Improving Pediatric Asthma Care Through Inhaled Steroids in Schools

NCT01891773 | Completed

• 1 other identifier: Pro00003859
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

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. 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. 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

Conditions

Asthma

Keywords

Asthma; Inhaled Corticosteroids; School Nurses

Outcome Measures

Primary Outcomes (1)

• Proportion of doses received

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

  60 day treatment period

Study Arms (2)

School-based therapy

EXPERIMENTAL

Daily dose of medication to be provided in the school setting.

Behavioral: Inhaled steroids in school.

Usual Care

NO INTERVENTION

Daily medication to be taken at home.

Interventions

Inhaled steroids in school. BEHAVIORAL

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

School-based therapy

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Children's National Research Institute: lead

MeSH Terms

Conditions

Asthma

Interventions

Schools

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Non-Medical Public and Private Facilities

Study Officials

• Stephen Teach, MD, MPH

  Children's National Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Chief, Division of Emergency Medicine

Study Record Dates

• First Submitted: June 28, 2013
• First Posted: July 3, 2013
• Study Start: August 1, 2013
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: September 12, 2014

Record last verified: 2014-09