Evaluation of the Asthma Management Program to Promote Activity for Students in Schools (Asthma-PASS)

NCT04576442 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 452

Last updated 2026-04-13

No results posted yet for this study

Summary

Physical activity (PA) is an important component of asthma management in children. Studies show that PA is associated with decreased severity of asthma symptoms, as well as improved disease control and quality of life. However, urban minority children with asthma face barriers to PA on multiple levels.The goal of this research project is to evaluate whether a multifaceted school-based intervention that addresses key barriers to physical activity reduces asthma morbidity among urban schoolchildren with asthma.

Conditions

  • Asthma in Children

Interventions

BEHAVIORAL

Asthma-PASS

The investigator will collaborate with the student's primary care provider (PCP) by sending a letter via facsimile, and/or e-mail to ensure appropriate medications are prescribed or adjusted and rescue medications are available at school. Community Health Workers (CHWs) will follow up with PCPs as needed to provide reminders about prescriptions for controlled medications and to ensure a medication administration form (MAF) is provided to schools to allow rescue medication administration by nurses. CHWs will work with local pharmacies when possible to have prescribed medications delivered to schools and homes. For students without a PCP, families will be referred to one of Montefiore Medical Center's 20 practices throughout the Bronx. For students without medical insurance or who are unable to go to a Montefiore clinic, New York City Department of Education (NYC DOE) physicians who routinely attend NYC schools will provide medical care and prescribe appropriate medications.

BEHAVIORAL

Basic Asthma Management (AM)

PCPs and caregivers will be notified that children in the AM group have persistent/uncontrolled asthma that warrants use of guideline-based preventative medications.

BEHAVIORAL

Child/Caregiver Education session

The investigator will provide in-school child asthma education sessions delivered by trained, bilingual (English-Spanish) Community Health Workers (CHWs) using an established manualized protocol from past and current studies designed to improve knowledge and self-efficacy. Each child will receive two 1-on 1, 20-minute developmentally appropriate educational sessions at school 3-4 weeks apart. Sessions will cover: 1) asthma basics, symptoms and triggers; and 2) medications and correct administration technique. Caregivers will be called after each child session to highlight key points reviewed with the child and answer questions.

Sponsors & Collaborators

  • University of Rochester

    collaborator OTHER
  • Columbia University

    collaborator OTHER
  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH
  • Montefiore Medical Center

    lead OTHER

Principal Investigators

  • Marina Reznik, MD, MS · Montefiore Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
4 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-09
Primary Completion
2025-08-27
Completion
2025-08-27

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04576442 on ClinicalTrials.gov