School-Based Management for Childhood Asthma

Overseen By Deanna Hamilton, MSEd

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: State University of New York at Buffalo

Must be taking: Preventive asthma medications

Disqualifiers: Cystic fibrosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 7 months

400 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to improve asthma care for children by using school-based health centers to manage the condition more effectively. It focuses on providing guideline-based asthma assessments and preventive medication management directly at schools, making it easier for children to adhere to their treatment plans. The trial tests this approach, known as the APP assessment and management of asthma, against the usual care provided by primary care providers. Children who might be a good fit have asthma that's hard to control and often disrupts their daily lives. As an unphased trial, this study offers a unique opportunity to contribute to innovative asthma care solutions in a school setting.

Will I have to stop taking my current medications?

The trial information does not specify whether participants must stop taking their current medications. It focuses on providing asthma care through school-based health centers.

What prior data suggests that this school-based asthma management is safe for children?

Research shows that health centers in schools can improve asthma in children, especially when they follow recommended care guidelines. Studies have found that when these centers manage medications and regularly monitor asthma, children often experience better health and perform better in school.

This trial focuses on using school health centers to care for asthma. These centers have been linked to fewer asthma attacks and emergency room visits for children. Children generally respond well to this approach, and studies have not reported any major safety issues. The centers help children adhere to their asthma treatments and manage their symptoms more effectively.

Overall, evidence suggests that this method of managing asthma is safe and can significantly improve children's health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the School-Based Management for Childhood Asthma trial because it aims to streamline asthma care using an app-based assessment and management approach. Unlike the standard of care that often involves visiting a primary care physician for asthma management, this method integrates asthma care directly into schools, potentially offering more immediate and consistent support for children. This innovative approach could improve asthma outcomes by providing timely interventions and enhancing communication between schools, families, and healthcare providers.

What evidence suggests that this school-based asthma management is effective for childhood asthma?

Research has shown that managing asthma at school can greatly improve children's health. In this trial, participants in the SBHC group will receive school-based asthma management, which studies have shown reduces trips to the emergency room and hospital. Regular check-ups and assistance with asthma medication at school contribute to this reduction. Additionally, digital tools and apps can help children adhere to their asthma plans and manage their condition more effectively. Overall, school programs have proven effective in reducing asthma problems in children, especially in areas with limited healthcare access. ^{2 3 4 6 7}

Are You a Good Fit for This Trial?

This trial is for children with uncontrolled asthma who are from communities with health disparities. It's not open to kids with other chronic lung diseases like cystic fibrosis.

Inclusion Criteria

My asthma is not under control.

Exclusion Criteria

I have a chronic lung condition like cystic fibrosis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

School-based health centers provide guideline-based asthma assessments, preventive medication management, directly observed therapy, and self-management support

7 months

Regular school-based visits

Follow-up

Participants are monitored for asthma symptoms, hospitalizations, and quality of life

1 month

End of school year assessment

What Are the Treatments Tested in This Trial?

Interventions

• APP assessment and management of asthma

Trial Overview

Project ASTHMA evaluates if school-based health centers can improve asthma care by providing assessments, directly observed therapy for preventive medication adherence, and self-management support.

How Is the Trial Designed?

Group I: SBHC group Experimental Treatment 1 Intervention

Group II: PCP group Active Control 1 Intervention

APP assessment and management of asthma is already approved in United States for the following indications:

Approved in United States as Asthma Management for:

• Chronic Asthma Management
• Preventive Medication Adherence
• Self-Management Support

Who Is Running the Clinical Trial?

State University of New York at Buffalo

Lead Sponsor

Trials

279

Recruited

52,600+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

Published Research Related to This Trial

The School-based Asthma Management Program (SAMPRO) offers a structured approach to improve asthma care for children by promoting collaboration among clinicians, schools, families, and communities.

