Behaviour and Cognitive Evaluation for Dialysis Elderly Patients (BCDE)
NCT ID: NCT01225458
Last Updated: 2016-09-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
48 participants
INTERVENTIONAL
2008-07-31
2015-01-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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exclusive nephrology follow-up
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.
shorter tests
Geriatric evaluation with MMS, GDS and ADL scoring
initial complete geriatric tests
evaluation of cognitive functions, psychological functions, dependency in activities, vision, audition, mobility and nutritional status : only at the first visit
geriatric follow-up
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.
shorter tests
Geriatric evaluation with MMS, GDS and ADL scoring
initial complete geriatric tests
evaluation of cognitive functions, psychological functions, dependency in activities, vision, audition, mobility and nutritional status : only at the first visit
follow-up complete geriatric tests
evaluation of cognitive functions, psychological functions, dependency in activities, vision, audition, mobility and nutritional status : every 6 month for 3 years
Interventions
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shorter tests
Geriatric evaluation with MMS, GDS and ADL scoring
initial complete geriatric tests
evaluation of cognitive functions, psychological functions, dependency in activities, vision, audition, mobility and nutritional status : only at the first visit
follow-up complete geriatric tests
evaluation of cognitive functions, psychological functions, dependency in activities, vision, audition, mobility and nutritional status : every 6 month for 3 years
Eligibility Criteria
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Inclusion Criteria
* Chronic kidney disease stage 5 defined by :
* 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"),
* 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"),
* Signed and dated informed consent.
Exclusion Criteria
* Major depression and/or GDS-15 \> 10/15,
* Severe dependency (ADL \< 3/6).,
* Psychosis, mutism or aphasia,
* Malignancy or any pathology with life expectancy \< one year.
* Ongoing specialized geriatric care
75 Years
ALL
No
Sponsors
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Centre Hospitalier Universitaire de Nice
OTHER
Responsible Party
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Locations
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CHU de Nice
Nice, , France
Countries
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Other Identifiers
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BCDE
Identifier Type: -
Identifier Source: org_study_id
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