Mobile Technology for Safer Automobile Driving

Overseen By Motao Zhu, MD,MS,PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Motao Zhu

Disqualifiers: Under 18, Learner's permit, Infrequent drivers, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

1200 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is mobile technology for safer driving generally safe for humans?

The research articles provided do not directly address the safety of mobile technology for safer driving, but they do discuss the use of mobile apps for monitoring adverse events in other contexts, such as drug administration and vaccination. These studies suggest that mobile apps can be safely used for real-time data collection and reporting, which may imply a general level of safety for similar technologies. ^{1 2 3 4 5}

How is the treatment 'Commercial Cellphone-Blocking App, Driving Mode' different from other treatments for reducing smartphone use while driving?

This treatment is unique because it uses 'soft blocking' technology to automatically silence and hide notifications and send automatic replies, reducing the temptation to use a smartphone while driving. Unlike other methods, it focuses on minimizing distractions without completely blocking phone functionality, which can help maintain driver focus and safety. ^{6 7 8 9 10}

Research Team

Motao Zhu

Principal Investigator

Abigail Wexner Research Institute at Nationwide Children's Hospital

Eligibility Criteria

This trial is for young adults aged 18-24 in the Columbus, Ohio area who have a full driver's license and own a smartphone with active service. Participants must drive regularly, have their own insured vehicle, and not be using any other driving study apps or devices. They should also admit to using their phone while driving at least once a week.

Inclusion Criteria

I use my phone for calls or texts while driving at least once a week.

I am willing to follow the study's requirements and accept random assignment.

Must not be enrolled in another driving-related research study during the study period

Exclusion Criteria

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

I am under 18 years old.

I drive 2 days a week or less.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants are randomized into one of three study groups to evaluate the effects of cellphone-blocking apps and driving mode interventions on driving behavior

5 months

Follow-up

Participants are monitored for safety and effectiveness after the intervention period

4 weeks

Treatment Details

Interventions

• Commercial Cellphone-Blocking App
• Driving Mode

Trial Overview The study is testing if a commercial cellphone-blocking app or activating a 'driving mode' can change how often young drivers use their phones while driving. Drivers will be randomly assigned to one of these interventions to see which is more effective.

Participant Groups

Group I: Driving Mode Experimental Treatment 1 Intervention

Driving mode blocks handheld phone use while driving or facilitates hands free use (exact functionality dependent on smartphone type and service provider).This group will also have the commercial cell-phone blocking app installed on smartphone, but app will be inactive.

Group II: Commercial Cellphone-Blocking App Experimental Treatment 1 Intervention

Commercial cellphone-blocking app that blocks handheld cellphone use while driving, but allows emergency calls and phone use after pressing the passenger button will be installed on smartphone.

Group III: Control Group Active Control 1 Intervention

Commercial cell-phone blocking app installed on smartphone, but app will be inactive.

Who Is Running the Clinical Trial?

Motao Zhu

Lead Sponsor

Trials

2

Recruited

1,400+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Ohio State University

Collaborator

Trials

891

Recruited

2,659,000+

University of Iowa

Collaborator

Trials

486

Recruited

934,000+

Findings from Research

The study successfully developed a mobile application called Cell-PREVEN for real-time monitoring of adverse events related to metronidazole use among female sex workers in Peru, demonstrating its feasibility for public health surveillance.

The system allows for immediate data collection and transmission, enabling quick alerts to health personnel about specific symptoms, which enhances the ability to monitor drug safety effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design and implementation of Cell-PREVEN: a real-time surveillance system for adverse events using cell phones in Peru. Curioso, WH., Karras, BT., Campos, PE., et al.[2019]

A study involving 1139 participants from a larger trial found that 96% of respondents supported the use of SMS for monitoring vaccine safety after immunization, indicating a strong public acceptance of this method.

While most participants favored SMS surveillance, 62% believed that consent should be obtained beforehand, highlighting a need for addressing privacy concerns and understanding demographic factors that may affect compliance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Consumer acceptability and validity of m-Health for the detection of adverse events following immunization - The Stimulated Telephone Assisted Rapid Safety Surveillance (STARSS) randomised control trial. Gold, MS., Lincoln, G., Bednarz, J., et al.[2021]

The STARSS trial, involving 6,338 participants, showed that using SMS prompts for reporting adverse events following immunization (AEFI) significantly improved detection rates, with a 13-fold increase in AEFI detection compared to traditional methods.

Out of the SMS group, 184 verified AEFIs were reported, while only 6 were reported in the control group, highlighting the efficacy of mobile health technology in enhancing vaccine safety surveillance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of m-Health for the detection of adverse events following immunization - The stimulated telephone assisted rapid safety surveillance (STARSS) randomised control trial. Gold, MS., Lincoln, G., Cashman, P., et al.[2021]

In a study involving 153 employees, 42% participated in testing an app designed for reporting adverse events following immunization (AEFI), with 63% of users rating the experience positively, indicating good acceptance of the app-based technology.

