ValidityNCT05422586
Way To Drive Validation Study
An observational study of Validity and Distracted Driving, run by University of Pennsylvania at 1 site in United States.
Trial summary
Way to Drive is a smart phone-based driving telematics application. Research participants are invited to download the app, which uses phone sensors to track driving behaviors including mileage, hard breaking events, and handheld phone use while driving, measured as the phone screen being unlocked while the phone is in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Validity, Distracted Driving, Driving Behaviors
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jul 2022to 13 Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Adults who completed in the study team's recent clinical trial with User Based Insurance customers and stated interest in being contacted about further research opportunities. The adults participated in a driving monitoring study (May 2021) and met the eligibility criteria, including 4 trips per week.
Who may be able to join
- 18 or older (only adult drivers will be invited)
- Willing to download Way to Drive and allow it to track the user's location while the user is in motion (i.e. over 5mph)
- Will make at least 4 driving trips per week for the duration of the study.
- Able to provide informed consent
Who cannot join
- Under 18 Cannot complete online surveys
- Does not have smart phone
- Not willing to download Way to Drive app and allow location tracking while in motion
- Will not be driving at least 4 times per week during the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Validation Study of Penn's Way to Drive Telematics Research Application
Way to Drive is a smart phone-based driving telematics application. Research participants are invited to download the app, which uses phone sensors to track driving behaviors including mileage, hard breaking events, and handheld phone use while driving, measured as the phone screen being unlocked while the phone is in the hand and the vehicle is in motion. Before the study team launches a clinical trial using the app, the researchers will test its capabilities and reliability.
- Conditions
- Validity, Distracted Driving, Driving Behaviors
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of driving trips classified correctly (driver/passenger) by the Way to Drive Telematics App
Measured by the driving and behavior when the car is in motion by the Way to Drive app.
Measured: 28 days
Secondary outcomes (1)
Number of driving events accurately captured (trip captured or missing) by Way to Drive Telematics App
Measured using phone sensor data to detect when the vehicle is in motion.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2022
- Study start17 Jul 2022
- Primary completion13 Aug 2022
- Study completion13 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ValidityStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, M. Kit Delgado, MD, University of Pennsylvania
- Investigators
- Mucio Delgado, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05422586
- Sponsor's protocol ID
- 849755
- Status last verified
- Jun 2023
- First submitted
- 13 Jun 2022
- Last updated
- 5 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified participant data will be made available to other researchers upon request.
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation Study of Penn's Way to Drive Telematics Research Application
- ClinicalTrials.gov ID
- NCT05422586
- Acronym / sponsor ID
- 849755
- Conditions
- Validity, Distracted Driving, Driving Behaviors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 17 Jul 2022 (actual)
- Primary completion
- 13 Aug 2022 (actual)
- Study completion
- 13 Aug 2022 (actual)
- First posted
- 16 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Way to Drive is a smart phone-based driving telematics application. Research participants are invited to download the app, which uses phone sensors to track driving behaviors including mileage, hard breaking events, and handheld phone use while driving, measured as the phone screen being unlocked while the phone is in the hand and the vehicle is in motion. Before the study team launches a clinical trial using the app, the researchers will test its capabilities and reliability.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adults who completed in the study team's recent clinical trial with User Based Insurance customers and stated interest in being contacted about further research opportunities. The adults participated in a driving monitoring study (May 2021) and met the eligibility criteria, including 4 trips per week.
Key inclusion criteria (4 listed)
- 18 or older (only adult drivers will be invited)
- Willing to download Way to Drive and allow it to track the user's location while the user is in motion (i.e. over 5mph)
- Will make at least 4 driving trips per week for the duration of the study.
- Able to provide informed consent
Key exclusion criteria (4 listed)
- Under 18 Cannot complete online surveys
- Does not have smart phone
- Not willing to download Way to Drive app and allow location tracking while in motion
- Will not be driving at least 4 times per week during the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of driving trips classified correctly (driver/passenger) by the Way to Drive Telematics App
Time frame: 28 days
Measured by the driving and behavior when the car is in motion by the Way to Drive app.
1 secondary outcome
Number of driving events accurately captured (trip captured or missing) by Way to Drive Telematics App
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2023.
- Individual participant dataSharing planned: Yes. Deidentified participant data will be made available to other researchers upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mucio Delgado principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Validity and Distracted Driving, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of driving trips classified correctly (driver/passenger) by the Way to Drive Telematics App (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2023.