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Trial registered on ANZCTR


Registration number
ACTRN12611001143910
Ethics application status
Approved
Date submitted
1/11/2011
Date registered
2/11/2011
Date last updated
5/02/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
He Tapu Te Ha: Space to breathe - Effectiveness of preschool asthma education
Scientific title
A community-based, cluster randomised controlled trial in children aged 2 to 5 years
Secondary ID [1] 273308 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 279079 0
Condition category
Condition code
Respiratory 279269 279269 0 0
Asthma
Public Health 279272 279272 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The trial utilises ‘Space to Breathe’ days, which consist of an asthma-specific, curriculum-linked learning and activity unit consisting of eight lesson plans, one introductory lesson and a professional development session for ECE staff/teachers. The ECE receives a ‘Space to Breathe’ Toolkit consisting of a asthma-specific, curriculum-based teacher resource, indoor activity house for all children, stickers, policy templates and a story book about asthma. A ‘Space to Breathe’ participating centre accreditation and asthma policy is aimed for and can be attained at any point during the study. This includes a two level standards based accreditation, risk management plan and policies and procedures relating to the management of asthma (including pragmatic information such as storage and record keeping related to asthma medication use by children at the centre), an accreditation certificate for display and website badge.
Bracelets for all ECE centre children with asthma will be provided. Such bracelets will be used in the ECE centre only and will provide a visual reinforcement mechanism for teachers and guardians/caregivers to identify children with asthma and any asthma management events that occurred during the school day;
ECE's will have access to related ‘Space to Breathe’ education resources via a password protected website; and ECE centre staff that smoke will be supported to become smokefree (through the provision of Quitcards

‘Space to Breathe’ days held at baseline and four months at each ECE centre will be used to facilitate pre-arranged appointments with guardians/caregivers of participating children with asthma. These appointments will occur throughout the day. Ministry of Done staff will be running the ‘Space to Breathe’ day activities with the wider ECE, and trained asthma nurses (GASP nurses) will conduct one-on-one sessions with the children who have asthma and their guardians/caregivers. GASP nurses will also be available to provide advice and support to ECE staff around establishing medicines policies and guidance on use and what to do with a child having an asthma attack. This advice and support will be standardised across all participating ECE centres.

Eligible and participating children with asthma attending the ECE centres randomised to the intervention will receive a GASP assessment to determine asthma symptomology, plus associated education on asthma medication use and asthma management. This assessment will be undertaken by a trained GASP nurse, employed by Harbour Health;
They will also receive a personalised asthma Self Management Plan (SMP) produced by the GASP tool, outlining prescribed medication, dosage and directions for use, and known triggers. The SMP will also be given to the child’s guardians/caregivers and ECE centre staff. Children with shared custody arrangements will be given more than one copy of their personalised asthma SMP. A copy of the associated decision support (but not the SMP) will be sent to the child’s usual GP. If the GASP assessment identifies a required change to the child’s asthma medication, the guardians/caregivers will be referred back to the child’s usual GP;
Compliance with medication will be stressed to the child and the child’s guardians/caregivers Various strategies will be used to improve compliance, with a focus on the child taking the required medication twice daily (ideally 12 hours apart). Routine behaviour change tools will be given to each child focussing on behaviour reinforcement around the management of their asthma. These tools will be held by the child’s guardians/caregivers at the child’s home, and the child will be encouraged to use them over the period of one month. Children with shared custody arrangements will be given more than one tool.These reminders will be delivered in the format preferred by the guardians/caregivers. To assist with routine, different options will be made available, including twice daily reminders in the form of text messages, phone alarms and clock alarms.

Guardians/caregivers (and other family members at the child’s home) that smoke will be supported to become smokefree (through the provision of Quitcards)

These assessments occur face to face at baseline, 1 month, 4 months and 12 months. The 8 month assessment is conducted over the telephone.
Intervention code [1] 283654 0
Other interventions
Intervention code [2] 283655 0
Behaviour
Intervention code [3] 283656 0
Lifestyle
Comparator / control treatment
Participating ECE centres randomised into the control arm will receive the following at baseline and four months a ‘Science with Dr Jellyman’ day, consisting of general science-based, curriculum-linked learning and activities consisting of eight lesson plans, one introductory lesson and a professional development session for ECE staff/teachers
The ‘Science with Dr Jellyman’ toolkit consists of a curriculum-based teacher resource, indoor activity mat / house for all children, stickers, policy templates and story book and access to related ‘science education’ resources via a password protected website.

