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
SexALL
Conditions studied
Asthma in Children
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: 2026-09-27.