Conception of an ICF Core Set for Systemic Sclerosis
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)
