Asthma Link for Childhood Asthma

Overseen By Michelle Trivedi, MD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Massachusetts, Worcester

Must be taking: Inhaled corticosteroids

Disqualifiers: Developmental delay, 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: 6

Duration: 6 months

350 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of a school-supervised asthma therapy program (Asthma Link) compared to using only an educational asthma workbook for children with poorly controlled asthma. It focuses on children aged 5-14 who frequently experience asthma issues, such as needing oral steroids or visiting the hospital for asthma in the past year. Children who often forget to take their daily inhaler medication might be well-suited for this study. The trial will determine if school staff assistance in managing treatment improves asthma symptoms. As an unphased trial, it offers the opportunity to explore innovative asthma management strategies that could significantly enhance daily life for children with asthma.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, since children must be prescribed a daily inhaled corticosteroid (ICS) for asthma to participate, it seems likely that they will continue with this medication during the trial.

What prior data suggests that the Asthma Link program is safe for children with asthma?

Research has shown that Asthma Link, a school-based program for managing asthma, is generally safe for children. In a past study, children in Asthma Link achieved much better control over their asthma symptoms. They required emergency asthma medication less frequently, with some studies reporting a 46% reduction in the use of rescue inhalers. These findings suggest that the program is both effective and safe for children with difficult-to-control asthma. Although specific side effects were not detailed in these studies, the overall positive outcomes indicate that Asthma Link is a safe option for managing asthma at school. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Asthma Link protocol because it offers a unique approach to managing childhood asthma that integrates school-supervised therapy. Unlike traditional treatments that rely solely on medication management by parents at home, Asthma Link involves training school health staff to help supervise and support asthma treatments during school hours. This method not only ensures consistent medication adherence but also provides an educational workbook to empower children and their families with knowledge about asthma management. By combining medical care with educational support and school involvement, Asthma Link aims to improve asthma control in children who struggle with maintaining regular treatment routines.

What evidence suggests that the Asthma Link program is effective for improving asthma symptoms in children?

Research has shown that the Asthma Link program, which participants in this trial may receive, can greatly help children manage their asthma. Studies have found that children in programs like Asthma Link experience better asthma outcomes, especially those in challenging social situations. For example, one study found a 46% reduction in the use of rescue inhalers among children in the program. Another study with 626 children demonstrated significant improvements in asthma control across all groups. These results suggest that Asthma Link can effectively help manage asthma symptoms in children. Meanwhile, the Enhanced Usual Care arm in this trial will provide brief training and educational resources to assist in asthma management. ^{1 2 3 5 6}

Who Is on the Research Team?

Michelle Trivedi, MD

Principal Investigator

UMass Chan Medical School

Are You a Good Fit for This Trial?

This trial is for children aged 5-14 with poorly controlled asthma. It's designed to see if a school program called Asthma Link can help manage their symptoms better than an educational workbook.

Inclusion Criteria

Child: Meet the eligibility criteria for Asthma Link, Enrolled in Asthma Link (if randomized to the Asthma Link Condition), Able and willing to provide informed assent

I am over 18, speak English or Spanish, and can consent for my child.

Exclusion Criteria

My child cannot give informed assent due to developmental delays.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Children receive school-supervised asthma therapy or an educational asthma workbook

6 months

Regular school visits for therapy administration

Follow-up

Participants are monitored for asthma control and medication adherence

6 months

Surveys and assessments at 6 and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• Asthma Link
• Enhanced Usual Care

Trial Overview The study is testing the effectiveness of 'Asthma Link', which involves supervised asthma therapy at school, against just using an educational workbook on asthma care. Children will be randomly placed in one of these two groups.

How Is the Trial Designed?

Group I: Asthma Link Experimental Treatment 1 Intervention

Practices in the Asthma Link condition will receive brief training on how to identify, refer and arrange for children with poorly controlled asthma to receive school-supervised therapy with the child's school health staff. Participants will receive an educational asthma workbook.

