He Tapu Te Ha: Space to breathe - Effectiveness of preschool asthma educatio

Phase 3

Completed

• Conditions: Asthma; Respiratory - Asthma; Public Health - Other public health

• Registration Number: ACTRN12611001143910
• Lead Sponsor: Pharmac NZ

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-11-02
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 800

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.[At one year after baseline]