SAMPRO includes key components such as establishing a support network, enhancing communication between healthcare providers and schools, providing asthma education, and addressing environmental triggers, all aimed at better managing asthma symptoms in school settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Building school health partnerships to improve pediatric asthma care: the School-based Asthma Management Program. Kakumanu, S., Antos, N., Szefler, SJ., et al.[2017]

The Thoracic Society of Australia and New Zealand developed national guidelines to help school staff manage asthma effectively, addressing the impact of asthma on children's education.

Key recommendations include ensuring the availability of asthma first aid kits, proper use of bronchodilator aerosols with puffer and spacer devices, and clear protocols for notifying parents and calling for emergency help.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A national policy on asthma management for schools. The Asthma Special Interest Group, Thoracic Society of Australia and New Zealand. Mellis, CM., Bowes, G., Henry, RL., et al.[2019]

A low-burden asthma screening algorithm was successfully implemented in two urban schools, with 69.7% of 1397 students screened, effectively identifying students in need of follow-up based on their asthma risk.

The algorithm identified new asthma cases in 46.4% of families reached in the high-priority group, demonstrating that this method is significantly better than chance at detecting asthma in students, allowing for targeted support for those most in need.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Risk Stratification Algorithm for Asthma Identification and Prioritization in a Low-Income Urban School. Rabner, M., Bissett, K., Johnson, SB., et al.[2021]

School-based interventions for asthma can help identify children with undiagnosed asthma and improve their health outcomes, especially in areas with high asthma prevalence and morbidity.

Despite the potential benefits of these programs, challenges such as competing educational priorities and the need for practical, cost-effective strategies hinder their successful implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

School-based asthma programs. Bruzzese, JM., Evans, D., Kattan, M.[2009]

Effective asthma management in schools requires a structured approach that includes assessing students, determining the severity of their condition, and ensuring clear communication with parents and training for school staff.

The development of state-specific asthma management guidelines can enhance the understanding and implementation of asthma care, aligning with local laws and emphasizing the role of school nurses and educators in supporting students with asthma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Asthma Management in Educational Settings: Implementing Guideline-Based Care in Washington State Schools. Evans-Agnew, RA., Klein, N., Lecce, S.[2017]

Clinicians must work closely with schools to create and implement an asthma treatment plan for children, ensuring that both families and school staff are educated about asthma management.

The School-based Asthma Management Program (SAMPRO™) includes four key components designed to improve communication and support for children with asthma, promoting better care in the school environment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Creation and implementation of SAMPRO™: A school-based asthma management program. Lemanske, RF., Kakumanu, S., Shanovich, K., et al.[2019]

Children with asthma often miss more school than their healthy peers due to uncontrolled symptoms, highlighting the need for effective management strategies.

The School-based Asthma Management Program, which includes four key components, has been shown to improve communication and coordination of care among families, clinicians, and schools, ultimately helping to manage asthma more effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Asthma in Schools: How School-Based Partnerships Improve Pediatric Asthma Care. Kakumanu, S., Lemanske, RF.[2019]

Recent advancements in school-based asthma management, including clinical trials and school-nurse led interventions, show promise in providing effective asthma care and reducing health inequities among children.

Innovative strategies like stock albuterol policies and school-based telemedicine have the potential to enhance access to guideline-based asthma care, improving health outcomes for children with asthma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Updates in school-based asthma management. Lowe, AA., Onge, IS., Trivedi, M.[2023]

School-based asthma management is seen as a key facilitator for improving asthma care, especially when supported by a full-time school nurse, as it helps reduce emergency room visits and lost learning time for children.

Barriers to effective asthma management include the need for better systemic support, improved communication among care community members, and a shift from crisis-mode responses to proactive care strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A multilevel perspective on goals, barriers, and facilitators of school-based asthma management. Mammen, JR., McGovern, CM., Schoonmaker, JD., et al.[2023]

Citations

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Asthma Management in Schools

The AAP identifies the key components of effective school-based asthma management and provides practical tips and resources to help schools.

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9974735/

Updates in School-Based Asthma Management - PMC

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sciencedirect.com

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This study demonstrates that digital tools, such as web technologies and mobile devices, can significantly improve the management of childhood asthma.

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