Mild Cognitive ImpairmentNCT01935219
Improving Performance in Drivers With Mild Cognitive Impairment
A study testing Goal Management Training, Processing Speed Training and Brain Health Workshop in people with Mild Cognitive Impairment, run by Baycrest at 1 site in Canada.
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). Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- Goal Management Training, Processing Speed Training and Brain Health Workshop
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2013to Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- mild cognitive impairment
- currently driving or voluntarily stopped driving within the past year
- fluent in English
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improving Performance in Drivers With Mild Cognitive Impairment: An RCT of Cognitive Training
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.
Read the 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.
- Conditions
- Mild Cognitive Impairment
- Being tested
- Goal Management Training, Processing Speed Training, Brain Health Workshop
- Keywords
- mild cognitive impairment, seniors, cognitive training, driving, driving simulation, intervention, goal management training, process speed training
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Goal Management TrainingBehavioural
Also called GMT
9 weeks, 2 hour session/week, 1 hour/day homework (6 days/week), 2 x 0.5 hour sessions with trainer
Processing Speed TrainingBehavioural
Also called PST (DriveSharp software)
9 weeks, a total of 10 hours of computer-based processing speed training; 60-75 minutes/week
Brain Health WorkshopBehavioural
Also called BHW
9 weeks, 2 hour session/week, 1 hour/day homework (6 days/week), 2 x 0.5 hour sessions with trainer
| Study group | Role | What they receive |
|---|---|---|
| Goal Management Training + Processing Speed Training | Experimental | Group receives both Goal Management Training and as well as Processing Speed Training using DriveSharp software. Receives: Behavioral: Goal Management Training; Behavioral: 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. Receives: Behavioral: Processing Speed Training; Behavioral: 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. Receives: Behavioral: Brain Health Workshop |
What is being measured
The primary outcome is the main question the study is designed to answer.
Driving Performance
Measurements obtained on a computer-based driving simulation
Measured: 9-14 weeks
Driving Performance
Measurements obtained on a computer-based driving simulation
Measured: 33-38 weeks
Secondary outcomes (7)
Sustained Attention to Response Task (SART)
Sustained attention
Measured: 9-14 weeks, 33-38 weeks
D-KEFs Tower Test
Visuospatial planning
Measured: 9-14 weeks, 33-38 weeks
Useful Field of View Test (UFOV)
Visual field of view
Measured: 9-14 weeks, 33-38 weeks
Cognitive Failures Questionnaire
Absentmindedness, executive dysfunction in daily life
Measured: 9-14 weeks, 33-38 weeks
Dysexecutive Questionnaire
Absentmindedness, executive dysfunction in daily life
Measured: 9-14 weeks, 33-38 weeks
Geriatric Depression Scale (GDS-15 item)
Depressive symptoms
Measured: 9-14 weeks, 33-38 weeks
Quality of Life: AD (QOL-AD)
Quality of life with MCI and Alzheimer's disease
Measured: 9-14 weeks, 33-38 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2013 (estimated)
- Study startAug 2013
- Primary completionMar 2019
- Study completionMar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baycrest
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Principal investigator, Gary Naglie, Baycrest
- Investigators
- Gary Naglie, MD, Principal investigator, Baycrest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01935219
- Sponsor's protocol ID
- CIHR MOP-119580
- Status last verified
- Jan 2020
- First submitted
- 15 Aug 2013
- Last updated
- 21 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Performance in Drivers With Mild Cognitive Impairment: An RCT of Cognitive Training
- ClinicalTrials.gov ID
- NCT01935219
- Acronym / sponsor ID
- CIHR MOP-119580
- Conditions
- Mild Cognitive Impairment
- Keywords
- mild cognitive impairment, seniors, cognitive training, driving, driving simulation, intervention, goal management training, process speed training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- BaycrestUniversity, hospital or other
- 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
- Study start
- Aug 2013
- Primary completion
- Mar 2019 (actual)
- Study completion
- Mar 2019 (actual)
- First posted
- 5 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Goal Management Training + Processing Speed Training | Experimental | Behavioral: Goal Management Training, Behavioral: Processing Speed TrainingGroup receives both Goal Management Training and as well as Processing Speed Training using DriveSharp software. |
| Processing Speed Training + Brain Health Workshop | Active comparator | Behavioral: Processing Speed Training, Behavioral: Brain Health WorkshopGroup 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. |
| Brain Health Workshop + computer assignments | Placebo comparator | Behavioral: Brain Health WorkshopGroup participates in Brain Health Workshop and is provided with computer assignments to match for time spent on the computer in the other arms. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- mild cognitive impairment
- currently driving or voluntarily stopped driving within the past year
- fluent in English
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Goal Management TrainingAlso: GMT9 weeks, 2 hour session/week, 1 hour/day homework (6 days/week), 2 x 0.5 hour sessions with trainer | Behavioural | Goal Management Training + Processing Speed Training |
| Processing Speed TrainingAlso: PST (DriveSharp software)9 weeks, a total of 10 hours of computer-based processing speed training; 60-75 minutes/week | Behavioural | Goal Management Training + Processing Speed Training, Processing Speed Training + Brain Health Workshop |
| Brain Health WorkshopAlso: BHW9 weeks, 2 hour session/week, 1 hour/day homework (6 days/week), 2 x 0.5 hour sessions with trainer | Behavioural | Brain Health Workshop + computer assignments, Processing Speed Training + Brain Health Workshop |
Primary outcome
Driving Performance
Time frame: 9-14 weeks
Measurements obtained on a computer-based driving simulation
Driving Performance
Time frame: 33-38 weeks
Measurements obtained on a computer-based driving simulation
7 secondary outcomes
Sustained Attention to Response Task (SART)
Time frame: 9-14 weeks, 33-38 weeks
D-KEFs Tower Test
Time frame: 9-14 weeks, 33-38 weeks
Useful Field of View Test (UFOV)
Time frame: 9-14 weeks, 33-38 weeks
Cognitive Failures Questionnaire
Time frame: 9-14 weeks, 33-38 weeks
Dysexecutive Questionnaire
Time frame: 9-14 weeks, 33-38 weeks
Geriatric Depression Scale (GDS-15 item)
Time frame: 9-14 weeks, 33-38 weeks
Quality of Life: AD (QOL-AD)
Time frame: 9-14 weeks, 33-38 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gary Naglie, MD principal investigator
Baycrest
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Goal Management Training, Processing Speed Training and Brain Health Workshop in people with Mild Cognitive Impairment, run by Baycrest at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Driving Performance (time frame: 9-14 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2020.