Identification of Vulnerability Factors in the Course of Pemphigus Patients

Not Applicable

• Conditions: Pemphigus; Dermatological Disease
• Interventions: Behavioral: psychological support and therapeutic education program

• Registration Number: NCT02237313
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2014-09-01
• Study First Submitted QC: 2014-09-08
• Study First Posted: 2014-09-11
• Study Start: 2015-07
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-29
• Last Update Posted: 2017-08-30
• Primary Completion: 2018-05
• Study Completion: 2018-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 48

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
prevalent cases	psychological support and therapeutic education program	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

Primary Outcome Measures

Name	Time	Method
analysis of vulnerability factors	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

Name	Time	Method
assessment of anxiety, uncertainty, fear, coping strategies	6 months	assessment of anxiety, uncertainty, fear, coping strategies using individual interview and questionnaire
analysis of vulnerability factors	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

Trial Locations

Locations (9)

Hôpital Avicenne; 🇫🇷 Bobigny, France

CH du Mans; 🇫🇷 le Mans, France

CHRU de Lille Hôpital Claude Huriez; 🇫🇷 Lille, France

Hôpital La Timone, Assistance publique hôpitaux de Marseille-Aix; 🇫🇷 Marseille, France

Hôpital Haut-Lévêque; 🇫🇷 Pessac, France

Hôpital Robert Debré, chu de Reims; 🇫🇷 Reims, France

University Hospital of Rouen; 🇫🇷 Rouen, France

CHU de Clermont-Ferrand Hôpital d'Estaing; 🇫🇷 Clermont-Ferrand, France

Centre hospitalier de Cornouaille; 🇫🇷 Quimper, France