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

Asthma in Children Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05814510
• Other study ID #: IRB00301358
• Secondary ID: HL157845
• Status: Recruiting
• Phase: N/A
• Start date: November 27, 2023
• Est. completion date: June 30, 2027

Study information

• Verified date: December 2023
• Source: Johns Hopkins University
• Contact: Michelle N Eakin, PhD
• Phone: 410-550-0487
• Email: meakin1[@]jhmi.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: June 30, 2027
• Est. primary completion date: June 30, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Asthma in Children

Intervention

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
• Asthma CHAMPS Wait List Control
Stepped wedge design

Locations

Country	Name	City	State
United States	Baltimore City Public Schools	Baltimore	Maryland

Sponsors (4)

Lead Sponsor	Collaborator
Johns Hopkins University	Baltimore City Health Department, Baltimore City Public Schools, National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Asthma-related absences	Administrative data from schools on attendance for child with asthma	4 years
Primary	Emergency Department (ED) utilization for asthma by children	Counts of ED visits for asthma	4 years
Primary	Hospitalization for asthma by children	Counts of hospital admissions for asthma	4 years
Primary	Oral corticosteroid steroid prescription for asthma by children	Counts of prescribed oral corticosteroids for asthma	4 years
Secondary	Intervention penetration as assessed by counts	Counts of asthma education sessions for family and staff	4 years
Secondary	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
Secondary	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
Secondary	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
Secondary	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