Clinical trial NCT03927300: Telemonitoring Impact by the ApTelecare Software in Dialysis Patient
Official title: Telemonitoring Impact by the ApTelecare Software in Dialysis Patient
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Renal Failure
Dialysis Related Complication
Keywords: Home Peritoneal Dialysis
Lead sponsor: Tmm Software
Sponsor class: INDUSTRY
Collaborators: name: Centre Hospitalier de Vichy
First posted: 2019-04-25
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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".

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).


Eligibility criteria: 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;

Primary outcomes:
measure: Cumulative duration (on retrospective two years of follow-up) of the unscheduled hospitalizations between the two patient groups.
timeFrame: up to two years.
measure: Cumulative duration (on retrospective two years of follow-up) of the scheduled hospitalizations between the two patient groups.
timeFrame: up to two years.
Secondary outcomes:
measure: Total length of hospitalisation
timeFrame: 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
measure: Number of events of cardiovascular complications
timeFrame: For both groups. Every two months (follow-up visit) on a retrospective period of two years. The study duration will be of 5 months
measure: Mortality rate
timeFrame: For both groups. At the end of this retrospective study (Study Period of 5 months).
measure: Rate of peritoneal infections
timeFrame: For both groups. At the end of this retrospective study.(Study Period of 5 months).
measure: Number of patient exit technique except death
timeFrame: For both groups. At the end of this retrospective study. (Study Period of 5 months).
measure: Charlson score : Comorbidity index
timeFrame: baseline
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Matthieu Merlot
Study officials:
References: