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临床试验/NCT04157764
NCT04157764Unknown不适用

The Impact of Telemonitoring on Compliance and Outcomes of Patients Undergoing Automated Peritoneal Dialysis With SHARESOURCE

E-DA Hospital0 个研究点目标入组 50 人开始时间: 2020年2月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
50
主要终点
Change of baseline patients' non-compliance rate at 3 months

研究概览

简要总结

This study is to investigate the non-compliance rate of patients undergoing automated peritoneal dialysis by using automated peritoneal dialysis with SHARESOURCE software, and to evaluate if telemonitoring can improve peritoneal dialysis compliance and outcomes in the observation period.

详细描述

The non-compliance of patients receiving automated peritoneal dialysis (APD) is around 10-20%, and was believed to be under-estimated. Recently, a two-way telehealth system, SHARESOURCE software, provide practitioners real-time monitoring and recording of the therapy of APD.

By using this APD with SHARESOURCE software, we want to investigate the non-compliance rate of patients undergoing automated peritoneal dialysis, want to see if it can improve peritoneal dialysis compliance and outcomes in the observation period.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • stable received peritoneal dialysis for over 1 year. Use automated peritoneal dialysis machine regularly by him/herself.

排除标准

  • Acute hospitalization events due to acute coronary syndrome, stroke, heart failure, liver cirrhosis, systemic infection in 1 month.
  • Life expectancy <1 year
  • Peritoneal dialysis prescriptions will be scheduled or expected to change in 3 months

结局指标

主要结局

Change of baseline patients' non-compliance rate at 3 months

时间窗: baseline(between week 0 and 12) and 3 months(week 12 and week 24)

Non compliance rate was calculated by the days of non-compliance divided by days of APD therapy

次要结局

  • Change of baseline peritoneal dialysis adequacy at 3 and 6 months(baseline, week 12 and week 24)
  • peritonitis rate (patient-month)(follow up to week 60)
  • Change of telephone contact frequency(baseline(between week 0 and 12) and 3 months(week 12 and week 24))
  • Change of baseline uremic toxin level at 3 and 6 months(baseline, week 12 and week 24)
  • change of body composition analysis(baseline, week 12 and week 24)
  • Hospitalization rate(follow up to week 60)

研究者

发起方
E-DA Hospital
申办方类型
Other
责任方
Sponsor

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