Continuous Ambulatory Peritoneal Dialysis With Telemedicine

Not Applicable

• Conditions: Peritoneal Dialysis, Continuous Ambulatory
• Interventions: Device: Telemedicine software for data transmission and analysis in CAPD.

• Registration Number: NCT04427514
• Lead Sponsor: Szeged University

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.

Study Timeline

• Study First Submitted: 2020-05-19
• Status Verified: 2020-06
• Study First Submitted QC: 2020-06-08
• Last Update Submitted: 2020-06-08
• Study First Posted: 2020-06-11
• Last Update Posted: 2020-06-11
• Study Start: 2020-07-01
• Primary Completion: 2021-08-01
• Study Completion: 2021-11-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 12

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CAPD group	Telemedicine software for data transmission and analysis in CAPD.	Standard CAPD therapy wtih telemedicine system

Primary Outcome Measures

Name	Time	Method
The average number of visits that can be omitted	13 months	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.