Clinical trial NCT04002440: Directed Use of REmote Patient Management System AMia to Achieve Prescribed Dry Weight
Official title: Directed Use of REmote Patient Management System AMia to Achieve Prescribed Dry Weight
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Efficacy
Safety Issues
Keywords: Estimated Dry Weight
Peritoneal Dialysis
AMIA
Sharesource
CCPD
Peritoneal Dialysis Cycler
HomeChoice PRO
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: Baxter Healthcare Corporation
name: Scripps Health
name: Home Dialysis Therapies of San Diego
First posted: 2019-06-28
Enrollment: 28
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: TREATMENT

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.

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).

Eligibility 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.

Primary outcomes:
measure: 3 month average of difference between the actual vs. prescribed dry weight
timeFrame: 3 months
Secondary outcomes:
measure: Nursing burden related to use of AMIA with SHARESOURCE
timeFrame: 12 months
measure: Patient Quality of Life while using AMIA with SHARESOURCE: Kidney Disease and Quality of Life -36 questionaire
timeFrame: 12 months
Other outcomes:
Locations:
city: Chula Vista
country: United States
facility: Home Dialysis Therapies of San Diego
state: California
city: San Diego
country: United States
facility: Home Dialysis Therapies of San Diego
state: California
Study officials:
affiliation: University of California, San Diego
name: Joachim H Ix, MD, MAS
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Diego
name: Bethany E Karl, DO
role: STUDY_DIRECTOR
References: