Supervised Asthma Medication in Schools (SAMS)

Phase 4

Completed

• Conditions: Childhood Asthma
• Interventions: Drug: Supervised asthma therapy in schools

• Registration Number: NCT01997463
• Lead Sponsor: University of Arizona

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2013-11-22
• Study First Submitted QC: 2013-11-27
• Study First Posted: 2013-11-28
• Study Start: 2014-08
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Results First Submitted: 2017-11-01
• Status Verified: 2022-02
• Results First Submitted QC: 2022-02-25
• Last Update Submitted: 2022-02-25
• Results First Posted: 2022-03-23
• Last Update Posted: 2022-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 442

Inclusion Criteria

• A child with asthma attending a Tucson Unified School District elementary school selected for the study.

Exclusion Criteria

• No asthma.
• Not attending a Tucson Unified School District elementary school selected for the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Supervised Therapy	Supervised asthma therapy in schools	Supervised asthma therapy in schools

Primary Outcome Measures

Name	Time	Method
The Primary Outcome Will be the Score on the Juniper Asthma Control Questionnaire (ACQ)	1 year	An ACQ score of \> 1.5 means asthma is not well controlled. An ACQ score of \<= 1.5 means asthma is well controlled.; Missing ACQ score = number of participants not administered an ACQ

Trial Locations

Locations (1)

The University of Arizona and the Tucson Unified School District; 🇺🇸 Tucson, Arizona, United States