Group II: Enhanced Usual Care Active Control 1 Intervention

Practices in the Enhanced Usual Care condition will receive brief training on how to identify and refer the same group of children with poorly controlled asthma and these children will receive an educational asthma workbook.

Asthma Link is already approved in United States for the following indications:

Approved in United States as Asthma Link for:

• Poorly controlled asthma in children aged 5-14

Who Is Running the Clinical Trial?

University of Massachusetts, Worcester

Lead Sponsor

Trials

372

Recruited

998,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Published Research Related to This Trial

The modified asthma education program, taught in ten 20-minute sessions, effectively increased children's knowledge about managing asthma triggers and symptoms, similar to the original program taught in six 40-minute sessions.

With 45 students participating in the modified program compared to 20 in the original, this approach offers a more flexible option for schools, potentially allowing more children to benefit from asthma education despite scheduling challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a modified open airways curriculum. Crane, LM., O'Neal, KS., Honey, BL., et al.[2015]

Asthma Link™ is a promising low-cost model for school-supervised inhaled corticosteroid therapy that has shown significant improvements in health outcomes for children with asthma, based on qualitative feedback from 29 participants.

Stakeholders identified key facilitators for success, such as simple procedures and positive health impacts, but also noted barriers like protocol deviations and insurance coverage issues, along with proposed solutions to enhance the program's real-world adoption.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Alignment of stakeholder agendas to facilitate the adoption of school-supervised asthma therapy. Trivedi, M., Patel, J., Hoque, S., et al.[2021]

The CALM program demonstrated significant improvements in asthma-related outcomes for 330 children, including reduced symptoms, less reliance on rescue inhalers, decreased healthcare visits, and lower school absenteeism.

Sustaining school-based asthma programs is achievable through policy and practice changes, such as regular asthma education and improved monitoring of students with asthma, highlighting the importance of collaboration among various stakeholders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sustaining school-based asthma interventions through policy and practice change. Carpenter, LM., Lachance, L., Wilkin, M., et al.[2018]

Stakeholders emphasized the importance of measuring outcomes such as healthcare utilization reduction, cost-effectiveness, and addressing health disparities in the clinical trial design for the AsthmaLink program, which aims to improve asthma management in schools.

Identified barriers to the adoption of AsthmaLink included challenges in securing resources and staffing, variability across school districts, and competition with other programs, highlighting the need for tailored strategies to facilitate implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incorporating systems-level stakeholder perspectives into the clinical trial design of school-supervised asthma therapy. Trivedi, M., Hoque, S., Luther, J., et al.[2022]

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 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]

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]

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]

Citations

1. childhealthequitycenter.org childhealthequitycenter.org/childhood-asthma-treatment-and-research/

Childhood Asthma Treatment and Research The first retrospective observation study of Asthma Link was enormously successful. Children enrolled in Asthma Link had a: 46% decline in asthma rescue ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06388460

NCT06388460 | Asthma Link Effectiveness Trial The investigators central hypothesis is that children in Asthma Link will have higher Asthma Control Test scores at 6 months compared with children in enhanced ...

3. jamanetwork.com jamanetwork.com/journals/jamapediatrics/fullarticle/2825197

Community Health Workers Linking Clinics and Schools ... Findings In this randomized clinical trial with 626 children, all groups had statistically significant improvements in asthma control from ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11568070/

Exploring the Relationship between School-Supervised ... Participants reported that SST programs like Asthma Link can especially improve asthma outcomes for children experiencing specific adverse SDoH.

5. sciencedirect.com sciencedirect.com/science/article/pii/S2772829325000293

Improving medication adherence, asthma control, and ... Our results indicate that the SBAT program is highly effective in improving children's asthma outcomes in a real-world setting, and we demonstrated progress in ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04942379?term=AREA%5BBasicSearch%5D(Link%20medicine)&rank=9

Study Details | NCT04942379 | Asthma Link: A Real World ... The goal of this study is to assess the feasibility of a clinical trial to evaluate the impact and process of deploying school-supervised asthma therapy in ...