NCT01225458

Behaviour and Cognitive Evaluation for Dialysis Elderly Patients (BCDE)

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Centre Hospitalier Universitaire de Nice · Academic / Other
• Sex: All
• Age: 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Renal Insufficiency
• Chronic Kidney Failure
• Aged

Interventions

Type	Name	Description
OTHER	shorter tests	Geriatric evaluation with MMS, GDS and ADL scoring
OTHER	initial complete geriatric tests	evaluation of cognitive functions, psychological functions, dependency in activities, vision, audition, mobility and nutritional status : only at the first visit
OTHER	follow-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

Timeline

• Start date: 2008-07-01
• Primary completion: 2015-01-01
• Completion: 2015-01-01
• First posted: 2010-10-21
• Last updated: 2016-09-15

Locations

1 site across 1 country: France