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

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®)

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03779828
Acronym
HELIPAD 1
Enrollment
11
Registered
2018-12-19
Start date
2017-11-27
Completion date
2019-06-03
Last updated
2021-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Inflammatory Demyelinating Polyneuropathy

Keywords

CIDP, Telemonitoring, Telemedicine

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.

Interventions

DEVICEHOME LINK

Telemonitoring system which include web platform and connected devices.

Sponsors

CSL Behring
Lead SponsorINDUSTRY

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Evaluate HOME LINK telemonitoring system for patients receiving home-based IVIg therapy52 weeksThe 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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026