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Implementing a Healthcare Provider Education Intervention in Rural Communities to Reduce Asthma Morbidity

Sponsor
University of Florida (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT04060823
Collaborator
(none)
140
Enrollment
4
Locations
1
Arm
43.6
Anticipated Duration (Months)
35
Patients Per Site
0.8
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Easy Breathing program
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
140 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Implementing a Healthcare Provider Education Intervention in Rural Communities to Reduce Asthma Morbidity
Actual Study Start Date :
Aug 12, 2019
Anticipated Primary Completion Date :
Apr 1, 2023
Anticipated Study Completion Date :
Apr 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Easy Breathing

Easy Breathing will be implemented in participating clinics. Asthma-related sick visits will be monitored for changes.

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.

Outcome Measures

Primary Outcome Measures

  1. Change in child asthma diagnosis rates [Baseline up to Year 1]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
6 Months to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Bradford County Health Department Starke Florida United States 32091
2 Shands Starke Medical Group Starke Florida United States 32091
3 Southside Elementary School Starke Florida United States 32091
4 Starke Elementary School Starke Florida United States 32091

Sponsors and Collaborators

  • University of Florida

Investigators

  • Principal Investigator: David A Fedele, PhD, University of Florida

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Florida
ClinicalTrials.gov Identifier:
NCT04060823
Other Study ID Numbers:
  • IRB201803077
First Posted:
Aug 19, 2019
Last Update Posted:
Dec 27, 2021
Last Verified:
Dec 1, 2021
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:
Asthma

Study Results

No Results Posted as of Dec 27, 2021