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Trial registered on ANZCTR

Registration number

ACTRN12618000604202

Ethics application status

Approved

Date submitted

24/03/2018

Date registered

18/04/2018

Date last updated

28/06/2022

Date data sharing statement initially provided

24/07/2019

Type of registration

Prospectively registered

Titles & IDs

Public title

A randomised controlled trial to determine if use of a Bronchiectasis Action Management Plans (BAMP) compared to usual care improves clinical outcomes in children with bronchiectasis.

Scientific title

Double blind randomised controlled trial (RCT) on the utility of personalised bronchiectasis action management plans (BAMP) for children with bronchiectasis

Secondary ID [1]

Nil Known

Universal Trial Number (UTN)

Trial acronym

BAMP Study

Linked study record

Health condition

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

Bronchiectasis

Condition category

Condition code

Respiratory

Other respiratory disorders / diseases

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Children will been seen by their paediatric respiratory physician in the outpatient department at Royal Darwin Hospital or Lady Cilento Hospital during a routine clinical visit. The consultation will range from 30-45 minutes. The respiratory physician will write an individualised written Bronchiectasis Action Management plan (BAMP) for each child. The BAMP consists of several key points.

1. Details of their bronchiectasis: type and which lobes are involved
2. A list of what the child should do on a daily basis e.g. type of medication and airway clearance technique
3. What to do when there is a flare up
4. Indications when to see a doctor
5. When to obtain their influenza vaccine.

In the intervention arm, carers will receive a copy of the letter written to the family/s general practitioner. This letter outlines the relevant medical history and treatment, management and follow-up required. In addition, the carers will receive a copy of the BAMP that is current for 12 months. A Research Nurse will deliver face to face education to carers at enrolment how to use the BAMP.

Intervention code [1]

Treatment: Other

Comparator / control treatment

The control group will receive routine care for the duration of the intervention period (12 months) i.e. a copy of the letter written to the family's general practitioner. This letter outlines the relevant medical history and treatment, management and follow-up required.

Control group

Active

Outcomes

Primary outcome [1]

Non-scheduled doctor visits

Timepoint [1]

Non-scheduled doctor visits will be captured using a study specific data collection form during monthly phone calls for 12 months with carers.

Secondary outcome [1]

Rates of respiratory exacerbations over the study period.

Timepoint [1]

Data will be captured using a study specific data collection form at the 12 month phone call with carers.

Secondary outcome [2]

Early uptake of the influenza vaccine (by 30th May each year).

Timepoint [2]

Data will be captured using a study specific data collection form at the 12 month phone call with carers.

Secondary outcome [3]

Parent-cough-specific quality of life [PC-QoL-8]

Timepoint [3]

PC-QoL-8 will be captured during follow up with carers at baseline, 6 and 12 months.

Eligibility

Key inclusion criteria

1. Children aged <19-yrs with chronic suppurative lung disease or bronchiectasis
2. At least 2 or more non-scheduled doctor visits or exacerbations in the previous 18 months
3. Do not currently have a BAMP

Minimum age

No limit

Maximum age

18 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

1. Cystic fibrosis
2. Children who have an existing written plan
3. Inability to follow-up due to no access to a landline or mobile phone

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)

Randomisation will be computer-generated (permuted blocks) from the next stratified position on the randomisation lists. Children will be stratified by age (<12 or > 12 years), type (new or old) and site (Darwin or Brisbane). Allocation is concealed for all participants at enrolment and maintained throughout the trial.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Permuted block randomisation

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people assessing the outcomes
The people analysing the results/data

Intervention assignment

Parallel

Other design features

Respiratory physicians and outcome assessors will be blinded to randomisation groups. Respiratory physicians will complete a personalised BAMP for each child and give to research nurses. Research nurses will be unblinded to randomisation groups. Research nurses will only provide the BAMP to the intervention group. For children in the control group, their BAMP will be filed in their study file.

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Intention-to-treat analyses will be used where possible.

For our primary outcomes, the difference between groups will be compared using Student’s T test for the continuous data comparisons (assuming normal distribution). Chi square will be used for comparisons of categorical variables.

