Improve Compliance in Automated Peritoneal Dialysis Machine With SHARESOURCE

Not Applicable

• Conditions: Compliance, Patient
• Interventions: Device: HomeChoice Claria APD machine with SHARESOURCE

• Registration Number: NCT04157764
• Lead Sponsor: E-DA Hospital

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.

Study Timeline

• Study First Submitted: 2019-10-14
• Status Verified: 2019-11
• Study First Submitted QC: 2019-11-06
• Study First Posted: 2019-11-08
• Last Update Submitted: 2019-11-16
• Last Update Posted: 2019-11-19
• Study Start: 2020-02-01
• Primary Completion: 2021-01-31
• Study Completion: 2022-01-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
APD	HomeChoice Claria APD machine with SHARESOURCE	-

Primary Outcome Measures

Name	Time	Method
Change of baseline patients' non-compliance rate at 3 months	baseline(between week 0 and 12) and 3 months(week 12 and week 24)	Non compliance rate was calculated by the days of non-compliance divided by days of APD therapy

Secondary Outcome Measures

Name	Time	Method
Change of baseline peritoneal dialysis adequacy at 3 and 6 months	baseline, week 12 and week 24	Dialysis adequacy is to see if dialysis is enough
peritonitis rate (patient-month)	follow up to week 60	calculate the number of peritonitis rate
Change of telephone contact frequency	baseline(between week 0 and 12) and 3 months(week 12 and week 24)	the telephone contact frequency (from patient to nurse) for peritoneal dialysis-related problems will be collected
Change of baseline uremic toxin level at 3 and 6 months	baseline, week 12 and week 24	concentration of uremic toxins(ex: indoxyl sulfate, and p-cresyl sulfate)
change of body composition analysis	baseline, week 12 and week 24	body composition exam (Body Composition Monitor, Fresenius Medical Care, Bad Homburg, Germany) will be done
Hospitalization rate	follow up to week 60	calculate the number of hospitalization rate