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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
4 Years to 12 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 12 months

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Participants will be followed for 12 months."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests PRAGMATIC-S, a program that links clinics and schools to improve asthma care. It is for children ages 4 to 12 with ongoing or poorly controlled asthma who attend schools in New York City or certain lower Hudson Valley areas.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • A doctor has diagnosed the child with asthma, and it is listed in the electronic health record.
  • The child has ongoing asthma without daily control medicine, or asthma that is not controlled with treatment. Signs include symptoms or rescue medicine use more than 2 days a week, nighttime symptoms more than 2 days a month, or more than 2 attacks a year needing steroid treatment. Age-based rules apply.
  • The child is 4 to 12 years old and in pre-K through 7th grade at a public, charter, or private school in New York City, mainly the Bronx, or Eastchester, Westchester, Rockland, or Yonkers.
  • The caregiver can speak and understand English or Spanish. Reading is not required; study staff will read survey questions aloud.
  • The main caregiver gives permission. Children age 7 or older must also agree to join.
  • Only one eligible sibling can join. The child with worse asthma symptoms is chosen. If screening results are exactly the same, one is chosen by chance.
  • The family has a phone for surveys and a smartphone, iPad, or computer to fill out and electronically sign the MAF form.

Who can't join

  • The family plans to leave the school or city within 6 months.
  • The child has a major health condition, such as a heart problem present at birth, cystic fibrosis, or another long-term lung disease.
  • The child is in foster care or another situation where permission cannot be obtained from a legal guardian.
  • The child is taking part in another study testing an asthma care program or treatment.
  • The child has a severe developmental delay, such as severe autism, that prevents completion of the asthma control survey.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (1)

NY