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

Phase 4

Completed

• Conditions: Gastroenteritis; Pharyngitis
• Interventions: Procedure: Patient Information Leaflets; Procedure: usual consultation

• Registration Number: NCT01398696
• Lead Sponsor: University Hospital, Grenoble

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2009-11
• Primary Completion: 2011-01
• Study Completion: 2011-01
• Study First Submitted: 2011-04-19
• Study First Submitted QC: 2011-07-19
• Study First Posted: 2011-07-20
• Status Verified: 2011-10
• Last Update Submitted: 2011-10-11
• Last Update Posted: 2011-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patient Information Leaflets	Patient Information Leaflets	Patient Information Leaflets (PIL) is given to the patient during consultation
usual consultation without PIL	usual consultation	no particular intervention during consultation for the patient.

Primary Outcome Measures

Name	Time	Method
The primary outcome measure was the mean behaviour score	In ten to fifteen days after patient after the visit	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.

Secondary Outcome Measures

Name	Time	Method
the mean comprehension score	in ten to fifteen days after the visit	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.
number of visit of patient's family for the same pathology	in ten to fifteen days after the visit	we get the information by a phone call to the patient, in ten to fifteen days after the visit

Trial Locations

Locations (2)

General practitioner office; 🇫🇷 Voiron, France

University Hospital Grenoble; 🇫🇷 Grenoble, France