Supervised Asthma Medication in Schools (SAMS)
This trial has been completed.
|Treatment||supervised asthma therapy in schools|
|Sponsor||University of Arizona|
|Collaborator||National Heart, Lung, and Blood Institute (NHLBI)|
|Start date||August 2014|
|End date||June 2016|
|Trial size||442 participants|
|Trial identifier||NCT01997463, 1200000709, 1R18HL110858|
The investigators hypothesize that school-based, direct supervision of daily controller therapy will result in more effective asthma control, as assessed by the Asthma Control Questionnaire than usual care. Additionally, as the result of enhanced asthma control and resulting decrease in health care utilization, school-based, direct supervision of daily controller therapy will result in lower cost per quality-adjusted life year (QALY) gained than usual care.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
Regular Asthma Therapy
Supervised asthma therapy in schools
The primary outcome will be the score on the Juniper Asthma Control Questionnaire (ACQ)
time frame: 1 year
Male or female participants from 5 years up to 12 years old.
- A child with asthma attending a Tucson Unified School District elementary school selected for the study.
- No asthma.
- Not attending a Tucson Unified School District elementary school selected for the study.
|Official title||The Cost Effectiveness of School-Based Supervised Asthma Therapy|
|Principal investigator||Lynn B Gerald, Ph.D., MSPH|
|Description||This research is being done to test if children with asthma will have fewer asthma symptoms if they are monitored at school to make sure they take their inhaled steroid medication (ICS) every day and take the medication the right way. All of the children with asthma in the school will be asked to participate. In the first year in one-half of the schools, children and school staff will participate in a standardized asthma education program presented by the American Lung Association (ALA). Children will have daily monitoring of their inhaled asthma medication. The other half of schools will continue with the usual treatment of children with asthma. In the second year of the study, all schools and children will have the asthma education program and monitoring. Parents will be queried quarterly for information about their child's asthma.|
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