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Technology-Based Asthma Care Intervention for Childhood Asthma (PRAGMATIC Trial)

N/A
Waitlist Available
Led By Marina Reznik, MD, MS
Research Sponsored by Montefiore Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Physician-diagnosed asthma (based on EHR)
Age 2 and 12 years, inclusive
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to improve asthma care for urban children aged 2-12 with severe or poorly controlled asthma. It involves educating doctors through electronic records and having outreach workers assist in managing the children's care. The goal is to ensure better treatment and reduce asthma-related problems.

Who is the study for?
This trial is for children aged 2-12 with physician-diagnosed asthma that's persistent or uncontrolled, as per specific guidelines. The caregiver must speak English or Spanish and give consent, along with the child's assent if they're over 7 years old. It excludes those without phone access, in foster care, or with conditions like heart disease or cystic fibrosis.
What is being tested?
The study tests a technology-based intervention called PRAGMATIC in urban primary care settings to see if it improves guideline-based asthma care and reduces symptoms among urban kids with serious asthma.
What are the potential side effects?
Since this trial focuses on a prompting intervention rather than medication, traditional side effects are not applicable. However, there may be indirect impacts related to changes in management of the child’s asthma.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My doctor has diagnosed me with asthma.
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I am between 2 and 12 years old.
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My asthma is uncontrolled according to my doctor's assessment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Proportion of visits with >1 guideline-based corrective actions
Secondary study objectives
Symptom free days
Other study objectives
Health care utilization: number hospitalizations for asthma
Health care utilization: number of ED visits for asthma
Pediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: PRAGMATICExperimental Treatment1 Intervention
Intervention practices will receive guideline information and assess children's asthma severity and control. For children with persistent/uncontrolled asthma, academic detailing and prompt in EHR following asthma guidelines will guide asthma management; outreach worker will follow up with patients referred to the by providers to receive care coordination to assure that provider management plan is followed by patient at home.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for childhood asthma include short-acting beta agonists (SABAs), inhaled corticosteroids (ICS), and long-acting beta agonists (LABAs) combined with ICS. SABAs work by quickly relaxing the bronchial muscles, providing rapid relief from acute symptoms such as wheezing and shortness of breath. ICS help reduce airway inflammation, thereby decreasing the frequency and severity of asthma attacks. LABAs, when used with ICS, offer prolonged bronchodilation and enhanced anti-inflammatory effects, making them effective for long-term asthma control. These treatments are essential for managing childhood asthma as they address both immediate symptoms and underlying inflammation, improving overall asthma control and reducing the risk of severe exacerbations.

Find a Location

Who is running the clinical trial?

Montefiore Medical CenterLead Sponsor
456 Previous Clinical Trials
588,156 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,913 Previous Clinical Trials
47,757,219 Total Patients Enrolled
6 Trials studying Childhood Asthma
1,906 Patients Enrolled for Childhood Asthma
Marina Reznik, MD, MSPrincipal InvestigatorMontefiore Medical Center
5 Previous Clinical Trials
1,313 Total Patients Enrolled

Media Library

PRAGMATIC Clinical Trial Eligibility Overview. Trial Name: NCT03066596 — N/A
Childhood Asthma Research Study Groups: PRAGMATIC
Childhood Asthma Clinical Trial 2023: PRAGMATIC Highlights & Side Effects. Trial Name: NCT03066596 — N/A
PRAGMATIC 2023 Treatment Timeline for Medical Study. Trial Name: NCT03066596 — N/A
~62 spots leftby Oct 2025