NCT01935219

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

August 15, 2013

Completed
21 days until next milestone

First Posted

Study publicly available on registry

September 5, 2013

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

January 21, 2020

Status Verified

January 1, 2020

Enrollment Period

5.6 years

First QC Date

August 15, 2013

Last Update Submit

January 17, 2020

Conditions

Mild Cognitive Impairment

Keywords

mild cognitive impairmentseniorscognitive trainingdrivingdriving simulationinterventiongoal management trainingprocess speed training

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (7)

  • Sustained Attention to Response Task (SART)

    9-14 weeks, 33-38 weeks

  • D-KEFs Tower Test

    9-14 weeks, 33-38 weeks

  • Useful Field of View Test (UFOV)

    9-14 weeks, 33-38 weeks

  • Cognitive Failures Questionnaire

    9-14 weeks, 33-38 weeks

  • Dysexecutive Questionnaire

    9-14 weeks, 33-38 weeks

  • +2 more secondary outcomes

Study Arms (3)

Goal Management Training + Processing Speed Training

EXPERIMENTAL

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

Behavioral: Goal Management TrainingBehavioral: Processing Speed Training

Processing Speed Training + Brain Health Workshop

ACTIVE COMPARATOR

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 TrainingBehavioral: Brain Health Workshop

Brain Health Workshop + computer assignments

PLACEBO COMPARATOR

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

Interventions

Goal Management TrainingBEHAVIORAL

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

Also known as: GMT
Goal Management Training + Processing Speed Training
Processing Speed TrainingBEHAVIORAL

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

Also known as: PST (DriveSharp software)
Goal Management Training + Processing Speed TrainingProcessing Speed Training + Brain Health Workshop
Brain Health WorkshopBEHAVIORAL

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

Also known as: BHW
Brain Health Workshop + computer assignmentsProcessing Speed Training + Brain Health Workshop

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • mild cognitive impairment
  • currently driving or voluntarily stopped driving within the past year
  • fluent in English

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baycrest Health Sciences

Toronto, Ontario, M6A 2E1, Canada

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Gary Naglie, MD

    Baycrest

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of Medicine

Study Record Dates

First Submitted

August 15, 2013

First Posted

September 5, 2013

Study Start

August 1, 2013

Primary Completion

March 1, 2019

Study Completion

March 1, 2019

Last Updated

January 21, 2020

Record last verified: 2020-01

Locations

CA(1)