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.
研究概览
地位
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Nice、法国、06000
- Chu De Nice
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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
学习计划
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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安慰剂比较：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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实验性的：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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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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death
大体时间：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)
大体时间：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
大体时间：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)
大体时间：every 6 month for 3 years since inclusion
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every 6 month for 3 years since inclusion
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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cognitive, psychic and autonomy scores
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：every 6 month for 3 years since inclusion
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every 6 month for 3 years since inclusion
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合作者和调查者
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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