Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000117415
Ethics application status
Approved
Date submitted
14/01/2007
Date registered
8/02/2007
Date last updated
8/01/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The detection and management of dementia in general practice
Scientific title
The effect of GP training in and use of a brief cognitive impairment screening tool and training in dementia management guidelines on the quality of life and depression of dementia patients.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dementia 1609 0
Condition category
Condition code
Neurological 1713 1713 0 0
Dementias
Mental Health 1714 1714 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention general practitioners (GPs) will be trained in the use of a brief cognitive impairment screening tool (the GPCOG), which is superior to other dementia screening instruments because of its brevity and its use of an informant report in borderline cases. GPs will also be trained in the use of dementia management guidelines (the Care of Patients with Dementia in General Practice Guidelines) funded by the NSW Department of Health and endorsed by the Royal Australian College of General Practitioners. These consensus guidelines have been developed by general practitioners for the use of general practitioners caring for patients with dementia in the community.Training will take place either in the GP's own surgery or at a central location. The training will include a detailing intervention or presentation by a GP educator which will run for approximately 20 minutes. It will also include practice in the administration of the GPCOG and discussion of relevant cases. All intervention GPs will be provided with support materials and the Guidelines. Both intervention and control GPs will complete patient audits at the beginning and end of the study.
Intervention code [1] 1504 0
Early detection / Screening
Comparator / control treatment
The waitlist or control GPs will provide usual care to their patients. They will be mailed the support materials and the Guidelines at the end of the study, after 12 month follow up data has been collected from their patients.
Control group
Active

Outcomes
Primary outcome [1] 2384 0
World Health Organization Quality of Life-Bref Scale (WHOQOL BREF) score for patients
Timepoint [1] 2384 0
12 months
Primary outcome [2] 2385 0
Geriatric Depression Scale score for patients
Timepoint [2] 2385 0
12 months
Secondary outcome [1] 4140 0
World Health Organization Quality of Life-Bref Scale (WHOQOL BREF) for carers
Timepoint [1] 4140 0
12 months
Secondary outcome [2] 4141 0
Beck Depression Inventory score for carers
Timepoint [2] 4141 0
12 months
Secondary outcome [3] 4142 0
GP hit rate in detection of dementia
Timepoint [3] 4142 0
12 months
Secondary outcome [4] 4143 0
GP differential diagnosis for dementia
Timepoint [4] 4143 0
12 months
Secondary outcome [5] 4144 0
GP identification and treatment of reversible causes of dementia
Timepoint [5] 4144 0
12 months
Secondary outcome [6] 4145 0
GP dementia related referrals made
Timepoint [6] 4145 0
12 months
Secondary outcome [7] 4146 0
General Practice Assessment Questionnaire score
Timepoint [7] 4146 0
12 months
Secondary outcome [8] 4147 0
Acceptability of the process scale score
Timepoint [8] 4147 0
12 months
Secondary outcome [9] 4148 0
Services accessed
Timepoint [9] 4148 0
12 months

