- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06320210
Chicago Asthma School-Directed Child-Centered Assessment and Dissemination of Evidence (CASCADE)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Significant health disparities persist in childhood asthma prevalence and morbidity despite existing evidence-based asthma guidelines that have been shown to improve outcomes. Schools are an integral partner in asthma management. Prior literature has outlined various targeted school-based interventions with some positive outcomes; however, these programs focus on individual components of the guidelines and take place transiently without integration into school processes for sustainability. To more comprehensively impact asthma care, schools have enacted policies to support guideline-based practices; however, implementation falls short and thus these policies have not led to effective, systemic practices. Therefore, this project aims to bridge the gap in the implementation of asthma guidelines and policies by developing and evaluating a pragmatic, multicomponent school-directed, child-centered asthma program that builds upon existing targeted interventions and is integrated in the school to foster sustainability. This innovative project contributes beyond existing school-based programs by simultaneously and pragmatically implementing multiple components of the asthma guidelines through school-wide systems and streamlined processes led by lay health workers.
A multi-level program will be put in place for all students and families within the school. Intervention components will include: in-depth training for current school staff who are critical in asthma care, restructured processes to identify students with asthma, technological adaptations to create integrated tracking systems for asthma care and absenteeism, strategies to enhance communication about asthma within school and between school and home, protocols for routine care (e.g., participation in gym/recess) and emergencies, and education for all students about asthma.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Anna Volerman, MD
- Phone Number: 773-702-5905
- Email: avbeaser@bsd.uchicago.edu
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60640
- Recruiting
- University of Chicago Charter Schools
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Study Population
Description
Participants will be included in the study if:
- The participant either works at, attends, or is the legal guardian of a child who attends one of the two elementary schools included in the study from the University of Chicago Charter Schools - North Kenwood Oakland and Donoghue.
- The child participant has a diagnosis of asthma OR the parent participant is legal guardian of a child with asthma.
- The adult stakeholder is 18 years or older.
Participants will be excluded from the study if:
- The participant declines or is unable to provide consent/assent
- The participant does not speak or read English
- The participant has already enrolled in the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Children with asthma, parents/guardians of children with asthma, school staff
Children will be recruited from two University of Chicago Charter elementary schools. Children with a diagnosis of asthma and their parents will be eligible for inclusion in the study and will specifically be targeted for study recruitment. Staff and administrators at each school will also be recruited through in-person, phone, and email communication, primarily through word of mouth and professional development days. UCCS teachers, staff, and administrators will also be included in the program evaluation and we will obtain appropriate consent. Up to 400 families with a child/children with asthma from two UCCS schools will be added to a registry database. A total of 68 children with a diagnosis of asthma and their parents will be recruited for evaluation of the multi-component program, resulting in a total of 136 children and parents. We will also recruit 24 teachers, staff, and administrators across the two schools to participate in the evaluation of the overall program. |
The intervention is a multi-component program that includes in-depth training for current school teachers/staff who are critical in asthma care, restructured processes to identify students with asthma, technological adaptations to support integrated systems for asthma care and absenteeism, strategies to enhance communication about asthma within school and between school and home, protocols for routine care (e.g., participation in gym/recess) and emergencies, and education for all students about asthma.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Asthma control
Time Frame: Years 1 and 2
|
Childhood Asthma Control Test
|
Years 1 and 2
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Missed work days in parents
Time Frame: Years 1 and 2
|
Parent reports, logs
|
Years 1 and 2
|
Asthma knowledge - parents
Time Frame: Years 1 and 2
|
Asthma Knowledge Scale
|
Years 1 and 2
|
Asthma knowledge - child
Time Frame: Years 1 and 2
|
Asthma Knowledge Scale
|
Years 1 and 2
|
Asthma quality of life - child
Time Frame: Years 1 and 2
|
Pediatric Asthma Quality of Life Questionnaire
|
Years 1 and 2
|
Caregiver quality of life
Time Frame: Years 1 and 2
|
Pediatric Asthma Caregiver's Quality of Life Questionnaire
|
Years 1 and 2
|
Asthma impact - parent
Time Frame: Years 1 and 2
|
Parent Proxy Asthma Impact Scale
|
Years 1 and 2
|
Missed school days
Time Frame: Years 1 and 2
|
School records, parent report, logs
|
Years 1 and 2
|
Healthcare utilization
Time Frame: Years 1 and 2
|
Parent report and logs of ambulatory visits, emergency department visits, hospitalizations
|
Years 1 and 2
|
Asthma impact - child
Time Frame: Years 1 and 2
|
Pediatric Asthma Impact Scale
|
Years 1 and 2
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Anna Volerman, MD, University Of Chicago
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB19-1308
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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