Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000212358
Ethics application status
Approved
Date submitted
7/02/2017
Date registered
9/02/2017
Date last updated
20/04/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
He Kura: Improving Asthma Support for School Children
Scientific title
He Kura: The effect of an asthma support intervention for primary school students on reducing absences
Secondary ID [1] 291102 0
None
Universal Trial Number (UTN)
U1111-1184-4537
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 299742 0
Condition category
Condition code
Respiratory 299677 299677 0 0
Asthma
Public Health 301604 301604 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Phase 2:

The overall duration of the intervention period will be 8 months.

Engagement:
Initial engagement will involve senior members of the research team meeting with the school principal and the board of trustees of individual schools who have indicated an interest in the study, to provide an overview of the intervention and to explain what it may involve for their school.

Identifying Needs:
Following this initial meeting, a workshop/meeting will take place with the principal and other available staff members e.g. admin staff, teachers, caretakers and members of the research team to identify the potential issues affecting asthma management in individual schools. Research staff will establish what support the school has e.g. access to a public health nurse; asthma first aid training and what services are available within the community. The schools level of community engagement will be assessed through a short series of questions with the school’s principal.

Rollout:
Using the information obtained from this meeting, researchers will work with individual schools to help customise the asthma toolkit suited to their needs. School principals can prioritise their schools needs if it is not possible to implement all of the intervention components at once. Researchers will explain in detail the processes involved with each intervention component. Individual schools can choose whether to include or exclude aspects of the following components from the toolkit intervention; school environmental assessments, school education, community engagement and education, school policy guidelines, staff training and linkages to healthcare providers.

Evaluation:
A process evaluation will examine the implementation of the intervention to determine whether it was implemented as intended. Members of the school community including, parents, board of trustees, principals, teachers, support staff and key-informants e.g. public health nurses, Maori health providers and GP’s will be encouraged to provide both qualitative and quantitative feedback. Following the intervention surveys will be conducted to capture a wide range of views. Semi-structured interviews and focus groups will also be offered to members of the school community to determine which elements of the intervention worked well and for suggestions regarding modification.

Complex interventions work best if they are tailored to local contexts rather than being completely standardised, hence this design allows for schools to customise the way in which they implement the Toolkit while following basic principles underpinning it. Study staff will work individually with intervention schools assisting them to use and customise the toolkit. Each school will receive both printed and electronic copies of the toolkit resources.

Intervention Components

1. Case Identification
An important component of the toolkit will be mechanisms to enable a school to identify children with asthma. This is also a necessary component of our outcome assessment measures i.e. we need to identify children with asthma in order to capture their baseline information, therefore case identification will be completed within all intervention schools. Total days away from school will be collected from school records as the primary outcome. Generally, school records often do not record the reason for absence. The total number of days away from school from the previous year will also be documented in order to compare absences pre and post intervention.

2. Medication Management
Policies will be recommended to intervention schools encouraging schools to allow students to have easy access to their asthma medication throughout the school day. Emergency bronchodilator medication will be available within asthma emergency kits at intervention schools. School staff will be educated on how and when to use this medication. These policies aim to reduce severe asthma symptoms and to promote full activity participation for students with asthma.

3. Staff Training
Intervention schools will be offered asthma education training either in the form of online training or through asthma education sessions with an asthma educator. The aim of the staff training is to increase staff awareness around asthma triggers, symptoms and management. As outlined in the School Policy Guidelines, school staff will be encouraged to receive education on acute asthma management once or twice a year.

4. Student Education
Students will be provided with an educational asthma activity workbook to take home and complete the activities with their parents/whanau. Researchers are available to answer any questions they might have and feedback on the usefulness of this activity book will be sought at the end of the trial.

5. Community Engagement and Education
The nature of this component will be determined in collaboration with individual schools. It is likely that the community engagement and education will occur at pre-established events such as whanau evenings or parent/teacher evenings. This component of the intervention is designed to increase the knowledge, skills and confidence of asthma for whanau and the wider community in a relaxed and informal environment. Each school’s level of community engagement will also be assessed; board members, teachers and principals will be asked the following questions:
Do you interact with parents or wider whanau?
What type of events do you provide to support parents/whanau engagement (e.g. Parent Teacher evenings, fundraisers, galas, hui, sports events)?
Are these events well attended by whanau/families? If so why?
Do community organisations support your school’s community health worker, sports clubs, and farmers?

6. Linkages to Healthcare Providers
Linkages to healthcare providers will also be developed in collaboration with intervention schools. Schools will decide the best course of action regarding individual asthma plans, whether parents are responsible for obtaining these from the GP and giving a copy to the school or if schools should get a copy directly from the GP. Research teams will make contact with appropriate healthcare providers within the community e.g. GPs, pharmacists and public health nurses to help establish better communication between medical professionals, schools and whanau.

