Purpose

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.

Condition

Eligibility

Eligible Ages
All ages
Eligible Sex
All
Accepts Healthy Volunteers
Yes

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Other
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
School staff
School staff in a K-8 school participating in Asthma CHAMPS
  • Behavioral: 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
  • Behavioral: Asthma CHAMPS Wait List Control
    Stepped wedge design
Experimental
Children with asthma
Aged 5-13 and enrolled in Baltimore City Public School participating in Asthma CHAMPS
  • Behavioral: 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
  • Behavioral: Asthma CHAMPS Wait List Control
    Stepped wedge design
Experimental
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
  • Behavioral: 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
  • Behavioral: Asthma CHAMPS Wait List Control
    Stepped wedge design

Recruiting Locations

Baltimore City Public Schools
Baltimore, Maryland 21202
Contact:
Christopher Wohn

More Details

NCT ID
NCT05814510
Status
Recruiting
Sponsor
Johns Hopkins University

Study Contact

Michelle N Eakin, PhD
410-550-0487
meakin1@jhmi.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.