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NCT Number: NCT06539312

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

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.

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Key information

Conditions

Asthma in Children Asthma Behavior Bronchial Diseases Directly Observed Therapy Health Behavior Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Medication Adherence Patient Acceptance of Health Care Patient Compliance Respiratory Hypersensitivity Respiratory Tract Diseases Treatment Adherence and Compliance

Age range

4 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University at Buffalo, Department of Pediatrics

Buffalo, New York, 14203, United States

Location status: Recruiting

Location contact

Lucy Holmes, MD, MPH

CONTACT

[email protected]

716-323-0034

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • uncontrolled asthma

Exclusion criteria

  • other chronic lung disease such as cystic fibrosis

Treatment and study plan

APP assessment and management of asthma

Other

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.

Other names: DOT of morning dose of controller medication

Primary outcomes

  1. 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.

    Number of asthma exacerbations requiring systemic steroids based on medical records

Secondary outcomes

  1. Daytime asthma symptoms

    Time frame: to be assessed at baseline and 1-, 3-, 5- and 7-months after enrollment for 1 school year

    Frequency of daytime asthma symptoms based on questionnaire minimum value: 0 days maximum value: 28 days Higher scores mean a worse outcome.

  2. Nighttime asthma symptoms

    Time frame: to be assessed at baseline and 1-, 3-, 5- and 7-months after enrollment for 1 school year

    Frequency of nighttime asthma symptoms based on questionnaire minimum value: 0 nights maximum value: 28 nights Higher scores mean a worse outcome.

  3. Spirometry - FEV1

    Time frame: to be assessed at baseline and 1-, 3-, 5- and 7-months after enrollment for 1 school year

    Forced Expiratory Volume in 1 second

  4. Spirometry - FEV1/FVC ratio

    Time frame: to be assessed at baseline and 1-, 3-, 5- and 7-months after enrollment for 1 school year

    FEV1/Forced Vital Capacity ratio

  5. 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.

    Number of ED visits for asthma symptoms based on medical records

  6. 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.

    Number of urgent care visits for asthma symptoms based on medical records

  7. 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.

    Number of hospitalizations based on medical records

  8. Quality of Life - caregiver

    Time frame: to be assessed at baseline and at 7-month follow-up for 1 school year

    Children's Health Survey for Asthma, American Academy of Pediatrics Higher scores mean a better outcome.

  9. Activity Limitation

    Time frame: to be assessed at baseline and 1-, 3-, 5- and 7-months after enrollment for 1 school year

    Degree of activity limitation based on questionnaire Higher scores mean a worse outcome.

  10. 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.

    Number of missed school days based on school records

Study contacts

Contact information is provided by the study sponsor or research team.

Deanna Hamilton, MSEd

CONTACT

[email protected]

716-323-0060

Lucy CY Holmes, MD, MPH

CONTACT

[email protected]

716-323-0034

Sponsors and collaborators

Lead sponsor

State University of New York at Buffalo

Other

Collaborators

  • National Institute on Minority Health and Health Disparities (NIMHD)

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Aug 6, 2024
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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