Behaviour and Cognitive Evaluation for Dialysis Elderly Patients (BCDE) (BCDE)

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.

Study Overview

• Status: Terminated
• Conditions: Aged; Chronic Renal Insufficiency; Chronic Kidney Failure
• Intervention / Treatment: Other: shorter tests; Other: initial complete geriatric tests; Other: follow-up complete geriatric tests

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Nice, France, 06000
    • Chu de Nice

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 75 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: exclusive nephrology follow-up; 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.	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
Experimental: geriatric follow-up; 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.	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

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nice

Study record dates

Study Major Dates

• Study Start: July 1, 2008
• Primary Completion (Actual): January 1, 2015
• Study Completion (Actual): January 1, 2015

Study Registration Dates

• First Submitted: October 20, 2010
• First Submitted That Met QC Criteria: October 20, 2010
• First Posted (Estimate): October 21, 2010

Study Record Updates

• Last Update Posted (Estimate): September 15, 2016
• Last Update Submitted That Met QC Criteria: September 14, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: Elderly patients; renal insufficiency; systematized gerontologic evaluation
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency, Chronic; Kidney Failure, Chronic; Renal Insufficiency
• Other Study ID Numbers: BCDE