Promoting Asthma Management Guidelines With Technology-Based Intervention and Care Coordination in Clinics and Schools
Recruiting · NCT07224061 · Interventional (participants receive a specific treatment) · Lead sponsor: Montefiore Medical Center
View the official record on ClinicalTrials.gov →Interventions studied
PRAGMATIC-S
What this trial is about
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.
Who can take part
Age range
4 Years to 12 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 is running
1 location listed across 1 US state.
- Children's Hospital at Montefiore, Albert Einstein College of Medicine - The Bronx, New York, United States