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
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Behaviour and Cognitive Evaluation for Dialysis Elderly Patients

Resource links provided by NLM:


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 and mortality,- 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 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
"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.
Experimental: 2
"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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: 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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00847275     History of Changes
Other Study ID Numbers: 06/12-K
Study First Received: February 17, 2009
Last Updated: January 25, 2010
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Nantes University Hospital:
Elderly patients
renal insufficiency
gerontologic evaluation

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on October 01, 2014