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

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.

Study Overview

• Status: Unknown
• Conditions: Compliance, Patient
• Intervention / Treatment: Device: HomeChoice Claria APD machine with SHARESOURCE

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 Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shih-Yuan Hung; Phone Number: 2980 +8867-615-0011; Email: ed100367@edah.org.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: APD	Device: HomeChoice Claria APD machine with SHARESOURCE; HomeChoice Claria APD machine with SHARESOURCE software. SHARESOURCE is a software can telemonitor patients' compliance

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: E-DA Hospital

Publications and helpful links

General Publications

• Saran R, Robinson B, Abbott KC, Agodoa LYC, Bragg-Gresham J, Balkrishnan R, Bhave N, Dietrich X, Ding Z, Eggers PW, Gaipov A, Gillen D, Gipson D, Gu H, Guro P, Haggerty D, Han Y, He K, Herman W, Heung M, Hirth RA, Hsiung JT, Hutton D, Inoue A, Jacobsen SJ, Jin Y, Kalantar-Zadeh K, Kapke A, Kleine CE, Kovesdy CP, Krueter W, Kurtz V, Li Y, Liu S, Marroquin MV, McCullough K, Molnar MZ, Modi Z, Montez-Rath M, Moradi H, Morgenstern H, Mukhopadhyay P, Nallamothu B, Nguyen DV, Norris KC, O'Hare AM, Obi Y, Park C, Pearson J, Pisoni R, Potukuchi PK, Repeck K, Rhee CM, Schaubel DE, Schrager J, Selewski DT, Shamraj R, Shaw SF, Shi JM, Shieu M, Sim JJ, Soohoo M, Steffick D, Streja E, Sumida K, Kurella Tamura M, Tilea A, Turf M, Wang D, Weng W, Woodside KJ, Wyncott A, Xiang J, Xin X, Yin M, You AS, Zhang X, Zhou H, Shahinian V. US Renal Data System 2018 Annual Data Report: Epidemiology of Kidney Disease in the United States. Am J Kidney Dis. 2019 Mar;73(3 Suppl 1):A7-A8. doi: 10.1053/j.ajkd.2019.01.001. Epub 2019 Feb 21. No abstract available.
• Bernardini J, Piraino B. Compliance in CAPD and CCPD patients as measured by supply inventories during home visits. Am J Kidney Dis. 1998 Jan;31(1):101-7. doi: 10.1053/ajkd.1998.v31.pm9428459.
• The USRDS Dialysis Morbidity and Mortality Study: Wave 2. United States Renal Data System. Am J Kidney Dis. 1997 Aug;30(2 Suppl 1):S67-85. No abstract available.
• Milan Manani S, Crepaldi C, Giuliani A, Virzi GM, Garzotto F, Riello C, de Cal M, Rosner MH, Ronco C. Remote Monitoring of Automated Peritoneal Dialysis Improves Personalization of Dialytic Prescription and Patient's Independence. Blood Purif. 2018;46(2):111-117. doi: 10.1159/000487703. Epub 2018 Apr 25.
• Uchiyama K, Washida N, Yube N, Kasai T, Shinozuka K, Morimoto K, Hishikawa A, Inoue H, Urai H, Hagiwara A, Fujii K, Wakino S, Deenitchina S, Itoh H. The impact of a remote monitoring system of healthcare resource consumption in patients on automated peritoneal dialysis (APD): A simulation study . Clin Nephrol. 2018 Nov;90(5):334-340. doi: 10.5414/CN109471.

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2020
• Primary Completion (Anticipated): January 31, 2021
• Study Completion (Anticipated): January 31, 2022

Study Registration Dates

• First Submitted: October 14, 2019
• First Submitted That Met QC Criteria: November 6, 2019
• First Posted (Actual): November 8, 2019

Study Record Updates

• Last Update Posted (Actual): November 19, 2019
• Last Update Submitted That Met QC Criteria: November 16, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: Telehealth; automated peritoneal dialysis
• Other Study ID Numbers: EMRP108057

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No