Behaviour and Cognitive Evaluation for Dialysis Elderly Patients (BCDE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2010 by Centre Hospitalier Universitaire de Nice
Sponsor:
Information provided by:
Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier:
NCT01225458
First received: October 20, 2010
Last updated: NA
Last verified: February 2010
History: No changes posted

October 20, 2010
October 20, 2010
July 2008
January 2015   (final data collection date for primary outcome measure)
  • death [ Time Frame: every 6 month for 3 years since inclusion ] [ Designated as safety issue: Yes ]
  • occurrence of a severe dementia (MMS < 10) [ Time Frame: every 6 month for 3 years since inclusion ] [ Designated as safety issue: Yes ]
  • major depression detected by GDS-15 > 10/15 and confirmed by DSM-IV criteria [ Time Frame: every 6 month for 3 years since inclusion ] [ Designated as safety issue: Yes ]
  • severe dependency (ADL < 3/6) [ Time Frame: every 6 month for 3 years since inclusion ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
  • cognitive, psychic and autonomy scores [ Time Frame: every 6 month for 3 years since inclusion ] [ Designated as safety issue: Yes ]
  • cardiovascular morbidity and mortality [ Time Frame: every 6 month for 3 years since inclusion ] [ Designated as safety issue: Yes ]
  • bone fracture [ Time Frame: every 6 month for 3 years since inclusion ] [ Designated as safety issue: Yes ]
  • nutritional parameters [ Time Frame: every 6 month for 3 years since inclusion ] [ Designated as safety issue: Yes ]
  • dialysis parameters [ Time Frame: every 6 month for 3 years since inclusion ] [ Designated as safety issue: No ]
  • biological follow-up of chronic kidney disease including haemoglobin level [ Time Frame: every 6 month for 3 years since inclusion ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Behaviour and Cognitive Evaluation for Dialysis Elderly Patients (BCDE)
Behaviour and Cognitive Evaluation for Dialysis Elderly Patients (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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Chronic Renal Insufficiency
  • Chronic Kidney Failure
  • Aged
  • 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
  • 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.
    Interventions:
    • Other: shorter tests
    • Other: initial complete geriatric tests
  • 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.

    Interventions:
    • Other: shorter tests
    • Other: initial complete geriatric tests
    • Other: follow-up complete geriatric tests
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
500
January 2015
January 2015   (final data collection date for primary outcome measure)

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
Both
75 Years and older
No
Contact: Vincent ESNAULT, Pr. 33(0)492038876 esnault.v@chu-nice.fr
France
 
NCT01225458
BCDE
No
Departement de la Recherche Clinique et de l'Innovation, CENTRE HOSPITALIER UNIVERSITAIRE DE NICE
Centre Hospitalier Universitaire de Nice
Not Provided
Not Provided
Centre Hospitalier Universitaire de Nice
February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP