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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05814510
Enrollment
1000
Registered
2023-04-18
Start date
2023-11-27
Completion date
2027-06-30
Last updated
2026-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma in Children

Brief summary

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.

Detailed description

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.

Interventions

BEHAVIORALAsthma CHAMPS full program

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

BEHAVIORALAsthma CHAMPS Wait List Control

Stepped wedge design

Sponsors

Johns Hopkins University
Lead SponsorOTHER
Baltimore City Public Schools
CollaboratorUNKNOWN
Baltimore City Health Department
CollaboratorOTHER
National Heart, Lung, and Blood Institute (NHLBI)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Asthma-related absences4 yearsAdministrative data from schools on attendance for child with asthma
Emergency Department (ED) utilization for asthma by children4 yearsCounts of ED visits for asthma
Hospitalization for asthma by children4 yearsCounts of hospital admissions for asthma
Oral corticosteroid steroid prescription for asthma by children4 yearsCounts of prescribed oral corticosteroids for asthma

Secondary

MeasureTime frameDescription
Intervention penetration as assessed by counts4 yearsCounts of asthma education sessions for family and staff
Acceptability of Intervention (AIM) as assessed by a 4 item questionnaire4 years4 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.
Intervention Appropriateness Measure (IAM) as assessed by a 4 item questionnaire4 years4 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.
Feasibility of Intervention (FIM) as assessed by a 4 item questionnaire4 years4 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.
Intervention Satisfaction as assessed by a composite measure4 yearsComposite 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.

Countries

United States

Contacts

CONTACTMichelle N Eakin, PhD
meakin1@jhmi.edu410-550-0487
CONTACTMeredith McCormack, MD MHS
mmccor16@jhmi.edu
PRINCIPAL_INVESTIGATORMichelle N Ealin, PhD

JHU

PRINCIPAL_INVESTIGATORMeredith McCormack, MD MHS

JHU

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 11, 2026