Directed Use of REmote Patient Management System AMia to Achieve Prescribed Dry Weight (DREAM-APD)

August 23, 2021 updated by: Joachim H. Ix, University of California, San Diego
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

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).

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Chula Vista, California, United States, 91915
        • Home Dialysis Therapies of San Diego
      • San Diego, California, United States, 92131
        • Home Dialysis Therapies of San Diego

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adults aged > 21 years with ESRD on peritoneal dialysis

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: AMIA with SHARESOURCE
For this arm, dialysis nurses will review those patients using the AMIA with SHARESOURCE connectivity platform twice a week and will contact patients who meet certain triggers. They will then offer patients interventions, ie. a change in the preset AMIA ultrafiltration program, in order to achieve prescribed dry weight.
Combination product: AMIA with SHARESOURCE Connectivity Platform
The investigators will conduct a randomized, cross-over study in peritoneal dialysis patients in which patients are randomized to either Home Choice Pro (which remains the most widely used Baxter cycler) versus treatment with the Baxter AMIA automated peritoneal dialysis system with SHARESOURCE connectivity.
Other Names:
  • Baxter AMIA
  • SHARESOURCE
PLACEBO_COMPARATOR: HomeChoice PRO
For this arm, routine standard of care for peritoneal dialysis patients will continue using the HomeChoice PRO device. Data regarding treatments will be captured on a chip to be analyzed at the end of 6 months to evaluate compliance with treatments.
Device: HomeChoice PRO
Usual care
Other Names:
  • Baxter HomeChoice PRO

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
3 month average of difference between the actual vs. prescribed dry weight
Time Frame: 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.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nursing burden related to use of AMIA with SHARESOURCE
Time Frame: 12 months
The investigators will observe the number of nursing time hours per month dedicated to patient care for patients using AMIA with SHARESOURCE compared to patients using HomeChoicePRO.
12 months
Patient Quality of Life while using AMIA with SHARESOURCE: Kidney Disease and Quality of Life -36 questionaire
Time Frame: 12 months
The investigators will assess quality of life scores using the Kidney Disease and Quality of Life -36 questionaire survey of patients using AMIA with SHARESOURCE compared to patients using HomeChoicePRO. The survey assesses 5 areas pertaining to quality of life on dialysis which include 1) physical component score 2) mental component score 3) burden 4) symptoms 5) effects. Patient answers are compared to their national demographic and reported on a scale of 0-100. The higher the score the better. The scores for each component will be reported and tracked separately.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Diego

Collaborators

Baxter Healthcare Corporation
Scripps Health
Home Dialysis Therapies of San Diego

Investigators

  • Principal Investigator: Joachim H Ix, MD, MAS, University of California, San Diego
  • Study Director: Bethany E Karl, DO, University of California, San Diego

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 8, 2018

Primary Completion (ANTICIPATED)

November 30, 2021

Study Completion (ANTICIPATED)

April 1, 2022

Study Registration Dates

First Submitted

October 11, 2018

First Submitted That Met QC Criteria

June 26, 2019

First Posted (ACTUAL)

June 28, 2019

Study Record Updates

Last Update Posted (ACTUAL)

August 25, 2021

Last Update Submitted That Met QC Criteria

August 23, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 180492

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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