NCT00910585

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
191

participants targeted

Target at P25-P50 for phase_3 asthma

Timeline
Completed

Started Jan 1997

Longer than P75 for phase_3 asthma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1997

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2002

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2002

Completed
7.4 years until next milestone

First Submitted

Initial submission to the registry

May 28, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 1, 2009

Completed
Last Updated

June 1, 2009

Status Verified

May 1, 2009

Enrollment Period

5 years

First QC Date

May 28, 2009

Last Update Submit

May 29, 2009

Conditions

Asthma

Keywords

childhoodasthma

Outcome Measures

Primary Outcomes (1)

  • Rehospitalization

    2 years

Study Arms (2)

Active coaching

EXPERIMENTAL

Telephone and in person coaching

Behavioral: Coaching, providing social support

Usual care

ACTIVE COMPARATOR

Return to PCP for usual care

Behavioral: Coaching, providing social support

Interventions

Coaching, providing social supportBEHAVIORAL

Active telephone and in person coaching

Active coachingUsual care

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Other respiratory disease present

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Robert Strunk, MD

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 28, 2009

First Posted

June 1, 2009

Study Start

January 1, 1997

Primary Completion

January 1, 2002

Study Completion

January 1, 2002

Last Updated

June 1, 2009

Record last verified: 2009-05

Locations

US(1)