- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07819747
Resources and Education for Addressing Chronic Health (REACH) (REACH)
Piloting REACH - a School-Based Care Coordination Service Model to Support Youth With Asthma: A Systems Approach
Study Overview
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Dr. Kelly M. Harris, PhD, CCC-SLP
- Phone Number: 314-273-3242
- Email: kmharris@wustl.edu
Study Contact Backup
- Name: Madelyn Yoo, MSOT
- Phone Number: 314-400-8118
- Email: m.g.yoo@wustl.edu
Study Locations
-
-
Missouri
-
St Louis, Missouri, United States, 63110
- Recruiting
- WashU School of Medicine
-
Contact:
- Madelyn Yoo, MSOT
- Phone Number: 314-400-8118
- Email: m.g.yoo@wustl.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Parents (N=200)/Children (N=200)
Inclusion criteria for recruited parents/children:
- parents/caregivers with at least one child with asthma or present to the nurse with asthma symptoms in the partner school district,
- child with asthma must have a diagnosis of asthma or suspected asthma due to asthma symptom-related healthcare utilization and/or multiple visits to the school nurse (>1)
- attend a school in one of the partner school districts
- have access to email and a computer or other mobile device
- receive care within the BJH/ WUSM system (an indicator of participation in the electronic health record system).
Exclusion Criteria for recruited families:
- Child does not have asthma and do not present to school nurse with asthma symptoms
- Child does not attend one of the identified schools in a partner school district
- Children in foster care or wards of the state
School Nurses (Implementers) (N=15)
Inclusion Criteria for school nurses:
- Employed by partner school district and work in an identified building
- Provide care to students with asthma or present with asthma symptoms
Exclusion Criteria for school nurses:
- Do not work for partner school district or for an identified building
Providers (N =15)
Inclusion Criteria for Providers:
- Provide care to a child participant on the study
Exclusion Criteria for Providers:
- Do not provide care to a child participant on 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: REACH
Consists of school nurses who serve as both participants and REACH intervention implementers, students and their caregivers, and student providers.
Though there are several participant types, there is only 1 experimental group.
All participants serve as their own controls.
|
The REACH intervention which includes (a) a strategic communication or messaging and dissemination strategy to build school and family relationships and trust, (b) capacity building activities to improve asthma knowledge and awareness through asthma education and resource provided both digitally and in-person, and (c) a tool or dashboard that allows records and communication sharing across healthcare and educational systems to facilitate care coordination (REACH tool).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Asthma knowledge and awareness
Time Frame: Measured at baseline and at study completion (average of 1 year)
|
Measured via survey.
Data collected from student caregivers and school nurse implementers.
|
Measured at baseline and at study completion (average of 1 year)
|
|
Implementation
Time Frame: Measured at mid-trial (school nurses only) and at study completion (average of 1 year)
|
Measured via surveys and post-trial semi-structured focus group/interview.
Data collected from student caregivers, school nurse implementers, and providers.
|
Measured at mid-trial (school nurses only) and at study completion (average of 1 year)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Asthma guideline adherence
Time Frame: Measured at baseline and at study completion (average of 1 year)
|
Measured via survey.
Data collected from student caregivers and school nurse implementers.
|
Measured at baseline and at study completion (average of 1 year)
|
|
School connectedness
Time Frame: Measured at baseline and at study completion (average of 1 year)
|
Measured via survey.
Data collected from student caregivers.
|
Measured at baseline and at study completion (average of 1 year)
|
|
Healthcare utilization
Time Frame: 24 months prior to intervention, during intervention, and 12 months following intervention completion
|
Number of asthma related emergency department visits, hospitalizations, and clinic/office visits collected from the electronic medical record.
|
24 months prior to intervention, during intervention, and 12 months following intervention completion
|
|
School Attendance/Absence
Time Frame: 24 months prior to intervention, during intervention, and 12 months following intervention completion
|
Number of days student is attends school, and number of school absence days.
Data provided by the school.
|
24 months prior to intervention, during intervention, and 12 months following intervention completion
|
Collaborators and Investigators
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
- 202605145
- SCH205081 (Other Grant/Funding Number: William T Grant Foundation)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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