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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

PRAGMATIC Trial Summary

This trial will test whether a prompting intervention can help providers give better asthma care to urban children, reducing asthma 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.Check my eligibility
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.See study design
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.

PRAGMATIC Trial 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.

PRAGMATIC Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of visits with >1 guideline-based corrective actions
Secondary outcome measures
Symptom free days
Other outcome measures
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)

PRAGMATIC 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.

Find a Location

Who is running the clinical trial?

Montefiore Medical CenterLead Sponsor
441 Previous Clinical Trials
581,666 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,834 Previous Clinical Trials
47,310,105 Total Patients Enrolled
5 Trials studying Childhood Asthma
1,556 Patients Enrolled for Childhood Asthma
Marina Reznik, MD, MSPrincipal InvestigatorMontefiore Medical Center
5 Previous Clinical Trials
1,277 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the research looking for volunteers at this time?

"According to information posted on clinicaltrials.gov, the recruitment for this particular trial has been halted. It was first introduced on March 7th 2017 and last updated August 23rd 2022. Despite not enrolling any more patients, there are still 322 other medical studies actively recruiting participants at this moment in time."

Answered by AI

Is there an opportunity for me to join this experiment?

"This clinical trial seeks out 530 participants aged between 2 and 12 years old who are currently suffering from asthma. These individuals must meet the following requirements as prescribed by NHLBI guidelines: having experienced symptoms more than twice per week, requiring rescue medication use for over two days in a month, nighttime distress exceeding two episodes within thirty days or systemic corticosteroid usage during the past year. Caregiver consent is fundamental to ensure child participation (for those above seven) along with sibling selection processes if necessary."

Answered by AI

Are participants of advanced age eligible for enrollment in this study?

"Prospective participants must meet the minimum age requirement of 2 years old, and should not exceed 12 years at the time of enrollment."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Promoting Asthma Guidelines and Management Through Technology-Based Intervention and Care Coordination
Marina Reznik 2017. "Promoting Asthma Guidelines and Management Through Technology-Based Intervention and Care Coordination". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03066596.
~24 spots leftby Aug 2024
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