None listed
Conditions
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.
Interventions
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 cent
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.
Sponsors
Pharmac NZ
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
2 Years to 5 Years
Healthy volunteers
No
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.
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.
Outcome results
None listed