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Supervised Asthma Medication in Schools (SAMS)

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University of Arizona

Status and phase

Completed
Phase 4

Conditions

Childhood Asthma

Treatments

Drug: Supervised asthma therapy in schools

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT01997463
1200000709
1R18HL110858 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

442 patients

Sex

All

Ages

5 to 12 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

442 participants in 2 patient groups

Regular Therapy
No Intervention group
Description:
Regular Asthma Therapy
Supervised Therapy
Experimental group
Description:
Supervised asthma therapy in schools
Treatment:
Drug: Supervised asthma therapy in schools

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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