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NCT Number: NCT07224061

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

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.

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Key information

Conditions

Age range

4 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital at Montefiore, Albert Einstein College of Medicine

The Bronx, New York, 10467, United States

Location status: Recruiting

Location contact

Marina Reznik, MD, MS

CONTACT

[email protected]

718-741-2494

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PRAGMATIC-S

Behavioral

Intervention combines EHR-based guideline prompts, electronic MAF submission, school-based directly observed therapy (DOT), and Asthma Outreach Workers (AOWs) providing care coordination, adherence support, and communication between families, schools, and providers.

Primary outcomes

  1. Asthma Control - continuous

    Time frame: 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 ("Everyday") to 5 ("Not at all"), 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 outcomes

  1. Pediatric Asthma Caregiver's Quality of Life

    Time frame: 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.

  2. Percent of participants with 1 or more guideline-based corrective actions taken

    Time frame: 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.

  3. Asthma Control - dichotomous

    Time frame: 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.

Other outcomes

  1. Health care utilization - number of Emergency Department (ED) visits for asthma

    Time frame: every 4 months up to 12 months

    The number of ED visits directly related to asthma will be summarized by study arm every four months up to 12 months in total.

  2. Health care utilization - number of hospitalizations for asthma

    Time frame: every 4 months up to 12 months

    The number of hospitalizations directly related to asthma will be summarized by study arm every four months up to 12 months in total.

Study contacts

Contact information is provided by the study sponsor or research team.

Marina Reznik, MD, MS

CONTACT

[email protected]

718-741-2494

Sponsors and collaborators

Lead sponsor

Montefiore Medical Center

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

Promoting Asthma Guidelines and Management Through Technology-Based Intervention and Care Coordination in Clinics and Schools (PRAGMATIC-S)

Acronym: PRAGMATIC-S

Important dates

Study start
2026
Primary completion
2031
Study completion
2033
First posted
Nov 3, 2025
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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