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.

Study Overview

• Status: Recruiting
• Conditions: Asthma in Children
• Intervention / Treatment: Behavioral: Asthma CHAMPS full program; Behavioral: Asthma CHAMPS Wait List Control

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.

• Study Type: Interventional
• Enrollment (Estimated): 1000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michelle N Eakin, PhD; Phone Number: 410-550-0487; Email: meakin1@jhmi.edu
• Study Contact Backup: Name: Meredith McCormack, MD MHS; Email: mmccor16@jhmi.edu

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21202
      • Recruiting
      • Baltimore City Public Schools
      • Contact: Christopher Wohn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Asthma-related absences	Administrative data from schools on attendance for child with asthma	4 years
Emergency Department (ED) utilization for asthma by children	Counts of ED visits for asthma	4 years
Hospitalization for asthma by children	Counts of hospital admissions for asthma	4 years
Oral corticosteroid steroid prescription for asthma by children	Counts of prescribed oral corticosteroids for asthma	4 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intervention penetration as assessed by counts	Counts of asthma education sessions for family and staff	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.	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.	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.	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.	4 years

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); Baltimore City Health Department; Baltimore City Public Schools
• Investigators: Principal Investigator: Michelle N Ealin, PhD, JHU; Principal Investigator: Meredith McCormack, MD MHS, JHU

Study record dates

Study Major Dates

• Study Start (Actual): November 27, 2023
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: March 20, 2023
• First Submitted That Met QC Criteria: March 31, 2023
• First Posted (Actual): April 18, 2023

Study Record Updates

• Last Update Posted (Actual): August 12, 2025
• Last Update Submitted That Met QC Criteria: August 7, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Asthma
• Other Study ID Numbers: IRB00301358; HL157845 (Other Identifier: NHLBI)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No