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

Trial Summary

What is the purpose of this trial?

Children with asthma from communities that experience health inequities frequently do not receive guideline-based asthma care, and as a result, account for a disproportionate percentage of asthma exacerbations, emergency department visits, and hospitalizations. Project ASTHMA (Aligning with Schools To Help Manage Asthma) tests the effectiveness of school-based health centers as a delivery model to improve health outcomes by providing children with guideline-based asthma assessments and preventive medication management, directly observed therapy of their preventive medication to support adherence, and self-management support. If successful, this multicomponent intervention will represent a cost effective and sustainable model to reduce asthma morbidity in historically marginalized communities, and has the potential to impact communities throughout the United States where over 2,500 school-based health centers operate.

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 data supports the effectiveness of the treatment School-Based Management for Childhood Asthma?

Research shows that school-based asthma management programs, like the School-based Asthma Management Program (SAMPRO™), improve asthma care by enhancing communication and coordination among families, clinicians, and schools. These programs help ensure children have access to asthma action plans and medications at school, reducing school absences and improving overall asthma control. ^{1 2 3 4 5}

Is school-based asthma management safe for children?

The research on school-based asthma management focuses on improving care coordination and communication among families, schools, and healthcare providers, but it does not specifically address safety concerns. However, these programs are widely endorsed and aim to provide expert-supported care, suggesting they are generally considered safe. ^{1 2 3 6 7}

How is the School-Based Management for Childhood Asthma treatment different from other asthma treatments?

This treatment is unique because it focuses on managing asthma within the school setting, involving coordination between families, clinicians, and schools to ensure children receive consistent care and support. It emphasizes building partnerships and communication to improve asthma management and reduce school absences due to asthma symptoms. ^{1 2 3 8 9}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Updates in school-based asthma management. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Asthma in Schools: How School-Based Partnerships Improve Pediatric Asthma Care. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Building school health partnerships to improve pediatric asthma care: the School-based Asthma Management Program. [2017]

4. United States pubmed.ncbi.nlm.nih.gov

Creation and implementation of SAMPRO™: A school-based asthma management program. [2019]

5. Australia 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. [2019]

6. England pubmed.ncbi.nlm.nih.gov

A multilevel perspective on goals, barriers, and facilitators of school-based asthma management. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

A Risk Stratification Algorithm for Asthma Identification and Prioritization in a Low-Income Urban School. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

School-based asthma programs. [2009]

9. United States pubmed.ncbi.nlm.nih.gov

Asthma Management in Educational Settings: Implementing Guideline-Based Care in Washington State Schools. [2017]