Using Bluetooth Beacon Technology to Reduce Distracted Pedestrian Behavior

• Sponsor: University of Alabama at Birmingham (Other)
• Overall Status: Completed
• CT.gov ID: NCT03604497
• Collaborator: National Institutes of Health (NIH) (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (NIH)
• Enrollment: 437
• Location: 1
• Arms: 3
• Actual Duration (Months): 4.2
• Patients Per Site Per Month: 103.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Health Behavior	Behavioral: beacon alerts; Behavioral: no alerts retention	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 437 participants
• Allocation: Non-Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Using Bluetooth Beacon Technology to Reduce Distracted Pedestrian Behavior
• Actual Study Start Date: Aug 15, 2019
• Actual Primary Completion Date: Dec 21, 2019
• Actual Study Completion Date: Dec 21, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: beacon alerts active intervention - participants are receiving alerts to warn them about distracted pedestrian behavior near intersections	Behavioral: beacon alerts; alerts via unidirectional communication from beacons to smartphones when smartphones are approaching pedestrian crossing at activated intersection
No Intervention: no alerts baseline baseline - participants do not receive any alerts on their mobile smartphone when near intersections
Other: no alerts retention retention phase - alerts have stopped after active intervention and behavior is monitored to test retention of learned behavior	Behavioral: no alerts retention; no alerts will appear, but we will measure retention of behavior learned during the active intervention stage

Outcome Measures

Primary Outcome Measures

1. Percentage of Street Crossings Distracted [12 weeks]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 25 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• 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

Exclusion Criteria:

• none

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UAB Youth Safety Lab, University of Alabama at Birmingham	Birmingham	Alabama	United States	35294

Sponsors and Collaborators

• University of Alabama at Birmingham
• National Institutes of Health (NIH)
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

• Principal Investigator: David C Schwebel, PhD, University of Alabama at Birmingham

Study Documents (Full-Text)

• Study Protocol - Aug 16, 2019
• Statistical Analysis Plan - Oct 9, 2020

More Information

Publications

None provided.

• Responsible Party: David Schwebel, Primary Investigator, University of Alabama at Birmingham
• ClinicalTrials.gov Identifier: NCT03604497
• Other Study ID Numbers: R21HD095270; R21HD095270
• First Posted: Jul 27, 2018
• Last Update Posted: Nov 24, 2020
• Last Verified: Nov 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

Participant Flow

Pre-assignment Detail	437 individuals enrolled and 385 crossed the street at least once during the protocol, suggesting they participated. The numbers do not add up since it is a crossover trial.

Arm/Group Title	All Study Participants
Arm/Group Description	baseline - participants do not receive any alerts on their mobile smartphone when near intersections active intervention phase - participants are receiving alerts to warn them about distracted pedestrian behavior near intersections (beacon alerts: alerts via unidirectional communication from beacons to smartphones when smartphones are approaching pedestrian crossing at activated intersection) retention phase - alerts have stopped after active intervention and behavior is monitored to test retention of learned behavior (no alerts retention: no alerts will appear, but we will measure retention of behavior learned during the active intervention stage) All participants engaged in all three phrases in the same order
Period Title: Overall Study
STARTED	437
COMPLETED	385
NOT COMPLETED	52

Baseline Characteristics

Arm/Group Title	All Study Participants
Arm/Group Description	baseline - participants do not receive any alerts on their mobile smartphone when near intersections active intervention - participants are receiving alerts to warn them about distracted pedestrian behavior near intersections (beacon alerts: alerts via unidirectional communication from beacons to smartphones when smartphones are approaching pedestrian crossing at activated intersection) retention phase - alerts have stopped after active intervention and behavior is monitored to test retention of learned behavior (no alerts retention: no alerts will appear, but we will measure retention of behavior learned during the active intervention stage)
Overall Participants	437
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	25.2 (9.6)
Sex: Female, Male (Count of Participants)
Female	287 65.7%
Male	144 33%
Race/Ethnicity, Customized (Count of Participants)
African American/Black	117 26.8%
Asian/Pacific Islander	88 20.1%
Hispanic	25 5.7%
Native American/American Indian/Alaskan Native	4 0.9%
White	178 40.7%
Other/Biracial/Biethnic/Prefer not to respond	25 5.7%
Region of Enrollment (participants) [Number]
United States	437 100%

Outcome Measures

1. Primary Outcome

Title	Percentage of Street Crossings Distracted
Description	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.
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

Participants who crossed the street at least once during study protocol; crossover trial and all participants completed phases in the same order with no alerts baseline first, beacon alerts second, and no alerts retention third

Arm/Group Title	Beacon Alerts	no Alerts Baseline	no Alerts Retention
Arm/Group Description	active intervention - participants are receiving alerts to warn them about distracted pedestrian behavior near intersections beacon alerts: alerts via unidirectional communication from beacons to smartphones when smartphones are approaching pedestrian crossing at activated intersection	baseline - participants do not receive any alerts on their mobile smartphone when near intersections	retention phase - alerts have stopped after active intervention and behavior is monitored to test retention of learned behavior no alerts retention: no alerts will appear, but we will measure retention of behavior learned during the active intervention stage
Measure Participants	385	385	385
Number [per cent of crossings distracted]	75	74	74

Adverse Events

Time Frame	10 weeks
Arm/Group Title	Beacon Alerts		no Alerts Baseline		no Alerts Retention
Arm/Group Description	active intervention - participants are receiving alerts to warn them about distracted pedestrian behavior near intersections beacon alerts: alerts via unidirectional communication from beacons to smartphones when smartphones are approaching pedestrian crossing at activated intersection		baseline - participants do not receive any alerts on their mobile smartphone when near intersections		retention phase - alerts have stopped after active intervention and behavior is monitored to test retention of learned behavior no alerts retention: no alerts will appear, but we will measure retention of behavior learned during the active intervention stage
All Cause Mortality
	Beacon Alerts		no Alerts Baseline		no Alerts Retention
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/385 (0%)		0/385 (0%)		0/385 (0%)
Serious Adverse Events
	Beacon Alerts		no Alerts Baseline		no Alerts Retention
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/385 (0%)		0/385 (0%)		0/385 (0%)
Other (Not Including Serious) Adverse Events
	Beacon Alerts		no Alerts Baseline		no Alerts Retention
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/385 (0%)		0/385 (0%)		0/385 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.