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Completed

NCT Number: NCT01935219

Improving Performance in Drivers With Mild Cognitive Impairment

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.

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Key information

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Baycrest Health Sciences

Toronto, Ontario, M6A 2E1, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Goal Management Training

Behavioral

9 weeks, 2 hour session/week, 1 hour/day homework (6 days/week), 2 x 0.5 hour sessions with trainer

Other names: GMT

Processing Speed Training

Behavioral

9 weeks, a total of 10 hours of computer-based processing speed training; 60-75 minutes/week

Other names: PST (DriveSharp software)

Brain Health Workshop

Behavioral

9 weeks, 2 hour session/week, 1 hour/day homework (6 days/week), 2 x 0.5 hour sessions with trainer

Other names: BHW

Primary outcomes

  1. Driving Performance

    Time frame: 9-14 weeks

    Measurements obtained on a computer-based driving simulation

  2. Driving Performance

    Time frame: 33-38 weeks

    Measurements obtained on a computer-based driving simulation

Secondary outcomes

  1. Sustained Attention to Response Task (SART)

    Time frame: 9-14 weeks, 33-38 weeks

    Sustained attention

  2. D-KEFs Tower Test

    Time frame: 9-14 weeks, 33-38 weeks

    Visuospatial planning

  3. Useful Field of View Test (UFOV)

    Time frame: 9-14 weeks, 33-38 weeks

    Visual field of view

  4. Cognitive Failures Questionnaire

    Time frame: 9-14 weeks, 33-38 weeks

    Absentmindedness, executive dysfunction in daily life

  5. Dysexecutive Questionnaire

    Time frame: 9-14 weeks, 33-38 weeks

    Absentmindedness, executive dysfunction in daily life

  6. Geriatric Depression Scale (GDS-15 item)

    Time frame: 9-14 weeks, 33-38 weeks

    Depressive symptoms

  7. Quality of Life: AD (QOL-AD)

    Time frame: 9-14 weeks, 33-38 weeks

    Quality of life with MCI and Alzheimer's disease

Sponsors and collaborators

Lead sponsor

Baycrest

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2019
Study completion
2019
First posted
Sep 5, 2013
Registry last updated
Jan 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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