Improving Performance in Drivers With Mild Cognitive Impairment

January 17, 2020 updated by: Gary Naglie, Baycrest

Improving Performance in Drivers With Mild Cognitive Impairment: An RCT of Cognitive Training

The objective of this study is to assess the effectiveness of an intervention to address both executive function and processing speed changes that contribute to poor driving performance in adults with Mild Cognitive Impairment (MCI).

Our hypotheses are that the study intervention will improve performance on a driving simulator and will improve (i) executive function, specifically attention and planning, (ii) useful field of view, (iii) mood, (iv) quality of life, and (v) reported motor vehicle crashes and driving infractions.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Executive function and processing speed are recognized critical correlates of driving performance and have been shown to decline in older adults and in persons with mild cognitive impairment. Members of our research team have shown that group executive function training such as Goal Management Training results in benefits for healthy older adults, including improved simulated daily activities. The ultimate purpose of our research is to develop interventions to help maintain older adults' mobility in order to assist their 'aging at home'. The planned study will assess the effectiveness of an intervention that includes Goal Management Training + processing speed training (using DriveSharp software), which is designed to address both executive function and processing speed changes that contribute to poor driving performance in people with diagnosed mild cognitive impairment. The investigators will measure the effectiveness of the intervention on driving performance, sustained attention, divided attention, executive function, depressive symptoms and quality of life.

Study Type

Interventional

Enrollment (Actual)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M6A 2E1
        • Baycrest Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • mild cognitive impairment
  • currently driving or voluntarily stopped driving within the past year
  • fluent in English

Exclusion Criteria:

  • visual problems that cannot be corrected with standard lenses
  • alcohol/substance abuse
  • stroke with residual motor /sensory deficit
  • traumatic brain injury
  • seizure in the past two years
  • Parkinson's disease
  • Multiple sclerosis
  • untreated sleep apnea
  • history of motion sickness
  • history of dizziness, vertigo
  • active primary psychiatric disorder requiring treatment
  • on a dose of cognitive enhancing medication for less than 3 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: FACTORIAL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Goal Management Training + Processing Speed Training
Group receives both Goal Management Training and as well as Processing Speed Training using DriveSharp software.
Behavioral: Goal Management Training
9 weeks, 2 hour session/week, 1 hour/day homework (6 days/week), 2 x 0.5 hour sessions with trainer
Other Names:
  • GMT
Behavioral: Processing Speed Training
9 weeks, a total of 10 hours of computer-based processing speed training; 60-75 minutes/week
Other Names:
  • PST (DriveSharp software)
ACTIVE_COMPARATOR: Processing Speed Training + Brain Health Workshop
Group receives both Processing Speed Training (using DriveSharp) and participates in a Brain Health Workshop that is matched to Goal Management Training for session length and contact with trainer.
Behavioral: Processing Speed Training
9 weeks, a total of 10 hours of computer-based processing speed training; 60-75 minutes/week
Other Names:
  • PST (DriveSharp software)
Behavioral: Brain Health Workshop
9 weeks, 2 hour session/week, 1 hour/day homework (6 days/week), 2 x 0.5 hour sessions with trainer
Other Names:
  • BHW
PLACEBO_COMPARATOR: Brain Health Workshop + computer assignments
Group participates in Brain Health Workshop and is provided with computer assignments to match for time spent on the computer in the other arms.
Behavioral: Brain Health Workshop
9 weeks, 2 hour session/week, 1 hour/day homework (6 days/week), 2 x 0.5 hour sessions with trainer
Other Names:
  • BHW

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Driving Performance
Time Frame: 9-14 weeks
Measurements obtained on a computer-based driving simulation
9-14 weeks
Driving Performance
Time Frame: 33-38 weeks
Measurements obtained on a computer-based driving simulation
33-38 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sustained Attention to Response Task (SART)
Time Frame: 9-14 weeks, 33-38 weeks
Sustained attention
9-14 weeks, 33-38 weeks
D-KEFs Tower Test
Time Frame: 9-14 weeks, 33-38 weeks
Visuospatial planning
9-14 weeks, 33-38 weeks
Useful Field of View Test (UFOV)
Time Frame: 9-14 weeks, 33-38 weeks
Visual field of view
9-14 weeks, 33-38 weeks
Cognitive Failures Questionnaire
Time Frame: 9-14 weeks, 33-38 weeks
Absentmindedness, executive dysfunction in daily life
9-14 weeks, 33-38 weeks
Dysexecutive Questionnaire
Time Frame: 9-14 weeks, 33-38 weeks
Absentmindedness, executive dysfunction in daily life
9-14 weeks, 33-38 weeks
Geriatric Depression Scale (GDS-15 item)
Time Frame: 9-14 weeks, 33-38 weeks
Depressive symptoms
9-14 weeks, 33-38 weeks
Quality of Life: AD (QOL-AD)
Time Frame: 9-14 weeks, 33-38 weeks
Quality of life with MCI and Alzheimer's disease
9-14 weeks, 33-38 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baycrest

Collaborators

University Health Network, Toronto
Sunnybrook Health Sciences Centre
McGill University
Centre for Addiction and Mental Health
Unity Health Toronto
Michael Garron Hospital
Lakehead University

Investigators

  • Principal Investigator: Gary Naglie, MD, Baycrest

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (ACTUAL)

March 1, 2019

Study Completion (ACTUAL)

March 1, 2019

Study Registration Dates

First Submitted

August 15, 2013

First Submitted That Met QC Criteria

August 30, 2013

First Posted (ESTIMATE)

September 5, 2013

Study Record Updates

Last Update Posted (ACTUAL)

January 21, 2020

Last Update Submitted That Met QC Criteria

January 17, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIHR MOP-119580

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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