Improve Compliance in Automated Peritoneal Dialysis Machine With SHARESOURCE

Compliance, Patient Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04157764
• Other study ID #: EMRP108057
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 1, 2020
• Est. completion date: January 31, 2022

Study information

• Verified date: November 2019
• Source: E-DA Hospital
• Contact: Shih-Yuan Hung
• Phone: +8867-615-0011
• Email: ed100367[@]edah.org.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: January 31, 2022
• Est. primary completion date: January 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Compliance, Patient

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
E-DA Hospital

References & Publications (5)

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. — View Citation

Milan Manani S, Crepaldi C, Giuliani A, Virzì 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. — View Citation

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(3S1):A7-A8. doi: 10.1053/j.ajkd.2019.01.001. Epub 2019 Feb 21. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	peritonitis rate (patient-month)	calculate the number of peritonitis rate	follow up to week 60
Secondary	Hospitalization rate	calculate the number of hospitalization rate	follow up to week 60
Secondary	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)