NCT04427514

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2020

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 19, 2020

Completed
23 days until next milestone

First Posted

Study publicly available on registry

June 11, 2020

Completed
20 days until next milestone

Study Start

First participant enrolled

July 1, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2021

Completed
Last Updated

June 11, 2020

Status Verified

June 1, 2020

Enrollment Period

1.1 years

First QC Date

May 19, 2020

Last Update Submit

June 8, 2020

Conditions

Peritoneal Dialysis, Continuous Ambulatory

Keywords

telemedicine

Outcome Measures

Primary Outcomes (1)

  • The average number of visits that can be omitted

    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.

    13 months

Study Arms (1)

CAPD group

EXPERIMENTAL

Standard CAPD therapy wtih telemedicine system

Device: Telemedicine software for data transmission and analysis in CAPD.

Interventions

Telemedicine software for data transmission and analysis in CAPD.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.

CAPD group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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.

    PMID: 14763048BACKGROUND

  • 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.

    PMID: 24385331BACKGROUND

  • 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.

    PMID: 28224937BACKGROUND

  • 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.

    PMID: 22429705BACKGROUND

MeSH Terms

Interventions

Peritoneal Dialysis, Continuous Ambulatory

Intervention Hierarchy (Ancestors)

Ambulatory CarePatient CareTherapeuticsPeritoneal DialysisRenal DialysisRenal Replacement TherapySorption DetoxificationHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Zoltán Ondrik, MD

    University of Szeged, First Department of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zoltán Ondrik, MD

CONTACT

+36202533732zoltan.ondrik@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 19, 2020

First Posted

June 11, 2020

Study Start

July 1, 2020

Primary Completion

August 1, 2021

Study Completion

November 1, 2021

Last Updated

June 11, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share