Peritoneal Dialysis (PD)
Conditions
Keywords
Peritoneal Dialysis, automated peritoneal dialysis, remote patient monitoring
Brief summary
To evaluate the impact of an integrated remote patient monitoring model on clinical, operational, and health-economic outcomes for patients receiving APD
Interventions
OTHERIntegrated remote patient monitoring (IRPM)
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.
Sponsors
First Affiliated Hospital, Sun Yat-Sen University
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Incident PD patients with age ≥18 years; * For APD-IRPM group, patients preferred to use the APD machine of Homechoice Claria®； * For Control group, patients treated with APD therapy (without RPM system) at the initiation of PD; * Signed an informed consent form.
Exclusion criteria
* Peritonitis occurred within 6 weeks before the baseline assessment. * Urinary catheter was removed or abdominal surgery was performed within 60 days before the baseline assessment. * Patients who have severe cognitive impairment or mental illness, rendering them unable to complete the follow-up.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | From date of randomization until the date of first event, whichever came first, assessed at least 24 months. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life (evaluated by SF36) | Change of quality of life in one year. | 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. |
| Residual renal function decline | From date of randomization until the end of follow-up, assessed at least 24 months. | Rate of residual renal function decline in one year. |
| Consumption of medical resources | From date of randomization until study completion, assessed at least 24 months. | Medical resource consumption is measured by the time of nurse reviews of remote monitoring data and alarm events. |
| Adverse events | From date of randomization until the end of follow-up, assessed at least 24 months | Rate of adverse events in one year. |
| Hospitalizations linked to adverse events possibly related to potentially preventable causes such as fluid overload (edema, hypertension and heart failure) | From date of randomization until the end of follow-up, assessed at least 24 months | Rate of hospitalizations in one year. |
| Nutritional condition (evaluated by SGA) | From date of randomization until study completion, assessed at least 24 months. | Change of nutritional condition in one year. |
| 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. | From date of randomization until the end of follow-up, assessed at least 24 months. | Rate of unplanned visits in one year. |
Outcome results
None listed