Identification of Vulnerability Factors in the Course of Pemphigus Patients

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pemphigus, Dermatological Disease

Intervention / Treatment
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* Behavioral: psychological support and therapeutic education program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient major Patients with pemphigus vulgaris, diagnosed on a combination of: clinical signs and histological image above basal epithelial detachment with intra acantholysis, 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: prevalent cases<br>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<br> <br> |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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psychological support, therapeutic education, vulnerability of patients