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| Sponsor: | National Heart, Lung, and Blood Institute (NHLBI) |
|---|---|
| Information provided by: | National Heart, Lung, and Blood Institute (NHLBI) |
| ClinicalTrials.gov Identifier: | NCT00110383 |
Purpose
| Condition | Intervention |
|---|---|
|
Asthma |
Behavioral: School-Based Supervised Asthma Therapy |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Effectiveness of School Based Supervised Asthma Therapy |
| Enrollment: | 295 |
| Study Start Date: | May 2004 |
| Study Completion Date: | May 2007 |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Supervised therapy
|
Behavioral: School-Based Supervised Asthma Therapy
Child's inhaled steroid use supervised daily at school
|
|
No Intervention: 2
Inhaled steroid use as usual care
|
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.
Eligibility| Ages Eligible for Study: | 6 Years to 12 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Contacts and Locations| United States, Alabama | |
| University of Alabama Birmingham Lung Health Center | |
| Birmingham, Alabama, United States, 35233-7337 | |
| Study Chair: | Lynn B. Gerald, PhD, MSPH | University of Alabama Birmingham Lung Health Center |
More Information
| Responsible Party: | Lynn B. Gerald, PhD, MSPH, University of Alabama at Birmingham |
| ClinicalTrials.gov Identifier: | NCT00110383 History of Changes |
| Other Study ID Numbers: | 174, R01 HL075043 |
| Study First Received: | May 6, 2005 |
| Last Updated: | December 11, 2007 |
| Health Authority: | United States: Federal Government |
|
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases |
Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |