Directed Use of REmote Patient Management System AMia to Achieve Prescribed Dry Weight
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Efficacy
- Safety Issues
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Crossover AssignmentIntervention 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
Participation Requirements
- Age
- Between 21 years and 125 years
- Gender
- Both males and females
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 t...
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).
Tracking Information
- NCT #
- NCT04002440
- 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
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