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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorJohns Hopkins University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Aged 18 or older

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

Disqualifiers

Unwilling to consent

Asthma diagnosis

Currently enrolled in Baltimore City K-8 Public School participating in Asthma CHAMPS

Unwilling to provide assent

Trial design

Design model

Sequential

Treatments tested in this trial

  • Asthma CHAMPS full program

    Behavioral

    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

    Behavioral

    Stepped wedge design

Treatment groups

1,000 Participants
are divided into 3 treatment groups
Group A: School staffExperimental treatment 2 interventions
Group B: Children with asthmaExperimental treatment 2 interventions
Group C: Caregivers of children with asthmaExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Asthma-related absences

Administrative data from schools on attendance for child with asthma

Time frame
4 years
2

Emergency Department (ED) utilization for asthma by children

Counts of ED visits for asthma

Time frame
4 years
3

Hospitalization for asthma by children

Counts of hospital admissions for asthma

Time frame
4 years
4

Oral corticosteroid steroid prescription for asthma by children

Counts of prescribed oral corticosteroids for asthma

Time frame
4 years

Secondary outcomes

1

Intervention penetration as assessed by counts

Counts of asthma education sessions for family and staff

Time frame
4 years
2

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.

Time frame
4 years
3

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.

Time frame
4 years
4

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.

Time frame
4 years

Other outcomes

Sponsors and contacts

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Johns Hopkins University

Lead sponsor

Baltimore City Public Schools

Collaborator

Baltimore City Health Department

Collaborator

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator