Quality of Life and Depression in Peritoneal Dialysis Patients and Hemodialysis Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,068
- 试验地点
- 1
- 主要终点
- Change of Kidney Disease Quality of Life Short Form 1.3 (KDQOL SF 1.3) Score and Beck Depression Inventory(BDI) Score From Visit 1 Period
研究概览
简要总结
The aim of this study is to evaluate quality of life (QOL) and depression in peritoneal dialysis patients compare to hemodialysis patients and assess hydration effect on QOL and depression over time.
详细描述
In dialysis patients, low QOL and depression affects clinical outcomes such as morbidity and mortality.
Therefore at the point of treating dialysis patients, It is important to provide not only physical health but also psychosocial health.
QOL could be decided by physical health (i.e. sign and symptom, laboratory results, death) and psychological health (i.e. fatigue, pain, consciousness of health and satisfaction).
And also generally it is well known that physical and psychological functions in dialysis patients are decreased.
And especially depression is common disease in dialysis patients. It is also well known that about from 25 to 50 percent of dialysis patients have depression which could result in low QOL moreover hospitalization, complication, and mortality.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Dialysis patients, age from 18 years to 75 years
- •Incident continuous ambulatory peritoneal dialysis(CAPD) or automated peritoneal dialysis(APD) patients who don't have any experience of dialysis treatment before this study
- •Prevalent peritoneal dialysis(PD) patients who are getting peritoneal dialysis treatment more than 6 months
- •Prevalent hemodialysis (HD) patients who are getting haemodialysis treatment more than 6 months
- •The subjects who are eligible for 1 year follow up
- •Written informed consent before any trial related activities
- •Eligible patients to complete questionnaire
排除标准
- •Prognosis for survival less than 3 months
- •Kidney transplantation less than 15 months
- •Ineligible patients for questionnaire
- •Any malignancies and ascites
- •Any condition which could interfere with the patient's ability to comply with the study protocol
- •Ineligible to measure BCM
- •pacemaker, defibrillator
- •pregnancy or lactation period
- •artificial joint
结局指标
主要结局
Change of Kidney Disease Quality of Life Short Form 1.3 (KDQOL SF 1.3) Score and Beck Depression Inventory(BDI) Score From Visit 1 Period
时间窗: Visit 1(zero month) and Visit 2 (12 months after Visit 1)
Health-related quality of life (HRQOL) is assessed via KDQOL SF 1.3 and depression is assessed via BDI at the visit 1 and Visit 2 period. KDQOL SF 1.3 and BDI are validated questionnaires to assess HRQOL and depression, respectively. Visit 2 period is followed 12 months after Visit 1 period. The outcome measure is the difference in averaged scores between Visit 1 and Visit 2; It is calculated as (Score at visit 2 - Score at visit 1). HRQOL is assessed by three components; physical health score, mental health score and kidney disease health score. Physical health score, mental health score and kidney disease health score are averaged scores of subscales. The range of each score and each subscale are 0 - 100, and higher values indicate better HRQOL status. The BDI score is a summed score of each component of BDI questionnaire, and the range is 5 to 63. Higher BDI scores are considered to represent more severe depression symptoms.
次要结局
- The Association Between Hydration Status and Depression and Quality of Life in Peritoneal Dialysis Patients(Visit 1(zero month) and Visit 2 (12 months after Visit 1))
- The Association Between Hydration Status and Depression and Quality of Life in Hemodialysis Patients(Visit 1(zero month) and Visit 2 (12 months after Visit 1))