Improving Performance in Drivers With Mild Cognitive Impairment

NCT ID: NCT01935219

Last Updated: 2020-01-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2019-03-31

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.

Conditions

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Mild Cognitive Impairment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Goal Management Training + Processing Speed Training

Group receives both Goal Management Training and as well as Processing Speed Training using DriveSharp software.

Group Type EXPERIMENTAL

Goal Management Training

Intervention Type BEHAVIORAL

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

Processing Speed Training

Intervention Type BEHAVIORAL

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

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.

Group Type ACTIVE_COMPARATOR

Processing Speed Training

Intervention Type BEHAVIORAL

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

Brain Health Workshop

Intervention Type BEHAVIORAL

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

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.

Group Type PLACEBO_COMPARATOR

Brain Health Workshop

Intervention Type BEHAVIORAL

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

Interventions

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Goal Management Training

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

Intervention Type BEHAVIORAL

Processing Speed Training

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

Intervention Type 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

Intervention Type BEHAVIORAL

Other Intervention Names

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GMT PST (DriveSharp software) BHW

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
Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Unity Health Toronto

OTHER

Sponsor Role collaborator

Sunnybrook Health Sciences Centre

OTHER

Sponsor Role collaborator

Lakehead University

OTHER

Sponsor Role collaborator

McGill University

OTHER

Sponsor Role collaborator

University Health Network, Toronto

OTHER

Sponsor Role collaborator

Michael Garron Hospital

OTHER

Sponsor Role collaborator

Centre for Addiction and Mental Health

OTHER

Sponsor Role collaborator

Baycrest

OTHER

Sponsor Role lead

Responsible Party

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Gary Naglie

Chief of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gary Naglie, MD

Role: PRINCIPAL_INVESTIGATOR

Baycrest

Locations

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Baycrest Health Sciences

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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CIHR MOP-119580

Identifier Type: -

Identifier Source: org_study_id

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