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

14. september 2016 oppdatert av: Centre Hospitalier Universitaire de Nice

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.

Studieoversikt

Status

Avsluttet

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

48

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Frankrike
      • Nice, Frankrike, 06000
        • Chu De Nice

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

75 år og eldre (Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
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.
Annen: shorter tests
Geriatric evaluation with MMS, GDS and ADL scoring
Annen: initial complete geriatric tests
evaluation of cognitive functions, psychological functions, dependency in activities, vision, audition, mobility and nutritional status : only at the first visit
Eksperimentell: 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.
Annen: shorter tests
Geriatric evaluation with MMS, GDS and ADL scoring
Annen: initial complete geriatric tests
evaluation of cognitive functions, psychological functions, dependency in activities, vision, audition, mobility and nutritional status : only at the first visit
Annen: follow-up complete geriatric tests
evaluation of cognitive functions, psychological functions, dependency in activities, vision, audition, mobility and nutritional status : every 6 month for 3 years

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
death
Tidsramme: every 6 month for 3 years since inclusion
every 6 month for 3 years since inclusion
occurrence of a severe dementia (MMS < 10)
Tidsramme: every 6 month for 3 years since inclusion
every 6 month for 3 years since inclusion
major depression detected by GDS-15 > 10/15 and confirmed by DSM-IV criteria
Tidsramme: every 6 month for 3 years since inclusion
every 6 month for 3 years since inclusion
severe dependency (ADL < 3/6)
Tidsramme: every 6 month for 3 years since inclusion
every 6 month for 3 years since inclusion

Sekundære resultatmål

Resultatmål
Tidsramme
cognitive, psychic and autonomy scores
Tidsramme: every 6 month for 3 years since inclusion
every 6 month for 3 years since inclusion
cardiovascular morbidity and mortality
Tidsramme: every 6 month for 3 years since inclusion
every 6 month for 3 years since inclusion
bone fracture
Tidsramme: every 6 month for 3 years since inclusion
every 6 month for 3 years since inclusion
nutritional parameters
Tidsramme: every 6 month for 3 years since inclusion
every 6 month for 3 years since inclusion
dialysis parameters
Tidsramme: every 6 month for 3 years since inclusion
every 6 month for 3 years since inclusion
biological follow-up of chronic kidney disease including haemoglobin level
Tidsramme: every 6 month for 3 years since inclusion
every 6 month for 3 years since inclusion

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Centre Hospitalier Universitaire de Nice

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. juli 2008

Primær fullføring (Faktiske)

1. januar 2015

Studiet fullført (Faktiske)

1. januar 2015

Datoer for studieregistrering

Først innsendt

20. oktober 2010

Først innsendt som oppfylte QC-kriteriene

20. oktober 2010

Først lagt ut (Anslag)

21. oktober 2010

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

15. september 2016

Siste oppdatering sendt inn som oppfylte QC-kriteriene

14. september 2016

Sist bekreftet

1. september 2016

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • BCDE

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