Clinical trial NCT01225458: Behaviour and Cognitive Evaluation for Dialysis Elderly Patients (BCDE)
Official title: Behaviour and Cognitive Evaluation for Dialysis Elderly Patients (BCDE)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Chronic Renal Insufficiency
Chronic Kidney Failure
Aged
Keywords: Elderly patients
renal insufficiency
systematized gerontologic evaluation
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2010-10-21
Enrollment: 48
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
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
Secondary outcomes:
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
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU de Nice
Study officials:
References: