Improving Pediatric Asthma Care Through Inhaled Steroids in Schools

Not Applicable

Completed

• Conditions: Asthma
• Interventions: Behavioral: Inhaled steroids in school.

• Registration Number: NCT01891773
• Lead Sponsor: Children's National Research Institute

Brief Summary

Asthma is the most common chronic pediatric disease in the United States, and is the most common cause of school absenteeism due to a chronic disease. Socioeconomically disadvantaged minority children receive disproportionately poor asthma care and incur a disproportionate share of asthma-related morbidity. The District of Columbia is particularly severely affected, with a lifetime asthma prevalence rate among children 0-17 years of age in 2010 of 22%, more than double the national average.

One of the major challenges in treating asthma is poor adherence to daily controller medications, particularly inhaled corticosteroids (ICS) which are the cornerstone of the NIH guidelines for asthma management. In an attempt to overcome poor compliance, investigators in Rochester, New York have partnered with primary care providers in their community to arrange for ICS administration at school by school nurses, and this approach yielded significant improvements in several asthma outcomes.

The investigators propose to collaborate in a pilot research project with the overall goal of improving asthma outcomes through reducing barriers to medication adherence. Specifically, the investigators aim to improve adherence to controller medications (inhaled corticosteroids - ICS) among DC children with asthma through the following activities:

1. A pilot prospective randomized clinical trial of home vs. school administration of ICS among DC children in grades kindergarten-8 with persistent asthma.

2. Qualitative interviews with nurses from DC public and public charter school to identify key barriers to administration of daily controller medications in the school setting

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-06-28
• Study First Submitted QC: 2013-07-02
• Study First Posted: 2013-07-03
• Study Start: 2013-08
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-10
• Last Update Posted: 2014-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

• Current enrollment in one of the grades K-8 at a DC public school (DCPS) or DC public charter school (DCPCS)
• Active public insurance
• Persistent asthma
• An Asthma Action Plan including daily ICS
• Child's primary asthma caregiver present, meaning the person who usually takes care of his/her asthma at home and can answer questions about his/her medical history.

Exclusion Criteria

• Chronic disease of the cardio-pulmonary system other than asthma
• Non-English speaking parent/guardian
• Currently enrolled in in another asthma study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
School-based therapy	Inhaled steroids in school.	Daily dose of medication to be provided in the school setting.

Primary Outcome Measures

Name	Time	Method
Proportion of doses received	60 day treatment period	Proportion of doses of ICS received during the 60 days outcome period