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

March 9, 2020 updated by: Tmm Software
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

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

72

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Montpellier, France, 34184
        • Matthieu Merlot

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total length of hospitalisation
Time Frame: 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
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
Time Frame: For both groups. Every two months (follow-up visit) on a retrospective period of two years. The study duration will be of 5 months
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
Time Frame: For both groups. At the end of this retrospective study (Study Period of 5 months).
For both groups. At the end of this retrospective study (Study Period of 5 months).
Rate of peritoneal infections
Time Frame: For both groups. At the end of this retrospective study.(Study Period of 5 months).
For both groups. At the end of this retrospective study.(Study Period of 5 months).
Number of patient exit technique except death
Time Frame: For both groups. At the end of this retrospective study. (Study Period of 5 months).
For example transplant, hemodialysis
For both groups. At the end of this retrospective study. (Study Period of 5 months).
Charlson score : Comorbidity index
Time Frame: 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.
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tmm Software

Collaborators

Centre Hospitalier de Vichy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe