Clinical trial NCT04427514: Continuous Ambulatory Peritoneal Dialysis With Telemedicine
Official title: Investigation of the Applicability of a Home Peritoneal Dialysis (CAPD= Continuous Ambulatory Peritonealis Dialysis) Application System
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Peritoneal Dialysis, Continuous Ambulatory
Keywords: telemedicine
Lead sponsor: Szeged University
Sponsor class: OTHER
First posted: 2020-06-11
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: The average number of visits that can be omitted
timeFrame: 13 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Szeged, First Department of Medicine
name: Zoltán Ondrik, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.