NCT02903147

Brief Summary

The objective of the study is to examine the effectiveness of a functional-meta-cognitive intervention program to reduce driving risk factors amongst professional bus drivers.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
77

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2010

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

September 7, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 16, 2016

Completed
Last Updated

September 16, 2016

Status Verified

September 1, 2016

Enrollment Period

4.6 years

First QC Date

September 7, 2016

Last Update Submit

September 15, 2016

Conditions

Keywords

IVDR; driving behavior patterns; Meta-Cognitive Intervention

Outcome Measures

Primary Outcomes (1)

  • Change in In Vehicle Data Recorder (IVDR) risk score

    Assessing the degree of change in the rate of IVDR events before and after intervention.

    Change from baseline IVDR risk score at 1 year

Secondary Outcomes (2)

  • Change in car accident rate

    Change from ratings of questionnaire pre intervention to ratings at an average of 1 year post intervention.

  • Change in subjective ratings of driving performance questionnaire.

    Change from ratings of questionnaire at baseline pre intervention to reratings at an average of 1 year post intervention..

Study Arms (2)

Functional Meta-Cognitive Intervention

EXPERIMENTAL

The intervention is aimed to improve human factors of professional bus drivers

Behavioral: Functional Meta-Cognitive Intervention

Control group

ACTIVE COMPARATOR

The control group had the employer's training - The company holds routine covert inspections, summons to conversations with the security offices and records in the drivers' personal files.

Behavioral: The employer's training

Interventions

Functional-Meta-Cognitive Intervention Program was focused on raising awareness to safe driving risk factors identified at pre-screening, with reference to the difficulties that the driver raises and providing coping strategies. The intervention has been customized for each driver and included three sessions of two hours.

Functional Meta-Cognitive Intervention
Control group

Eligibility Criteria

Age21 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male gender.
  • Having a valid bus driver's license.
  • Working for a specific large bus company in the center of Israel.

You may not qualify if:

  • Drivers who had less than 50 hours of IVDR data were excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Navah Ratzon, Prof.

    Tel Aviv University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Occupational Therapist

Study Record Dates

First Submitted

September 7, 2016

First Posted

September 16, 2016

Study Start

June 1, 2010

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

September 16, 2016

Record last verified: 2016-09