Evaluating the Effectiveness of Telemonitoring System in the Management of Patients With CIDP (HELIPAD 1)
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|ClinicalTrials.gov Identifier: NCT03779828|
Recruitment Status : Completed
First Posted : December 19, 2018
Last Update Posted : January 28, 2020
Chronic inflammatory demyelinating polyneuropathy (CIDP) is a chronic demyelinating polyneuropathy of autoimmune origin with a progressive or relapsing course.
Diagnosis is based on clinical presentation and electrophysiological findings in accordance with the EFNS/PNS consensus guidelines. IVIg is the first line treatment witch has been shown to be effective in several placebo-controlled trials.
Once IVIg therapy produces a response and is well tolerated, some patients are able to continue their treatment in the home setting. The HOME LINK system offers an integrated, global solution based on telemonitoring technology providing continuous, remote monitoring of Privigen® infusions administered at home.
|Condition or disease||Intervention/treatment|
|Chronic Inflammatory Demyelinating Polyneuropathy||Device: HOME LINK|
|Study Type :||Observational|
|Actual Enrollment :||11 participants|
|Official Title:||A Multicenter Pilot Study to Determine Criteria for Evaluating the Effectiveness of Two Comparative Monitoring Methods in the Management of Patients With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Receiving Home-based Treatment With IVIg (Privigen®)|
|Actual Study Start Date :||November 27, 2017|
|Actual Primary Completion Date :||June 3, 2019|
|Actual Study Completion Date :||June 3, 2019|
- Device: HOME LINK
Telemonitoring system which include web platform and connected devices.
- Evaluate HOME LINK telemonitoring system for patients receiving home-based IVIg therapy [ Time Frame: 52 weeks ]The conventional method of home monitoring requires using a visiting nurse. HOME LINK is a telemonitoring system that is an alternative to this conventional method offering remote at-home monitoring. HOME LINK monitors the patient's health parameters from home. In this way it enables an adjustment of the infusion conditions or intervention of a qualified healthcare professional in the event of an incident. Home Link will be evaluated for failure rate of connection to the telemonitoring platform, failure rate of transmission of self-measurements to the telemonitoring platform, failure rate of transmission of documents relating to home-based treatment, and failure rate of contacting one of the healthcare professionals involved in patient care during the at-home infusions.
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): NCT03779828
|Hôpital Pellegrin, Bordeaux University Hospital (CHU)|
|Hôpital Henri Mondor - APHP|
|Hôpital Roger Salengro - CHRU|
|Hôpital Pierre Wertheimer - HCL|
|Hôpital La Timone - APHM|
|Hôpital Gui de Chauliac - Montpellier University Hospital (CHU)|
|Hôpital Pasteur 2 - Nice University Hospital (CHU)|
|Hôpital La Pitié-Salpêtrière - APHP|
|Hôpital Lariboisière - APHP|
|Hôpital Nord - Saint Etienne University Hospital (CHU)|
|Saint Etienne, France|