RecruitingNot ApplicableNCT07224061

Promoting Asthma Management Guidelines With Technology-Based Intervention and Care Coordination in Clinics and Schools

Promoting Asthma Guidelines and Management Through Technology-Based Intervention and Care Coordination in Clinics and Schools (PRAGMATIC-S)

Sponsor

Montefiore Medical Center

Enrollment

420 participants

Start Date

Feb 12, 2026

Study Type

INTERVENTIONAL

Conditions

Asthma in Children

Summary

The overall goal of this research study is to evaluate a multi-level program called PRAGMATIC-S to improve the delivery of guideline-based asthma care through a unique partnership between clinical practices and schools. PRAGMATIC-S represents a novel approach that addresses multiple barriers to adherence by bridging primary care and schools, ensuring delivery of guideline-based asthma care to urban children across these settings thereby improving adherence to therapy and clinical outcomes.

Eligibility

Min Age: 4 YearsMax Age: 12 Years

Inclusion Criteria6

Physician-diagnosed asthma documented in EHR
Persistent asthma, not on controller medications or uncontrolled asthma despite therapy (with any one of the following per age-specific guidelines: in past month, >2 days/week with symptoms, >2 days/week using rescue medication, >2 days/month with nighttime symptoms, or >2 episodes/year that required systemic corticosteroids
Age 4 to 12 years, inclusive, attending pre-kindergarten through 7th grade in public / charter / private schools in New York City (the Bronx primarily) and also schools in lower Hudson Valley (Eastchester, Westchester, Rockland, Yonkers)
Caregiver is able to speak and understand either English or Spanish. Participants unable to read will be eligible as all surveys will be administered verbally by research personnel
Consent from primary caregiver and assent from child (age ≥7 years). If there are eligible siblings with exact same asthma severity/control screening results, one child will be randomly selected to participate, otherwise the sibling with worse asthma symptoms will be selected.
Presence of a phone to conduct surveys and smartphone, iPad or computer to electronically complete and e-sign MAF

Exclusion Criteria5

Family plans to leave school or city within 6 months
Significant medical conditions (e.g., congenital heart disease, cystic fibrosis, or other chronic lung disease)
Children in foster care or other situations in which consent cannot be obtained from a legal guardian
Participation in concurrent asthma intervention study
Severe developmental delay (e.g., severe autism) precluding completion of asthma control questionnaire

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Interventions

BEHAVIORALPRAGMATIC-S

Intervention combines EHR-based guideline prompts, electronic MAF submission, school-based directly observed therapy (DOT), and Asthma Outreach Workers (AOWs) providing care coordination, adherence support, and communication between families, schools, and providers.