School-Based Asthma Therapy: Stage 2 Effectiveness Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Rochester
- Enrollment
- 530
- Locations
- 1
- Primary Endpoint
- Number of Symptom Free Days
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 3 Years to 10 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Usual Care
Usual asthma 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).
Intervention: School-based Care (Behavioral)
Outcomes
Primary Outcomes
Number of Symptom Free Days
Time Frame: 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 Outcomes
- Cotinine Level(2 month and approximately 9 month (end of school year) follow-up assessments)
- Cost Effectiveness of the Intervention(approximately 9 months (length of school year))
- Additional Asthma Morbidity Outcomes(1-9 months (Monthly Follow-up assessments))
Investigators
Jill Halterman
Associate Professor of Pediatrics
University of Rochester