Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00110383
Status:
COMPLETED
Last Update Posted:
2014-03-04
First Post:
2005-05-06
Brief Title:
Comparison of School-Based Supervised Versus Parental Supervised Asthma Therapy
Sponsor:
University of Alabama at Birmingham
Organization:
University of Alabama at Birmingham
Study Overview
Official Title:
Effectiveness of School Based Supervised Asthma Therapy
Status:
COMPLETED
Status Verified Date:
2007-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
1 Develop a simple school-based intervention using school-based supervised asthma therapy to increase adherence to asthma medication
2 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
3 Randomly assign 250 children from inner-city school systems to either school-based supervised asthma therapy or parental supervised asthma therapy
4 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
2 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
3 Randomly assign 250 children from inner-city school systems to either school-based supervised asthma therapy or parental supervised asthma therapy
4 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL075043 | NIH | None | httpsreporternihgovquickSearchR01HL075043 |