Behaviour and Cognitive Evaluation for Dialysis Elderly Patients (BCDE)

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

• Renal Insufficiency

Interventions

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.

Sponsors & Collaborators

• Nantes University Hospital

  lead OTHER

Principal Investigators

• Vincent ESNAULT, Profesor · CHU NICE

• Christian COMBE, Profesor · University Hospital, Bordeaux

• Muriel RAINFRAY, Profesor · University Hospital, Bordeaux

• Tugdual TANQUEREL, Doctor · CHU Brest

• Armelle TILLY-GENTRIC, Profesor · CHU de Brest

• Mokhtar AMRANDI, Doctor · CH Cholet

• Jacques d'AVIGNEAU, Doctor · CH Cholet

• Patrice DETEIX, Profesor · University Hospital, Clermont-Ferrand

• Bruno LESOURD, Profesor · University Hospital, Clermont-Ferrand

• Bernadette FALLER, Colmar · CHU Colmar

• Nathalie SCHMITT, Doctor · CHU Colmar

• Philippe ZAOUI, Profesor · University Hospital, Grenoble

• Claire MILLET, Doctor · University Hospital, Grenoble

• Jean-Noël OTTAVIOLI, Doctor · CHD La Roche sur Yon

• Pierre LERMITE, Doctor · CHD La Roche sur Yon

• Eric BOULANGER, Doctor · CHRU LILLE

• François PUISIEUX, Profesor · CHRU LILLE

• Jean-Claude ALDIGIER, Profesor · University Hospital, Limoges

• Jean-Pierre CHARMES, Doctor · University Hospital, Limoges

• Maurice LAVILLE, Profesor · Hospices Civils de Lyon

• Brigitte COMTE, Doctor · Hospices Civils de Lyon

• Michel LABEEUW, Profesor · Hospices Civils de Lyon

• Marc BONNEFOY, Profesor · Hospices Civils de Lyon

• Philippe BRUNET, Profesor · CHU Marseille

• Sylvie BONIN-GUILLAUME, Doctor · CHU Marseille

• Bernard CANAUD, Profesor · University Hospital, Montpellier

• Claude JEANDEL, Profesor · University Hospital, Montpellier

• Catherine DELCROIX, Doctor · Nantes University Hospital

• Gilles BERRUT, Profesor · Nantes University Hospital

• Patrice BROCKER, Profesor · CHU NICE

• Bernard BRANGER, Doctor · CHU Nîmes

• Benoît de WAZIERES, Profesor · CHU Nîmes

• François VRTOVSNIK, Profesor · AP-HP (Hôpital Bichat)

• Fannie ONEN, Doctor · AP-HP (Hôpital Bichat)

• Dominique JOLY, Doctor · AP-HP (Hôpital Necker)

• Gilbert DERAY, Profesor · AP-HP (La Pitié-Salpétrière)

• Marc VERNY, Profesor · AP-HP (La Pitié-Salpétrière)

• Marc SOUID, Doctor · CH Poissy

• Marie-Gabrielle CORD'HOMME, Doctor · CH Poissy

• Véronique JOYEUX, Doctor · CHU Rennes

• Gwenaëlle SOST, Doctor · CHU Rennes

• Dominique BESNIER, Doctor · CH Saint-Nazaire

• Philippe LEROUX, Doctor · CH Saint-Nazaire

• Philippe NICOUD, Doctor · CH Sallanches

• Serge PAYRAUD, Doctor · CH Sallanches

• Bruno MOULIN, Profesor · CHU Strasbourg

• Georges KALTENBACH, Profesor · CHU Strasbourg

• Eric MICHEZ, Doctor · CH Vannes

• Jean-Max GOLDFARB, Doctor · CH Vannes

• Marie-Paule GUILLODO-HAMELET, Doctor · Dialysis center - Brest

• Mohammed HADJ-ABDELKADER, Doctor · University Hospital, Clermont-Ferrand

• Elodie CRETEL-DURAND, Doctor · CHU Marseille

• Pierre JOUANNY, Profesor · CHU Rennes

• Sylvie HILY, Doctor · CHU Saint-Nazaire

Study Design

Allocation

RANDOMIZED

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2008-07-31

Primary Completion

2015-01-31

Completion

2015-01-31

Countries

• France

Study Locations