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.
연구 개요
상태
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Nice, 프랑스, 06000
- CHU de Nice
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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위약 비교기: 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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실험적: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
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death
기간: 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)
기간: 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
기간: 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)
기간: every 6 month for 3 years since inclusion
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every 6 month for 3 years since inclusion
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2차 결과 측정
결과 측정 |
기간 |
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cognitive, psychic and autonomy scores
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: every 6 month for 3 years since inclusion
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every 6 month for 3 years since inclusion
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
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추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
shorter tests에 대한 임상 시험
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Istituto di Neuroscienze Consiglio Nazionale delle...University of Pisa; Medical University of Vienna모병