Effect of IRPM-APD on Clinical Outcomes for PD Patients

NCT07798024 | Not Yet Recruiting

• 1 other identifier: IIT-2026-535
• Study Type: observational
• Target: 600
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Peritoneal Dialysis (PD)

Keywords

Peritoneal Dialysis; automated peritoneal dialysis; remote patient monitoring

Outcome Measures

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.

  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.

  From date of randomization until the date of first event, whichever came first, assessed at least 24 months.

Secondary Outcomes (7)

• Adverse events

  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)

  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.

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

• Nutritional condition (evaluated by SGA)

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

• Quality of life (evaluated by SF36)

  Change of quality of life in one year.

Study Arms (2)

CON

In the APD group, the PD team did not have access to the information transmitted by the RPM device; the management of patients in the APD group was carried out in the usual way.

IRPM-APD

Doctors and nurses were instructed to review daily the data provided by the IRPM-APD device for IRPM-APD arms patients. In detail, daily data includes the day and time of connection, the duration of treatment per day, total exchange volume, the number of cycles, use or not of wet day (i.e. daytime exchange in the preceding day), dialysate volume infused, total dwell time, dwell time per exchange, actual time for filling and draining per exchange, drain volume per dwell and total treatment, cycle profile, total and dwell ultrafiltration, and number of events per treatment. The number and reason for alarms, events and bypass drain were also recorded and reviewed.

Other: Integrated remote patient monitoring (IRPM)

Interventions

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.

IRPM-APD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Incident APD patients of multiple centesr who meet the inclusion criteria will be recruited.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Affiliated Hospital, Sun Yat-Sen University: lead

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 24 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 19, 2026
• First Posted: September 1, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: September 1, 2026

Record last verified: 2026-08