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Behavioural Intervention
Prevention of Distracted Driving with Bluetooth and Non-Bluetooth Interventions
Phase 2
Recruiting
Led By Sara Seifert, MPH
Research Sponsored by Minnesota HealthSolutions
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 weeks
Awards & highlights
Study Summary
This trial studies if a phone app can help teens & parents reduce phone use while driving. The app warns before sending a message if the recipient is driving.
Who is the study for?
This trial is for licensed drivers who are either teens aged 16 to 19 or adults up to age 75. Participants must own an iPhone and drive at least twice a week. The study aims to include those who could benefit from reduced mobile phone distractions while driving.Check my eligibility
What is being tested?
The study is testing the effectiveness of a smartphone app designed to decrease phone use by drivers. It notifies people trying to send messages that the recipient is currently driving. There are four groups: with/without Bluetooth and with/without intervention.See study design
What are the potential side effects?
Since this trial involves using a smartphone app, there aren't typical medical side effects; however, participants may experience increased awareness about their driving habits or changes in how they interact with their phones while on the road.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Changes in frequency of smartphone use while driving
Secondary outcome measures
Acceptability and Usability of the App
Changes in frequency of self-reported smartphone use while driving
Changes in frequency of text messages sent to Bluetooth device users
Trial Design
4Treatment groups
Experimental Treatment
Group I: Intervention non-BluetoothExperimental Treatment1 Intervention
Participant received the app with all features turned on, so the parent gets a notification when the teen is driving before they go to send a text message to the teen. They will self-report their smartphone communication while driving via periodic surveys. Participants will not receive a Bluetooth device.
Group II: Intervention BluetoothExperimental Treatment1 Intervention
Participant received the app with all features turned on, so the parent gets a notification when the teen is driving before they go to send a text message to the teen. They will self-report their smartphone communication while driving via periodic surveys. Participants will receive a Bluetooth device to keep in their primary vehicle for the duration of the study.
Group III: Control non-BluetoothExperimental Treatment1 Intervention
Participants receive a the same app as the intervention group, but the feature that notifies the teens parent when they are driving is turned off. They will self-report their smartphone communication while driving via periodic surveys. Participants will not receive a Bluetooth device.
Group IV: Control BluetoothExperimental Treatment1 Intervention
Participants receive a the same app as the intervention group, but the feature that notifies the teens parent when they are driving is turned off. They will self-report their smartphone communication while driving via periodic surveys. Participants will receive a Bluetooth device to keep in their primary vehicle for the duration of the study.
Find a Location
Who is running the clinical trial?
Children's Hospital of PhiladelphiaOTHER
708 Previous Clinical Trials
8,580,559 Total Patients Enrolled
1 Trials studying Distracted Driving
134 Patients Enrolled for Distracted Driving
Minnesota HealthSolutionsLead Sponsor
11 Previous Clinical Trials
961 Total Patients Enrolled
1 Trials studying Distracted Driving
134 Patients Enrolled for Distracted Driving
Sara Seifert, MPHPrincipal InvestigatorStudy Principal Investigator
4 Previous Clinical Trials
403 Total Patients Enrolled
1 Trials studying Distracted Driving
134 Patients Enrolled for Distracted Driving
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You must have a valid driver's license.You are between 16 and 19 years old.You have an iPhone.You are between 18 and 75 years old.You must be able to drive for at least two days every week.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention non-Bluetooth
- Group 2: Control Bluetooth
- Group 3: Intervention Bluetooth
- Group 4: Control non-Bluetooth
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA certified Intervention as a legitimate medical treatment?
"Although there is some evidence illustrating Intervention's security, the lack of clinical data supporting efficacy resulted in this trial receiving a score of 2."
Answered by AI
Do I meet the prerequisites to join this research endeavor?
"To enroll in this trial, applicants must meet certain criteria such as having a history of distracted driving and being between the ages 16-75. Approximately 500 participants are accepted into the study."
Answered by AI
Is this investigation open to those aged above sixty?
"This trial has an age requirement of 16 years and under 75 for potential participants."
Answered by AI
Are there any openings available to join this scientific exploration?
"As listed on clinicaltrials.gov, the trial that was first posted on March 1st 2023 is currently not seeking new participants and no longer requires additional enrollees. Nevertheless, there are 2 alternative medical studies open for recruitment at this time."
Answered by AI
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