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NCT Number: NCT07798024

Effect of IRPM-APD on Clinical Outcomes for PD Patients

To evaluate the impact of an integrated remote patient monitoring model on clinical, operational, and health-economic outcomes for patients receiving APD

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Key information

Conditions

Peritoneal Dialysis (PD)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Integrated remote patient monitoring (IRPM)

Other

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.

Primary outcomes

  1. 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.

    Time frame: 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 outcomes

  1. Adverse events

    Time frame: From date of randomization until the end of follow-up, assessed at least 24 months

    Rate of adverse events in one year.

  2. Hospitalizations linked to adverse events possibly related to potentially preventable causes such as fluid overload (edema, hypertension and heart failure)

    Time frame: From date of randomization until the end of follow-up, assessed at least 24 months

    Rate of hospitalizations in one year.

  3. 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.

    Time frame: From date of randomization until the end of follow-up, assessed at least 24 months.

    Rate of unplanned visits in one year.

  4. Nutritional condition (evaluated by SGA)

    Time frame: From date of randomization until study completion, assessed at least 24 months.

    Change of nutritional condition in one year.

  5. Quality of life (evaluated by SF36)

    Time frame: 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.

  6. Residual renal function decline

    Time frame: From date of randomization until the end of follow-up, assessed at least 24 months.

    Rate of residual renal function decline in one year.

  7. Consumption of medical resources

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital, Sun Yat-Sen University

Other

Registry information

Official study title

Impact of Integrated Remote Patient Monitoring on Clinical Outcomes for Patients With Automated Peritoneal Dialysis: a Historical Control Prospective Study

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Sep 1, 2026
Registry last updated
Sep 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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