SHS-Pemphigus: Identification of Vulnerability Factors in the Course of Pemphigus Patients

Sponsor

University Hospital, Rouen (Other)

Overall Status

Unknown status

CT.gov ID

NCT02237313

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

5.3

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

48 participants

Allocation:

N/A

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 :

Jul 1, 2015

Anticipated Primary Completion Date :

May 1, 2018

Anticipated Study Completion Date :

Nov 1, 2018

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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
assessment of anxiety, uncertainty, fear, coping strategies [12 months]
assessment of anxiety, uncertainty, fear, coping strategies using individual interview and questionnaire
assessment of anxiety, uncertainty, fear, coping strategies [6 months]
assessment of anxiety, uncertainty, fear, coping strategies using individual interview and questionnaire

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Hôpital Avicenne	Bobigny	France	93000
2	CHU de Clermont-Ferrand Hôpital d'Estaing	Clermont-Ferrand	France	63003
3	CH du Mans	le Mans	France	72037
4	CHRU de Lille Hôpital Claude Huriez	Lille	France	59037
5	Hôpital La Timone, Assistance publique hôpitaux de Marseille-Aix	Marseille	France
6	Hôpital Haut-Lévêque	Pessac	France	33604
7	Centre hospitalier de Cornouaille	Quimper	France	29107
8	Hôpital Robert Debré, chu de Reims	Reims	France	51 092
9	University Hospital of Rouen	Rouen	France	76031