The main effect of our the intervention will be to determine the difference between groups in the rate of acute doctor visits for BE exacerbation's. Our secondary outcomes are: (a) PC-QoL-8 score at 6 and 12 months, (b) BE exacerbation rate and (c) proportion who received influenza vaccination by 30th May. All measurements are validated for children and previously used in our many studies. In addition, we will report on hospitalisations in each group but we do not have the required sample size for this outcome.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

1/05/2018

Actual

3/07/2018

Date of last participant enrolment

Anticipated

31/12/2020

Actual

18/12/2020

Date of last data collection

Anticipated

31/12/2021

Actual

20/12/2021

Sample size

Target

198

Accrual to date

Final

206

Recruitment in Australia

Recruitment state(s)

NT,QLD,WA

Recruitment hospital [1]

Royal Darwin Hospital - Tiwi

Recruitment hospital [2]

Lady Cilento Children's Hospital - South Brisbane

Recruitment hospital [3]

Perth Children's Hospital - Nedlands

Recruitment postcode(s) [1]

0810 - Tiwi

Recruitment postcode(s) [2]

4101 - South Brisbane

Recruitment postcode(s) [3]

6009 - Nedlands

Funding & Sponsors

Funding source category [1]

Other Collaborative groups

Name [1]

NHMRC Centre for Research Excellence Hot North - Menzies School of Health Research

Address [1]

PO Box 41096
Casuarina NT 0811

Country [1]

Australia

Primary sponsor type

Other

Name

Menzies School of Health Research

Address

PO Box 41096
Casuarina NT 0811

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Human Research Ethics Committee of the Northern Territory Department of Health and Menzies School of Health Research

Ethics committee address [1]

PO Box 41096
Casuarina NT 0811

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

28/03/2018

Approval date [1]

14/05/2018

Ethics approval number [1]

2018-3081

Ethics committee name [2]

The University of Queensland

Ethics committee address [2]

Human Ethics Research Office
Cumbrae-Stewart Building #72
The University of Queensland
St Lucia, QLD 4072

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

12/12/2018

Approval date [2]

13/12/2018

Ethics approval number [2]

HREC/18/QCHQ/45348

Summary

Brief summary

Although once regarded as an ‘orphan disease’, BE remains a contributor to chronic respiratory morbidity and mortality in both children and adults in both low and high-income countries, in particular Indigenous people of high-income countries. Postnatally, lung growth is maximised in the first 7-yrs of life. While low birth weight impacts on future lung health, there is increasing evidence that early life events such as acute lung respiratory infections (ALRI) can reduce future lung function trajectories, and increase BE risk. In early childhood, severe (hospitalised) and repeated ALRI are independent risk factors for future chronic lung diseases, such as BE and non-smoking related COPD which are prevalent amongst Indigenous populations. Interventions to reduce ALRI during infancy and early childhood are important and needed for future lung health i.e. preserve lung function and improve quality of life (QoL).

Our double blind RCT is designed to answer our primary question: To determine if the routine use of a personalised written BAMP (compared to standard care) improves clinical outcomes [improves cough-specific QoL (8 items) (PC-QoL -8) and reduces non-scheduled doctor visits]. We aim to enrol 198 (children less than 19 years old) from Royal Darwin Hospital and Lady Cilento Hospital. Participants will be seen clinically at enrolment and followed up monthly with phone calls for 12 months.

To date, there are no such published studies in children or adults using BAMP with BE. It is not surprising that BAMP is not routinely used even in tertiary centres. If effective, this RCT will lead to a change in routine clinical practice in children with BE. This will be of great importance, particularly to those living in remote Indigenous communities, where specialist respiratory services are limited. The results will provide evidence for/against the use of BAMP when managing Indigenous and non-Indigenous children with BE.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Gabrielle McCallum

Address

Menzies School of Health Research
PO Box 41096
Casuarina NT 0811

Country

Australia

Phone

+61 8 89468565

Fax

[email protected]

Contact person for public queries

Name

Gabrielle McCallum

Address

Menzies School of Health Research
PO Box 41096
Casuarina NT 0811

Country

Australia

Phone

+61 8 89468565

Fax

[email protected]

Contact person for scientific queries

Name

Gabrielle McCallum

Address

Menzies School of Health Research
PO Box 41096
Casuarina NT 0811

Country

Australia

Phone

+61 8 89468565

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

Due to cultural considerations for our Aboriginal and/or Torres Strait Islander participants, their data is not planned for public access.

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

Source	Title	Year of Publication	DOI
Embase	Utility of a personalised B ronchiectasis A ction M anagement P lan (BAMP) for children with bronchiectasis: Protocol for a multicentre, double-blind parallel, superiority randomised controlled trial.	2021	https://dx.doi.org/10.1136/bmjopen-2021-049007

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

Trial Review

Documents added manually

Documents added automatically