An Educational Intervention to Promote Safe Driving

Driver Sleepiness Clinical Trial

Official title:

An Educational Intervention to Promote Safe and Economic Truck Driving

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01697189
• Other study ID #: EISD-109378-FWF
• Secondary ID: EISD-109378-FWEF
• Status: Completed
• Phase: N/A
• First received: November 5, 2010
• Last updated: September 28, 2012
• Start date: August 2010
• Est. completion date: May 2012

Study information

• Verified date: September 2012
• Source: Finnish Institute of Occupational Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: The ethics committee of the Hospital District of Helsinki and Uusimaa
• Study type: Interventional

Clinical Trial 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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Driver Sleepiness

Intervention

Behavioral:
• Fatigue management training
Experimental group took part in a single half-day (4 hours) fatigue management training grounded on Problem Based Learning (PBL).

Locations

Country	Name	City	State
Finland	Finnish Institute of Occupational Health	Helsinki

Sponsors (4)

Lead Sponsor	Collaborator
Finnish Institute of Occupational Health	Taipale Telematics Ltd, Tampere University of Technology, University of Jyvaskyla

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	one year	Yes
Secondary	driver stress	Self-rating scale of stress and heart rate measures of stress (heart rate variability)	one year	Yes
Secondary	sleep	wrist-worn actigraphy and sleep diary based measures of sleep quantity, timing and quality	one year	No
Secondary	driving behaviour	vehicle movement-based measures of driving behaviour (speed, accelerations, deceleration)	one year	Yes