Aligning With Schools To Help Manage Asthma (Project ASTHMA)

Study Overview
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Brief Summary
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Project ASTHMA is a school-based health center intervention program that institutes guideline-based chronic asthma care and provides supervised administration with daily preventive asthma medications to improve asthma symptoms and lung function, reduce emergency visits, and decrease missed days of school among children from communities with health disparities.

Detailed Description
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Project ASTHMA in schools is a 7 month randomized control intervention pilot trial. Forty students, ages 4 to 14 years, with persistent asthma, or who utilize acute care facilities frequently for their asthma, will be recruited from 3 urban SBHCs in the fall of 2018. All students will receive NHLBI guideline-based asthma assessments to determine eligibility and proper dosing of preventive medication. The asthma assessment will include spirometry testing. All enrolled students and parents will receive asthma education at the time of enrollment. Eligible students will be randomized to an intervention or usual care group using permuted block randomization stratified by SBHCs. In collaboration with the student's PCP, the SBHCs' mid-level providers will prescribe the preventive medication to the students in the intervention group. These students will receive the morning dose of their preventive medication from the school nurse each school day for the remainder of the school year. Students and their parents will be responsible to administer the evening and non-school day doses. Students randomized to the usual care group will be referred back to their PCP for further asthma management. All participants will be re-evaluated at 1, 3 and 7 months after enrollment, and medication dose adjustments will be made in the intervention group as needed.

Official Title
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Aligning With Schools To Help Manage Asthma

Conditions
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Asthma

Intervention / Treatment
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* Other: Asthma Assessment & Management
* Other: Asthma Education
* Other: Controller medication at school


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Active asthma Diagnosed with asthma for at least 12 months Enrolled in the school-based health center Persistent asthma as defined by NAEPP-EPR3 guidelines OR at least 1 hospitalizations OR at least 2 ED/urgent care visits OR at least 2 courses of oral steroids for asthma in the previous 12 months for asthma Exclusion Criteria: Underlying heart or lung disease other than asthma Student has well controlled asthma

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Intervention group will receive the morning dose of their daily preventive asthma medication at school. The student & family will be responsible to administer the evening dose & both doses on non-school days.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>All participants will undergo an initial asthma assessment per the NAEPP-EPR3 (National Asthma Education and Prevention Program - Expert Panel Report 3) guidelines, as well as asthma education. Participants randomized to the intervention group will be prescribed the appropriate asthma therapy based on their assessment (i.e. providing 'asthma assessment & management'), and receive the morning dose of their daily asthma controller medication at school on school days. | Other: Asthma Assessment & Management<br>* Asthma Assessment & Management based on NAEPP-EPR3 guidelines<br>Other: Asthma Education<br>* Asthma education on medications<br>Other: Controller medication at school<br>* Students will receive the morning dose of their daily preventive asthma medication at school on school days.<br>|
| Active Comparator: Usual Care<br>All participants will undergo an initial asthma assessment per the NAEPP-EPR3 (National Asthma Education and Prevention Program - Expert Panel Report 3) guidelines, as well as asthma education. Participants randomized to the usual care group will be provided with the results of their asthma assessment and be instructed to follow up with their primary care provider. They will continue to receive all of their daily asthma controller medication at home. | Other: Asthma Assessment & Management<br>* Asthma Assessment & Management based on NAEPP-EPR3 guidelines<br>Other: Asthma Education<br>* Asthma education on medications<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Asthma Symptoms | decrease in asthma symptoms as defined by NAEPP-EPR3 guidelines, including ACT score | 7 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in ACT Score | Improvement in ACT score, a validated questionnaire for the assessment of asthma symptoms, which is included in the NAEPP-EPR3 guidelines for components of control. | 7 months | 
| Change in Lung function | improvement in spirometry | 7 months | 
| Change in ED/urgent care visits | Decrease in ED/urgent care visits | 2 years | 
| Change in Hospitalizations | Decrease in hospitalizations | 2 years | 
| Change in Oral/parenteral steroid use | Decrease in oral/parenteral steroid use | 2 years | 
| Change in Missed days of school | decrease in missed days of school | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pediatric, School Based Health Center