7. School Environment
Classroom allergen testing and school environmental assessments will be carried out at the beginning of the intervention. Classroom allergen testing will involve researchers obtaining a vacuumed sample from the floor surface of each classroom to test for allergens know to trigger asthma. The School Environmental Assessment involves researchers assessing each classroom for potential asthma triggers; the questionnaire assesses the type of floor coverings, types of pets in the classroom etc. A broader assessment of the whole school is also offered with researchers assessing the school grounds for environmental factors such as types of plants on the schools grounds, chemicals used in the school pool etc. In order for schools to minimise student exposure to potential asthma triggers, recommendations will be given to individual schools based on the results of their classroom allergen samples and environmental assessments.

Dust samples will be collected from all classrooms and halls of each school by standardised vacuuming techniques. For allergen levels, the dust samples will be extracted with phosphate-buffered saline and the major allergens to house dust mite, cat, dog, mouse, rat, cockroach, horse and cow quantified by established commercial monoclonal and polyclonal enzyme-linked immunoassays as previously described. Bacterial endotoxin and fungal B-glucan will be quantified in dust extracts by specific Limulus amebocyte lysate assays as previously described. Additionally, we will inspect the classrooms for visible mould, note the presence of carpets or rugs, type of heating appliance, and occupancy.

8. Process Evaluation
A process evaluation examines the implementation of a programme to determine whether it is being implemented as designed and planned, and what aspects of the programmes operating environment help or hinder programme implementation and the subsequent achievement of outcomes.
Qualitative Experiences
This will include acceptability of the toolkit and participant experiences with the trial and community engagement as well as any suggestions for modification to the intervention prior to recommendations for National use.
Data Collection (Quantitative):
A brief survey will be conducted post-intervention in order to capture a wider range of views from all categories of participants. This will allow health professionals, parents and school staff to feedback their views and thus contribute to evidencing what worked and what could be improved.
Data collection (Qualitative):
This will involve focus groups and semi-structured interviews (n= 5-10 per category, per school) allowing participants to choose their preferred method.

Intervention code [1] 295495 0
Lifestyle
Comparator / control treatment
Not applicable

The overall duration of the intervention period will be 8 months.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 299137 0
Total days missed from school by students identified as having asthma as assessed by absence data from student management system.
Timepoint [1] 299137 0
At the completion of the 8 month intervention.
Primary outcome [2] 299138 0
Number of students identified with asthma as assessed by medical information on student management system.
Timepoint [2] 299138 0
At the completion of the 8 month intervention.
Primary outcome [3] 299139 0
Educational attainment of students with asthma as assessed by the OTJ (Overall Teacher Judgement) grade in reading writing and maths as recorded on the student management system.
Timepoint [3] 299139 0
At the completion of the 8 month intervention..
Secondary outcome [1] 326302 0
Overall student absentee rates of intervention schools compared to absentee rates of overall other schools in the region will be assessed using Ministry of Education absence data. This will be tested using a quasi-poisson generalised linear model with an over-dispersion.
Timepoint [1] 326302 0
At the completion of the 8 month intervention.

Eligibility
Key inclusion criteria
Schools located within the territorial authority boundaries of: Wellington, Lower Hutt, Upper Hutt, Porirua, Kapiti Coast and Whanganui Districts.
Schools which enrol children aged 5-13 (i.e. years 1-8) including: contributing; full primary; intermediate; and composite (junior) schools.
Have at least 50 Maori pupils on the school role (as listed in the Ministry of Education Directory of Schools).
Minimum age
5 Years
Maximum age
13 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Schools outside of the territorial authority boundaries of Wellington, Lower Hutt, Upper Hutt, Porirua, Kapiti Coast and the Whanganui districts.
Schools which do not enrol students who are primarily aged between 5-13 years old (e.g. secondary schools and secondary schools which incorporate intermediate school aged students).
Schools with less than 50 Maori pupils on the school role (as listed in the Ministry of Education Directory of Schools). (For the purposes of feasibility in deploying the intervention.)
Schools which were involved in piloting the intervention and phase one of the intervention.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Quantitative Data & Power Calculation:

The number of school days absent (all causes, asthma-related), will be calculated for the interval of the follow-up period (10-months). Scores for educational attainment will be calculated according to the instructions of the respective assessments used by schools. Outcome variables will be presented by group by means of appropriate tabulated descriptive statistics. In all analyses, SAS v9.2 software (SAS Institute, Cary, North Carolina, USA) will be used, with level of significance set at 0.05 (two-tailed test).

The difference in school absence will be tested using a quasi-poisson generalised linear model with an over-dispersion term; this over-dispersion term will vary by school to allow for the clustering. Sensitivity analysis will be also be conducted to assess the robustness of the data analysis by removing outliers and comparing outcomes within the ‘as-treated’ subgroup.