Eligibility
Key inclusion criteria
GP inclusion criteria:*Consent to participate in study*Have patients on a computerised database*Have patients aged 75 years and over and living in the community*Consent to being randomised to either-Intervention group or-Wait list control group.
Patient inclusion criteria:*Listed on participating GPs' databases*Previously visited recruited GPs within the last 24 months*Consent to a home visit or surgery visit by project staff*Speak and understand English.
Carer inclusion criteria:*Primary carer for a person suffering from dementia and participating in the project. *Prior consent from the person with dementia for his/her carer to participate in the study*Speak and understand English*Consent to a home visit or surgery visit by the project staff.
Minimum age
75 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
GP exclusion criteria:*Involved in project development*Does not meet inclusion criteria.
Patient exclusion criteria:*Parkinson’s disease, multiple sclerosis, motor neuron disease or central nervous system inflammation*Psychotic symptoms*Developmental disability*Insufficient English to complete a psychometric assessment (judged by interviewer)*Progressive malignancy*Substance abuse*Deemed too sick to complete study by the GP*Lives in a residential aged care facility*Does not meet inclusion criteria*Valid and informed consent cannot be obtained from the person involved and they do not have a person responsible for them.
Carer exclusion criteria:*Insufficient English to complete testing (judged by the interviewer)*Non-consenting patient-participant*Does not consent to a home visit or surgery visit by the project staff.*Too unwell to participate*Does not meet inclusion criteria.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
GPs are approached to participate from a randomised sequence of GP practice names. The approach is made by study personnel blind to the GP allocation. Patients are recruited by a mail out to all eligible patients on those GPs' databases. Patients and carers are interviewed by study personnel blind to the GP allocation. After recruitment and baseline interviews, allocation involves contacting the holder of the allocation schedule who is “off-site”.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Practices are allocated in a ratio of 2:1 to the intervention or control group. The randomisation code was developed using a computer random number generator to select random permuted blocks. The block lengths were varied randomly.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
GP Recruiter and nurse assessor are blinded.
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
31/01/2007
Actual
5/03/2007
Date of last participant enrolment
Anticipated
Actual
13/11/2009
Date of last data collection
Anticipated
Actual
17/12/2010
Sample size
Target
2000
Accrual to date
Final
2030
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1864 0
Government body
Name [1] 1864 0
National Health and Medical Research Council
Country [1] 1864 0
Australia
Primary sponsor type
Individual
Name
Professor Dimity Pond, University of Newcastle.
Address
Country
Australia
Secondary sponsor category [1] 1673 0
Individual
Name [1] 1673 0
Professor Henry Brodaty
Address [1] 1673 0
University of New South Wales
Country [1] 1673 0
Australia
Secondary sponsor category [2] 1674 0
Individual
Name [2] 1674 0
Professor John Marley
Address [2] 1674 0
University of Newcastle
Country [2] 1674 0
Australia
Secondary sponsor category [3] 1675 0
Individual
Name [3] 1675 0
Professor Charles Bridges-Webb
Address [3] 1675 0
The Royal Australian College of General Practitioners New South Wales (RACGP NSW) Projects
Research & Development Unit
Country [3] 1675 0
Australia
Secondary sponsor category [4] 1676 0
Individual
Name [4] 1676 0
Professor Jane Gunn
Address [4] 1676 0
University of Melbourne
Country [4] 1676 0
Australia
Secondary sponsor category [5] 1677 0
Individual
Name [5] 1677 0
Professor Justin Beilby
Address [5] 1677 0
University of Adelaide
Country [5] 1677 0
Australia
Secondary sponsor category [6] 1678 0
Individual
Name [6] 1678 0
Professor Nigel Stocks
Address [6] 1678 0
University of Adelaide
Country [6] 1678 0
Australia
Secondary sponsor category [7] 1679 0
Individual
Name [7] 1679 0
Dr Terry Joyce
Address [7] 1679 0
University of Newcastle
Country [7] 1679 0
Australia
Secondary sponsor category [8] 1680 0
Individual
Name [8] 1680 0
Mr Glen Rees
Address [8] 1680 0
Alzheimer's Australia
Country [8] 1680 0
Australia
Secondary sponsor category [9] 1681 0
Individual
Name [9] 1681 0
Dr Karen Mate
Address [9] 1681 0
University of Newcastle
Country [9] 1681 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3473 0
University of Newcastle
Ethics committee address [1] 3473 0
Ethics committee country [1] 3473 0
Australia
Date submitted for ethics approval [1] 3473 0
Approval date [1] 3473 0
14/12/2005
Ethics approval number [1] 3473 0
H-151-1205

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27438 0
Address 27438 0
Country 27438 0
Phone 27438 0
Fax 27438 0
Email 27438 0
Contact person for public queries
Name 10693 0
Dr Karen Mate
Address 10693 0
Discipline of General Practice
Faculty of Health
University of Newcastle
Callaghan NSW 2308
Country 10693 0
Australia
Phone 10693 0
+61 2 49686738
Fax 10693 0
+61 2 49686727
Email 10693 0
[email protected]
Contact person for scientific queries
Name 1621 0
Professor Dimity Pond
Address 1621 0
Discipline of General Practice
Faculty of Health
Discipline of General Practice
Faculty of Health
University of Newcastle
Callaghan NSW 2308
Country 1621 0
Australia
Phone 1621 0
+61 2 49686797
Fax 1621 0
+61 2 49686727
Email 1621 0
[email protected]

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
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseAgeing in general practice (AGP) trial: a cluster randomised trial to examine the effectiveness of peer education on GP diagnostic assessment and management of dementia.2012https://dx.doi.org/10.1186/1471-2296-13-12
EmbaseScreening for Dementia in Primary Care: A Comparison of the GPCOG and the MMSE.2016https://dx.doi.org/10.1159/000450992
EmbasePrevalence of Drug-Drug Interactions in Older Community-Dwelling Individuals: A Systematic Review and Meta-analysis.2023https://dx.doi.org/10.1007/s40266-022-01001-5
N.B. These documents automatically identified may not have been verified by the study sponsor.