Trial from ANZCTR


Trial ID ACTRN12607000117415
Trial Status: Registered
Date Submitted: 14/01/2007
Date Registered: 8/02/2007
Retrospectively registered

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Public title The detection and management of dementia in general practice
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Study title in 'Participant- Intervention- Comparator- Outcome (PICO)' format 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.
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UTN
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Trial acronym
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Health condition(s) or problem(s) studied:
Dementia 1609 0
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Condition category: Condition code:
Neurological Dementias
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1713 1713 0 0
Mental Health Depression
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1714 1714 0 0

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Descriptions 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.
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Intervention Code:
Early detection / Screening 1504 0
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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.
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Control group Active
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Primary Outcome: World Health Organization Quality of Life-Bref Scale (WHOQOL BREF) score for patients 2384 0
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Timepoint: 12 months 2384 0
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Primary Outcome: Geriatric Depression Scale score for patients 2385 0
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Timepoint: 12 months 2385 0
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Secondary Outcome: World Health Organization Quality of Life-Bref Scale (WHOQOL BREF) for carers 4140 0
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Timepoint: 12 months 4140 0
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Secondary Outcome: Beck Depression Inventory score for carers 4141 0
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Timepoint: 12 months 4141 0
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Secondary Outcome: GP hit rate in detection of dementia 4142 0
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Timepoint: 12 months 4142 0
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Secondary Outcome: GP differential diagnosis for dementia 4143 0
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Timepoint: 12 months 4143 0
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Secondary Outcome: GP identification and treatment of reversible causes of dementia 4144 0
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Timepoint: 12 months 4144 0
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Secondary Outcome: GP dementia related referrals made 4145 0
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Timepoint: 12 months 4145 0
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Secondary Outcome: General Practice Assessment Questionnaire score 4146 0
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Timepoint: 12 months 4146 0
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Secondary Outcome: Acceptability of the process scale score 4147 0
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Timepoint: 12 months 4147 0
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Secondary Outcome: Services accessed 4148 0
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Timepoint: 12 months 4148 0
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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.
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Minimum age 75 Years
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Maximum age No limit
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Gender Both males and females
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Healthy volunteers? No
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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.
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Study type Interventional
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Purpose of the study Diagnosis
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Allocation to intervention Randomised controlled trial
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Describe the 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”.
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Describe the 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.
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Masking / blinding Blinded (masking used)
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Who is / are masked / blinded (choose all that apply)


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Assignment Parallel
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Other design features GP Recruiter and nurse assessor are blinded.
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Type of endpoint(s) Efficacy
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Statistical Methods/Analysis
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Phase
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Anticipated date of first participant enrolment 31/01/2007
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Date of first participant enrolment
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Anticipated date last participant recruited/enrolled
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Actual date last participant recruited/enrolled
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Target sample size 2000
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Recruitment status Not yet recruiting
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Recruitment in Australia

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Recruitment outside Australia

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Funding Source: Government body 1864 0
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Name: National Health and Medical Research Council 1864 0
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Address: 1864 0
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Country: Australia 1864 0
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Primary Sponsor Individual
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Name: Professor Dimity Pond, University of Newcastle.
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Country: Australia
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Secondary Sponsor: Individual 1673 0
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Name: Professor Henry Brodaty 1673 0
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Address: University of New South Wales 1673 0
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Country: Australia 1673 0
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Secondary Sponsor: Individual 1674 0
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Name: Professor John Marley 1674 0
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Address: University of Newcastle 1674 0
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Country: Australia 1674 0
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Secondary Sponsor: Individual 1675 0
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Name: Professor Charles Bridges-Webb 1675 0
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Address: The Royal Australian College of General Practitioners New South Wales (RACGP NSW) Projects
Research & Development Unit
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Country: Australia 1675 0
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Secondary Sponsor: Individual 1676 0
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Name: Professor Jane Gunn 1676 0
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Address: University of Melbourne 1676 0
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Country: Australia 1676 0
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Secondary Sponsor: Individual 1677 0
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Name: Professor Justin Beilby 1677 0
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Address: University of Adelaide 1677 0
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Country: Australia 1677 0
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Secondary Sponsor: Individual 1678 0
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Name: Professor Nigel Stocks 1678 0
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Address: University of Adelaide 1678 0
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Country: Australia 1678 0
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Secondary Sponsor: Individual 1679 0
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Name: Dr Terry Joyce 1679 0
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Address: University of Newcastle 1679 0
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Country: Australia 1679 0
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Secondary Sponsor: Individual 1680 0
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Name: Mr Glen Rees 1680 0
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Address: Alzheimer's Australia 1680 0
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Country: Australia 1680 0
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Secondary Sponsor: Individual 1681 0
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Name: Dr Karen Mate 1681 0
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Address: University of Newcastle 1681 0
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Country: Australia 1681 0
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Has the study received approval from at least one Ethics Committee? Yes
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Ethics Committee name: University of Newcastle 3473 0
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Address: 3473 0
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Country: Australia 3473 0
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Approval Date: 14/12/2005 3473 0
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Submitted Date: 3473 0
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HREC: H-151-1205 3473 0
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Brief summary This project aims to determine whether training in and use of a brief cognitive impairment screening tool and training in dementia management guidelines can improve diagnostic rates, management techniques and patient and carer outcomes compared with General Practitioners (GPs) who are not so trained and their patients and carers who undergo usual care. It will also evaluate the benefits of screening as opposed to case finding for early dementia in general practice.
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Trial website
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Public Notes
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Principal Investigator
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Contact person for public queries
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Name: Dr Karen Mate
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Address: Discipline of General Practice Faculty of Health University of Newcastle Callaghan NSW 2308
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Country: Australia
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Tel: +61 2 49686738
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Fax: +61 2 49686727
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Email: karen.mate@newcastle.edu.au
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Contact person for scientific queries
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Name: Professor Dimity Pond
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Address: Discipline of General Practice Faculty of Health Discipline of General Practice Faculty of Health University of Newcastle Callaghan NSW 2308
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Country: Australia
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Tel: +61 2 49686797
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Email: dimity.pond@newcastle.edu.au
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