NCT03604497

Brief Summary

Over 4,800 American pedestrians die annually, a figure that is current increasing. One hypothesized reason for the increasing trend in pedestrian injuries and deaths is the role of mobile technology in distracting both pedestrians and drivers. The investigators propose to develop and then evaluate Bluetooth beacon technology as a means to alert and warn pedestrians when they are approaching dangerous intersections, reminding them to attend to the traffic environment and cross the street safely rather than engaging with mobile technology. One aspect of the research will involve a crossover research trial to evaluate efficacy of the program. Bluetooth beacons are very small (about the size of a dime) and inexpensive (\~$20 range) devices that broadcast information unidirectionally (beacon to smartphone) within a closed proximal network. The investigators propose placing beacons at intersection corners (e.g., on signposts) frequently trafficked by urban college students. The beacons will transmit to an app installed on users' smartphones, signaling users to attend to their environment and cross the street safely. The app will be developed to be flexible based on user preferences; for research purposes, the app also will download data concerning the users' behavior while crossing the street. The crossover trial will evaluate the app with a sample of about 411 young adults whose behavior is monitored for: (a) 3 weeks without the app being activated, (b) 3 weeks with the app activated, and then (c) 6 weeks without the app activated to assess retention of behavior. Throughout the 12 week period, the investigators will monitor user behavior at multiple intersections around campus, along with gathering self-report questionnaire perceptions and behavior at baseline and 12-week post-intervention assessments.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
437

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 11, 2018

Completed
16 days until next milestone

First Posted

Study publicly available on registry

July 27, 2018

Completed
1.1 years until next milestone

Study Start

First participant enrolled

August 15, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 21, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 21, 2019

Completed
11 months until next milestone

Results Posted

Study results publicly available

November 24, 2020

Completed
Last Updated

November 24, 2020

Status Verified

November 1, 2020

Enrollment Period

4 months

First QC Date

July 11, 2018

Results QC Date

October 9, 2020

Last Update Submit

November 2, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Percentage of Street Crossings Distracted

    percentage of street-crossings participants is distracted while crossing streets in intersections involved in the study, as measured electronically by smartphone behavior near those intersections. Electronic measurement was based on x-y-z coordinates of the smartphone during the crossing, as assessed and stored in the participants' phone storage.

    12 weeks

Study Arms (3)

beacon alerts

EXPERIMENTAL

active intervention - participants are receiving alerts to warn them about distracted pedestrian behavior near intersections

Behavioral: beacon alerts

no alerts baseline

NO INTERVENTION

baseline - participants do not receive any alerts on their mobile smartphone when near intersections

no alerts retention

OTHER

retention phase - alerts have stopped after active intervention and behavior is monitored to test retention of learned behavior

Behavioral: no alerts retention

Interventions

beacon alertsBEHAVIORAL

alerts via unidirectional communication from beacons to smartphones when smartphones are approaching pedestrian crossing at activated intersection

beacon alerts

no alerts will appear, but we will measure retention of behavior learned during the active intervention stage

no alerts retention

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • individuals who cross streets on the UAB campus at least twice daily
  • ownership of an Android phone
  • willingness to install the app on phone
  • ability to communicate in English

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UAB Youth Safety Lab, University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Health Behavior

Condition Hierarchy (Ancestors)

Behavior

Results Point of Contact

Title
Dr David Schwebel
Organization
University of Alabama at Birmingham

Study Officials

  • David C Schwebel, PhD

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Primary Investigator

Study Record Dates

First Submitted

July 11, 2018

First Posted

July 27, 2018

Study Start

August 15, 2019

Primary Completion

December 21, 2019

Study Completion

December 21, 2019

Last Updated

November 24, 2020

Results First Posted

November 24, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will share

Will communicate with qualified investigators to share anonymous data if research goals are justified

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
after publication of final results and for 3 years
Access Criteria
contact study PI

Locations