Study Stopped
Due to logistical concerns
Evaluating the Effectiveness of Telemonitoring System in the Management of Patients With CIDP
HELIPAD 1
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®)
2 other identifiers
observational
11
1 country
10
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Nov 2017
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 27, 2017
CompletedFirst Submitted
Initial submission to the registry
December 14, 2018
CompletedFirst Posted
Study publicly available on registry
December 19, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 3, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 3, 2019
CompletedJanuary 15, 2021
January 1, 2021
1.5 years
December 14, 2018
January 13, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Interventions
Telemonitoring system which include web platform and connected devices.
Eligibility Criteria
Patients receiving home-based IVIg therapy with Privigen
You may qualify if:
- Patient with a diagnosis of CIDP as per EFNS/PNS criteria.
- Patient already receiving home-based treatment with Privigen®
You may not qualify if:
- Not applicable
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- CSL Behringlead
Study Sites (10)
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, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 14, 2018
First Posted
December 19, 2018
Study Start
November 27, 2017
Primary Completion
June 3, 2019
Study Completion
June 3, 2019
Last Updated
January 15, 2021
Record last verified: 2021-01
Data Sharing
- IPD Sharing
- Will not share