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.
Studie Overzicht
Toestand
Interventie / Behandeling
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Nice, Frankrijk, 06000
- Chu De Nice
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Placebo-vergelijker: 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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Experimenteel: 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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
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death
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: every 6 month for 3 years since inclusion
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every 6 month for 3 years since inclusion
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Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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cognitive, psychic and autonomy scores
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: every 6 month for 3 years since inclusion
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every 6 month for 3 years since inclusion
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Medewerkers en onderzoekers
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- BCDE
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