Effect of IRPM-APD on Clinical Outcomes for PD Patients
ConditionPeritoneal Dialysis (PD)
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFirst Affiliated Hospital, Sun Yat-Sen University
About this trial
To evaluate the impact of an integrated remote patient monitoring model on clinical, operational, and health-economic outcomes for patients receiving APD
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
Incident APD patients of multiple centesr who meet the inclusion criteria will be recruited.
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Integrated remote patient monitoring (IRPM)
Other interventionIRPM 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.
Treatment groups
600 Participants
are divided into 2 treatment groupsGroup A: CON0 interventions
Group B: IRPM-APD1 intervention
Trial outcomes
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.
Time frame
From date of randomization until the date of first event, whichever came first, assessed at least 24 months.Secondary outcomes
1
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 months2
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 months3
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.4
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.Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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