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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Placebo Comparator | "Exclusive nephrology follow-up" arm |
|
| 2 | Experimental | "Geriatric follow-up" arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | 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). | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary outcomes are: - cognitive, psychic and autonomy scores,- cardiovascular morbidity and mortality,- biological follow-up of chronic kidney disease including haemoglobin level. | 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vincent ESNAULT, Profesor | Contact | 0492038876 | esnault.v@chu-nice.fr |
| Name | Affiliation | Role |
|---|---|---|
| Vincent ESNAULT, Profesor | Centre Hospitalier Universitaire de Nice | Study Chair |
| Christian COMBE, Profesor | University Hospital, Bordeaux | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Nantes | Recruiting | Nantes | France |
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| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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|
| 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. |
|
| 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 | Centre Hospitalier Universitaire de 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 | Rennes University Hospital | Study Chair |
| Gwenaëlle SOST, Doctor | Rennes University Hospital | 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 | Rennes University Hospital | Study Chair |
| Sylvie HILY, Doctor | CHU Saint-Nazaire | Study Chair |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |