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Trial registered on ANZCTR
Registration number
ACTRN12615001374550
Ethics application status
Approved
Date submitted
9/12/2015
Date registered
17/12/2015
Date last updated
17/12/2015
Type of registration
Prospectively registered
Titles & IDs
Public title
Driving and Dementia: This study aims to investigate the positives and negatives associated with people with dementia continuing to drive and to identify the factors associated with the decision of people with dementia to stop driving.
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Scientific title
Driving and Dementia: This study aims to identify the factors associated with people recently diagnosed with dementia or Alzheimer's Disease to stop driving.
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Secondary ID [1]
288100
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Nil Known
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Universal Trial Number (UTN)
U1111-1177-3954
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Trial acronym
DAD
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Dementia
296961
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Alzheimer's Disease
297064
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Condition category
Condition code
Neurological
297222
297222
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0
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Dementias
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Neurological
297291
297291
0
0
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Alzheimer's disease
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Intervention/exposure
Study type
Observational
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Patient registry
False
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
This study will establish a cohort of people with dementia who can be followed up for two years, to identify the factors associated with the decision for people with dementia to cease driving.
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Intervention code [1]
293406
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Not applicable
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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The primary outcome of this study is to identify the factors associated with the decision of people recently diagnosed with dementia to stop driving. This will be assessed over two years using 5 interviews designed especially for this study ), over a period of 2 years. Carers or Next of Kin of participants will also be interviewed a total of 5 times.
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Assessment method [1]
296809
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Timepoint [1]
296809
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Questionnaires will be completed with participants and carers at baseline, at six months, at 12 months, at 18 months and at 24 months. Three interviews (baseline, 12 month interview and 24 month interview) will be done face to face at the participants home and two (6 and 18 months) will be done over the telephone.
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Secondary outcome [1]
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Quality of life of participant
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Assessment method [1]
319421
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Timepoint [1]
319421
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EQ5D-L and Visual Analogue Scale will be used at baseline, at six months, at 18 months and at 12 months.
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Secondary outcome [2]
319476
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Health state of Carer. Carers will simply be asked whether they consider their health to be Excellent, very good, good, fair or poor, at all 5 interviews.
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Assessment method [2]
319476
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Timepoint [2]
319476
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The health state of carer question will be asked at baseline, 6 months, 12 months, 18 months and 24 months.
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Secondary outcome [3]
319562
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Cognitive Decline of Participants will be measured by using the Mini Mental Examination (MMSE) and the Montreal Cognitive Assessment (MOCA)
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Assessment method [3]
319562
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Timepoint [3]
319562
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Cognition will be measured at Baseline, 12 months and at 24 months at the face to face interviews conducted in participants homes.
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Eligibility
Key inclusion criteria
People aged 65 and older
People who have had a diagnosis of Dementia or Alzheimer’s disease from the
Hornsby Ku-ring-gai memory clinic in the previous six months
Be driving at the time of recruitment
Participant does not need to have a carer/NOK to be part of the trial but if they do nominate a carer/NOK they will be asked to complete an interview as well.
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Minimum age
65
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Non English speaking persons
People with Parkinson’s disease or other degenerative illnesses that may inhibit
their ability to drive over time (e.g. poor vision, epilepsy)
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Study design
Purpose
Natural history
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Duration
Longitudinal
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Selection
Defined population
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Timing
Prospective
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Statistical methods / analysis
This is an Observational study. Analysis will be comparative and offered for dissemination following peer review in the form of a medical/scientific journal report. The sample size of 100 people (and 100 carers) has been selected based on time available and budget. There will be no interim analyses; however data will be monitored by an independent committee for any adverse effects.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/01/2016
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Actual
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Date of last participant enrolment
Anticipated
1/01/2019
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
100
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
4869
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Hornsby Ku-ring-gai Hospital - Hornsby
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Recruitment postcode(s) [1]
12374
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2077 - Hornsby
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Funding & Sponsors
Funding source category [1]
292523
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Hospital
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Name [1]
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Hornsby Ku-ring-gai Hospital
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Address [1]
292523
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Palmerston Road
Hornsby NSW 2077
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Country [1]
292523
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Australia
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Primary sponsor type
Other Collaborative groups
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Name
John Walsh Centre for Rehabilitation Research
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Address
Level 13
Kolling Building
RNSH
St Leonards
NSW 2065
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Country
Australia
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Secondary sponsor category [1]
291243
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Hospital
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Name [1]
291243
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Hornsby Ku-ring-gai Hospital
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Address [1]
291243
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Palmerston Road
Hornsby
NSW 2077
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Country [1]
291243
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
293999
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Northern Sydney Local Health District Human Research Ethics Committee
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Ethics committee address [1]
293999
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Research Office The Kolling Building RNSH Reserve Road St Leonards NSW 2065
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Ethics committee country [1]
293999
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Australia
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Date submitted for ethics approval [1]
293999
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10/11/2015
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Approval date [1]
293999
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04/12/2015
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Ethics approval number [1]
293999
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LNRSSA/HAWKE/475
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Summary
Brief summary
This study will follow-up drivers who have a diagnosis of dementia for a period of 2 years - which is the period after diagnosis in which many people with dementia stop driving. The primary objective is to identify the factors which are associated with participants deciding to give up driving and also to record how both the participant and the carers feel about the changes in the participants driving over the two year period following a diagnosis of dementia or Alzheimer’s disease.
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Trial website
N/A
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Trial related presentations / publications
N/A
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Public notes
N/A
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Contacts
Principal investigator
Name
62050
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Prof Ian Cameron
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Address
62050
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John Walsh Centre for Rehabilitation Research
Level 13
The Kolling Building
Reserve Road
RNSH
St Leonards
NSW 2065
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Country
62050
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Australia
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Phone
62050
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+61 2 9926 4698
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Fax
62050
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Email
62050
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ianc@mail.usyd.edu.au
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Contact person for public queries
Name
62051
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Keri Lockwood
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Address
62051
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Hornsby Ku-ring-gai Hospital
Palmerston Road
Hornsby NSW 2077
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Country
62051
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Australia
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Phone
62051
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+61 2 9477 9389
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Fax
62051
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Email
62051
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keri.lockwood@health.nsw.gov.au
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Contact person for scientific queries
Name
62052
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Ian Cameron
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Address
62052
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John Walsh Centre for Rehabilitation Research
Level 13
The Kolling Building
RNSH
Reserve Road
St Leonards
NSW 2065
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Country
62052
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Australia
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Phone
62052
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+61 2 9926 4698
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Fax
62052
0
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Email
62052
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ianc@mail.usyd.edu.au
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
Type
Is Peer Reviewed?
DOI
Citations or Other Details
Attachment
Basic results
No
369748-(Uploaded-25-11-2020-15-41-10)-Basic results summary.docx
Plain language summary
No
People with dementia, who drive, stop driving at s...
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