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Improving Performance in Drivers With Mild Cognitive Impairment

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01935219
Enrollment
66
Registered
2013-09-05
Start date
2013-08-31
Completion date
2019-03-31
Last updated
2020-01-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mild Cognitive Impairment

Keywords

mild cognitive impairment, seniors, cognitive training, driving, driving simulation, intervention, goal management training, process speed training

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.

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.

Interventions

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

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

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

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
55 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Driving Performance9-14 weeksMeasurements obtained on a computer-based driving simulation

Secondary

MeasureTime frameDescription
Geriatric Depression Scale (GDS-15 item)9-14 weeks, 33-38 weeksDepressive symptoms
Sustained Attention to Response Task (SART)9-14 weeks, 33-38 weeksSustained attention
D-KEFs Tower Test9-14 weeks, 33-38 weeksVisuospatial planning
Dysexecutive Questionnaire9-14 weeks, 33-38 weeksAbsentmindedness, executive dysfunction in daily life
Cognitive Failures Questionnaire9-14 weeks, 33-38 weeksAbsentmindedness, executive dysfunction in daily life
Quality of Life: AD (QOL-AD)9-14 weeks, 33-38 weeksQuality of life with MCI and Alzheimer's disease
Useful Field of View Test (UFOV)9-14 weeks, 33-38 weeksVisual field of view

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026