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Initiation of Chronic Asthma Care Regimens in the Pediatric Emergency Department
This study is not yet open for participant recruitment.
Verified by Baylor College of Medicine, October 2006
Sponsors and Collaborators: Baylor College of Medicine
AstraZeneca
Information provided by: Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT00388739
  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

MedlinePlus related topics: Asthma
Drug Information available for: Budesonide
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind, Active Control, Factorial Assignment, Efficacy Study
Official Title: Initiation of Chronic Asthma Care Regimens in the Pediatric Emergency Department

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
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
Houston, Texas, United States, 77030
Sponsors and Collaborators
Baylor College of Medicine
AstraZeneca
Investigators
Principal Investigator: Charles B Macias, MD, MPH Baylor College of Medicine
  More Information

Study ID Numbers: IRUSBUPR0045
Study First Received: October 13, 2006
Last Updated: October 13, 2006
ClinicalTrials.gov Identifier: NCT00388739  
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

Study placed in the following topic categories:
Hypersensitivity
Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases
Budesonide
Hypersensitivity, Immediate
Emergencies
Asthma
Respiratory Hypersensitivity

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Respiratory System Agents
Disease Attributes
Bronchial Diseases
Immune System Diseases
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Asthmatic Agents
Hormones
Glucocorticoids
Pharmacologic Actions
Pathologic Processes
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents
Bronchodilator Agents

ClinicalTrials.gov processed this record on January 16, 2009