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Trial registered on ANZCTR


Registration number
ACTRN12619001686190
Ethics application status
Approved
Date submitted
20/11/2019
Date registered
2/12/2019
Date last updated
2/12/2019
Date data sharing statement initially provided
2/12/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Lung function test impact on Clinical decision making and Quality of life in children (LoCQ) Study
Scientific title
The impact of lung function testing (spirometry) on clinical decision making and quality of life in children, a single centre randomised controlled trial (RCT).
Secondary ID [1] 299735 0
Nil known
Universal Trial Number (UTN)
Trial acronym
LoCQ
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Respiratory disorders 315079 0
Asthma 315400 0
Condition category
Condition code
Respiratory 313419 313419 0 0
Asthma
Respiratory 313420 313420 0 0
Other respiratory disorders / diseases
Public Health 313696 313696 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is spirometry. Both the intervention and control groups will have spirometry with bronchodilator testing using the Queensland Children’s Hospital standard practice guide. This standard practice guide follows American Thoracic Society (ATS) and European Respiratory Society (ERS) criteria for lung function testing in children (Miller MR, et al. Standardisation of spirometry. The European respiratory journal. 2005;26(2):319-38; Beydon N, et al. An official American Thoracic Society/European Respiratory Society statement: pulmonary function testing in preschool children. American journal of respiratory and critical care medicine. 2007;175(12):1304-45)
In this standard guide each child performs at least 3 acceptable manoeuvres, including
o Good start of forceful exhalation without hesitation or gradual onset
o Smooth flow of spirograms without artefacts
o At least 3 seconds of exhalation showing plateau of lung volume
o At least 2 manoeuvres which have FVC and FEV1 repeatability, not more than 10% or 100 ml of difference
These standards ensure acceptability, reproducibility and fidleity of the intervention. Further the spirometers are calibrated daily before use.
The intervention will be one single session of 15-30 minutes for each participant enrolled in the study. All spirometry testing will be administered by experienced paediatric respiratory scientists in a tertiary hospital laboratory.

The intervention group sees the doctor before the spirometry results are given to the doctor (compared to control group who sees the doctor with the spirometry results as is standard clincial practice). They then see the doctor again a second time with the spirometry results.
Intervention code [1] 315999 0
Diagnosis / Prognosis
Comparator / control treatment
While both groups will perform spirometry, the control group will have the spirometry results at the first consultation with doctor (this is the usual practice at our hospital),
Control group
Active

Outcomes
Primary outcome [1] 321896 0
Proportion of change in diagnosis and/or management based on 4 categories: medication(s) including dose, investigation, follow-up schedule, and education when doctors have the spirometry results
Data will be completed by respiratory paediatricians using standardised data collection sheets including
- Routine respiratory examination (e.g. cough pointers, digital clubbing, chest wall deformity, ENT, auscultation)
- Change in clinical assessment (diagnosis and/or management) between before and after viewing spirometry
- Benefits of spirometry on how much spirometry improve their confidence and contribute to management and education for each patient scoring by a 10-point Likert scale
Timepoint [1] 321896 0
at first doctor's consultation for both groups
Secondary outcome [1] 376619 0
Change in QoL determined by State-Trait Anxiety Inventory (STAI) ± Parent-Proxy QoL questionnaire for paediatric chronic cough (PC-QoL) between before and after visiting the doctor with or without the spirometry results
Timepoint [1] 376619 0
at first doctor's consultation for both groups
Secondary outcome [2] 376620 0
Change in QoL determined by State-Trait Anxiety Inventory (STAI) ± Parent-Proxy QoL questionnaire for paediatric chronic cough (PC-QoL) between before and after visiting the doctor with the spirometry results
Timepoint [2] 376620 0
at second doctor's consultation for the intervention group only

Eligibility
Key inclusion criteria
• A child with parents/guardians in attendance and able to provide written consent.
• A child aged from 4 to 18 years, who can perform acceptable spirometry
• Parent/guardian that is able to complete QoL questionnaires
• A child whose physician is willing to being part of the LoCQ Study
Minimum age
4 Years
Maximum age
18 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Previously enrolled
• Contraindication for spirometry including dyspnoea, pneumothorax, haemoptysis, vital signs instability, lung cyst or bleb, and recent chest/eye surgery (<3 weeks)
• Have taken salbutamol within 4 hours prior to clinic visit

