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Completed

NCT Number: NCT03927300

Telemonitoring Impact by the ApTelecare Software in Dialysis Patient

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).

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Key information

Conditions

Chronic Renal Failure Chronic Disease Dialysis Related Complication Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Matthieu Merlot

Montpellier, 34184, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

Telemonitoring Software

Device

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

Primary outcomes

  1. Cumulative duration (on retrospective two years of follow-up) of the unscheduled hospitalizations between the two patient groups.

    Time frame: up to two years.

  2. Cumulative duration (on retrospective two years of follow-up) of the scheduled hospitalizations between the two patient groups.

    Time frame: up to two years.

Secondary outcomes

  1. 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

  2. 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

  3. Mortality rate

    Time frame: For both groups. At the end of this retrospective study (Study Period of 5 months).

  4. Rate of peritoneal infections

    Time frame: For both groups. At the end of this retrospective study.(Study Period of 5 months).

  5. 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

  6. 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.

Sponsors and collaborators

Lead sponsor

Tmm Software

Industry

Collaborators

  • Centre Hospitalier de Vichy

Registry information

Acronym: MEDIA

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Apr 25, 2019
Registry last updated
Mar 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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