The ‘Science with Dr Jellyman’ day at each ECE centre will be used to facilitate pre-arranged appointments with guardians/caregivers of participating children with asthma. These appointments will occur throughout the day, with Ministry of Done staff running the ‘Science with Dr Jellyman’ day activities with the wider ECE, while additional Ministry of Done staff conduct one-on-one sessions with the children who have asthma and their guardians/caregivers to collect outcome data. Eligible children (and their guardians/caregivers) will receive usual asthma care (as delivered by each child’s GP), which currently consists of brief discussion about asthma medication use and asthma management, and verbal advise/education on management.
Control group
Active

Outcomes
Primary outcome [1] 279890 0
A total of 188 ECE centres (94 per arm), will provide at least 90% power (p = 0.05) to detect a 50% reduction in the proportion of children that had an unscheduled medical or ED attendance for asthma in the last 12 months for the intervention group compared to the control group.
Timepoint [1] 279890 0
At one year after baseline
Secondary outcome [1] 294689 0
Frequency of short-acting bronchodilator (SABA) use, since last seen. This is self - reported by the parent / guardian of the child at each assessment.
Timepoint [1] 294689 0
baseline, 1,4,8,12 months
Secondary outcome [2] 294690 0
Frequency of corticosteroid use for asthma in the last 12 months (oral and inhaled). This is self - reported by the parent / guardian of the child at each assessment.
Timepoint [2] 294690 0
Baseline, 12 months
Secondary outcome [3] 294691 0
Asthma symptoms since last seen (daytime symptoms, nocturnal awakenings, and activity limitations). This is self - reported by the parent / guardian of the child at each assessment.
Timepoint [3] 294691 0
baseline, 1,4,8,12 months
Secondary outcome [4] 294692 0
Absenteeism due to asthma (from preschool, other activities). This is self - reported by the parent / guardian of the child at each assessment.
Timepoint [4] 294692 0
baseline, 1,4,8,12 months
Secondary outcome [5] 294693 0
Adherence: inhaler technique, and adherence to medication and SMP. Parents / guardians or the child if they are able to do so, will be asked to demonstrate in front of the research staff the inhaler technique. A score is used to determine if the technique is good, medium or poor.
Timepoint [5] 294693 0
Baseline, 1, 4, 12 months
Secondary outcome [6] 294694 0
Time to first unscheduled medical or ED attendance for asthma, after baseline measure. This is self - reported by the parent / guardian of the child at each assessment. Hospital and General Practice medical records will also be reviewed.
Timepoint [6] 294694 0
baseline, 1,4,8,12 months
Secondary outcome [7] 294695 0
? Number of unscheduled medical or ED attendances for asthma, after baseline measure. This is self - reported by the parent / guardian of the child at each assessment. Hospital and General Practice medical records will also be reviewed.
Timepoint [7] 294695 0
baseline, 1,4,8,12 months
Secondary outcome [8] 294696 0
Quality of Life (main guardian/caregiver), as measured by the TAPQoL
Timepoint [8] 294696 0
Baseline, 12 months
Secondary outcome [9] 294697 0
Costs incurred as a result of any unscheduled medical or ED attendance for their child for asthma. This is self - reported by the parent / guardian of the child at each assessment and includes the costs that the parent / guardian can recall that related to them for that visit.
Timepoint [9] 294697 0
baseline, 1,4,8,12 months
Secondary outcome [10] 294698 0
Number of ECE centres in intervention group that become fully Space to breathe accredited (Level 2) over 12 months
Timepoint [10] 294698 0
baseline, 1 and 12 months
Secondary outcome [11] 294699 0
Number of asthma related interventions on ECE incident register
Timepoint [11] 294699 0
baseline, 1 and 12 months

Eligibility
Key inclusion criteria
Main criteria for inclusion
ECE centres will be eligible for inclusion in this trial if they are located within areas of high deprivation within the Waitemata district (defined as the Ministry of Education Northern Region boundary); if they are on the Ministry of Education 1st July 2010 roll and enrol 2-5 year olds.

Children will be eligible for inclusion in this trial if they are aged between 2 and 4 years 8 months years at the time of enrolment into the study; if they have previously received a diagnosis of asthma from a medical practitioner; if they attend one of the participating ECE centres; and if informed consent has been obtained from the child’s guardian/caregiver.
Minimum age
2 Years
Maximum age
5 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
ECE centres will be excluded from the trial if they are located outside the Waitemata district (defined as the Ministry of Education Northern Region boundary); if they are not on the Ministry of Education 1st July 2010 roll; or if they enrol 0-2 year olds only.

