Telemonitoring Impact by the ApTelecare Software in Dialysis Patient

Completed

• Conditions: Dialysis Related Complication; Chronic Renal Failure
• Interventions: Device: Telemonitoring Software

• Registration Number: NCT03927300
• Lead Sponsor: Tmm Software

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-04-12
• Study First Submitted QC: 2019-04-24
• Study First Posted: 2019-04-25
• Study Start: 2019-07-17
• Primary Completion: 2019-07-17
• Study Completion: 2019-12-11
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-09
• Last Update Posted: 2020-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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;

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with implementation of Telemonitoring with ApTelecare	Telemonitoring Software	-

Primary Outcome Measures

Name	Time	Method
Cumulative duration (on retrospective two years of follow-up) of the unscheduled hospitalizations between the two patient groups.	up to two years.
Cumulative duration (on retrospective two years of follow-up) of the scheduled hospitalizations between the two patient groups.	up to two years.

Secondary Outcome Measures

Name	Time	Method
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
Mortality rate	For both groups. At the end of this retrospective study (Study Period of 5 months).
Number of patient exit technique except death	For both groups. At the end of this retrospective study. (Study Period of 5 months).	For example transplant, hemodialysis
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
Rate of peritoneal infections	For both groups. At the end of this retrospective study.(Study Period of 5 months).
Charlson score : Comorbidity index	baseline	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.

Trial Locations

Locations (1)

Matthieu Merlot; 🇫🇷 Montpellier, France