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

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ClinicalTrials.gov Identifier: NCT04060823
Recruitment Status : Recruiting
First Posted : August 19, 2019
Last Update Posted : August 19, 2019
Sponsor:
Information provided by (Responsible Party):
University of Florida

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 and Putnam County, Florida. The investigators propose to assess the feasibility and acceptability of implementing the Easy Breathing programs in two rural, medically underserved counties and evaluate changes in healthcare provider practices and asthma-related outcomes of rural youth diagnosed with asthma.

Condition or disease Intervention/treatment Phase
Asthma Other: Easy Breathing program Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
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 : August 12, 2019
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

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 and school health personnel (e.g., nurses, health aides) 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.




Primary Outcome Measures :
  1. Change in child asthma diagnosis rates [ Time Frame: Baseline; 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Any child between 6 months and 18 years of age at one of the primary care clinics in Braford or Putnam counties.
  • Any child attending either Starke Elementary School and Southside Elementary School in Florida.

Exclusion Criteria:

  • Unable to meet inclusion criteria.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04060823


Contacts
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Contact: David A Fedele, PhD 352-294-5765 dfedele@phhp.ufl.edu
Contact: Deborah Amburgey, BS 352-733-0336 damburgey@phhp.ufl.edu

Locations
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United States, Florida
Azalea Health Not yet recruiting
Palatka, Florida, United States, 32177
Bradford County Health Department Not yet recruiting
Starke, Florida, United States, 32091
Shands Starke Medical Group Recruiting
Starke, Florida, United States, 32091
Southside Elementary School Not yet recruiting
Starke, Florida, United States, 32091
Starke Elementary School Not yet recruiting
Starke, Florida, United States, 32091
Sponsors and Collaborators
University of Florida
Investigators
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Principal Investigator: David A Fedele, PhD University of Florida

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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT04060823     History of Changes
Other Study ID Numbers: IRB201803077
First Posted: August 19, 2019    Key Record Dates
Last Update Posted: August 19, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases