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临床试验/NCT04617431
NCT04617431已完成不适用

Application of Wearable Devices to Build a Self-Management Model in Chronic Kidney Disease Patients- Analysis of Healthcare Cost

National Taiwan University Hospital2 个研究点 分布在 1 个国家目标入组 49 人开始时间: 2019年1月13日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
49
试验地点
2
主要终点
Change from Baseline Renal function at 3 months

研究概览

简要总结

Aim: By application of wearable devices and health management platform to build self-management model in CKD patients and analyze the cost of healthcare.

Material and Methods: The investigators plan to recruit 60 CKD patients as trial subjects. The intervention group is composed of 30 participants, and the control group 30 participants. The intervention group received intervention with wearable devices and health management platform for 90 days. Patients record diet diary by a smartphone application, and their exercise-related data are collected by wearable devices. Then, all the collected information will be upload to health management platform. The investigators also create a LINE group to encourage exercise in the experimental group. The investigators compare the scores of self-management sheet and physical and laboratory examinations before and after the intervention. The investigators also analyze the cost of healthcare within 180 days.

详细描述

Background: End stage renal disease (ESRD) is a global public health issue. The dialysis therapy brings huge economic burden to many countries. According to the report of 2015 United States Renal Data System (USRDS), the incidence rate of ESRD is 458 people per million populations. And the prevalence rate is 3,138 people per million populations, which is the highest one in the world. Chronic kidney disease (CKD) can be classified into five stages according to glomerular filtration rate. Whatever the stage it is, patients should keep healthy habits about diet and exercise and good adherence to medication. If patients are able to monitor their lifestyle, it not only promotes health, but also reduces the cost of health care.

Aim: By application of wearable devices and health management platform to build self-management model in CKD patients and analyze the cost of healthcare.

Material and Methods

The investigators plan to recruit 60 CKD patients as trial subjects. The intervention group is composed of 30 participants, and the control group 30 participants. The intervention group received intervention with wearable devices and health management platform for 90 days. Patients record their own diet diary by a smartphone application, and their exercise-related data are collected by wearable devices. Then, all the collected information will be upload to health management platform. The investigators also create a LINE group to encourage exercise in the experimental group. The investigators compare the scores of self-management sheet and physical and laboratory examinations before and after the intervention. The investigators also analyze the cost of healthcare within 180 days.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • 未提供

排除标准

  • Can not use a smartphone
  • Have impaired walking capacity
  • Psychiatric disorder
  • Have been hospitalized during the previous three months

结局指标

主要结局

Change from Baseline Renal function at 3 months

时间窗: (1) baseline, (2) after the 90-day intervention

estimated glomerular filtration rate in mL/min/1.73m2

Change from Baseline Self-efficacy at 3 months

时间窗: (1) baseline, (2) after the 90-day intervention

the score of self-efficacy questionnaire (score 0-200, the higher the better) in units

Change from Baseline Self-management at 3 months

时间窗: (1) baseline, (2) after the 90-day intervention

the score of self-management questionnaire (score 16-64, the higher the better) in units

Change from Baseline Quality of life score at 3 months

时间窗: (1) baseline, (2) after the 90-day intervention

the score of Kidney Disease Quality of Life (KDQOL-SF™) questionnaire (score 74-360, the higher the better) in units

Change from Baseline Body composition at 3 month

时间窗: (1) baseline, (2) after the 90-day intervention

weight and height will be combined to report BMI in kg/m\^2

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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