Continuous Ambulatory Peritoneal Dialysis With Telemedicine

NCT ID: NCT04427514

Last Updated: 2020-06-11

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

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-01

Study Completion Date

2021-11-01

Brief Summary

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This clinical trial is an open-label, prospective, single-arm, single center study.

In this study is planned to involve 12 patients, who need continuous ambulatory peritonealis dialysis (CAPD). Telemedicine software is related to peritoneal dialysis. With the help of a tablet device running an Android system on patients and the care team and the smart devices attached to it (scales, blood pressure monitor), patients perform measurements in their homes in connection with solution changes. The resulting data is transmitted through the telemedicine system to the care team, which can take immediate intervention if necessary and notify the patient of any change in therapy.

Detailed Description

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After enrollment, the patient is educated about the using of telemedicine system and then the standard CAPD will be continued in their home treatment supplemented with a telemedicine system.

There is a monthly follow-up visit in the CAPD therapy. Before each control visit a telemedicine doctor, for whom are available telemedicine data, decides whether a control visit is necessary. After that line the patient will be subjected to a personal check - up visit by another specialist, for whom the result of the telemedicine visit is unknown. At the end of the control visit, the doctor declares whether it could have been triggered the examination with the review of telemedicine data.

In the end of the study will be summarized the average number of visits that can be omitted and will be analyzed the extent to which the two medical opinions and the necessity of the visit matched.

Conditions

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Peritoneal Dialysis, Continuous Ambulatory

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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CAPD group

Standard CAPD therapy wtih telemedicine system

Group Type EXPERIMENTAL

Telemedicine software for data transmission and analysis in CAPD.

Intervention Type DEVICE

Telemedicine software is related to peritoneal dialysis. With the help of a tablet device running an Android system on patients and the care team and the smart devices attached to it (scales, blood pressure monitor), patients perform measurements in their homes in connection with solution changes. The resulting data is transmitted through the telemedicine system to the care team, which can take immediate intervention if necessary and notify the patient of any change in therapy.

Interventions

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Telemedicine software for data transmission and analysis in CAPD.

Telemedicine software is related to peritoneal dialysis. With the help of a tablet device running an Android system on patients and the care team and the smart devices attached to it (scales, blood pressure monitor), patients perform measurements in their homes in connection with solution changes. The resulting data is transmitted through the telemedicine system to the care team, which can take immediate intervention if necessary and notify the patient of any change in therapy.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Age over 18 years;
* Signed Informed consent form;
* Patients treated with CAPD;
* The subject communicates well with the investigator and is able to help understand and adhere to the requirements of the study plan.

Exclusion Criteria

* The consent was withdrawn by the volunteers at any time after the information and the signed informed consent form;
* Poor general condition;
* Any disease which, in the opinion of the investigator, endangers the health of the volunteer and / or contraindicates the conduct of the study.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Szeged University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Zoltán Ondrik, MD

Role: PRINCIPAL_INVESTIGATOR

University of Szeged, First Department of Medicine

Central Contacts

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Zoltán Ondrik, MD

Role: CONTACT

+36202533732

References

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Nakamoto H, Kawamoto A, Tanabe Y, Nakagawa Y, Nishida E, Akiba T, Suzuki H. Telemedicine system using a cellular telephone for continuous ambulatory peritoneal dialysis patients. Adv Perit Dial. 2003;19:124-9.

Reference Type BACKGROUND
PMID: 14763048 (View on PubMed)

Li J, Wang H, Xie H, Mei G, Cai W, Ye J, Zhang J, Ye G, Zhai H. Effects of post-discharge nurse-led telephone supportive care for patients with chronic kidney disease undergoing peritoneal dialysis in China: a randomized controlled trial. Perit Dial Int. 2014 May;34(3):278-88. doi: 10.3747/pdi.2012.00268. Epub 2014 Jan 2.

Reference Type BACKGROUND
PMID: 24385331 (View on PubMed)

Krishna VN, Managadi K, Smith M, Wallace E. Telehealth in the Delivery of Home Dialysis Care: Catching up With Technology. Adv Chronic Kidney Dis. 2017 Jan;24(1):12-16. doi: 10.1053/j.ackd.2016.11.014.

Reference Type BACKGROUND
PMID: 28224937 (View on PubMed)

Rygh E, Arild E, Johnsen E, Rumpsfeld M. Choosing to live with home dialysis-patients' experiences and potential for telemedicine support: a qualitative study. BMC Nephrol. 2012 Mar 19;13:13. doi: 10.1186/1471-2369-13-13.

Reference Type BACKGROUND
PMID: 22429705 (View on PubMed)

Other Identifiers

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TMED_CAPD_001

Identifier Type: -

Identifier Source: org_study_id

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