Improve Compliance in Automated Peritoneal Dialysis Machine With SHARESOURCE

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Impact of Telemonitoring on Compliance and Outcomes of Patients Undergoing Automated Peritoneal Dialysis With SHARESOURCE

Conditions
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Compliance, Patient

Intervention / Treatment
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* Device: HomeChoice Claria APD machine with SHARESOURCE


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: use automated peritoneal dialysis machine without SHARESOURCE for 12 weeks, then use automated peritoneal dialysis machine with SHARESOURCE for 12 weeks
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: APD<br> | Device: HomeChoice Claria APD machine with SHARESOURCE<br>* HomeChoice Claria APD machine with SHARESOURCE software. SHARESOURCE is a software can telemonitor patients' compliance<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Telehealth, automated peritoneal dialysis