Status:
UNKNOWN
Utility of Telemedicine in the Follow-Up of Patients in Peritoneal Dialysis
Lead Sponsor:
Coordinación de Investigación en Salud, Mexico
Conditions:
Chronic Kidney Disease Stage 5
Peritoneal Dialysis Complication
Eligibility:
All Genders
18-80 years
Phase:
NA
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, hospitalizati...
Detailed Description
Study Background \& Rationale: (background information including previous studies as applicable ) Chronic kidney disease (CKD) is a growing problem world-wide which increases in parallel with some ri...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 20 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2020
Estimated Enrollment :
750 Patients enrolled
Trial Details
Trial ID
NCT04034966
Start Date
June 20 2019
End Date
June 1 2020
Last Update
July 29 2019
Active Locations (1)
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1
Unidad de Investigacion Medica en Enfermedades Nefrologicas, Hospital de Especialidades Centro Medico Nacional Siglo XXI
Mexico City, Mexico, 06720