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临床试验/NCT03649516
NCT03649516已完成不适用

The Impact of Mobile APP Intervention ( iCKD APP) on Chronic Kidney Disease Care: A Multicenter, Randomized, Open, Controlled Trial

Kaohsiung Medical University Chung-Ho Memorial Hospital1 个研究点 分布在 1 个国家目标入组 101 人开始时间: 2018年6月26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
101
试验地点
1
主要终点
Compare clinics and home blood pressure

研究概览

简要总结

  • Apply Mobile APP Intervention ( iCKD APP) to current chronic kidney disease care program.
  • Conduct a randomized clinical trial to evaluate the clinical effectiveness of this mobile device on health behavior improvement in chronic kidney disease patients.

详细描述

A mHealth app (iCKD APP) was designed to assist CKD patients to monitor their home bio-information data. Patients will be randomly assigned into the iCKD APP group(intervention) and traditional care group (control). Participants will be randomized into an 1:1 manner (intervention : control). Random assignment occurred after the consent and initial enrollment interview. Individuals randomized to the iCKD APP will provide with the equipment after randomization. Participants will follow for at least 6 months before the exit interview.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
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

  • Subjects are 20 years old and above, Chinese speaking, and able and willing to provide informed consent.
  • Subjects own mobile devices such as cell phones and tablets.
  • Subjects were diagnosed with Chronic Kidney Diseases and were taking a single antihypertensive agent for more than three months or they are not receiving treatment but with systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg.

排除标准

  • starting dialysis or having a kidney transplant (RRT)
  • participating in other interventional study
  • cognitively impaired
  • unable to give consent
  • life expectancy less than 1 year

结局指标

主要结局

Compare clinics and home blood pressure

时间窗: 3 months

Systolic and diastolic blood pressure levels measured at both clinics and home will be compared between and within groups at various time points in study period.

次要结局

  • Achievement of Blood pressure control target(3 months)
  • The monitor rate of Home Blood pressure(3 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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