, followed by the Manual Mode for 4 weeks. |
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| Arm 3 | Experimental | Participants use the Background Mode of the app for 4 weeks, followed by the Auto-Detect Mode of the app for 4 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Background Mode | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in frequency of smartphone use while driving | 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. | Week 2, 4, 6, and post-intervention at Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in frequency of self-reported smartphone use while driving | 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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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Allison Curry, PhD, MPH | Children's Hospital of Philadelphia | Principal Investigator |
| Sara Seifert, MPH | Minnesota HealthSolutions | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Philadelphia Roberts Center for Pediatric Research | Philadelphia | Pennsylvania | 19146 | United States |
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).
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.
IRB approval, data use agreement
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Feb 25, 2020 | Nov 11, 2021 | ICF_000.pdf |
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This study will utilize a crossover design with randomized assignment to three study arms to allow for comparison of app modes within drivers as each driver will act as their own control. The three app modes are: Background Mode (app runs in background and participants do not lock/unlock the phone), Manual Mode (participants manually unlock the phone), and Auto-Detect Mode (participants are automatically locked out of their phone if their phone camera detects them to be a driver or are automatically allowed to use their phone if the camera detects them to be a passenger).
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Participants are aware of the differences between the app modes, and that the order in which they test out the different app modes is randomly assigned to them. The study team is not blinded to which study arm participants are assigned to.
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| Manual Mode | Device | 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. |
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| Auto-Detect Mode | Device | 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. |
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| Weeks 2, 4, 6, and Post-Intervention at Week 8 |
| Participant acceptability of the smartphone App: survey | 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. | Post-Intervention at Week 8 |
| Participant usability of the smartphone app: survey | 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. | Post-Intervention at Week 8 |