Overview

This trial has been completed.

Condition childhood asthma
Treatment supervised asthma therapy in schools
Phase phase 4
Sponsor University of Arizona
Collaborator National Heart, Lung, and Blood Institute (NHLBI)
Start date August 2014
End date June 2016
Trial size 442 participants
Trial identifier NCT01997463, 1200000709, 1R18HL110858

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(No Intervention)
Regular Asthma Therapy
(Experimental)
Supervised asthma therapy in schools
supervised asthma therapy in schools Inhaled Corticosteroid
Therapy observed daily in school. Asthma education by American Lung Association

Primary Outcomes

Measure
The primary outcome will be the score on the Juniper Asthma Control Questionnaire (ACQ)
time frame: 1 year

Eligibility Criteria

Male or female participants from 5 years up to 12 years old.

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.

Additional Information

Official title The Cost Effectiveness of School-Based Supervised Asthma Therapy
Principal investigator Lynn B Gerald, Ph.D., MSPH
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by University of Arizona.