School-based Asthma Therapy: Stage 2 Effectiveness Study

Study Overview
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Brief Summary
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Asthma is the most common chronic illness of childhood, and hospitalization rates are increasing. In the US, impoverished children and children from minority ethnic and racial backgrounds suffer disproportionately from asthma. While National Heart, Lung, and Blood Institute (NHLBI) guidelines recommend daily preventive medications for all children with mild persistent to severe persistent asthma, studies indicate that many children in the US who should receive preventive medications are not receiving them. The overall goal of this project is to target an ethnically diverse population of inner-city schoolchildren with asthma and explore a school-based program to reduce asthma morbidity. We hypothesize that children receiving a comprehensive school-based intervention will experience less asthma-related morbidity compared to children receiving usual care. Our comprehensive school-based intervention consists of both administration of recommended preventive asthma medications in school (with dose adjustments according to NHLBI guidelines) and an environmental tobacco smoke (ETS) reduction program in the home for smoke-exposed children. Our secondary hypothesis is that, among the subgroup of smoke-exposed children, those who receive the school-based intervention with ETS reduction will experience less asthma morbidity than those who receive usual care.

Official Title
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School-Based Asthma Therapy: Stage 2 Effectiveness Study

Conditions
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Asthma

Intervention / Treatment
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* Behavioral: School-based Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Physician-diagnosed asthma Mild persistent to severe persistent asthma Ages 3-10 years Attending school in the Rochester City School District preschools or elementary schools Signed physician permission to enroll the child Parent or caregiver must consent to the intervention Exclusion Criteria: Inability to speak and understand either English or Spanish No access to a working phone for follow-up surveys The family planning to leave the school district within fewer than 6 months The child having other significant medical conditions that could interfere with the assessment of asthma-related outcome measures children in foster care or other situations in which consent cannot be obtained from a guardian Current participation in other local asthma interventions

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 10 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 |
| --- | --- |
| No Intervention: Usual Care<br>Usual asthma care | |
| Experimental: School-based Care<br>The intervention includes directly observed administration of preventive medications in school and a home-based ETS reduction program (for those living with one or more smokers). | Behavioral: School-based Care<br>* The intervention includes directly observed administration of preventive medications in school and a home-based ETS reduction program (for those living with one or more smokers).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Symptom Free Days | The primary outcome variable is the average number of symptom free days over 2 weeks assessed during peak asthma season (data collected during November, December, January and February during the school year). | Average Symptom Free Days, over 2 weeks, during peak asthma season (November-February) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cotinine Level | To test the effectiveness of the environmental tobacco smoke (ETS) reduction portion of the study, we will compare baseline cotinine values to 2 month (for smoke exposed participants) and final follow-up assessments (for all participants). | 2 month and approximately 9 month (end of school year) follow-up assessments | 
| Cost Effectiveness of the Intervention | Cost-effectiveness will examine the net program costs to the number of symptom-free days gained. Benefits will be described as the net difference in medical and productivity costs between children in the treatment and control groups. | approximately 9 months (length of school year) | 
| Additional Asthma Morbidity Outcomes | We will look at additional asthma morbidity outcomes including symptom nights, days needing rescue medications, functional severity, days absent from school, and quality of life. | 1-9 months (Monthly Follow-up assessments) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Asthma