Distracted Driving App Study for Teens and Parents/Caregivers (IDD)
11. november 2021 oppdatert av: 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
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Faktiske)
134
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Pennsylvania
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Philadelphia, Pennsylvania, Forente stater, 19146
- Children's Hospital of Philadelphia Roberts Center for Pediatric Research
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
16 år og eldre (Barn, Voksen, Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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).
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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.
Andre navn:
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.
Andre navn:
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Eksperimentell: Arm 2
Participants use the Auto-Detect Mode of the app for 4 weeks, followed by the Manual Mode for 4 weeks.
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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.
Andre navn:
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.
Andre navn:
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Eksperimentell: 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.
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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.
Andre navn:
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.
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change in frequency of smartphone use while driving
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change in frequency of self-reported smartphone use while driving
Tidsramme: Weeks 2, 4, 6, and Post-Intervention at Week 8
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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
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Sara Seifert, MPH, Minnesota HealthSolutions
- Hovedetterforsker: Allison Curry, PhD, MPH, Children's Hospital of Philadelphia
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
23. januar 2020
Primær fullføring (Faktiske)
31. august 2021
Studiet fullført (Faktiske)
31. august 2021
Datoer for studieregistrering
Først innsendt
22. november 2019
Først innsendt som oppfylte QC-kriteriene
25. november 2019
Først lagt ut (Faktiske)
26. november 2019
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
19. november 2021
Siste oppdatering sendt inn som oppfylte QC-kriteriene
11. november 2021
Sist bekreftet
1. november 2021
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- 19-016717
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
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-delingstidsramme
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.
Tilgangskriterier for IPD-deling
IRB approval, data use agreement
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
- ICF
- ANALYTIC_CODE
- CSR
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
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Nei
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