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Recruiting NCT06539312

Project ASTHMA - Aligning With Schools To Help Manage Asthma and Improve Outcomes

No phase Interventional Asthma in Children Directly Observed Therapy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: APP assessment and management of asthma.
Who it may be relevant to
Registry conditions: Asthma in Children, Directly Observed Therapy. Basic parameters: 4 years — 13 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Project ASTHMA - Aligning With Schools To Help Manage Asthma and Decrease Health Inequities

Overview

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.

Interventions

  • Other APP assessment and management of asthma
    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.

Primary outcome measures

  • Asthma exacerbations [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 outcome measures (10)
  • Daytime asthma symptoms [Time frame: to be assessed at baseline and 1-, 3-, 5- and 7-months after enrollment for 1 school year]
  • Nighttime asthma symptoms [Time frame: to be assessed at baseline and 1-, 3-, 5- and 7-months after enrollment for 1 school year]
  • Spirometry - FEV1 [Time frame: to be assessed at baseline and 1-, 3-, 5- and 7-months after enrollment for 1 school year]
  • Spirometry - FEV1/FVC ratio [Time frame: to be assessed at baseline and 1-, 3-, 5- and 7-months after enrollment for 1 school year]
  • ED visits [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.]
  • Urgent care visits [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.]
  • Hospitalizations [Time frame: from 1 month after enrollment to the end of the school year; to be assessed after the end of the school year.]
  • Quality of Life - caregiver [Time frame: to be assessed at baseline and at 7-month follow-up for 1 school year]
  • Activity Limitation [Time frame: to be assessed at baseline and 1-, 3-, 5- and 7-months after enrollment for 1 school year]
  • school absenteeism [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.]

Eligibility criteria

Inclusion criteria

  • uncontrolled asthma

Exclusion criteria

  • other chronic lung disease such as cystic fibrosis

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Open label
Primary purpose
Health services research

Study locations

United States · 1 center
  • University at Buffalo, Department of Pediatrics — Buffalo

Identifiers

NCT: NCT06539312 · STUDY00007712 · R01MD018384

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