Behaviour and Cognitive Evaluation for Dialysis Elderly Patients (BCDE)
This study is currently recruiting participants.
Verified January 2010 by Nantes University Hospital
Sponsor:
Nantes University Hospital
Information provided by:
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT00847275
First received: February 17, 2009
Last updated: January 25, 2010
Last verified: January 2010
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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
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 May 23, 2013