Behaviour and Cognitive Evaluation for Dialysis Elderly Patients (BCDE)

Study Overview
=================
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.

Official Title
-----------------
Behaviour and Cognitive Evaluation for Dialysis Elderly Patients

Conditions
-----------------
Renal Insufficiency

Intervention / Treatment
-----------------
* Other: Exclusive nephrology follow-up
* Other: Geriatric follow-up


Participation Criteria
=================
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 whatever the duration of previous monitoring by the nephrologist(Pre-dialysis cohort), or a dialysis treatment started for more than 3 months and less than one year, whatever the duration of pre-dialysis follow-up by the nephrologist(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

Ages Eligible for Study
-----------------
Minimum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br>Exclusive nephrology follow-up arm | Other: Exclusive nephrology follow-up<br>* 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.<br>|
| Experimental: 2<br>Geriatric follow-up arm | Other: Geriatric follow-up<br>* 250 patients will be included and randomized in geriatric 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. Patients randomized in the geriatric follow-up 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| First outcome reached among: - death, - occurrence of a severe dementia (MMS < 10),- major depression detected by GDS-15 > 10/15 and confirmed by DSM-IV criteria,- severe dependency (ADL < 3/6). |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary outcomes are: - cognitive, psychic and autonomy scores,- cardiovascular morbidity and mortality,- biological follow-up of chronic kidney disease including haemoglobin level. |  | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Elderly patients, renal insufficiency, gerontologic evaluation