Conception of an ICF Core Set for Systemic Sclerosis (SCISCIF)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01848418|
Recruitment Status : Recruiting
First Posted : May 7, 2013
Last Update Posted : March 2, 2018
|Condition or disease|
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.
|Study Type :||Observational|
|Estimated Enrollment :||130 participants|
|Official Title:||Conception of an ICF Core Set for Systemic Sclerosis|
|Actual Study Start Date :||October 27, 2012|
|Estimated Primary Completion Date :||October 2018|
|Estimated Study Completion Date :||November 2018|
- Validation of an ICF core Set for Systemic sclerosis [ Time Frame: Between the 13th and 24th month ]Submit the list of items to a cohort of 100 patients and experts.
- Translation of concepts identified such as items ICF (linking). [ Time Frame: Between the 10th and 12th month ]Translation of extracted data and set up the core set
- Creation of a database from a qualitative survey [ Time Frame: 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01848418
|Contact: Agathe Papelard, MDemail@example.com|
|Contact: Laurence Lecomte, PhD||+33 1 71 19 64 firstname.lastname@example.org|
|Paris, France, 75014|
|Contact: Agathe Papelard, MD +33158005263 email@example.com|
|Principal Investigator:||Agathe Papelard, MD||Cochin Hospital, India|