NCT03737578Unknown不适用
Efficacy of Daily Hemodialysis Compared With in Center Hemodialysis 3 Times Per Week
适应症
试验速览
- 阶段
- 不适用
- 发起方
- Physidia
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- Physical activity of patients (total average number of steps taken per day through connected pedometer/accelerometer)
研究概览
简要总结
The objective of this study is to describe the characteristics of patients on daily home hemodialysis and to confirm in real practice in France the effectiveness shown in studies, mainly American, both in terms of clinical outcomes and quality of life. Due to the few studies available in this population, the focus will be particularly on physical activity.
详细描述
Primary objective :
The main objective of this study is to evaluate the physical activity in the daily life of patients in daily hemodialysis in comparison with patients treated 3 times a week (conventional hemodialysis) others objectives are also:
- To describe the characteristics of daily hemodialysis patients;
- To describe the prescription procedures of the home daily HD;
- To compare the evolution of the blood pressure between the 2 modalities of hemodialysis;
- To compare the frequency of hospitalizations, duration and hospitalization reasons between the 2 hemodialysis modalities;
- To compare the quality of life of the patients between the 2 modalities ;
- To evaluate the quality of the sleep of the patients between the 2 modalities ;
- Compare the percentage of patients with restless leg syndrome (RLS) and the severity of RLS between the two modalities;
- Compare the evolution of drug intake between the two modalities;
- Evaluate the number of abandoning subjects and causes of discontinuation of HQD;
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female aged 18 years or over
- •Patient who dated and signed the consent form
- •Patient (s) affiliated to a Social Security scheme
- •Interventional arm: patient who begins or will begin daily hemodialysis training (5, 6 or 7 times per week) at home.
- •Comparator arm: prevalent or incident patient treated by conventional hemodialysis (3 times per week) and fitting with the matching criteria of an interventional patient included in the center
排除标准
- •Patient with needs any help to walk (wheelchair, crutch, walker, cane ...)
- •Patient with active neoplasia;
- •Patient with predicted life expectancy of less than one year;
- •Patient with significant reading or writing difficulties;
- •Patient participating in a clinical trial or other interventional study;
- •Patient with history of mental instability, major cognitive impairment in the previous 5 years, or major psychiatric condition not adequately controlled or stable under pharmacological treatment
结局指标
主要结局
Physical activity of patients (total average number of steps taken per day through connected pedometer/accelerometer)
时间窗: 12 months
The main criteria is the total average number of steps taken per day
次要结局
- Evolution of the frequency of hospitalizations during the study period(During visit at month 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12)
- Change in quality of the sleep of the patients through questionnaire during the study period(At inclusion and during visit at month 3, 6, 9 and 12)
- Change of drug intake during the study period (posology of drugs linked with ESRD)(During visit at month 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12)
- Evolution of the blood pressure during the study period(At inclusion and during visit at month 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12)
- Change in quality of life of the patients measured through questionnaire during the study period(At inclusion and during visit at month 3, 6, 9 and 12)
- Change of the percentage of patients with restless leg syndrome (RLS) during the study period(At inclusion and during visit at month 3, 6, 9 and 12)
研究者
研究点 (2)
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