Telemonitoring Impact by the ApTelecare Software in Dialysis Patient

NCT03927300 | Completed DMC

• 1 other identifier: KM-00153
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 1

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).

Conditions

Chronic Renal Failure; Dialysis Related Complication

Keywords

Home Peritoneal Dialysis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• 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 both groups. At the end of this retrospective study. (Study Period of 5 months).

Study Arms (2)

Patients without Telemonitoring with ApTelecare Software

Patients with implementation of Telemonitoring with ApTelecare

Device: Telemonitoring Software

Interventions

Telemonitoring Software DEVICE

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

Patients with implementation of Telemonitoring with ApTelecare

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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".

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Tmm Software: lead
• Centre Hospitalier de Vichy: collaborator

Study Sites (1)

Matthieu Merlot

Montpellier, 34184, France

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 1 Day
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2019
• First Posted: April 25, 2019
• Study Start: July 17, 2019
• Primary Completion: July 17, 2019
• Study Completion: December 11, 2019
• Last Updated: March 10, 2020

Record last verified: 2020-03

Locations

FR (1)