Improving Performance in Drivers With Mild Cognitive Impairment

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Baycrest
Sponsor:
Collaborators:
St. Michael's Hospital, Toronto
Sunnybrook Health Sciences Centre
Lakehead University
McGill University
University Health Network, Toronto
Toronto East General Hospital
Centre for Addiction and Mental Health
Information provided by (Responsible Party):
Gary Naglie, Baycrest
ClinicalTrials.gov Identifier:
NCT01935219
First received: August 15, 2013
Last updated: August 30, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention
Mild Cognitive Impairment
Behavioral: Goal Management Training
Behavioral: Processing Speed Training
Behavioral: Brain Health Workshop

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Improving Performance in Drivers With Mild Cognitive Impairment: An RCT of Cognitive Training

Resource links provided by NLM:


Further study details as provided by Baycrest:

Primary Outcome Measures:
  • Driving Performance [ Time Frame: 9-14 weeks ] [ Designated as safety issue: No ]
    Measurements obtained on a computer-based driving simulation

  • Driving Performance [ Time Frame: 33-38 weeks ] [ Designated as safety issue: No ]
    Measurements obtained on a computer-based driving simulation


Secondary Outcome Measures:
  • Sustained Attention to Response Task (SART) [ Time Frame: 9-14 weeks, 33-38 weeks ] [ Designated as safety issue: No ]
    Sustained attention

  • D-KEFs Tower Test [ Time Frame: 9-14 weeks, 33-38 weeks ] [ Designated as safety issue: No ]
    Visuospatial planning

  • Useful Field of View Test (UFOV) [ Time Frame: 9-14 weeks, 33-38 weeks ] [ Designated as safety issue: No ]
    Visual field of view

  • Cognitive Failures Questionnaire [ Time Frame: 9-14 weeks, 33-38 weeks ] [ Designated as safety issue: No ]
    Absentmindedness, executive dysfunction in daily life

  • Dysexecutive Questionnaire [ Time Frame: 9-14 weeks, 33-38 weeks ] [ Designated as safety issue: No ]
    Absentmindedness, executive dysfunction in daily life

  • Geriatric Depression Scale (GDS-15 item) [ Time Frame: 9-14 weeks, 33-38 weeks ] [ Designated as safety issue: No ]
    Depressive symptoms

  • Quality of Life: AD (QOL-AD) [ Time Frame: 9-14 weeks, 33-38 weeks ] [ Designated as safety issue: No ]
    Quality of life with MCI and Alzheimer's disease

  • Driving Habits Questionnaire (DHQ) [ Time Frame: 9-14 weeks, 33-38 weeks ] [ Designated as safety issue: No ]
    Driving habits


Estimated Enrollment: 128
Study Start Date: August 2013
Estimated Study Completion Date: August 2018
Estimated Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Goal Management Training + Processing Speed Training
Group receives both Goal Management Training and as well as Processing Speed Training using DriveSharp software.
Behavioral: Goal Management Training
9 weeks, 2 hour session/week, 1 hour/day homework (6 days/week), 2 x 0.5 hour sessions with trainer
Other Name: GMT
Behavioral: Processing Speed Training
9 weeks, a total of 10 hours of computer-based processing speed training; 60-75 minutes/week
Other Name: PST (DriveSharp software)
Active Comparator: 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.
Behavioral: Processing Speed Training
9 weeks, a total of 10 hours of computer-based processing speed training; 60-75 minutes/week
Other Name: PST (DriveSharp software)
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
Other Name: BHW
Placebo Comparator: 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.
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
Other Name: BHW

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

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • mild cognitive impairment
  • currently driving
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01935219

Contacts
Contact: Gary Naglie, MD 4167852500 ext 2073 gnaglie@baycrest.org
Contact: Natasa Tusevljak, MSc 4167852500 ext 5476 ntusevljak@baycrest.org

Locations
Canada, Ontario
Baycrest Health Sciences Recruiting
Toronto, Ontario, Canada, M6A 2E1
Contact: Gary Naglie, MD    41647852500 ext 2073    gnaglie@baycrest.org   
Principal Investigator: Gary Naglie, MD         
Sponsors and Collaborators
Baycrest
St. Michael's Hospital, Toronto
Sunnybrook Health Sciences Centre
Lakehead University
McGill University
University Health Network, Toronto
Toronto East General Hospital
Centre for Addiction and Mental Health
Investigators
Principal Investigator: Gary Naglie, MD Baycrest
  More Information

No publications provided

Responsible Party: Gary Naglie, Chief of Medicine, Baycrest
ClinicalTrials.gov Identifier: NCT01935219     History of Changes
Other Study ID Numbers: CIHR MOP-119580
Study First Received: August 15, 2013
Last Updated: August 30, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by Baycrest:
mild cognitive impairment
seniors
cognitive training
driving
driving simulation
intervention
goal management training
process speed training

Additional relevant MeSH terms:
Cognition Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 26, 2014