AsthmaNCT00110383
Comparison of School-Based Supervised Versus Parental Supervised Asthma Therapy
A study testing School-Based Supervised Asthma Therapy in people with Asthma, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Asthma
- What is being tested?
- School-Based Supervised Asthma Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 295 participants
- Where
- 1 siteUnited States
- Study dates
- May 2004to May 2007
- Phase
- Interventional
- 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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Persistent asthma requiring daily controller medication
- Enrolled at a participating elementary school
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama Birmingham Lung Health Center
Birmingham, Alabama, 35233-7337
About this study
Official title: Effectiveness of School Based Supervised Asthma Therapy
- Develop a simple school-based intervention using school-based supervised asthma therapy to increase adherence to asthma medication.
- 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.
- Randomly assign 250 children from inner-city school systems to either school-based supervised asthma therapy or parental supervised asthma therapy.
- 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.
Read the 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.
- Conditions
- Asthma
- Being tested
- School-Based Supervised Asthma Therapy
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
School-Based Supervised Asthma TherapyBehavioural
Child's inhaled steroid use supervised daily at school
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Supervised therapy Receives: Behavioral: School-Based Supervised Asthma Therapy |
| 2 | No intervention | Inhaled steroid use as usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Asthma exacerbations
Measured: Measured at 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2005 (estimated)
- Study startMay 2004
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 295 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Investigators
- Lynn B. Gerald, PhD, MSPH, Study chair, University of Alabama Birmingham Lung Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00110383
- Sponsor's protocol ID
- 174
- Other IDs
- R01HL075043
- Status last verified
- Dec 2007
- First submitted
- 6 May 2005
- Last updated
- 4 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Gerald LB, Gerald JK, Gibson L, Patel K, Zhang S, McClure LA. Changes in environmental tobacco smoke exposure and asthma morbidity among urban school children. Chest. 2009 Apr;135(4):911-916. doi: 10.1378/chest.08-1869. Epub 2008 Nov 18.
PubMed 19017893
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of School Based Supervised Asthma Therapy
- ClinicalTrials.gov ID
- NCT00110383
- Acronym / sponsor ID
- 174
- Conditions
- Asthma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 295 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- May 2004
- Study completion
- May 2007 (actual)
- First posted
- 9 May 2005 (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.
- Develop a simple school-based intervention using school-based supervised asthma therapy to increase adherence to asthma medication.
- 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.
- Randomly assign 250 children from inner-city school systems to either school-based supervised asthma therapy or parental supervised asthma therapy.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: School-Based Supervised Asthma TherapySupervised therapy |
| 2 | No intervention | –Inhaled steroid use as usual care |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Persistent asthma requiring daily controller medication
- Enrolled at a participating elementary school
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| School-Based Supervised Asthma TherapyChild's inhaled steroid use supervised daily at school | Behavioural | 1 |
Primary outcome
Asthma exacerbations
Time frame: Measured at 15 months
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 4 Mar 2014.
- Derived from this study: PubMed 19017893Gerald LB, Gerald JK, Gibson L, Patel K, Zhang S, McClure LA. Changes in environmental tobacco smoke exposure and asthma morbidity among urban school children. Chest. 2009 Apr;135(4):911-916. doi: 10.1378/chest.08-1869. Epub 2008 Nov 18.
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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.
Lynn B. Gerald, PhD, MSPH study chair
University of Alabama Birmingham Lung Health Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing School-Based Supervised Asthma Therapy in people with Asthma, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does the primary outcome measure?
Asthma exacerbations (time frame: Measured at 15 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00110383, which also lists 1 linked publication.
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 4 Mar 2014.