Promoting Asthma Management Guidelines With Technology-Based Intervention and Care Coordination in Clinics and Schools

Not Applicable

Not yet recruiting

• Conditions: Asthma in Children

• Registration Number: NCT07224061
• Lead Sponsor: Montefiore Medical Center

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.

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-S) will receive updated guideline-based care prompts, with providers completing the medication administration form (MAF), electronically signing it, and routing it directly to the school via the EHR system. Asthma Outreach Worker (AOW) care coordination will support daily adherence to prescribed treatments at home and school. Children in the control group will receive enhanced usual care, which includes EHR prompts for guideline-based care but without the additional PRAGMATIC-S components.

Participants will be followed for 12 months. Outcomes will be assessed as outlined in this registration.

Study Timeline

• Status Verified: 2025-10
• Study First Submitted: 2025-10-30
• Study First Submitted QC: 2025-10-30
• Last Update Submitted: 2025-10-30
• Study First Posted: 2025-11-03
• Last Update Posted: 2025-11-03
• Study Start: 2026-01-02
• Primary Completion: 2031-06-30
• Study Completion: 2032-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 420

Inclusion Criteria

• 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 Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Asthma Control - continuous	Baseline, 4 months, 8 months, and 12 months	Asthma control will be measured using the Childhood Asthma Control Test (cACT), 7-item scale which determines a score based on the sum of the response codes. The child answers the first 4 questions on a 4-point scale ranging from 0-3 and the caregiver provides responses for the final 3 items using a reverse-coded scale ranging from 0-5, yielding an overall possible scoring range of 0-27, with higher scores indicating better asthma control.; Asthma control will be analyzed as a continuous variable.

Secondary Outcome Measures

Name	Time	Method
Pediatric Asthma Caregiver's Quality of Life	Baseline, 4 months, 8 months, and 12 months	The caregiver's quality of life will be assessed using the validated Pediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ; also referred to as Juniper's Asthma Quality of Life Questionnaire). This questionnaire consists of 13 items which evaluate the impact of the child's asthma on the caregiver's quality of life. Responses to each item are rated on a 7-point scale ranging from 1-7, wherein 1 means "all of the time" or "very, very worried/concerned," and 7 means "none of the time" or "not worried/concerned," yielding an overall possible scoring range of 7-91, such that higher scores are indicative of less asthma related quality of life impairment.
Percent of participants with 1 or more guideline-based corrective actions taken	Up to 24 months (following intervention)	Percent of participants with 1 or more guideline-based corrective actions taken (i.e., controller medication prescription or adjustment, trigger evaluation), as recorded in the electronic health record (EHR), will be summarized by study arm.
Asthma Control - dichotomous	Baseline, 4 months, 8 months, and 12 months	Asthma control will also be measured as a dichotomous variable using the Childhood Asthma Control Test (cACT), 7-item scale which determines a score based on the sum of the response codes. The child answers the first 4 questions on a 4-point scale ranging from 0-3 and the caregiver provides responses for the final 3 items using a reverse-coded scale ranging from 0-5, yielding an overall possible scoring range of 0-27, with higher scores indicating better asthma control.; Asthma control will be analyzed as dichotomous variable with a score of 19 or less indicating uncontrolled asthma.

Trial Locations

Locations (1)

Children's Hospital at Montefiore, Albert Einstein College of Medicine; 🇺🇸 The Bronx, New York, United States