School-Based Asthma Program for Childhood Asthma

Recruiting at 12 trial locations

Overseen By Michaela Brtnikova, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Disqualifiers: No asthma, Controlled asthma

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

Compensation: Varies

Number of Visits: Unknown

500 Participants Needed

Trial Summary

What is the purpose of this trial?

Our UH3 clinical trial, "Reducing Asthma Attacks in Disadvantaged School Children with Asthma," seeks broad-scale implementation of our effective school-based approach to improve asthma disparities for children, ages 5-12 years, in low-income communities. The investigators will contextualize dissemination and implementation (D\&I) of our Colorado school-based asthma program (Col-SBAP) that reduces asthma exacerbations and missed school days, while also addressing social determinants of health. Our Better Asthma Control for Kids (BACK) Program will evaluate key metrics identified by diverse stakeholders during this dissemination trial in rural and small metropolitan areas of Colorado. Our clinical trial includes two implementation strategies: our standard Col-SBAP, titled BACK-Standard (BACK-S) and an enhanced community-centered approach, titled Back-Enhanced (BACK-E). These two strategies are designed for sustainable delivery by school asthma navigators and school nurses who coordinate with primary care and community resources. The Exploration, Preparation, Implementation, Sustainment (EPIS) D\&I framework was applied with community partners during the UG3 planning phase to tailor implementation plans that meet local community needs, resources and priorities (EPIS Phases 1 \& 2). BACK-S and BACK-E will be delivered from years 1-3 with data collection for implementation and effectiveness outcomes in 4 Colorado regions. In year 4, the investigators will collect data for sustainment outcomes (EPIS phase 3). The investigators will apply the work from EPIS phases 1-3 to refine our "dissemination playbook" that guides adoption by other school systems (EPIS Phase 4). Our primary implementation hypothesis is: Reach will be greater among students when delivered using the BACK-E arm as compared to BACK-S. Our effectiveness hypothesis is: BACK will be more effective than usual care at reducing asthma exacerbations. The BACK playbook includes training materials and a calculation of return on investment. The investigators are targeting schools with high levels of uncontrolled asthma and asthma associated burden. Our UH3 trial includes partner engagement to ensure BACK is disseminated to diverse geopolitical areas of Colorado with attention to sustainability. Collectively, our approach will accelerate dissemination of BACK nationally to communities experiencing health inequities in pediatric asthma care.

Will I have to stop taking my current medications?

The trial information does not specify whether participants must stop taking their current medications.

What data supports the effectiveness of the school-based asthma treatment BACK-E, BACK-Enhanced, Better Asthma Control for Kids - Enhanced, BACK-S, Better Asthma Control for Kids - Standard, BACK-Standard, Col-SBAP?

Research shows that school-based asthma programs can significantly reduce asthma episodes and improve asthma management in children. For example, a pilot program in Buffalo schools led to an 80% decrease in emergency asthma treatments, and another study found that delivering asthma medication at school improved asthma control compared to home-based delivery. ^{1 2 3 4 5}

Is the School-Based Asthma Program safe for children?

The research does not provide specific safety data for the School-Based Asthma Program, but it shows that school-based asthma management can improve asthma control in children, suggesting it is generally safe when implemented properly. ^{1 2 5 6 7}

What makes the BACK-E and BACK-S treatments for childhood asthma unique?

The BACK-E and BACK-S treatments are unique because they are part of a school-based asthma program that focuses on improving asthma care through strong partnerships between families, clinicians, and schools, ensuring better communication and management of asthma action plans and medications directly in the school setting. ^{1 8 9 10 11}

Research Team

Stanley Szefler

Principal Investigator

Childrens Hospital Colorado

Eligibility Criteria

This trial is for children aged 5-12 with poorly controlled asthma, attending selected schools in rural Colorado that have high needs based on lunch subsidies or rural status. It's not for kids under 5 or over 12, or those whose asthma is already well-managed.

Inclusion Criteria

My asthma is not well-controlled according to my school's health form.

I am between 5 and 12 years old.

You go to a school in rural Colorado with high rates of students who need help with meals or because it's in a rural area.

Exclusion Criteria

I am either younger than 5 years old or older than 12 years old.

I am a student with no asthma or my asthma is under control.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preparation

Preparation phase involving tailoring implementation plans to meet local community needs, resources, and priorities

6 months

Implementation

Implementation of BACK-S and BACK-E strategies in schools to improve asthma management

36 months

Regular visits by school nurses and asthma navigators

Sustainment

Data collection for sustainment outcomes and refinement of dissemination playbook

12 months

Follow-up

Participants are monitored for safety and effectiveness after implementation

12 months

Treatment Details

Interventions

• BACK-E
• BACK-S

Trial Overview The trial tests two school-based strategies to manage childhood asthma: BACK-Standard (BACK-S) and an enhanced version (BACK-E). Both are delivered by school staff coordinated with healthcare providers to reduce asthma attacks and missed school days.

Participant Groups

Group I: BACK-S Experimental Treatment 1 Intervention

The BACK -Standard package includes a tailor-and-adapt to context strategy of approaches necessary to implement BACK in schools based on our past work, operationalized as an implementation blueprint to coordinate with partner roles of child/family, schools, healthcare teams and community resource agencies. This includes a facilitation strategy to support problem-solving through regular learning collaborative meetings for asthma navigators (bi-weekly), school nurses (monthly to bi-monthly) and health care champions (quarterly).

Group II: BACK-E Experimental Treatment 1 Intervention

The BACK-Enhanced package includes the BACK-Standard package plus an Enhanced strategy to develop interrelationships with students/family, schools, and community agencies providing resources to address social determinants of health.

