AsthmaNCT00005734
Intervention to Improve Asthma Management/Prevention
An observational study of Asthma and Lung Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial 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. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Asthma, Lung Diseases
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Sep 1995to Sep 2002
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
No eligibility criteria
About this study
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.
Read the 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.
- Conditions
- Asthma, Lung Diseases
- Medical subject headings
- Asthma, Lung Diseases
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2000 (estimated)
- Study startSep 1995
- Study completionSep 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- William Bailey, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005734
- Sponsor's protocol ID
- 4943
- Status last verified
- Mar 2005
- First submitted
- 25 May 2000
- Last updated
- 24 Jun 2005
- Results posted
- No
Publications
Feinstein RA, Hains CS, Hemstreet MP, Turner-Henson A, Redden DT, Martin B, Erwin S, Bailey WC. A simple "step-test" protocol for identifying suspected unrecognized exercise-induced asthma (EIA) in children. Allergy Asthma Proc. 1999 May-Jun;20(3):181-8. doi: 10.2500/108854199778553019.
PubMed 10389551Gerald LB, Redden D, Turner-Henson A, Feinstein R, Hemstreet MP, Hains C, Brooks CM, Erwin S, Bailey WC. A multi-stage asthma screening procedure for elementary school children. J Asthma. 2002 Feb;39(1):29-36. doi: 10.1081/jas-120000804.
PubMed 11883737
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention to Improve Asthma Management/Prevention
- ClinicalTrials.gov ID
- NCT00005734
- Acronym / sponsor ID
- 4943
- Conditions
- Asthma, Lung Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Sep 1995
- Study completion
- Sep 2002
- First posted
- 26 May 2000 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
- Background: PubMed 10389551Feinstein RA, Hains CS, Hemstreet MP, Turner-Henson A, Redden DT, Martin B, Erwin S, Bailey WC. A simple "step-test" protocol for identifying suspected unrecognized exercise-induced asthma (EIA) in children. Allergy Asthma Proc. 1999 May-Jun;20(3):181-8. doi: 10.2500/108854199778553019.
- Background: PubMed 11883737Gerald LB, Redden D, Turner-Henson A, Feinstein R, Hemstreet MP, Hains C, Brooks CM, Erwin S, Bailey WC. A multi-stage asthma screening procedure for elementary school children. J Asthma. 2002 Feb;39(1):29-36. doi: 10.1081/jas-120000804.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William Bailey
University of Alabama at Birmingham
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma and Lung Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00005734, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2005.