Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000347662
Ethics application status
Approved
Date submitted
9/03/2023
Date registered
3/04/2023
Date last updated
3/04/2024
Date data sharing statement initially provided
3/04/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
The potential benefit of air purifiers in the rooms of residents in Australian Aged Care Facilities
Scientific title
Identifying the effect of air purifiers on the incidence of Acute Respiratory Infections (ARIs) among residents in Australian Residential Aged Care Facilities (RACFs): A Randomised Control Trial
Secondary ID [1] 309011 0
Nil known
Universal Trial Number (UTN)
U1111-1288-5784
Trial acronym
CAFACS (Clean Air For Aged Care Study)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Respiratory Infections 329055 0
Condition category
Condition code
Infection 326035 326035 0 0
Studies of infection and infectious agents
Respiratory 326294 326294 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The project is a clinical trial using air purifiers. The air purifier with HEPA filter is the intervention for the trial.
-The air purifier with a High-Efficiency Particulate Absorbing (HEPA) filter will be placed in the resident's room and turned on continuously for 24 hours. The participants will be exposed to the effect of air filtration for a minimum of 8 hours per day for 3 months.
-The intervention will be administered by Ph.D. student
-The adherence to the intervention will be monitored by utilising a cross-sectional observational audit. The nominated staff will record any breakout period with a long gap in participants’ exposure to air purifiers.
- 1 week washout period will be applied between 2 crossover periods. As the mean incubation and infectious period for common respiratory viral pathogens are less than 7 days, a 1-week washout period will be sufficient within this study. Where a person acquires an infection during a phase, the infection will be attributed to that phase (noting that we are measuring infection as a dichotomous variable). Because our measurement of infection is a dichotomous variable, symptoms must resolve before a new infection can be counted.
Intervention code [1] 325453 0
Treatment: Devices
Comparator / control treatment
The air purifier with no HEPA filter will be the control or comparator for the trial.
The project is a clinical trial using air purifiers.
-The air purifier without a HEPA filter will be placed in the resident's room and turned on continuously for 24 hours. The participants in the control group will be exposed to zero filtration for 24 hours for 3 months.
-the Ph.D. student will administer the comparator for this trial
-The adherence to the comparator will be monitored by utilizing a cross-sectional observational audit. The nominated staff will record any breakout period with a long gap in participants’ exposure to air purifiers without HEPA filters,
Control group
Active

Outcomes
Primary outcome [1] 333896 0
Any change in the occurrence of acute respiratory infections (ARI) in which case ARI is defined as the sudden/acute onset of at least one of the following four respiratory symptoms:
o cough
o sore throat
o shortness of breath
o coryza
AND
o a clinician’s judgment that the illness is due to an infection
The outcome will be assessed by a review of medical records including laboratory records. The confirmed infection will be determined by nasal or oral swab results.
Timepoint [1] 333896 0
The effectiveness of treatment will be assessed by comparing the proportion of infections over the two cross-over study periods. the incidence of respiratory infections will be assessed monthly.
Secondary outcome [1] 418651 0
Time to the first infection for participants.
The outcome will be assessed by a review of medical records including laboratory records. The confirmed infection will be determined by nasal or oral swab results.
Timepoint [1] 418651 0

Tests or measurements occur Monthly through a review of medical records including those previewed monthly after the commencement of the study until the study is completed (around 7 months).

Symptoms onset of ARI or pathology / rapid antigen test date will be used to determine the date of diagnosis.
Secondary outcome [2] 419592 0

The number of visits to an emergency department due to an ARI

The outcomes will be assessed through a review of Medical records including those previewed monthly after the commencement of the study until the study is completed (around 7 months).

Symptoms onset of ARI or pathology / rapid antigen test date will be used to determine the date of diagnosis”.
Timepoint [2] 419592 0

The outcomes will be assessed by a monthly review of medical records for a maximum duration of 7 months (until the study is completed).
Secondary outcome [3] 419593 0
The number of hospital admissions due to ARI

The outcomes will be assessed through a review of medical records including those previewed monthly after the commencement of the study until the study is completed (around 7 months).

Symptoms onset of ARI or pathology / rapid antigen test date will be used to determine the date of diagnosis”.
Timepoint [3] 419593 0
The outcomes will be assessed by a monthly review of medical records for a maximum duration of 7 months (until the study is completed
Secondary outcome [4] 419594 0
The number of medical consultations including GP and NP reviews due to an ARI.

The outcomes will be assessed through a review of Medical records including those previewed monthly after the commencement of the study until the study is completed (around 7 months).

Symptoms onset of ARI or pathology / rapid antigen test date will be used to determine the date of diagnosis”.
Timepoint [4] 419594 0
The outcomes will be assessed by a monthly review of medical records for a maximum duration of 7 months (until the study is completed

