Ignite Creation Date:
2025-12-26 @ 11:10 AM
Ignite Modification Date:
2026-02-26 @ 8:12 PM
Study NCT ID:
NCT01904812
Status:
COMPLETED
Last Update Posted:
2018-12-27
First Post:
2013-07-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Longitudinal Study of Quality of Life and Activity in Systemic Lupus Erythematosus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 356}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-07', 'completionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-12-26', 'studyFirstSubmitDate': '2013-07-12', 'studyFirstSubmitQcDate': '2013-07-17', 'lastUpdatePostDateStruct': {'date': '2018-12-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-07-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'data for quality of life and satisfaction', 'timeFrame': 'participants will be followed for the duration of hospital stay, an expected average of 3 months', 'description': 'Quality of life and satisfaction will be evaluate by questionnaire as Questionnaire SLEQOL, QUESTIONNAIRE LUPUSQOL, QUESTIONNAIRE MFI-20'}], 'secondaryOutcomes': [{'measure': 'Clinical data', 'timeFrame': 'participants will be followed for the duration of hospital stay, an expected average of 3 months', 'description': 'Question about any recent hospitalization pregnancy contraception Compliance score of Girerd Fatigue score MFI-20 tobacco consumption Score of CES-D depression Score stress response WCC'}]}, 'conditionsModule': {'conditions': ['Lupus Erythematosus']}, 'referencesModule': {'references': [{'pmid': '36655762', 'type': 'DERIVED', 'citation': 'Thibault T, Bourredjem A, Maurier F, Wahl D, Muller G, Aumaitre O, Seve P, Blaison G, Pennaforte JL, Martin T, Magy-Bertrand N, Audia S, Arnaud L, Amoura Z, Devilliers H; EQUAL Study Group. The mediating effect of fatigue in impaired quality of life in systemic lupus erythematosus: mediation analysis of the French EQUAL cohort. Rheumatology (Oxford). 2023 Sep 1;62(9):3051-3058. doi: 10.1093/rheumatology/kead020.'}, {'pmid': '31620787', 'type': 'DERIVED', 'citation': 'Corneloup M, Maurier F, Wahl D, Muller G, Aumaitre O, Seve P, Blaison G, Pennaforte JL, Martin T, Magy-Bertrand N, Berthier S, Arnaud L, Bourredjem A, Amoura Z, Devilliers H; EQUAL Study Group. Disease-specific quality of life following a flare in systemic lupus erythematosus: an item response theory analysis of the French EQUAL cohort. Rheumatology (Oxford). 2020 Jun 1;59(6):1398-1406. doi: 10.1093/rheumatology/kez451.'}]}, 'descriptionModule': {'briefSummary': 'Systemic lupus erythematosus is a complex disease whose evaluation in everyday practice and in clinical research requires several aspects to be taken into account, in particular the impact of disease activity on quality of life. To date, the effect of systemic lupus on quality of life has only been described using generic questionnaires. Among the specific questionnaires for systemic lupus, the LupusQol, which has been validated in French, shows interesting psychometric properties. The determinants of quality of life specifically related to the disease are still unknown and could be studied using a longitudinal cohort thanks to the French version of the LupusQol.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\- Patients meeting ACR 1997 classification criteria for systemic lupus erythematosus.\n* Patients able to understand written and spoken French.\n* Patients aged from 18 to 75 years\n* Patients who have received written and oral information about the research.\n\nExclusion Criteria:\n\n* \\- Patients aged less than 18 years\n* Patients aged more than 75 years\n* Severe mental retardation Any impairment of abilities to understand that make self-evaluation impossible'}, 'identificationModule': {'nctId': 'NCT01904812', 'acronym': 'EQUAL', 'briefTitle': 'Longitudinal Study of Quality of Life and Activity in Systemic Lupus Erythematosus', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire Dijon'}, 'orgStudyIdInfo': {'id': 'Besancenot PHRC N 2010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Lupus erythematosus', 'interventionNames': ['Other: Questionnaire about quality of life and satisfaction']}], 'interventions': [{'name': 'Questionnaire about quality of life and satisfaction', 'type': 'OTHER', 'armGroupLabels': ['Lupus erythematosus']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21079', 'city': 'Dijon', 'country': 'France', 'facility': 'CHU de Dijon', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}], 'overallOfficials': [{'name': 'Jean-François BESANCENOT', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU Dijon - Department of Internal Medicine and Systemic Diseases'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire Dijon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}