To account for the effects of clustering within schools, a random effects model will be used to test for a change in outcomes pre and post intervention. We anticipate that, with 10 schools participating, each with at least 50 Maori students, we will have a total sample size of approximately 770 children with asthma, and approximately 130 Maori children with asthma. That will provide sufficient (80%) power to detect, at the 0.05 level, an increase of 50% in the number of children attaining an educational level of at or above national standard (odds ratio = 1.5). Multivariable modelling (with school as the random effect) will enable us to control for confounders at the school level (e.g., school size, percent Maori).


Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
14/02/2017
Date of last participant enrolment
Anticipated
31/03/2017
Actual
Date of last data collection
Anticipated
22/12/2017
Actual
Sample size
Target
770
Accrual to date
Final
Recruitment outside Australia
Country [1] 8068 0
New Zealand
State/province [1] 8068 0
Wellington

Funding & Sponsors
Funding source category [1] 294203 0
Government body
Name [1] 294203 0
Health Research Council of New Zealand
Country [1] 294203 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
Bernadette Jones
Principal Investigator He Kura Study
University of Otago, Wellington
Department of Medicine
23A Mein Street
Newtown
Wellington 6021
New Zealand

PO Box 7343
Wellington South
Wellington 6242
New Zealand
Country
New Zealand
Secondary sponsor category [1] 293036 0
None
Name [1] 293036 0
nil
Address [1] 293036 0
nil
Country [1] 293036 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295611 0
Health and Disability Ethics Committees
Ethics committee address [1] 295611 0
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
Ethics committee country [1] 295611 0
New Zealand
Date submitted for ethics approval [1] 295611 0
27/07/2016
Approval date [1] 295611 0
17/11/2016
Ethics approval number [1] 295611 0
16/NTA/118

Summary
Brief summary
Asthma is extremely common in New Zealand, with up to 26% of children reporting having experienced asthma by age 6 years. New Zealand has the second highest rate of asthma in the world, following the UK and it is estimated that 550,000 school days are lost each year due to asthma. Significant ethnic disparities exist for Maori with respect to asthma morbidity. In particular, Maori children suffer more severe symptoms, higher rates of hospitalisations, and more time off school. Hospitalisation rates for asthma are highest amongst children <14 years and in this group Maori are nearly twice as likely to be hospitalised with asthma compared to non-Maori. Evidence suggests that access to preventative care and differential treatment by ethnicity contributes to these inequalities for Maori..

The aim of this study is to assess whether a comprehensive, school-based asthma intervention (using a culturally appropriate toolkit) leads to improved outcomes amongst asthmatic children aged 5-13 years. This is an unblinded, multicentre, pre-post trial evaluating the effect of a school-based asthma intervention among primary school children with asthma, in 10 intervention schools, within the Greater Wellington and Whanganui regions, over a eight month follow-up period. Phase One has used hui, focus groups and semi-structured interviews to identify support needs and wellbeing goals for Maori children with asthma and highlighted pathways to achieving these goals in the school environment. Based on this evidence an asthma toolkit has been developed which provides resources, guidelines and tools to enable schools to better support asthmatic children. Phase Two will assess the effect of the toolkit intervention on the identification of children with asthma, school absences and educational attainment of students with asthma. The Kaupapa Maori research methodology, Maori-led research team, use of an equity lens and equal explanatory power will collectively ensure that the needs, views and aspirations of Maori will be privileged throughout the research.
This study will be conducted using a Pre-post intervention design. Pretesting will provide baseline measures; researchers with the help of school staff will obtain data on the number of students identified as having asthma. Following the intervention researchers will again obtain data on the number of identified students with asthma, the absence rates of these students will be compared between the intervention year and the year prior. The educational attainment of students with asthma will also be compared between the intervention year and the year prior. The overall absence rate of students at non-intervention schools will be compared to our intervention schools as a secondary measure.

This study will be underpinned by a Kaupapa Maori Research (KMR) paradigm that takes for granted the legitimacy and validity of Maori living, succeeding and aspiring as Maori.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 67918 0
Mrs Bernadette Jones
Address 67918 0
University of Otago, Wellington
23A Mein Street
Newtown
Wellington 6021
New Zealand

PO Box 7343
Wellington South
Wellington 6242
New Zealand
Country 67918 0
New Zealand
Phone 67918 0
+6449186845
Fax 67918 0
Email 67918 0
[email protected]
Contact person for public queries
Name 67919 0
Mrs Bernadette Jones
Address 67919 0
University of Otago, Wellington
23A Mein Street
Newtown
Wellington 6021
New Zealand
Country 67919 0
New Zealand
Phone 67919 0
+6449186845
Fax 67919 0
Email 67919 0
[email protected]
Contact person for scientific queries
Name 67920 0
Mrs Bernadette Jones
Address 67920 0
University of Otago, Wellington
23A Mein Street
Newtown
Wellington 6021
New Zealand
Country 67920 0
New Zealand
Phone 67920 0
+6449186845
Fax 67920 0
Email 67920 0
[email protected]

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