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临床试验/NCT04049773
NCT04049773已完成不适用

Fatigue in Chronic Haemodialysis Patients: an Experience Sampling Method Study

Zuyderland Medisch Centrum1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2019年7月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
42
试验地点
1
主要终点
Change in fatigue symptoms throughout the day

研究概览

简要总结

To investigate the course and diurnal change of fatigue symptoms and haemodialysis related symptoms in chronic haemodialysis patients, its relation to haemodialysis treatment and the association with other factors by implementing an ecological momentary assessment procedure incorporated in a webapplication.

详细描述

The course and diurnal change of fatigue symptoms in the daily life of chronic haemodialysis (HD) patients, its relation to haemodialysis treatment and the association with other factors such as mood, activities, location and social context will be evaluated during 7 consecutive days by using an ecological momentary assessment (EMA) procedure, incorporated into a webapplication. Using an EMA procedure will more accurately represent fatigue symptoms and its relation to other factors in the daily life of chronic HD patients compared to conventional measurement instruments (i.e. questionnaires evaluating fatigue over a period of a week or more, which are therefore liable to a recall bias).

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • End stage renal disease requiring chronic haemodialysis treatment currently being treated for at least 6 months.
  • Good understanding of Dutch based on clinical judgment (since the web-application is only available in the Dutch language).

排除标准

  • The participant cannot independently handle the web-application based on clinical judgment.
  • Dementia or insufficient cognitive skills to handle the web-application based on clinical judgement by the attending physician.

结局指标

主要结局

Change in fatigue symptoms throughout the day

时间窗: 7 consecutive days

self-reported fatigue intensity on a 7-point Likert scale (from 1 "not fatigued" to 7 "very fatigued") at ten occasions randomly throughout the day.

次要结局

  • Change in haemodialysis related symptoms (such as muscle cramps, itch, bone pain, headache) throughout the day(7 consecutive days)
  • Change in fatigue symptoms (primary outcome) and its association with location, activities and social context(7 consecutive days)
  • Change in fatigue symptoms (primary outcome) and its association with mood(7 consecutive days)

研究者

发起方
Zuyderland Medisch Centrum
申办方类型
Other
责任方
Sponsor

研究点 (1)

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