Improving Pediatric Asthma Care Through Inhaled Steroids in Schools (ISIS)
Primary Purpose
Asthma
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Inhaled steroids in school.
Sponsored by
About this trial
This is an interventional health services research trial for Asthma focused on measuring Asthma, Inhaled Corticosteroids, School Nurses
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
School-based therapy
Usual Care
Arm Description
Daily dose of medication to be provided in the school setting.
Daily medication to be taken at home.
Outcomes
Primary Outcome Measures
Proportion of doses received
Proportion of doses of ICS received during the 60 days outcome period
Secondary Outcome Measures
Full Information
NCT ID
NCT01891773
First Posted
June 28, 2013
Last Updated
September 10, 2014
Sponsor
Children's National Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT01891773
Brief Title
Improving Pediatric Asthma Care Through Inhaled Steroids in Schools
Acronym
ISIS
Official Title
Improving Pediatric Asthma Care Through Inhaled Steroids in Schools (ISIS)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Children's National Research Institute
4. Oversight
Data Monitoring Committee
No
5. Study Description
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:
A pilot prospective randomized clinical trial of home vs. school administration of ICS among DC children in grades kindergarten-8 with persistent asthma.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Asthma, Inhaled Corticosteroids, School Nurses
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
School-based therapy
Arm Type
Experimental
Arm Description
Daily dose of medication to be provided in the school setting.
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Daily medication to be taken at home.
Intervention Type
Behavioral
Intervention Name(s)
Inhaled steroids in school.
Intervention Description
Morning dose of inhaled steroids given in school by school nurse instead of at home.
Primary Outcome Measure Information:
Title
Proportion of doses received
Description
Proportion of doses of ICS received during the 60 days outcome period
Time Frame
60 day treatment period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen Teach, MD, MPH
Organizational Affiliation
Children's National Research Institute
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Improving Pediatric Asthma Care Through Inhaled Steroids in Schools
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