Coaching in Childhood Asthma (Coach)

May 29, 2009 updated by: Washington University School of Medicine

Phase 4 Study of Case Management and Environmental Control in Asthma

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

191

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • St. Louis, Missouri, United States, 63110
        • Washington University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active coaching
Telephone and in person coaching
Behavioral: Coaching, providing social support
Active telephone and in person coaching
Active Comparator: Usual care
Return to PCP for usual care
Behavioral: Coaching, providing social support
Active telephone and in person coaching

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rehospitalization
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Investigators

  • Principal Investigator: Robert Strunk, MD, Washington University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 1997

Primary Completion (Actual)

January 1, 2002

Study Completion (Actual)

January 1, 2002

Study Registration Dates

First Submitted

May 28, 2009

First Submitted That Met QC Criteria

May 29, 2009

First Posted (Estimate)

June 1, 2009

Study Record Updates

Last Update Posted (Estimate)

June 1, 2009

Last Update Submitted That Met QC Criteria

May 29, 2009

Last Verified

May 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ES08711

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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