Implementation of Asthma Community Home and School Management Program (Asthma CHAMPS)
NCT ID: NCT05814510
Last Updated: 2025-08-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
1000 participants
INTERVENTIONAL
2023-11-27
2027-06-30
Brief Summary
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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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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
OTHER
NONE
Study Groups
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School staff
School staff in a K-8 school participating in Asthma CHAMPS
Asthma CHAMPS full program
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
Stepped wedge design
Children with asthma
Aged 5-13 and enrolled in Baltimore City Public School participating in Asthma CHAMPS
Asthma CHAMPS full program
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
Stepped wedge design
Caregivers of children with asthma
Caregiver of a child with asthma that is aged 5-13 enrolled in a Baltimore City Public School participating in Asthma CHAMPS
Asthma CHAMPS full program
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
Stepped wedge design
Interventions
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Asthma CHAMPS full program
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
Stepped wedge design
Eligibility Criteria
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Inclusion Criteria
* Current caregiver of child with asthma or staff member at a Baltimore City K-8 Public School in Asthma CHAMPS
* Asthma diagnosis
* Currently enrolled in Baltimore City K-8 Public School participating in Asthma CHAMPS
Exclusion Criteria
Children with asthma
* Unwilling to provide assent
ALL
Yes
Sponsors
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Baltimore City Public Schools
UNKNOWN
Baltimore City Health Department
OTHER
National Heart, Lung, and Blood Institute (NHLBI)
NIH
Johns Hopkins University
OTHER
Responsible Party
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Principal Investigators
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Michelle N Ealin, PhD
Role: PRINCIPAL_INVESTIGATOR
JHU
Meredith McCormack, MD MHS
Role: PRINCIPAL_INVESTIGATOR
JHU
Locations
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Baltimore City Public Schools
Baltimore, Maryland, United States
Countries
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Central Contacts
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Facility Contacts
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Christopher Wohn
Role: primary
Other Identifiers
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HL157845
Identifier Type: OTHER
Identifier Source: secondary_id
IRB00301358
Identifier Type: -
Identifier Source: org_study_id
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