The Implementation of a Gastroenteritis Education Program
1 other identifier
interventional
105
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Mar 2006
Typical duration for phase_3
1 active site
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
CompletedFirst Submitted
Initial submission to the registry
April 4, 2006
CompletedFirst Posted
Study publicly available on registry
April 6, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2010
CompletedApril 17, 2018
April 1, 2018
4.1 years
April 4, 2006
April 16, 2018
Conditions
Keywords
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 COMPARATOR2
EXPERIMENTALInterventions
Subjects in this arm of the study will receive an educational handout on gastroenteritis education.
Subjects in this arm of the study will receive an gastroenteritis educational handout as well a home visitation from a trained counselor.
Eligibility Criteria
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
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.
PMID: 20825796DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stephen B Freedman, MD
The Hospital for Sick Children, Toronto Canada
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