Status:
NOT_YET_RECRUITING
Promoting Asthma Management Guidelines With Technology-Based Intervention and Care Coordination in Clinics and Schools
Lead Sponsor:
Montefiore Medical Center
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Asthma in Children
Eligibility:
All Genders
4-12 years
Phase:
NA
Brief 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 pra...
Detailed Description
The research team will conduct a cluster randomized controlled trial, enrolling 420 children, ages 4-12, from 18 Montefiore clinics during office visits. Children in the intervention group (PRAGMATIC-...
Eligibility Criteria
Inclusion
- Physician-diagnosed asthma documented in EHR
- Persistent or uncontrolled asthma, defined by age-specific guidelines (symptoms ≥2 days/week, rescue medication use ≥2 days/week, nighttime symptoms ≥2 days/month, or ≥2 steroid-requiring episodes/year)
- Age 4 to 12 years, attending pre-kindergarten through 6th grade in NYC public schools
- Caregiver able to speak English or Spanish
- Consent from primary caregiver and assent from child (if ≥7 years)
- Presence of phone and device (smartphone, iPad, or computer) to complete electronic forms
Exclusion
- Family plans to leave school/city within 6 months
- Significant comorbidities (e.g., congenital heart disease, cystic fibrosis, chronic lung disease)
- Children in foster care or situations where legal guardian consent cannot be obtained
- Participation in concurrent asthma intervention study
- Severe developmental delay precluding completion of ACT questionnaire
Key Trial Info
Start Date :
January 2 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2032
Estimated Enrollment :
420 Patients enrolled
Trial Details
Trial ID
NCT07224061
Start Date
January 2 2026
End Date
June 30 2032
Last Update
November 3 2025
Active Locations (1)
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1
Children's Hospital at Montefiore, Albert Einstein College of Medicine
The Bronx, New York, United States, 10467