Conception of an ICF Core Set for Systemic Sclerosis

Systemic Sclerosis Clinical Trial

— SCISCIF  

Official title:

Conception of an ICF Core Set for Systemic Sclerosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01848418
• Other study ID #: AOR - 10050
• Status: Completed
• Start date: October 27, 2012
• Est. completion date: March 2018

Study information

• Verified date: May 2020
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 113
• Est. completion date: March 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Scleroderma, Diffuse
• Scleroderma, Systemic
• Sclerosis
• Systemic Sclerosis

Locations

Country	Name	City	State
France	Cochin Hospital	Paris

Sponsors (3)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Cabinet d’étude INTERLIS, Ecole des Hautes Etudes en Santé Publique

Country where clinical trial is conducted

France, 

References & Publications (5)

Cieza A, Geyh S, Chatterji S, Kostanjsek N, Ustün B, Stucki G. ICF linking rules: an update based on lessons learned. J Rehabil Med. 2005 Jul;37(4):212-8. — View Citation

Cieza A, Geyh S, Chatterji S, Kostanjsek N, Ustün BT, Stucki G. Identification of candidate categories of the International Classification of Functioning Disability and Health (ICF) for a Generic ICF Core Set based on regression modelling. BMC Med Res Methodol. 2006 Jul 27;6:36. — View Citation

Clements PJ. Systemic sclerosis (scleroderma) and related disorders: clinical aspects. Baillieres Best Pract Res Clin Rheumatol. 2000 Mar;14(1):1-16. Review. — View Citation

Coenen M, Cieza A, Stamm TA, Amann E, Kollerits B, Stucki G. Validation of the International Classification of Functioning, Disability and Health (ICF) Core Set for rheumatoid arthritis from the patient perspective using focus groups. Arthritis Res Ther. 2006;8(4):R84. — View Citation

Daste C, Abdoul H, Foissac F, Papelard A, Alami S, Kwakkenbos L, Carrier ME, Lefèvre-Colau MM, Thombs BD, Poiraudeau S, Rannou F, Mouthon L, Nguyen C. Development of a new patient-reported outcome measure to assess activities and participation in people w — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Validation of an ICF core Set for Systemic sclerosis	Submit the list of items to a cohort of 100 patients and experts.	Between the 13th and 24th month
Secondary	Translation of concepts identified such as items ICF (linking).	Translation of extracted data and set up the core set	Between the 10th and 12th month
Secondary	Creation of a database from a qualitative survey	This database will be elaborated considering information from a qualitative survey of 100 patients, a consultation with experts and a review of the literature	During the first 9 months