ANZCTR - Registration

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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

Condition category

Condition code

Neurological

Dementias

Mental Health

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]

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]

World Health Organization Quality of Life-Bref Scale (WHOQOL BREF) score for patients

Timepoint [1]

12 months

Primary outcome [2]

Geriatric Depression Scale score for patients

Timepoint [2]

12 months

Secondary outcome [1]

World Health Organization Quality of Life-Bref Scale (WHOQOL BREF) for carers

Timepoint [1]

12 months

Secondary outcome [2]

Beck Depression Inventory score for carers

Timepoint [2]

12 months

Secondary outcome [3]

GP hit rate in detection of dementia

Timepoint [3]

12 months

Secondary outcome [4]

GP differential diagnosis for dementia

Timepoint [4]

12 months

Secondary outcome [5]

GP identification and treatment of reversible causes of dementia

Timepoint [5]

12 months

Secondary outcome [6]

GP dementia related referrals made

Timepoint [6]

12 months

Secondary outcome [7]

General Practice Assessment Questionnaire score

Timepoint [7]

12 months

Secondary outcome [8]

Acceptability of the process scale score

Timepoint [8]

12 months

Secondary outcome [9]

Services accessed

Timepoint [9]

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?

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]

Government body

Name [1]

National Health and Medical Research Council

Address [1]

Country [1]

Australia

Primary sponsor type

Individual

Name

Professor Dimity Pond, University of Newcastle.

Address

Country

Australia

Secondary sponsor category [1]

Individual

Name [1]

Professor Henry Brodaty

Address [1]

University of New South Wales

Country [1]

Australia

Secondary sponsor category [2]

Individual

Name [2]

Professor John Marley

Address [2]

University of Newcastle

Country [2]

Australia

Secondary sponsor category [3]

Individual

Name [3]

Professor Charles Bridges-Webb

Address [3]

The Royal Australian College of General Practitioners New South Wales (RACGP NSW) Projects
Research & Development Unit

Country [3]

Australia

Secondary sponsor category [4]

Individual

Name [4]

Professor Jane Gunn

Address [4]

University of Melbourne

Country [4]

Australia

Secondary sponsor category [5]

Individual

Name [5]

Professor Justin Beilby

Address [5]

University of Adelaide

Country [5]

Australia

Secondary sponsor category [6]

Individual

Name [6]

Professor Nigel Stocks

Address [6]

University of Adelaide

Country [6]

Australia

Secondary sponsor category [7]

Individual

Name [7]

Dr Terry Joyce

Address [7]

University of Newcastle

Country [7]

Australia

Secondary sponsor category [8]

Individual

Name [8]

Mr Glen Rees

Address [8]

Alzheimer's Australia

Country [8]

Australia

Secondary sponsor category [9]

Individual

Name [9]

Dr Karen Mate

Address [9]

University of Newcastle

Country [9]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University of Newcastle

Ethics committee address [1]

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

14/12/2005

Ethics approval number [1]

H-151-1205

Summary

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.

Trial website

Trial related presentations / publications

Mate, K. E., Magin, P. J., Brodaty, H., Stocks, N. P., Gunn, J., Disler, P. B., . . . Pond, C. D. (2017). An evaluation of the additional benefit of population screening for dementia beyond a passive case-finding approach. International Journal of Geriatric Psychiatry, 32(3), 316-323. doi:10.1002/gps.446

Brodaty, H., Connors, M. H., Loy, C., Teixeira-Pinto, A., Stocks, N., Gunn, J., . . . Pond, C. D. (2016). Screening for Dementia in Primary Care: A Comparison of the GPCOG and the MMSE. Dementia and Geriatric Cognitive Disorders, 42(5-6), 323-330. doi:10.1159/000450992

Pond, C. D., Mate, K. E., Phillips, J., Stocks, N. P., Magin, P. J., Weaver, N., & Brodaty, H. (2013). Predictors of agreement between general practitioner detection of dementia and the revised Cambridge Cognitive Assessment (CAMCOG-R). International Psychogeriatrics, 25(10), 1639-1647. doi:10.1017/S1041610213000884

Pond, C., Magin, P., Brodaty, H., Gunn, J., Stocks, N., Phllips, J., . . . Mate, K. (2013). Improving GP detection and management of dementia: outcomes of an RCT. In 2013 Primary Health Care Research Conference: Program & Abstracts (pp. 1). Sydney: Primary Health Care Research and Information Service.

