跳至主要内容
临床试验/NCT04002440
NCT04002440进行中(未招募)不适用

Directed Use of REmote Patient Management System AMia to Achieve Prescribed Dry Weight

University of California, San Diego3 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2018年11月8日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
28
试验地点
3
主要终点
3 month average of difference between the actual vs. prescribed dry weight

研究概览

简要总结

Among ambulatory peritoneal dialysis patients, does use of the Baxter AMIA peritoneal dialysis cycler with SHARESOURCE connectivity platform achieve dry weight targets better than use of the Baxter Home Choice Pro cycler.

详细描述

The remote patient management system Baxter AMIA automated peritoneal dialysis system with SHARESOURCE connectivity platform incorporates innovative technology (two-way remote connectivity, touch screen controls, voice guidance) to record patient treatments which are then able to be transmitted to their dialysis clinic for review and monitoring in near real-time. This has tremendous potential clinical utility given the struggles to achieve dry weights for most peritoneal dialysis patients using other systems, where typically, management regarding fluid balance is reviewed and revised only monthly. The new technology is the only device cleared in the US with patient-centric features. Abstracts available have demonstrated that AMIA can improve efficiency of patient training and focus PD nursing time towards proactive tasks to help patients. There has also been insight into how remote patient management systems like AMIA can be used to objectively monitor patient compliance or catheter function above and beyond subjective endorsement from patients. However, with new technology comes new training for patient and staff (nurses, physicians) without understanding if interfacing with this new patient-centric featured technology improves patient-centric clinical outcomes. The new AMIA and SHARESOURCE programs may also require additional nurse and physician provider time to monitor data in real-time and to react to these data, which may incur additional expense to medical practices. Thus, it is imperative to demonstrate the utility of the AMIA and SHARESOURCE programs for important improvement in patient management, which may ultimately translate into improved clinical outcomes (e.g. fewer hospital admissions, less heart failure, improved quality, and length of life).

研究设计

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

盲法说明

The study is not blinded, as the intervention does not provide an opportunity to blind either the physician or the patient. The PI will be masked to randomization and not involved in patient care or data collection. Statistical analyses will be conducted by Dr. Ronit Katz who is not an investigator for this trial and PI Dr.Joachim Ix after being provided secure study results.

入排标准

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

入选标准

  • Adults aged > 21 years with ESRD on peritoneal dialysis

排除标准

  • Unable to commit to 12 months of monitoring.
  • Unable to stand safely on scale for weight
  • Hospitalization for heart failure, volume overload, or cardiovascular disease within the last 3 months.
  • Peritonitis within the past 3 months.
  • Not responsible for self-care of peritoneal dialysis (proxy care will be excluded).
  • Patients residing in a nursing home or other institutionalized individuals.
  • Inability or unwillingness to provide informed consent (lacks decision making capacity)
  • Alcohol, substance use, or other social conditions which preclude close follow-up and reliable participation, in the opinion of the primary nephrology physician or study investigator.

结局指标

主要结局

3 month average of difference between the actual vs. prescribed dry weight

时间窗: 3 months

The investigators will evaluate the average difference between the actual dry weight vs. prescribed dry weight achieved through use of Baxter AMIA automated peritoneal dialysis system with SHARESOURCE connectivity compared to use of HomeChoicePRO.

次要结局

  • Nursing burden related to use of AMIA with SHARESOURCE(12 months)
  • Patient Quality of Life while using AMIA with SHARESOURCE: Kidney Disease and Quality of Life -36 questionaire(12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Joachim H. Ix

Professor of Medicine

University of California, San Diego

研究点 (3)

Loading locations...

相似试验