Improving Performance in Drivers With Mild Cognitive Impairment

Not Applicable

Completed

• Conditions: Mild Cognitive Impairment

• Registration Number: NCT01935219
• Lead Sponsor: Baycrest

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.

Study Timeline

• Study Start: 2013-08
• Study First Submitted: 2013-08-15
• Study First Submitted QC: 2013-08-30
• Study First Posted: 2013-09-05
• Primary Completion: 2019-03
• Study Completion: 2019-03
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-17
• Last Update Posted: 2020-01-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Driving Performance	33-38 weeks	Measurements obtained on a computer-based driving simulation

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Baycrest Health Sciences; 🇨🇦 Toronto, Ontario, Canada