Improving Pediatric Asthma Care Through Inhaled Steroids in Schools

Study Overview
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Brief Summary
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Asthma is the most common chronic pediatric disease in the United States, and is the most common cause of school absenteeism due to a chronic disease. Socioeconomically disadvantaged minority children receive disproportionately poor asthma care and incur a disproportionate share of asthma-related morbidity. The District of Columbia is particularly severely affected, with a lifetime asthma prevalence rate among children 0-17 years of age in 2010 of 22%, more than double the national average. One of the major challenges in treating asthma is poor adherence to daily controller medications, particularly inhaled corticosteroids (ICS) which are the cornerstone of the NIH guidelines for asthma management. In an attempt to overcome poor compliance, investigators in Rochester, New York have partnered with primary care providers in their community to arrange for ICS administration at school by school nurses, and this approach yielded significant improvements in several asthma outcomes. The investigators propose to collaborate in a pilot research project with the overall goal of improving asthma outcomes through reducing barriers to medication adherence. Specifically, the investigators aim to improve adherence to controller medications (inhaled corticosteroids - ICS) among DC children with asthma through the following activities: A pilot prospective randomized clinical trial of home vs. school administration of ICS among DC children in grades kindergarten-8 with persistent asthma. Qualitative interviews with nurses from DC public and public charter school to identify key barriers to administration of daily controller medications in the school setting

Official Title
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Improving Pediatric Asthma Care Through Inhaled Steroids in Schools (ISIS)

Conditions
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Asthma

Intervention / Treatment
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* Behavioral: Inhaled steroids in school.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Current enrollment in one of the grades K-8 at a DC public school (DCPS) or DC public charter school (DCPCS) Active public insurance Persistent asthma An Asthma Action Plan including daily ICS Child's primary asthma caregiver present, meaning the person who usually takes care of his/her asthma at home and can answer questions about his/her medical history. Exclusion Criteria: Chronic disease of the cardio-pulmonary system other than asthma Non-English speaking parent/guardian Currently enrolled in in another asthma study

Ages Eligible for Study
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Minimum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: School-based therapy<br>Daily dose of medication to be provided in the school setting. | Behavioral: Inhaled steroids in school.<br>* Morning dose of inhaled steroids given in school by school nurse instead of at home.<br>|
| No Intervention: Usual Care<br>Daily medication to be taken at home. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of doses received | Proportion of doses of ICS received during the 60 days outcome period | 60 day treatment period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Asthma, Inhaled Corticosteroids, School Nurses