An Educational Intervention to Promote Safe Driving
Primary Purpose
Driver Sleepiness
Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Fatigue management training
Sponsored by
About this trial
This is an interventional prevention trial for Driver Sleepiness focused on measuring professional drivers, sleepiness, stress, safe driving, training
Eligibility Criteria
Inclusion Criteria:
- working as a truck driver at the moment of the study
- having both day and night trips
- having at least 2 years of experience in truck driving
Exclusion Criteria:
- not fluent in Finnish (the intervention is in Finnish)
Sites / Locations
- Finnish Institute of Occupational Health
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Fatigue management training
No fatigue management training
Arm Description
Experimental group subjects participated in a single half-day fatigue management training session.
The control group subjects did not participate in the fatigue management training.
Outcomes
Primary Outcome Measures
driver sleepiness
Self-reported sleepiness measured by the the Karolinska Sleepiness Scale Questionnaire and behavioral sleepiness measured by the Observer Rating of Drowsiness (based on video materia).
Secondary Outcome Measures
driver stress
Self-rating scale of stress and heart rate measures of stress (heart rate variability)
sleep
wrist-worn actigraphy and sleep diary based measures of sleep quantity, timing and quality
driving behaviour
vehicle movement-based measures of driving behaviour (speed, accelerations, deceleration)
Full Information
NCT ID
NCT01697189
First Posted
November 5, 2010
Last Updated
September 28, 2012
Sponsor
Finnish Institute of Occupational Health
Collaborators
University of Jyvaskyla, Tampere University of Technology, Taipale Telematics Ltd
1. Study Identification
Unique Protocol Identification Number
NCT01697189
Brief Title
An Educational Intervention to Promote Safe Driving
Official Title
An Educational Intervention to Promote Safe and Economic Truck Driving
Study Type
Interventional
2. Study Status
Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Finnish Institute of Occupational Health
Collaborators
University of Jyvaskyla, Tampere University of Technology, Taipale Telematics Ltd
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The general aim of the study is to promote safe, economic, and environmental-friendly driving among long-haul truck drivers. To do this, the investigators will conduct an on-road study on i) the relationship of driver sleepiness and stress with driving behaviour and fuel consumption and ii) effectiveness of an educational intervention in mitigating sleepiness at the wheel. The educational intervention is designed to be employed by occupational health care professionals in the future. This solution clearly facilitates the implementation of the intervention into practice if it turns out to be effective.
The investigators specified research questions are the following:
Do truck driver sleepiness and stress at the wheel reach levels that affect driving behaviour, fuel consumption and carbon emissions?
What are the sources of sub-optimal arousal at the wheel in truck drivers?
Can truck driver sleepiness be mitigated by an educational intervention, and if yes, does it improve driving behaviour and decrease fuel consumption and carbon emissions as well?
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Driver Sleepiness
Keywords
professional drivers, sleepiness, stress, safe driving, training
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
54 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fatigue management training
Arm Type
Experimental
Arm Description
Experimental group subjects participated in a single half-day fatigue management training session.
Arm Title
No fatigue management training
Arm Type
No Intervention
Arm Description
The control group subjects did not participate in the fatigue management training.
Intervention Type
Behavioral
Intervention Name(s)
Fatigue management training
Intervention Description
Experimental group took part in a single half-day (4 hours) fatigue management training grounded on Problem Based Learning (PBL).
Primary Outcome Measure Information:
Title
driver sleepiness
Description
Self-reported sleepiness measured by the the Karolinska Sleepiness Scale Questionnaire and behavioral sleepiness measured by the Observer Rating of Drowsiness (based on video materia).
Time Frame
one year
Secondary Outcome Measure Information:
Title
driver stress
Description
Self-rating scale of stress and heart rate measures of stress (heart rate variability)
Time Frame
one year
Title
sleep
Description
wrist-worn actigraphy and sleep diary based measures of sleep quantity, timing and quality
Time Frame
one year
Title
driving behaviour
Description
vehicle movement-based measures of driving behaviour (speed, accelerations, deceleration)
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
working as a truck driver at the moment of the study
having both day and night trips
having at least 2 years of experience in truck driving
Exclusion Criteria:
not fluent in Finnish (the intervention is in Finnish)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mikael Sallinen, PhD
Organizational Affiliation
Finnish Institute of Occupational Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Finnish Institute of Occupational Health
City
Helsinki
ZIP/Postal Code
00250
Country
Finland
12. IPD Sharing Statement
Learn more about this trial
An Educational Intervention to Promote Safe Driving
We'll reach out to this number within 24 hrs