Clinical trial NCT01935219: Improving Performance in Drivers With Mild Cognitive Impairment
Official title: Improving Performance in Drivers With Mild Cognitive Impairment: An RCT of Cognitive Training
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mild Cognitive Impairment
Keywords: mild cognitive impairment
seniors
cognitive training
driving
driving simulation
intervention
goal management training
process speed training
Lead sponsor: Baycrest
Sponsor class: OTHER
Collaborators: name: Unity Health Toronto
name: Sunnybrook Health Sciences Centre
name: Lakehead University
name: McGill University
name: University Health Network, Toronto
name: Michael Garron Hospital
name: Centre for Addiction and Mental Health
First posted: 2013-09-05
Enrollment: 66
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Driving Performance
timeFrame: 9-14 weeks
measure: Driving Performance
timeFrame: 33-38 weeks
Secondary outcomes:
measure: Sustained Attention to Response Task (SART)
timeFrame: 9-14 weeks, 33-38 weeks
measure: D-KEFs Tower Test
timeFrame: 9-14 weeks, 33-38 weeks
measure: Useful Field of View Test (UFOV)
timeFrame: 9-14 weeks, 33-38 weeks
measure: Cognitive Failures Questionnaire
timeFrame: 9-14 weeks, 33-38 weeks
measure: Dysexecutive Questionnaire
timeFrame: 9-14 weeks, 33-38 weeks
measure: Geriatric Depression Scale (GDS-15 item)
timeFrame: 9-14 weeks, 33-38 weeks
measure: Quality of Life: AD (QOL-AD)
timeFrame: 9-14 weeks, 33-38 weeks
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Baycrest Health Sciences
state: Ontario
Study officials:
affiliation: Baycrest
name: Gary Naglie, MD
role: PRINCIPAL_INVESTIGATOR
References: