Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2025-12-26 @ 3:10 AM
Study NCT ID:
NCT06068920
Status:
UNKNOWN
Last Update Posted:
2023-10-05
First Post:
2023-09-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Distress in Rheumatoid Arthritis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-01-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2023-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-29', 'studyFirstSubmitDate': '2023-09-29', 'studyFirstSubmitQcDate': '2023-09-29', 'lastUpdatePostDateStruct': {'date': '2023-10-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Distress', 'timeFrame': '10 months', 'description': 'Presence of distress related with rheumatoid arthritis will be evaluated by Rheumatoid Arthritis Distress Scale.'}], 'secondaryOutcomes': [{'measure': 'Disease activity', 'timeFrame': '10 months', 'description': 'Disease activity will be evaluated by DAS 28 score.'}, {'measure': 'Functional status', 'timeFrame': '10 months', 'description': 'Functional status of patients will be evaluated by HAQ.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['rheumatoid arthritis, distress'], 'conditions': ['Arthritis, Rheumatoid', 'Distress, Emotional']}, 'referencesModule': {'references': [{'pmid': '24003249', 'type': 'BACKGROUND', 'citation': 'Matcham F, Rayner L, Steer S, Hotopf M. The prevalence of depression in rheumatoid arthritis: a systematic review and meta-analysis. Rheumatology (Oxford). 2013 Dec;52(12):2136-48. doi: 10.1093/rheumatology/ket169. Epub 2013 Sep 3.'}, {'pmid': '20669340', 'type': 'BACKGROUND', 'citation': 'Book K, Marten-Mittag B, Henrich G, Dinkel A, Scheddel P, Sehlen S, Haimerl W, Schulte T, Britzelmeir I, Herschbach P. Distress screening in oncology-evaluation of the Questionnaire on Distress in Cancer Patients-short form (QSC-R10) in a German sample. Psychooncology. 2011 Mar;20(3):287-93. doi: 10.1002/pon.1821.'}, {'pmid': '27345064', 'type': 'BACKGROUND', 'citation': 'Woodward S, Dibley L, Coombes S, Bellamy A, Clark C, Czuber-Dochan W, Everelm L, Kutner S, Sturt J, Norton C. Identifying disease-specific distress in patients with inflammatory bowel disease. Br J Nurs. 2016 Jun 23;25(12):649-60. doi: 10.12968/bjon.2016.25.12.649.'}, {'pmid': '34782021', 'type': 'BACKGROUND', 'citation': 'Silke L, Kirresh O, Sturt J, Lempp H. Development of the Rheumatoid Arthritis Distress Scale (RADS): a new tool to identify disease-specific distress in patients with Rheumatoid Arthritis. BMC Rheumatol. 2021 Nov 16;5(1):51. doi: 10.1186/s41927-021-00220-4.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to determine the frequency of psychological distress caused by the rheumatoid arthritis disease in patients with rheumatoid arthritis and to determine the factors associated with the distress.\n\nA routine rheumatoid arthritis patient examination (number of swollen and tender joints, disease activity, functional status, etc.) will be performed by the doctor to evaluate the patients. Patients will be asked to fill out the questionnaires to evaluate their functional status and distress levels.\n\nDemographic data such as age, gender, body mass index and disease duration will be recorded during routine follow-up of the patients. The duration of morning stiffness, the number of swollen and tender joints, disease activity and functional status will be evaluated by the doctor. Disease activity will be evaluated with the DAS 28 score and functional status will be evaluated with the Health Assessment Questionnaire. Rheumatoid Arthritis Distress Scale (RADS) will be used to evaluate the distress due to rheumatoid arthritis.Patients will be asked to fill out the questionnaires to evaluate their functional status and distress levels.', 'detailedDescription': "Demographic data such as age, gender, body mass index and disease duration will be recorded during routine follow-up of the patients. The duration of morning stiffness, the number of swollen and tender joints, disease activity and functional status will be evaluated by the doctor. Disease activity will be evaluated with the DAS 28 score and functional status will be evaluated with the Health Assessment Questionnaire. Rheumatoid Arthritis Distress Scale (RADS) will be used to evaluate the distress due to rheumatoid arthritis.\n\nDAS28 score is a score calculated by a mathematical formula based on the patient's swollen and tender joint counts, erythrocyte sedimentation rate and the patient's global assessment of disease activity.\n\nThe Health Assessment Questionnaire consists of twenty items and evaluates the degree of difficulty patients have in performing daily living activities. The total score varies between 0 and 3, with a higher score indicating a more serious impact on daily functional status.\n\nRheumatoid Arthritis Distress Scale (RADS) is a scale developed to evaluate the psychological distress experienced in patients with rheumatoid arthritis due to the effects of the disease. The total score varies between 0 and 5, with a higher score indicating more impact."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients aged 18 years and older, diagnosed with rheumatoid arthritis.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Having rheumatoid arthritis over the age of 18\n2. Having the cognitive state to understand what you read and answer questions\n\nExclusion Criteria:\n\n1. Being currently receiving treatment for known psychological disorders such as depression and anxiety.\n2. Having another chronic disease that may cause psychological distress'}, 'identificationModule': {'nctId': 'NCT06068920', 'briefTitle': 'Distress in Rheumatoid Arthritis Patients', 'organization': {'class': 'OTHER', 'fullName': 'Bozyaka Training and Research Hospital'}, 'officialTitle': 'Evaluation of Distress and Related Factors in Patients With Rheumatoid Arthritis', 'orgStudyIdInfo': {'id': 'IBEAH'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Distress evaluation', 'type': 'OTHER', 'description': 'To evaluate the effects of psychological distress caused by living with a chronic disease such as rheumatoid arthritis.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Izmir', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Altınay Göksel Karatepe, MD', 'role': 'CONTACT', 'email': 'altinaygoksel@yahoo.com', 'phone': '+905323026793'}], 'facility': 'University of Health Sciences Turkey', 'geoPoint': {'lat': 38.41273, 'lon': 27.13838}}], 'overallOfficials': [{'name': 'Altınay Göksel Karatepe, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Professor doctor'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bozyaka Training and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor Doctor', 'investigatorFullName': 'Altınay Göksel Karatepe', 'investigatorAffiliation': 'Bozyaka Training and Research Hospital'}}}}