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

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ClinicalTrials.gov Identifier: NCT03927300
Recruitment Status : Completed
First Posted : April 25, 2019
Last Update Posted : March 10, 2020
Sponsor:
Collaborator:
Centre Hospitalier de Vichy
Information provided by (Responsible Party):
Tmm Software

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).

Condition or disease Intervention/treatment
Chronic Renal Failure Dialysis Related Complication Device: Telemonitoring Software

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Study Type : Observational [Patient Registry]
Actual Enrollment : 72 participants
Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration: 1 Day
Official Title: Telemonitoring Impact by the ApTelecare Software in Dialysis Patient
Actual Study Start Date : July 17, 2019
Actual Primary Completion Date : July 17, 2019
Actual Study Completion Date : December 11, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

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.




Primary Outcome Measures :
  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 Outcome Measures :
  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.




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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".
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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03927300


Locations
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France
Matthieu Merlot
Montpellier, France, 34184
Sponsors and Collaborators
Tmm Software
Centre Hospitalier de Vichy
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Responsible Party: Tmm Software
ClinicalTrials.gov Identifier: NCT03927300    
Other Study ID Numbers: KM-00153
First Posted: April 25, 2019    Key Record Dates
Last Update Posted: March 10, 2020
Last Verified: March 2020

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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
Keywords provided by Tmm Software:
Home Peritoneal Dialysis
Additional relevant MeSH terms:
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Kidney Failure, Chronic
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic