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Distracted Driving App Study for Teens and Parents/Caregivers (IDD)

11. november 2021 opdateret af: 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

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret 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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

134

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forenede Stater, 19146
        • Children's Hospital of Philadelphia Roberts Center for Pediatric Research

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

16 år og ældre (Barn, Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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).
Enhed: Manual Mode
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 navne:
  • Mode 2
Enhed: Auto-Detect Mode
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 navne:
  • Mode 3
Eksperimentel: Arm 2
Participants use the Auto-Detect Mode of the app for 4 weeks, followed by the Manual Mode for 4 weeks.
Enhed: Manual Mode
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 navne:
  • Mode 2
Enhed: Auto-Detect Mode
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 navne:
  • Mode 3
Eksperimentel: 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.
Enhed: Auto-Detect Mode
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 navne:
  • Mode 3
Enhed: Background Mode
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 navne:
  • Mode 1

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in frequency of smartphone use while driving
Tidsramme: Week 2, 4, 6, and post-intervention at Week 8
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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in frequency of self-reported smartphone use while driving
Tidsramme: 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.
Weeks 2, 4, 6, and Post-Intervention at Week 8
Participant acceptability of the smartphone App: survey
Tidsramme: Post-Intervention at Week 8
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
Tidsramme: Post-Intervention at Week 8
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Children's Hospital of Philadelphia

Samarbejdspartnere

Minnesota HealthSolutions

Efterforskere

  • Ledende efterforsker: Sara Seifert, MPH, Minnesota HealthSolutions
  • Ledende efterforsker: Allison Curry, PhD, MPH, Children's Hospital of Philadelphia

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

23. januar 2020

Primær færdiggørelse (Faktiske)

31. august 2021

Studieafslutning (Faktiske)

31. august 2021

Datoer for studieregistrering

Først indsendt

22. november 2019

Først indsendt, der opfyldte QC-kriterier

25. november 2019

Først opslået (Faktiske)

26. november 2019

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

19. november 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

11. november 2021

Sidst verificeret

1. november 2021

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • 19-016717

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (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.

IPD-delingsadgangskriterier

IRB approval, data use agreement

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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