Ignite Creation Date:
2025-12-24 @ 11:28 PM
Ignite Modification Date:
2025-12-25 @ 9:15 PM
Study NCT ID:
NCT06652256
Status:
COMPLETED
Last Update Posted:
2024-12-17
First Post:
2024-10-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Fatigue in Systemic Lupus Erythematosus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005221', 'term': 'Fatigue'}], 'ancestors': [{'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 39}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-10-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2024-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-15', 'studyFirstSubmitDate': '2024-10-17', 'studyFirstSubmitQcDate': '2024-10-21', 'lastUpdatePostDateStruct': {'date': '2024-12-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fatigue Assesment Scale', 'timeFrame': 'Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.', 'description': 'It is a scale consisting 10 items. The maximum score is 50. High score indicates high fatigue.'}, {'measure': 'FACIT Fatigue Scale', 'timeFrame': 'Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.', 'description': 'It is scale consisting 13 items. Scores range from 0-52. High score indicates low fatigue'}], 'secondaryOutcomes': [{'measure': 'Cognitive Exercise Therapy Approach-Biopsychosocial Questionnaire (BETY-BQ)', 'timeFrame': 'Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.', 'description': 'It is a scale consist of 30 items. Scores range from 0-120. Higher scores indicate worse biopsychosocial status.'}, {'measure': 'Short Form 36 (SF-36) Health Survey', 'timeFrame': 'Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.', 'description': 'The SF-36 consists of two dimensions, generating a profile of health-related quality of life.These dimensions are: physical health and mental health. Higher scores indicate better health.'}, {'measure': 'HEALTH ASSESSMENT QUESTIONNAIRE (HAQ)', 'timeFrame': 'Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.', 'description': 'The scale consists of 20 questions and includes 8 activities. The total score is obtained by summing the points earned from 8 activities and then dividing that sum by 8. Higher scores indicate worse functional status'}, {'measure': 'Routine blood test results', 'timeFrame': 'Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.', 'description': "Participants' routine blood test results such as neutrophil (NEU (K/uL)) , monocyte (MONO (K/uL)), eosinophil (EO (K/uL)), leukocyte (WBC (K/uL)), lymphocyte (LYM (K/uL)), platelet (PLT (K/uL)) will be recorded."}, {'measure': 'Routine Blood Test Results', 'timeFrame': 'Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.', 'description': "Participants' routine blood test results such as calcium (Ca (mg/dL)), creatinine (mg/dL), c-reactive protein (CRP (mg/L)), uric acid (mg/dL) will be recorded."}, {'measure': 'Routine Blood Test Results', 'timeFrame': 'Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.', 'description': "The participants' rutin blood test such as aspartate aminotransferase (AST IU/L), alanine aminotransferase (ALT IU/L) will be recorded."}, {'measure': 'Hematological indices', 'timeFrame': 'Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.', 'description': 'Neutrophil/lymphocyte (NLR), monocyte/lymphocyte (MLR), platelet/lymphocyte (PLR), platelet\\*neutrophil/lymphocyte (systemic inflammatory index), monocyte/platelet (MTO), neutrophil\\*monocyte/lymphocyte (systemic inflammatory response index), neutrophil\\*monocyte\\*platelet/lymphocyte (systemic inflammation aggregate index) obtained from complete blood counts will be calculated and recorded.'}, {'measure': 'Routine Blood Test Results', 'timeFrame': 'Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.', 'description': 'Procolcytonin (PCT (%)), erythrocyte distribution width (RDW (%)), platelet distribution width (PDW (%)) levels will be recorded.'}, {'measure': 'Routine Blood Test Results', 'timeFrame': 'Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.', 'description': 'Erythrocyte distribution width standard deviation (RDW-SD (fL)) will be recorded.'}, {'measure': 'Routine Blood Test Results', 'timeFrame': 'Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.', 'description': 'C3 complement (g/L) and C4 complement (g/L) levels will be recorded.'}, {'measure': 'Routine Blood Test Results', 'timeFrame': 'Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.', 'description': 'Blood urea nitrogen (BUN (mg/dL)) levels will be recorded.'}, {'measure': 'Routine Blood Test Results', 'timeFrame': 'Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.', 'description': 'Sedimentation (mm/h) will be recorded.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Fatigue', 'Systemic Lupus Erthematosus']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to investigate the effects of biopsychosocial status, quality of life, functional status and hematological markers on fatigue in individuals with SLE.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The study will include individuals aged 18 and older who are receiving treatment for SLE at a university hospital in Turkey, and meet the inclusion and exclusion criteria.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Being diagnosed with SLE according to the 2019 ACR/EULAR diagnostic criteria\n* Being 18 years of age or older\n\nExclusion Criteria:\n\n* Not being able to speak or understand Turkish fluently\n* Having a psychiatric illness that will affect cooperation\n* Heart failure or lung pathology that will affect daily life activities\n* Additional autoimmune disease'}, 'identificationModule': {'nctId': 'NCT06652256', 'briefTitle': 'Fatigue in Systemic Lupus Erythematosus', 'organization': {'class': 'OTHER', 'fullName': 'Pamukkale University'}, 'officialTitle': 'Fatigue in Systemic Lupus Erythematosus: Which Variables Play a Role?', 'orgStudyIdInfo': {'id': 'Fatigue'}}, 'contactsLocationsModule': {'locations': [{'city': 'Denizli', 'country': 'Turkey (Türkiye)', 'facility': 'Pamukkale University', 'geoPoint': {'lat': 37.77417, 'lon': 29.0875}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pamukkale University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Assitant', 'investigatorFullName': 'Zülal TATAR', 'investigatorAffiliation': 'Pamukkale University'}}}}