Asthma in ChildrenNCT05814510
Implementation of Asthma Community Home and School Management Program (Asthma CHAMPS)
A study testing Asthma CHAMPS full program in people with Asthma in Children, run by Johns Hopkins University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Asthma in Children
- What is being tested?
- Asthma CHAMPS full program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Nov 2023to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Aged 18 or older
- Current caregiver of child with asthma or staff member at a Baltimore City K-8 Public School in Asthma CHAMPS
- Asthma diagnosis
- Currently enrolled in Baltimore City K-8 Public School participating in Asthma CHAMPS
Who cannot join
- Unwilling to consent
- Children with asthma
- Unwilling to provide assent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Meredith McCormack, MD MHS contact
United States1 site, 1 recruiting
- Recruiting
Baltimore City Public Schools
Baltimore, Maryland, 21202
Christopher Wohn
About this study
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:
- Evaluate the effectiveness of a tailored implementation plan of Asthma CHAMPS in 32 Baltimore city elementary schools to reduce asthma disparities.
- 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.
- 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.
Read the 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.
- Conditions
- Asthma in Children
- Being tested
- Asthma CHAMPS full program, Asthma CHAMPS Wait List Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Asthma CHAMPS full programBehavioural
Full program includes (1) education for staff, students, and caregivers (2) environmental education and intervention (3) asthma care coordination (4) resources
Asthma CHAMPS Wait List ControlBehavioural
Stepped wedge design
| Study group | Role | What they receive |
|---|---|---|
| School staff | Experimental | School staff in a K-8 school participating in Asthma CHAMPS Receives: Behavioral: Asthma CHAMPS full program; Behavioral: Asthma CHAMPS Wait List Control |
| Children with asthma | Experimental | Aged 5-13 and enrolled in Baltimore City Public School participating in Asthma CHAMPS Receives: Behavioral: Asthma CHAMPS full program; Behavioral: 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 Receives: Behavioral: Asthma CHAMPS full program; Behavioral: Asthma CHAMPS Wait List Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Asthma-related absences
Administrative data from schools on attendance for child with asthma
Measured: 4 years
Emergency Department (ED) utilization for asthma by children
Counts of ED visits for asthma
Measured: 4 years
Hospitalization for asthma by children
Counts of hospital admissions for asthma
Measured: 4 years
Oral corticosteroid steroid prescription for asthma by children
Counts of prescribed oral corticosteroids for asthma
Measured: 4 years
Secondary outcomes (5)
Intervention penetration as assessed by counts
Counts of asthma education sessions for family and staff
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start27 Nov 2023
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma in ChildrenStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Baltimore City Public Schools, Baltimore City Health Department, National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Michelle N Ealin, PhD, Principal investigator, JHUMeredith McCormack, MD MHS, Principal investigator, JHU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05814510
- Sponsor's protocol ID
- IRB00301358
- Other IDs
- HL157845
- Status last verified
- Aug 2026
- First submitted
- 20 Mar 2023
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of Asthma Community Home and School Management Program (Asthma CHAMPS)
- ClinicalTrials.gov ID
- NCT05814510
- Acronym / sponsor ID
- IRB00301358
- Conditions
- Asthma in Children
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Baltimore City Public Schools, Baltimore City Health Department, National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 27 Nov 2023 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 18 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Evaluate the effectiveness of a tailored implementation plan of Asthma CHAMPS in 32 Baltimore city elementary schools to reduce asthma disparities.
- 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.
- 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| School staff | Experimental | Behavioral: Asthma CHAMPS full program, Behavioral: Asthma CHAMPS Wait List ControlSchool staff in a K-8 school participating in Asthma CHAMPS |
| Children with asthma | Experimental | Behavioral: Asthma CHAMPS full program, Behavioral: Asthma CHAMPS Wait List ControlAged 5-13 and enrolled in Baltimore City Public School participating in Asthma CHAMPS |
| Caregivers of children with asthma | Experimental | Behavioral: Asthma CHAMPS full program, Behavioral: Asthma CHAMPS Wait List ControlCaregiver of a child with asthma that is aged 5-13 enrolled in a Baltimore City Public School participating in Asthma CHAMPS |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 18 or older
- Current caregiver of child with asthma or staff member at a Baltimore City K-8 Public School in Asthma CHAMPS
- Asthma diagnosis
- Currently enrolled in Baltimore City K-8 Public School participating in Asthma CHAMPS
Key exclusion criteria (3 listed)
- Unwilling to consent
- Children with asthma
- Unwilling to provide assent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Asthma CHAMPS full programFull program includes (1) education for staff, students, and caregivers (2) environmental education and intervention (3) asthma care coordination (4) resources | Behavioural | Caregivers of children with asthma, Children with asthma, School staff |
| Asthma CHAMPS Wait List ControlStepped wedge design | Behavioural | Caregivers of children with asthma, Children with asthma, School staff |
Primary outcome
Asthma-related absences
Time frame: 4 years
Administrative data from schools on attendance for child with asthma
Emergency Department (ED) utilization for asthma by children
Time frame: 4 years
Counts of ED visits for asthma
Hospitalization for asthma by children
Time frame: 4 years
Counts of hospital admissions for asthma
Oral corticosteroid steroid prescription for asthma by children
Time frame: 4 years
Counts of prescribed oral corticosteroids for asthma
5 secondary outcomes
Intervention penetration as assessed by counts
Time frame: 4 years
Acceptability of Intervention (AIM) as assessed by a 4 item questionnaire
Time frame: 4 years
Intervention Appropriateness Measure (IAM) as assessed by a 4 item questionnaire
Time frame: 4 years
Feasibility of Intervention (FIM) as assessed by a 4 item questionnaire
Time frame: 4 years
Intervention Satisfaction as assessed by a composite measure
Time frame: 4 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Asthma in Children
Not yet recruiting
Asthma Ctrl SMART Trial
Asthma in Children, Asthma Chronic
Not yet recruiting
Artificially Intelligent Robot Control
Asthma in Children, Artificial Intelligence
Not yet recruiting
Bilevel Positive Airway Pressure (BPAP) for Severe Asthma
Pediatric Asthma, Acute Asthma
Recruiting
Effects of Tele-rehabilitation-Guided Qigong on Children and Adolescents With Asthma
Asthma Childhood
Enrolling by invitationObservational study
Investigating Novel Strategies in Pediatric Immune Responses and Microbiome Environment: Comprehensive Lung Disease Investigation in Children.
Lung Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Meredith McCormack, MD MHS contact
Michelle N Ealin, PhD principal investigator
JHU
Meredith McCormack, MD MHS principal investigator
JHU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Asthma CHAMPS full program in people with Asthma in Children, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michelle N Eakin, PhD (410-550-0487, meakin1@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Asthma-related absences (time frame: 4 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.