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Completed

NCT Number: NCT01997463

Supervised Asthma Medication in Schools (SAMS)

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.

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Key information

Conditions

Childhood Asthma

Age range

5 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The University of Arizona and the Tucson Unified School District

Tucson, Arizona, 85724, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Supervised asthma therapy in schools

Drug

Therapy observed daily in school. Asthma education by American Lung Association

Other names: Inhaled Corticosteroid, Ventolin

Primary outcomes

  1. The Primary Outcome Will be the Score on the Juniper Asthma Control Questionnaire (ACQ)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Arizona

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

The Cost Effectiveness of School-Based Supervised Asthma Therapy

Acronym: SAMS

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Nov 28, 2013
Registry last updated
Mar 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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