Behaviour and Cognitive Evaluation for Dialysis Elderly Patients (BCDE)
NCT ID: NCT00847275
Last Updated: 2010-01-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
500 participants
INTERVENTIONAL
2008-07-31
2015-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
NONE
Study Groups
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1
"Exclusive nephrology follow-up" arm
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.
2
"Geriatric follow-up" arm
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
75 Years
ALL
No
Sponsors
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Nantes University Hospital
OTHER
Principal Investigators
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Vincent ESNAULT, Profesor
Role: STUDY_CHAIR
CHU NICE
Christian COMBE, Profesor
Role: STUDY_CHAIR
University Hospital, Bordeaux
Muriel RAINFRAY, Profesor
Role: STUDY_CHAIR
University Hospital, Bordeaux
Tugdual TANQUEREL, Doctor
Role: STUDY_CHAIR
CHU Brest
Armelle TILLY-GENTRIC, Profesor
Role: STUDY_CHAIR
CHU de Brest
Mokhtar AMRANDI, Doctor
Role: STUDY_CHAIR
CH Cholet
Jacques d'AVIGNEAU, Doctor
Role: STUDY_CHAIR
CH Cholet
Patrice DETEIX, Profesor
Role: STUDY_CHAIR
University Hospital, Clermont-Ferrand
Bruno LESOURD, Profesor
Role: STUDY_CHAIR
University Hospital, Clermont-Ferrand
Bernadette FALLER, Colmar
Role: STUDY_CHAIR
CHU Colmar
Nathalie SCHMITT, Doctor
Role: STUDY_CHAIR
CHU Colmar
Philippe ZAOUI, Profesor
Role: STUDY_CHAIR
University Hospital, Grenoble
Claire MILLET, Doctor
Role: STUDY_CHAIR
University Hospital, Grenoble
Jean-Noël OTTAVIOLI, Doctor
Role: STUDY_CHAIR
CHD La Roche sur Yon
Pierre LERMITE, Doctor
Role: STUDY_CHAIR
CHD La Roche sur Yon
Eric BOULANGER, Doctor
Role: STUDY_CHAIR
CHRU LILLE
François PUISIEUX, Profesor
Role: STUDY_CHAIR
CHRU LILLE
Jean-Claude ALDIGIER, Profesor
Role: STUDY_CHAIR
University Hospital, Limoges
Jean-Pierre CHARMES, Doctor
Role: STUDY_CHAIR
University Hospital, Limoges
Maurice LAVILLE, Profesor
Role: STUDY_CHAIR
Hospices Civils de Lyon
Brigitte COMTE, Doctor
Role: STUDY_CHAIR
Hospices Civils de Lyon
Michel LABEEUW, Profesor
Role: STUDY_CHAIR
Hospices Civils de Lyon
Marc BONNEFOY, Profesor
Role: STUDY_CHAIR
Hospices Civils de Lyon
Philippe BRUNET, Profesor
Role: STUDY_CHAIR
CHU Marseille
Sylvie BONIN-GUILLAUME, Doctor
Role: STUDY_CHAIR
CHU Marseille
Bernard CANAUD, Profesor
Role: STUDY_CHAIR
University Hospital, Montpellier
Claude JEANDEL, Profesor
Role: STUDY_CHAIR
University Hospital, Montpellier
Catherine DELCROIX, Doctor
Role: STUDY_CHAIR
Nantes University Hospital
Gilles BERRUT, Profesor
Role: STUDY_CHAIR
Nantes University Hospital
Patrice BROCKER, Profesor
Role: STUDY_CHAIR
CHU NICE
Bernard BRANGER, Doctor
Role: STUDY_CHAIR
CHU Nîmes
Benoît de WAZIERES, Profesor
Role: STUDY_CHAIR
CHU Nîmes
François VRTOVSNIK, Profesor
Role: STUDY_CHAIR
AP-HP (Hôpital Bichat)
Fannie ONEN, Doctor
Role: STUDY_CHAIR
AP-HP (Hôpital Bichat)
Dominique JOLY, Doctor
Role: STUDY_CHAIR
AP-HP (Hôpital Necker)
Gilbert DERAY, Profesor
Role: STUDY_CHAIR
AP-HP (La Pitié-Salpétrière)
Marc VERNY, Profesor
Role: STUDY_CHAIR
AP-HP (La Pitié-Salpétrière)
Marc SOUID, Doctor
Role: STUDY_CHAIR
CH Poissy
Marie-Gabrielle CORD'HOMME, Doctor
Role: STUDY_CHAIR
CH Poissy
Véronique JOYEUX, Doctor
Role: STUDY_CHAIR
CHU Rennes
Gwenaëlle SOST, Doctor
Role: STUDY_CHAIR
CHU Rennes
Dominique BESNIER, Doctor
Role: STUDY_CHAIR
CH Saint-Nazaire
Philippe LEROUX, Doctor
Role: STUDY_CHAIR
CH Saint-Nazaire
Philippe NICOUD, Doctor
Role: STUDY_CHAIR
CH Sallanches
Serge PAYRAUD, Doctor
Role: STUDY_CHAIR
CH Sallanches
Bruno MOULIN, Profesor
Role: STUDY_CHAIR
CHU Strasbourg
Georges KALTENBACH, Profesor
Role: STUDY_CHAIR
CHU Strasbourg
Eric MICHEZ, Doctor
Role: STUDY_CHAIR
CH Vannes
Jean-Max GOLDFARB, Doctor
Role: STUDY_CHAIR
CH Vannes
Marie-Paule GUILLODO-HAMELET, Doctor
Role: STUDY_CHAIR
Dialysis center - Brest
Mohammed HADJ-ABDELKADER, Doctor
Role: STUDY_CHAIR
University Hospital, Clermont-Ferrand
Elodie CRETEL-DURAND, Doctor
Role: STUDY_CHAIR
CHU Marseille
Pierre JOUANNY, Profesor
Role: STUDY_CHAIR
CHU Rennes
Sylvie HILY, Doctor
Role: STUDY_CHAIR
CHU Saint-Nazaire
Locations
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CHU de Nantes
Nantes, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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06/12-K
Identifier Type: -
Identifier Source: org_study_id
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