Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001000291
Ethics application status
Approved
Date submitted
25/05/2018
Date registered
14/06/2018
Date last updated
15/11/2019
Date data sharing statement initially provided
15/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The impacts of a Community Jury on participants’ health interactions and decision between 1 and 5 years after the experience.
Scientific title
The impacts of a Community Jury on participants’ health interactions and decision between 1 and 5 years after the experience.
Secondary ID [1] 294950 0
Nil
Universal Trial Number (UTN)
U1111-1214-4028
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heath Literacy 307949 0
Health education 308009 0
Condition category
Condition code
Public Health 307048 307048 0 0
Other public health

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Semi-structured telephone interviews will be conducted between one and five years after participation in a health focused CJ. Each participant will be followed up once, with interviews audio recorded and transcribed for analysis. Semi-structured interviews were selected as a method of eliciting participant experience and allowing for the opportunity to further explore themes emerging from participant responses. Two researchers will independently review transcripts to develop a preliminary thematic analysis to identify a list of themes/topics. Further iteration of themes will be explored with other authors to develop a comprehensive list.
Intervention code [1] 301273 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 305966 0
Whether participation in health-focused community juries altered how participants thought about the health topic of their specific CJ (e.g., role of organisations in supporting weight management, case-finding for dementia, screening for prostate cancer). This will be achieved through semi-structured interviews, conducted via telephone, and audio recorded and transcribed for analysis.
Timepoint [1] 305966 0
At a single time point at the telephone interview.
Secondary outcome [1] 347130 0
We will also explore whether participating in the CJ influenced participants sharing the information with friends and/or family. This will be achieved through qualitative analysis of the audio recorded interviews.
Timepoint [1] 347130 0
At a single time point at the telephone interview.
Secondary outcome [2] 347131 0
We will also explore whether participating in the CJ influenced participants thoughts about their own health and how they interacted with healthcare providers. This will be achieved through qualitative analysis of the audio recorded interviews.
Timepoint [2] 347131 0
At a single time point at the telephone interview.

Eligibility
Key inclusion criteria
The current potential participant pool is 52 participants from four community juries. Participants will be recruited from individuals who have participated in health-focused CJs, conducted at Bond University between 2013 and 2018.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Non-consent to participate; unable to contact.

Study design
Purpose
Psychosocial
Duration
Cross-sectional
Selection
Defined population
Timing
Both
Statistical methods / analysis
Thematic analysis of audio recorded interviews, with two researchers analysing transcripts independently.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
18/06/2018
Actual
20/08/2018
Date of last participant enrolment
Anticipated
2/07/2018
Actual
12/11/2018
Date of last data collection
Anticipated
31/08/2018
Actual
12/11/2018
Sample size
Target
52
Accrual to date
Final
31
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 22734 0
4220 - Burleigh
Recruitment postcode(s) [2] 22736 0
4226 - Robina
Recruitment postcode(s) [3] 22737 0
4229 - Bond University

Funding & Sponsors
Funding source category [1] 299535 0
Government body
Name [1] 299535 0
NHMRC Program Grant
Country [1] 299535 0
Australia
Primary sponsor type
University
Name
Bond University
Address
14 University Dr, Robina, QLD, 4226
Country
Australia
Secondary sponsor category [1] 299125 0
None
Name [1] 299125 0
Address [1] 299125 0
Country [1] 299125 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300434 0
Bond University Human Research Ethics Committee
Ethics committee address [1] 300434 0
Ethics committee country [1] 300434 0
Australia
Date submitted for ethics approval [1] 300434 0
02/03/2018
Approval date [1] 300434 0
20/04/2018
Ethics approval number [1] 300434 0
AS03257

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

Contacts
Principal investigator
Name 83650 0
A/Prof Rae Thomas
Address 83650 0
Bond University
14 University Drive, Robina, QLD, 4226
Country 83650 0
Australia
Phone 83650 0
+6175595552
Fax 83650 0
Email 83650 0
[email protected]
Contact person for public queries
Name 83651 0
Rae Thomas
Address 83651 0
Bond University
14 University Drive, Robina, QLD, 4226
Country 83651 0
Australia
Phone 83651 0
+6175595552
Fax 83651 0
Email 83651 0
[email protected]
Contact person for scientific queries
Name 83652 0
Rae Thomas
Address 83652 0
Bond University
14 University Drive, Robina, QLD, 4226
Country 83652 0
Australia
Phone 83652 0
+6175595552
Fax 83652 0
Email 83652 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified participant data will be available, in addition to study protocols and semi-structured interview questions
When will data be available (start and end dates)?
Protocol and semi-structured interview questions available from trial registration
De-identified participant data will be made available post analysis
Start date of data availability will be March 2020. No end date determined.
Available to whom?
Individuals conducting similar research
Available for what types of analyses?
Qualitative
How or where can data be obtained?
Through contacting the trial's lead investigator Dr Rae Thomas, [email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
5712Study protocol  [email protected]
5713Informed consent form  [email protected]
5714Ethical approval  [email protected]



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.