Supervised Asthma Medication in Schools (SAMS)

NCT ID: NCT01997463

Last Updated: 2022-03-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 442 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-31
• Study Completion Date: 2016-06-30

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.

Conditions

Childhood Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Regular Therapy

Regular Asthma Therapy

Group Type: NO_INTERVENTION

No interventions assigned to this group

Supervised Therapy

Supervised asthma therapy in schools

Group Type: EXPERIMENTAL

Supervised asthma therapy in schools

Intervention Type: DRUG

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

Interventions

Supervised asthma therapy in schools

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

Intervention Type: DRUG

Other Intervention Names

Inhaled Corticosteroid; Ventolin

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.

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

University of Arizona

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lynn B Gerald, Ph.D., MSPH

Role: PRINCIPAL_INVESTIGATOR

University of Arizona, Mel and Enid Zuckerman College of Public Health

Locations

The University of Arizona and the Tucson Unified School District

Tucson, Arizona, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 30118728 (View on PubMed)

Other Identifiers

1R18HL110858

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1200000709

Identifier Type: -

Identifier Source: org_study_id