Behaviour and Cognitive Evaluation for Dialysis Elderly Patients (BCDE)
Not Applicable
Terminated
- Conditions
- Chronic Renal InsufficiencyChronic Kidney FailureAged
- Interventions
- Other: shorter testsOther: initial complete geriatric testsOther: follow-up complete geriatric tests
- Registration Number
- NCT01225458
- Lead Sponsor
- Centre Hospitalier Universitaire de Nice
- Brief Summary
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.
The 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 48
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description geriatric follow-up shorter tests 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. About 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. geriatric follow-up initial complete geriatric tests 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. About 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. geriatric follow-up follow-up complete geriatric tests 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. About 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. exclusive nephrology follow-up shorter tests 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. exclusive nephrology follow-up initial complete geriatric tests 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.
- Primary Outcome Measures
Name Time Method death every 6 month for 3 years since inclusion occurrence of a severe dementia (MMS < 10) every 6 month for 3 years since inclusion major depression detected by GDS-15 > 10/15 and confirmed by DSM-IV criteria every 6 month for 3 years since inclusion severe dependency (ADL < 3/6) every 6 month for 3 years since inclusion
- Secondary Outcome Measures
Name Time Method cognitive, psychic and autonomy scores every 6 month for 3 years since inclusion bone fracture every 6 month for 3 years since inclusion nutritional parameters every 6 month for 3 years since inclusion dialysis parameters every 6 month for 3 years since inclusion cardiovascular morbidity and mortality every 6 month for 3 years since inclusion biological follow-up of chronic kidney disease including haemoglobin level every 6 month for 3 years since inclusion
Trial Locations
- Locations (1)
CHU de Nice
🇫🇷Nice, France