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
|Condition or disease||Intervention/treatment||Phase|
|Chronic Kidney Disease Stage 5 Peritoneal Dialysis Complication||Device: Claria telemedicine device||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||750 participants|
|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|
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.
- 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.
- 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.
- 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.
- COSTS [ Time Frame: 2 years ]These are the costs of using necessary services with the provision of dialysis and associated complications and comorbidities.
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
|Unidad de Investigacion Medica en Enfermedades Nefrologicas, Hospital de Especialidades Centro Medico Nacional Siglo XXI|
|Mexico City, Mexico, 06720|
|Study Chair:||Fabio Salamanca, PhD||Instituto Mexicano del Seguro Social|