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

Trial Summary

What is the purpose of this trial?

This trial aims to help children in Baltimore City elementary schools manage their asthma better. The program teaches kids and their caregivers how to control asthma symptoms, reducing school absences and emergency healthcare visits.

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 data supports the effectiveness of the Asthma CHAMPS treatment 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, such as reducing missed school days and urgent care visits, and increasing asthma knowledge. Additionally, school-based asthma programs that involve strong partnerships among families, clinicians, and schools have been successful in improving asthma care for children. ^{1 2 3 4 5}

Is the Asthma CHAMPS Program for Childhood Asthma safe for children?

The available research on asthma management programs, including those similar to Asthma CHAMPS, suggests they are generally safe for children. These programs focus on education and self-management, which have been shown to improve asthma control and reduce hospital visits without indicating any safety concerns. ^{5 6 7 8 9}

How is the Asthma CHAMPS treatment different from other asthma treatments?

The Asthma CHAMPS program is unique because it combines community, home, and school management strategies to improve asthma care, focusing on education and self-management for children and their families, which is not typically emphasized in standard treatments. ^{1 5 7 10 11}

Research Team

Michelle N Ealin, PhD

Principal Investigator

JHU

Meredith McCormack, MD MHS

Principal Investigator

JHU

Eligibility Criteria

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.

I am 18 years old or older.

Exclusion Criteria

Unwilling to consent

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

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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]

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]

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]

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]

References

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

Can children teach their parents about asthma? [2017]

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

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

4. United States 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. [2019]

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

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

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

Translating evidence-based interventions into practice: the design and development of the Merck Childhood Asthma Network, Inc. (MCAN). [2011]

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

A community-based strategy for improving asthma management and outcomes for preschoolers. [2021]

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

An offsite activity policy for asthma camp. [2010]

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

The awesome Asthma School Days Program: educating children, inspiring a community. [2019]

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

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

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

Strategies for improving asthma outcomes: a case-based review of successes and pitfalls. [2023]