Supervised Asthma Medication in Schools (SAMS)

Childhood Asthma Clinical Trial

— SAMS  

Official title:

The Cost Effectiveness of School-Based Supervised Asthma Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01997463
• Other study ID #: 1200000709
• Secondary ID: 1R18HL110858
• Status: Completed
• Phase: Phase 4
• Start date: August 2014
• Est. completion date: June 2016

Study information

• Verified date: February 2022
• Source: University of Arizona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 442
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthma
• Childhood Asthma

Intervention

Drug:
• Supervised asthma therapy in schools
Therapy observed daily in school. Asthma education by American Lung Association

Locations

Country	Name	City	State
United States	The University of Arizona and the Tucson Unified School District	Tucson	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
University of Arizona	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Primary Outcome Will be the Score on the Juniper Asthma Control Questionnaire (ACQ)	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	1 year