To evaluate the impact of an integrated remote patient monitoring model on clinical, operational, and health-economic outcomes for patients receiving APD
Study Type
OBSERVATIONAL
Enrollment
600
IRPM provided information gathered by RPM of treatment data day-by-day, and achieved higher-frequency information feedback and clinical decision support. Additionally, the current knowledge about the effects of RPM in APD limited real-world research.
Composite indices were constructed based on four SONG-PD (Standardized Outcomes in Nephrology-Peritoneal Dialysis) core outcomes: mortality, cardiovascular (CV) diseases, PD infection and technique survival, complemented by SONG-PD middle.
Primary endpoints were time to the first event of Composite Index, including mortality (all-cause mortality and CV-related mortality), transferring to hemodialysis (technique failure), and peritonitis.
Time frame: From date of randomization until the date of first event, whichever came first, assessed at least 24 months.
Adverse events
Rate of adverse events in one year.
Time frame: From date of randomization until the end of follow-up, assessed at least 24 months
Hospitalizations linked to adverse events possibly related to potentially preventable causes such as fluid overload (edema, hypertension and heart failure)
Rate of hospitalizations in one year.
Time frame: From date of randomization until the end of follow-up, assessed at least 24 months
Unplanned visits, defined as any unscheduled medical contacts (including outpatient visits, emergency room visits, or phone calls) made by peritoneal dialysis patients because of unexpected health issues, beyond the routine follow-up schedule.
Rate of unplanned visits in one year.
Time frame: From date of randomization until the end of follow-up, assessed at least 24 months.
Nutritional condition (evaluated by SGA)
Change of nutritional condition in one year.
Time frame: From date of randomization until study completion, assessed at least 24 months.
Quality of life (evaluated by SF36)
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The Short Form 36-item Health Survey (SF-36) scores range from 0 to 100, with higher scores indicating better health status and fewer limitations.
Time frame: Change of quality of life in one year.
Residual renal function decline
Rate of residual renal function decline in one year.
Time frame: From date of randomization until the end of follow-up, assessed at least 24 months.
Consumption of medical resources
Medical resource consumption is measured by the time of nurse reviews of remote monitoring data and alarm events.
Time frame: From date of randomization until study completion, assessed at least 24 months.