Behaviour and Cognitive Evaluation for Dialysis Elderly Patients (BCDE) - Full Text View

Sponsored by:	Nantes University Hospital
Information provided by:	Nantes University Hospital
ClinicalTrials.gov Identifier:	NCT00847275

Purpose

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.

Condition	Intervention
Renal Insufficiency	Other: Exclusive nephrology follow-up Other: Geriatric follow-up

MedlinePlus related topics: Dementia Depression

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Open Label, Placebo Control, Parallel Assignment
Official Title:	Behaviour and Cognitive Evaluation for Dialysis Elderly Patients

Further study details as provided by Nantes University Hospital:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	500
Study Start Date:	July 2008
Estimated Study Completion Date:	January 2014
Estimated Primary Completion Date:	January 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Placebo Comparator "Exclusive nephrology follow-up" arm	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.
2: Experimental "Geriatric follow-up" arm	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.

Arms

Assigned Interventions

1: Placebo Comparator

"Exclusive nephrology follow-up" arm

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.

2: Experimental

"Geriatric follow-up" arm

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.

Eligibility

Ages Eligible for Study:	75 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00847275

Contacts

Contact: Vincent ESNAULT, Profesor

0492038876

esnault.v@chu-nice.fr

Locations

France
CHU de Nantes	Recruiting
Nantes, France
Contact: Vincent ESNAULT, Profesor 0492038876 esnault.v@chu-nice.fr
Principal Investigator: ESNAULT Vincent, Profesor

Sponsors and Collaborators

Nantes University Hospital

Investigators

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:	Diiab Mohamed MAHMOUD, 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:	Jacques HILD, 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	CHU de Limoges
Study Chair:	Jean-Pierre CHARMES, Doctor	CHU de 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	CHU Montpellier
Study Chair:	Claude JEANDEL, Profesor	CHU Montpellier
Study Chair:	Luc FRIMAT, Profesor	CHU Nancy
Study Chair:	Christine PERRET-GUILLAUME, Doctor	CHU Nancy
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:	Valéry ANTOINE, 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

More Information

No publications provided

Study ID Numbers:	06/12-K
Study First Received:	February 17, 2009
Last Updated:	February 17, 2009
ClinicalTrials.gov Identifier:	NCT00847275 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Nantes University Hospital:

Elderly patients
renal insufficiency
gerontologic evaluation

Study placed in the following topic categories:

Renal Insufficiency
Urologic Diseases
Kidney Diseases

Additional relevant MeSH terms:

Renal Insufficiency
Urologic Diseases
Kidney Diseases

ClinicalTrials.gov processed this record on May 07, 2009