Identification of Vulnerability Factors in the Course of Pemphigus Patients - SHS Pemphigus Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 9
- 主要终点
- analysis of vulnerability factors
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Person placed under judicial protection,
- •Patient without liberty by administrative or judicial decision,
- •Patient participating in another trial for the duration of monitoring.
研究组 & 干预措施
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
干预措施: psychological support and therapeutic education program (Behavioral)
结局指标
主要结局
analysis of vulnerability factors
时间窗: 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
次要结局
- assessment of anxiety, uncertainty, fear, coping strategies(6 months)
- analysis of vulnerability factors(6 months)
- assessment of anxiety, uncertainty, fear, coping strategies(12 months)