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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.
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.
Secondary ID [1] 288100 0
Nil Known
Universal Trial Number (UTN)
U1111-1177-3954
Trial acronym
DAD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dementia 296961 0
Alzheimer's Disease 297064 0
Condition category
Condition code
Neurological 297222 297222 0 0
Dementias
Neurological 297291 297291 0 0
Alzheimer's disease

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
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.
Intervention code [1] 293406 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 296809 0
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.
Timepoint [1] 296809 0
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.
Secondary outcome [1] 319421 0
Quality of life of participant
Timepoint [1] 319421 0
EQ5D-L and Visual Analogue Scale will be used at baseline, at six months, at 18 months and at 12 months.
Secondary outcome [2] 319476 0
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.
Timepoint [2] 319476 0
The health state of carer question will be asked at baseline, 6 months, 12 months, 18 months and 24 months.
Secondary outcome [3] 319562 0
Cognitive Decline of Participants will be measured by using the Mini Mental Examination (MMSE) and the Montreal Cognitive Assessment (MOCA)
Timepoint [3] 319562 0
Cognition will be measured at Baseline, 12 months and at 24 months at the face to face interviews conducted in participants homes.

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.
Minimum age
65 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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)

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
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.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 4869 0
Hornsby Ku-ring-gai Hospital - Hornsby
Recruitment postcode(s) [1] 12374 0
2077 - Hornsby

Funding & Sponsors
Funding source category [1] 292523 0
Hospital
Name [1] 292523 0
Hornsby Ku-ring-gai Hospital
Address [1] 292523 0
Palmerston Road
Hornsby NSW 2077
Country [1] 292523 0
Australia
Primary sponsor type
Other Collaborative groups
Name
John Walsh Centre for Rehabilitation Research
Address
Level 13
Kolling Building
RNSH
St Leonards
NSW 2065
Country
Australia
Secondary sponsor category [1] 291243 0
Hospital
Name [1] 291243 0
Hornsby Ku-ring-gai Hospital
Address [1] 291243 0
Palmerston Road
Hornsby
NSW 2077
Country [1] 291243 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293999 0
Northern Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 293999 0
Research Office
The Kolling Building
RNSH
Reserve Road
St Leonards NSW 2065
Ethics committee country [1] 293999 0
Australia
Date submitted for ethics approval [1] 293999 0
10/11/2015
Approval date [1] 293999 0
04/12/2015
Ethics approval number [1] 293999 0
LNRSSA/HAWKE/475

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.
Trial website
N/A
Trial related presentations / publications
N/A
Public notes
N/A

Contacts
Principal investigator
Name 62050 0
Prof Ian Cameron
Address 62050 0
John Walsh Centre for Rehabilitation Research
Level 13
The Kolling Building
Reserve Road
RNSH
St Leonards
NSW 2065
Country 62050 0
Australia
Phone 62050 0
+61 2 9926 4698
Fax 62050 0
Email 62050 0
ianc@mail.usyd.edu.au
Contact person for public queries
Name 62051 0
Ms Keri Lockwood
Address 62051 0
Hornsby Ku-ring-gai Hospital
Palmerston Road
Hornsby NSW 2077
Country 62051 0
Australia
Phone 62051 0
+61 2 9477 9389
Fax 62051 0
Email 62051 0
keri.lockwood@health.nsw.gov.au
Contact person for scientific queries
Name 62052 0
Prof Ian Cameron
Address 62052 0
John Walsh Centre for Rehabilitation Research
Level 13
The Kolling Building
RNSH
Reserve Road
St Leonards
NSW 2065
Country 62052 0
Australia
Phone 62052 0
+61 2 9926 4698
Fax 62052 0
Email 62052 0
ianc@mail.usyd.edu.au

No information has been provided regarding IPD availability
Summary results
No Results