Improve Compliance in Automated Peritoneal Dialysis Machine With SHARESOURCE

NCT04157764 | Unknown

• 1 other identifier: EMRP108057
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Compliance, Patient

Keywords

Telehealth; automated peritoneal dialysis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Change of baseline peritoneal dialysis adequacy at 3 and 6 months

  baseline, week 12 and week 24

• Change of baseline uremic toxin level at 3 and 6 months

  baseline, week 12 and week 24

• change of body composition analysis

  baseline, week 12 and week 24

• peritonitis rate (patient-month)

  follow up to week 60

• Hospitalization rate

  follow up to week 60

Study Arms (1)

APD

EXPERIMENTAL

Device: HomeChoice Claria APD machine with SHARESOURCE

Interventions

HomeChoice Claria APD machine with SHARESOURCE DEVICE

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

APD

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• stable received peritoneal dialysis for over 1 year. Use automated peritoneal dialysis machine regularly by him/herself.

You may not qualify if:

• 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

Sponsors & Collaborators

• E-DA Hospital: lead

Related Publications (5)

• 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.

  PMID: 30798791 BACKGROUND

• 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.

  PMID: 9428459 BACKGROUND

• 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.

  PMID: 9259694 BACKGROUND

• 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.

  PMID: 29694954 BACKGROUND

• 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.

  PMID: 30106369 BACKGROUND

MeSH Terms

Conditions

Patient Compliance

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Central Study Contacts

Shih-Yuan Hung

CONTACT

+8867-615-0011; ed100367@edah.org.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: October 14, 2019
• First Posted: November 8, 2019
• Study Start: February 1, 2020
• Primary Completion: January 31, 2021
• Study Completion: January 31, 2022
• Last Updated: November 19, 2019

Record last verified: 2019-11