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Identification of Vulnerability Factors in the Course of Pemphigus Patients (SHS-Pemphigus)

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ClinicalTrials.gov Identifier: NCT02237313
Recruitment Status : Recruiting
First Posted : September 11, 2014
Last Update Posted : August 30, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital, Rouen

Brief Summary:
The bullous pemphigoid treatment is based on corticosteroids continued for several years. Pemphigus causes some patients a psychological impact and sometimes major vulnerability that can occur not only at diagnosis but also at later stages of disease progression. Our hypothesis is that these episodes of vulnerability may be under four kinds of factors that may be connected to the plurality of the history of these patients, and the resources they can mobilize throughout this experience, generating inequality in management and "work" around the disease.

Condition or disease Intervention/treatment Phase
Pemphigus Dermatological Disease Behavioral: psychological support and therapeutic education program Not Applicable

Detailed Description:
The originality of the project lies in its multidisciplinary approach (dermatology, psychology, sociology). No such study has yet been carried out in the pemphigus who has been the subject of a very small number of works in sociology or psychology. The only studies are studies of quality of life with no longitudinal follow-up. The perspective of qualitative and quantitative data, sociological and psychological approaches, should allow more innovative and adapted to the medico-social and psychological care of patients with pemphigus approaches. The purpose of this study is to identify the determinants leading to moments of vulnerability in the course of patients with pemphigus in order to be able to offer preventive or corrective actions to improve the experience of the disease.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Identification of Vulnerability Factors in the Course of Pemphigus Patients - SHS Pemphigus Clinical Trial
Study Start Date : July 2015
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : November 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pemphigus
U.S. FDA Resources

Arm Intervention/treatment
Experimental: prevalent cases

40 prevalent cases correspond to patients with known pemphigus. Emphasis will be on included patients at different times of the course of their disease.

8 incident cases recruited through the center of Rouen and following an intervention program with psychological support and therapeutic education program

Behavioral: psychological support and therapeutic education program



Primary Outcome Measures :
  1. analysis of vulnerability factors [ Time Frame: 12 months ]
    evaluation of : perception by the patient of misdiagnosis, perception of a possible difference in assessment of the severity of his illness between himself and healthcare professionals, patient behavior in relation to available information sources, and the influence of information gathered on the illness experience, Patient trajectory during the diagnostic phase using individual interview and questionnaire


Secondary Outcome Measures :
  1. analysis of vulnerability factors [ Time Frame: 6 months ]
    evaluation of : perception by the patient of misdiagnosis, perception of a possible difference in assessment of the severity of his illness between himself and healthcare professionals, patient behavior in relation to available information sources, and the influence of information gathered on the illness experience, Patient trajectory during the diagnostic phase using individual interview and questionnaire

  2. assessment of anxiety, uncertainty, fear, coping strategies [ Time Frame: 12 months ]
    assessment of anxiety, uncertainty, fear, coping strategies using individual interview and questionnaire

  3. assessment of anxiety, uncertainty, fear, coping strategies [ Time Frame: 6 months ]
    assessment of anxiety, uncertainty, fear, coping strategies using individual interview and questionnaire



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient major
  • Patients with pemphigus vulgaris, diagnosed on a combination of:

    1. clinical signs and
    2. histological image above basal epithelial detachment with intra acantholysis,
    3. direct immunofluorescence showing deposition of Immunoglobulin G and / or C3 to the surface of keratinocytes
  • Join a social security scheme
  • patient has been informed and have signed consent to participate in the study

Exclusion Criteria:

  • Person placed under judicial protection,
  • Patient without liberty by administrative or judicial decision,
  • Patient participating in another trial for the duration of monitoring.

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): NCT02237313


Contacts
Contact: Pascal JOLY, Professor 2 32 88 68 41 ext +33 pacal.joly@chu-rouen.fr

Locations
France
Hôpital Avicenne Recruiting
Bobigny, France, 93000
Contact: Catherine PROST-SQUARCIONI, Professor    1 48 95 77 07 ext +33    catherine.prost@avc.aphp.fr   
Principal Investigator: Catherine PROST-SQUARCIONI, professor         
CHU de Clermont-Ferrand Hôpital d'Estaing Recruiting
Clermont-Ferrand, France, 63003
Contact: Michel D'Incan, professor    4 73 75 05 50 ext +33    mdincan@chu-clermontferrand.fr   
Principal Investigator: Michel D'Incan, Professor         
CH du Mans Recruiting
le Mans, France, 72037
Contact: Hervé MAILLARD, Professor    2 43 43 43 58 ext +33    hmaillard@ch-lemans.fr   
Principal Investigator: Hervé MAILLARD, Professor         
CHRU de Lille Hôpital Claude Huriez Recruiting
Lille, France, 59037
Contact: Emmanuel DELAPORTE, Professor    3 20 44 41 91 ext +33    Emmanuel.Delaporte@chru-lille.fr   
Principal Investigator: Emmanuel DELAPORTE, Professor         
Hôpital La Timone, Assistance publique hôpitaux de Marseille-Aix Recruiting
Marseille, France
Contact: Marie-Aleth RICHARD LALLEMAND, Professor    4 91 38 79 91 ext +33    mrichard@ap-hm.fr   
Principal Investigator: Marie Alteh RICHARD LALLEMAND, Professor         
Hôpital Haut-Lévêque Recruiting
Pessac, France, 33604
Contact: Marie Sylvie DOUTRE, Professor       marie-sylvie.doutre@chu-bordeaux.fr   
Principal Investigator: Marie Sylvie DOUTRE, Professor         
Centre hospitalier de Cornouaille Recruiting
Quimper, France, 29107
Contact: Ingrid KUPFER-BESSAGUET, Doctor    2 98 52 60 60 ext +33    i.kupfer@ch-cornouaille.fr   
Principal Investigator: Ingrid KUPFER-BESSAGUET, Doctor         
Hôpital Robert Debré, chu de Reims Recruiting
Reims, France, 51 092
Contact: Philippe BERNARD, Professor    3 26 78 43 68 ext +33    pbernard@chu-reims.fr   
Principal Investigator: Philippe BERNARD, Professor         
University Hospital of Rouen Recruiting
Rouen, France, 76031
Contact: Pascal JOLY, Professor    2 32 88 80 39 ext +33    Pascal.Joly@chu-rouen.fr   
Sub-Investigator: Sophie DUVERT LEHEMBRE, Doctor         
Sponsors and Collaborators
University Hospital, Rouen
Investigators
Principal Investigator: Pascal Joly, Professor University Hospital, Rouen

Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT02237313     History of Changes
Other Study ID Numbers: 2014/063/HP
2014A0067740 ( Registry Identifier: RCB number )
First Posted: September 11, 2014    Key Record Dates
Last Update Posted: August 30, 2017
Last Verified: August 2017

Keywords provided by University Hospital, Rouen:
psychological support
therapeutic education
vulnerability of patients

Additional relevant MeSH terms:
Pemphigus
Skin Diseases
Skin Diseases, Vesiculobullous
Autoimmune Diseases
Immune System Diseases