Behaviour and Cognitive Evaluation for Dialysis Elderly Patients (BCDE)

Nantes University Hospital (NUH)

Status: Unknown

Conditions: Renal Insufficiency

Treatments: Other: Geriatric follow-up; Other: Exclusive nephrology follow-up

Study type: Interventional

Funder types: Other

Identifiers

NCT00847275

06/12-K

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: 500 estimated patients

Sex: All

Ages: 75+ years old

Volunteers: No Healthy Volunteers

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

Trial design

500 participants in 2 patient groups, including a placebo group

1

Placebo Comparator group

Description:

"Exclusive nephrology follow-up" arm

Treatment:

Other: Exclusive nephrology follow-up

2

Experimental group

Description:

"Geriatric follow-up" arm

Treatment:

Other: Geriatric follow-up