NCT01848418

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
113

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 27, 2012

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 3, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 7, 2013

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

March 27, 2026

Status Verified

March 1, 2026

Enrollment Period

5.3 years

First QC Date

May 3, 2013

Last Update Submit

March 23, 2026

Conditions

Systemic Sclerosis

Keywords

ICFCore setsSystemic sclerosisFunctionEvaluation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Translation of concepts identified such as items ICF (linking).

    Between the 10th and 12th month

  • Creation of a database from a qualitative survey

    During the first 9 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cochin Hospital

Paris, 75014, France

Location

Related Publications (6)

  • Cieza A, Geyh S, Chatterji S, Kostanjsek N, Ustun B, Stucki G. ICF linking rules: an update based on lessons learned. J Rehabil Med. 2005 Jul;37(4):212-8. doi: 10.1080/16501970510040263.

    PMID: 16024476BACKGROUND

  • Cieza A, Geyh S, Chatterji S, Kostanjsek N, Ustun 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. doi: 10.1186/1471-2288-6-36.

    PMID: 16872536BACKGROUND

  • Clements PJ. Systemic sclerosis (scleroderma) and related disorders: clinical aspects. Baillieres Best Pract Res Clin Rheumatol. 2000 Mar;14(1):1-16. doi: 10.1053/berh.1999.0074.

    PMID: 10882211BACKGROUND

  • 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. doi: 10.1186/ar1956.

    PMID: 16684371BACKGROUND

  • Papelard A, Daste C, Alami S, Sanchez K, Roren A, Segretin F, Lefevre-Colau MM, Rannou F, Mouthon L, Poiraudeau S, Nguyen C. Construction of an ICF core set and ICF-based questionnaire assessing activities and participation in patients with systemic sclerosis. Rheumatology (Oxford). 2019 Dec 1;58(12):2260-2272. doi: 10.1093/rheumatology/kez209.

    PMID: 31219594RESULT

  • Daste C, Abdoul H, Foissac F, Papelard A, Alami S, Kwakkenbos L, Carrier ME, Lefevre-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 with systemic sclerosis: the Cochin 17-item Scleroderma Functional scale. Br J Dermatol. 2020 Oct;183(4):710-718. doi: 10.1111/bjd.18922. Epub 2020 Mar 18.

    PMID: 32017013RESULT

MeSH Terms

Conditions

Scleroderma, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesSkin Diseases

Study Officials

  • Agathe Papelard, MD

    Cochin Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 3, 2013

First Posted

May 7, 2013

Study Start

October 27, 2012

Primary Completion

March 1, 2018

Study Completion

March 1, 2018

Last Updated

March 27, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)