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Initiation of Chronic Asthma Care Regimens in the Pediatric Emergency Department

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2006 by Baylor College of Medicine.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
AstraZeneca
Information provided by:
Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT00388739
First received: October 13, 2006
Last updated: NA
Last verified: October 2006
History: No changes posted
  Purpose

Hypothesis: Initiating chronic management treatment plans in conjunction with an asthma educational intervention in the pediatric Emergency Department (ED) with anti-inflammatory medication will result in an improvement of ED revisits (and unscheduled return visits). Chronic management intitiation in conjunction with an asthma educational intervention in the pediatric ED with anti-inflammatory medication will also result in improved Quality of Life measure.

Specific aims: 1. To demonstrate that the initiation controller medication therapy in conjunction with asthma education will result in:

  1. Decreased return ED visits (or unscheduled primary care physician visits) as compared to a control group over a 12 month period
  2. Improved Quality of Life as measured by Bukstein’s ITG Quality of Life measure.

    2. To describe the relationship of the initiation of controller medication therapy in conjunction with asthma education with well child visits, missed school/daycare days and behavioral capabilities.

    Objective: To determine the impact of beginning chronic asthma medication regimens after an educational intervention in the ED in pediatric patients 1-18 years of age with mild to moderate persistent asthma.

    Long-term goal/purpose: To demonstrate the success of a model of care that utilizes the emergency department physician to initiate National Asthma Education and Prevention Program (NAEPP) guided chronic asthma therapy in children 1-18 years of age. This model will attempt to bridge the gap in initiation of chronic asthma therapy currently left by a failure of both emergency department and primary care physicians.


Condition Intervention
Asthma
Drug: Pulmicort
Behavioral: TEDAS ED Educational Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Initiation of Chronic Asthma Care Regimens in the Pediatric Emergency Department

Resource links provided by NLM:


Further study details as provided by Baylor College of Medicine:

Primary Outcome Measures:
  • Decreased return ED visits (or unscheduled primary care physician visits) as compared to a control group over a 12 month period will be measured by comparisons of total number of ED visits (and unscheduled PCP visits) in each group

Secondary Outcome Measures:
  • Improved Quality of Life as measured by Bukstein’s ITG will utilize the scoring system developed by Bukstein to evaluate individual parameters as well as aggregate scores in the control and intervention group at each of the 3 month intervals. Significan
  • Improved confidence in management will be measured utilizing confidence scores (a process delineated by the PI and referenced above).

Estimated Enrollment: 251
Study Start Date: November 2006
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   1 Year to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The enrollees involved must be a child who is 1-18 years of age, with a diagnosis of persistent asthma or reactive airway disease and no other cardiovascular or pulmonary disease not currently on the NAEPP recommended chronic care regimen for controller medication therapy.

Exclusion Criteria:

  • Patients without a physician’s confirmed diagnosis of asthma. Children with concurrent cardiovascular or pulmonary disease. Patients will also be excluded if they do not speak English or Spanish as their primary language.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00388739

Contacts
Contact: Troy Bush, B.S. 832-824-5459 tbush@bcm.edu

Locations
United States, Texas
Texas Children's Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Charles G Macias, MD, MPH    832-824-5416    cmacias@bcm.edu   
Sponsors and Collaborators
Baylor College of Medicine
AstraZeneca
Investigators
Principal Investigator: Charles B Macias, MD, MPH Baylor College of Medicine
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00388739     History of Changes
Other Study ID Numbers: IRUSBUPR0045
Study First Received: October 13, 2006
Last Updated: October 13, 2006
Health Authority: United States: Institutional Review Board

Keywords provided by Baylor College of Medicine:
Pediatric Asthma
Pulmicort
TEDAS ED
Acute exacerbation of asthma
Chronic asthma

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on November 25, 2014