Back to resultsImplementation of Asthma Community Home and School Management Program (Asthma CHAMPS)
Primary Purpose
Asthma in Children
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Asthma CHAMPS full program
Asthma CHAMPS Wait List Control
Sponsored by
About this trial
This is an interventional other trial for Asthma in Children
Eligibility Criteria
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
Sites / Locations
- Baltimore City Public Schools
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
School staff
Children with asthma
Caregivers of children with asthma
Arm Description
School staff in a K-8 school participating in Asthma CHAMPS
Aged 5-13 and enrolled in Baltimore City Public School participating in Asthma CHAMPS
Caregiver of a child with asthma that is aged 5-13 enrolled in a Baltimore City Public School participating in Asthma CHAMPS
Outcomes
Primary Outcome Measures
Asthma-related absences
Administrative data from schools on attendance for child with asthma
Emergency Department (ED) utilization for asthma by children
Counts of ED visits for asthma
Hospitalization for asthma by children
Counts of hospital admissions for asthma
Oral corticosteroid steroid prescription for asthma by children
Counts of prescribed oral corticosteroids for asthma
Secondary Outcome Measures
Intervention penetration as assessed by counts
Counts of asthma education sessions for family and staff
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.
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.
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.
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.
Full Information
NCT ID
NCT05814510
First Posted
March 20, 2023
Last Updated
August 7, 2023
Sponsor
Johns Hopkins University
Collaborators
Baltimore City Public Schools, Baltimore City Health Department, National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT05814510
Brief Title
Implementation of Asthma Community Home and School Management Program (Asthma CHAMPS)
Official Title
Implementation of Asthma Community Home and School Management Program (Asthma CHAMPS)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 1, 2023 (Anticipated)
Primary Completion Date
June 30, 2027 (Anticipated)
Study Completion Date
June 30, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
Baltimore City Public Schools, Baltimore City Health Department, National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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:
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma in Children
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
School staff
Arm Type
Experimental
Arm Description
School staff in a K-8 school participating in Asthma CHAMPS
Arm Title
Children with asthma
Arm Type
Experimental
Arm Description
Aged 5-13 and enrolled in Baltimore City Public School participating in Asthma CHAMPS
Arm Title
Caregivers of children with asthma
Arm Type
Experimental
Arm Description
Caregiver of a child with asthma that is aged 5-13 enrolled in a Baltimore City Public School participating in Asthma CHAMPS
Intervention Type
Behavioral
Intervention Name(s)
Asthma CHAMPS full program
Intervention Description
Full program includes (1) education for staff, students, and caregivers (2) environmental education and intervention (3) asthma care coordination (4) resources
Intervention Type
Behavioral
Intervention Name(s)
Asthma CHAMPS Wait List Control
Intervention Description
Stepped wedge design
Primary Outcome Measure Information:
Title
Asthma-related absences
Description
Administrative data from schools on attendance for child with asthma
Time Frame
4 years
Title
Emergency Department (ED) utilization for asthma by children
Description
Counts of ED visits for asthma
Time Frame
4 years
Title
Hospitalization for asthma by children
Description
Counts of hospital admissions for asthma
Time Frame
4 years
Title
Oral corticosteroid steroid prescription for asthma by children
Description
Counts of prescribed oral corticosteroids for asthma
Time Frame
4 years
Secondary Outcome Measure Information:
Title
Intervention penetration as assessed by counts
Description
Counts of asthma education sessions for family and staff
Time Frame
4 years
Title
Acceptability of Intervention (AIM) as assessed by a 4 item questionnaire
Description
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
Title
Intervention Appropriateness Measure (IAM) as assessed by a 4 item questionnaire
Description
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
Title
Feasibility of Intervention (FIM) as assessed by a 4 item questionnaire
Description
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
Title
Intervention Satisfaction as assessed by a composite measure
Description
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.
Time Frame
4 years
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michelle N Eakin, PhD
Phone
410-550-0487
Email
meakin1@jhmi.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Meredith McCormack, MD MHS
Email
mmccor16@jhmi.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michelle N Ealin, PhD
Organizational Affiliation
JHU
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Meredith McCormack, MD MHS
Organizational Affiliation
JHU
Official's Role
Principal Investigator
Facility Information:
Facility Name
Baltimore City Public Schools
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21202
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christopher Wohn
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Implementation of Asthma Community Home and School Management Program (Asthma CHAMPS)
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