Clinical trial NCT02237313: Identification of Vulnerability Factors in the Course of Pemphigus Patients
Official title: Identification of Vulnerability Factors in the Course of Pemphigus Patients - SHS Pemphigus Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pemphigus
Dermatological Disease
Keywords: psychological support
therapeutic education
vulnerability of patients
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2014-09-11
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Eligibility 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.

Primary outcomes:
measure: analysis of vulnerability factors
timeFrame: 12 months
Secondary outcomes:
measure: analysis of vulnerability factors
timeFrame: 6 months
measure: assessment of anxiety, uncertainty, fear, coping strategies
timeFrame: 12 months
measure: assessment of anxiety, uncertainty, fear, coping strategies
timeFrame: 6 months
Other outcomes:
Locations:
city: Bobigny
country: France
facility: Hôpital Avicenne
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand Hôpital d'Estaing
city: le Mans
country: France
facility: CH du Mans
city: Lille
country: France
facility: CHRU de Lille Hôpital Claude Huriez
city: Marseille
country: France
facility: Hôpital La Timone, Assistance publique hôpitaux de Marseille-Aix
city: Pessac
country: France
facility: Hôpital Haut-Lévêque
city: Quimper
country: France
facility: Centre hospitalier de Cornouaille
city: Reims
country: France
facility: Hôpital Robert Debré, chu de Reims
city: Rouen
country: France
facility: University Hospital of Rouen
Study officials:
affiliation: University Hospital, Rouen
name: Pascal Joly, Professor
role: PRINCIPAL_INVESTIGATOR
References: