Improving Pediatric Asthma Care Through Inhaled Steroids in Schools

Asthma Clinical Trial

— ISIS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01891773
• Other study ID #: Pro00003859
• Status: Completed
• Phase: N/A
• First received: June 28, 2013
• Last updated: September 10, 2014
• Start date: August 2013
• Est. completion date: August 2014

Study information

• Verified date: September 2014
• Source: Children's Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Asthma

Intervention

Behavioral:
• Inhaled steroids in school.
Morning dose of inhaled steroids given in school by school nurse instead of at home.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Children's Research Institute

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of doses received	Proportion of doses of ICS received during the 60 days outcome period	60 day treatment period	No