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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
22/08/2018
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] 294440 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
BAMP Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bronchiectasis 307190 0
Condition category
Condition code
Respiratory 306301 306301 0 0
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] 300731 0
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] 305306 0
Non-scheduled doctor visits
Timepoint [1] 305306 0
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] 344818 0
Rates of respiratory exacerbations over the study period.
Timepoint [1] 344818 0
Data will be captured using a study specific data collection form at the 12 month phone call with carers.
Secondary outcome [2] 345688 0
Early uptake of the influenza vaccine (by 30th May each year).
Timepoint [2] 345688 0
Data will be captured using a study specific data collection form at the 12 month phone call with carers.
Secondary outcome [3] 345714 0
Parent-cough-specific quality of life [PC-QoL-8]
Timepoint [3] 345714 0
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
Gender
Both males and females
Can healthy volunteers participate?
No
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 not concealed at enrolment
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
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)
NT,QLD
Recruitment hospital [1] 10474 0
Royal Darwin Hospital - Tiwi
Recruitment hospital [2] 11707 0
Lady Cilento Children's Hospital - South Brisbane
Recruitment postcode(s) [1] 22187 0
0810 - Tiwi
Recruitment postcode(s) [2] 23788 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 299069 0
Other Collaborative groups
Name [1] 299069 0
NHMRC Centre for Research Excellence Hot North - Menzies School of Health Research
Address [1] 299069 0
PO Box 41096
Casuarina NT 0811
Country [1] 299069 0
Australia
Primary sponsor type
Other
Name
Menzies School of Health Research
Address
PO Box 41096
Casuarina NT 0811
Country
Australia
Secondary sponsor category [1] 298308 0
None
Name [1] 298308 0
Address [1] 298308 0
Country [1] 298308 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300003 0
Human Research Ethics Committee of the Northern Territory Department of Health and Menzies School of Health Research
Ethics committee address [1] 300003 0
PO Box 41096
Casuarina NT 0811
Ethics committee country [1] 300003 0
Australia
Date submitted for ethics approval [1] 300003 0
28/03/2018
Approval date [1] 300003 0
14/05/2018
Ethics approval number [1] 300003 0
2018-3081

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 82230 0
Dr Gabrielle McCallum
Address 82230 0
Menzies School of Health Research
PO Box 41096
Casuarina NT 0811
Country 82230 0
Australia
Phone 82230 0
+61 8 89468565
Fax 82230 0
Email 82230 0
gabrielle.mccallum@menzies.edu.au
Contact person for public queries
Name 82231 0
Dr Gabrielle McCallum
Address 82231 0
Menzies School of Health Research
PO Box 41096
Casuarina NT 0811
Country 82231 0
Australia
Phone 82231 0
+61 8 89468565
Fax 82231 0
Email 82231 0
gabrielle.mccallum@menzies.edu.au
Contact person for scientific queries
Name 82232 0
Dr Gabrielle McCallum
Address 82232 0
Menzies School of Health Research
PO Box 41096
Casuarina NT 0811
Country 82232 0
Australia
Phone 82232 0
+61 8 89468565
Fax 82232 0
Email 82232 0
gabrielle.mccallum@menzies.edu.au

No data has been provided for results reporting
Summary results
Not applicable