Back to resultsCoaching in Childhood Asthma (Coach)
Primary Purpose
Asthma
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Coaching, providing social support
Sponsored by
About this trial
This is an interventional prevention trial for Asthma focused on measuring childhood, asthma
Eligibility Criteria
Inclusion Criteria:
- Mothers of children with asthma 2-8 years of age and hospitalized for an acute exacerbation, with Medicaid insurance, and living in St. Louis City
Exclusion Criteria:
- Other respiratory disease present
Sites / Locations
- Washington University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Active coaching
Usual care
Arm Description
Telephone and in person coaching
Return to PCP for usual care
Outcomes
Primary Outcome Measures
Rehospitalization
Secondary Outcome Measures
Full Information
NCT ID
NCT00910585
First Posted
May 28, 2009
Last Updated
May 29, 2009
Sponsor
Washington University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT00910585
Brief Title
Coaching in Childhood Asthma
Acronym
Coach
Official Title
Phase 4 Study of Case Management and Environmental Control in Asthma
Study Type
Interventional
2. Study Status
Record Verification Date
May 2009
Overall Recruitment Status
Completed
Study Start Date
January 1997 (undefined)
Primary Completion Date
January 2002 (Actual)
Study Completion Date
January 2002 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Washington University School of Medicine
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. Demonstrations of reductions in disproportionate hospitalizations in controlled trials 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
childhood, asthma
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
191 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active coaching
Arm Type
Experimental
Arm Description
Telephone and in person coaching
Arm Title
Usual care
Arm Type
Active Comparator
Arm Description
Return to PCP for usual care
Intervention Type
Behavioral
Intervention Name(s)
Coaching, providing social support
Intervention Description
Active telephone and in person coaching
Primary Outcome Measure Information:
Title
Rehospitalization
Time Frame
2 years
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Mothers of children with asthma 2-8 years of age and hospitalized for an acute exacerbation, with Medicaid insurance, and living in St. Louis City
Exclusion Criteria:
Other respiratory disease present
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert 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
Learn more about this trial
Coaching in Childhood Asthma
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