Children will be excluded from the trial if they are younger than 2 or older than 4 years 8 months at the time of enrolment; if they have a respiratory illness other than asthma, as diagnosed by a medical practitioner; if they have previously been assessed by a GASP nurse, using the GASP tool; if they are enrolled or attending another ECE centre or if they are currently enrolled in another respiratory-based research study.

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)
After baseline data have been recorded for each ECE centre that wishes to participate and verbal consent has been obtained from the guardians/caregivers of children with asthma from each ECE centre, centres will be randomised (with allocation by computer).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The study statistician will generate a block randomisation list, stratified by centre license size (40 or 75) and centre age group (2-5 years olds or 0-5 year olds) to ensure a balance in these key prognostic indicators between the intervention and control group clusters
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Cluster
Phase
Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/09/2011
Actual
30/08/2011
Date of last participant enrolment
Anticipated
3/07/2012
Actual
3/07/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
800
Accrual to date
Final
Recruitment outside Australia
Country [1] 3938 0
New Zealand
State/province [1] 3938 0
Waitemata

Funding & Sponsors
Funding source category [1] 284137 0
Government body
Name [1] 284137 0
Pharmac NZ
Country [1] 284137 0
New Zealand
Primary sponsor type
Government body
Name
Pharmac NZ
Address
PO Box 10-254,
Level 9, 40 Mercer Street,
Wellington
New Zealand
Country
New Zealand
Secondary sponsor category [1] 269096 0
None
Name [1] 269096 0
Address [1] 269096 0
Country [1] 269096 0
Other collaborator category [1] 252323 0
University
Name [1] 252323 0
Auckland University
Address [1] 252323 0
Clinical Trials Research Unit,
University of Auckland,
Private Bag 92019,
Auckland 1142,
New Zealand
Country [1] 252323 0
New Zealand
Other collaborator category [2] 252324 0
Commercial sector/Industry
Name [2] 252324 0
Ministry of Done
Address [2] 252324 0
24 Garden Place, Level 4,
Suite 406,
Hamilton 3204,
New Zealand
Country [2] 252324 0
New Zealand
Other collaborator category [3] 252325 0
Other
Name [3] 252325 0
Harbour Health
Address [3] 252325 0
42B Tawa Drive, Albany, Auckland 0632, New Zealand
Country [3] 252325 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 272095 0
Upper South A
Ethics committee address [1] 272095 0
Upper South A Ethics Committee
Ministry of Health
Montgomery Watson Building
6 Hazeldean Road
Christchurch 8023
Ethics committee country [1] 272095 0
New Zealand
Date submitted for ethics approval [1] 272095 0
Approval date [1] 272095 0
01/08/2011
Ethics approval number [1] 272095 0

Summary
Brief summary
This study has been designed to assess the effect of two different asthma education strategies on pre-school children; one using curriculum based education and resources and the other consisting of a “Giving Asthma Support to Patients” (GASP) assessment and education plan for the child and their guardian/caregiver. This study will be undertaken in early childhood education (ECE) centres as they offer an ideal way to identify and access pre-school children in the community, particularly as the teachers/staff within such facilities need to be fully aware of children with asthma under their care.

Study aim
The primary objective of the proposed study is to ascertain whether provision of an asthma intervention (asthma education in an ECE setting in conjunction with a GASP assessment, education and self-management plan [SMP]) to children aged 2-5 years with diagnosed asthma, and their guardians/caregivers, improves asthma outcomes at 12 months after the introduction of the intervention compared with provision of usual care.
Trial website
https://www.ctru.auckland.ac.nz/stb
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33331 0
Dr Natalie Walker
Address 33331 0
University of Auckland
Clinical Trials Research Unit,
Private Bag 92019
Auckland 1142
Country 33331 0
New Zealand
Phone 33331 0
+6499239884
Fax 33331 0
Email 33331 0
[email protected]
Contact person for public queries
Name 16578 0
Dr Natalie Walker
Address 16578 0
Clinical Trials Research Unit (CTRU)
University of Auckland
Private Bag 92019
Auckland 1142,
New Zealand
Country 16578 0
New Zealand
Phone 16578 0
+64 9 373 7599 ext. 89884
Fax 16578 0
+64 9 373 1710
Email 16578 0
[email protected]
Contact person for scientific queries
Name 7506 0
Dr Natalie Walker
Address 7506 0
Clinical Trials Research Unit (CTRU)
University of Auckland
Private Bag 92019
Auckland 1142,
New Zealand
Country 7506 0
New Zealand
Phone 7506 0
+64 9 373 7599 ext. 89884
Fax 7506 0
+64 9 373 1710
Email 7506 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



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