Behaviour and Cognitive Evaluation for Dialysis Elderly Patients (BCDE) (BCDE)

January 25, 2010 updated by: Nantes University Hospital

Behaviour and Cognitive Evaluation for Dialysis Elderly Patients

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
500

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Nantes, France
        • Recruiting
        • CHU de Nantes
        • Contact:
        • Principal Investigator:
          • ESNAULT Vincent, Profesor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

75 years and older (OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
3 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
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
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nantes University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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, 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, 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2008

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2015

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 17, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 17, 2009

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 19, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 26, 2010

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 25, 2010

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 06/12-K

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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