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N/A N=530 Randomized Single-blind Health Services Research

School-based Asthma Therapy: Stage 2 Effectiveness Study

Asthma

Enrolled (actual)
530
Serious AEs
0.0%
Results posted
Feb 2013
Primary outcome: Primary: Number of Symptom Free Days — 10.7; 11.6 Days

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
School-based Care (Behavioral)
Age
Pediatric · 3+ yrs
Sex
All
Sponsor
University of Rochester
Primary completion
Jun 2009

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Symptom Free Days
10.7; 11.6
SECONDARY
Cotinine Level
SECONDARY
Cost Effectiveness of the Intervention
SECONDARY
Additional Asthma Morbidity Outcomes

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.

Eligibility Criteria

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01175369). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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