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临床试验/NCT02310204
NCT02310204已完成不适用

Evaluation of a Therapeutic Education Program in Patients With Moderate to Severe Psoriasis : a Multicenter Randomized Controlled Study

University Hospital, Toulouse17 个研究点 分布在 1 个国家目标入组 187 人开始时间: 2011年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
187
试验地点
17
主要终点
skindex quality of life

研究概览

简要总结

The primary objective of this research protocol is to assess the effect of a structured therapeutic education program on the quality of life of patients with moderate to severe psoriasis

详细描述

Psoriasis is a chronic inflammatory skin disease affecting 1 to 3% of the French population. Moderate to severe psoriasis has a significant impact on quality of life. Psoriasis is associated with an increased risk of depression, social isolation, unemployment. In addition, it has recently be shown that patients with moderate to severe psoriasis have an increased incidence of cardiovascular risk factors such as hypertension, overweight, hyperlipidemia and exposure to tobacco and alcohol. These so-called comorbidites may have a negative impact on psoriasis management. They also may account for the reduced life expectancy reported in patients with severe psoriasis. Therapeutic education is a structured process whose objective is to help patients to acquire or to maintain competencies that are required to live with a chronic disease. Therapeutic education is an important process to be integrated into the therapeutic strategy. It has to take into account co-morbidities, social and psychological context and its priorities need to be defined with the patient.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
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

入选标准

  • Moderate to severe psoriasis defined as patients receiving a systemic psoriasis treatment including methotrexate, cyclosporine, PUVA, retinoids or a biological agent and with significant impact on quality of life defined as a Skindex > 18
  • Patients with palmo-plantar or erythrodermic psoriasis may be included if they can be classified as moderate to severe according the above described definitions

排除标准

  • Patients not able to give informed consent,
  • Patients not able to follow the program,
  • Patients without social security affiliation.

结局指标

主要结局

skindex quality of life

时间窗: 3 months

evaluation of quality of life

次要结局

  • SF36 - Short Form 36(3 MONTHS)
  • PASI - Psoriasis Area and Severity Index(3 MONTHS)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (17)

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