New treatment option for Asthma in Children
Official title Promoting Asthma Management Guidelines With Technology-Based Intervention and Care Coordination in Clinics and Schools
ClinicalTrials.gov ID: NCT07224061
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 4 to 12
You may be able to join if
- 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...
- Age 4 to 12 years, inclusive, attending pre-kindergarten through 7th grade in public / charter / private schools in New York City (the Bronx...
- Caregiver is able to speak and understand either English or Spanish. Participants unable to read will be eligible as all surveys will be administered...
- Consent from primary caregiver and assent from child (age ≥7 years). If there are eligible siblings with exact same asthma severity/control screening...
You likely can't join if
- 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
See the full eligibility 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...
- 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...
- 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...
- Presence of a phone to conduct surveys and smartphone, iPad or computer to electronically complete and e-sign MAF
- 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
The study team makes the final eligibility decision.
Where it's taking place
- The Bronx, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 4 years to 12 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include The Bronx, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.