Improve Compliance in Automated Peritoneal Dialysis Machine With SHARESOURCE

NCT ID: NCT04157764

Last Updated: 2019-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-01

Study Completion Date

2022-01-31

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.

Conditions

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Compliance, Patient

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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

TREATMENT

Blinding Strategy

NONE

Study Groups

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APD

Group Type EXPERIMENTAL

HomeChoice Claria APD machine with SHARESOURCE

Intervention Type DEVICE

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

Interventions

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HomeChoice Claria APD machine with SHARESOURCE

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

Intervention Type DEVICE

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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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E-DA Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Shih-Yuan Hung

Role: CONTACT

+8867-615-0011 ext. 2980

References

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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.

Reference Type BACKGROUND
PMID: 30798791 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9428459 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9259694 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29694954 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30106369 (View on PubMed)

Other Identifiers

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EMRP108057

Identifier Type: -

Identifier Source: org_study_id

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