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

Sponsor
Johns Hopkins University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05814510
Collaborator
Baltimore City Public Schools (Other), Baltimore City Health Department (Other), National Heart, Lung, and Blood Institute (NHLBI) (NIH)
1,000
1
3
46.9
21.3

Study Details

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:

  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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Asthma CHAMPS full program
  • Behavioral: Asthma CHAMPS Wait List Control
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
1000 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Implementation of Asthma Community Home and School Management Program (Asthma CHAMPS)
Anticipated Study Start Date :
Aug 1, 2023
Anticipated Primary Completion Date :
Jun 30, 2027
Anticipated Study Completion Date :
Jun 30, 2027

Arms and Interventions

Arm Intervention/Treatment
Experimental: School staff

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

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

Behavioral: Asthma CHAMPS Wait List Control
Stepped wedge design

Experimental: Children with asthma

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

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

Behavioral: Asthma CHAMPS Wait List Control
Stepped wedge design

Experimental: Caregivers of children with asthma

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

Behavioral: Asthma CHAMPS Wait List Control
Stepped wedge design

Outcome Measures

Primary Outcome Measures

  1. Asthma-related absences [4 years]

    Administrative data from schools on attendance for child with asthma

  2. Emergency Department (ED) utilization for asthma by children [4 years]

    Counts of ED visits for asthma

  3. Hospitalization for asthma by children [4 years]

    Counts of hospital admissions for asthma

  4. Oral corticosteroid steroid prescription for asthma by children [4 years]

    Counts of prescribed oral corticosteroids for asthma

Secondary Outcome Measures

  1. Intervention penetration as assessed by counts [4 years]

    Counts of asthma education sessions for family and staff

  2. Acceptability of Intervention (AIM) as assessed by a 4 item questionnaire [4 years]

    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.

  3. Intervention Appropriateness Measure (IAM) as assessed by a 4 item questionnaire [4 years]

    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. Feasibility of Intervention (FIM) as assessed by a 4 item questionnaire [4 years]

    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.

  5. Intervention Satisfaction as assessed by a composite measure [4 years]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Baltimore City Public Schools Baltimore Maryland United States 21202

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Michelle N Ealin, PhD, JHU
  • Principal Investigator: Meredith McCormack, MD MHS, JHU

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT05814510
Other Study ID Numbers:
  • IRB00301358
  • HL157845
First Posted:
Apr 18, 2023
Last Update Posted:
Apr 18, 2023
Last Verified:
Mar 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 18, 2023