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Improving Pediatric Asthma Care Through Inhaled Steroids in Schools

Improving Pediatric Asthma Care Through Inhaled Steroids in Schools (ISIS)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01891773
Acronym
ISIS
Enrollment
48
Registered
2013-07-03
Start date
2013-08-31
Completion date
2014-08-31
Last updated
2014-09-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Keywords

Asthma, Inhaled Corticosteroids, School Nurses

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

Interventions

BEHAVIORALInhaled steroids in school.

Morning dose of inhaled steroids given in school by school nurse instead of at home.

Sponsors

Children's National Research Institute
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
5 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Proportion of doses received60 day treatment periodProportion of doses of ICS received during the 60 days outcome period

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026