Behaviour and Cognitive Evaluation for Dialysis Elderly Patients (BCDE)

NCT01225458 | Terminated

• 1 other identifier: BCDE
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Renal Insufficiency; Chronic Kidney Failure; Aged

Keywords

Elderly patients; renal insufficiency; systematized gerontologic evaluation

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (6)

• 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

Study Arms (2)

exclusive nephrology follow-up

PLACEBO COMPARATOR

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; Other: initial complete geriatric tests

geriatric follow-up

EXPERIMENTAL

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; Other: initial complete geriatric tests; Other: follow-up complete geriatric tests

Interventions

shorter tests OTHER

Geriatric evaluation with MMS, GDS and ADL scoring

exclusive nephrology follow-up; geriatric follow-up

initial complete geriatric tests OTHER

evaluation of cognitive functions, psychological functions, dependency in activities, vision, audition, mobility and nutritional status : only at the first visit

exclusive nephrology follow-up; geriatric follow-up

follow-up complete geriatric tests OTHER

evaluation of cognitive functions, psychological functions, dependency in activities, vision, audition, mobility and nutritional status : every 6 month for 3 years

geriatric follow-up

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

CHU de Nice

Nice, 06000, France

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Kidney Failure, Chronic; Renal Insufficiency

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2010
• First Posted: October 21, 2010
• Study Start: July 1, 2008
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: September 15, 2016

Record last verified: 2016-09

Locations

FR (1)