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| Tracking Information | |||||
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| First Received Date ICMJE | May 25, 2000 | ||||
| Last Updated Date | June 23, 2005 | ||||
| Start Date ICMJE | September 1995 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00005734 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Intervention to Improve Asthma Management/Prevention | ||||
| Official Title ICMJE | |||||
| 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. |
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| 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. |
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| Study Phase | |||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Natural History | ||||
| Condition ICMJE |
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| Intervention ICMJE | |||||
| Study Arms / Comparison Groups | |||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | |||||
| Completion Date | September 2002 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | No eligibility criteria |
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| Gender | Male | ||||
| Ages | |||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | |||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00005734 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | 4943 | ||||
| Study Sponsor ICMJE | National Heart, Lung, and Blood Institute (NHLBI) | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | National Heart, Lung, and Blood Institute (NHLBI) | ||||
| Verification Date | March 2005 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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