Improve Compliance in Automated Peritoneal Dialysis Machine With SHARESOURCE

• Sponsor: E-DA Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT04157764
• Collaborator: (none)
• Enrollment: 50
• Arm: 1
• Anticipated Duration (Months): 24

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Compliance, Patient	Device: HomeChoice Claria APD machine with SHARESOURCE	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 50 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: use automated peritoneal dialysis machine without SHARESOURCE for 12 weeks, then use automated peritoneal dialysis machine with SHARESOURCE for 12 weeksuse automated peritoneal dialysis machine without SHARESOURCE for 12 weeks, then use automated peritoneal dialysis machine with SHARESOURCE for 12 weeks
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Impact of Telemonitoring on Compliance and Outcomes of Patients Undergoing Automated Peritoneal Dialysis With SHARESOURCE
• Anticipated Study Start Date: Feb 1, 2020
• Anticipated Primary Completion Date: Jan 31, 2021
• Anticipated Study Completion Date: Jan 31, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Change of baseline patients' non-compliance rate at 3 months [baseline(between week 0 and 12) and 3 months(week 12 and week 24)]

   Non compliance rate was calculated by the days of non-compliance divided by days of APD therapy

Secondary Outcome Measures

1. Change of baseline peritoneal dialysis adequacy at 3 and 6 months [baseline, week 12 and week 24]

   Dialysis adequacy is to see if dialysis is enough

2. Change of baseline uremic toxin level at 3 and 6 months [baseline, week 12 and week 24]

   concentration of uremic toxins(ex: indoxyl sulfate, and p-cresyl sulfate)

3. change of body composition analysis [baseline, week 12 and week 24]

   body composition exam (Body Composition Monitor, Fresenius Medical Care, Bad Homburg, Germany) will be done

4. peritonitis rate (patient-month) [follow up to week 60]

   calculate the number of peritonitis rate

5. Hospitalization rate [follow up to week 60]

   calculate the number of hospitalization rate

6. Change of telephone contact frequency [baseline(between week 0 and 12) and 3 months(week 12 and week 24)]

   the telephone contact frequency (from patient to nurse) for peritoneal dialysis-related problems will be collected

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• E-DA Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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.
• 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.
• 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.

• Responsible Party: E-DA Hospital
• ClinicalTrials.gov Identifier: NCT04157764
• Other Study ID Numbers: EMRP108057
• First Posted: Nov 8, 2019
• Last Update Posted: Nov 19, 2019
• Last Verified: Nov 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by E-DA Hospital: Telehealth; automated peritoneal dialysis

Study Results

No Results Posted as of Nov 19, 2019