Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005734
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
2000-05-25
Brief Title:
Intervention to Improve Asthma ManagementPrevention
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2005-03
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:
To implement and evaluate a comprehensive asthma education and prevention program in all 54 public elementary schools in the predominantly minority Birmingham Alabama school system
Detailed Description:
BACKGROUND
The study was part of an initiative Interventions to Improve Asthma Management and Prevention at School The Broad Agency Announcement was released in June 1994
DESIGN NARRATIVE
The study had several objectives The first was to demonstrate that a comprehensive school-based asthma education program could be implemented using existing resources in a largely poor inner city educational environment The second objective was to provide broad information on asthma and its management to elementary school faculties in order to help reduce fear and anxiety due to lack of knowledge about asthma The third was to provide curriculum-based information about asthma to the general student bodies of elementary schools The fourth objective was to institute a cost effective screening program that would identify elementary school students with asthma The fifth was to provide an education program designed to improve knowledge and prevention The sixth was to develop an individual asthma action plan for students with asthma that would improve their management and prevention skills and to coordinate the individual asthma action plan with school personnel and activities in order to improve support for the students in following their management plans
The program was evaluated through a randomized controlled design with the schools as the unit of randomization and the students the unit of analysis The Birmingham public schools were divided into three cohorts of 18 schools each on the basis of geographic location Schools were randomly assigned within cohorts so that nine schools were experimental and nine were control The research protocol was implemented in the first cohort in the fall of 1995 in the second cohort in the fall of 1996 and in the third cohort in the fall of 1997 Students with asthma were followed for three school terms following collection of baseline data and implementation of the education program Outcomes were assessed in terms of school absences and performance health care utilization quality of life and asthma morbidity during school
The study was part of an initiative Interventions to Improve Asthma Management and Prevention at School The Broad Agency Announcement was released in June 1994
DESIGN NARRATIVE
The study had several objectives The first was to demonstrate that a comprehensive school-based asthma education program could be implemented using existing resources in a largely poor inner city educational environment The second objective was to provide broad information on asthma and its management to elementary school faculties in order to help reduce fear and anxiety due to lack of knowledge about asthma The third was to provide curriculum-based information about asthma to the general student bodies of elementary schools The fourth objective was to institute a cost effective screening program that would identify elementary school students with asthma The fifth was to provide an education program designed to improve knowledge and prevention The sixth was to develop an individual asthma action plan for students with asthma that would improve their management and prevention skills and to coordinate the individual asthma action plan with school personnel and activities in order to improve support for the students in following their management plans
The program was evaluated through a randomized controlled design with the schools as the unit of randomization and the students the unit of analysis The Birmingham public schools were divided into three cohorts of 18 schools each on the basis of geographic location Schools were randomly assigned within cohorts so that nine schools were experimental and nine were control The research protocol was implemented in the first cohort in the fall of 1995 in the second cohort in the fall of 1996 and in the third cohort in the fall of 1997 Students with asthma were followed for three school terms following collection of baseline data and implementation of the education program Outcomes were assessed in terms of school absences and performance health care utilization quality of life and asthma morbidity during school
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: