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

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ClinicalTrials.gov Identifier: NCT01398696
Recruitment Status : Completed
First Posted : July 20, 2011
Last Update Posted : October 12, 2011
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble

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

Condition or disease Intervention/treatment Phase
Gastroenteritis Pharyngitis Procedure: Patient Information Leaflets Procedure: usual consultation Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Impact of Four Patient Information Leaflets (PIL) on Patient Behaviour : a Randomised Controlled Trial in Primary Care.
Study Start Date : November 2009
Actual Primary Completion Date : January 2011
Actual Study Completion Date : January 2011

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Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01398696


Locations
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France
General practitioner office
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, 38000
University Hospital Grenoble
Grenoble, France
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
Sponsors and Collaborators
University Hospital, Grenoble
Investigators
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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
More Information
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Publications of Results:
Sustersic M, Meneau A, Dremont R, Bosson JL. Fiches d'information patient: quelle méthodologie? La revue du praticien Médecine générale. 2007;790:1167-8.
Sustersic M, Meneau A, Drémont R, Paris A, Laborde L, Bosson JL. Elaboration d'un outil d'aide à l'éducation du patient pas la réalisation de 125 fiches d'information et de conseil concernant des motifs de consultation les plus fréquents en médecin générale. Université Joseph Fourier, faculté de médecine de Grenoble. juillet 2007.

Other Publications:
Dedianne MC, Hauzanneau P, Labarere J, Moreau A. Relation médecin-malade en soins primaires: qu'attendent les patients? Investigation par la méthode qualitative des focus groups. La revue du praticien Médecine générale. 2003;17 (612):653-6.
Sustersic M, Voorhoeve M, Menuret H, Baudrant M, Meneau A, Bosson JL. Fiches d'information pour les patients: quel intérêt? L'étude EDIMAP. La Revue de la médecine générale. 2010;276:332-9.

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Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT01398696    
Other Study ID Numbers: n° IRB 5891
First Posted: July 20, 2011    Key Record Dates
Last Update Posted: October 12, 2011
Last Verified: October 2011
Keywords provided by University Hospital, Grenoble:
Patient Information Leaflets
primary care
patient behaviour
pharyngitis
gastroenteritis
Additional relevant MeSH terms:
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Pharyngitis
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Respiratory Tract Infections
 Infections
Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases