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Case Management and Environmental Control in Asthma

Primary Purpose

Asthma

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Asthma coaching
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Asthma focused on measuring Asthma, children, low-income, underserved, Reduction in hospitalization

Eligibility Criteria

2 Years - 8 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 2-8 years of age
  • Admitted to hospital for acute asthma
  • African American ethnicity
  • Medicaid coverage

Exclusion Criteria:

  • Parent refusal to sign consent
  • Living outside service area

Sites / Locations

  • Washington University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Usual care

Behavioral

Arm Description

Usual care consisted of referral back to primary care provider after index hospitalization

Asthma coaching, inperson contact followed by telephone contact

Outcomes

Primary Outcome Measures

Hospitalization

Secondary Outcome Measures

Emergency department visits

Full Information

First Posted
August 8, 2007
Last Updated
December 8, 2015
Sponsor
Washington University School of Medicine
Collaborators
National Institute of Environmental Health Sciences (NIEHS)
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1. Study Identification

Unique Protocol Identification Number
NCT00514436
Brief Title
Case Management and Environmental Control in Asthma
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
January 1997 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2001 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Washington University School of Medicine
Collaborators
National Institute of Environmental Health Sciences (NIEHS)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Asthma among low-income, minority children remains a prime example of health disparities that are resistant to change. Controlled demonstrations of reductions in disproportionate hospital or emergency care are limited. We performed a controlled clinical trial of an "Asthma Coach" to reduce hospitalizations among low-income, African American children.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Asthma, children, low-income, underserved, Reduction in hospitalization

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
189 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual care
Arm Type
No Intervention
Arm Description
Usual care consisted of referral back to primary care provider after index hospitalization
Arm Title
Behavioral
Arm Type
Experimental
Arm Description
Asthma coaching, inperson contact followed by telephone contact
Intervention Type
Behavioral
Intervention Name(s)
Asthma coaching
Intervention Description
Inperson contact followed by telephone with approach by issues raised by family
Primary Outcome Measure Information:
Title
Hospitalization
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Emergency department visits
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 2-8 years of age Admitted to hospital for acute asthma African American ethnicity Medicaid coverage Exclusion Criteria: Parent refusal to sign consent Living outside service area
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert C Strunk, MD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States

12. IPD Sharing Statement

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Case Management and Environmental Control in Asthma

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