NCT05814510

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. 1.Evaluate the effectiveness of a tailored implementation plan of Asthma CHAMPS in 32 Baltimore city elementary schools to reduce asthma disparities.
  2. 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for not_applicable

Timeline
14mo left

Started Nov 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress69%
Nov 2023Jun 2027

First Submitted

Initial submission to the registry

March 20, 2023

Completed
29 days until next milestone

First Posted

Study publicly available on registry

April 18, 2023

Completed
7 months until next milestone

Study Start

First participant enrolled

November 27, 2023

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2027

Last Updated

August 12, 2025

Status Verified

August 1, 2025

Enrollment Period

3.6 years

First QC Date

March 20, 2023

Last Update Submit

August 7, 2025

Conditions

Asthma in Children

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (5)

  • Intervention penetration as assessed by counts

    4 years

  • Acceptability of Intervention (AIM) as assessed by a 4 item questionnaire

    4 years

  • Intervention Appropriateness Measure (IAM) as assessed by a 4 item questionnaire

    4 years

  • Feasibility of Intervention (FIM) as assessed by a 4 item questionnaire

    4 years

  • Intervention Satisfaction as assessed by a composite measure

    4 years

Study Arms (3)

School staff

EXPERIMENTAL

School staff in a K-8 school participating in Asthma CHAMPS

Behavioral: Asthma CHAMPS full programBehavioral: Asthma CHAMPS Wait List Control

Children with asthma

EXPERIMENTAL

Aged 5-13 and enrolled in Baltimore City Public School participating in Asthma CHAMPS

Behavioral: Asthma CHAMPS full programBehavioral: Asthma CHAMPS Wait List Control

Caregivers of children with asthma

EXPERIMENTAL

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 programBehavioral: Asthma CHAMPS Wait List Control

Interventions

Asthma CHAMPS full programBEHAVIORAL

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

Caregivers of children with asthmaChildren with asthmaSchool staff
Asthma CHAMPS Wait List ControlBEHAVIORAL

Stepped wedge design

Caregivers of children with asthmaChildren with asthmaSchool staff

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 18 or older
  • Current caregiver of child with asthma or staff member at a Baltimore City K-8 Public School in Asthma CHAMPS

You may not qualify if:

  • Unwilling to consent
  • Children with asthma
  • Asthma diagnosis
  • Currently enrolled in Baltimore City K-8 Public School participating in Asthma CHAMPS
  • Unwilling to provide assent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baltimore City Public Schools

Baltimore, Maryland, 21202, United States

RECRUITING

Study Officials

  • Michelle N Ealin, PhD

    JHU

    PRINCIPAL INVESTIGATOR

  • Meredith McCormack, MD MHS

    JHU

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Michelle N Eakin, PhD

CONTACT

410-550-0487meakin1@jhmi.edu

Meredith McCormack, MD MHS

CONTACT

mmccor16@jhmi.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 20, 2023

First Posted

April 18, 2023

Study Start

November 27, 2023

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

June 30, 2027

Last Updated

August 12, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)