Ignite Creation Date:
2025-12-25 @ 4:36 AM
Ignite Modification Date:
2026-03-08 @ 1:07 AM
Study NCT ID:
NCT01848418
Status:
COMPLETED
Last Update Posted:
2020-05-13
First Post:
2013-05-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Conception of an ICF Core Set for Systemic Sclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012595', 'term': 'Scleroderma, Systemic'}], 'ancestors': [{'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 113}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-10-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2018-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-12', 'studyFirstSubmitDate': '2013-05-03', 'studyFirstSubmitQcDate': '2013-05-03', 'lastUpdatePostDateStruct': {'date': '2020-05-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-05-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Validation of an ICF core Set for Systemic sclerosis', 'timeFrame': 'Between the 13th and 24th month', 'description': 'Submit the list of items to a cohort of 100 patients and experts.'}], 'secondaryOutcomes': [{'measure': 'Translation of concepts identified such as items ICF (linking).', 'timeFrame': 'Between the 10th and 12th month', 'description': 'Translation of extracted data and set up the core set'}, {'measure': 'Creation of a database from a qualitative survey', 'timeFrame': 'During the first 9 months', 'description': 'This database will be elaborated considering information from a qualitative survey of 100 patients, a consultation with experts and a review of the literature'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ICF', 'Core sets', 'Systemic sclerosis', 'Function', 'Evaluation'], 'conditions': ['Systemic Sclerosis']}, 'referencesModule': {'references': [{'pmid': '16024476', 'type': 'BACKGROUND', 'citation': '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': '16872536', 'type': 'BACKGROUND', 'citation': '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': '10882211', 'type': 'BACKGROUND', 'citation': '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': '16684371', 'type': 'BACKGROUND', '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. doi: 10.1186/ar1956.'}, {'pmid': '32017013', 'type': 'RESULT', 'citation': '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': '31219594', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to create and validate an ICF core Set for Systemic sclerosis', 'detailedDescription': '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.\n\nICF 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Male or female aged 18 and older with a diagnosis of ScS made according to ACR and/or Leroy et Medsger criteria', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or female aged 18 and older\n* Diagnosis of ScS made according to ACR and/or Leroy et Medsger criteria\n* Patient giving his informed consent to participate in the study\n\nExclusion Criteria:\n\n* Severe chronic disease associated with ScS : stroke, multiple sclerosis, Parkinson's disease,…\n* Cognitive or behavioral disorders making assessment impossible\n* Inability to speak and write French"}, 'identificationModule': {'nctId': 'NCT01848418', 'acronym': 'SCISCIF', 'briefTitle': 'Conception of an ICF Core Set for Systemic Sclerosis', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Conception of an ICF Core Set for Systemic Sclerosis', 'orgStudyIdInfo': {'id': 'AOR - 10050'}}, 'contactsLocationsModule': {'locations': [{'zip': '75014', 'city': 'Paris', 'country': 'France', 'facility': 'Cochin Hospital', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Agathe Papelard, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cochin Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'collaborators': [{'name': "Cabinet d'étude INTERLIS", 'class': 'UNKNOWN'}, {'name': 'Ecole des Hautes Etudes en Santé Publique', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}