Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000484549
Ethics application status
Approved
Date submitted
19/03/2024
Date registered
19/04/2024
Date last updated
16/05/2024
Date data sharing statement initially provided
19/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy of a school-based air filtration project on indoor air quality and children's health
Scientific title
Efficacy of a school-based air filtration project on indoor air quality and children's health : a cluster-randomized controlled trial
Secondary ID [1] 311770 0
Nil known
Universal Trial Number (UTN)
U1111-1305-7871
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Respiratory health 333276 0
Mental health 333277 0
Allergy 333278 0
Condition category
Condition code
Respiratory 329969 329969 0 0
Normal development and function of the respiratory system
Mental Health 329970 329970 0 0
Studies of normal psychology, cognitive function and behaviour
Inflammatory and Immune System 329971 329971 0 0
Allergies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Active (intervention group) high-efficiency particulate air (HEPA) filters will be conducted in the classrooms in Primary schools from Monday to Friday for three months.
We will choose the Air filter: Samsung AX7500 (Samsung Co., Ltd, South Korea, also known as AX90T). Samsung AX7500 has 3 layers of filters: washable pre-filter for large particles, activated carbon deodorization filter for gas and odours, and HEPA filtration with ultra-fine dust filter for ultra-fine dust. Air filters will be checked for functionality by professional personnel from Samsung before deploying in a school. Researchers will install air filters in the appropriate place in the classroom.
During the implementation of the intervention, the teachers or another staff assigned by the principal of the school will be required to switch on and off the air filters, check the quality, and fill in the air filter usage log every day. All purifiers should be switched on 1 h before schoolchildren enter the classroom and switched off after the schoolchildren leave the room. The intervention will be starting at 7:30 and ending at 15:30 from Monday to Friday according to the school schedule. Regular weekly field observations will be made. A research assistant will assess the air filters at the school visits to document functionality and whether the air filters are on at the time of the school visit. If the air filters do not work properly, the research assistant will contact professional personnel from Samsung to repair it. If the air filters are turned off, the research assistant will communicate with the school contacts to encourage compliance.
Intervention code [1] 328224 0
Treatment: Devices
Comparator / control treatment
Sham (placebo, control group) HEPA air filters will be conducted in the classrooms in Primary schools from Monday to Friday for three months.
During a sham filtration session, the air filter will be modified by removing the HEPA filter and the activated carbon filter while keeping the external appearance identical to the HEPA filter Procedures.
Control group
Placebo

Outcomes
Primary outcome [1] 337732 0
Fractional exhaled nitric oxide (FeNO)
Timepoint [1] 337732 0
Baseline and one month, two months, three months (primary timepoint), and nine months post commencement of intervention
Primary outcome [2] 337733 0
Forced expiratory volume in 1 second (FEV1)
Timepoint [2] 337733 0
Baseline and one month, two months, three months (primary timepoint), and nine months post commencement of intervention
Primary outcome [3] 337734 0
Total difficulties scores
Timepoint [3] 337734 0
Baseline and one month, two months, three months (primary timepoint), and nine months post commencement of intervention
Secondary outcome [1] 433001 0
Allergic symptoms, including asthma and allergic rhinitis
Timepoint [1] 433001 0
Baseline and one month, two months, three months, and nine months post commencement of intervention
Secondary outcome [2] 433002 0
Pittsburgh Sleep Quality Index (PSQI)
Timepoint [2] 433002 0
Baseline and one month, two months, three months, and nine months post commencement of intervention
Secondary outcome [3] 433999 0
Forced vital capacity (FVC)
Timepoint [3] 433999 0
Baseline and one month, two months, three months, and nine months post commencement of intervention
Secondary outcome [4] 434000 0
FEV1/FVC ratio,
Timepoint [4] 434000 0
Baseline and one month, two months, three months, and nine months post commencement of intervention
Secondary outcome [5] 434001 0
Forced expiratory flow at 25% of FVC (FEF25%),
Timepoint [5] 434001 0
Baseline and one month, two months, three months, and nine months post commencement of intervention
Secondary outcome [6] 434002 0
Forced expiratory flow at 50% of FVC (FEF50%),
Timepoint [6] 434002 0
Baseline and one month, two months, three months, and nine months post commencement of intervention
Secondary outcome [7] 434003 0
Forced expiratory flow at 25-75% of FVC (FEF25-75%)
Timepoint [7] 434003 0
Baseline and one month, two months, three months, and nine months post commencement of intervention
Secondary outcome [8] 434004 0
Forced expiratory flow at 75% of FVC (FEF75%)
Timepoint [8] 434004 0
Baseline and one month, two months, three months, and nine months post commencement of intervention
Secondary outcome [9] 434005 0
Peak expiratory flow (PEF).
Timepoint [9] 434005 0
Baseline and one month, two months, three months, and nine months post commencement of intervention

Eligibility
Key inclusion criteria
(1) Students aged 6-13 years in the selected classes.
(2) Have no plans to change schools or households within the upcoming 3 months.
(3) Students and their caregivers are able to understand and provide informed consent.
Minimum age
6 Years
Maximum age
13 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
(1) Lung disease, other than asthma, that requires daily medication.
(2) Inability to do lung function testing.
(3) Current and diagnosed cardiovascular disease, hepatitis, nephritis, mental illness, or other major diseases.
(4) Decorated or plan to decorate home within three months.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomization by computers will be performed by an independent person in Monash University who will not participate in any other processes of the trial
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
50 students in the intervention group and 50 students in the control group will be recruited in the study.
Generalized linear mixed models will be used to evaluate the effects of the intervention on air quality and health outcomes, accounting for the multiple levels of data (school, classroom, and children).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2024
Actual
Date of last participant enrolment
Anticipated
31/07/2024
Actual
Date of last data collection
Anticipated
30/04/2025
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 316103 0
Government body
Name [1] 316103 0
National Health and Medical Research Council
Country [1] 316103 0
Australia
Primary sponsor type
Individual
Name
Yuming Guo
Address
Country
Australia
Secondary sponsor category [1] 318271 0
Individual
Name [1] 318271 0
Shanshan Li
Address [1] 318271 0
Country [1] 318271 0
Australia
Secondary sponsor category [2] 318277 0
Individual
Name [2] 318277 0
Michael Abramson
Address [2] 318277 0
Country [2] 318277 0
Australia
Secondary sponsor category [3] 318278 0
Individual
Name [3] 318278 0
Matthew Carroll
Address [3] 318278 0
Country [3] 318278 0
Australia
Secondary sponsor category [4] 318279 0
Individual
Name [4] 318279 0
Emily Berger
Address [4] 318279 0
Country [4] 318279 0
Australia
Secondary sponsor category [5] 318280 0
Individual
Name [5] 318280 0
Caroline Gao
Address [5] 318280 0
Country [5] 318280 0
Australia
Secondary sponsor category [6] 318281 0
Individual
Name [6] 318281 0
Jiangning Song
Address [6] 318281 0
Country [6] 318281 0
Australia
Secondary sponsor category [7] 318282 0
Individual
Name [7] 318282 0
Wei-Chung Chang
Address [7] 318282 0
Country [7] 318282 0
Australia
Secondary sponsor category [8] 318283 0
Individual
Name [8] 318283 0
Shyamali Dharmage
Address [8] 318283 0
Country [8] 318283 0
Australia
Secondary sponsor category [9] 318284 0
Individual
Name [9] 318284 0
Jenny Zhou
Address [9] 318284 0
Country [9] 318284 0
Australia
Secondary sponsor category [10] 318285 0
Individual
Name [10] 318285 0
Shuang Zhou
Address [10] 318285 0
Country [10] 318285 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314930 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 314930 0
https://www.monash.edu/researchoffice/ethics
Ethics committee country [1] 314930 0
Australia
Date submitted for ethics approval [1] 314930 0
04/03/2024
Approval date [1] 314930 0
06/05/2024
Ethics approval number [1] 314930 0
Project ID: 41449

Summary
Brief summary
This study is a cluster-randomized controlled trial to develop a school-based HEPA filter intervention program targeting school children aged 6-13 years in Melbourne, Australia, and evaluate its effectiveness to improve school indoor air quality and children’s health.
We hypothesized that the intervention would improve school indoor air quality and children's health. The study will fill information gaps for the indoor air quality regulatory framework, providing guidelines and recommendations that support health promotion and disease prevention for children in schools.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 133170 0
Prof Yuming Guo
Address 133170 0
Monash University, 553 St Kilda Road, Melbourne, VIC 3004 Australia
Country 133170 0
Australia
Phone 133170 0
+61 3 9905 6100
Fax 133170 0
Email 133170 0
yuming.guo@monash.edu
Contact person for public queries
Name 133171 0
Shuang Zhou
Address 133171 0
Monash University, 553 St Kilda Road, Melbourne, VIC 3004 Australia
Country 133171 0
Australia
Phone 133171 0
+61406123507
Fax 133171 0
Email 133171 0
shuang.zhou@monash.edu
Contact person for scientific queries
Name 133172 0
Yuming Guo
Address 133172 0
Monash University, 553 St Kilda Road, Melbourne, VIC 3004 Australia
Country 133172 0
Australia
Phone 133172 0
+61 3 9905 6100
Fax 133172 0
Email 133172 0
yuming.guo@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
1. Privacy Concerns: Protecting the privacy of participants is paramount. Sharing IPD could potentially expose individuals to privacy breaches.
2.Ethical Considerations: There might be ethical concerns regarding the potential misuse or misinterpretation of IPD.
3.Participant Consent: Participants may not have consented to the sharing of their individual data beyond the scope outlined in the initial consent agreements. Respecting participant autonomy and honoring consent agreements is essential in clinical 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.