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

Identification of Vulnerability Factors in the Course of Pemphigus Patients - SHS Pemphigus Clinical Trial

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.

Study Overview

• Status: Unknown
• Conditions: Pemphigus; Dermatological Disease
• Intervention / Treatment: Behavioral: psychological support and therapeutic education program

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
• Enrollment (Anticipated): 48
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pascal JOLY, Professor; Phone Number: +33 2 32 88 68 41; Email: pacal.joly@chu-rouen.fr

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
analysis of vulnerability factors	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	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
analysis of vulnerability factors	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	6 months
assessment of anxiety, uncertainty, fear, coping strategies	assessment of anxiety, uncertainty, fear, coping strategies using individual interview and questionnaire	12 months
assessment of anxiety, uncertainty, fear, coping strategies	assessment of anxiety, uncertainty, fear, coping strategies using individual interview and questionnaire	6 months

Collaborators and Investigators

• Sponsor: University Hospital, Rouen
• Investigators: Principal Investigator: Pascal Joly, Professor, University Hospital, Rouen

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Anticipated): May 1, 2018
• Study Completion (Anticipated): November 1, 2018

Study Registration Dates

• First Submitted: September 1, 2014
• First Submitted That Met QC Criteria: September 8, 2014
• First Posted (Estimate): September 11, 2014

Study Record Updates

• Last Update Posted (Actual): August 30, 2017
• Last Update Submitted That Met QC Criteria: August 29, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: therapeutic education; psychological support; vulnerability of patients
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Skin Diseases, Vesiculobullous; Skin Diseases; Pemphigus
• Other Study ID Numbers: 2014/063/HP; 2014A0067740 (Registry Identifier: RCB number)