Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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?
Scientific title
Community Jury: Case finding for dementia, what do community members think GPs should do?
Secondary ID [1] 291122 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dementia 301950 0
Condition category
Condition code
Neurological 301601 301601 0 0
Dementias
Public Health 301711 301711 0 0
Health service research

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
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.
Intervention code [1] 297104 0
Early Detection / Screening
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 301002 0
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?”
Timepoint [1] 301002 0
End of Community jury (i.e. after two days of presentations and deliberation)
Secondary outcome [1] 331399 0
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.
Timepoint [1] 331399 0
End of Community jury (i.e. after two days of presentations and deliberation).
Secondary outcome [2] 331460 0
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.
Timepoint [2] 331460 0
End of Community Jury (i.e. after two days of presentations and deliberation).
Secondary outcome [3] 331687 0
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.
Timepoint [3] 331687 0
End of Community Jury (i.e. after two days of presentations and deliberation).
Secondary outcome [4] 331750 0
Individual's knowledge of dementia will be assessed through a researcher developed survey.
Timepoint [4] 331750 0
End of Community Jury (i.e. after two days of presentations and deliberation).
Secondary outcome [5] 331751 0
Individual's knowledge of dementia will be assessed through a researcher developed survey.
Timepoint [5] 331751 0
Three month follow up.
Secondary outcome [6] 331752 0
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.
Timepoint [6] 331752 0
Three month follow up.

Eligibility
Key inclusion criteria
Living on the Gold Coast, Australia.
Minimum age
50 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
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.

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
Quantitative and Qualitative analyses.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
6/03/2017
Actual
14/03/2017
Date of last participant enrolment
Anticipated
17/03/2017
Actual
18/03/2017
Date of last data collection
Anticipated
30/06/2017
Actual
18/03/2017
Sample size
Target
15
Accrual to date
Final
10
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 295561 0
University
Name [1] 295561 0
Bond University Vice-Chancellor Research Grant
Country [1] 295561 0
Australia
Primary sponsor type
University
Name
Bond University
Address
14 University Drive, Robina, QLD 4226
Country
Australia
Secondary sponsor category [1] 294383 0
None
Name [1] 294383 0
Address [1] 294383 0
Country [1] 294383 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296881 0
Bond University Human Research Ethics Committee
Ethics committee address [1] 296881 0
14 University Drive, Robina, QLD, 4226
Ethics committee country [1] 296881 0
Australia
Date submitted for ethics approval [1] 296881 0
07/10/2016
Approval date [1] 296881 0
16/12/2016
Ethics approval number [1] 296881 0
RO15810

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?”
Trial website
Trial related presentations / publications
Public notes
Although originally intended, three month follow up of jurors intention to test for dementia was not completed.

Contacts
Principal investigator
Name 72322 0
Dr Rae Thomas
Address 72322 0
Bond University, 14 University Drive, Robina, QLD, 4226.
Country 72322 0
Australia
Phone 72322 0
+61 7 5595 5521
Fax 72322 0
Email 72322 0
[email protected]
Contact person for public queries
Name 72323 0
Rae Thomas
Address 72323 0
Bond University, 14 University Drive, Robina, QLD, 4226.
Country 72323 0
Australia
Phone 72323 0
+61 7 5595 5521
Fax 72323 0
Email 72323 0
[email protected]
Contact person for scientific queries
Name 72324 0
Rae Thomas
Address 72324 0
Bond University, 14 University Drive, Robina, QLD, 4226.
Country 72324 0
Australia
Phone 72324 0
+61 7 5595 5521
Fax 72324 0
Email 72324 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
No additional documents have been identified.