Evaluating the Effectiveness of Telemonitoring System in the Management of Patients With CIDP
- Conditions
- Chronic Inflammatory Demyelinating Polyneuropathy
- Registration Number
- NCT03779828
- Lead Sponsor
- CSL Behring
- 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庐 infusions administered at home.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 11
- Patient with a diagnosis of CIDP as per EFNS/PNS criteria.
- Patient already receiving home-based treatment with Privigen庐
- Not applicable
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (10)
H么pital Pellegrin, Bordeaux University Hospital (CHU)
馃嚝馃嚪Bordeaux, France
H么pital Henri Mondor - APHP
馃嚝馃嚪Cr茅teil, France
H么pital Roger Salengro - CHRU
馃嚝馃嚪Lille, France
H么pital Pierre Wertheimer - HCL
馃嚝馃嚪Lyon, France
H么pital La Piti茅-Salp锚tri猫re - APHP
馃嚝馃嚪Paris, France
H么pital La Timone - APHM
馃嚝馃嚪Marseille, France
H么pital Pasteur 2 - Nice University Hospital (CHU)
馃嚝馃嚪Nice, France
H么pital Lariboisi猫re - APHP
馃嚝馃嚪Paris, France
H么pital Gui de Chauliac - Montpellier University Hospital (CHU)
馃嚝馃嚪Montpellier, France
H么pital Nord - Saint Etienne University Hospital (CHU)
馃嚝馃嚪Saint Etienne, France