Impact of Four Patient Information Leaflets (PIL) on Patient Behaviour

Study Overview
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Brief Summary
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To assess the impact of four Patient Information Leaflets (PIL) on patient behaviour in primary care.

Detailed Description
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A patient who visited, for a gastroenteritis or a pharyngitis, one GP of the intervention group, received a Patient Information Leaflets (PIL) related to his disease and his age: either the gastroenteritis leaflet for adult or the one for child, either the pharyngitis leaflet for adult or the one for child.

Official Title
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Impact of Four Patient Information Leaflets (PIL) on Patient Behaviour : a Randomised Controlled Trial in Primary Care.

Conditions
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Pharyngitis, Gastroenteritis

Intervention / Treatment
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* Procedure: Patient Information Leaflets
* Procedure: usual consultation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patient. Minor child accompanied by a responsible adult. The patient or the caregiver must be reachable by telephone within ten to fifteen days following the consultation. Exclusion Criteria: Illiterate patient Patient refusing follow-up call. Patient with visual or hearing impairment. Patient non-Francophone. Private patient of liberty by judicial or administrative. Person being a measure of legal protection.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Patient Information Leaflets<br>Patient Information Leaflets (PIL) is given to the patient during consultation | Procedure: Patient Information Leaflets<br>* Patient Information Leaflets (PIL) about adult gastroenteritis, children gastroenteritis, adult pharyngitis or either children pharyngitis in consultation room<br>|
| Placebo Comparator: usual consultation without PIL<br>no particular intervention during consultation for the patient. | Procedure: usual consultation<br>* No particular intervention during consultation for the Patient. No Information Leaflets (PIL) is given<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome measure was the mean behaviour score | All patients were called, ten to fifteen days after the visit, to answer a questionnaire on their behaviour related to the disease since they visited the GP. It permitted to calculate a behaviour score. Better was the score, better was the patient's behaviour related to his disease. | In ten to fifteen days after patient after the visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the mean comprehension score | All patients (or their parent) were called, ten to fifteen days after the visit, to answer a questionnaire on their comprehension related to the disease since they visited the GP. It permitted to calculate a comprehension score. Better was this score, better was the patient's comprehension. | in ten to fifteen days after the visit | 
| number of visit of patient's family for the same pathology | we get the information by a phone call to the patient, in ten to fifteen days after the visit | in ten to fifteen days after the visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Patient Information Leaflets, primary care, patient behaviour, pharyngitis, gastroenteritis