Clinical trial NCT04157764: Improve Compliance in Automated Peritoneal Dialysis Machine With SHARESOURCE
Official title: The Impact of Telemonitoring on Compliance and Outcomes of Patients Undergoing Automated Peritoneal Dialysis With SHARESOURCE
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Compliance, Patient
Keywords: Telehealth
automated peritoneal dialysis
Lead sponsor: E-DA Hospital
Sponsor class: OTHER
First posted: 2019-11-08
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: use automated peritoneal dialysis machine without SHARESOURCE for 12 weeks, then use automated peritoneal dialysis machine with SHARESOURCE for 12 weeks
Primary purpose: TREATMENT

Brief summary: This study is to investigate the non-compliance rate of patients undergoing automated peritoneal dialysis by using automated peritoneal dialysis with SHARESOURCE software, and to evaluate if telemonitoring can improve peritoneal dialysis compliance and outcomes in the observation period.

Detailed description: The non-compliance of patients receiving automated peritoneal dialysis (APD) is around 10-20%, and was believed to be under-estimated. Recently, a two-way telehealth system, SHARESOURCE software, provide practitioners real-time monitoring and recording of the therapy of APD.

By using this APD with SHARESOURCE software, we want to investigate the non-compliance rate of patients undergoing automated peritoneal dialysis, want to see if it can improve peritoneal dialysis compliance and outcomes in the observation period.

Eligibility criteria: Inclusion Criteria:

* stable received peritoneal dialysis for over 1 year. Use automated peritoneal dialysis machine regularly by him/herself.

Exclusion Criteria:

* Acute hospitalization events due to acute coronary syndrome, stroke, heart failure, liver cirrhosis, systemic infection in 1 month.
* Life expectancy \<1 year
* Peritoneal dialysis prescriptions will be scheduled or expected to change in 3 months

Primary outcomes:
measure: Change of baseline patients' non-compliance rate at 3 months
timeFrame: baseline(between week 0 and 12) and 3 months(week 12 and week 24)
Secondary outcomes:
measure: Change of baseline peritoneal dialysis adequacy at 3 and 6 months
timeFrame: baseline, week 12 and week 24
measure: Change of baseline uremic toxin level at 3 and 6 months
timeFrame: baseline, week 12 and week 24
measure: change of body composition analysis
timeFrame: baseline, week 12 and week 24
measure: peritonitis rate (patient-month)
timeFrame: follow up to week 60
measure: Hospitalization rate
timeFrame: follow up to week 60
measure: Change of telephone contact frequency
timeFrame: baseline(between week 0 and 12) and 3 months(week 12 and week 24)
Other outcomes:
Locations:
Study officials:
References:
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