Evaluating the Effectiveness of Telemonitoring System in the Management of Patients With CIDP

Chronic Inflammatory Demyelinating Polyneuropathy Clinical Trial

— HELIPAD 1  

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®)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03779828
• Other study ID #: IgPro10_5004
• Secondary ID: 2016-A00147-44
• Status: Terminated
• Start date: November 27, 2017
• Est. completion date: June 3, 2019

Study information

• Verified date: January 2021
• Source: CSL Behring
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: June 3, 2019
• Est. primary completion date: June 3, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patient with a diagnosis of CIDP as per EFNS/PNS criteria.

• Patient already receiving home-based treatment with Privigen®

Exclusion Criteria:

• Not applicable

Related Conditions & MeSH terms

• Chronic Inflammatory Demyelinating Polyneuropathy
• Polyneuropathies
• Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

Intervention

Device:
• HOME LINK
Telemonitoring system which include web platform and connected devices.

Locations

Country	Name	City	State
France	Hôpital Pellegrin, Bordeaux University Hospital (CHU)	Bordeaux
France	Hôpital Henri Mondor - APHP	Créteil
France	Hôpital Roger Salengro - CHRU	Lille
France	Hôpital Pierre Wertheimer - HCL	Lyon
France	Hôpital La Timone - APHM	Marseille
France	Hôpital Gui de Chauliac - Montpellier University Hospital (CHU)	Montpellier
France	Hôpital Pasteur 2 - Nice University Hospital (CHU)	Nice
France	Hôpital La Pitié-Salpêtrière - APHP	Paris
France	Hôpital Lariboisière - APHP	Paris
France	Hôpital Nord - Saint Etienne University Hospital (CHU)	Saint Etienne

Sponsors (1)

Lead Sponsor	Collaborator
CSL Behring

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate HOME LINK telemonitoring system for patients receiving home-based IVIg therapy	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.	52 weeks