Behaviour and Cognitive Evaluation for Dialysis Elderly Patients (BCDE)

Not Applicable

Terminated

• Conditions: Chronic Renal Insufficiency; Chronic Kidney Failure; Aged

• Registration Number: NCT01225458
• Lead Sponsor: Centre Hospitalier Universitaire de Nice

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07
• Study First Submitted: 2010-10-20
• Study First Submitted QC: 2010-10-20
• Study First Posted: 2010-10-21
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-14
• Last Update Posted: 2016-09-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
cognitive, psychic and autonomy scores	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
cardiovascular morbidity and mortality	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

Trial Locations

Locations (1)

CHU de Nice; 🇫🇷 Nice, France