Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2025-12-26 @ 3:11 AM
Study NCT ID:
NCT05441020
Status:
COMPLETED
Last Update Posted:
2023-08-01
First Post:
2022-05-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Development, Feasibility Testing and Validation of a Survey Set to Measure Patient-Reported Outcomes Among Hemodialysis Patients in Turkey
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007676', 'term': 'Kidney Failure, Chronic'}], 'ancestors': [{'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': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'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': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 173}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-11-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2023-03-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-30', 'studyFirstSubmitDate': '2022-05-18', 'studyFirstSubmitQcDate': '2022-06-29', 'lastUpdatePostDateStruct': {'date': '2023-08-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Validation of Patient Reported Outcome Measures Information System-29 (PROMIS-29)', 'timeFrame': '2 weeks between test and retest'}, {'measure': 'Translating and testing PROMIS Cognitive Function and Abilities Subscale (PROMIS-CFS)', 'timeFrame': '2 weeks between test and retest'}, {'measure': 'Translating and testing feasibility of a new post-dialysis recovery time module adapted from PROMIS scale on fatigue', 'timeFrame': 'Single Administration in cross-sectional design'}, {'measure': 'Testing feasibility and usefulness of measuring Social Support, potential reduction of items and internal consistency of the MOS-Social Support Scale (MOS-SSS)', 'timeFrame': 'Single Administration in cross-sectional design'}, {'measure': 'Assessing feasibility and usefulness of measuring General Self-Efficacy Scale (GSE)', 'timeFrame': 'Single Administration in cross-sectional design'}, {'measure': 'Testing feasibility of the Telephone Cognitive Screen (T-Cog-S)', 'timeFrame': 'Single Administration in cross-sectional design'}, {'measure': 'Testing feasibility of the kidney disease targeted subscales (sexual function & cognitive function) of the Kidney Disease Quality of Life Short Form Version 1.3 (KDQOL SF 1.3)', 'timeFrame': 'Single Administration in cross-sectional design'}, {'measure': 'Testing feasibility of Health Services Utilization and Productivity Loss Survey', 'timeFrame': 'Single Administration in cross-sectional design'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hemodialysis', 'Psychometric tests', 'Patient questionnaire'], 'conditions': ['Renal Failure', 'End Stage Renal Disease']}, 'descriptionModule': {'briefSummary': 'Development, feasibility testing and validation of a Survey Set to Measure Patient-Reported Outcomes among Hemodialysis Patients in Turkey: Creating and testing an electronic patient questionnaire that is suitable to measure health-related quality of life in Turkish dialysis patients in clinical as well as in home care settings.', 'detailedDescription': 'Individuals with chronic kidney disease represent a growing population in adult and pediatric practices. This has resulted in a drive to optimize patient care and outcomes. Historically, healthcare outcomes focused on morbidity, mortality or complication rates, but failed to provide meaningful data on the value of medicine to patients and the quality of life gained or lost. Several studies have revealed that treatments aimed at minimizing morbidity and mortality in end-stage renal disease (ESRD) have very often been ineffective. Therefore, attention to HRQOL among ESRD patients is crucial.