Ignite Creation Date:
2025-12-25 @ 3:55 AM
Ignite Modification Date:
2026-04-06 @ 11:50 AM
Study NCT ID:
NCT06591702
Status:
RECRUITING
Last Update Posted:
2024-09-19
First Post:
2024-09-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigation of the Validity, Reliability, and Responsiveness of BETY-BQ in Chronic Kidney Disease, on Dialysis, and Kidney Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'targetDuration': '3 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-02-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-10', 'studyFirstSubmitDate': '2024-09-08', 'studyFirstSubmitQcDate': '2024-09-08', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02-21', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'BETY-Biopsychosocial Questionnaire', 'timeFrame': 'Three months', 'description': 'The biopsychosocial status is evaluated through questions about pain, functionality, mood, sociability, sexuality, and sleep. Each question has 30 items, with scores ranging from 0 to 120, categorized as follows: 0 (never), 1 (yes rarely), 2 (yes sometimes), 3 (yes often), and 4 (yes always). Higher scores reflect a poorer biopsychosocial status.'}], 'secondaryOutcomes': [{'measure': 'Hospital Anxiety Depression Scale', 'timeFrame': 'Three months', 'description': 'The Hospital Anxiety and Depression Scale (HADS) comprises 14 items, with 7 items assessing anxiety and the other 7 evaluating depression. Each item is scored on a scale of 0 to 3, resulting in a total score ranging from 0 to 21. Higher scores indicate more severe levels of anxiety and depression.'}, {'measure': 'Kidney Disease and Quality of Life™ (KDQOL™-36)', 'timeFrame': 'Three months', 'description': 'The 36-item scale includes three specific dimensions: symptoms/problems, burden of kidney disease and effects of kidney disease, and physical component and mental component components derived from SF12. The scale, which consists of 5 sub-dimensions, is scored between 0-100. Higher scores indicate better health-related quality of life.'}, {'measure': 'Clinical Frailty Scale', 'timeFrame': 'Three months', 'description': 'A scale that can be easily administered in most clinical settings and is scored from 1 (very fit) to 9 (terminally ill) about fitness, active illness, activities of daily living, and cognition. The assessment is based on the subjective judgment of a clinician.'}, {'measure': 'Frail Scale', 'timeFrame': 'Three months', 'description': 'The FRAIL scale is based on a table of self-reported fatigue, mobility, strength, weight loss, and comorbidities. Each item is scored between 0-1, totaling 5 points. A high score indicates a high level of frailty.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['biopsychosocial model', 'validity and reliability', 'BETY-BQ', 'Chronic Kidney Disease', 'Kidney Transplantation', 'Dialysis'], 'conditions': ['Chronic Kidney Disease(CKD)', 'Chronic Kidney Disease Requiring Chronic Dialysis', 'Kidney Transplantation']}, 'descriptionModule': {'briefSummary': 'A review of the literature has shown that Chronic Kidney Disease (CKD) is strongly associated with an increasing degree of psychosocial impact, such as depression and anxiety and a decrease in quality of life. Therefore, while determining the psychosocial aspects of the disease gains importance, it is reported that determining and evaluating the biopsychosocial characteristics may facilitate the disease management of individuals. Considering that CKD is associated with various comorbidities, psychosocial features, and symptom burden, it is interpreted that patient-reported outcome measures may support the complex management of these individuals. Routine collection and use of patient-reported outcome measures may provide valuable data for understanding the disease from both individual and community perspectives, with the potential to improve the quality of care and outcomes.\n\nThe Cognitive Exercise Therapy Approach (Bilişsel Egzersiz Terapi Yaklaşımı-BETY) is an innovative exercise model based on physical exercise and an example of a biopsychosocial approach developed for patients with rheumatism. The BETY-Biopsychosocial Questionnaire (BETY-BQ) was created by repeated statistics of improvement characteristics reported by individuals who participated in BETY sessions for many years. The BETY-BQ holistically assesses many biopsychosocial characteristics of the person, such as pain, functionality, mood, sociability, sexuality, and sleep. Therefore, there is a need for scales that assess these symptoms holistically in chronic kidney disease. BETY-BQ can be envisaged as an assessment tool for interdisciplinary healthcare team members who want to evaluate the CKD population, including individuals on dialysis and kidney transplant recipients. Since the BETY-BQ can assess biopsychosocial characteristics quickly and its structure was created with the feedback of individuals with chronic diseases, it aimed to examine its validation in this disease group.\n\nIn this study, which investigators planned to contribute to this field, investigators aimed to investigate the validity, reliability, and sensitivity of BETY-BQ in individuals diagnosed with chronic kidney disease on dialysis and kidney transplantation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The study population will consist of individuals who come to the university hospital for routine controls.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Individuals with chronic kidney disease:\n\nInclusion Criteria:\n\n* Being diagnosed with chronic kidney disease\n* To be over 18 years old\n* Consent of the participant\n\nExclusion Criteria:\n\n* Acute infection\n* Being diagnosed with cancer\n\nIndividuals on dialysis:\n\nInclusion Criteria:\n\n* Being a dialysis patient\n* To be over 18 years old\n* Consent of the participant\n\nExclusion Criteria:\n\n* Acute infection\n* Being diagnosed with cancer\n\nKidney transplant recipients:\n\nInclusion Criteria:\n\n* To have had a kidney transplant\n* To be over 18 years old\n* Consent of the participant\n\nExclusion Criteria:\n\n* Acute infection\n* Being diagnosed with cancer'}, 'identificationModule': {'nctId': 'NCT06591702', 'briefTitle': 'Investigation of the Validity, Reliability, and Responsiveness of BETY-BQ in Chronic Kidney Disease, on Dialysis, and Kidney Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'Hacettepe University'}, 'officialTitle': 'Investigation of the Validity, Reliability, and Responsiveness of BETY-Biopsychosocial Questionnaire in Individuals with Chronic Kidney Disease, on Dialysis, and Kidney Transplantation', 'orgStudyIdInfo': {'id': 'SBA 24/097'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Questionnaire study', 'type': 'OTHER', 'otherNames': ['BETY-Biopsychosocial Questionnaire'], 'description': 'Questionnaire application'}]}, 'contactsLocationsModule': {'locations': [{'zip': '06100', 'city': 'Ankara', 'state': 'Altındağ', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Orkun Tüfekçi, PT, PhD(c)', 'role': 'CONTACT', 'email': 'orkuntf@gmail.com', 'phone': '+90 312 305 25 25'}], 'facility': 'Hacettepe University', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'centralContacts': [{'name': 'Orkun Tüfekçi, PT, PhD (c)', 'role': 'CONTACT', 'email': 'orkuntf@gmail.com', 'phone': '5319502648'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Will not be shared to protect the data of individuals'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hacettepe University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator, PT, PhD(c)', 'investigatorFullName': 'Orkun Tüfekçi', 'investigatorAffiliation': 'Hacettepe University'}}}}