NCT00514436

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
189

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
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2001

Completed
6.6 years until next milestone

First Submitted

Initial submission to the registry

August 8, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 10, 2007

Completed
Last Updated

December 9, 2015

Status Verified

December 1, 2015

First QC Date

August 8, 2007

Last Update Submit

December 8, 2015

Conditions

Asthma

Keywords

Asthmachildrenlow-income, underservedReduction in hospitalization

Outcome Measures

Primary Outcomes (1)

  • Hospitalization

    2 years

Secondary Outcomes (1)

  • Emergency department visits

    2 years

Study Arms (2)

Usual care

NO INTERVENTION

Usual care consisted of referral back to primary care provider after index hospitalization

Behavioral

EXPERIMENTAL

Asthma coaching, inperson contact followed by telephone contact

Behavioral: Asthma coaching

Interventions

Asthma coachingBEHAVIORAL

Inperson contact followed by telephone with approach by issues raised by family

Behavioral

Eligibility Criteria

Age2 Years - 8 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • years of age
  • Admitted to hospital for acute asthma
  • African American ethnicity
  • Medicaid coverage

You may not qualify if:

  • Parent refusal to sign consent
  • Living outside service area

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 C Strunk, MD

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 8, 2007

First Posted

August 10, 2007

Study Start

January 1, 1997

Study Completion

January 1, 2001

Last Updated

December 9, 2015

Record last verified: 2015-12

Locations

US(1)