Skip to content

Improve Compliance in Automated Peritoneal Dialysis Machine With SHARESOURCE

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04157764
Enrollment
50
Registered
2019-11-08
Start date
2020-02-01
Completion date
2022-01-31
Last updated
2019-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Compliance, Patient

Keywords

Telehealth, automated peritoneal dialysis

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.

Interventions

DEVICEHomeChoice Claria APD machine with SHARESOURCE

HomeChoice Claria APD machine with SHARESOURCE software. SHARESOURCE is a software can telemonitor patients' compliance

Sponsors

E-DA Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

use automated peritoneal dialysis machine without SHARESOURCE for 12 weeks, then use automated peritoneal dialysis machine with SHARESOURCE for 12 weeks

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change of baseline patients' non-compliance rate at 3 monthsbaseline(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

MeasureTime frameDescription
Change of baseline uremic toxin level at 3 and 6 monthsbaseline, week 12 and week 24concentration of uremic toxins(ex: indoxyl sulfate, and p-cresyl sulfate)
change of body composition analysisbaseline, week 12 and week 24body composition exam (Body Composition Monitor, Fresenius Medical Care, Bad Homburg, Germany) will be done
Change of baseline peritoneal dialysis adequacy at 3 and 6 monthsbaseline, week 12 and week 24Dialysis adequacy is to see if dialysis is enough
Hospitalization ratefollow up to week 60calculate the number of hospitalization rate
Change of telephone contact frequencybaseline(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
peritonitis rate (patient-month)follow up to week 60calculate the number of peritonitis rate

Contacts

Primary ContactShih-Yuan Hung
ed100367@edah.org.tw+8867-615-0011

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026