Asthma CHAMPS Program for Childhood Asthma

Overseen By Meredith McCormack, MD MHS

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Unwilling to consent, 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

1000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve asthma management in Baltimore City elementary schools through an intervention program called Asthma CHAMPS (Asthma Community Home and School Management Program). The goal is to reduce asthma-related issues such as school absences, doctor visits, and flare-ups in children with asthma. The trial will also collect feedback from parents, school staff, and healthcare workers to enhance the program's effectiveness. Children with asthma enrolled in participating schools and their caregivers can join this study. As an unphased trial, this study provides a unique opportunity to contribute to innovative asthma management strategies in schools.

Will I have to stop taking my current medications?

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

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

Research has shown that programs like Asthma CHAMPS are generally safe for children. These programs assist in managing asthma at school and home, aiming to improve control and reduce symptoms. No evidence indicates serious side effects from these programs. Instead, they have helped children manage their asthma better, resulting in fewer asthma attacks and less need for emergency care. This suggests that Asthma CHAMPS is a safe and well-tolerated option for children with asthma. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Asthma CHAMPS program because it takes a community-based approach to managing childhood asthma. Unlike traditional treatments that focus solely on medication management, this program involves school staff, children, and caregivers in a comprehensive strategy to improve asthma outcomes. By integrating education and support directly within the school environment, the program aims to enhance asthma management and reduce emergency incidents. This holistic approach could offer a more sustainable and accessible way to help children manage their asthma effectively.

What evidence suggests that the Asthma CHAMPS program is effective for childhood asthma?

Research has shown that the Asthma CHAMPS program can improve asthma in children. This trial involves various groups, including school staff, children with asthma, and their caregivers. The program features one-on-one sessions with nurses, which have greatly improved asthma control. Studies also indicate that community health workers are crucial in connecting care between schools and homes, facilitating asthma management. By linking the places where children live and learn, the program ensures more consistent asthma care. Overall, evidence suggests that Asthma CHAMPS can reduce issues like school absences and doctor visits by enhancing asthma management in schools. ^{1 3 6 7 8}

Who Is on the Research Team?

Michelle N Ealin, PhD

Principal Investigator

JHU

Meredith McCormack, MD MHS

Principal Investigator

JHU

Are You a Good Fit for This Trial?

This trial is for adults who care for children with asthma or staff at Baltimore City K-8 Public Schools. It includes kids diagnosed with asthma and enrolled in schools participating in Asthma CHAMPS. Those unwilling to consent, or children unwilling to provide assent are excluded.

Inclusion Criteria

Currently attending a K-8 public school in Baltimore City and participating in the Asthma CHAMPS program.

My child has been diagnosed with asthma.

You are currently taking care of a child with asthma or working at a specific public school program for asthma in Baltimore.

Exclusion Criteria

Unwilling to consent

Kids with asthma who don't want to agree to be in the study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implementation

Implementation of the Asthma CHAMPS program in Baltimore City Public Schools, involving school staff, children with asthma, and their caregivers.

4 years

Regular school-based activities and interventions

Qualitative Feedback

Use of qualitative methods such as observation and semi-structured interviews to obtain stakeholder feedback and evaluate the impact of the program.

Ongoing throughout the trial

Follow-up

Participants are monitored for asthma-related outcomes such as absences, ED visits, hospitalizations, and medication use.

4 years

What Are the Treatments Tested in This Trial?

Interventions

• Asthma CHAMPS

Trial Overview The study tests the Asthma CHAMPS program's effectiveness in reducing asthma disparities among children by implementing it across 32 elementary schools. The design involves a stepped wedge trial to assess its impact on school attendance, healthcare use, and overall asthma control.

How Is the Trial Designed?

Group I: School staff Experimental Treatment 2 Interventions

School staff in a K-8 school participating in Asthma CHAMPS

Group II: Children with asthma Experimental Treatment 2 Interventions

Aged 5-13 and enrolled in Baltimore City Public School participating in Asthma CHAMPS

Group III: Caregivers of children with asthma Experimental Treatment 2 Interventions

Caregiver of a child with asthma that is aged 5-13 enrolled in a Baltimore City Public School participating in Asthma CHAMPS

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

Approved in United States as Asthma CHAMPS for:

• Asthma management
• Reducing asthma disparities
• Improving asthma control

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

Baltimore City Public Schools

Collaborator

Trials

1

Recruited

1,000+

Baltimore City Health Department

Collaborator

Trials

9

Recruited

19,200+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Published Research Related to This Trial

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]

A six-month asthma self-management program involving one-on-one education by nurse champions significantly improved asthma outcomes in 201 high-risk patients, including better quality of life and increased asthma knowledge.

The program led to notable decreases in missed work or school days, urgent care visits, and hospital admissions, while also increasing preventive care visits by over 40%, highlighting its effectiveness in managing asthma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of one-on-one nurse education on the outcomes of high-risk adult and pediatric patients with asthma. Forshee, JD., Whalen, EB., Hackel, R., et al.[2019]

The Asthma Basics for Children program significantly improved asthma management for preschoolers, with reductions in daytime symptoms from 78% to 42% and nighttime symptoms from 81% to 49% after program participation.

Parents who engaged in the program reported better communication with physicians and a greater ability to manage their child's asthma, leading to substantial decreases in emergency department visits (from 72% to 37%) and hospitalizations (from 35% to 15%).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A community-based strategy for improving asthma management and outcomes for preschoolers. Findley, SE., Thomas, G., Madera-Reese, R., et al.[2021]

The Merck Childhood Asthma Network (MCAN) aims to improve pediatric asthma management by translating evidence-based interventions into practice, focusing on urban U.S. settings with high asthma rates.

MCAN emphasizes the importance of integrating services across healthcare providers, schools, and community organizations to create comprehensive care approaches for children with asthma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Translating evidence-based interventions into practice: the design and development of the Merck Childhood Asthma Network, Inc. (MCAN). Viswanathan, M., Lux, L., Lohr, KN., et al.[2011]

Asthma camps for children and young people significantly improve their understanding of asthma, adherence to medication, participation in physical activities, and self-confidence.

The development of a local offsite activity policy using a clinical governance framework ensures the safety of participants and staff during these camps, addressing the lack of a national policy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An offsite activity policy for asthma camp. Clack, G.[2010]

The Awesome Asthma School Days program, involving 1,400 students from 74 Milwaukee elementary schools, successfully improved children's understanding of asthma and their expectations regarding normal play and sleep despite their condition.

Survey results revealed significant issues, such as 40% of children experiencing interruptions in play and sleep due to asthma, highlighting the need for educational interventions and community action plans to address asthma management in schools.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The awesome Asthma School Days Program: educating children, inspiring a community. Meurer, JR., McKenzie, S., Mischler, E., 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]

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]

Asthma self-management programs, particularly those like Open Airways, are crucial for minority children and have shown to be effective in reducing asthma recidivism when they include interactive and culturally relevant education.

Programs that also focus on improving literacy skills in asthmatic children can lead to significant health benefits, including a 47% decrease in asthma recidivism and very few hospitalizations over 18 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pediatric asthma self-management: current concepts. Robinson, LD.[2018]

The Open Airways for Schools (OAS) program significantly improved parental self-management skills regarding asthma, as evidenced by a 1-year follow-up analysis of children in Grades 3 to 5 who participated in the program.

Children's involvement in OAS not only enhanced their own self-management skills but also positively influenced their parents' understanding and management of asthma, demonstrating the effectiveness of involving families in health education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can children teach their parents about asthma? Evans, D., Clark, NM., Levison, MJ., et al.[2017]

The Kansas City Children's Asthma Management Program (KC CAMP) and the Asthma Network of West Michigan (ANWM) have successfully improved asthma care through education and support, leading to increased provider satisfaction and adherence to treatment guidelines.

Both programs have significantly reduced emergency department visits and hospitalizations for asthma, demonstrating their effectiveness in long-term disease management and cost reduction in healthcare.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Strategies for improving asthma outcomes: a case-based review of successes and pitfalls. Williams, D., Portnoy, JM., Meyerson, K.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05814510

Implementation of Asthma Community Home and School ... Hypothesis: Children with asthma who attend schools engaged in Asthma CHAMPS program will have improved asthma outcomes, including improved asthma control, ...

2. withpower.com withpower.com/trial/phase-asthma-7-2023-98f6e

Asthma CHAMPS Program for Childhood Asthma The effectiveness of the Asthma CHAMPS treatment is supported by research showing that one-on-one nurse education programs significantly improve asthma outcomes ...

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

Community Health Workers Linking Clinics and Schools ... The findings of this study support that connecting all lived environments for care of children with asthma is feasible through linkages by community health ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551714420301993

A community-based asthma program: Study design and ... The aims of this study are to assess the effect of RVA Breathes on asthma-related healthcare utilization, as well as secondary outcomes of asthma control, ...

5. cdc.gov cdc.gov/pcd/issues/2024/24_0344.htm

Public Health Actions to Reduce the Burden of Asthma Across the US, public health and clinical institutions work to meet the health care needs of children and adults with asthma (1–3).

6. health.maryland.gov health.maryland.gov/phpa/OEHFP/EH/pages/asthma.aspx

Pages - Asthma - Maryland Department of Health The Childhood Lead Poisoning Prevention and Environmental Case Management Program provides in-home services to reduce exposures to lead and to asthma triggers.

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

Updates in School-Based Asthma Management - PMC Evaluating outcomes of children's asthma self-management education through sustainable community-university partnerships. Public Health Nurs. 2020;37(4):525 ...

8. asthmacommunitynetwork.org asthmacommunitynetwork.org/

Home | AsthmaCommunityNetwork.org AsthmaCommunityNetwork.org is an interactive space for community-based asthma programs and the organizations that sponsor them—including health plans and ...