Identification of Vulnerability Factors in the Course of Pemphigus Patients

Pemphigus Clinical Trial

— SHS-Pemphigus  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02237313
• Other study ID #: 2014/063/HP
• Secondary ID: 2014A0067740
• Status: Recruiting
• Phase: N/A
• First received: September 1, 2014
• Last updated: August 29, 2017
• Start date: July 2015
• Est. completion date: November 2018

Study information

• Verified date: August 2017
• Source: University Hospital, Rouen
• Contact: Pascal JOLY, Professor
• Phone: 2 32 88 68 41
• Email: pacal.joly[@]chu-rouen.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: November 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dermatological Disease
• Pemphigus
• Skin Diseases

Intervention

Behavioral:
• psychological support and therapeutic education program

Locations

Country	Name	City	State
France	Hôpital Avicenne	Bobigny
France	CHU de Clermont-Ferrand Hôpital d'Estaing	Clermont-Ferrand
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	Centre hospitalier de Cornouaille	Quimper
France	Hôpital Robert Debré, chu de Reims	Reims
France	University Hospital of Rouen	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	assessment of anxiety, uncertainty, fear, coping strategies	assessment of anxiety, uncertainty, fear, coping strategies using individual interview and questionnaire	12 months
Secondary	assessment of anxiety, uncertainty, fear, coping strategies	assessment of anxiety, uncertainty, fear, coping strategies using individual interview and questionnaire	6 months