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Appropriate Care of URI (ACURI): Early Head Start

Primary Purpose

Upper Respiratory Infection

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Education
Sponsored by
Columbia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Upper Respiratory Infection

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Attending an infant or toddler EHS group at participating site

Exclusion Criteria:

  • Participant in pilot study
  • Participant in community intervention regarding URI

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Education

    Standard Curriculum

    Arm Description

    Upper Respiratory Infection education in Fall

    Outcomes

    Primary Outcome Measures

    Number of pediatric emergency department visits

    Secondary Outcome Measures

    Use of over-the-counter medication
    Use of incorrect measuring tool
    Use of unprescribed antibiotic
    Knowledge regarding URI
    Composite score

    Full Information

    First Posted
    August 1, 2013
    Last Updated
    August 1, 2013
    Sponsor
    Columbia University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01916031
    Brief Title
    Appropriate Care of URI (ACURI): Early Head Start
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    May 2010 (Actual)
    Study Completion Date
    May 2010 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Columbia University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Upper Respiratory Infection

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized

    8. Arms, Groups, and Interventions

    Arm Title
    Education
    Arm Type
    Experimental
    Arm Description
    Upper Respiratory Infection education in Fall
    Arm Title
    Standard Curriculum
    Arm Type
    No Intervention
    Intervention Type
    Behavioral
    Intervention Name(s)
    Education
    Primary Outcome Measure Information:
    Title
    Number of pediatric emergency department visits
    Time Frame
    5 months
    Secondary Outcome Measure Information:
    Title
    Use of over-the-counter medication
    Time Frame
    5 months
    Title
    Use of incorrect measuring tool
    Time Frame
    5 months
    Title
    Use of unprescribed antibiotic
    Time Frame
    5 months
    Title
    Knowledge regarding URI
    Description
    Composite score
    Time Frame
    5 months

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Melissa Stockwell, MD MPH
    Organizational Affiliation
    Columbia University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    24709931
    Citation
    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.
    Results Reference
    derived

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    Appropriate Care of URI (ACURI): Early Head Start

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