Aligning With Schools To Help Manage Asthma (Project ASTHMA)
- Conditions
- Asthma
- Interventions
- Other: Asthma Assessment & ManagementOther: Asthma EducationOther: Controller medication at school
- Registration Number
- NCT03032744
- Lead Sponsor
- State University of New York at Buffalo
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 29
- 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
- Underlying heart or lung disease other than asthma
- Student has well controlled asthma
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Asthma Assessment & Management 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. Usual Care Asthma Assessment & Management 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. Usual Care Asthma Education 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. Intervention Asthma Education 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. Intervention Controller medication at school 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.
- Primary Outcome Measures
Name Time Method Change in Asthma Symptoms 7 months decrease in asthma symptoms as defined by NAEPP-EPR3 guidelines, including ACT score
- Secondary Outcome Measures
Name Time Method Change in ED/urgent care visits 2 years Decrease in ED/urgent care visits
Change in Missed days of school 2 years decrease in missed days of school
Change in ACT Score 7 months 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.
Change in Hospitalizations 2 years Decrease in hospitalizations
Change in Oral/parenteral steroid use 2 years Decrease in oral/parenteral steroid use
Change in Lung function 7 months improvement in spirometry
Trial Locations
- Locations (1)
John R. Oishei Children's Hospital
🇺🇸Buffalo, New York, United States