NCT07224061 Promoting Asthma Management Guidelines With Technology-Based Intervention and Care Coordination in Clinics and Schools
| NCT ID | NCT07224061 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Montefiore Medical Center |
| Condition | Asthma in Children |
| Study Type | INTERVENTIONAL |
| Enrollment | 420 participants |
| Start Date | 2026-02-12 |
| Primary Completion | 2031-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 420 participants in total. It began in 2026-02-12 with a primary completion date of 2031-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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 Criteria
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
Contact & Investigator
Marina Reznik, MD, MS
PRINCIPAL INVESTIGATOR
Montefiore Medical Center
Frequently Asked Questions
Who can join the NCT07224061 clinical trial?
This trial is open to participants of all sexes, aged 4 Years or older, up to 12 Years, studying Asthma in Children. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07224061 currently recruiting?
Yes, NCT07224061 is actively recruiting participants. Contact the research team at mreznik@montefiore.org for enrollment information.
Where is the NCT07224061 trial being conducted?
This trial is being conducted at The Bronx, United States.
Who is sponsoring the NCT07224061 clinical trial?
NCT07224061 is sponsored by Montefiore Medical Center. The principal investigator is Marina Reznik, MD, MS at Montefiore Medical Center. The trial plans to enroll 420 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.