Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2025-12-27 @ 1:42 PM
Study NCT ID:
NCT06357793
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-30
First Post:
2024-04-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Work Productivity and Activities of the Fibromyalgia Patients' Relatives
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005356', 'term': 'Fibromyalgia'}, {'id': 'D059350', 'term': 'Chronic Pain'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'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': 'ESTIMATED', 'count': 122}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-06-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2024-12-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-29', 'studyFirstSubmitDate': '2024-04-05', 'studyFirstSubmitQcDate': '2024-04-05', 'lastUpdatePostDateStruct': {'date': '2024-05-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Work Productivity and Activity of Fibromyalgia Patients' Relatives", 'timeFrame': '1 day', 'description': 'Work Productivity and Activity Impairment questionnaire'}], 'secondaryOutcomes': [{'measure': "Quality of life Fibromyalgia Patients' Relatives", 'timeFrame': '1 day', 'description': 'World Health Organization Quality of Life questionnaire'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['fibromyalgia', 'work productivity and activity impairment', 'quality of life'], 'conditions': ['Fibromyalgia', 'Work Productivity', 'Quality of Life', 'Pain, Chronic']}, 'referencesModule': {'references': [{'pmid': '35699070', 'type': 'BACKGROUND', 'citation': 'Salaffi F, Di Carlo M, Farah S, Mariani C, Fulginei S, Martino GP, Sarzi-Puttini P. A cross-sectional research on female workers examining the loss of productivity caused by mild, moderate and severe fibromyalgia. Clin Exp Rheumatol. 2022 Jun;40(6):1151-1158. doi: 10.55563/clinexprheumatol/hut4ft. Epub 2022 Jun 8.'}, {'pmid': '9213382', 'type': 'BACKGROUND', 'citation': 'Neumann L, Buskila D. Quality of life and physical functioning of relatives of fibromyalgia patients. Semin Arthritis Rheum. 1997 Jun;26(6):834-9. doi: 10.1016/s0049-0172(97)80027-3.'}, {'pmid': '24402006', 'type': 'BACKGROUND', 'citation': 'Tutoglu A, Boyaci A, Koca I, Celen E, Korkmaz N. Quality of life, depression, and sexual dysfunction in spouses of female patients with fibromyalgia. Rheumatol Int. 2014 Aug;34(8):1079-84. doi: 10.1007/s00296-014-2944-z. Epub 2014 Jan 9.'}]}, 'descriptionModule': {'briefSummary': 'Patients suffering from fibromyalgia (FM) are challenged by symptoms such as chronic pain, fatigue, sleep disturbance and emotional distress. Patients diagnosed with fibromyalgia can also negatively affect the relatives they live with due to their existing complaints. It is possible that their relatives accompanying them may lose their workforce due to untreated pain complaints and frequent hospital admissions. The main purpose of our study is to examine whether there is any impact on the working life of the people they live with and whether there is a decrease in their work productivity.', 'detailedDescription': "This cross-sectional study will evaluate FM patients and their relatives, who are in paid full- or part time employment at the time of the assessment. The study protocol doesn't require any medical intervention. Fibromyalgia severity will be assessed with the fibromyalgia impact questionnaire (FIQ). Evaluation of patient relatives' work productivity and activities will be made with the Work Productivity and Activity Impairment questionnaire: General Health (WPAI:GH). Analyzes will be completed with a group of healthy controls in the study."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The revised 2016 American College of Rheumatology (ACR) FM diagnostic criteria were used to diagnose FM. Our study group participants have to live with FM patients. Also they have to work in a full or part-time job.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nStudy Group:\n\nMust live together with a patient diagnosed with FM 18-65 years old Must work in a full-time/part-time job\n\nControl Group:\n\nMust live with a healthy relative 18-65 years old Must work in a full-time/part-time job\n\nExclusion Criteria:\n\nMust live alone Not having a full-time/part-time job'}, 'identificationModule': {'nctId': 'NCT06357793', 'briefTitle': "Evaluation of Work Productivity and Activities of the Fibromyalgia Patients' Relatives", 'organization': {'class': 'OTHER_GOV', 'fullName': 'Başakşehir Çam & Sakura City Hospital'}, 'officialTitle': 'Evaluation of Work Productivity and Activities of the Relative Living With a Patient With Fibromyalgia Syndrome', 'orgStudyIdInfo': {'id': 'camsakuraftr'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'fibromyalgia', 'description': 'The revised 2016 American College of Rheumatology (ACR) FM diagnostic criteria going to be use to diagnose FM participants group. Their relatives will fill out the WPAI:GH Questionnaire and World Health Organization Quality of Life (WHOQOL).'}, {'label': 'control', 'description': "Healthy participants' relatives will fill out the WPAI:GH Questionnaire and World Health Organization Quality of Life (WHOQOL)."}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'DEMET FERAHMAN, MD', 'role': 'CONTACT', 'email': 'demetferahman@gmail.com', 'phone': '+905364702930'}, {'name': 'OMER BUCAK, MD', 'role': 'CONTACT', 'phone': '+905326079446'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Başakşehir Çam & Sakura City Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}