NCT00311831

Brief Summary

The purpose of this study is to determine whether the caregivers of children presenting to the emergency department (ED) with acute gastroenteritis who receive extensive gastroenteritis education (standard education plus home nursing visit) will improve their gastroenteritis knowledge more than those who receive standard education (an information sheet) in the emergency department.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Mar 2006

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 4, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 6, 2006

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

April 17, 2018

Status Verified

April 1, 2018

Enrollment Period

4.1 years

First QC Date

April 4, 2006

Last Update Submit

April 16, 2018

Conditions

Keywords

PediatricsGastroenteritisEducation

Outcome Measures

Primary Outcomes (1)

  • Change in parental knowledge as assessed on a gastroenteritis/dehydration questionnaire.

    This will be completed on day 1, at 1 month, at 6 months, and at 12 months

Secondary Outcomes (2)

  • Mean score on the caregiver gastroenteritis questionnaire (CGQ)

    One year

  • Number of repeat ED visits for the specific diagnoses of "gastroenteritis", "diarrhea", "vomiting" or "dehydration"

    One year

Study Arms (2)

1

ACTIVE COMPARATOR
Behavioral: Standard gastroenteritis education

2

EXPERIMENTAL
Behavioral: Extensive gastroenteritis education

Interventions

Subjects in this arm of the study will receive an educational handout on gastroenteritis education.

1

Subjects in this arm of the study will receive an gastroenteritis educational handout as well a home visitation from a trained counselor.

2

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Caregiver of a child aged 3 months to 4 years of age, presenting to the emergency department with a diagnosis of gastroenteritis, which may be manifested by vomiting, diarrhea, or both
  • Age \> 16 years
  • Ability to speak and read English

You may not qualify if:

  • Do not live in the metropolitan Toronto area
  • Previously enrolled in this trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Related Publications (1)

  • Freedman SB, Couto M, Spooner L, Haladyn JK. The implementation of a gastroenteritis education program. Am J Emerg Med. 2011 Mar;29(3):271-7. doi: 10.1016/j.ajem.2009.09.032. Epub 2010 Mar 26.

MeSH Terms

Conditions

Gastroenteritis

Condition Hierarchy (Ancestors)

Gastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Stephen B Freedman, MD

    The Hospital for Sick Children, Toronto Canada

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Adjunct Scientist

Study Record Dates

First Submitted

April 4, 2006

First Posted

April 6, 2006

Study Start

March 1, 2006

Primary Completion

April 1, 2010

Study Completion

April 1, 2010

Last Updated

April 17, 2018

Record last verified: 2018-04

Locations