Improving Performance in Drivers With Mild Cognitive Impairment

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Mild Cognitive Impairment

Intervention / Treatment
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* Behavioral: Goal Management Training
* Behavioral: Processing Speed Training
* Behavioral: Brain Health Workshop


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Goal Management Training + Processing Speed Training<br>Group receives both Goal Management Training and as well as Processing Speed Training using DriveSharp software. | Behavioral: Goal Management Training<br>* 9 weeks, 2 hour session/week, 1 hour/day homework (6 days/week), 2 x 0.5 hour sessions with trainer<br>* Other names: GMT;Behavioral: Processing Speed Training<br>* 9 weeks, a total of 10 hours of computer-based processing speed training; 60-75 minutes/week<br>* Other names: PST (DriveSharp software);|
| Active Comparator: Processing Speed Training + Brain Health Workshop<br>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<br>* 9 weeks, a total of 10 hours of computer-based processing speed training; 60-75 minutes/week<br>* Other names: PST (DriveSharp software);Behavioral: Brain Health Workshop<br>* 9 weeks, 2 hour session/week, 1 hour/day homework (6 days/week), 2 x 0.5 hour sessions with trainer<br>* Other names: BHW;|
| Placebo Comparator: Brain Health Workshop + computer assignments<br>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<br>* 9 weeks, 2 hour session/week, 1 hour/day homework (6 days/week), 2 x 0.5 hour sessions with trainer<br>* Other names: BHW;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Driving Performance | Measurements obtained on a computer-based driving simulation | 9-14 weeks | 
| Driving Performance | Measurements obtained on a computer-based driving simulation | 33-38 weeks | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mild cognitive impairment, seniors, cognitive training, driving, driving simulation, intervention, goal management training, process speed training