Improving Performance in Drivers With Mild Cognitive Impairment

Sponsor
Baycrest (Other)
Overall Status
Completed
CT.gov ID
NCT01935219
Collaborator
Unity Health Toronto (Other), Sunnybrook Health Sciences Centre (Other), Lakehead University (Other), McGill University (Other), University Health Network, Toronto (Other), Michael Garron Hospital (Other), Centre for Addiction and Mental Health (Other)
66
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67
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Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Goal Management Training
  • Behavioral: Processing Speed Training
  • Behavioral: Brain Health Workshop
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
66 participants
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Improving Performance in Drivers With Mild Cognitive Impairment: An RCT of Cognitive Training
Study Start Date :
Aug 1, 2013
Actual Primary Completion Date :
Mar 1, 2019
Actual Study Completion Date :
Mar 1, 2019

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. Driving Performance [9-14 weeks]

      Measurements obtained on a computer-based driving simulation

    2. Driving Performance [33-38 weeks]

      Measurements obtained on a computer-based driving simulation

    Secondary Outcome Measures

    1. Sustained Attention to Response Task (SART) [9-14 weeks, 33-38 weeks]

      Sustained attention

    2. D-KEFs Tower Test [9-14 weeks, 33-38 weeks]

      Visuospatial planning

    3. Useful Field of View Test (UFOV) [9-14 weeks, 33-38 weeks]

      Visual field of view

    4. Cognitive Failures Questionnaire [9-14 weeks, 33-38 weeks]

      Absentmindedness, executive dysfunction in daily life

    5. Dysexecutive Questionnaire [9-14 weeks, 33-38 weeks]

      Absentmindedness, executive dysfunction in daily life

    6. Geriatric Depression Scale (GDS-15 item) [9-14 weeks, 33-38 weeks]

      Depressive symptoms

    7. Quality of Life: AD (QOL-AD) [9-14 weeks, 33-38 weeks]

      Quality of life with MCI and Alzheimer's disease

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    55 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Baycrest Health Sciences Toronto Ontario Canada M6A 2E1

    Sponsors and Collaborators

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

    Investigators

    • Principal Investigator: Gary Naglie, MD, Baycrest

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Gary Naglie, Chief of Medicine, Baycrest
    ClinicalTrials.gov Identifier:
    NCT01935219
    Other Study ID Numbers:
    • CIHR MOP-119580
    First Posted:
    Sep 5, 2013
    Last Update Posted:
    Jan 21, 2020
    Last Verified:
    Jan 1, 2020
    Keywords provided by Gary Naglie, Chief of Medicine, Baycrest
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 21, 2020