Appropriate Care of URI (ACURI): Early Head Start | NCT01916031

Studies
Appropriate Care of URI (ACURI): Early Head Start

NCT01916031

Sponsor

Columbia University

Status

Completed

Last Update Posted

Aug 5, 2013Estimated

Enrollment

Not provided

Phase

Not Applicable

Conditions

Upper Respiratory Infection

Interventions

Education

Countries

Not provided

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

Aug 2013

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

Not provided

Primary Completion Date

May 2010Actual

Completion Date

May 2010Actual

First Submitted Date

Aug 1, 2013

First Submission Date that Met QC Criteria

Aug 1, 2013

First Posted Date

Aug 5, 2013Estimated

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

Aug 1, 2013

Last Update Posted Date

Aug 5, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Melissa Stockwell, MD, MPH, Asst Professor of Pediatrics and Population and Family Health, Columbia UniversityPrincipal Investigator

Lead Sponsor

Columbia UniversityOTHER

Collaborators

Not provided

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

The purpose of this study is to comparatively assess the effectiveness of a tailored educational intervention to improve health literacy levels regarding upper respiratory infections (URIs) and to decrease pediatric emergency department (PED) visits, among Latino households in Early Head Start.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Education	Experimental	Upper Respiratory Infection education in Fall	Behavioral: Education
Standard Curriculum	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Education	Behavioral		Education

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of pediatric emergency department visits		5 months

Secondary Outcomes

Measure	Description	Time Frame
Use of over-the-counter medication		5 months
Use of incorrect measuring tool		5 months
Use of unprescribed antibiotic

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Attending an infant or toddler EHS group at participating site

Exclusion Criteria:

Participant in pilot study
Participant in community intervention regarding URI

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

Name	Affiliation	Role
Melissa Stockwell, MD MPH	Columbia University	Principal Investigator

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24709931	Derived	Stockwell MS, Catallozzi M, Larson E, Rodriguez C, Subramony A, Andres Martinez R, Martinez E, Barrett A, Meyer D. Effect of a URI-related educational intervention in early head start on ED visits. Pediatrics. 2014 May;133(5):e1233-40. doi: 10.1542/peds.2013-2350. Epub 2014 Apr 7.

ID	Term
D007239	Infections
D012140	Respiratory Tract Diseases

ID	Term
D012959	Socioeconomic Factors
D011154	Population Characteristics