跳至主要内容
临床试验/NCT01848418
NCT01848418已完成不适用

Conception of an ICF Core Set for Systemic Sclerosis

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 113 人开始时间: 2012年10月27日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
113
试验地点
1
主要终点
Validation of an ICF core Set for Systemic sclerosis

研究概览

简要总结

The purpose of this study is to create and validate an ICF core Set for Systemic sclerosis

详细描述

In 2002 was published WHO's International Classification of Functioning, Disability and Health (ICF). ICF defines disability as "the negative aspects of the interaction between an individual (with a health condition) and that individual's contextual factors (personal and environmental factors)". Interactions are specified in five domains, classified from body, individual and societal perspectives by means of two lists: a list of body functions and structure, and a list of domains of activity and participation. Since an individual's functioning and disability occurs in a context, the ICF also includes a list of environmental factors.

ICF core sets, which are short lists of ICF categories relevant for specific conditions, serve as practical tools for clinical practice and allow standardisation of data for health information and research. Core sets have already been developed and validated for several musculoskeletal diseases, such as low back pain, osteoarthritis, or osteoporosis, but not yet for systemic sclerosis.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

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

  • •Male or female aged 18 and older
  • •Diagnosis of ScS made according to ACR and/or Leroy et Medsger criteria
  • •Patient giving his informed consent to participate in the study

排除标准

  • •Severe chronic disease associated with ScS : stroke, multiple sclerosis, Parkinson's disease,…
  • •Cognitive or behavioral disorders making assessment impossible
  • •Inability to speak and write French

结局指标

主要结局

Validation of an ICF core Set for Systemic sclerosis

时间窗: Between the 13th and 24th month

Submit the list of items to a cohort of 100 patients and experts.

次要结局

  • Translation of concepts identified such as items ICF (linking).(Between the 10th and 12th month)
  • Creation of a database from a qualitative survey(During the first 9 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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