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

University of California San Diego

Status: Active, not recruiting

Conditions: Safety Issues; Efficacy

Treatments: Device: HomeChoice PRO; Combination Product: AMIA with SHARESOURCE Connectivity Platform

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04002440

180492

Details and patient eligibility

About

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.

Full 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).

Enrollment: 28 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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28 participants in 2 patient groups, including a placebo group

AMIA with SHARESOURCE

Active Comparator group

Description:

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.

Treatment:

Combination Product: AMIA with SHARESOURCE Connectivity Platform

HomeChoice PRO

Placebo Comparator group

Description:

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.

Treatment:

Device: HomeChoice PRO