Telemonitoring Impact by the ApTelecare Software in Dialysis Patient (MEDIA)

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).

Study Overview

• Status: Completed
• Conditions: Chronic Renal Failure; Dialysis Related Complication
• Intervention / Treatment: Device: Telemonitoring Software

• Study Type: Observational
• Enrollment (Actual): 72

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34184
    • Matthieu Merlot

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with a chronic renal failure who are take care in the dialysis unit. These patients are their peritoneal dialysis at home and use or not the telemonitoring software "ApTelecare".

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients without Telemonitoring with ApTelecare Software
Patients with implementation of Telemonitoring with ApTelecare	Device: Telemonitoring Software; Recovery of retrospective data in dialysis patients follow or not follow by a telemonitoring application.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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
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
Mortality rate		For both groups. At the end of this retrospective study (Study Period of 5 months).
Rate of peritoneal infections		For both groups. At the end of this retrospective study.(Study Period of 5 months).
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).
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

Collaborators and Investigators

• Sponsor: Tmm Software
• Collaborators: Centre Hospitalier de Vichy

Study record dates

Study Major Dates

• Study Start (Actual): July 17, 2019
• Primary Completion (Actual): July 17, 2019
• Study Completion (Actual): December 11, 2019

Study Registration Dates

• First Submitted: April 12, 2019
• First Submitted That Met QC Criteria: April 24, 2019
• First Posted (Actual): April 25, 2019

Study Record Updates

• Last Update Posted (Actual): March 10, 2020
• Last Update Submitted That Met QC Criteria: March 9, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Home Peritoneal Dialysis
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Failure, Chronic
• Other Study ID Numbers: KM-00153

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No