Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000441516
Ethics application status
Approved
Date submitted
6/03/2024
Date registered
10/04/2024
Date last updated
15/05/2024
Date data sharing statement initially provided
10/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Preschool Outcomes of Wheeze Employing Reliable Ergonomic Digital-technology (POWERED)
Scientific title
A multicentre RCT study to determine whether using a bundle (use of WzS with a management plan) reduces unscheduled doctor visits in preschool aged children with recurrent wheeze
Secondary ID [1] 311257 0
None
Universal Trial Number (UTN)
Trial acronym
POWERED
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Recurrent wheeze in pre-school children (Preschool Wheeze) 332480 0
Condition category
Condition code
Respiratory 329171 329171 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Use of WheezeScan (WzS) with a management plan (called the 'bundle'). WzS is a portable user-friendly digital device that listens to 30sec of breathing then objectively documents wheeze using AI-informed signal processing. WzS is manufactured by Omron (Japan).

Parents will be trained by the research nurses/assistants using a standard protocol provided by the manufacturers (sse link https://www.omron-healthcare.co.uk/nebulisers/wheezescan.html). Training occcurs face-to-face and takes between 5 to 15 minutes where the parents are shown how to use the WheezeScan and then does them with the researcher watching. The video on how to use a Wheezescan is also available https://www.youtube.com/watch?app=desktop&v=DnZh-p0ZgP4

Parents are also given a cheat sheet on how to use the Wheezescan and how to complete the e-diary.

Adherence will be monitored using participant diaries recorded on-line. Wheezescan will be used at least once a day over the study period of 12 months. The management plan consists of an asthma management plan with the use of inhaled corticosteroids if there is wheeze that is reversed by using salbutamol (400 ugm via space +/-mask). The use of recommended inhaled corticosteroids (fluticasone propionate (250 micrograms) metered dose inhaler, at 2 puffs twice a day) will be intermittent at the onset of a viral infection and/or wheeze for a maximum of 2 weeks for each episode.
Intervention code [1] 327712 0
Treatment: Other
Intervention code [2] 328241 0
Treatment: Devices
Comparator / control treatment
Usual care (as per local treating doctor). This varies between centres and not possible to describe exactly what is done but includes as necessary use of short acting beta-2 agonist (SABA) or no treatment at all.
Control group
Active

Outcomes
Primary outcome [1] 337015 0
Rate of unscheduled doctor visits for respiratory-related episodes
Timepoint [1] 337015 0
12 months from randomisation
Secondary outcome [1] 430356 0
Difference in a quality-of-life
Timepoint [1] 430356 0
6 and 12 months from randomisation
Secondary outcome [2] 430357 0
Difference in parent asthma management self-efficacy scale
Timepoint [2] 430357 0
6 and 12 months from randomisation
Secondary outcome [3] 430358 0
Time-to-next unscheduled doctor visit
Timepoint [3] 430358 0
Censored at 12 months from randomisation
Secondary outcome [4] 430359 0
Proportion of children hospitalised
Timepoint [4] 430359 0
12 months from randomisation
Secondary outcome [5] 430360 0
Adverse events (e.g. from corticosteroids - linear growth, thrush)
Timepoint [5] 430360 0
12 months from randomisation
Secondary outcome [6] 430361 0
Cough-specific Quality-of-Life (only in subgroup with chronic cough)
Timepoint [6] 430361 0
6 and 12 months from randomisation
Secondary outcome [7] 430362 0
Number of wheezing episodes
Timepoint [7] 430362 0
12 months from randomisation
Secondary outcome [8] 430363 0
Cost effectiveness
Timepoint [8] 430363 0
By 12 months from randomisation

Eligibility
Key inclusion criteria
Children (aged 0.5 to 6 years) with recurrent wheeze (2 or more reported wheeze episodes) and/or suspected asthma (e.g. chronic (>4 weeks) cough with recurrent exertional breathlessness).
Minimum age
6 Months
Maximum age
6 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(a) suspected chronic suppurative lung disease e.g. chronic wet cough,
(b) daily maintenance inhaled corticosteroids (ICS) prescribed by a paediatric respiratory specialist,
(c) previously enrolled,
(d) conditions that also cause wheeze (e.g. cystic fibrosis, tracheomalacia or
(e) unable to complete patient reported outcomes (PROs)