Concerns about data protection were the main reason for declining participation, suggesting that improving data security measures could enhance the acceptability and effectiveness of app-based AEFI reporting systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

User preferences for a mobile application to report adverse events following vaccination. Nguyen, MTH., Ott, JJ., Caputo, M., et al.[2020]

The study evaluated 22 smartphone applications designed for reporting adverse drug reactions (ADRs), finding that these apps can significantly increase the number of ADR reports submitted, especially in regions like the WHO African region.

Developers and users reported positive experiences with the apps, but noted that factors such as user age and internet connectivity can affect app usage, highlighting the need for tailored app features to enhance accessibility and engagement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smartphone-based mobile applications for adverse drug reactions reporting: global status and country experience. Fukushima, A., Iessa, N., Balakrishnan, MR., et al.[2023]

A naturalistic study involving 167 young Israeli drivers showed that using 'soft blockers' on smartphones, which silence notifications and send automatic replies, led to a 20% reduction in screen-touches while driving.

The study also found that when drivers did touch their screens, it was more likely to occur when the vehicle was not in motion, suggesting that awareness of monitoring may help reduce risky smartphone usage while driving.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring the impact of "soft blocking" on smartphone usage of young drivers. Albert, G., Lotan, T.[2019]

Hand-held cellular phone use by drivers in Michigan more than doubled from 2.7% in 2001 to 5.8% in 2005, indicating a significant increase in this risky behavior over a 4-year period.

If the trend continues, it is predicted that by 2010, approximately 8.6% of drivers will be using hand-held phones while driving, which could lead to increased traffic safety concerns and the need for effective interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Driver hand-held cellular phone use: a four-year analysis. Eby, DW., Vivoda, JM., St Louis, RM.[2018]

The implementation of handheld cell phone bans in D.C., New York, and Connecticut led to significant immediate reductions in usage, with D.C. showing a 41% decrease and Connecticut a remarkable 76% decrease right after the ban.

Long-term effects were also observed, with reductions maintained at 43% in D.C. and 65% in Connecticut after several years, indicating that such bans can have lasting impacts on driver behavior, although the overall effect on crash rates remains unclear.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term effects of handheld cell phone laws on driver handheld cell phone use. McCartt, AT., Hellinga, LA., Strouse, LM., et al.[2018]

Universal hand-held cell phone bans significantly reduced the number of drivers using hand-held phones while driving across all demographic groups, with an adjusted odds ratio of 0.34 for females and 0.47 for males, indicating a strong effect of the legislation.

The effectiveness of these bans varied by region, with the greatest reduction in hand-held phone use observed in Western states (aOR 0.31), suggesting that public health interventions can be tailored to target specific demographics and locations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hand-held cell phone use while driving legislation and observed driver behavior among population sub-groups in the United States. Rudisill, TM., Zhu, M.[2021]

The web-based tool Drive in the Moment (DITM) effectively reduced smartphone use while driving (SWD) among 180 young drivers aged 17-25, showing significant decreases in both actual SWD behaviors and future intentions to engage in SWD after the intervention.

Participants reported an increased perception of the risks associated with SWD, indicating that the DITM not only changed behaviors but also influenced attitudes towards the dangers of distracted driving.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Drive in the Moment: An evaluation of a web-based tool designed to reduce smartphone use among young drivers. Brown, PM., George, AM., van Boxtel, JJA., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Design and implementation of Cell-PREVEN: a real-time surveillance system for adverse events using cell phones in Peru. [2019]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Consumer acceptability and validity of m-Health for the detection of adverse events following immunization - The Stimulated Telephone Assisted Rapid Safety Surveillance (STARSS) randomised control trial. [2021]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Efficacy of m-Health for the detection of adverse events following immunization - The stimulated telephone assisted rapid safety surveillance (STARSS) randomised control trial. [2021]

4. Germany pubmed.ncbi.nlm.nih.gov

User preferences for a mobile application to report adverse events following vaccination. [2020]

5. England pubmed.ncbi.nlm.nih.gov

Smartphone-based mobile applications for adverse drug reactions reporting: global status and country experience. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Exploring the impact of "soft blocking" on smartphone usage of young drivers. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Driver hand-held cellular phone use: a four-year analysis. [2018]

8. England pubmed.ncbi.nlm.nih.gov

Long-term effects of handheld cell phone laws on driver handheld cell phone use. [2018]

9. England pubmed.ncbi.nlm.nih.gov

Hand-held cell phone use while driving legislation and observed driver behavior among population sub-groups in the United States. [2021]

10. England pubmed.ncbi.nlm.nih.gov

Drive in the Moment: An evaluation of a web-based tool designed to reduce smartphone use among young drivers. [2023]