Back to results

Case Management and Environmental Control in Asthma

Primary Purpose

Asthma

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Asthma coaching

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

NCT ID

NCT00514436

First Posted

August 8, 2007

Last Updated

December 8, 2015

Sponsor

Washington University School of Medicine

Collaborators

National Institute of Environmental Health Sciences (NIEHS)

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

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

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

Learn more about this trial

Case Management and Environmental Control in Asthma

We'll reach out to this number within 24 hrs