NCT06539312|RecruitingDMC
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Sponsor study identifier
Secondary identifiers
NIH
interventional
400
1 country
1
Study Start
September 27, 2024
Actual (reported)Primary Completion
April 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
April 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Children with asthma from communities that experience health inequities frequently do not receive guideline-based asthma care, and as a result, account for a disproportionate percentage of asthma exacerbations, emergency department visits, and hospitalizations. Project ASTHMA (Aligning with Schools To Help Manage Asthma) tests the effectiveness of school-based health centers as a delivery model to improve health outcomes by providing children with guideline-based asthma assessments and preventive medication management, directly observed therapy of their preventive medication to support adherence, and self-management support. If successful, this multicomponent intervention will represent a cost effective and sustainable model to reduce asthma morbidity in historically marginalized communities, and has the potential to impact communities throughout the United States where over 2,500 school-based health centers operate.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 31, 2024
Actual (reported)August 6, 2024
Actual (reported)September 27, 2024
Actual (reported)April 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
April 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Asthma exacerbations
Number of asthma exacerbations requiring systemic steroids based on medical records
from 1 month after enrollment to the end of the school year for 1 school year; to be assessed after the end of the school year.
Daytime asthma symptoms
to be assessed at baseline and 1-, 3-, 5- and 7-months after enrollment for 1 school year
Nighttime asthma symptoms
to be assessed at baseline and 1-, 3-, 5- and 7-months after enrollment for 1 school year
Spirometry - FEV1
to be assessed at baseline and 1-, 3-, 5- and 7-months after enrollment for 1 school year
Spirometry - FEV1/FVC ratio
to be assessed at baseline and 1-, 3-, 5- and 7-months after enrollment for 1 school year
ED visits
from 1 month after enrollment to the end of the school year for 1 school year; to be assessed after the end of the school year.
APPs will be trained to follow NIH guidelines for assessment and management of asthma, and to apply their knowledge to the care of the students. Students will also receive DOT of the morning dose of their controller medication.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
University at Buffalo, Department of Pediatrics
Buffalo, New York, 14203, United States
First Submitted
July 31, 2024
First Posted
August 6, 2024
Study Start
September 27, 2024
Actual (reported)Primary Completion
April 30, 2028
EstimatedA Culturally Tailored Scalable Asthma Intervention for Hispanic Children (Asthma Guardian)
Telehealth-Enhanced Asthma Care for Home After the Emergency Room
Contact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
April 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
June 25, 2026
Record last verified: 2026-06
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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