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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04060823
Other study ID # IRB201803077
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 12, 2019
Est. completion date December 31, 2021

Study information

Verified date May 2023
Source University of Florida
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of the study is to pilot test the implementation of healthcare provider education interventions to improve asthma outcomes in rural youth residing in Bradford County, Florida. The investigators propose to assess the feasibility and acceptability of implementing the Easy Breathing program a rural, medically underserved county and evaluate changes in healthcare provider practices and asthma-related outcomes of rural youth diagnosed with asthma.


Recruitment information / eligibility

Status Completed
Enrollment 512
Est. completion date December 31, 2021
Est. primary completion date December 31, 2021
Accepts healthy volunteers No
Gender All
Age group 6 Months to 18 Years
Eligibility Inclusion Criteria: - Any child between 6 months and 18 years of age at one of the primary care clinics in Braford county. Exclusion Criteria: - Unable to meet inclusion criteria.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Easy Breathing program
Easy Breathing is a longstanding, nationally recognized program that translates asthma management guidelines into a standardized and usable format for healthcare providers. As part of the program primary healthcare providers will identify children at-risk for adverse asthma outcomes and provide care coordination services. Patients receive a tailored, comprehensive Asthma Treatment Plan with information regarding daily medication use and management of acute symptoms based on asthma severity.

Locations

Country Name City State
United States Bradford County Health Department Starke Florida
United States Shands Starke Medical Group Starke Florida
United States Southside Elementary School Starke Florida
United States Starke Elementary School Starke Florida

Sponsors (1)

Lead Sponsor Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in child asthma diagnosis rates Asthma diagnosis yearly rates (number of children newly diagnosed / number of children seen per year) will be compared before and after implementation of the Easy Breathing program. Baseline up to Year 1
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