Conception of an ICF Core Set for Systemic Sclerosis
- Conditions
- Systemic Sclerosis
- Registration Number
- NCT01848418
- Lead Sponsor
- Assistance Publique - Hôpitaux de Paris
- Brief Summary
The purpose of this study is to create and validate an ICF core Set for Systemic sclerosis
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 113
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Validation of an ICF core Set for Systemic sclerosis Between the 13th and 24th month Submit the list of items to a cohort of 100 patients and experts.
- Secondary Outcome Measures
Name Time Method Translation of concepts identified such as items ICF (linking). Between the 10th and 12th month Translation of extracted data and set up the core set
Creation of a database from a qualitative survey During the first 9 months This database will be elaborated considering information from a qualitative survey of 100 patients, a consultation with experts and a review of the literature
Trial Locations
- Locations (1)
Cochin Hospital
🇫🇷Paris, France