Behaviour and Cognitive Evaluation for Dialysis Elderly Patients (BCDE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2010 by Nantes University Hospital
Sponsor:
Information provided by:
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT00847275
First received: February 17, 2009
Last updated: January 25, 2010
Last verified: January 2010

February 17, 2009
January 25, 2010
July 2008
January 2015   (final data collection date for primary outcome measure)
First outcome reached among: - 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). [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00847275 on ClinicalTrials.gov Archive Site
Secondary outcomes are: - cognitive, psychic and autonomy scores,- cardiovascular morbidity and mortality,- biological follow-up of chronic kidney disease including haemoglobin level. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Secondary outcomes are: - cognitive, psychic and autonomy scores,- cardiovascular morbidity andmortality,- bone fracture,- nutritional parameters,- dialysis parameters,- biological follow-up of chronic kidney disease including haemoglobin level. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
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Behaviour and Cognitive Evaluation for Dialysis Elderly Patients (BCDE)
Behaviour and Cognitive Evaluation for Dialysis Elderly Patients

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
Renal Insufficiency
  • Other: 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: Geriatric follow-up
    250 patients will be included and randomized in "geriatric 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. Patients randomized in the "geriatric follow-up" 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.
  • Placebo Comparator: 1
    "Exclusive nephrology follow-up" arm
    Intervention: Other: Exclusive nephrology follow-up
  • Experimental: 2
    "Geriatric follow-up" arm
    Intervention: Other: Geriatric follow-up
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 whatever the duration of previous monitoring by the nephrologist("Pre-dialysis cohort"),
  • or a dialysis treatment started for more than 3 months and less than one year, whatever the duration of pre-dialysis follow-up by the nephrologist("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, Profesor 0492038876 esnault.v@chu-nice.fr
France
 
NCT00847275
06/12-K
Yes
Not Provided
Nantes University Hospital
Not Provided
Study Chair: Vincent ESNAULT, Profesor CHU Nice
Study Chair: Christian COMBE, Profesor CHU Bordeaux
Study Chair: Muriel RAINFRAY, Profesor CHU Bordeaux
Study Chair: Tugdual TANQUEREL, Doctor CHU Brest
Study Chair: Armelle TILLY-GENTRIC, Profesor CHU de Brest
Study Chair: Mokhtar AMRANDI, Doctor CH Cholet
Study Chair: Jacques d'AVIGNEAU, Doctor CH Cholet
Study Chair: Patrice DETEIX, Profesor University Hospital, Clermont-Ferrand
Study Chair: Bruno LESOURD, Profesor University Hospital, Clermont-Ferrand
Study Chair: Bernadette FALLER, Colmar CHU Colmar
Study Chair: Nathalie SCHMITT, Doctor CHU Colmar
Study Chair: Philippe ZAOUI, Profesor CHU Grenoble
Study Chair: Claire MILLET, Doctor CHU Grenoble
Study Chair: Jean-Noël OTTAVIOLI, Doctor CHD La Roche-sur-Yon
Study Chair: Pierre LERMITE, Doctor CHD La Roche-sur-Yon
Study Chair: Eric BOULANGER, Doctor CHRU Lille
Study Chair: François PUISIEUX, Profesor CHRU Lille
Study Chair: Jean-Claude ALDIGIER, Profesor University Hospital, Limoges
Study Chair: Jean-Pierre CHARMES, Doctor University Hospital, Limoges
Study Chair: Maurice LAVILLE, Profesor CHU Lyon
Study Chair: Brigitte COMTE, Doctor CHU Lyon
Study Chair: Michel LABEEUW, Profesor CHU Lyon
Study Chair: Marc BONNEFOY, Profesor CHU Lyon
Study Chair: Philippe BRUNET, Profesor CHU Marseille
Study Chair: Sylvie BONIN-GUILLAUME, Doctor CHU Marseille
Study Chair: Bernard CANAUD, Profesor University Hospital, Montpellier
Study Chair: Claude JEANDEL, Profesor University Hospital, Montpellier
Study Chair: Catherine DELCROIX, Doctor CHU Nantes
Study Chair: Gilles BERRUT, Profesor CHU Nantes
Study Chair: Patrice BROCKER, Profesor CHU Nice
Study Chair: Bernard BRANGER, Doctor CHU Nîmes
Study Chair: Benoît de WAZIERES, Profesor CHU Nîmes
Study Chair: François VRTOVSNIK, Profesor AP-HP (Hôpital Bichat)
Study Chair: Fannie ONEN, Doctor AP-HP (Hôpital Bichat)
Study Chair: Dominique JOLY, Doctor AP-HP (Hôpital Necker)
Study Chair: Gilbert DERAY, Profesor AP-HP (La Pitié-Salpétrière)
Study Chair: Marc VERNY, Profesor AP-HP (La Pitié-Salpétrière)
Study Chair: Marc SOUID, Doctor CH Poissy
Study Chair: Marie-Gabrielle CORD'HOMME, Doctor CH Poissy
Study Chair: Véronique JOYEUX, Doctor CHU Rennes
Study Chair: Gwenaëlle SOST, Doctor CHU Rennes
Study Chair: Dominique BESNIER, Doctor CH Saint-Nazaire
Study Chair: Philippe LEROUX, Doctor CH Saint-Nazaire
Study Chair: Philippe NICOUD, Doctor CH Sallanches
Study Chair: Serge PAYRAUD, Doctor CH Sallanches
Study Chair: Bruno MOULIN, Profesor CHU Strasbourg
Study Chair: Georges KALTENBACH, Profesor CHU Strasbourg
Study Chair: Eric MICHEZ, Doctor CH Vannes
Study Chair: Jean-Max GOLDFARB, Doctor CH Vannes
Study Chair: Marie-Paule GUILLODO-HAMELET, Doctor Dialysis center - Brest
Study Chair: Mohammed HADJ-ABDELKADER, Doctor University Hospital, Clermont-Ferrand
Study Chair: Elodie CRETEL-DURAND, Doctor CHU Marseille
Study Chair: Pierre JOUANNY, Profesor CHU Rennes
Study Chair: Sylvie HILY, Doctor CHU Saint-Nazaire
Nantes University Hospital
January 2010

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