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

Primary Purpose

Gastroenteritis, Pharyngitis

Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Patient Information Leaflets
usual consultation
Sponsored by
University Hospital, Grenoble
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Gastroenteritis focused on measuring Patient Information Leaflets, primary care, patient behaviour, pharyngitis, gastroenteritis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • General practitioner office
  • General practitioner office
  • General practitioner office
  • General practitioner office
  • General practitioner office
  • General practitioner office
  • General practitioner office
  • General practitioner office
  • University Hospital Grenoble
  • General practitioner office
  • General practitioner office
  • General practitioner office
  • General practitioner office
  • General practitioner office
  • General practitioner office
  • General practitioner office
  • General practitioner office
  • General practitioner office
  • General practitioner office
  • General practitioner office
  • General practitioner office
  • General practitioner office
  • General practitioner office

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Patient Information Leaflets

usual consultation without PIL

Arm Description

Patient Information Leaflets (PIL) is given to the patient during consultation

no particular intervention during consultation for the patient.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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

Full Information

First Posted
April 19, 2011
Last Updated
October 11, 2011
Sponsor
University Hospital, Grenoble
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1. Study Identification

Unique Protocol Identification Number
NCT01398696
Brief Title
Impact of Four Patient Information Leaflets (PIL) on Patient Behaviour
Acronym
PIL
Official Title
Impact of Four Patient Information Leaflets (PIL) on Patient Behaviour : a Randomised Controlled Trial in Primary Care.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
January 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroenteritis, Pharyngitis
Keywords
Patient Information Leaflets, primary care, patient behaviour, pharyngitis, gastroenteritis

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patient Information Leaflets
Arm Type
Active Comparator
Arm Description
Patient Information Leaflets (PIL) is given to the patient during consultation
Arm Title
usual consultation without PIL
Arm Type
Placebo Comparator
Arm Description
no particular intervention during consultation for the patient.
Intervention Type
Procedure
Intervention Name(s)
Patient Information Leaflets
Intervention Description
Patient Information Leaflets (PIL) about adult gastroenteritis, children gastroenteritis, adult pharyngitis or either children pharyngitis in consultation room
Intervention Type
Procedure
Intervention Name(s)
usual consultation
Intervention Description
No particular intervention during consultation for the Patient. No Information Leaflets (PIL) is given
Primary Outcome Measure Information:
Title
The primary outcome measure was the mean behaviour score
Description
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.
Time Frame
In ten to fifteen days after patient after the visit
Secondary Outcome Measure Information:
Title
the mean comprehension score
Description
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.
Time Frame
in ten to fifteen days after the visit
Title
number of visit of patient's family for the same pathology
Description
we get the information by a phone call to the patient, in ten to fifteen days after the visit
Time Frame
in ten to fifteen days after the visit

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Melanie Sustersic, GP
Organizational Affiliation
University Hospital, Grenoble
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Jean-Luc Bosson, PHD
Organizational Affiliation
University Hospital, Grenoble
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
LUCILE REIN, MD
Organizational Affiliation
University Hospital, Grenoble
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
EVA JEANNET, MD
Organizational Affiliation
University Hospital, Grenoble
Official's Role
Principal Investigator
Facility Information:
Facility Name
General practitioner office
City
Antibes Juan Les Pins
Country
France
Facility Name
General practitioner office
City
Beaulieu Sur Mer
Country
France
Facility Name
General practitioner office
City
Chambery
Country
France
Facility Name
General practitioner office
City
Charolles
Country
France
Facility Name
General practitioner office
City
Chirens
Country
France
Facility Name
General practitioner office
City
Coublevie
Country
France
Facility Name
General practitioner office
City
Echirolles
Country
France
Facility Name
General practitioner office
City
Grenoble
ZIP/Postal Code
38000
Country
France
Facility Name
University Hospital Grenoble
City
Grenoble
Country
France
Facility Name
General practitioner office
City
La Buisse
Country
France
Facility Name
General practitioner office
City
La Murette
Country
France
Facility Name
General practitioner office
City
Lyon
Country
France
Facility Name
General practitioner office
City
Massy
Country
France
Facility Name
General practitioner office
City
Megeve
Country
France
Facility Name
General practitioner office
City
Plessis Robinson
Country
France
Facility Name
General practitioner office
City
Saint Etienne de Crossey
Country
France
Facility Name
General practitioner office
City
Saint Marcellin
Country
France
Facility Name
General practitioner office
City
Saint Martin D'heres
Country
France
Facility Name
General practitioner office
City
Saint Priest
Country
France
Facility Name
General practitioner office
City
Saint Sorlin
Country
France
Facility Name
General practitioner office
City
Ugine
Country
France
Facility Name
General practitioner office
City
Valence
Country
France
Facility Name
General practitioner office
City
Voiron
Country
France

12. IPD Sharing Statement

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

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