School-based Asthma Therapy: Stage 2 Effectiveness Study

Not Applicable

Completed

Brief Summary: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
School-based Care	School-based Care	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).

Primary Outcome Measures

Name	Time	Method
Number of Symptom Free Days	Average Symptom Free Days, over 2 weeks, during peak asthma season (November-February)	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).

Secondary Outcome Measures

Name	Time	Method
Cotinine Level	2 month and approximately 9 month (end of school year) follow-up assessments	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).
Cost Effectiveness of the Intervention	approximately 9 months (length of school year)	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.
Additional Asthma Morbidity Outcomes	1-9 months (Monthly Follow-up assessments)	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.