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Telemonitoring Impact by the ApTelecare Software in Dialysis Patient

Telemonitoring Impact by the ApTelecare Software in Dialysis Patient

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03927300
Acronym
MEDIA
Enrollment
72
Registered
2019-04-25
Start date
2019-07-17
Completion date
2019-12-11
Last updated
2020-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Renal Failure, Dialysis Related Complication

Keywords

Home Peritoneal Dialysis

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).

Interventions

DEVICETelemonitoring Software

Recovery of retrospective data in dialysis patients follow or not follow by a telemonitoring application.

Sponsors

Centre Hospitalier de Vichy
CollaboratorOTHER
Tmm Software
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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;

Design outcomes

Primary

MeasureTime 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

MeasureTime frameDescription
Number of events of cardiovascular complicationsFor both groups. Every two months (follow-up visit) on a retrospective period of two years. The study duration will be of 5 months
Mortality rateFor both groups. At the end of this retrospective study (Study Period of 5 months).
Number of patient exit technique except deathFor both groups. At the end of this retrospective study. (Study Period of 5 months).For example transplant, hemodialysis
Charlson score : Comorbidity indexbaselineThis 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.
Rate of peritoneal infectionsFor both groups. At the end of this retrospective study.(Study Period of 5 months).
Total length of hospitalisationFor 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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026