Improving Pediatric Asthma Care Through Inhaled Steroids in Schools

NCT ID: NCT01891773

Last Updated: 2014-09-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2014-08-31

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

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

School-based therapy

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

Group Type: EXPERIMENTAL

Inhaled steroids in school.

Intervention Type: BEHAVIORAL

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

Usual Care

Daily medication to be taken at home.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Inhaled steroids in school.

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children's National Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Stephen J. Teach, MD, MPH

Associate Chief, Division of Emergency Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stephen Teach, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Children's National Research Institute

Other Identifiers

Pro00003859

Identifier Type: -

Identifier Source: org_study_id