Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

An Educational Intervention to Promote Safe Driving

This study has been completed.
University of Jyvaskyla
Tampere University of Technology
Taipale Telematics Ltd
Information provided by (Responsible Party):
Finnish Institute of Occupational Health Identifier:
First received: November 5, 2010
Last updated: September 28, 2012
Last verified: September 2012

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?

Condition Intervention
Driver Sleepiness
Behavioral: Fatigue management training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: An Educational Intervention to Promote Safe and Economic Truck Driving

Resource links provided by NLM:

Further study details as provided by Finnish Institute of Occupational Health:

Primary Outcome Measures:
  • driver sleepiness [ Time Frame: one year ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: one year ] [ Designated as safety issue: Yes ]
    Self-rating scale of stress and heart rate measures of stress (heart rate variability)

  • sleep [ Time Frame: one year ] [ Designated as safety issue: No ]
    wrist-worn actigraphy and sleep diary based measures of sleep quantity, timing and quality

  • driving behaviour [ Time Frame: one year ] [ Designated as safety issue: Yes ]
    vehicle movement-based measures of driving behaviour (speed, accelerations, deceleration)

Enrollment: 54
Study Start Date: August 2010
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fatigue management training
Experimental group subjects participated in a single half-day fatigue management training session.
Behavioral: Fatigue management training
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.


Ages Eligible for Study:   20 Years to 65 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01697189

Finnish Institute of Occupational Health
Helsinki, Finland, 00250
Sponsors and Collaborators
Finnish Institute of Occupational Health
University of Jyvaskyla
Tampere University of Technology
Taipale Telematics Ltd
Principal Investigator: Mikael Sallinen, PhD Finnish Institute of Occupational Health
  More Information

Responsible Party: Finnish Institute of Occupational Health Identifier: NCT01697189     History of Changes
Other Study ID Numbers: EISD-109378-FWF  EISD-109378-FWEF 
Study First Received: November 5, 2010
Last Updated: September 28, 2012
Health Authority: Finland: The ethics committee of the Hospital District of Helsinki and Uusimaa

Keywords provided by Finnish Institute of Occupational Health:
professional drivers
safe driving
training processed this record on October 21, 2016