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Identification of Vulnerability Factors in the Course of Pemphigus Patients (SHS-Pemphigus)

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ClinicalTrials.gov Identifier: NCT02237313
Recruitment Status : Unknown
Verified August 2017 by University Hospital, Rouen.
Recruitment status was:  Recruiting
First Posted : September 11, 2014
Last Update Posted : August 30, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital, Rouen

Tracking Information
First Submitted Date  ICMJE September 1, 2014
First Posted Date  ICMJE September 11, 2014
Last Update Posted Date August 30, 2017
Study Start Date  ICMJE July 2015
Estimated Primary Completion Date May 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 8, 2014)
analysis of vulnerability factors [ Time Frame: 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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02237313 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 8, 2014)
  • analysis of vulnerability factors [ Time Frame: 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 [ Time Frame: 12 months ]
    assessment of anxiety, uncertainty, fear, coping strategies using individual interview and questionnaire
  • assessment of anxiety, uncertainty, fear, coping strategies [ Time Frame: 6 months ]
    assessment of anxiety, uncertainty, fear, coping strategies using individual interview and questionnaire
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Identification of Vulnerability Factors in the Course of Pemphigus Patients
Official Title  ICMJE Identification of Vulnerability Factors in the Course of Pemphigus Patients - SHS Pemphigus Clinical Trial
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Pemphigus
  • Dermatological Disease
Intervention  ICMJE Behavioral: psychological support and therapeutic education program
Study Arms  ICMJE 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

Intervention: Behavioral: psychological support and therapeutic education program
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: September 8, 2014)
48
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2018
Estimated Primary Completion Date May 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02237313
Other Study ID Numbers  ICMJE 2014/063/HP
2014A0067740 ( Registry Identifier: RCB number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital, Rouen
Study Sponsor  ICMJE University Hospital, Rouen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Pascal Joly, Professor University Hospital, Rouen
PRS Account University Hospital, Rouen
Verification Date August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP