Behaviour and Cognitive Evaluation for Dialysis Elderly Patients (BCDE)

Centre Hospitalier Universitaire de Nice

Status: Terminated

Conditions: Chronic Kidney Failure; Aged; Chronic Renal Insufficiency

Treatments: Other: initial complete geriatric tests; Other: follow-up complete geriatric tests; Other: shorter tests

Study type: Interventional

Funder types: Other

Identifiers

NCT01225458

BCDE

Details and patient eligibility

About

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.

Enrollment: 48 patients

Sex: All

Ages: 75+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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48 participants in 2 patient groups, including a placebo group

exclusive nephrology follow-up

Placebo Comparator group

Description:

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.

Treatment:

Other: shorter tests

Other: initial complete geriatric tests

geriatric follow-up

Experimental group

Description:

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.

Treatment:

Other: shorter tests

Other: initial complete geriatric tests

Other: follow-up complete geriatric tests