Summary

for people ages 21 years and up (full criteria)
at San Diego, California and other locations
study started
estimated completion
Joachim H Ix, MD, MAS

Description

Summary

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.

Details

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).

Keywords

Efficacy Safety Issues Estimated Dry Weight Peritoneal Dialysis AMIA Sharesource CCPD Peritoneal Dialysis Cycler HomeChoice PRO Candesartan cilexetil Candesartan AMIA with SHARESOURCE Connectivity Platform

Eligibility

You can join if…

Open to people ages 21 years and up

  • Adults aged > 21 years with ESRD on peritoneal dialysis

You CAN'T join if...

  • 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.

Locations

  • Home Dialysis Therapies of San Diego accepting new patients
    San Diego California 92131 United States
  • Home Dialysis Therapies of San Diego accepting new patients
    Chula Vista California 91915 United States

Lead Scientist

  • Joachim H Ix, MD, MAS
    Adjunct Professor, Family Medicine and Public Health. Authored (or co-authored) 336 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Diego
ID
NCT04002440
Study Type
Interventional
Last Updated