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)
Group allocation will not be concealed from those involved in the clinical care.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer generated permuted block 2-6 size, randomisation sequence generated by an external statistician, will be used. Children will be stratified by status (new/review), and cough condition (cough present/absent).
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
Intention-to-treat analyses will be used where possible. For our primary outcome, the difference between groups will be compared using Chi square for proportion with change in diagnosis and management. Paired T-test will be used for comparisons of change in QoL scores, assuming normal distribution of the data comparisons.
We aim to enrol 105 children to detect proportion change in clinical management.
Estimated sample size (SS) for one-sample comparison of proportion to hypothesized value
• Test Ho: p = 0.3000, where p is the proportion in the population
• Assumptions: 5% significance (alpha = 0.0500, two-sided), 90% power (power = 0.9000), alternative p = 0.4500
• Estimated required sample size without drop out, n = 105
• For QoL, to detect minimal importance difference (MID) of normalized score for PedsQL (using SD of 4.4) for 98% power, need n = 68

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 15114 0
Queensland Children's Hospital - South Brisbane
Recruitment postcode(s) [1] 28408 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 304207 0
University
Name [1] 304207 0
Cough, Asthma & Airways Research Group, Queensland University of Technology
Address [1] 304207 0
Cough, Asthma & Airways Research Group
Centre for Children’s Health Research
62 Graham Street
South Brisbane, Queensland, 4101
Country [1] 304207 0
Australia
Primary sponsor type
Individual
Name
Dr Wicharn Boonjindasup
Address
Cough, Asthma & Airways Research Group
Centre for Children’s Health Research
62 Graham Street
South Brisbane, Queensland, 4101
Country
Australia
Secondary sponsor category [1] 304438 0
None
Name [1] 304438 0
Address [1] 304438 0
Country [1] 304438 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304672 0
Children's Health Queensland Hospital and Health Service
Ethics committee address [1] 304672 0
Level 7, Centre for Children's Health Research
Queensland Children's Hospital Precinct
62 Graham Street
South Brisbane, Queensland, 4101
Ethics committee country [1] 304672 0
Australia
Date submitted for ethics approval [1] 304672 0
14/10/2019
Approval date [1] 304672 0
20/11/2019
Ethics approval number [1] 304672 0
HREC/19/QCHQ/58722

Summary
Brief summary
The low utility of lung function testing in clinical practice, despite its importance, is not surprising as to date there are no randomised controlled trials (RCT) that have assessed the benefits in routine clinical practice. This RCT will assess the benefit of spirometry, in all paediatric respiratory conditions, which may lead to a change in routine clinical practice. If this study shows that spirometry has a positive impact on clinical decision making and quality of life, this evidence will encourage the use of spirometry as an important clinical assessment tool in both tertiary and primary care practice.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 97806 0
Dr Wicharn Boonjindasup
Address 97806 0
Cough, Asthma & Airways Research Group
Centre for Children’s Health Research
62 Graham Street
South Brisbane, Queensland, 4101
Country 97806 0
Australia
Phone 97806 0
+61 730697280
Fax 97806 0
Email 97806 0
wicharn.boonjindasup@qut.edu.au
Contact person for public queries
Name 97807 0
Dr Wicharn Boonjindasup
Address 97807 0
Cough, Asthma & Airways Research Group
Centre for Children’s Health Research
62 Graham Street
South Brisbane, Queensland, 4101
Country 97807 0
Australia
Phone 97807 0
+61 730697280
Fax 97807 0
Email 97807 0
wicharn.boonjindasup@qut.edu.au
Contact person for scientific queries
Name 97808 0
Dr Wicharn Boonjindasup
Address 97808 0
Cough, Asthma & Airways Research Group
Centre for Children’s Health Research
62 Graham Street
South Brisbane, Queensland, 4101
Country 97808 0
Australia
Phone 97808 0
+61 730697280
Fax 97808 0
Email 97808 0
wicharn.boonjindasup@qut.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
The information gathered during this study will be held in confidence. No names or details of any children who took part in this study will be revealed in any publications or reports produced from the study. Access to any identifiable information will be limited to members of the research team directly involved with this project.
What supporting documents are/will be available?
No other documents available
Summary results
No Results