Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000856617
Ethics application status
Approved
Date submitted
22/07/2023
Date registered
8/08/2023
Date last updated
24/03/2024
Date data sharing statement initially provided
8/08/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Paediatric Asthma and Wheeze Study - Part 2
Scientific title
Using a wheeze scan device (WheezeScan) in the management of preschool wheeze and paediatric asthma: a multicentre cohort study - Part 2
Secondary ID [1] 310179 0
Improving the management and outcomes of preschool wheeze and paediatric asthma: a multicentre cohort study
Universal Trial Number (UTN)
Trial acronym
PAWS-2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma in children 330766 0
Condition category
Condition code
Respiratory 327602 327602 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Use of WheezeScan (WzS), 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). Adherence will be monitored using participant diaries.

Parents will use the WheezeScan at least once a day for the duration of the study (total of 5 weeks).
Intervention code [1] 326574 0
Early detection / Screening
Comparator / control treatment
No control
Control group
Uncontrolled

Outcomes
Primary outcome [1] 335438 0
Primary: proportion of children with change in asthma control assessment (ACA) from timepoint (T) T2 to T1.

T1=baselines; T2=one week after baseline.

ACA is based on the child asthma control test. Child-asthma control test consist of questions. It is validated and widely used both clinically and in research. [Bonini M, Di PM, Bagnasco D, et al. Minimal clinically important difference for asthma endpoints: an expert consensus report. Eur Respir Rev 2020;29: 190137].
Timepoint [1] 335438 0
One week after baseline
Secondary outcome [1] 424514 0
Change in asthma control questionnaire (interviewer-administered); T3-T2.
T3 = five weeks after baseline.
T2 = oneweek after baseline.
Timepoint [1] 424514 0
T3 (5 weeks after baseline) and T2 (1 week after baseline).
Secondary outcome [2] 424515 0
Parent asthma management self-efficacy scale (T3-T1) .
T3 = five weeks after baseline.
T1 = baseline.
Timepoint [2] 424515 0
T3 (5 weeks post T1) and T1 (baseline).
Secondary outcome [3] 424516 0
Child-asthma control test scores including WheezeScan data and Child-asthma control test scores excluding WheezeScan data.

Child-asthma control test consist of questions. It is validated and widely used both clinically and in research. [Bonini M, Di PM, Bagnasco D, et al. Minimal clinically important difference for asthma endpoints: an expert consensus report. Eur Respir Rev 2020;29: 190137].
Timepoint [3] 424516 0
T1 (baseline), T2 (one week after T1) and T3 (5 weeks after T1)
Secondary outcome [4] 424517 0
Healthcare resource use collected from medical records and from participants
Timepoint [4] 424517 0
T3 (5 weeks post-baseline)
Secondary outcome [5] 424933 0
Change in Paediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ); T3-T2.
Timepoint [5] 424933 0
T3 = five weeks after baseline.
T2 = one week after baseline.
Secondary outcome [6] 424934 0
Change in 8-item Parent-Proxy Cough-Specific Quality of Life in those with cough; T3-T2
Timepoint [6] 424934 0
T3 = five weeks after baseline.
T2 = one week after baseline.

Eligibility
Key inclusion criteria
Children with respiratory specialist defined asthma.
Minimum age
4 Years
Maximum age
11 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Concurrent other chronic disease eg. bronchiectasis, previously enrolled or unable to complete questionnaires or PROs.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
For primary endpoint: The proportion change in assessment between T2 to T1 will be assessed using McNemar’s test.
Secondary endpoints: Change in PAMS and PROs scores will be presented as means and SD (assuming normal distribution). We will compare these differences assessed by paired T-test. Healthcare resource use associated with respiratory healthcare will be costed using actual costs (when known) or market rates from the perspectives of healthcare system provider and families for each pathway.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
15/01/2024
Actual
8/02/2024
Date of last participant enrolment
Anticipated
24/06/2027
Actual
Date of last data collection
Anticipated
31/07/2027
Actual
Sample size
Target
125
Accrual to date
2
Final
Recruitment in Australia
Recruitment state(s)
NSW,NT,QLD
Recruitment hospital [1] 25240 0
Queensland Children's Hospital - South Brisbane
Recruitment hospital [2] 25241 0
Gold Coast University Hospital - Southport
Recruitment hospital [3] 25242 0
The Children's Hospital at Westmead - Westmead
Recruitment hospital [4] 25243 0
Royal Darwin Hospital - Tiwi
Recruitment postcode(s) [1] 40912 0
4101 - South Brisbane
Recruitment postcode(s) [2] 40913 0
4215 - Southport
Recruitment postcode(s) [3] 40914 0
2145 - Westmead
Recruitment postcode(s) [4] 40915 0
0810 - Tiwi

Funding & Sponsors
Funding source category [1] 314345 0
Government body
Name [1] 314345 0
National Health and Medical Research Council - MRFF
Country [1] 314345 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] 316293 0
None
Name [1] 316293 0
Address [1] 316293 0
Country [1] 316293 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313442 0
Children’s Health Queensland Human Research Ethics Committee
Ethics committee address [1] 313442 0
Ethics committee country [1] 313442 0
Australia
Date submitted for ethics approval [1] 313442 0
07/07/2023
Approval date [1] 313442 0
01/08/2023
Ethics approval number [1] 313442 0
HREC/23/QCHQ/100691

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

Contacts
Principal investigator
Name 128174 0
Prof Anne Chang
Address 128174 0
Queensland Children's Hospital
Stanley Street, South Brisbane, Qld 4101
Country 128174 0
Australia
Phone 128174 0
+61 07 30681078
Fax 128174 0
Email 128174 0
[email protected]
Contact person for public queries
Name 128175 0
Margaret McElrea
Address 128175 0
Queensland Children's Hospital
Stanley Street, South Brisbane, Qld 4101
Country 128175 0
Australia
Phone 128175 0
+61 7 30697283
Fax 128175 0
Email 128175 0
[email protected]
Contact person for scientific queries
Name 128176 0
Anne Chang
Address 128176 0
Queensland Children's Hospital
Stanley Street, South Brisbane, Qld 4101
Country 128176 0
Australia
Phone 128176 0
+61 07 30681111
Fax 128176 0
Email 128176 0
[email protected]

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 includes 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.