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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
Children's National Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Asthma focused on measuring Asthma, Inhaled Corticosteroids, School Nurses

Eligibility Criteria

5 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    June 28, 2013
    Last Updated
    September 10, 2014
    Sponsor
    Children's National Research Institute
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    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

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