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Utility of Telemedicine in the Follow-Up of Patients in Peritoneal Dialysis

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ClinicalTrials.gov Identifier: NCT04034966
Recruitment Status : Unknown
Verified June 2019 by Coordinación de Investigación en Salud, Mexico.
Recruitment status was:  Active, not recruiting
First Posted : July 29, 2019
Last Update Posted : July 29, 2019
Sponsor:
Information provided by (Responsible Party):
Coordinación de Investigación en Salud, Mexico

Brief Summary:
Peritoneal dialysis (PD) technology is available but has not been tested in the real world. Therefore, the aim of this study is to test the utility of telemedicine in reducing mortality, hospitalizations, unscheduled visits, and cost derived from preventable complications. Incident patients to PD treatment will be followed from various hospitals in Mexico City and Guadalajara. Direct medical costs will be evaluated, along with unplanned hospital visits and complications over 2 years using the Claria telemedicine apparatus from Baxter Laboratories.

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Stage 5 Peritoneal Dialysis Complication Device: Claria telemedicine device Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 750 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

The Project will consist in the conventional clinical treatment of the APD patient cared for in IMSS regarding the kind of dialysis solution, handling of laboratory and office procedures, as well as the handling of complications. One arm will utilize the Claria device, and the other will utilize normal treatment procedures.

The APD device in the control group will be called Claria® (Baxter, S.A. de C.V.) without the telemedicine device, and in the intervention group it will be the same device with the telemedicine module. Handling will be done according to the basic operating instructions established by the manufacturer.

According to the preliminary analysis of the flow of patients in PD indicated in the above paragraphs, recruitment of the sample size will not represent a problem. Infrastructure available in both technical and experienced human resources makes the study feasible.

Masking: None (Open Label)
Masking Description: 750 Patients will be cluster randomized.
Primary Purpose: Supportive Care
Official Title: Utility of Telemedicine in the Follow-Up of Patients in Peritoneal Dialysis
Actual Study Start Date : June 20, 2019
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

Arm Intervention/treatment
Active Comparator: Claria
The APD device in the control group will be called Claria® (Baxter, S.A. de C.V.) with the telemedicine module. The telemedicine module is the platform for storing patient information directly from the PD machine. Handling will be done according to the basic operating instructions established by the manufacturer.
Device: Claria telemedicine device
Use of Claria telemedicine module, which stores patient information in the cloud.

No Intervention: Control
The APD device in the control group will be called Claria® (Baxter, S.A. de C.V.) without the telemedicine device. the device is used for automated peritoneal dialysis. Handling will be done according to the basic operating instructions established by the manufacturer.



Primary Outcome Measures :
  1. MORTALITY RATE [ Time Frame: 2 years ]
    Number of patients who lose their lives for every 100 years / patient at risk. Deaths/100 years/patient at risk.

  2. DAYS OF HOSPITALIZATION [ Time Frame: 2 years ]
    Number of days in the hospital per 100 years / patient at risk. Days/100 years/patient at risk.

  3. DAYS OF PREVENTABLE HOSPITALIZATION [ Time Frame: 2 years ]
    Number of days in the hospital for causes that can be corrected with efficient PD for every 100 years / patient at risk. Days/100 years/patient at risk.


Secondary Outcome Measures :
  1. COSTS [ Time Frame: 2 years ]
    These are the costs of using necessary services with the provision of dialysis and associated complications and comorbidities.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: Hospitals will be randomly assigned to control (without telemedicine device) or intervention groups (with telemedicine device). Hospitals will be selected and matched according their basic infrastructure (Outpatient dialysis clinic, Emergency Room, Laboratory and Radiology Departments, Hospitalization Facility, accessibility to the internet and direct telephone communication with the patient and/or contact or person in charge of the patient), as well as Human Resources (Nephrologist, Internist, specialists to attend to the most frequent complications of PD, Nurses trained in PD, and Social Workers), and availability of a structured PD Program (Manuals, Supervised training programs for patients and caregivers, Registers for peritonitis, technique failure, and mortality rates).

Inclusion criteria

  • Over 18 years of age
  • Diagnosed with chronic kidney disease
  • Incident to automated peritoneal dialysis
  • Agree to sign informed consent

Exclusion Criteria:

  • seropositive for HIV, hepatitis B or C, with cancer
  • in treatment with immunosuppressors or with acute complications in the 30 days previous to recruitment.
  • patients who voluntarily withdraw from the study, who change residence or who lose social security coverage.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04034966


Locations
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Mexico
Unidad de Investigacion Medica en Enfermedades Nefrologicas, Hospital de Especialidades Centro Medico Nacional Siglo XXI
Mexico City, Mexico, 06720
Sponsors and Collaborators
Coordinación de Investigación en Salud, Mexico
Investigators
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Study Chair: Fabio Salamanca, PhD Instituto Mexicano del Seguro Social
Publications:
USRDS Annual Report 2015. Chapter 11: Medicare Expenditures for Persons with ESRD
Informe al Ejecutivo Federal y al Congreso de la Unión 2015-2016V.6.1. Análisis del gasto en enfermedades crónico-degenerativas de alto impacto financiero para el IMSS. El Consejo Técnico del Instituto Mexicano del Seguro Social. Ciudad de México, junio de 2016
USRDS Annual Report 2015. Chapter 13: International Comparisons.

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Responsible Party: Coordinación de Investigación en Salud, Mexico
ClinicalTrials.gov Identifier: NCT04034966    
Other Study ID Numbers: R-2018-785-035
First Posted: July 29, 2019    Key Record Dates
Last Update Posted: July 29, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Coordinación de Investigación en Salud, Mexico:
peritoneal dialysis
Claria
telemedicine
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency