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NCT Number: NCT05814510

Implementation of Asthma Community Home and School Management Program (Asthma CHAMPS)

The long-term goal is to implement an evidence-based asthma intervention based on the Center for Disease Control's recommended framework (EXHALE) within Baltimore City Public Schools (BCPS). As part of a stepped wedge pragmatic trial the investigators will:

1. Evaluate the effectiveness of a tailored implementation plan of Asthma CHAMPS in 32 Baltimore city elementary schools to reduce asthma disparities. 2. Conduct a pragmatic trail using a stepped wedge design to evaluate implementation of a school and home asthma intervention program to reduce asthma-related absences, healthcare utilization and exacerbations and improve asthma control, among children enrolled in 32 Baltimore City elementary schools. 3. Use qualitative methods (observation and semi structured interviews) to obtain stakeholder feedback (parents, community health workers, school personnel and administrators) on impact of Asthma CHAMPS, identify potential refinements in intervention and implementation strategies, and evaluate impact of local adaptation and fidelity on implementation success and sustainability.

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Key information

Conditions

Asthma in Children

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Baltimore City Public Schools

Baltimore, Maryland, 21202, United States

Location status: Recruiting

Location contact

Christopher Wohn

CONTACT

About this study

Implementation Aim: Evaluate the effectiveness of a tailored implementation plan of Asthma CHAMPS in 32 Baltimore city elementary schools to reduce asthma disparities.

Hypothesis: The investigators hypothesize that Baltimore City schools will have greater adoption and penetration of Asthma CHAMPS (e.g. more schools participating, and more staff and family asthma education sessions), greater feasibility/acceptability (e.g. more staff participating in asthma care activities, greater staff confidence in managing asthma) and greater satisfaction and appropriateness with a tailored implementation strategy compared to wait list-control group.

The long-term goal is to implement an evidence-based asthma intervention based on the Centers for Disease Control (CDC) recommended framework (EXHALE)14 within BCPS. To provide the foundation for success, the investigators will identify and engage local key stakeholders, conduct a community needs assessment to inform necessary refinement and adaptations of the interventions, and develop a tailored collaborative strategy to ensure successful implementation of an asthma intervention program. Results for this multi-phase project will identify best practices for implementation of a tailored multi-level asthma intervention program (Asthma CHAMPS: Community and Home Asthma Management Program in Schools), within Baltimore City Schools to reduce asthma disparities.

Effectiveness Aim: Conduct a pragmatic trail using a stepped wedge design to evaluate implementation of a school and home asthma intervention program to reduce asthma-related absences, healthcare utilization and exacerbations and improve asthma control, among children enrolled in 32 Baltimore City elementary schools.

Hypothesis: Children with asthma who attend schools engaged in Asthma CHAMPS program will have improved asthma outcomes, including improved asthma control, reduced ED visits/hospitalizations and courses of oral corticosteroids and impact (reduced asthma-related school absences).

Qualitative Aim: Use qualitative methods (observation and semi structured interviews) to obtain stakeholder feedback (parents, community health workers, school personnel and administrators) on impact of Asthma CHAMPS, identify potential refinements in intervention and implementation strategies, and evaluate impact of local adaptation and fidelity on implementation success and sustainability.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Adult

Inclusion criteria

  • Aged 18 or older
  • Current caregiver of child with asthma or staff member at a Baltimore City K-8 Public School in Asthma CHAMPS

Exclusion criteria

  • Unwilling to consent

Children with asthma

Inclusion criteria

  • Asthma diagnosis
  • Currently enrolled in Baltimore City K-8 Public School participating in Asthma CHAMPS

Exclusion criteria

  • Unwilling to provide assent

Treatment and study plan

Asthma CHAMPS full program

Behavioral

Full program includes (1) education for staff, students, and caregivers (2) environmental education and intervention (3) asthma care coordination (4) resources

Asthma CHAMPS Wait List Control

Behavioral

Stepped wedge design

Primary outcomes

  1. Asthma-related absences

    Time frame: 4 years

    Administrative data from schools on attendance for child with asthma

  2. Emergency Department (ED) utilization for asthma by children

    Time frame: 4 years

    Counts of ED visits for asthma

  3. Hospitalization for asthma by children

    Time frame: 4 years

    Counts of hospital admissions for asthma

  4. Oral corticosteroid steroid prescription for asthma by children

    Time frame: 4 years

    Counts of prescribed oral corticosteroids for asthma

Secondary outcomes

  1. Intervention penetration as assessed by counts

    Time frame: 4 years

    Counts of asthma education sessions for family and staff

  2. Acceptability of Intervention (AIM) as assessed by a 4 item questionnaire

    Time frame: 4 years

    4 item measure of implementation outcome often considered "leading indicator" of implementation success. Administered on a 5 point Likert scale with higher scores indicating greater agreement with specific items.

  3. Intervention Appropriateness Measure (IAM) as assessed by a 4 item questionnaire

    Time frame: 4 years

    4 item measure of implementation outcome often considered "leading indicator" of implementation success. Administered on a 5 point Likert scale with higher scores indicating greater agreement with specific items.

  4. Feasibility of Intervention (FIM) as assessed by a 4 item questionnaire

    Time frame: 4 years

    4 item measure of implementation outcome often considered "leading indicator" of implementation success. Administered on a 5 point Likert scale with higher scores indicating greater agreement with specific items.

  5. Intervention Satisfaction as assessed by a composite measure

    Time frame: 4 years

    Composite measure administered to staff and caregivers with items assessing asthma management motivation and confidence. Answer options are on a scale of 1-10 with higher scores generally indicating greater agreement.

Study contacts

Contact information is provided by the study sponsor or research team.

Meredith McCormack, MD MHS

CONTACT

[email protected]

Michelle N Eakin, PhD

CONTACT

[email protected]

410-550-0487

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • Baltimore City Health Department
  • Baltimore City Public Schools
  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Apr 18, 2023
Registry last updated
Aug 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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