School-based Asthma Therapy: Stage 2 Effectiveness Study

University of Rochester530 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE

Enrollment

530

Conditions

Asthma

Eligibility

Sex: ALLMin age: 3 YearsMax age: 10 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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).

Time frame: Average Symptom Free Days, over 2 weeks, during peak asthma season (November-February)

Secondary Outcomes

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).

Time frame: 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.

Time frame: 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.

Time frame: 1-9 months (Monthly Follow-up assessments)