Ignite Creation Date:
2025-12-26 @ 10:20 PM
Ignite Modification Date:
2025-12-26 @ 10:20 PM
Study NCT ID:
NCT05613712
Status:
UNKNOWN
Last Update Posted:
2023-03-28
First Post:
2022-11-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Chronic Inflammatory Rheumatism: Management of Comorbidities in Ambulatory Medicine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}, {'id': 'D025242', 'term': 'Spondylarthropathies'}, {'id': 'D025241', 'term': 'Spondylarthritis'}, {'id': 'D013167', 'term': 'Spondylitis, Ankylosing'}, {'id': 'D015535', 'term': 'Arthritis, Psoriatic'}, {'id': 'D010349', 'term': 'Patient Compliance'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D013166', 'term': 'Spondylitis'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D000089183', 'term': 'Axial Spondyloarthritis'}, {'id': 'D000844', 'term': 'Ankylosis'}, {'id': 'D011565', 'term': 'Psoriasis'}, {'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-02-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2024-02-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-24', 'studyFirstSubmitDate': '2022-11-04', 'studyFirstSubmitQcDate': '2022-11-04', 'lastUpdatePostDateStruct': {'date': '2023-03-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Identification of the factors limiting compliance with the recommendations established during the evaluation of the SCORIC population by the rheumatology department of the CHU Grenoble Alpes, through questionnaires', 'timeFrame': '1 day', 'description': 'Identification of the factors limiting compliance with the recommendations established during the evaluation of the SCORIC population by the rheumatology department of the CHU Grenoble Alpes'}], 'secondaryOutcomes': [{'measure': 'Elements limiting the good ambulatory follow-up, according to the patients', 'timeFrame': '1 day', 'description': 'Description by the patients through the questionnaire of the elements limiting the good ambulatory follow-up'}, {'measure': 'Elements limiting the applicability of the recommendations issued by the rheumatology department of the CHU Grenoble Alpes, according to the patients', 'timeFrame': '1 day', 'description': 'Description by the referring physicians through the questionnaire of the elements limiting the applicability of the recommendations issued by the rheumatology department of the CHU Grenoble Alpes'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['rheumatoid arthritis', 'spondyloarthropathy', 'spondylarthritis', 'ankylosing spondylitis', 'psoriatic arthritis', 'chronic inflammatory rheumatic diseases', 'comorbidities', 'continuity of patient care', 'patient compliance', 'adherence', 'non-adherence'], 'conditions': ['Chronic Inflammatory Disease']}, 'descriptionModule': {'briefSummary': 'Identification of factors limiting compliance with the recommendations established during the evaluation of the SCORIC population by the rheumatology department of the CHU Grenoble Alpes', 'detailedDescription': "In the rheumatology department of the CHU Grenoble Alpes, Professor Baillet and other rheumatologists have set up a holistic assessment of inflammatory rheumatism (rheumatoid arthritis, spondyloarthritis and psoriatic arthritis) and associated co-morbidities in a day hospital. Based on this assessment, a hospital report is drawn up summarising the patient's treatment options, which is then sent to the patient's referring physician. They analysed the first 100 patients in the cohort and showed that 98% of patients were not up to date with their care. Their longitudinal analysis shows that patients update two thirds of the recommendations made within 12 to 18 months. Therefore, the investigators would like to assess the applicability of this screening in these patients, through a questionnaire sent to the 400 patients of the cohort and to their treating physicians."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The SCORIC population targeted by the patient questionnaire represents all patients followed by the rheumatology department of the CHU Grenoble Alpes, having benefited from a holistic analysis of their disease and their comorbidities.\n\nThe referring physician population will be generated from the medical records of the patients of the SCORIC cohort.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patient cohort :\n* men and women over 18 years of age\n* Informed volunteers who have consented to participate in the study\n* have rheumatoid arthritis, spondyloarthritis or psoriatic arthritis\n* have been hospitalised in a day hospital in the rheumatology department of the Grenoble-Alpes University = SCORIC cohort of the department\n* Cohort of referring physicians :\n* volunteers who received informed information and consented to participate in the study\n* be the referring physician of a patient of the SCORIC cohort of the rheumatology department of the South Hospital of the CHU Grenoble-Alpes\n\nExclusion Criteria:\n\n* Patient cohort :\n* psychiatric pathologies or history of behavioural disorders\n* persons referred to in articles L1121-5 to L1121-8 of the Public Health Code\n* persons under guardianship or curatorship\n* not affiliated to the social security system\n* minors\n* Refusal to participate by the patient and/or unreturned questionnaire\n* Cohort of referring physicians:\n* the physician is no longer the patient's referring physician\n* refusal of the doctor to participate and/or questionnaire not returned"}, 'identificationModule': {'nctId': 'NCT05613712', 'acronym': 'SCORIC-A', 'briefTitle': 'Chronic Inflammatory Rheumatism: Management of Comorbidities in Ambulatory Medicine', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Grenoble'}, 'officialTitle': 'Chronic Inflammatory Rheumatism: Management of Comorbidities in Ambulatory Medicine', 'orgStudyIdInfo': {'id': '38RC22.0355'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients', 'description': 'Patients followed by the rheumatology department of the CHU Grenoble Alpes, constituting the SCORIC group', 'interventionNames': ['Other: Patients']}, {'label': 'Referring physician', 'description': 'Physicians identified as the referring physician for patients in the SCORIC group', 'interventionNames': ['Other: Referring physician']}], 'interventions': [{'name': 'Patients', 'type': 'OTHER', 'description': 'Description by the patients through the questionnaire of the elements limiting the good ambulatory follow-up', 'armGroupLabels': ['Patients']}, {'name': 'Referring physician', 'type': 'OTHER', 'description': 'Description by the referring physicians through the questionnaire of the elements limiting the applicability of the recommendations issued by the rheumatology department of the CHU Grenoble Alpes', 'armGroupLabels': ['Referring physician']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38043', 'city': 'Grenoble', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Xavier ROMAND, Phd', 'role': 'CONTACT', 'email': 'xromand@chu-grenoble.fr', 'phone': '0476769291'}], 'facility': 'CHU Grenoble Alpes', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}], 'centralContacts': [{'name': 'Athan BAILLET, PU-PH', 'role': 'CONTACT', 'email': 'abaillet@chu-grenoble.fr', 'phone': '0476767082'}], 'overallOfficials': [{'name': 'Xavier ROMAND, PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU Grenoble Alpes'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Grenoble', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}