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Completed

NCT Number: NCT01848418

Conception of an ICF Core Set for Systemic Sclerosis

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

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Key information

Conditions

Systemic Sclerosis Connective Tissue Diseases Scleroderma, Systemic Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cochin Hospital

Paris, 75014, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • Cabinet d'étude INTERLIS
  • Ecole des Hautes Etudes en Santé Publique
  • URC-CIC Paris Descartes Necker Cochin

Registry information

Acronym: SCISCIF

Important dates

Study start
2012
Primary completion
2018
Study completion
2018
First posted
May 7, 2013
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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