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Asthma Management Program for Childhood Asthma

N/A
Recruiting
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
Attending kindergarten through 5th grade in Bronx elementary schools
Parent is able to speak and understand either English or Spanish
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3-12 months
Awards & highlights
No Placebo-Only Group

Study Summary

This trial will test whether a school-based intervention that addresses key barriers to physical activity can reduce asthma morbidity among children with asthma.

Who is the study for?
This trial is for children in kindergarten to 5th grade with physician-diagnosed asthma, attending Bronx schools. They must have mild persistent or more severe asthma and be able to participate in physical activities. Caregivers must consent and speak English or Spanish. Children with other significant medical conditions, involved in another asthma study, or unable to stay in the area for 6 months are excluded.Check my eligibility
What is being tested?
The Asthma-PASS program aims to reduce barriers to physical activity (PA) for urban schoolchildren with asthma by providing a multifaceted intervention that includes education sessions on managing asthma effectively and promoting increased PA as part of their treatment plan.See study design
What are the potential side effects?
Since this trial focuses on educational interventions and increasing physical activity rather than medication, there are no direct side effects like those associated with drugs. However, increased PA could potentially lead to an increase in short-term asthma symptoms if not managed properly.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a student in grades K-5 in a Bronx elementary school.
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I can speak and understand either English or Spanish.
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My child's caregiver and my child (if over 7) have agreed to participate in the trial.
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My child's doctor has diagnosed them with asthma.
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My asthma is persistent or severe, or not controlled by my current treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3-12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3-12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Symptom free days
Secondary outcome measures
Physical activity
Other outcome measures
Adherence
Asthma knowledge
Asthma self-management questionnaire
+2 more

Awards & Highlights

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

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Asthma-PASS InterventionExperimental Treatment2 Interventions
Collaboration with PCPs to optimize management. Community Health Worker (CHW) to ensure PCP plan is followed. Two asthma education sessions with children/caregivers focusing on self-efficacy and physical activity promotion. Promotion of asthma awareness in school. School personnel training in asthma
Group II: Asthma Management Comparison GroupActive Control2 Interventions
Includes two sessions of basic asthma education and PCP notification of child's asthma severity level.

Find a Location

Who is running the clinical trial?

National Heart, Lung, and Blood Institute (NHLBI)NIH
3,796 Previous Clinical Trials
47,279,862 Total Patients Enrolled
6 Trials studying Childhood Asthma
2,086 Patients Enrolled for Childhood Asthma
Montefiore Medical CenterLead Sponsor
438 Previous Clinical Trials
580,590 Total Patients Enrolled
1 Trials studying Childhood Asthma
530 Patients Enrolled for Childhood Asthma
University of RochesterOTHER
830 Previous Clinical Trials
516,234 Total Patients Enrolled

Media Library

Asthma-PASS Clinical Trial Eligibility Overview. Trial Name: NCT04576442 — N/A
Childhood Asthma Research Study Groups: Asthma-PASS Intervention, Asthma Management Comparison Group
Childhood Asthma Clinical Trial 2023: Asthma-PASS Highlights & Side Effects. Trial Name: NCT04576442 — N/A
Asthma-PASS 2023 Treatment Timeline for Medical Study. Trial Name: NCT04576442 — N/A

Frequently Asked Questions

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

Does this research project grant access to participants of 40 years or older?

"This trial has set the minimum age to enroll at 5 years old and capped the upper limit of eligibility at 11."

Answered by AI

Can I qualify to be a contributor in this investigation?

"This medical trial is seeking 416 participants who are aged between five and eleven years old, with a diagnosis of asthma."

Answered by AI

What is the recruitment size for this research project?

"Correct. Information hosted on clinicaltrials.gov reports that recruitments for this medical trial, which was initially posted on February 9th 2021, are still ongoing. 416 patients need to be enrolled from a single location."

Answered by AI

What are the current enrollment criteria of this trial?

"According to the clinicaltrials.gov listing, this study is presently seeking participants. It was initially publicized on February 9th 2021 and most recently updated on January 14th 2022."

Answered by AI
~144 spots leftby Sep 2025