Group III: Usual care Active Control 1 Intervention

School nurses/schools randomized to usual care will continue to receive their usual care from school nurses and then subsequently provide the intervention given their asthma remains poorly controlled at the start of the next school year following enrollment.

BACK-E is already approved in United States for the following indications:

Approved in United States as BACK-E for:

• Asthma management in school settings

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Findings from Research

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]

In a 16-week crossover trial involving children aged 6 to 17 with mild-to-moderate persistent asthma, fluticasone propionate (an inhaled corticosteroid) showed significantly better improvements in asthma control, pulmonary function, and inflammatory markers compared to montelukast (a leukotriene receptor antagonist).

Exhaled nitric oxide (eNO) levels were identified as a useful predictor of asthma control days, helping to determine which children might benefit more from using an inhaled corticosteroid over a leukotriene receptor antagonist.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Response profiles to fluticasone and montelukast in mild-to-moderate persistent childhood asthma. Zeiger, RS., Szefler, SJ., Phillips, BR., et al.[2023]

The school asthma program led to an impressive 80% reduction in the need for rescue treatments for asthma in the first year of implementation, indicating its effectiveness in managing asthma exacerbations among students.

In a broader expansion to five additional schools, there was a 17% overall decrease in rescue treatments, and 65% of physicians provided necessary Asthma Care Plans, demonstrating the program's feasibility and positive impact on asthma management in schools.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A school-based asthma intervention program in the Buffalo, New York, schools. Lwebuga-Mukasa, J., Dunn-Georgiou, E.[2019]

The 'Partners in School Asthma Management' program successfully improved asthma knowledge, self-efficacy, and self-management behaviors among 835 inner-city elementary school children, but did not significantly impact their overall health status or school attendance.

An enhanced intervention that included direct meetings with a project physician and personalized asthma action plans led to better school performance and fewer absences, highlighting the importance of tailored medical support in asthma management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Partners in school asthma management: evaluation of a self-management program for children with asthma. Bartholomew, LK., Sockrider, M., Abramson, SL., et al.[2022]

Providing low-dose inhaled corticosteroids (ICS) to asthmatic children at school led to better asthma control compared to home-based delivery, with significant improvements in peak flow and reduced need for bronchodilators over a 14-week study involving 50 students.

Both school-based and home-based ICS delivery resulted in better asthma management than the control group, which received no additional treatment, highlighting the effectiveness of structured medication delivery in improving health outcomes for children with asthma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled trial using the school for anti-inflammatory therapy in asthma. Millard, MW., Johnson, PT., McEwen, M., et al.[2022]

The School-Based Asthma Therapy (SBAT) program significantly increased the number of symptom-free days (SFDs) for urban children with asthma, providing about 158 additional SFDs per 100 children each month.

Despite the program costing an extra $4822 per 100 children monthly, it resulted in net savings of $3240 due to reduced medical costs and improved school attendance, making it cost-effective at $10 per additional SFD gained.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cost-effectiveness of the School-Based Asthma Therapy (SBAT) program. Noyes, K., Bajorska, A., Fisher, S., et al.[2021]

The Building Bridges for Asthma Care Program, implemented in 28 schools across Colorado and Connecticut, successfully coordinated asthma management by engaging families, health providers, and schools, leading to significant improvements in asthma care plans and inhaler techniques.

Key outcomes included increased completion of School Asthma Care Plans and Home Asthma Action Plans, as well as better access to quick-relief inhalers at school, demonstrating the program's effectiveness in supporting at-risk children with asthma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Building Bridges for Asthma Care Program: A School-Centered Program Connecting Schools, Families, and Community Health-Care Providers. Cicutto, L., Gleason, M., Haas-Howard, C., et al.[2023]

In a study of 1,029 school children with asthma, 63% were found to have comorbid allergic rhinitis (AR), which significantly worsened their asthma symptoms and overall health outcomes.

Children with AR experienced fewer symptom-free days, increased daytime symptoms, higher use of rescue medications, and more activity limitations due to asthma, highlighting the need for better recognition and treatment of AR to reduce asthma morbidity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Allergic rhinitis co-morbidity on asthma outcomes in city school children. Stern, J., Chen, M., Fagnano, M., et al.[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]

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]

A school-based asthma program involving 130 schools and 1316 children significantly reduced school absenteeism (50% vs 60%) and urgent care visits for asthma (41% vs 51%) after one year, indicating improved management of asthma among students.

The program also enhanced the quality of life for children with asthma and fostered a more supportive school environment, demonstrating that such interventions can effectively empower children to manage their condition better.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of a public health nurse-delivered asthma program to elementary schools. Cicutto, L., To, T., Murphy, S.[2018]

References

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

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

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

Response profiles to fluticasone and montelukast in mild-to-moderate persistent childhood asthma. [2023]

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

A school-based asthma intervention program in the Buffalo, New York, schools. [2019]

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

Partners in school asthma management: evaluation of a self-management program for children with asthma. [2022]

5. England pubmed.ncbi.nlm.nih.gov

A randomized controlled trial using the school for anti-inflammatory therapy in asthma. [2022]

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

Cost-effectiveness of the School-Based Asthma Therapy (SBAT) program. [2021]

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

Building Bridges for Asthma Care Program: A School-Centered Program Connecting Schools, Families, and Community Health-Care Providers. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Allergic rhinitis co-morbidity on asthma outcomes in city school children. [2023]

9. England pubmed.ncbi.nlm.nih.gov

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

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

Updates in school-based asthma management. [2023]

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

A randomized controlled trial of a public health nurse-delivered asthma program to elementary schools. [2018]