NCT01916031

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.

Trial Health

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

August 1, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 5, 2013

Completed
Last Updated

August 5, 2013

Status Verified

August 1, 2013

First QC Date

August 1, 2013

Last Update Submit

August 1, 2013

Conditions

Upper Respiratory Infection

Outcome Measures

Primary Outcomes (1)

  • Number of pediatric emergency department visits

    5 months

Secondary Outcomes (4)

  • Use of over-the-counter medication

    5 months

  • Use of incorrect measuring tool

    5 months

  • Use of unprescribed antibiotic

    5 months

  • Knowledge regarding URI

    5 months

Study Arms (2)

Education

EXPERIMENTAL

Upper Respiratory Infection education in Fall

Behavioral: Education

Standard Curriculum

NO INTERVENTION

Interventions

EducationBEHAVIORAL
Education

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Attending an infant or toddler EHS group at participating site

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 24709931DERIVED

MeSH Terms

Conditions

Respiratory Tract Infections

Interventions

Educational Status

Condition Hierarchy (Ancestors)

InfectionsRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Officials

  • Melissa Stockwell, MD MPH

    Columbia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst Professor of Pediatrics and Population and Family Health

Study Record Dates

First Submitted

August 1, 2013

First Posted

August 5, 2013

Primary Completion

May 1, 2010

Study Completion

May 1, 2010

Last Updated

August 5, 2013

Record last verified: 2013-08