Case Management and Environmental Control in Asthma | NCT00514436

Studies
Case Management and Environmental Control in Asthma

NCT00514436

Sponsor

Washington University School of Medicine

Status

Completed

Last Update Posted

Dec 9, 2015Estimated

Enrollment

189Actual

Phase

Phase 3

Conditions

Asthma

Interventions

Asthma coaching

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1997

Primary Completion Date

Not provided

Completion Date

Jan 2001Actual

First Submitted Date

Aug 8, 2007

First Submission Date that Met QC Criteria

Aug 8, 2007

First Posted Date

Aug 10, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 8, 2015

Last Update Posted Date

Dec 9, 2015Estimated

Name	Class
National Institute of Environmental Health Sciences (NIEHS)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

189Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Asthma coaching	Behavioral	Inperson contact followed by telephone with approach by issues raised by family	Behavioral

Measure	Description	Time Frame
Hospitalization		2 years

Measure	Description	Time Frame
Emergency department visits		2 years

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Years

Maximum Age

8 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Robert C Strunk, MD	Washington University School of Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Washington University School of Medicine		St Louis	Missouri	63110	United States

Condition Browse Module

MeSH Terms

ID	Term
D001249	Asthma

Ancestor Terms

ID	Term
D001982	Bronchial Diseases
D012140	Respiratory Tract Diseases
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases

Browse Leaves

Not provided

Browse Branches

Not provided