NCT01733537

Brief Summary

The purpose of this study is to determine whether providing motorcycle taxi drivers with a free reflective fluorescent vest will result in increased use of reflective or fluorescent clothing compared to education about wearing reflective or fluorescent clothing alone.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2013

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

November 21, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 27, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

August 9, 2013

Status Verified

August 1, 2013

Enrollment Period

4 months

First QC Date

November 21, 2012

Last Update Submit

August 6, 2013

Conditions

Keywords

traffic accidents, motorcycle, injury, conspicuity

Outcome Measures

Primary Outcomes (1)

  • Use of reflective or fluorescent clothing

    The use of reflective or fluorescent clothing will be compared between the intervention and control groups over the observation period

    3-5 months

Secondary Outcomes (2)

  • Wearing White Helmet

    3-5 months

  • Daytime Running Headlights

    3-5 months

Study Arms (2)

Vest and Education

EXPERIMENTAL

Motorcycle Taxi Drivers provided with a reflective, fluorescent vest and basic education about recommended measures to increase their visibility

Other: Free reflective, fluorescent vestBehavioral: Education

Education Alone

OTHER

Motorcycle Taxi Drivers provided with basic education about recommended measures to increase their visibility

Behavioral: Education

Interventions

Motorcycle taxi drivers in the intervention arm will receive a free reflective, fluorescent vest

Vest and Education
EducationBEHAVIORAL

Both arms will receive brief, basic education about recommended measures to increase their visibility

Education AloneVest and Education

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • motorcycle riders who identify themselves as motorcycle taxi drivers
  • individuals must work at least 2 days a week as a motorcycle taxi driver
  • have a telephone number for ride solicitation
  • have a license plate that is able to be recorded
  • are at least 18 years old
  • are willing to have us contact them in the future for repeat surveys

You may not qualify if:

  • motorcycle riders who do not meet the above criteria
  • motorcycle riders who do not consent to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kilimanjaro Region, Tanzania

Kilimanjaro Region, Kilimanjaro, Tanzania

Location

MeSH Terms

Conditions

Wounds and Injuries

Interventions

Educational Status

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Officials

  • Nathan M Thielman, MD, MPH

    Duke University

    PRINCIPAL INVESTIGATOR
  • Steven A Sumner, MD

    Duke University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 21, 2012

First Posted

November 27, 2012

Study Start

February 1, 2013

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

August 9, 2013

Record last verified: 2013-08

Locations