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| ID | Type | Description | Link |
|---|---|---|---|
| R21HD095270 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| beacon alerts | Experimental | active intervention - participants are receiving alerts to warn them about distracted pedestrian behavior near intersections |
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| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| beacon alerts | Behavioral | alerts via unidirectional communication from beacons to smartphones when smartphones are approaching pedestrian crossing at activated intersection |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David C Schwebel, PhD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UAB Youth Safety Lab, University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States |
Will communicate with qualified investigators to share anonymous data if research goals are justified
after publication of final results and for 3 years
contact study PI
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | All Study Participants | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Analysis population is same as assignment in participant flow.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | 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) |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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 | Posted | Number | per cent of crossings distracted | 12 weeks |
|
10 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Beacon Alerts | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr David Schwebel | University of Alabama at Birmingham | 2059348745 | schwebel@uab.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 16, 2019 | Aug 21, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 9, 2020 | Oct 9, 2020 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D015438 | Health Behavior |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| no alerts retention | Behavioral | no alerts will appear, but we will measure retention of behavior learned during the active intervention stage |
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| years |
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| Sex: Female, Male | A handful of participants declined to provide gender or indicated non-binary gender. Those cells are left as missing. | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| OG001 | no Alerts Baseline | baseline - participants do not receive any alerts on their mobile smartphone when near intersections |
| OG002 | no Alerts Retention | 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 |
|
|
| 0 |
| 385 |
| 0 |
| 385 |
| 0 |
| 385 |
| EG001 | no Alerts Baseline | baseline - participants do not receive any alerts on their mobile smartphone when near intersections | 0 | 385 | 0 | 385 | 0 | 385 |
| EG002 | no Alerts Retention | 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 | 0 | 385 | 0 | 385 | 0 | 385 |
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