Behaviour and Cognitive Evaluation for Dialysis Elderly Patients (BCDE) (BCDE)
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.
Studienübersicht
Status
Intervention / Behandlung
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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Nice, Frankreich, 06000
- Chu de Nice
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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 with a nephrology follow-up > 3 months ("Pre-dialysis cohort"),
- or a dialysis treatment started for more than 3 months and less than one year, after a pre-dialysis follow-up > 3 months ("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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Placebo-Komparator: 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.
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Geriatric evaluation with MMS, GDS and ADL scoring
evaluation of cognitive functions, psychological functions, dependency in activities, vision, audition, mobility and nutritional status : only at the first visit
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Experimental: geriatric follow-up
250 patients will be included and randomized in the "geriatric follow-up" arm. They 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. About geriatric evaluation Patients randomized in this 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. |
Geriatric evaluation with MMS, GDS and ADL scoring
evaluation of cognitive functions, psychological functions, dependency in activities, vision, audition, mobility and nutritional status : only at the first visit
evaluation of cognitive functions, psychological functions, dependency in activities, vision, audition, mobility and nutritional status : every 6 month for 3 years
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
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death
Zeitfenster: every 6 month for 3 years since inclusion
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every 6 month for 3 years since inclusion
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occurrence of a severe dementia (MMS < 10)
Zeitfenster: every 6 month for 3 years since inclusion
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every 6 month for 3 years since inclusion
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major depression detected by GDS-15 > 10/15 and confirmed by DSM-IV criteria
Zeitfenster: every 6 month for 3 years since inclusion
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every 6 month for 3 years since inclusion
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severe dependency (ADL < 3/6)
Zeitfenster: every 6 month for 3 years since inclusion
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every 6 month for 3 years since inclusion
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
|
cognitive, psychic and autonomy scores
Zeitfenster: every 6 month for 3 years since inclusion
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every 6 month for 3 years since inclusion
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cardiovascular morbidity and mortality
Zeitfenster: every 6 month for 3 years since inclusion
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every 6 month for 3 years since inclusion
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bone fracture
Zeitfenster: every 6 month for 3 years since inclusion
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every 6 month for 3 years since inclusion
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nutritional parameters
Zeitfenster: every 6 month for 3 years since inclusion
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every 6 month for 3 years since inclusion
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dialysis parameters
Zeitfenster: every 6 month for 3 years since inclusion
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every 6 month for 3 years since inclusion
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biological follow-up of chronic kidney disease including haemoglobin level
Zeitfenster: every 6 month for 3 years since inclusion
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every 6 month for 3 years since inclusion
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Mitarbeiter und Ermittler
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- BCDE
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