Back to resultsSupervised Asthma Medication in Schools (SAMS) (SAMS)
Primary Purpose
Childhood Asthma
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Supervised asthma therapy in schools
Sponsored by
About this trial
This is an interventional treatment trial for Childhood Asthma
Eligibility Criteria
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.
Sites / Locations
- The University of Arizona and the Tucson Unified School District
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Regular Therapy
Supervised Therapy
Arm Description
Regular Asthma Therapy
Supervised asthma therapy in schools
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT01997463
First Posted
November 22, 2013
Last Updated
February 25, 2022
Sponsor
University of Arizona
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT01997463
Brief Title
Supervised Asthma Medication in Schools (SAMS)
Acronym
SAMS
Official Title
The Cost Effectiveness of School-Based Supervised Asthma Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
August 2014 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Arizona
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Asthma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
442 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Regular Therapy
Arm Type
No Intervention
Arm Description
Regular Asthma Therapy
Arm Title
Supervised Therapy
Arm Type
Experimental
Arm Description
Supervised asthma therapy in schools
Intervention Type
Drug
Intervention Name(s)
Supervised asthma therapy in schools
Other Intervention Name(s)
Inhaled Corticosteroid, Ventolin
Intervention Description
Therapy observed daily in school. Asthma education by American Lung Association
Primary Outcome Measure Information:
Title
The Primary Outcome Will be the Score on the Juniper Asthma Control Questionnaire (ACQ)
Description
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
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lynn B Gerald, Ph.D., MSPH
Organizational Affiliation
University of Arizona, Mel and Enid Zuckerman College of Public Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Arizona and the Tucson Unified School District
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
30118728
Citation
Gerald JK, Fisher JM, Brown MA, Clemens CJ, Moore MA, Carvajal SC, Bryson D, Stefan N, Billheimer D, Gerald LB. School-supervised use of a once-daily inhaled corticosteroid regimen: A cluster randomized trial. J Allergy Clin Immunol. 2019 Feb;143(2):755-764. doi: 10.1016/j.jaci.2018.06.048. Epub 2018 Aug 14.
Results Reference
derived
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Supervised Asthma Medication in Schools (SAMS)
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