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)
Central administration site via REDCap
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation (2-8 block sizes) and stratified by site (n=7) and age (<3, =>3 years)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2024
Actual
Date of last participant enrolment
Anticipated
30/06/2027
Actual
Date of last data collection
Anticipated
30/06/2028
Actual
Sample size
Target
206
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,NT,QLD,WA,VIC
Recruitment hospital [1] 25971 0
Queensland Children's Hospital - South Brisbane
Recruitment hospital [2] 25972 0
Gold Coast University Hospital - Southport
Recruitment hospital [3] 25973 0
The Children's Hospital at Westmead - Westmead
Recruitment hospital [4] 25974 0
Royal Darwin Hospital - Tiwi
Recruitment hospital [5] 25976 0
The Royal Childrens Hospital - Parkville
Recruitment hospital [6] 25977 0
Perth Children's Hospital - Nedlands
Recruitment postcode(s) [1] 41816 0
0810 - Tiwi
Recruitment postcode(s) [2] 41815 0
2145 - Westmead
Recruitment postcode(s) [3] 41818 0
3052 - Parkville
Recruitment postcode(s) [4] 42188 0
4068 - Taringa
Recruitment postcode(s) [5] 41813 0
4101 - South Brisbane
Recruitment postcode(s) [6] 41814 0
4215 - Southport
Recruitment postcode(s) [7] 41819 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 315512 0
Government body
Name [1] 315512 0
National Health and Medical Research Council - MRFF
Country [1] 315512 0
Australia
Primary sponsor type
University
Name
Queensland University of Technology
Address
2 George St, Brisbane City QLD 4000
Country
Australia
Secondary sponsor category [1] 317595 0
None
Name [1] 317595 0
Address [1] 317595 0
Country [1] 317595 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314416 0
Children’s Health Queensland Human Research Ethics Committee
Ethics committee address [1] 314416 0
Level 7, Centre for Children’s Health Research 62 Graham St South Brisbane, Queensland 4101
Ethics committee country [1] 314416 0
Australia
Date submitted for ethics approval [1] 314416 0
26/02/2024
Approval date [1] 314416 0
11/04/2024
Ethics approval number [1] 314416 0
HREC Reference number: HREC/24/QCHQ/105893

Summary
Brief summary
Preschool children with wheeze (PSW) is very common and has higher morbidity than any other asthma group. PSWs very high unmet needs are documented in international parent/end-user surveys. Although many no longer wheeze by 6y, ~40% have recurrences, require hospitalisation and it is not a benign illness. Yet, identifying wheezing is challenging for parents (>50% disagreement between doctors & parents) and many cultures (incl. Indigenous Australians) do not have a word for wheeze. This may cause under- or over-diagnosis of asthma, & lead to over- or underuse of medications, children undergoing unnecessary procedures & high parental anxiety. Giving all children asthma meds is very poor practice as there are adverse events associated with these meds and it is against parents’ wishes.

Our multicentre RCT study addresses the need to manage recurrent PSW by objectively defining wheeze using as a bundle (1) an AI-developed tool (WheezeScan, WzS) and (2) a wheeze management plan. Recruiting children from hospitals and community clinics, we plan to recruit 206 children with recurrent PSW including those from our remote Indigenous clinics to determine if this intervention (WzS with management bundle) reduces unscheduled doctor visits (primary aim), and other clinically important outcomes (hospitalisation, time to next unscheduled doctor visit, quality-of life).
Trial website
Trial related presentations / publications
Public notes
MRFF Scientific Title is: Improving outcomes of recurrent preschool wheeze: a multicentre randomised controlled trial (RCT) with biomarker discovery

Contacts
Principal investigator
Name 131498 0
Prof Anne Chang
Address 131498 0
Queensland Children's Hospital Stanley Street, South Brisbane, Qld 4101
Country 131498 0
Australia
Phone 131498 0
+61 7 30697283
Fax 131498 0
Email 131498 0
anne.chang@menzies.edu.au
Contact person for public queries
Name 131499 0
Prof Stephanie Yerkovich
Address 131499 0
Queensland Children's Hospital Stanley Street, South Brisbane, Qld 4101
Country 131499 0
Australia
Phone 131499 0
+61 7 30697283
Fax 131499 0
Email 131499 0
Stephanie.Yerkovich@menzies.edu.au
Contact person for scientific queries
Name 131500 0
Prof Anne Chang
Address 131500 0
Queensland Children's Hospital Stanley Street, South Brisbane, Qld 4101
Country 131500 0
Australia
Phone 131500 0
+61 7 30697283
Fax 131500 0
Email 131500 0
anne.chang@menzies.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
As study involves Aboriginal and Torres Straits Islander children, specific permission is required and thus it is not possible to share the data.


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.