Behaviour and Cognitive Evaluation for Dialysis Elderly Patients (BCDE)

Centre Hospitalier Universitaire de Nice48 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Chronic Renal Insufficiency Chronic Kidney Failure Aged

Interventions

shorter testsOTHER

Geriatric evaluation with MMS, GDS and ADL scoring

initial complete geriatric testsOTHER

evaluation of cognitive functions, psychological functions, dependency in activities, vision, audition, mobility and nutritional status : only at the first visit

follow-up complete geriatric testsOTHER

evaluation of cognitive functions, psychological functions, dependency in activities, vision, audition, mobility and nutritional status : every 6 month for 3 years

Eligibility

Sex: ALLMin age: 75 Years

Medical Language ↔ Plain English

Inclusion criteria : * Patients aged of 75 years old or more, * 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 : * Moderately severe to severe dementia (MMS ≤ 15), * 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