- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01697189
An Educational Intervention to Promote Safe Driving
An Educational Intervention to Promote Safe and Economic Truck Driving
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?
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Helsinki, Finland, 00250
- Finnish Institute of Occupational Health
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Fatigue management training
Experimental group subjects participated in a single half-day fatigue management training session.
|
Experimental group took part in a single half-day (4 hours) fatigue management training grounded on Problem Based Learning (PBL).
|
|
No Intervention: No fatigue management training
The control group subjects did not participate in the fatigue management training.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
driver sleepiness
Time Frame: one year
|
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).
|
one year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
driver stress
Time Frame: one year
|
Self-rating scale of stress and heart rate measures of stress (heart rate variability)
|
one year
|
|
sleep
Time Frame: one year
|
wrist-worn actigraphy and sleep diary based measures of sleep quantity, timing and quality
|
one year
|
|
driving behaviour
Time Frame: one year
|
vehicle movement-based measures of driving behaviour (speed, accelerations, deceleration)
|
one year
|
Collaborators and Investigators
Investigators
- Principal Investigator: Mikael Sallinen, PhD, Finnish Institute of Occupational Health
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EISD-109378-FWF
- EISD-109378-FWEF (Other Grant/Funding Number: Finnish Work Environment Fund)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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