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Trial registered on ANZCTR
Registration number
ACTRN12624000852550
Ethics application status
Approved
Date submitted
4/06/2024
Date registered
9/07/2024
Date last updated
9/07/2024
Date data sharing statement initially provided
9/07/2024
Type of registration
Retrospectively registered
Titles & IDs
Public title
Acceptability and feasibility of community (home-based) self-sampling of Australian adults with influenza-like illness: A pilot study
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Scientific title
Acceptability and feasibility of community (home-based) self-sampling of Australian adults with influenza-like illness: A pilot study
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Secondary ID [1]
312190
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Nil
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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:
influenza
333859
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Condition category
Condition code
Infection
330534
330534
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0
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Other infectious diseases
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Public Health
330791
330791
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0
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Health service research
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
The iSwab study tests the feasibility and acceptability of community (home)-based self-swabbing for patients experiencing influenza-like-illness (ILI) (self-reported fever, cough, and fatigue).
Participating GPs will invite eligible patients to take an iSwab (self-swab) kit home, swab themselves, and return the swab, consent materials, and surveys about their experience by post. Participants will receive a $50 Prezzee gift card for completing the surveys and returning the swab.
The iSwab kit is a complete self-swab kit for patients to review and complete research material, conduct a deep nasal swab on themselves, place the swab in viral transport media, and return the swab to the pathology lab by Express post.
The iSwab kit contains:
- Participant informed consent information containing information about the study
- Consent form to complete to participate
- Written instructions for how to self-swab and return the swab via post
- Personal protective equipment (PPE) (gloves), a nasal swab, viral transport media tube to place the swab inside, and safe postal packaging
- Two surveys to complete to assess the feasibility and acceptability of the process
- Reply paid envelopes for the surveys and consent, and pre-paid express post envelopes the swab.
Reading the information, conducting the swab, and completing the surveys is expected to take 30 minutes, Participants are asked to complete the swab and study materials as soon as possible after receiving them. The swab can be returned up to two weeks after being taken (if the envelope is stored in the fridge). Travel time to the nearest Australia Post Express post box will depend on the participant's location.
Pathology results will be collected by the study team but will not be used to monitor adherence. Identifiable participant details will be collected only to send remuneration ($50 gift card).
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Intervention code [1]
328744
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Early detection / Screening
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Number of swabs returned
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Assessment method [1]
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Assessed by data linkage with pathology provider
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Timepoint [1]
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Within 14 days of patient receiving swab
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Secondary outcome [1]
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Acceptability of home-swabbing
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Assessment method [1]
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Pre- and post-swab survey developed for the study
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Timepoint [1]
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prior to and after swab
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Eligibility
Key inclusion criteria
Patients over 16 years who:
1. are able to give informed consent, read and understand written instructions and deemed able to take a respiratory swab on themselves by their general practitioner.
AND
2. are identified as fitting the Australian Sentinel Practices Research Network (ASPREN) ILI case definition (cough, fever (self-reported) and fatigue with onset in the last 7 days) or World Health Organisation (WHO) ILI case definition (acute respiratory infection with a fever of greater than or equal to 38 C°, cough and onset within the last 10 days)
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Minimum age
16
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Children and patients who the general practitioner considers should not take part in the research study.
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Stopped early
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Data analysis
Data collected is being analysed
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Reason for early stopping/withdrawal
Participant recruitment difficulties
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Date of first participant enrolment
Anticipated
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Actual
16/02/2022
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Date of last participant enrolment
Anticipated
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Actual
11/10/2023
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Date of last data collection
Anticipated
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Actual
13/10/2023
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Sample size
Target
1000
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Accrual to date
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Final
468
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
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Funding & Sponsors
Funding source category [1]
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Commercial sector/Industry
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Name [1]
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Sanofi International
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Address [1]
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Country [1]
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France
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Primary sponsor type
Individual
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Name
Nigel Stocks
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Address
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
318860
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Country [1]
318860
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
315352
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University of Adelaide Human Research Ethics Committee
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Ethics committee address [1]
315352
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https://www.adelaide.edu.au/research-services/ethics-compliance-integrity/human-research-ethics/human-research-ethics-committee
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Ethics committee country [1]
315352
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Australia
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Date submitted for ethics approval [1]
315352
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20/02/2021
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Approval date [1]
315352
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25/05/2021
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Ethics approval number [1]
315352
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H-2021-077
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Summary
Brief summary
This research study tests whether people, who are feeling unwell with an influenza-like illness, find swabbing themselves at home to be an acceptable method of detecting influenza and other viruses. Patients experiencing cough, fever, and fatigue will be provided with a home-swab kit by their GPs. After they swab themselves at home, patients will return the swab by post to the pathology provider, and answer survey questions about their experience.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof Nigel Stocks
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Address
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Discipline of General Practice, University of Adelaide, Level 8, 115 Grenfell Street, Adelaide SA 5000
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Country
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Australia
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Phone
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+61 8 8313 3462
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Monique Chilver
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Address
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ASPREN, University of Adelaide, Level 8, 115 Grenfell Street, Adelaide SA 5000
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Country
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Australia
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Phone
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+61 8 8313 3463
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Fax
134431
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Email
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[email protected]
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Contact person for scientific queries
Name
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Monique Chilver
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Address
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ASPREN, University of Adelaide, Level 8, 115 Grenfell Street, Adelaide SA 5000
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Country
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Australia
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Phone
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+61 8 8313 3463
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Fax
134432
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Email
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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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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