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
About this trial
This is an interventional health services research trial for Upper Respiratory Infection
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
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
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
Learn more about this trial
Appropriate Care of URI (ACURI): Early Head Start
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