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Improving Performance in Drivers With Mild Cognitive Impairment

Primary Purpose

Mild Cognitive Impairment

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Goal Management Training
Processing Speed Training
Brain Health Workshop
Sponsored by
Baycrest
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mild Cognitive Impairment focused on measuring mild cognitive impairment, seniors, cognitive training, driving, driving simulation, intervention, goal management training, process speed training

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Baycrest Health Sciences

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Goal Management Training + Processing Speed Training

Processing Speed Training + Brain Health Workshop

Brain Health Workshop + computer assignments

Arm Description

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

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 participates in Brain Health Workshop and is provided with computer assignments to match for time spent on the computer in the other arms.

Outcomes

Primary Outcome Measures

Driving Performance
Measurements obtained on a computer-based driving simulation
Driving Performance
Measurements obtained on a computer-based driving simulation

Secondary Outcome Measures

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

Full Information

First Posted
August 15, 2013
Last Updated
January 17, 2020
Sponsor
Baycrest
Collaborators
Unity Health Toronto, Sunnybrook Health Sciences Centre, Lakehead University, McGill University, University Health Network, Toronto, Michael Garron Hospital, Centre for Addiction and Mental Health
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1. Study Identification

Unique Protocol Identification Number
NCT01935219
Brief Title
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

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
March 2019 (Actual)
Study Completion Date
March 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baycrest
Collaborators
Unity Health Toronto, Sunnybrook Health Sciences Centre, Lakehead University, McGill University, University Health Network, Toronto, Michael Garron Hospital, Centre for Addiction and Mental Health

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment
Keywords
mild cognitive impairment, seniors, cognitive training, driving, driving simulation, intervention, goal management training, process speed training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Goal Management Training + Processing Speed Training
Arm Type
Experimental
Arm Description
Group receives both Goal Management Training and as well as Processing Speed Training using DriveSharp software.
Arm Title
Processing Speed Training + Brain Health Workshop
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Brain Health Workshop + computer assignments
Arm Type
Placebo Comparator
Arm Description
Group participates in Brain Health Workshop and is provided with computer assignments to match for time spent on the computer in the other arms.
Intervention Type
Behavioral
Intervention Name(s)
Goal Management Training
Other Intervention Name(s)
GMT
Intervention Description
9 weeks, 2 hour session/week, 1 hour/day homework (6 days/week), 2 x 0.5 hour sessions with trainer
Intervention Type
Behavioral
Intervention Name(s)
Processing Speed Training
Other Intervention Name(s)
PST (DriveSharp software)
Intervention Description
9 weeks, a total of 10 hours of computer-based processing speed training; 60-75 minutes/week
Intervention Type
Behavioral
Intervention Name(s)
Brain Health Workshop
Other Intervention Name(s)
BHW
Intervention Description
9 weeks, 2 hour session/week, 1 hour/day homework (6 days/week), 2 x 0.5 hour sessions with trainer
Primary Outcome Measure Information:
Title
Driving Performance
Description
Measurements obtained on a computer-based driving simulation
Time Frame
9-14 weeks
Title
Driving Performance
Description
Measurements obtained on a computer-based driving simulation
Time Frame
33-38 weeks
Secondary Outcome Measure Information:
Title
Sustained Attention to Response Task (SART)
Description
Sustained attention
Time Frame
9-14 weeks, 33-38 weeks
Title
D-KEFs Tower Test
Description
Visuospatial planning
Time Frame
9-14 weeks, 33-38 weeks
Title
Useful Field of View Test (UFOV)
Description
Visual field of view
Time Frame
9-14 weeks, 33-38 weeks
Title
Cognitive Failures Questionnaire
Description
Absentmindedness, executive dysfunction in daily life
Time Frame
9-14 weeks, 33-38 weeks
Title
Dysexecutive Questionnaire
Description
Absentmindedness, executive dysfunction in daily life
Time Frame
9-14 weeks, 33-38 weeks
Title
Geriatric Depression Scale (GDS-15 item)
Description
Depressive symptoms
Time Frame
9-14 weeks, 33-38 weeks
Title
Quality of Life: AD (QOL-AD)
Description
Quality of life with MCI and Alzheimer's disease
Time Frame
9-14 weeks, 33-38 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gary Naglie, MD
Organizational Affiliation
Baycrest
Official's Role
Principal Investigator
Facility Information:
Facility Name
Baycrest Health Sciences
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6A 2E1
Country
Canada

12. IPD Sharing Statement

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Improving Performance in Drivers With Mild Cognitive Impairment

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