Evaluating the effect of real time feedback (real time alert beep and SMS on a daily basis), gain reward and lose reward for controlling speed level in commercial drivers in order to reduce traffic injuries in Iran; a field randomized trial
Assess how real-time feedback, rewards, and penalties and speed cameras affect speeding among commercial drivers in Iran
Design
data will be collected for 24 months: 1-month Run-In, 3 months baseline, 9 months of intervention, and 6 months post-intervention. 5 months of analysis and report. Driver age and sex will be ascertained from drivers via phone interviews at the time of recruitment. Trip weather conditions will be obtained by polling the Weather Underground Application Program Interface (API) at the end of each trip.
Settings and conduct
This trial aims to investigate the effect of feedback (alarm system and daily SMS), reward system, and deprivation of rewards to control speed in the city in drivers of public vehicles.
Participants/Inclusion and exclusion criteria
All commercial drivers with a cell phone. Drivers will be randomly assigned to study arms stratified according to vehicle type.
Intervention groups
CONTROLS: Drivers will be unobtrusively monitored using telematics devices.
GROUP A: Drivers will receive real-time alerts and daily text messages.
GROUP B: Drivers will receive real-time alerts, daily text messages, and rewards that would increase to a maximum of 100000 Tomans per month based on their daily performance
GROUP C: Drivers will receive real-time alerts, daily text messages, and will be offered 100000 Tomans at the beginning of each month if they maintain a perfect driving record but will see the rewards diminish with poor performance.
Main outcome variables
The primary outcome is the distance traveled per trip at speeds more than 10% above the speed limit as a proportion of total travel on high-speed roads.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171122037572N1
Registration date:2020-08-03, 1399/05/13
Registration timing:prospective
Last update:2020-08-03, 1399/05/13
Update count:0
Registration date
2020-08-03, 1399/05/13
Registrant information
Name
Negar Rezaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8670 5503
Email address
n.rezaei81@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-22, 1399/07/01
Expected recruitment end date
2022-09-23, 1401/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effect of real time feedback (real time alert beep and SMS on a daily basis), gain reward and lose reward for controlling speed level in commercial drivers in order to reduce traffic injuries in Iran; a field randomized trial
Public title
Evaluating the effect of real time feedback (real time alert beep and SMS on a daily basis), gain reward and lose reward for controlling speed level in commercial drivers in order to reduce traffic injuries in Iran; a field randomized trial
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
All commercial drivers
Exclusion criteria:
Not having cell phone
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
400
Randomization (investigator's opinion)
Randomized
Randomization description
Drivers will be randomly assigned to study arms stratified according to vehicle type. We have the list of names of all available drivers and vehicle types. Stratified randomization is achieved by generating a separate block for vehicle type, and subjects are assigned to the appropriate block. After all, subjects have been identified and assigned into blocks, computerized simple randomization is performed within each block to assign subjects to one of the groups.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
National Institute for Medical Research Development
Street address
#21 , Besat St., Fatemi St.
City
Tehran
Province
Tehran
Postal code
1419693111
Approval date
2019-12-07, 1398/09/16
Ethics committee reference number
IR.NIMAD.REC.1399.032
Health conditions studied
1
Description of health condition studied
Injury
ICD-10 code
T14.9
ICD-10 code description
Unspecified injury
Primary outcomes
1
Description
distance traveled per trip at speeds more than 10% above speed limit as a proportion of total travel on high-speed roads (speed limits > 90 km/h).
Timepoint
In time of speed increase by Telematics and GPS
Method of measurement
Telematics
Secondary outcomes
1
Description
proportion of distance traveled at more than 20% above speed limit on high-speed roads
Timepoint
In time of speed increase
Method of measurement
Telematics devices
2
Description
number of harsh acceleration/braking events
Timepoint
when harsh acceleration/braking
Method of measurement
Telematics devices
3
Description
harsh turns
Timepoint
when harsh turns
Method of measurement
Telematics devices
4
Description
crash/near-crash events
Timepoint
whenever crash/near-crash events happens
Method of measurement
Telematics devices
Intervention groups
1
Description
Intervention group: GROUP A (INFORMATION ONLY): Drivers will receive real-time alerts and daily text messages. The alerts will be loud audio beeps by the telematics device when speed exceeds 10% of posted limit. Text messages will provide a summary indicator of time spent speeding in the last day and comparisons with performance of other drivers. Drivers will be able to text back to receive locations of speed violations in the last day.
Category
Behavior
2
Description
Intervention group: GROUP B (GAIN OF REWARD): Drivers will receive real-time alerts, daily text messages, and rewards that would increase to a maximum of 100000 Tomans per month based on their daily performance
Category
Behavior
3
Description
Intervention group: GROUP C (LOSS OF REWARD): Drivers will receive real-time alerts, daily text messages, and will be offered 100000 Tomans at the beginning of each month if they maintain a perfect driving record but will see the rewards diminish with poor performance.
Category
Behavior
4
Description
Control group(NO INTERVENTION): Drivers will be unobtrusively monitored using telematics devices
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Non Communicable Diseases Research Center
Full name of responsible person
Negar Rezaei
Street address
Jalal Al-e-Ahmad Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1911713735
Phone
+98 21 8863 1293
Email
rezaei@ncdrc.info
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
National Institute for Medical Research Development
Full name of responsible person
Dr Malekzadeh
Street address
#21,Besat St., Fatemi St, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419693111
Phone
+98 21 6692 3561
Email
nimadiran@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
National Institute for Medical Research Development
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Negar Rezaei
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
Second Floor, No.10, Jalal Al-e-Ahmad Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1911713735
Phone
+98 21 8863 1293
Email
rezaei@ncdrc.info
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Negar Rezaei
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
Second Floor, No.10, Jalal Al-e-Ahmad Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1911713735
Phone
+98 21 8863 1293
Email
rezaei@ncdrc.info
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Nazila Rezaei
Position
MD
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Second Floor, No.10, Jalal Al-e-Ahmad Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1911713735
Phone
+98 21 8863 1293
Email
n.rezaei@ncdrc.info
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
a part of data related to primary outcome
When the data will become available and for how long
The access period begins a few months after the publication of the results, depending on the opinion of the Steering Committee
To whom data/document is available
For researchers working in academic, scientific and non-academic institutions who are also engaged in the industry
Under which criteria data/document could be used
The use of documents is in any case subject to the permission of the Steering Committee
From where data/document is obtainable
Dr. Negar Rezaei
What processes are involved for a request to access data/document
It varies depending on the type of application and the process of the Steering Committee