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NCT00514436 Clinical Trial

Case Management and Environmental Control in Asthma

Asthma Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00514436
Other study ID # ES 08711
Secondary ID
Status Completed
Phase Phase 3
First received August 8, 2007
Last updated December 8, 2015
Start date January 1997
Est. completion date January 2001

Study information
Verified date December 2015
Source Washington University School of Medicine
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review BoardUnited States: Federal Government
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 189
Est. completion date January 2001
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 2 Years to 8 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Behavioral:
• Asthma coaching
Inperson contact followed by telephone with approach by issues raised by family

Locations
Country Name City State
United States Washington University School of Medicine St. Louis Missouri

Sponsors (2)
Lead Sponsor Collaborator
Washington University School of Medicine National Institute of Environmental Health Sciences (NIEHS)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Hospitalization 2 years No
Secondary Emergency department visits 2 years No
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