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

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ClinicalTrials.gov Identifier: NCT04002440
Recruitment Status : Recruiting
First Posted : June 28, 2019
Last Update Posted : July 15, 2020
Sponsor:
Collaborators:
Baxter Healthcare Corporation
Scripps Health
Home Dialysis Therapies of San Diego
Information provided by (Responsible Party):
Joachim H. Ix, University of California, San Diego

Brief 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.

Condition or disease Intervention/treatment Phase
Efficacy Safety Issues Combination Product: AMIA with SHARESOURCE Connectivity Platform Device: HomeChoice PRO Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Participants will be consented and then randomized to one of 2 modality groups; AMIA or HomeChoice PRO. Participants will receive PD care with randomized modality for 6 months, then cross-over to other modality for next 6 months. Nephrologists will see patients once a month. Each visit, the nephrologist will define the patient's desired dry weight (DW) at the subsequent visit. The primary end-point will be the average difference between actual DW vs. prescribed DW. The investigators envision a learning curve with each cycler change, and therefore have set the primary endpoint to average the final 3 visits, rather than using all 6 visits. All solutions and supplies will be from Baxter. Labs will be obtained monthly and quarterly per routine. Dialysis RN will review patients on AMIA twice a week and contact those off target DW and offer interventions to achieve prescribed DW. HomeChoice PRO will record data on a chip analyzed at the end of 6 months to evaluate compliance.
Masking: None (Open Label)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: Directed Use of REmote Patient Management System AMia to Achieve Prescribed Dry Weight
Actual Study Start Date : November 8, 2018
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : April 2022

Resource links provided by the National Library of Medicine


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 Name: Baxter HomeChoice PRO




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04002440


Contacts
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Contact: Bethany E Karl, DO 619-471-0752 bkarl@ucsd.edu
Contact: Joachim H Ix, MD, MAS 858-552-7528 joeix@ucsd.edu

Locations
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United States, California
Home Dialysis Therapies of San Diego Recruiting
Chula Vista, California, United States, 91915
Contact: Denise Barnes, RN    619-422-0003    denise@homedialysistherapies.com   
Sub-Investigator: Bethany E Karl, DO         
Sub-Investigator: Andrew King, MD         
Sub-Investigator: Kimberly Harper, MD         
Home Dialysis Therapies of San Diego Recruiting
San Diego, California, United States, 92131
Contact: Denise Barnes, RN    858-549-3400    denise@homedialysistherapies.com   
Sub-Investigator: Bethany E Karl, DO         
Sub-Investigator: Andrew King, MD         
Sub-Investigator: Kimberly Harper, MD         
Sponsors and Collaborators
University of California, San Diego
Baxter Healthcare Corporation
Scripps Health
Home Dialysis Therapies of San Diego
Investigators
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Principal Investigator: Joachim H Ix, MD, MAS University of California, San Diego
Study Director: Bethany E Karl, DO University of California, San Diego
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Responsible Party: Joachim H. Ix, Professor of Medicine, University of California, San Diego
ClinicalTrials.gov Identifier: NCT04002440    
Other Study ID Numbers: 180492
First Posted: June 28, 2019    Key Record Dates
Last Update Posted: July 15, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Keywords provided by Joachim H. Ix, University of California, San Diego:
Estimated Dry Weight
Peritoneal Dialysis
AMIA
Sharesource
CCPD
Peritoneal Dialysis Cycler
HomeChoice PRO
Additional relevant MeSH terms:
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Candesartan cilexetil
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action