Recruiting
Promoting Asthma Management Guidelines With Technology-Based Intervention and Care Coordination in Clinics and Schools
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.
ClinicalTrials.gov IDNCT07224061
PhaseNA
Enrollment420
SponsorMontefiore Medical Center
Age4 Years – 12 Years
SexALL
About this study
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.
Interventions
- Behavioral: PRAGMATIC-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.
Primary outcomes
- Asthma Control - continuous (Baseline, 4 months, 8 months, and 12 months)
Eligibility information
Inclusion Criteria:
* 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 Criteria:
* 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
Study locations
- Children's Hospital at Montefiore, Albert Einstein College of Medicine, The Bronx, New York 10467 United States
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-26.