An interventional study of Asthma CHAMPS full program and Asthma CHAMPS Wait List Control in Asthma in Children, sponsored by Johns Hopkins University. Recruiting at 1 site in United States. Per ClinicalTrials.gov, last updated 2026-08-10.
Sponsored by Johns Hopkins University · Not applicable, Interventional, and Other
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:
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.
Johns Hopkins University is the lead sponsor of 1,783 studies on the registry; 313 are open to participants now.
Of its 203 completed or terminated interventional studies of FDA-regulated products, 140 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
Adult
Inclusion Criteria:
Exclusion Criteria:
Children with asthma
Inclusion Criteria:
Exclusion Criteria:
School staff in a K-8 school participating in Asthma CHAMPS
Behavioral: Asthma CHAMPS full program · Behavioral: Asthma CHAMPS Wait List Control
Aged 5-13 and enrolled in Baltimore City Public School participating in Asthma CHAMPS
Behavioral: Asthma CHAMPS full program · Behavioral: Asthma CHAMPS Wait List Control
Caregiver of a child with asthma that is aged 5-13 enrolled in a Baltimore City Public School participating in Asthma CHAMPS
Behavioral: Asthma CHAMPS full program · Behavioral: Asthma CHAMPS Wait List Control
Full program includes (1) education for staff, students, and caregivers (2) environmental education and intervention (3) asthma care coordination (4) resources
Stepped wedge design
Asthma-related absences
Administrative data from schools on attendance for child with asthma
Time frame: 4 years
Emergency Department (ED) utilization for asthma by children
Counts of ED visits for asthma
Time frame: 4 years
Hospitalization for asthma by children
Counts of hospital admissions for asthma
Time frame: 4 years
Oral corticosteroid steroid prescription for asthma by children
Counts of prescribed oral corticosteroids for asthma
Time frame: 4 years
Intervention penetration as assessed by counts
Counts of asthma education sessions for family and staff
Time frame: 4 years
Acceptability of Intervention (AIM) as assessed by a 4 item questionnaire
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.
Time frame: 4 years
Intervention Appropriateness Measure (IAM) as assessed by a 4 item questionnaire
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.
Time frame: 4 years
Feasibility of Intervention (FIM) as assessed by a 4 item questionnaire
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.
Time frame: 4 years
Intervention Satisfaction as assessed by a composite measure
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.
Time frame: 4 years
Plan to share: No
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