Aged, Chronic Kidney Failure, Chronic Renal Insufficiency
Conditions
Keywords
Elderly patients, renal insufficiency, systematized gerontologic evaluation
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.
Interventions
OTHERshorter tests
Geriatric evaluation with MMS, GDS and ADL scoring
OTHERinitial complete geriatric tests
evaluation of cognitive functions, psychological functions, dependency in activities, vision, audition, mobility and nutritional status : only at the first visit
OTHERfollow-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
Sponsors
Centre Hospitalier Universitaire de Nice
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
75 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| cognitive, psychic and autonomy scores | every 6 month for 3 years since inclusion |
| cardiovascular morbidity and mortality | 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 |
| biological follow-up of chronic kidney disease including haemoglobin level | every 6 month for 3 years since inclusion |
Countries
France
Outcome results
None listed