\n\nThe aim of this pilot study is creating and testing an electronic patient questionnaire that is suitable to measure health-related quality of life in Turkish dialysis patients. This questionnaire consists of the PROMIS Cognitive Function and Abilities Subset, the PROMIS-29, a new post-dialysis recovery time module, the MOS-Social Support Scale (MOS-SSS), Subscales of the KDQOL SF 1.3 (sexual function \\& cognitive function), the General Self-Efficacy Scale and the Health Services Utilization And Productivity Loss Survey which are to be delivered together on a tablet computer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Turkish dialysis patients (in center or home dialysis)', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Informed consent signed and dated by study patient and investigator/authorized physician\n* Age of 18 -80 years\n* Ability to understand the nature and requirements of the study\n* Literacy in Turkish including the ability to read with regards to visual acuity and the ability to understand what is read\n* General ability to use a tablet (the study nurse will instruct the patient how to use the study-tablet during the conduct of the study)\n* To be on stable maintenance hemodialysis (HD) for over 3 months (prevalent patients)\n\nExclusion Criteria:\n\n* Any conditions which could interfere with the patient's ability to comply with the study\n* Previous participation in the same study\n* Participation in an interventional clinical study during the preceding 30 days\n* Serious life-limiting co-morbid situations, namely active malignancy, active infection, end-stage cardiac, pulmonary, or hepatic disease, which causes life-expectancy less than a year,\n* Acute cardiovascular events including myocardial infarction, stroke and unstable angina pectoris requiring hospitalization within the last 6 months,\n* To have cognitive or mental co-morbidities which prevent reliable answering of questions"}, 'identificationModule': {'nctId': 'NCT05441020', 'acronym': 'DOPRO', 'briefTitle': 'Development, Feasibility Testing and Validation of a Survey Set to Measure Patient-Reported Outcomes Among Hemodialysis Patients in Turkey', 'organization': {'class': 'INDUSTRY', 'fullName': 'Fresenius Medical Care Deutschland GmbH'}, 'officialTitle': 'Development, Feasibility Testing and Validation of a Survey Set to Measure Patient-Reported Outcomes Among Hemodialysis Patients in Turkey', 'orgStudyIdInfo': {'id': 'HD-HOME-01-TR'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Administration of patient questionnaire', 'type': 'OTHER', 'description': 'Patients undergoing maintenance hemodialysis complete electronic questionnaires on a tablet computer during this study to assess patient reported outcomes.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '35040', 'city': 'Izmir', 'country': 'Turkey (Türkiye)', 'facility': 'Fresenius Nefroloji Hizmetleri A.Ş.-Bornova Branch', 'geoPoint': {'lat': 38.41273, 'lon': 27.13838}}, {'zip': '35340', 'city': 'Izmir', 'country': 'Turkey (Türkiye)', 'facility': 'Fresenius Nefroloji Hizmetleri A.Ş.-Buca Branch', 'geoPoint': {'lat': 38.41273, 'lon': 27.13838}}, {'zip': '35340', 'city': 'Izmir', 'country': 'Turkey (Türkiye)', 'facility': 'Fresenius Nefroloji Hizmetleri A.Ş.-İzmir Üçkuyular Branch', 'geoPoint': {'lat': 38.41273, 'lon': 27.13838}}, {'zip': '35360', 'city': 'Izmir', 'country': 'Turkey (Türkiye)', 'facility': 'Fresenius Nefroloji Hizmetleri A.Ş.-İzmir Hatay Branch', 'geoPoint': {'lat': 38.41273, 'lon': 27.13838}}, {'zip': '35370', 'city': 'Izmir', 'country': 'Turkey (Türkiye)', 'facility': 'İzmir Renal Özel Sağlık Tesisleri ve Malzemeleri Sanayi Tic. A.Ş- Yeşilyurt Branch', 'geoPoint': {'lat': 38.41273, 'lon': 27.13838}}, {'zip': '35410', 'city': 'Izmir', 'country': 'Turkey (Türkiye)', 'facility': 'Gaziemir Özel Sağlık Hizmetleri Tesisleri Malzemeleri Sanayi ve Tic. A.Ş. - Gaziemir Branch', 'geoPoint': {'lat': 38.41273, 'lon': 27.13838}}, {'zip': '35510', 'city': 'Izmir', 'country': 'Turkey (Türkiye)', 'facility': 'Fresenius Nefroloji Hizmetleri A.Ş.-Karşıyaka Branch', 'geoPoint': {'lat': 38.41273, 'lon': 27.13838}}], 'overallOfficials': [{'name': 'Hayriye Elbi, Prof Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ege University Medical Faculty'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fresenius Medical Care Deutschland GmbH', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'acromion GmbH', 'class': 'INDUSTRY'}, {'name': 'Vector Psychometric Group, LLC', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}