Supervised Asthma Medication in Schools (SAMS)

Study Overview
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Brief Summary
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The investigators hypothesize that school-based, direct supervision of daily controller therapy will result in more effective asthma control, as assessed by the Asthma Control Questionnaire than usual care. Additionally, as the result of enhanced asthma control and resulting decrease in health care utilization, school-based, direct supervision of daily controller therapy will result in lower cost per quality-adjusted life year (QALY) gained than usual care.

Detailed Description
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This research is being done to test if children with asthma will have fewer asthma symptoms if they are monitored at school to make sure they take their inhaled steroid medication (ICS) every day and take the medication the right way. All of the children with asthma in the school will be asked to participate. In the first year in one-half of the schools, children and school staff will participate in a standardized asthma education program presented by the American Lung Association (ALA). Children will have daily monitoring of their inhaled asthma medication. The other half of schools will continue with the usual treatment of children with asthma. In the second year of the study, all schools and children will have the asthma education program and monitoring. Parents will be queried quarterly for information about their child's asthma.

Official Title
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The Cost Effectiveness of School-Based Supervised Asthma Therapy

Conditions
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Childhood Asthma

Intervention / Treatment
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* Drug: Supervised asthma therapy in schools


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A child with asthma attending a Tucson Unified School District elementary school selected for the study. Exclusion Criteria: No asthma. Not attending a Tucson Unified School District elementary school selected for the study.

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 12 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Regular Therapy<br>Regular Asthma Therapy | |
| Experimental: Supervised Therapy<br>Supervised asthma therapy in schools | Drug: Supervised asthma therapy in schools<br>* Therapy observed daily in school. Asthma education by American Lung Association<br>* Other names: Ventolin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Primary Outcome Will be the Score on the Juniper Asthma Control Questionnaire (ACQ) | An ACQ score of > 1.5 means asthma is not well controlled. An ACQ score of <= 1.5 means asthma is well controlled. Missing ACQ score = number of participants not administered an ACQ | 1 year |