Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000531516
Ethics application status
Approved
Date submitted
8/03/2024
Date registered
29/04/2024
Date last updated
29/04/2024
Date data sharing statement initially provided
29/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Reliability and validity of salivary cortisol levels of healthy adults measured using a point of collection analysis method
Scientific title
Reliability and validity of salivary cortisol levels of healthy adults measured using a point of collection analysis method
Secondary ID [1] 311684 0
NIL
Universal Trial Number (UTN)
Trial acronym
POCSS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy adults 333488 0
Condition category
Condition code
Other 330165 330165 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This is a prospective observational cross-sectional, study, designed to assess concurrent validity and reliability of the IPRO© method point of collection salivary cortisol measurement method.
This project will be conducted in the physiotherapy practical examination rooms of the exercise and rehabilitation sciences building (43), and the biomedical science laboratories at JCU Bebegu Yumba campus in Townsville, Queensland.
All participants will be healthy adults and will provide a sample of saliva whilst sitting in a rested state. Participants will have provided informed written consent prior to saliva sampling. The whole sampling process will take a maximum of 30 minutes. Participants will place three swabs into their mouth until they are soaked in saliva, They will then spit the swabs into three sterile vials. Once the saliva samples have been provided participants involvement in the study is complete. Analysis of the saliva samples will be conducted independently of the participants.
Intervention code [1] 328373 0
Not applicable
Comparator / control treatment
The comparator is the standard laboratory Salimetrics© Cortisol Enzyme Immunoassay Kit (Reference Standard). Participants act as their own controls. At least 50 µl of whole saliva will be collected into a polypropylene vial. The Salimetrics kit measures salivary cortisol levels using a drool collection technique. Analysis of the salivary cortisol levels will be conducted via enzyme-linked immunosorbent assays [ELISA] The samples are thawed, vortexed, and centrifuged at 1500 x g for 15 minutes to remove elements that may affect results. Samples are added to an assay plate and pipetted into wells. They are then immediately refrozen. The assays will then be run using thawed plates according to usual JCU biomedical analysis methods. SC level will be recorded as ng/mL.

Control group
Active

Outcomes
Primary outcome [1] 337609 0
Salivary Cortisol levels (nmol/L) measured using both a point of collection IPRO© salivary cortisol and the reference standard laboratory collection and analysis method
Timepoint [1] 337609 0
single collection time point. single analysis timepoint. Both samples are collected at the same time at a single visit, Saliva sampling for the reference standard (drooling) is first, then immediately after the index test sampling (swab) will occur,
Secondary outcome [1] 433124 0
repeated measurement reliability of the ipro system over time
Timepoint [1] 433124 0
These will be at 1 minute intervals prior to, at and following the 10 minute manufacturers recommended time for recording the cortisol level from the ipro cube reader. For example researcher will record the cortisol level from the cubes reader at 6 , 7 , 8 , 9 , 10 (recommended time), 11 , 12, 13, and 14 minutes following application of the saliva sample to the lateral flow device.

Eligibility
Key inclusion criteria
The eligibility criteria for participant inclusion in the study are adults (>18 years) who are:
• Willing and able to attend the study site and provide saliva samples at one collection session.
• Willing and able to provide informed, written consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
smoking, caffeine or food within 6o minutes prior to saliva collection
not willing to provide consent
under 18 years old

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis
Concurrent validity will be assessed using the Pearson product-moment correlation coefficient (r) analyses, as the study will yield two sets of measurements (Index and Reference) from the same population. A test of significance will be conducted to rule out an observed value due to chance.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2024
Actual
Date of last participant enrolment
Anticipated
31/07/2024
Actual
Date of last data collection
Anticipated
31/07/2024
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 42215 0
4811 - James Cook University

Funding & Sponsors
Funding source category [1] 316010 0
University
Name [1] 316010 0
James Cook University
Country [1] 316010 0
Australia
Primary sponsor type
University
Name
James Cook University
Address
Country
Australia
Secondary sponsor category [1] 318184 0
None
Name [1] 318184 0
Address [1] 318184 0
Country [1] 318184 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314836 0
James Cook University Human Research Ethics Committee
Ethics committee address [1] 314836 0
https://www.jcu.edu.au/jcu-connect/ethics-and-integrity/human-ethics
Ethics committee country [1] 314836 0
Australia
Date submitted for ethics approval [1] 314836 0
05/04/2023
Approval date [1] 314836 0
11/04/2023
Ethics approval number [1] 314836 0
H8333

Summary
Brief summary
The aim of this project is to assess the psychometric properties of a ‘point of collection’ technology to measure salivary cortisol levels in adults.
Objectives are to use the IPRO© ‘point of collection’ saliva analysis method to report: 1) concurrent validity by comparison with reference standard cortisol assay analysis; 2) over-time reliability of cortisol measurements; 3) inter-rater reliability of cortisol measurements.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 132878 0
Dr Carol Ann Flavell
Address 132878 0
Rm 013, Building 43 James Cook University, Townsville , QLD, 4811
Country 132878 0
Australia
Phone 132878 0
+61 747816472
Fax 132878 0
Email 132878 0
carol.flavell@jcu.edu.au
Contact person for public queries
Name 132879 0
Carol Ann Flavell
Address 132879 0
Rm 013, Building 43 James Cook University, Townsville ,QLD 4811
Country 132879 0
Australia
Phone 132879 0
+61 747816472
Fax 132879 0
Email 132879 0
carol.flavell@jcu.edu.au
Contact person for scientific queries
Name 132880 0
Carol Ann Flavell
Address 132880 0
Rm 013, Building 43 James Cook University, Townsville , QLD 4811
Country 132880 0
Australia
Phone 132880 0
+61 747816472
Fax 132880 0
Email 132880 0
carol.flavell@jcu.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Breaches confidentiality of the participant who supplies the saliva


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.