Project ASTHMA - Aligning With Schools To Help Manage Asthma and Improve Outcomes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-13
SponsorState University of New York at Buffalo
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
uncontrolled asthma
Disqualifiers
other chronic lung disease such as cystic fibrosis
Trial design
Design model
Crossover
Treatments tested in this trial
APP assessment and management of asthma
Other interventionAPPs 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.
Treatment groups
400 Participants
are divided into 2 treatment groupsGroup A: SBHC groupExperimental treatment 1 intervention
Group B: PCP groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Asthma exacerbations
Number of asthma exacerbations requiring systemic steroids based on medical records
Time frame
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.Secondary outcomes
1
Daytime asthma symptoms
Frequency of daytime asthma symptoms based on questionnaire minimum value: 0 days maximum value: 28 days Higher scores mean a worse outcome.
Time frame
to be assessed at baseline and 1-, 3-, 5- and 7-months after enrollment for 1 school year2
Nighttime asthma symptoms
Frequency of nighttime asthma symptoms based on questionnaire minimum value: 0 nights maximum value: 28 nights Higher scores mean a worse outcome.
Time frame
to be assessed at baseline and 1-, 3-, 5- and 7-months after enrollment for 1 school year3
Spirometry - FEV1
Forced Expiratory Volume in 1 second
Time frame
to be assessed at baseline and 1-, 3-, 5- and 7-months after enrollment for 1 school year4
Spirometry - FEV1/FVC ratio
FEV1/Forced Vital Capacity ratio
Time frame
to be assessed at baseline and 1-, 3-, 5- and 7-months after enrollment for 1 school yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
State University of New York at Buffalo
Lead sponsor
National Institute on Minority Health and Health Disparities (NIMHD)
Collaborator
Source ClinicalTrials.gov