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Conception of an ICF Core Set for Systemic Sclerosis (SCISCIF)

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ClinicalTrials.gov Identifier: NCT01848418
Recruitment Status : Recruiting
First Posted : May 7, 2013
Last Update Posted : June 28, 2016
Sponsor:
Collaborators:
Cabinet d’étude INTERLIS
Ecole des Hautes Etudes en Santé Publique
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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

Condition or disease
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.


Study Type : Observational
Estimated Enrollment : 130 participants
Time Perspective: Prospective
Official Title: Conception of an ICF Core Set for Systemic Sclerosis
Study Start Date : January 2013
Estimated Primary Completion Date : February 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scleroderma
U.S. FDA Resources




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Male or female aged 18 and older with a diagnosis of ScS made according to ACR and/or Leroy et Medsger criteria
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

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


Contacts
Contact: Agathe Papelard, MD +33158005263 agathe.papelard@cch.aphp.fr
Contact: Laurence Lecomte, PhD +33 1 71 19 64 94 laurence.lecomte@nck.aphp.fr

Locations
France
Cochin Hospital Recruiting
Paris, France, 75014
Contact: Agathe Papelard, MD    +33158005263    agathe.papelard@cch.aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Cabinet d’étude INTERLIS
Ecole des Hautes Etudes en Santé Publique
Investigators
Principal Investigator: Agathe Papelard, MD Cochin Hospital, India