HELIPAD 1: Evaluating the Effectiveness of Telemonitoring System in the Management of Patients With CIDP
Study Details
Study Description
Brief Summary
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 | Phase |
|---|---|---|
|
Study Design
Outcome Measures
Primary Outcome Measures
- Evaluate HOME LINK telemonitoring system for patients receiving home-based IVIg therapy [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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Patient with a diagnosis of CIDP as per EFNS/PNS criteria.
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Patient already receiving home-based treatment with Privigen®
Exclusion Criteria:
- Not applicable
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hôpital Pellegrin, Bordeaux University Hospital (CHU) | Bordeaux | France | ||
| 2 | Hôpital Henri Mondor - APHP | Créteil | France | ||
| 3 | Hôpital Roger Salengro - CHRU | Lille | France | ||
| 4 | Hôpital Pierre Wertheimer - HCL | Lyon | France | ||
| 5 | Hôpital La Timone - APHM | Marseille | France | ||
| 6 | Hôpital Gui de Chauliac - Montpellier University Hospital (CHU) | Montpellier | France | ||
| 7 | Hôpital Pasteur 2 - Nice University Hospital (CHU) | Nice | France | ||
| 8 | Hôpital La Pitié-Salpêtrière - APHP | Paris | France | ||
| 9 | Hôpital Lariboisière - APHP | Paris | France | ||
| 10 | Hôpital Nord - Saint Etienne University Hospital (CHU) | Saint Etienne | France |
Sponsors and Collaborators
- CSL Behring
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IgPro10_5004
- 2016-A00147-44