Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001174774
Ethics application status
Approved
Date submitted
26/08/2022
Date registered
30/08/2022
Date last updated
6/04/2023
Date data sharing statement initially provided
30/08/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Mask-fit education in health workforce students: comparing the efficacy of self-fitting versus quantitative fit testing on mask fit.
Scientific title
Mask-fit education in health workforce students: comparing the efficacy of self-fitting versus quantitative fit testing on mask fit.
Secondary ID [1] 307847 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
infection 327459 0
Condition category
Condition code
Public Health 324584 324584 0 0
Other public health
Infection 324585 324585 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will receive education on mask selection and mask fit checking.
The content provided focuses on learning objectives:
1) To identify the rationale behind mask fit testing for clinical health care settings.
2) To identify factors affecting mask performance
3) To compare the difference between a mask fit check and a mask fit test
4) To identify factors in the selection of an appropriate P2/N95 mask
5) Demonstrate correct fitting of a P2/N95 mask
This education resource has been specifically designed for this study.
The duration of education is approximately 30 minutes as a one-off session.
The mode of administration is online (text and video materials).
Adherence is monitored via online platform, participants must complete an online quiz opened after opening of online material before they are allowed to book for physical testing.
Participants will then self-select from a range of brands/models of N95 masks and undertake self-performed fit-checks until they are satisfied that they have a suitably fit mask. Self-performed fit-checks will take place within 1 week of undertaking the educational component. Testing will take <10 minutes. Physical testing will take place at the Monash University Peninsula or Clayton Campus depending on the student course location.
Intervention code [1] 324313 0
Prevention
Comparator / control treatment
Gold standard comparator:
Participants will the same receive education on mask selection and mask fit checking as provided to the intervention group.
Participants will then undertake a Quantitative Fit Test procedure. This involves selection of 3 brands/models of N95 masks followed by particle counting of participants' ambient air (via porta-count machine). The method requires a device that counts particles of a predefined size, and provides a 'fit factor' calculated as the ratio of substance concentration outside to inside a face mask respirator. Fit factor values > 100 indicate adequate fit (pass). To achieve this sampling, quantitative fit testing requires the filtering facepiece respirator to be pierced in order to insert a sampling tube that is then sealed airtight. The sample inside the mask is compared to the ambient measure. Participants will be asked to perform five tasks while sampling is conducted:
1. Normal breathing;
2. Speaking;
3. Bending from the waist to 90 degrees;
4. Nodding head up and down; and
5. Turning head from side to side.
These participants will be told of their quantitative fit testing result and the brand/model of mask that best fits them. Physical testing will take place within 1 week of undertaking the educational component. Physical testing will take ~45 minutes. Physical testing will take place at the Monash University Peninsula or Clayton Campus depending on the student course location.
Control group
Active

Outcomes
Primary outcome [1] 332404 0
Proportion of participants who "pass" the fit factor threshold of 100 calculated via Quantitative Particle Count Fit Test
Timepoint [1] 332404 0
Immediately following provision of intervention / control condition.
Primary outcome [2] 332405 0
Proportion of participants who "pass" the fit factor threshold of 100 calculated via Quantitative Particle Count Fit Test
Timepoint [2] 332405 0
2 weeks following provision of intervention / control condition.
Secondary outcome [1] 413383 0
Mask selection brand/model. This is recorded based on reading the brand/model label of the mask product that was selected.
Timepoint [1] 413383 0
Immediately following provision of intervention / control condition.
Secondary outcome [2] 413412 0
Mean score for the fit factor calculated via Quantitative Particle Count Fit Test
Timepoint [2] 413412 0
Immediately following provision of the intervention / control condition.
Secondary outcome [3] 413413 0
Mean score for the fit factor calculated via Quantitative Particle Count Fit Test
Timepoint [3] 413413 0
2 weeks following provision of the intervention / control condition

Eligibility
Key inclusion criteria
Students at Monash University undertaking health professional courses
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Have previously undertaken mask fit education and/or testing
Unwillingness to be clean shaven (interferes with Quantitative Fit Testing)
Aged younger than 18 years

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation generated via computer
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Participants allocated to the intervention group will receive the gold standard control condition immediately following their 2-week follow-up assessment.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Fit factor scores will be compared between groups at the immediately following provision of the intervention / control condition time point using ordinary least squares "linear" regression.
Fit factor scores will be compared between groups at the 2-weeks following provision of the intervention / control condition time point using ordinary least squares "linear" regression.
An interaction effect will be examined between intervention group and time point using ordinary least squares "linear" regression with data clustered within participant and use of robust variance estimates.
Differences between groups in mask brand/model selection (secondary outcome) proportions will be examined for each model using logistic regression.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
2/09/2022
Actual
31/08/2022
Date of last participant enrolment
Anticipated
30/06/2023
Actual
Date of last data collection
Anticipated
21/07/2023
Actual
Sample size
Target
400
Accrual to date
160
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 312122 0
University
Name [1] 312122 0
Monash University
Country [1] 312122 0
Australia
Primary sponsor type
University
Name
Monash University
Address
McMahons Road, Frankston, Victoria, 3199
Country
Australia
Secondary sponsor category [1] 313670 0
None
Name [1] 313670 0
Address [1] 313670 0
Country [1] 313670 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311521 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 311521 0
1 Wellington Rd, Clayton, Victoria, 3168
Ethics committee country [1] 311521 0
Australia
Date submitted for ethics approval [1] 311521 0
02/03/2022
Approval date [1] 311521 0
14/03/2022
Ethics approval number [1] 311521 0
2022-31488-73118

Summary
Brief summary
Well fitting filtering masks (N95 masks) have become standard practice for personal protective equipment for workers performing aerosol-generating procedures during COVID-19. Currently, all health care workers in forward facing hospital roles are required to be undertake education (~20 minutes, low cost) regarding mask fitting and complete mask fit testing as directed by the Victorian Department of Health. This is also true for all Monash University students entering hospital and emergency service placements.
However, there is scant evidence supporting the effectiveness or sustained benefit of current procedures used to undertake mask fit testing in this context.
We hypothesise that there will be no difference between the intervention and control group in terms of the proportion of participants who "pass" the Quantitative Particle Count Fit Test either immediately following provision of the intervention / control condition or 2 weeks later.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 121390 0
Prof Terry Haines
Address 121390 0
Room 304, building G, Monash University Peninsula Campus, McMahons Road, Frankston, Victoria, 3199
Country 121390 0
Australia
Phone 121390 0
+61 433 596526
Fax 121390 0
Email 121390 0
terry.haines@monash.edu
Contact person for public queries
Name 121391 0
Prof Terry Haines
Address 121391 0
Room 304, building G, Monash University Peninsula Campus, McMahons Road, Frankston, Victoria, 3199
Country 121391 0
Australia
Phone 121391 0
+61 433 596526
Fax 121391 0
Email 121391 0
terry.haines@monash.edu
Contact person for scientific queries
Name 121392 0
Prof Terry Haines
Address 121392 0
Room 304, building G, Monash University Peninsula Campus, McMahons Road, Frankston, Victoria, 3199
Country 121392 0
Australia
Phone 121392 0
+61 433 596526
Fax 121392 0
Email 121392 0
terry.haines@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Deidentified demographics and outcome measures.
When will data be available (start and end dates)?
Available following publication of trial results, and for 7 years following this date.
Available to whom?
Available to the public
Available for what types of analyses?
Any
How or where can data be obtained?
https://www.monash.edu/medicine/spahc/research


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.