Ignite Creation Date:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2025-12-26 @ 4:12 AM
Study NCT ID:
NCT01509027
Status:
UNKNOWN
Last Update Posted:
2012-05-30
First Post:
2012-01-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of the Compliance With Phosphorus Restricted Diet and Phosphate Binder Therapy in Hemodialysis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D010349', 'term': 'Patient Compliance'}], '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'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}, {'id': 'D064686', 'term': 'Nutritionists'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D006282', 'term': 'Health Personnel'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-01', 'completionDateStruct': {'date': '2012-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-05-29', 'studyFirstSubmitDate': '2012-01-09', 'studyFirstSubmitQcDate': '2012-01-11', 'lastUpdatePostDateStruct': {'date': '2012-05-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-01-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'compliance', 'timeFrame': 'baseline and after intervention', 'description': 'impact of education (by DVD and interview with dietician)on compliance with phosphorus restricted diet and phosphate binder therapy'}, {'measure': 'serum phosphate levels', 'timeFrame': 'baseline and after intervention', 'description': 'impact of education (by DVD and interview with dietician) on serum phosphate levels'}], 'secondaryOutcomes': [{'measure': 'risk factors of noncompliance', 'timeFrame': 'baseline', 'description': 'identification of risk factors for non compliance with emphasis on cognitive function and depression'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['hemodialysis', 'hyperphoshatemia', 'compliance'], 'conditions': ['Chronic Kidney Disease']}, 'descriptionModule': {'briefSummary': 'Hyperphosphatemia is a common and severe complication in chronic kidney disease patients treated with hemodialysis. A phosphate restricted diet and oral phosphate binders are the cornerstones in the prevention and treatment of this complication. However, noncompliance is an prevalent problem resulting in poorly controled hyperphosphatemia in a substantial proportion of hemodialysis patients. The present study aims at identifying risk factors for non compliance and also test the hypothesis that compliance can be improved by education patients on the consequences of hyperphosphatemia and the importance of diet and phosphate binder therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* prevalent (\\>3months) hemodialysis patients\n* aged \\> 18 years\n* informed consent\n\nExclusion Criteria:\n\n* decreased consciousness\n* unstable\n* medical contraindication for phosphorus restricted diet or phsophate binder therapy'}, 'identificationModule': {'nctId': 'NCT01509027', 'briefTitle': 'Study of the Compliance With Phosphorus Restricted Diet and Phosphate Binder Therapy in Hemodialysis Patients', 'organization': {'class': 'OTHER', 'fullName': 'Universitaire Ziekenhuizen KU Leuven'}, 'officialTitle': 'A Randomized Controlled Trial to Evaluate the Impact of Education on the Knowledge About and Compliance With a Phosphorus Restricted Diet and Phosphate Binder Therapy in Maintenance Dialysis Patients', 'orgStudyIdInfo': {'id': 'B322201112895'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Education by DVD and dietician', 'description': 'Information on detrimental conseqences of hyperphosphatemia is presented on DVD and individual dietary counseling is given by dieticican', 'interventionNames': ['Behavioral: Education by DVD and dietician']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Education by unpersonalised DVD', 'description': 'Information on detrimental consequences of hyperphosphatemia is presented on DVD', 'interventionNames': ['Behavioral: education by DVD']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Standard Care', 'description': 'standard care', 'interventionNames': ['Behavioral: Standard care']}], 'interventions': [{'name': 'education by DVD', 'type': 'BEHAVIORAL', 'description': 'Information on detrimental conseqences of hyperphosphatemia is presented on DVD', 'armGroupLabels': ['Education by unpersonalised DVD']}, {'name': 'Standard care', 'type': 'BEHAVIORAL', 'description': 'standard care', 'armGroupLabels': ['Standard Care']}, {'name': 'Education by DVD and dietician', 'type': 'BEHAVIORAL', 'description': 'Information on detrimental conseqences of hyperphosphatemia is presented on DVD and individual dietary counseling is given by dieticican', 'armGroupLabels': ['Education by DVD and dietician']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3000', 'city': 'Leuven', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Pieter Evenepoel', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Fabienne Dobbels', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University Hospitals Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}], 'centralContacts': [{'name': 'Pieter Evenepoel, MD', 'role': 'CONTACT', 'email': 'pieter.evenepoel@uz.kuleuven.ac.be', 'phone': '003216344580'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitaire Ziekenhuizen KU Leuven', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}