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Trial registered on ANZCTR
Registration number
ACTRN12617000255381
Ethics application status
Approved
Date submitted
14/02/2017
Date registered
20/02/2017
Date last updated
19/03/2018
Type of registration
Prospectively registered
Titles & IDs
Public title
Community Jury: Case finding for dementia, what do community members think General Practitioners (GPs) should do?
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Scientific title
Community Jury: Case finding for dementia, what do community members think GPs should do?
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Secondary ID [1]
291122
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Dementia
301950
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Condition category
Condition code
Neurological
301601
301601
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0
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Dementias
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Public Health
301711
301711
0
0
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Health service research
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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
We will conduct a community jury (CJ) to consider the potential benefits and harms of case finding for dementia in primary care and ask the jury to propose a recommendation for the question, “Should the health system encourage GPs to practice ‘case finding’ of dementia in people over 50?”
The CJ will be facilitated by the lead researcher, Dr Rae Thomas, a Psychologist with over 20 years experience. The jurors will watch and discuss prerecorded presentations from leading researchers in the field addressing the aforementioned question. The jury will be held on Saturday and Sunday at Bond University, with followup questionnaires mailed to participants three months later.
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Intervention code [1]
297104
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Early Detection / Screening
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Comparator / control treatment
None
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Our primary outcome will be juror recommendations for the posed question: “Should the health system encourage GPs to practice ‘case finding’ of dementia in people over 50?”
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Assessment method [1]
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Timepoint [1]
301002
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End of Community jury (i.e. after two days of presentations and deliberation)
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Secondary outcome [1]
331399
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The time point at which jurors achieve consistency in their individual responses to the jury question (i.e. enough information has been given for the jury to no longer change their answer). This will be assessed through surveying of jurors using OLT KeePad electronic clickers throughout the presentations and deliberation.
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Assessment method [1]
331399
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Timepoint [1]
331399
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End of Community jury (i.e. after two days of presentations and deliberation).
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Secondary outcome [2]
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The proportion of jurors that made an informed decision.
This will be assessed through a combination of adequate knowledge concept questions and congruence between attitude to case finding and intention to test (dichotomous outcome). It will also be assessed through qualitative analyses of deliberations.
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Assessment method [2]
331460
0
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Timepoint [2]
331460
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End of Community Jury (i.e. after two days of presentations and deliberation).
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Secondary outcome [3]
331687
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Individual's intention to be tested for MCI or dementia will also be measured, given the current tests and treatments available. This will be assessed through survey questions assessing attitudes to case finding for dementia and individual likelihood to test for dementia.
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Assessment method [3]
331687
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Timepoint [3]
331687
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End of Community Jury (i.e. after two days of presentations and deliberation).
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Secondary outcome [4]
331750
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Individual's knowledge of dementia will be assessed through a researcher developed survey.
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Assessment method [4]
331750
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Timepoint [4]
331750
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End of Community Jury (i.e. after two days of presentations and deliberation).
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Secondary outcome [5]
331751
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Individual's knowledge of dementia will be assessed through a researcher developed survey.
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Assessment method [5]
331751
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Timepoint [5]
331751
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Three month follow up.
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Secondary outcome [6]
331752
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Intention to test for dementia. This will be assessed through survey questions assessing attitudes to case finding for dementia and individual likelihood to test for dementia.
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Assessment method [6]
331752
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Timepoint [6]
331752
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Three month follow up.
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Eligibility
Key inclusion criteria
Living on the Gold Coast, Australia.
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Minimum age
50
Years
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Maximum age
70
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
We will exclude individuals who have been, have immediate family members (e.g. partner, parents, sisters/brothers, sister/brother-in-laws), diagnosed with MCI, dementia, or Alzheimer's, or who are carers for a person diagnosed with any of these conditions, We will also exclude individuals actively taking cognitive enhancing medications.
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Study design
Purpose
Screening
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Duration
Longitudinal
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Selection
Convenience sample
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Timing
Prospective
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Statistical methods / analysis
Quantitative and Qualitative analyses.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
6/03/2017
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Actual
14/03/2017
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Date of last participant enrolment
Anticipated
17/03/2017
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Actual
18/03/2017
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Date of last data collection
Anticipated
30/06/2017
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Actual
18/03/2017
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Sample size
Target
15
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Accrual to date
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Final
10
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Recruitment in Australia
Recruitment state(s)
QLD
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Funding & Sponsors
Funding source category [1]
295561
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University
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Name [1]
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Bond University Vice-Chancellor Research Grant
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Address [1]
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14 University Drive, Robina, QLD 4226
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Country [1]
295561
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Australia
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Primary sponsor type
University
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Name
Bond University
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Address
14 University Drive, Robina, QLD 4226
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Country
Australia
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Secondary sponsor category [1]
294383
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None
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Name [1]
294383
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Address [1]
294383
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Country [1]
294383
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
296881
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Bond University Human Research Ethics Committee
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Ethics committee address [1]
296881
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14 University Drive, Robina, QLD, 4226
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Ethics committee country [1]
296881
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Australia
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Date submitted for ethics approval [1]
296881
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07/10/2016
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Approval date [1]
296881
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16/12/2016
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Ethics approval number [1]
296881
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RO15810
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Summary
Brief summary
Government policy on health care should seek to reflect the views of the community but current methods for community engagement are limited. Strategies such as opinion polling, community forums, and engaging consumer representatives on decision making panels may not be able to fully consider issues that are complex, require a greater understanding of potential benefits and harms, and may provide only a limited number of viewpoints from the community. A community jury is a deliberative process that can help to establish the community’s preferences and values on a particular topic. This research team has successfully conducted the first randomised controlled trial of a community jury process in health and demonstrated proof of concept that this form of public engagement could be potentially beneficial to health policy. Our findings demonstrated a community jury was capable of considering complex information on the harms and benefits of screening, and to distinguish individual from community choices. Our community jury also identified an innovative solution to the question being deliberated. Cognitive impairment ranges from mild impairment to severe dementia. It causes problems with memory, learning, and organising and mild cognitive impairment can be a precursor for dementia. The benefit evidence for case finding for dementia is scarce, the medication benefits not significant, and the nonpharmacological interventions mostly ineffective. We will conduct a community jury to consider the potential benefits and harms of case finding for dementia in primary care and ask the jury to propose a recommendation for the question, “Should the health system encourage GPs to practice ‘case finding’ of dementia in people over 50?”
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Trial website
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Trial related presentations / publications
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Public notes
Although originally intended, three month follow up of jurors intention to test for dementia was not completed.
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Contacts
Principal investigator
Name
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Dr Rae Thomas
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Address
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Bond University, 14 University Drive, Robina, QLD, 4226.
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Country
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Australia
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Phone
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+61 7 5595 5521
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Fax
72322
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Email
72322
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[email protected]
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Contact person for public queries
Name
72323
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Rae Thomas
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Address
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Bond University, 14 University Drive, Robina, QLD, 4226.
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Country
72323
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Australia
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Phone
72323
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+61 7 5595 5521
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Fax
72323
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Email
72323
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[email protected]
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Contact person for scientific queries
Name
72324
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Rae Thomas
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Address
72324
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Bond University, 14 University Drive, Robina, QLD, 4226.
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Country
72324
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Australia
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Phone
72324
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+61 7 5595 5521
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Fax
72324
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Email
72324
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[email protected]
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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
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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