<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04427514</url>
  </required_header>
  <id_info>
    <org_study_id>TMED_CAPD_001</org_study_id>
    <nct_id>NCT04427514</nct_id>
  </id_info>
  <brief_title>Continuous Ambulatory Peritoneal Dialysis With Telemedicine</brief_title>
  <official_title>Investigation of the Applicability of a Home Peritoneal Dialysis (CAPD= Continuous Ambulatory Peritonealis Dialysis) Application System</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Szeged University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Szeged University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This clinical trial is an open-label, prospective, single-arm, single center study.&#xD;
&#xD;
      In this study is planned to involve 12 patients, who need continuous ambulatory peritonealis&#xD;
      dialysis (CAPD). Telemedicine software is related to peritoneal dialysis. With the help of a&#xD;
      tablet device running an Android system on patients and the care team and the smart devices&#xD;
      attached to it (scales, blood pressure monitor), patients perform measurements in their homes&#xD;
      in connection with solution changes. The resulting data is transmitted through the&#xD;
      telemedicine system to the care team, which can take immediate intervention if necessary and&#xD;
      notify the patient of any change in therapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      After enrollment, the patient is educated about the using of telemedicine system and then the&#xD;
      standard CAPD will be continued in their home treatment supplemented with a telemedicine&#xD;
      system.&#xD;
&#xD;
      There is a monthly follow-up visit in the CAPD therapy. Before each control visit a&#xD;
      telemedicine doctor, for whom are available telemedicine data, decides whether a control&#xD;
      visit is necessary. After that line the patient will be subjected to a personal check - up&#xD;
      visit by another specialist, for whom the result of the telemedicine visit is unknown. At the&#xD;
      end of the control visit, the doctor declares whether it could have been triggered the&#xD;
      examination with the review of telemedicine data.&#xD;
&#xD;
      In the end of the study will be summarized the average number of visits that can be omitted&#xD;
      and will be analyzed the extent to which the two medical opinions and the necessity of the&#xD;
      visit matched.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">July 1, 2020</start_date>
  <completion_date type="Anticipated">November 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">August 1, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The average number of visits that can be omitted</measure>
    <time_frame>13 months</time_frame>
    <description>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.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">12</enrollment>
  <condition>Peritoneal Dialysis, Continuous Ambulatory</condition>
  <arm_group>
    <arm_group_label>CAPD group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Standard CAPD therapy wtih telemedicine system</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Telemedicine software for data transmission and analysis in CAPD.</intervention_name>
    <description>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.</description>
    <arm_group_label>CAPD group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age over 18 years;&#xD;
&#xD;
          -  Signed Informed consent form;&#xD;
&#xD;
          -  Patients treated with CAPD;&#xD;
&#xD;
          -  The subject communicates well with the investigator and is able to help understand and&#xD;
             adhere to the requirements of the study plan.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The consent was withdrawn by the volunteers at any time after the information and the&#xD;
             signed informed consent form;&#xD;
&#xD;
          -  Poor general condition;&#xD;
&#xD;
          -  Any disease which, in the opinion of the investigator, endangers the health of the&#xD;
             volunteer and / or contraindicates the conduct of the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Zoltán Ondrik, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Szeged, First Department of Medicine</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Zoltán Ondrik, MD</last_name>
    <phone>+36202533732</phone>
    <email>zoltan.ondrik@gmail.com</email>
  </overall_contact>
  <reference>
    <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>
    <PMID>14763048</PMID>
  </reference>
  <reference>
    <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>
    <PMID>24385331</PMID>
  </reference>
  <reference>
    <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>
    <PMID>28224937</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>22429705</PMID>
  </reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>May 19, 2020</study_first_submitted>
  <study_first_submitted_qc>June 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>June 8, 2020</last_update_submitted>
  <last_update_submitted_qc>June 8, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 11, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>telemedicine</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04427514
org study id: TMED_CAPD_001
nct id: NCT04427514
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: The average number of visits that can be omitted
time frame: 13 months
description: 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.
arm group label: CAPD group
arm group type: Experimental
description: Standard CAPD therapy wtih telemedicine system
intervention type: Device
intervention name: Telemedicine software for data transmission and analysis in CAPD.
description: 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.
arm group label: CAPD group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Zoltán Ondrik, MD
role: Principal Investigator
affiliation: University of Szeged, First Department of Medicine
last name: Zoltán Ondrik, MD
phone: +36202533732
email: zoltan.ondrik@gmail.com
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.
PMID: 14763048
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.
PMID: 24385331
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.
PMID: 28224937
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.
PMID: 22429705
responsible party type: Sponsor
sharing ipd: No