NCT04576442

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 452 (actual)
• Sponsor: Montefiore Medical Center · Academic / Other
• Sex: All
• Age: 4 Years – 12 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Investigators will conduct a cluster-randomized controlled trial with eligible children with persistent or uncontrolled asthma from 60 Bronx schools. Schools will be randomly assigned to either (1) the Asthma-PASS intervention or an asthma management (AM) comparison group. Both groups will participate in an existing classroom-based daily activity program. Enrollment will occur over 4 consecutive school years with 4-8 schools joining the study each year. The investigators will assess the effectiveness of Asthma-PASS in reducing asthma morbidity and improving PA as well as additional clinical and functional outcomes. The investigators will also identify potential mediators and moderators of the intervention effect. They will evaluate the process of intervention implementation by applying the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework. The RE-AIM framework is a public health tool used for planning and evaluating programs to improve translation from research into practice and ensure sustainability in real-world settings.

Conditions

• Asthma in Children

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-02-09
• Primary completion: 2025-08-27
• Completion: 2025-08-27
• First posted: 2020-10-06
• Last updated: 2026-04-13

Locations

1 site across 1 country: United States