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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

25/01/2023

Date data sharing statement initially provided

2/12/2019

Date results provided

17/01/2023

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]

Nil known

Universal Trial Number (UTN)

Trial acronym

LoCQ

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Respiratory disorders

Asthma

PBB/Bronchiectasis

Condition category

Condition code

Respiratory

Asthma

Respiratory

Other respiratory disorders / diseases

Public Health

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 with the spirometry report. The control group sees the doctor without the spirometry report. The control group then sees the doctor again a second time with the spirometry report.

Intervention code [1]

Diagnosis / Prognosis

Comparator / control treatment

While both groups will perform spirometry, the intervention group will have the spirometry results at the first consultation with doctor and the control group will not.

Control group

Active

Outcomes

Primary outcome [1]

Our primary outcome is the proportion of children with any change in clinical decision making (diagnosis and management) and change scores between groups. This consists of a-priori list that consists of (i) any change in diagnosis based on 2 categories (disease and severity) and (ii) management based on 4 categories (medication, investigation, follow-up schedule and education). Change in each category is dichotomised as ‘yes’ or ‘no’. Each ‘yes’ scores one point, so the range in change score is 0 to a maximum of 6 (2 points from change in diagnosis and 4 points from change in management).

Timepoint [1]

After first doctor's consultation with spirometry for the intervention group or without spirometry for the control group

Secondary outcome [1]

Change of the patient-reported outcome measure scores (State-Trait Anxiety Inventory ± Parent-Proxy QoL for paediatric chronic cough) from baseline

Timepoint [1]

After first doctor's consultation with spirometry for the intervention group or without spirometry for the control group

Secondary outcome [2]

Opinions relating to the benefit of integrating spirometry into clinical practice assessed by 10-point Likert scales

Timepoint [2]

At the end of clinic visit for both groups

Secondary outcome [3]

Degree of diagnosis certainty (definite, probable or doubtful)

Timepoint [3]

After first doctor's consultation with spirometry for the intervention group or without spirometry for the control group

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

Sex

Both males and females

Can healthy volunteers participate?

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)

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

We wish to detect a significant difference in the proportion of children with any change in clinical decision making between the intervention and control groups. We assume the proportion in the population is 30% (Ho: p = 0.30). To find 45% proportion of children with any change (alternative p = 0.45) with 5% significance (alpha = 0.05, two-sided) and 90% power (power = 0.90), we require outcome data from 105 children (rounded up to 106 children).

Intention-to-treat analyses will be used. For our primary outcome, the difference between groups will be compared using Chi-Square test for the proportion of children with any change in diagnosis and management. T-test or Mann-Whitney U test will be used depending on normality of the data to determine the difference of change scores.

For secondary outcomes, inter-group differences will be determined by T-test or Mann-Whitney if not normally distributed. Change in outcomes within the control group after review of spirometry will be assessed by McNemar test, paired T-test or Wilcoxon Signed Rank test. 10-point Likert scales will be reported as mean with SD or median with P25-P75. Degree of diagnostic certainty will be reported as frequency.

In the control group only, changes in the primary outcome and secondary outcomes [1] and [3], compared at timepoints before and after the spirometry is presented will also be analysed using statistical methods as discussed above.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

1/01/2020

Actual

17/03/2020

Date of last participant enrolment

Anticipated

31/03/2022

Actual

17/02/2022

Date of last data collection

Anticipated

31/03/2022

Actual

17/02/2022

Sample size

Target

106

Accrual to date

Final

106

Recruitment in Australia

Recruitment state(s)

QLD

Recruitment hospital [1]

Queensland Children's Hospital - South Brisbane

Recruitment postcode(s) [1]

4101 - South Brisbane

Funding & Sponsors

Funding source category [1]

University

Name [1]

Cough, Asthma & Airways Research Group, Queensland University of Technology

Address [1]

Cough, Asthma & Airways Research Group
Centre for Children’s Health Research
62 Graham Street
South Brisbane, Queensland, 4101

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Children's Health Queensland Hospital and Health Service

Ethics committee address [1]

Level 7, Centre for Children's Health Research
Queensland Children's Hospital Precinct
62 Graham Street
South Brisbane, Queensland, 4101

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

14/10/2019

Approval date [1]

20/11/2019

Ethics approval number [1]

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

Dr Wicharn Boonjindasup

Address

Cough, Asthma & Airways Research Group
Centre for Children’s Health Research
62 Graham Street
South Brisbane, Queensland, 4101

Country

Australia

Phone

+61 730697280

Fax

[email protected]

Contact person for public queries

Name

Wicharn Boonjindasup

Address

Cough, Asthma & Airways Research Group
Centre for Children’s Health Research
62 Graham Street
South Brisbane, Queensland, 4101

Country

Australia

Phone

+61 730697280

Fax

[email protected]

Contact person for scientific queries

Name

Wicharn Boonjindasup

Address

Cough, Asthma & Airways Research Group
Centre for Children’s Health Research
62 Graham Street
South Brisbane, Queensland, 4101

Country

Australia

Phone

+61 730697280

Fax

[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?

Individual participant data underlying published results only, after de-identification

When will data be available (start and end dates)?

Immediately following publication, ending 5 years following main results publication

Available to whom?

Only researchers who provide a methodologically sound proposal and obtain an approval from the Human Research Ethics Commitee

Available for what types of analyses?

Only to achieve the aims in the approved proposal

How or where can data be obtained?

Access subject to approvals by Principal Investigator ([email protected])

What supporting documents are/will be available?

Doc. No.	Type	Citation	Email
18060	Study protocol	Boonjindasup W, Marchant JM, McElrea MS, Yerkovich ST, Masters IB, Chang AB. Impact of using spirometry on clinical decision making and quality of life in children: protocol for a single centre randomised controlled trial. BMJ Open. 2021 Sep 21;11(9):e050974. doi: 10.1136/bmjopen-2021-050974. PMID: 34548360; PMCID: PMC8458340.
18061	Statistical analysis plan		[email protected]
18062	Ethical approval		[email protected]

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Impact of using spirometry on clinical decision making and quality of life in children: Protocol for a single centre randomised controlled trial.	2021	https://dx.doi.org/10.1136/bmjopen-2021-050974
Embase	Does routine spirometry impact on clinical decisions and patient-related outcome measures of children seen in respiratory clinics: an open-label randomised controlled trial.	2023	https://dx.doi.org/10.1136/bmjresp-2022-001402
Embase	Clinical determinants for State-Trait Anxiety Inventory of the parents of children with respiratory problems.	2024	https://dx.doi.org/10.1002/ppul.26702

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically