Improving Performance in Drivers With Mild Cognitive Impairment

Mild Cognitive Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01935219
• Other study ID #: CIHR MOP-119580
• Status: Completed
• Phase: N/A
• Start date: August 2013
• Est. completion date: March 2019

Study information

• Verified date: January 2020
• Source: Baycrest
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: March 2019
• Est. primary completion date: March 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Mild Cognitive Impairment

Intervention

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
• Processing Speed Training
9 weeks, a total of 10 hours of computer-based processing speed training; 60-75 minutes/week
• Brain Health Workshop
9 weeks, 2 hour session/week, 1 hour/day homework (6 days/week), 2 x 0.5 hour sessions with trainer

Locations

Country	Name	City	State
Canada	Baycrest Health Sciences	Toronto	Ontario

Sponsors (8)

Lead Sponsor	Collaborator
Baycrest	Centre for Addiction and Mental Health, Lakehead University, McGill University, St. Michael's Hospital, Toronto, Sunnybrook Health Sciences Centre, Toronto East General Hospital, University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Driving Performance	Measurements obtained on a computer-based driving simulation	9-14 weeks
Primary	Driving Performance	Measurements obtained on a computer-based driving simulation	33-38 weeks
Secondary	Sustained Attention to Response Task (SART)	Sustained attention	9-14 weeks, 33-38 weeks
Secondary	D-KEFs Tower Test	Visuospatial planning	9-14 weeks, 33-38 weeks
Secondary	Useful Field of View Test (UFOV)	Visual field of view	9-14 weeks, 33-38 weeks
Secondary	Cognitive Failures Questionnaire	Absentmindedness, executive dysfunction in daily life	9-14 weeks, 33-38 weeks
Secondary	Dysexecutive Questionnaire	Absentmindedness, executive dysfunction in daily life	9-14 weeks, 33-38 weeks
Secondary	Geriatric Depression Scale (GDS-15 item)	Depressive symptoms	9-14 weeks, 33-38 weeks
Secondary	Quality of Life: AD (QOL-AD)	Quality of life with MCI and Alzheimer's disease	9-14 weeks, 33-38 weeks