Comparison of School-Based Supervised Versus Parental Supervised Asthma Therapy
Primary Purpose
Asthma
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
School-Based Supervised Asthma Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Asthma
Eligibility Criteria
Inclusion Criteria: Persistent asthma requiring daily controller medication Enrolled at a participating elementary school
Sites / Locations
- University of Alabama Birmingham Lung Health Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
1
2
Arm Description
Supervised therapy
Inhaled steroid use as usual care
Outcomes
Primary Outcome Measures
Asthma exacerbations
Secondary Outcome Measures
Full Information
NCT ID
NCT00110383
First Posted
May 6, 2005
Last Updated
March 2, 2014
Sponsor
University of Alabama at Birmingham
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT00110383
Brief Title
Comparison of School-Based Supervised Versus Parental Supervised Asthma Therapy
Official Title
Effectiveness of School Based Supervised Asthma Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
May 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Alabama at Birmingham
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Develop a simple school-based intervention using school-based supervised asthma therapy to increase adherence to asthma medication.
Implement a school-based internet monitoring system within both the school-based supervised asthma therapy and parent supervised asthma therapy groups to record asthma symptoms, peak flow meter readings, school absences, and usage of rescue medications at school.
Randomly assign 250 children from inner-city school systems to either school-based supervised asthma therapy or parental supervised asthma therapy.
Compare children assigned to school-based supervised asthma therapy with children assigned to parent supervised asthma therapy, in regards to time-averaged proportion having at least one exacerbation per month, rescue medication use, peak flow meter readings, asthma symptoms, school absences, and asthma self-management knowledge.
Detailed Description
BACKGROUND:
Pediatric asthma is a well-documented public health issue in the United States. The impact of pediatric asthma can be measured by both health care costs and morbidity. Whereas many factors contribute to the high health care costs of asthma, much of the morbidity can be directly attributed to lack of adherence to medical treatments. The consequence of non-adherence for most individuals with ashtma is exacerbations. Greater numbers of exacerbations lead to increased school absenteeism, greater activity limitations, decreased quality of life for both parent and child, increased urgent health care use and costs, and increased parental days missed at work. Therefore, adherence to treatment is essential for proper asthma management and ultimate reductions in morbidity.
Asthma morbidity, as measured by the number of exacerbations, is largely preventable with patient education and optimal treatment. However, it has been demonstrated that patient education alone is insufficient to decrease asthma morbidity. Optimal treatment is essential to control asthma morbidity. Inhaled corticosteroids offer considerable protection against asthma exacerbations. However, only a minority of asthma patients take their inhaled steroids as recommended by the National Asthma Education and Prevention Program (NAEPP) guidelines. Therefore, the Pediatric Asthma Guidelines recommend development and testing of programs (including school-based programs) to increase adherence with therapy.
Because morbidity is higher in inner-city, low-income, minority children, this study will collaborate with several inner-city, low-income, minority school districts to examine the effects of school-based supervised asthma therapy.
DESIGN NARRATIVE:
This study is a longitudinal two-group trial of the effectiveness of a school-based supervised asthma therapy program. Two hundred and fifty children will be randomly assigned to one of two groups: school-based supervised asthma therapy or parental supervised asthma therapy. The children will be followed for 16 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
295 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Supervised therapy
Arm Title
2
Arm Type
No Intervention
Arm Description
Inhaled steroid use as usual care
Intervention Type
Behavioral
Intervention Name(s)
School-Based Supervised Asthma Therapy
Intervention Description
Child's inhaled steroid use supervised daily at school
Primary Outcome Measure Information:
Title
Asthma exacerbations
Time Frame
Measured at 15 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Persistent asthma requiring daily controller medication
Enrolled at a participating elementary school
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lynn B. Gerald, PhD, MSPH
Organizational Affiliation
University of Alabama Birmingham Lung Health Center
Official's Role
Study Chair
Facility Information:
Facility Name
University of Alabama Birmingham Lung Health Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233-7337
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
19017893
Citation
Gerald LB, Gerald JK, Gibson L, Patel K, Zhang S, McClure LA. Changes in environmental tobacco smoke exposure and asthma morbidity among urban school children. Chest. 2009 Apr;135(4):911-916. doi: 10.1378/chest.08-1869. Epub 2008 Nov 18.
Results Reference
derived
Learn more about this trial
Comparison of School-Based Supervised Versus Parental Supervised Asthma Therapy
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