Coaching in Childhood Asthma | NCT00910585

Studies
Coaching in Childhood Asthma

NCT00910585

Sponsor

Washington University School of Medicine

Status

Completed

Last Update Posted

Jun 1, 2009Estimated

Enrollment

191Actual

Phase

Phase 3

Conditions

Asthma

Interventions

Coaching, providing social support

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

May 2009

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

Jan 2002Actual

Completion Date

Jan 2002Actual

First Submitted Date

May 28, 2009

First Submission Date that Met QC Criteria

May 29, 2009

First Posted Date

Jun 1, 2009Estimated

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

May 29, 2009

Last Update Posted Date

Jun 1, 2009Estimated

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. 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.

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

191Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Coaching, providing social support	Behavioral	Active telephone and in person coaching	Active coaching Usual care

Measure	Description	Time Frame
Rehospitalization		2 years

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Robert 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