Pond, C. D., Brodaty, H., Stocks, N. P., Gunn, J., Disler, P., Paterson, N. E., . . . Weaver, N. A. (2012). Improving general practitioner identification rates of dementia: The effectiveness of medical detailing plus audit. In IPA 2012: International Psychigeriatric Association International Meeting Abstracts (pp. 80). Cairns: IPA.

Mate, K. E., Pond, C. D., Magin, P. J., Goode, S. M., McElduff, P., & Stocks, N. P. (2012). Diagnosis and disclosure of a memory problem is associated with quality of life in community based older Australians with dementia. International Psychogeriatrics, 24(12), 1962-1971.

Pond, C. D., Brodaty, H., Stocks, N. P., Gunn, J., Marley, J. E., Disler, P., . . . Mate, K. E. (2012). Ageing in general practice (AGP) trial: A cluster randomised trial to examine the effectiveness of peer education on GP diagnostic assessment and management of dementia. BMC Family Practice, 13(-), 1-9.

Pond, C. D., Mate, K. E., Phillips, J., Goode, S. M., Paterson, N. E., Magin, P. J., . . . Howell, C. (2012). A particularly difficult diagnosis to make: Factors that facilitate GP diagnosis of dementia. In 2012 Primary Health Care Research Conference: Program & Abstracts Vol. - (pp. 1). Adelaide, SA: PHC RIS.

Pond, C. D., Brodaty, H., Stocks, N., Paterson, N. E., Magin, P. J., Gunn, J., . . . Marley, J. E. (2011). The attitudes of Australian general practitioners to breaking news of dementia: A qualitative and quantitative exploration. In Alzheimer's and Dementia Vol. 7(4) (pp. S164). Amsterdam: Elsevier.

Pond, C. D., Goode, S. M., Mate, K. E., Magin, P. J., Brodaty, H., Brodaty, H., & Marley, J. E. (2011). GP evaluation of a dementia education project. In 2011 PHC Research Conference Abstracts. Brisbane, QLD: PHCRIS.

Mate, K. E., Pond, C. D., Swain, J., Goode, S. M., & Magin, P. J. (2010). The relationship of GP diagnosis of dementia with patient depression and quality of life measures. In 2010 Primary Health Care Research Conference: Program & Abstracts. Darwin, NT: Primary Health Care Research and Information Service.

Pond, C. D., Brodaty, H., Gunn, J., Stocks, N., Disler, P., Mate, K. E., . . . Crombie, A. (2010). GP identification of dementia: effect of gender, age and size of practice. Alzheimer's & Dementia, 6(4), S364-S365.

Pond, C. D., Mate, K. E., Swain, J., Goode, S. M., Magin, P. J., Brodaty, H., . . . Stocks, N. (2010). Dementia detection in general practice: Clinical diagnosis or brief screening instrument?. In 2010 Primary Health Care Research Conference: Program & Abstracts. Darwin, NT: Primary Health Care Research and Information Service.

Pond, C. D., Bridges-Webb, C., Beilby, J., Brodaty, H., Gunn, J., Mate, K. E., & Stocks, N. (2007). The detection of dementia by Australian general practitioners. In Australian and New Zealand Journal of Psychiatry Vol. 41 (Supplement 2) (pp. A316). London: Informa Healthcare.

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Contact person for public queries

Name

Dr Karen Mate

Address

Discipline of General Practice
Faculty of Health
University of Newcastle
Callaghan NSW 2308

Country

Australia

Phone

+61 2 49686738

Fax

+61 2 49686727

karen.mate@newcastle.edu.au

Contact person for scientific queries

Name

Professor Dimity Pond

Address

Discipline of General Practice
Faculty of Health
Discipline of General Practice
Faculty of Health
University of Newcastle
Callaghan NSW 2308

Country

Australia

Phone

+61 2 49686797

Fax

+61 2 49686727

dimity.pond@newcastle.edu.au

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

Source	Title	Year of Publication	DOI
Embase	Ageing in general practice (AGP) trial: a cluster randomised trial to examine the effectiveness of peer education on GP diagnostic assessment and management of dementia.	2012	https://dx.doi.org/10.1186/1471-2296-13-12
Embase	Screening for Dementia in Primary Care: A Comparison of the GPCOG and the MMSE.	2016	https://dx.doi.org/10.1159/000450992
Embase	Prevalence of Drug-Drug Interactions in Older Community-Dwelling Individuals: A Systematic Review and Meta-analysis.	2023	https://dx.doi.org/10.1007/s40266-022-01001-5

N.B. These documents automatically identified may not have been verified by the study sponsor.

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