NCT04060823

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
512

participants targeted

Target at P75+ for not_applicable asthma

Timeline
Completed

Started Aug 2019

Typical duration for not_applicable asthma

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 12, 2019

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

August 16, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 19, 2019

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

May 10, 2023

Status Verified

May 1, 2023

Enrollment Period

2.4 years

First QC Date

August 16, 2019

Last Update Submit

May 9, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Easy Breathing

EXPERIMENTAL

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

Other: Easy Breathing program

Interventions

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.

Easy Breathing

Eligibility Criteria

Age6 Months - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Any child between 6 months and 18 years of age at one of the primary care clinics in Braford county.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Bradford County Health Department

Starke, Florida, 32091, United States

Location

Shands Starke Medical Group

Starke, Florida, 32091, United States

Location

Southside Elementary School

Starke, Florida, 32091, United States

Location

Starke Elementary School

Starke, Florida, 32091, United States

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • David A Fedele, PhD

    University of Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 16, 2019

First Posted

August 19, 2019

Study Start

August 12, 2019

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

May 10, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations