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Completed

NCT Number: NCT01891773

Improving Pediatric Asthma Care Through Inhaled Steroids in Schools

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

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Inhaled steroids in school.

Behavioral

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

Primary outcomes

  1. Proportion of doses received

    Time frame: 60 day treatment period

    Proportion of doses of ICS received during the 60 days outcome period

Sponsors and collaborators

Lead sponsor

Children's National Research Institute

Other

Registry information

Official study title

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

Acronym: ISIS

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jul 3, 2013
Registry last updated
Sep 12, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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