- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00311831
The Implementation of a Gastroenteritis Education Program
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Worldwide, diarrhea remains a leading cause of childhood morbidity and mortality, with 2.5 million deaths estimated to occur annually among children < 5 years of age. In the United States, acute gastroenteritis accounts for > 1.5 million outpatient visits, 200,000 hospitalizations and approximately 300 deaths/year. The incidence of diarrhea varies between one and 2.5 episodes per child per year. In Ontario, children account for over 28,000 Emergency Department visits for gastroenteritis annually, and the pediatric admission rate for gastroenteritis remains greater than 400/100,000. In a Toronto based report from 1978, viral gastroenteritis was found as the etiologic agent in the deaths of 21 children over a 5 year period. Over 10% of patients seen at The Hospital for Sick Children ED present with acute gastroenteritis (vomiting, diarrhea or both). Last year over 4500 children with these complaints were seen.
It has been suggested that education can improve caregiver knowledge, beliefs and practices related to gastroenteritis. Children of caregivers who are less knowledgeable about diarrhea, dehydration and oral rehydration have been found to be at increased risk for presenting to a hospital secondary to dehydration.
However, it has been difficult to determine if this will translate into a reduction in non-urgent ED use. Very few studies have evaluated education in the ED. When it has been studied, they have been unsuccessful in altering ED utilization habits. One possible explanation for the lack of success is that some interventions have attempted to teach the parents while they were awaiting discharge. At that point in time, the parents are tired, distracted, and probably anxious to leave, thereby diminishing the effect of the intervention. Furthermore, providing patients with information handouts is not the optimal approach to achieve patient/parent education.
This study will compare two interventions for caregivers of children with gastroenteritis: extensive gastroenteritis education (standard education plus home nursing visit) and standard education in the emergency department(an information sheet). By adding on a home health nurse visit 12 to 36 hours later, we hope to achieve several benefits:
- Increased parental knowledge regarding gastroenteritis. This includes etiology and prevention, signs and symptoms of dehydration, when to seek care, the appropriate use of oral rehydration solutions, re-feeding, and the role of medications (or lack thereof).
- Increased parental knowledge will hopefully translate into reduced resource use. This may translate into improved use for other non-acute illnesses such as fever and colds. Improved resource use may include a reduction in ED visits and potentially even primary care provider use.
- This may also translate into improved patient outcomes by avoiding dehydration, decreasing transmission and seeking medications for the illness. Fewer ED visits may additionally translate into fewer investigations and intravenous requirements.
Thus we will compare improvement in caregiver knowledge of gastroenteritis and dehydration and number of emergency department visits at one year in the two treatment groups.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 3
Contatti e Sedi
Luoghi di studio
-
-
Ontario
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Toronto, Ontario, Canada, M5G 1X8
- The Hospital for Sick Children
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- 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
Exclusion Criteria:
- Do not live in the metropolitan Toronto area
- Previously enrolled in this trial
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Altro
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: 2
|
Subjects in this arm of the study will receive an gastroenteritis educational handout as well a home visitation from a trained counselor.
|
Comparatore attivo: 1
|
Subjects in this arm of the study will receive an educational handout on gastroenteritis education.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
---|---|
Change in parental knowledge as assessed on a gastroenteritis/dehydration questionnaire.
Lasso di tempo: This will be completed on day 1, at 1 month, at 6 months, and at 12 months
|
This will be completed on day 1, at 1 month, at 6 months, and at 12 months
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Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
---|---|
Mean score on the caregiver gastroenteritis questionnaire (CGQ)
Lasso di tempo: One year
|
One year
|
Number of repeat ED visits for the specific diagnoses of "gastroenteritis", "diarrhea", "vomiting" or "dehydration"
Lasso di tempo: One year
|
One year
|
Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Stephen B Freedman, MD, The Hospital for Sick Children, Toronto Canada
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 1000008727
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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