Using technology and school–clinic coordination to improve asthma care for children.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a cluster randomized trial enrolling 420 children ages 4–12 from 18 Montefiore clinics to compare a multi-level intervention (PRAGMATIC-S) to enhanced usual care. The PRAGMATIC-S arm adds EHR-based guideline prompts, a medication administration form that providers sign and route electronically to schools, and Asthma Outreach Worker coordination to support daily adherence at home and school. The control arm receives enhanced usual care with EHR prompts but without the electronic school routing or outreach worker support. Participants are followed for 12 months with clinical and adherence outcomes collected through the medical record and study visits.

Why it matters

Who can join: the full rules

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

Where it's running

• Children's Hospital at Montefiore, Albert Einstein College of Medicine
  The Bronx, New York, United States Recruiting

Study contacts

• Principal investigator: Marina Reznik, MD, MS — Montefiore Medical Center
• Study coordinator: Marina Reznik, MD, MS
• Email: mreznik@montefiore.org
• Phone: 718-741-2494

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• N-WATCH: Can a simple breath device help monitor asthma in kids

  This study tests the N-Tidal C device to see if it helps monitor asthma in children aged 5 to under 16 who have wheeze or asthma and are not critically ill.

  Recruiting at 2 sites University of Nottingham · Nottingham, Nottinghamshire and 1 other locations · NCT07833826

• Smart Inhaler Use at Home for Adolescents with IDD and Asthma

  This study tests whether daily use of active smart inhalers at home helps adolescents with intellectual disabilities manage asthma better.

  Recruiting Children's Hospital Los Angeles · Los Angeles, California · NCT07746921

• ASMact: Managing bronchial asthma attacks in children

  This study tries a GINA 2025-based staff education and care-standardization approach to see if emergency treatment for children aged 6–17 with acute asthma attacks improves outcomes.

  Recruiting at 2 sites Meyer Children's Hospital IRCCS · Ferrara, FE and 1 other locations · NCT07412769

• Biomarkers and Respiratory Omics in Children: Predicting Disease Course

  This study tests whether biomarkers from the lungs and blood can predict how asthma and protracted bacterial bronchitis in children will progress and respond to current therapies.

  Recruiting Medical University of Warsaw · Warsaw · NCT07232550

• Boosting use of SMART inhaler therapy for children with moderate-to-severe asthma

  This project will test whether adding community health workers and nurse care managers to electronic health record decision support and education helps children ages 5–18 with uncontrolled asthma use single maintenance and reliever therapy (SMART).

  Recruiting Children's Hospital of Philadelphia · Philadelphia, Pennsylvania · NCT07138027

• Implementing SMART asthma care in pediatric primary clinics

  This project will test whether electronic medical record decision support plus clinician education helps pediatric clinics adopt SMART single maintenance and reliever inhaler therapy for children ages 5–18 with uncontrolled asthma.

  Recruiting Children's Hospital of Philadelphia · Philadelphia, Pennsylvania · NCT07137923

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.