Ignite Creation Date:
2025-12-25 @ 12:20 AM
Ignite Modification Date:
2026-02-24 @ 2:08 PM
Study NCT ID:
NCT01225458
Status:
TERMINATED
Last Update Posted:
2016-09-15
First Post:
2010-10-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Behaviour and Cognitive Evaluation for Dialysis Elderly Patients (BCDE)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D007676', 'term': 'Kidney Failure, Chronic'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}], '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': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2008-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-14', 'studyFirstSubmitDate': '2010-10-20', 'studyFirstSubmitQcDate': '2010-10-20', 'lastUpdatePostDateStruct': {'date': '2016-09-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-10-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'death', 'timeFrame': 'every 6 month for 3 years since inclusion'}, {'measure': 'occurrence of a severe dementia (MMS < 10)', 'timeFrame': 'every 6 month for 3 years since inclusion'}, {'measure': 'major depression detected by GDS-15 > 10/15 and confirmed by DSM-IV criteria', 'timeFrame': 'every 6 month for 3 years since inclusion'}, {'measure': 'severe dependency (ADL < 3/6)', 'timeFrame': 'every 6 month for 3 years since inclusion'}], 'secondaryOutcomes': [{'measure': 'cognitive, psychic and autonomy scores', 'timeFrame': 'every 6 month for 3 years since inclusion'}, {'measure': 'cardiovascular morbidity and mortality', 'timeFrame': 'every 6 month for 3 years since inclusion'}, {'measure': 'bone fracture', 'timeFrame': 'every 6 month for 3 years since inclusion'}, {'measure': 'nutritional parameters', 'timeFrame': 'every 6 month for 3 years since inclusion'}, {'measure': 'dialysis parameters', 'timeFrame': 'every 6 month for 3 years since inclusion'}, {'measure': 'biological follow-up of chronic kidney disease including haemoglobin level', 'timeFrame': 'every 6 month for 3 years since inclusion'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Elderly patients', 'renal insufficiency', 'systematized gerontologic evaluation'], 'conditions': ['Chronic Renal Insufficiency', 'Chronic Kidney Failure', 'Aged']}, 'descriptionModule': {'briefSummary': 'The trial is a multicenter, prospective, randomized, open study. A total of 500 elderly patients aged over 75 years with renal insufficiency stage 5 will be included in the study after signed informed consent. Patients will be randomized 1/1 in two arms : 250 patients in the "exclusive nephrology follow-up" arm will continue their usual follow-up; 250 patients in the "geriatric follow-up" arm will have both their usual nephrology follow-up and a geriatric follow-up.\n\nThe aim of the study is to determine if a systematized gerontologist evaluation delay the occurrence of a composite primary endpoint : death, dementia, depression and severe dependency. The hypothesis is that the functional and vital prognosis of a patient with renal insufficiency depends not only on common and classical factors but also on cognitive and psychological functions and dependence, particularly in elderly patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '75 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria :\n\n* Patients aged of 75 years old or more,\n* Chronic kidney disease stage 5 defined by :\n* either an estimated GFR (MDRD) ≤ 15ml/mn/1,73 m² in a non-dialysis patient with a nephrology follow-up \\> 3 months ("Pre-dialysis cohort"),\n* or a dialysis treatment started for more than 3 months and less than one year, after a pre-dialysis follow-up \\> 3 months ("post-dialysis cohort"),\n* Signed and dated informed consent.\n\nExclusion criteria :\n\n* Moderately severe to severe dementia (MMS ≤ 15),\n* Major depression and/or GDS-15 \\> 10/15,\n* Severe dependency (ADL \\< 3/6).,\n* Psychosis, mutism or aphasia,\n* Malignancy or any pathology with life expectancy \\< one year.\n* Ongoing specialized geriatric care'}, 'identificationModule': {'nctId': 'NCT01225458', 'acronym': 'BCDE', 'briefTitle': 'Behaviour and Cognitive Evaluation for Dialysis Elderly Patients (BCDE)', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nice'}, 'officialTitle': 'Behaviour and Cognitive Evaluation for Dialysis Elderly Patients (BCDE)', 'orgStudyIdInfo': {'id': 'BCDE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'exclusive nephrology follow-up', 'description': '250 patients will be included and randomized in the "exclusive nephrology follow-up" arm will continue their usual nephrology follow-up with consultations every 6 months during 3 years for dialysis patients or with consultations every 6 months before dialysis, 3 months after starting dialysis and every 6 months for a total duration of 3 years for non-dialysis patients. In addition to their nephrology consultations, patients will benefit from a geriatric evaluation with MMS, GDS and ADL scoring.', 'interventionNames': ['Other: shorter tests', 'Other: initial complete geriatric tests']}, {'type': 'EXPERIMENTAL', 'label': 'geriatric follow-up', 'description': '250 patients will be included and randomized in the "geriatric follow-up" arm. They will continue their usual nephrology follow-up with consultations every 6 months during 3 years for dialysis patients or with consultations every 6 months before dialysis, 3 months after starting dialysis and every 6 months for a total duration of 3 years for non-dialysis patients.\n\nAbout geriatric evaluation Patients randomized in this arm will also have more complete tests to evaluate cognitive functions (memory, language and movements), psychological functions (depression and anxiety) and dependency in activities of daily living. Other tests will allow evaluate vision, audition, mobility and nutritional status.', 'interventionNames': ['Other: shorter tests', 'Other: initial complete geriatric tests', 'Other: follow-up complete geriatric tests']}], 'interventions': [{'name': 'shorter tests', 'type': 'OTHER', 'description': 'Geriatric evaluation with MMS, GDS and ADL scoring', 'armGroupLabels': ['exclusive nephrology follow-up', 'geriatric follow-up']}, {'name': 'initial complete geriatric tests', 'type': 'OTHER', 'description': 'evaluation of cognitive functions, psychological functions, dependency in activities, vision, audition, mobility and nutritional status : only at the first visit', 'armGroupLabels': ['exclusive nephrology follow-up', 'geriatric follow-up']}, {'name': 'follow-up complete geriatric tests', 'type': 'OTHER', 'description': 'evaluation of cognitive functions, psychological functions, dependency in activities, vision, audition, mobility and nutritional status : every 6 month for 3 years', 'armGroupLabels': ['geriatric follow-up']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06000', 'city': 'Nice', 'country': 'France', 'facility': 'CHU de Nice', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nice', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}