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

Primary Purpose

Chronic Renal Insufficiency, Chronic Kidney Failure, Aged

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
shorter tests
initial complete geriatric tests
follow-up complete geriatric tests
Sponsored by
Centre Hospitalier Universitaire de Nice
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Chronic Renal Insufficiency focused on measuring Elderly patients, renal insufficiency, systematized gerontologic evaluation

Eligibility Criteria

75 Years - undefined (Older Adult)All SexesDoes not accept 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 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

Sites / Locations

  • CHU de Nice

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

exclusive nephrology follow-up

geriatric follow-up

Arm 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.

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.

Outcomes

Primary Outcome Measures

death
occurrence of a severe dementia (MMS < 10)
major depression detected by GDS-15 > 10/15 and confirmed by DSM-IV criteria
severe dependency (ADL < 3/6)

Secondary Outcome Measures

cognitive, psychic and autonomy scores
cardiovascular morbidity and mortality
bone fracture
nutritional parameters
dialysis parameters
biological follow-up of chronic kidney disease including haemoglobin level

Full Information

First Posted
October 20, 2010
Last Updated
September 14, 2016
Sponsor
Centre Hospitalier Universitaire de Nice
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1. Study Identification

Unique Protocol Identification Number
NCT01225458
Brief Title
Behaviour and Cognitive Evaluation for Dialysis Elderly Patients (BCDE)
Acronym
BCDE
Official Title
Behaviour and Cognitive Evaluation for Dialysis Elderly Patients (BCDE)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Terminated
Study Start Date
July 2008 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Renal Insufficiency, Chronic Kidney Failure, Aged
Keywords
Elderly patients, renal insufficiency, systematized gerontologic evaluation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
exclusive nephrology follow-up
Arm Type
Placebo Comparator
Arm 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.
Arm Title
geriatric follow-up
Arm Type
Experimental
Arm 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.
Intervention Type
Other
Intervention Name(s)
shorter tests
Intervention Description
Geriatric evaluation with MMS, GDS and ADL scoring
Intervention Type
Other
Intervention Name(s)
initial complete geriatric tests
Intervention Description
evaluation of cognitive functions, psychological functions, dependency in activities, vision, audition, mobility and nutritional status : only at the first visit
Intervention Type
Other
Intervention Name(s)
follow-up complete geriatric tests
Intervention Description
evaluation of cognitive functions, psychological functions, dependency in activities, vision, audition, mobility and nutritional status : every 6 month for 3 years
Primary Outcome Measure Information:
Title
death
Time Frame
every 6 month for 3 years since inclusion
Title
occurrence of a severe dementia (MMS < 10)
Time Frame
every 6 month for 3 years since inclusion
Title
major depression detected by GDS-15 > 10/15 and confirmed by DSM-IV criteria
Time Frame
every 6 month for 3 years since inclusion
Title
severe dependency (ADL < 3/6)
Time Frame
every 6 month for 3 years since inclusion
Secondary Outcome Measure Information:
Title
cognitive, psychic and autonomy scores
Time Frame
every 6 month for 3 years since inclusion
Title
cardiovascular morbidity and mortality
Time Frame
every 6 month for 3 years since inclusion
Title
bone fracture
Time Frame
every 6 month for 3 years since inclusion
Title
nutritional parameters
Time Frame
every 6 month for 3 years since inclusion
Title
dialysis parameters
Time Frame
every 6 month for 3 years since inclusion
Title
biological follow-up of chronic kidney disease including haemoglobin level
Time Frame
every 6 month for 3 years since inclusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
CHU de Nice
City
Nice
ZIP/Postal Code
06000
Country
France

12. IPD Sharing Statement

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Behaviour and Cognitive Evaluation for Dialysis Elderly Patients (BCDE)

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