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Recruiting NCT05163119

Randomized Trial on Mobile Technology and Young Drivers' Cellphone Use

No phase Interventional Cell Phone Use Automobile Driving

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Commercial Cellphone-Blocking App (Active), Driving Mode.
Who it may be relevant to
Registry conditions: Cell Phone Use, Automobile Driving. Basic parameters: 18 years — 24 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

The purpose of this study is to conduct a randomized controlled trial to determine the effects of a cellphone app and a driving mode intervention on driving behavior in drivers aged 18-24 years.

Detailed description

For this study, 1200 teens aged 18-24 years will be randomized into one of three study groups for 6 months. Researchers aim to evaluate the effectiveness of commercial cellphone-blocking apps and driving mode interventions on cellphone use while driving and evaluate the effectiveness of commercial cellphone-blocking apps and driving mode interventions on high-risk driving events.

Interventions

  • Behavioral Commercial Cellphone-Blocking App (Active)
    The Fleetsafer app, which is a commercial cellphone app that uses a cellphone's standard sensors and function to block handheld cellphone use while driving, will be downloaded on the participant's smartphone.
  • Behavioral Driving Mode
    Apple's "Do Not Disturb" driving mode provided by Apple for iPhones or Google Do Not Disturb, Verizon Messages +, Android Auto or have another app, called LifeSaver installed on their Android phone (collectively referred to as driving modes; the specific driving mode for participants in this arm will be determined based on smartphone type and service provider).

Primary outcome measures

  • Calling, texting, and handheld cell phone use while driving [Time frame: 5-month intervention period]
  • High-risk driving events [Time frame: 5-month intervention period]

Eligibility criteria

Inclusion criteria

  • Adults 18-24 years of age at time of recruitment
  • Must have ownership and exclusive access to a passenger vehicle
  • Must have car insurance with at least state-minimum coverage
  • Must live in Greater Columbus (Ohio) area
  • Must drive at least 2 days a week on average
  • Must have functioning iPhone or Android smartphone with an active phone service account (Ex: Verizon, AT\&T, etc.)
  • Must self-report handheld calling or texting while driving (≥ 1 time/week)
  • Must not be enrolled in another driving-related research study during the study period.
  • Must be willing to be randomized and comply with study requirements
  • Must have no plans to change cellphones or vehicles in next 6 months or agree to transfer FleetSafer app/DriveCam if they change cellphones or vehicles
  • Must speak and read English

Exclusion criteria

  • Drivers under 18 years of age
  • Drivers holding learner's permits
  • Drivers who share a vehicle with a family member or others
  • Infrequent drivers (Drive 2 days a week or less)
  • Participants from the pilot R21 project
  • Current users of a cellphone-blocking app or driving mode who do not agree to uninstall/de-activate the app for the duration of participation in the study
  • Current users of a car insurance monitoring device (physical device or app)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

United States · 1 center
  • Nationwide Children's Hospital — Columbus

Identifiers

NCT: NCT05163119 · STUDY00001601 · R01HD102439

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