Supervised Asthma Medication in Schools (SAMS)
SAMS
The Cost Effectiveness of School-Based Supervised Asthma Therapy
2 other identifiers
interventional
442
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Aug 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 22, 2013
CompletedFirst Posted
Study publicly available on registry
November 28, 2013
CompletedStudy Start
First participant enrolled
August 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedResults Posted
Study results publicly available
March 23, 2022
CompletedMarch 23, 2022
February 1, 2022
1.8 years
November 22, 2013
November 1, 2017
February 25, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Regular Therapy
NO INTERVENTIONRegular Asthma Therapy
Supervised Therapy
EXPERIMENTALSupervised asthma therapy in schools
Interventions
Therapy observed daily in school. Asthma education by American Lung Association
Eligibility Criteria
You may qualify if:
- A child with asthma attending a Tucson Unified School District elementary school selected for the study.
You may not qualify if:
- No asthma.
- Not attending a Tucson Unified School District elementary school selected for the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The University of Arizona and the Tucson Unified School District
Tucson, Arizona, 85724, United States
Related Publications (1)
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.
PMID: 30118728DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clara Ehrman
- Organization
- University of Arizona
Study Officials
- PRINCIPAL INVESTIGATOR
Lynn B Gerald, Ph.D., MSPH
University of Arizona, Mel and Enid Zuckerman College of Public Health
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 22, 2013
First Posted
November 28, 2013
Study Start
August 1, 2014
Primary Completion
June 1, 2016
Study Completion
June 1, 2016
Last Updated
March 23, 2022
Results First Posted
March 23, 2022
Record last verified: 2022-02