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

October 11, 2011 updated by: University Hospital, Grenoble

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

400

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Antibes Juan Les Pins, France
        • General practitioner office
      • Beaulieu Sur Mer, France
        • General practitioner office
      • Chambery, France
        • General practitioner office
      • Charolles, France
        • General practitioner office
      • Chirens, France
        • General practitioner office
      • Coublevie, France
        • General practitioner office
      • Echirolles, France
        • General practitioner office
      • Grenoble, France
        • University Hospital Grenoble
      • Grenoble, France, 38000
        • General practitioner office
      • La Buisse, France
        • General practitioner office
      • La Murette, France
        • General practitioner office
      • Lyon, France
        • General practitioner office
      • Massy, France
        • General practitioner office
      • Megeve, France
        • General practitioner office
      • Plessis Robinson, France
        • General practitioner office
      • Saint Etienne de Crossey, France
        • General practitioner office
      • Saint Marcellin, France
        • General practitioner office
      • Saint Martin D'heres, France
        • General practitioner office
      • Saint Priest, France
        • General practitioner office
      • Saint Sorlin, France
        • General practitioner office
      • Ugine, France
        • General practitioner office
      • Valence, France
        • General practitioner office
      • Voiron, France
        • General practitioner office

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The primary outcome measure was the mean behaviour score
Time Frame: 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.
In ten to fifteen days after patient after the visit

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the mean comprehension score
Time Frame: 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.
in ten to fifteen days after the visit
number of visit of patient's family for the same pathology
Time Frame: 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
in ten to fifteen days after the visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Investigators

  • Study Director: Melanie Sustersic, GP, University Hospital, Grenoble
  • Study Director: Jean-Luc Bosson, PHD, University Hospital, Grenoble
  • Principal Investigator: LUCILE REIN, MD, University Hospital, Grenoble
  • Principal Investigator: EVA JEANNET, MD, University Hospital, Grenoble

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Actual)

January 1, 2011

Study Completion (Actual)

January 1, 2011

Study Registration Dates

First Submitted

April 19, 2011

First Submitted That Met QC Criteria

July 19, 2011

First Posted (Estimate)

July 20, 2011

Study Record Updates

Last Update Posted (Estimate)

October 12, 2011

Last Update Submitted That Met QC Criteria

October 11, 2011

Last Verified

October 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • n° IRB 5891

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Gastroenteritis

Clinical Trials on Patient Information Leaflets

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Montenegro

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe