Telemonitoring Impact by the ApTelecare Software in Dialysis Patient

Chronic Renal Failure Clinical Trial

— MEDIA  

Official title:

Telemonitoring Impact by the ApTelecare Software in Dialysis Patient

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03927300
• Other study ID #: KM-00153
• Status: Completed
• Start date: July 17, 2019
• Est. completion date: December 11, 2019

Study information

• Verified date: March 2020
• Source: Tmm Software
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The investigators proposed to conduct a retrospective study to evaluate the impact of the implementation of apTeleCare software on the management of dialysis patients at home in terms of the number and duration of hospitalizations. For this purpose, the investigators will compare patients' data over a 2-year interval before the introduction of Telemonitoring (January 2012 and December 2013 inclusive - Group 1) with patients data who have benefited from this application (between August 2016 and July 2018).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: December 11, 2019
• Est. primary completion date: July 17, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients (= 18 years) with no age limit;

• Patients receiving peritoneal dialysis on the investigation center between 2012 and 2014 (Group1) and between 2016 and 2018 (Group 2);

• Patient information in this retrospective study;

Exclusion Criteria:

• Patients who have started a peritoneal dialysis program before the periods of investigation;

• Patients who have been equipped with apTeleCare during the dialysis program;

• Subject under guardianship, curators or safeguard of justice;

• Patient not affiliated to a French social protection;

Related Conditions & MeSH terms

• Chronic Renal Failure
• Dialysis Related Complication
• Kidney Failure, Chronic

Intervention

Device:
• Telemonitoring Software
Recovery of retrospective data in dialysis patients follow or not follow by a telemonitoring application.

Locations

Country	Name	City	State
France	Matthieu Merlot	Montpellier

Sponsors (2)

Lead Sponsor	Collaborator
Tmm Software	Centre Hospitalier de Vichy

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative duration (on retrospective two years of follow-up) of the unscheduled hospitalizations between the two patient groups.		up to two years.
Primary	Cumulative duration (on retrospective two years of follow-up) of the scheduled hospitalizations between the two patient groups.		up to two years.
Secondary	Total length of hospitalisation		For both groups. Every two months (follow-up visit) on a retrospective period of two years, the outcome 2 will be measured. The study duration will be of 5 months
Secondary	Number of events of cardiovascular complications		For both groups. Every two months (follow-up visit) on a retrospective period of two years. The study duration will be of 5 months
Secondary	Mortality rate		For both groups. At the end of this retrospective study (Study Period of 5 months).
Secondary	Rate of peritoneal infections		For both groups. At the end of this retrospective study.(Study Period of 5 months).
Secondary	Number of patient exit technique except death	For example transplant, hemodialysis	For both groups. At the end of this retrospective study. (Study Period of 5 months).
Secondary	Charlson score : Comorbidity index	This scale measure the comorbidity symptoms of patients at the beginning of the care by the physician. The minimum score will be "0" and the maximum will be 39.; Its validation is based on a prediction of health French insurance, as well as on several clinical areas such as oncology or nephrology.	baseline