Behaviour and Cognitive Evaluation for Dialysis Elderly Patients (BCDE)

NCT00847275 | Unknown DMC

• 1 other identifier: 06/12-K
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Elderly patients; renal insufficiency; gerontologic evaluation

Outcome Measures

Primary Outcomes (1)

• 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).

  3 years

Secondary Outcomes (1)

• Secondary outcomes are: - cognitive, psychic and autonomy scores,- cardiovascular morbidity and mortality,- biological follow-up of chronic kidney disease including haemoglobin level.

  3 years

Study Arms (2)

1

PLACEBO COMPARATOR

"Exclusive nephrology follow-up" arm

Other: Exclusive nephrology follow-up

2

EXPERIMENTAL

"Geriatric follow-up" arm

Other: Geriatric follow-up

Interventions

Exclusive nephrology follow-up OTHER

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.

1

Geriatric follow-up OTHER

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.

2

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

CHU de Nantes

Nantes, France

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Vincent ESNAULT, Profesor

  CHU NICE

  STUDY CHAIR

• Christian COMBE, Profesor

  University Hospital, Bordeaux

  STUDY CHAIR

• Muriel RAINFRAY, Profesor

  University Hospital, 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

  University Hospital, Grenoble

  STUDY CHAIR

• Claire MILLET, Doctor

  University Hospital, 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

  Hospices Civils de Lyon

  STUDY CHAIR

• Brigitte COMTE, Doctor

  Hospices Civils de Lyon

  STUDY CHAIR

• Michel LABEEUW, Profesor

  Hospices Civils de Lyon

  STUDY CHAIR

• Marc BONNEFOY, Profesor

  Hospices Civils de 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

  Nantes University Hospital

  STUDY CHAIR

• Gilles BERRUT, Profesor

  Nantes University Hospital

  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

  STUDY CHAIR

Central Study Contacts

Vincent ESNAULT, Profesor

CONTACT

0492038876; esnault.v@chu-nice.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 17, 2009
• First Posted: February 19, 2009
• Study Start: July 1, 2008
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: January 26, 2010

Record last verified: 2010-01

Locations

FR (1)