<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01697189</url>
  </required_header>
  <id_info>
    <org_study_id>EISD-109378-FWF</org_study_id>
    <secondary_id>EISD-109378-FWEF</secondary_id>
    <nct_id>NCT01697189</nct_id>
  </id_info>
  <brief_title>An Educational Intervention to Promote Safe Driving</brief_title>
  <official_title>An Educational Intervention to Promote Safe and Economic Truck Driving</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Finnish Institute of Occupational Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Jyvaskyla</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Tampere University of Technology</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Taipale Telematics Ltd</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Finnish Institute of Occupational Health</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The general aim of the study is to promote safe, economic, and environmental-friendly driving&#xD;
      among long-haul truck drivers. To do this, the investigators will conduct an on-road study on&#xD;
      i) the relationship of driver sleepiness and stress with driving behaviour and fuel&#xD;
      consumption and ii) effectiveness of an educational intervention in mitigating sleepiness at&#xD;
      the wheel. The educational intervention is designed to be employed by occupational health&#xD;
      care professionals in the future. This solution clearly facilitates the implementation of the&#xD;
      intervention into practice if it turns out to be effective.&#xD;
&#xD;
      The investigators specified research questions are the following:&#xD;
&#xD;
        -  Do truck driver sleepiness and stress at the wheel reach levels that affect driving&#xD;
           behaviour, fuel consumption and carbon emissions?&#xD;
&#xD;
        -  What are the sources of sub-optimal arousal at the wheel in truck drivers?&#xD;
&#xD;
        -  Can truck driver sleepiness be mitigated by an educational intervention, and if yes,&#xD;
           does it improve driving behaviour and decrease fuel consumption and carbon emissions as&#xD;
           well?&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2010</start_date>
  <completion_date type="Actual">May 2012</completion_date>
  <primary_completion_date type="Actual">May 2012</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>driver sleepiness</measure>
    <time_frame>one year</time_frame>
    <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).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>driver stress</measure>
    <time_frame>one year</time_frame>
    <description>Self-rating scale of stress and heart rate measures of stress (heart rate variability)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>sleep</measure>
    <time_frame>one year</time_frame>
    <description>wrist-worn actigraphy and sleep diary based measures of sleep quantity, timing and quality</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>driving behaviour</measure>
    <time_frame>one year</time_frame>
    <description>vehicle movement-based measures of driving behaviour (speed, accelerations, deceleration)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">54</enrollment>
  <condition>Driver Sleepiness</condition>
  <arm_group>
    <arm_group_label>Fatigue management training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Experimental group subjects participated in a single half-day fatigue management training session.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No fatigue management training</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The control group subjects did not participate in the fatigue management training.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Fatigue management training</intervention_name>
    <description>Experimental group took part in a single half-day (4 hours) fatigue management training grounded on Problem Based Learning (PBL).</description>
    <arm_group_label>Fatigue management training</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  working as a truck driver at the moment of the study&#xD;
&#xD;
          -  having both day and night trips&#xD;
&#xD;
          -  having at least 2 years of experience in truck driving&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  not fluent in Finnish (the intervention is in Finnish)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mikael Sallinen, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Finnish Institute of Occupational Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Finnish Institute of Occupational Health</name>
      <address>
        <city>Helsinki</city>
        <zip>00250</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Finland</country>
  </location_countries>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>November 5, 2010</study_first_submitted>
  <study_first_submitted_qc>September 28, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 2, 2012</study_first_posted>
  <last_update_submitted>September 28, 2012</last_update_submitted>
  <last_update_submitted_qc>September 28, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 2, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>professional drivers</keyword>
  <keyword>sleepiness</keyword>
  <keyword>stress</keyword>
  <keyword>safe driving</keyword>
  <keyword>training</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sleepiness</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01697189
org study id: EISD-109378-FWF
secondary id: EISD-109378-FWEF
nct id: NCT01697189
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
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?
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: driver sleepiness
time frame: one year
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).
measure: driver stress
time frame: one year
description: Self-rating scale of stress and heart rate measures of stress (heart rate variability)
measure: sleep
time frame: one year
description: wrist-worn actigraphy and sleep diary based measures of sleep quantity, timing and quality
measure: driving behaviour
time frame: one year
description: vehicle movement-based measures of driving behaviour (speed, accelerations, deceleration)
arm group label: Fatigue management training
arm group type: Experimental
description: Experimental group subjects participated in a single half-day fatigue management training session.
arm group label: No fatigue management training
arm group type: No Intervention
description: The control group subjects did not participate in the fatigue management training.
intervention type: Behavioral
intervention name: Fatigue management training
description: Experimental group took part in a single half-day (4 hours) fatigue management training grounded on Problem Based Learning (PBL).
arm group label: Fatigue management training
criteria: 
gender: All
minimum age: 20 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Mikael Sallinen, PhD
role: Principal Investigator
affiliation: Finnish Institute of Occupational Health
facility: 
country: Finland
responsible party type: Sponsor
mesh term: Sleepiness