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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-08

Study Completion Date

2022-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Performance Evaluation of the AMIA APD Solution Generation System in Patients End Stage Renal Disease (ESRD)

NCT03812679

End Stage Renal Disease (ESRD)

TERMINATED NA

Designer Dialysis Peritoneal Dialysis

NCT03100188

Peritoneal Dialysis Quality of Life

COMPLETED NA

Use of a Bimodal Solution for Peritoneal Dialysis

NCT01242904

End Stage Renal Disease

COMPLETED PHASE2

Adjuvant Peritoneal Dialysis on a Background of Thrice-Weekly Hemodialysis

NCT02044614

Functionally Anuric Hemodialysis/Peritoneal Dialysis

TERMINATED NA

Novel Treatments in Improving Renal Outcomes in Light Chain Cast Nephropathy

NCT06483139

Multiple Myeloma Light Chain Nephropathy Acute Kidney Injury

RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Efficacy Safety Issues

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type ACTIVE_COMPARATOR

AMIA with SHARESOURCE Connectivity Platform

Intervention Type COMBINATION_PRODUCT

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.

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.

Group Type PLACEBO_COMPARATOR

HomeChoice PRO

Intervention Type DEVICE

Usual care

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type COMBINATION_PRODUCT

HomeChoice PRO

Usual care

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Baxter AMIA SHARESOURCE Baxter HomeChoice PRO

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No