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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT01398696
First received: April 19, 2011
Last updated: October 11, 2011
Last verified: October 2011
  Purpose

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


Condition Intervention Phase
Gastroenteritis
Pharyngitis
Procedure: Patient Information Leaflets
Procedure: usual consultation
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by University Hospital, Grenoble:

Primary Outcome Measures:
  • The primary outcome measure was the mean behaviour score [ Time Frame: In ten to fifteen days after patient after the visit ] [ Designated as safety issue: No ]
    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 [ Time Frame: in ten to fifteen days after the visit ] [ Designated as safety issue: No ]
    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 [ Time Frame: in ten to fifteen days after the visit ] [ Designated as safety issue: No ]
    we get the information by a phone call to the patient, in ten to fifteen days after the visit


Enrollment: 400
Study Start Date: November 2009
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01398696

Locations
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
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

Publications:

Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT01398696     History of Changes
Other Study ID Numbers: n° IRB 5891
Study First Received: April 19, 2011
Last Updated: October 11, 2011
Health Authority: France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé
France: Commission nationale de l' informatique et des libertés

Keywords provided by University Hospital, Grenoble:
Patient Information Leaflets
primary care
patient behaviour
pharyngitis
gastroenteritis

Additional relevant MeSH terms:
Gastroenteritis
Pharyngitis
Digestive System Diseases
Gastrointestinal Diseases
Otorhinolaryngologic Diseases
Pharyngeal Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Stomatognathic Diseases

ClinicalTrials.gov processed this record on November 27, 2014