Eligibility
Key inclusion criteria
At the time of project commencement; the participants must:
o be a permanent resident of an Australian Residential Aged Care Facility enrolled in the study,
o reside in a private room (i.e., not a shared room).
o not be on palliative Trajectory-C comfort care.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
At the time of project commencement, particpants:
o are respite residents.
o reside in shared rooms,
o are on palliative Trajectory-C comfort care,
o are unable to provide consent and require public guardian approval.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Prior to the enrolment of participants, all air purifiers in the study will be pre-labeled. Air purifiers will either have a HEPA filter removed (control) or will have the air purifier remain in place (intervention). A database listing the air purifier (label) and whether it is a control or intervention will be established. This database will be held by researcher 1. Other members of the research team will enrol participants. When a participant is enrolled, the researcher will notify researcher 1 of their name. No other baseline or demographic data will be provided.
Allocation concealment will be ensured as researcher 1 (the researcher who will not be involved in the enrolment (including recruitment and consent), data collection, or decisions regarding the outcome ) will not disclose the outcome of randomisation to the remainder of the team and will hold the allocation in a password-protected database on a file not accessible to the remainder of the team. Upon the immediate commencement of the trial at a site and after all baseline data is collected, researcher 1 will inform the remainder of the team of which air purifier should be provided to which participant. As air purifiers are already pre-labeled, researchers allocating the air purifiers to participants will not be able to visually tell whether an air purifier has a filter (intervention) or not (control).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Researcher 1 will randomise participants using a protocol of block randomisation stratified by site. Randomisation will occur in a 1:1 ratio into one of the two sequences of intervention and control groups using a computer-generated randomisation schedule.
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
Crossover
Other design features
The trial will be a multi-center double-blind randomised two-period two-treatment crossover design.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size
An estimate of a 50% reduction in ARI by keeping 40% as the current incidence rate requires a 40% respiratory infection proportion in the control group and a 20% proportion in the treatment group. For the AB-BA sequence of the crossover trial, the required number of participants will be 94 in total i.e., 47 for the AB sequence and another 47 for the BA sequence. Assuming the proportion of respiratory infections under control conditions is 40% and the expected proportion of respiratory infections is 20% when using air purification, a cross-over trial with 94 participants (47 in each sequence) will have 80% power to detect this difference at the 5% significance level. This corresponds to an odds ratio of 0.375 for air purification (filtration) vs control (no filtration)..

Primary outcome
The effectiveness of treatment will be assessed by comparing the proportion of infections over the two cross-over study periods. Each participant will have a binary outcome, no infection, and infection, for their control and intervention study period and analysis will include fixed effect for each site. The treatment effect will be measured using logistic regression mixed effects models, where the main effects in the model will be treatment, study collection time, and cross over design characteristics. A random intercept effect for an individual will correct for non-independent observations made between the cross over study periods. The model will estimate an odds ratio that will compare the odds of infection when having air filtration active against not having air filtration active.
As the mean incubation and infectious period for common respiratory viral pathogens is less than 7 days, a 1-week washout period will be sufficient within this study. Where a person acquires an infection during a phase, the infection will be attributed to that phase (noting that we are measuring infection as a dichotomous variable). Because our measurement of infection is a dichotomous variable, symptoms must resolve before a new infection can be counted.

Secondary outcome
Time to respiratory infection will be modelled using survival analysis with lost-to-follow-up and death to be considered as censoring events. Kaplan-Meir curves will be used to estimate the survival function. A mixed-effect cox regression model will be used to assess the change in hazards between the treatment and control arms of the study, where a random effect will account for within patient correlation. The effect of the treatment will be assessed by the hazard ratio, which will compare the change in hazards between the two-treatment cross-over arms.
Assuming the proportion of respiratory infections under control conditions is 40% and the expected proportion of respiratory infections is 20% when using air purification, a cross-over trial with 94 participants (47 in each sequence) will have 80% power to detect this difference at the 5% significance level. This corresponds to an odds ratio of 0.375 for air purification vs control.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
6/03/2023
Date of last participant enrolment
Anticipated
3/04/2023
Actual
4/04/2023
Date of last data collection
Anticipated
12/04/2023
Actual
31/10/2023
Sample size
Target
94
Accrual to date
Final
135
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 39569 0
2430 - Taree

Funding & Sponsors
Funding source category [1] 313224 0
Government body
Name [1] 313224 0
University of Newcastle .
Country [1] 313224 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
University Dr, Callaghan NSW 2308
Country
Australia
Secondary sponsor category [1] 314949 0
None
Name [1] 314949 0
none
Address [1] 314949 0
none
Country [1] 314949 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312454 0
Hunter New England (HNE) Human Research Ethics Committee
Ethics committee address [1] 312454 0
Ethics committee country [1] 312454 0
Australia
Date submitted for ethics approval [1] 312454 0
28/11/2022
Approval date [1] 312454 0
03/02/2023
Ethics approval number [1] 312454 0
2022/PID02776

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

Contacts
Principal investigator
Name 124726 0
Mrs Bismi Thottiyil Sultanmuhammed Abdul Khadar
Address 124726 0
School of Nursing and Midwifery, University of Newcastle; University Dr, Callaghan NSW 2308
Country 124726 0
Australia
Phone 124726 0
+61405087353
Fax 124726 0
Email 124726 0
[email protected]
Contact person for public queries
Name 124727 0
Brett Mitchell
Address 124727 0
School of Nursing and Midwifery, University of Newcastle; University Dr, Callaghan NSW 2308
Country 124727 0
Australia
Phone 124727 0
+61 02 4349 4536
Fax 124727 0
Email 124727 0
[email protected]
Contact person for scientific queries
Name 124728 0
Brett Mitchell
Address 124728 0
School of Nursing and Midwifery, University of Newcastle; University Dr, Callaghan NSW 2308
Country 124728 0
Australia
Phone 124728 0
+61 02 4349 4536
Fax 124728 0
Email 124728 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?
Full de-identified facility-based infection data sets.
When will data be available (start and end dates)?
Data will be available following publication, no end date has been decided yet.
Available to whom?
Available to Participating facilities
Available for what types of analyses?
To inform local priorities and practices.
How or where can data be obtained?
Full de-identified data sets and statistical codes will only be available by contacting a chief investigator and providing the appropriate ethical approvals. The principal investigator can be contacted via email at [email protected]


What supporting documents are/will be available?




Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseAir purifiers for reducing the incidence of acute respiratory infections in australian residential aged care facilities: A study protocol for a randomised control trial.2023https://dx.doi.org/10.1016/j.idh.2023.05.006
N.B. These documents automatically identified may not have been verified by the study sponsor.