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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04157764
Other study ID # EMRP108057
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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)
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