RecruitingNCT04304898

An International Patient-led Registry in Fibrotic Interstitial Lung Diseases Using eHealth Technology

An International Patient-led Registry in Fibrotic Interstitial Lung Diseases Using eHealth Technology: I-FILE

Sponsor

Erasmus Medical Center

Enrollment

700 participants

Start Date

May 1, 2020

Study Type

OBSERVATIONAL

Conditions

Pulmonary Fibrosis

Summary

The I-FILE study is a prospective multicenter, multinational observational study where the feasibility of a patient-led registry using home monitoring in patients with pulmonary fibrosis will be evaluated. The aim of the study is to gain more insights in disease behavior in patients with pulmonary fibrosis, so in future patients with progressive disease can be better identified.

Eligibility

Min Age: 18 Years

Inclusion Criteria3

Newly diagnosed patients with F-ILD according to the ATS/ERS criteria by a multidisciplinary ILD team :
MDT diagnosis ≤ 6 months before inclusion
Treatment for F-ILD ≤ than 1 month

Exclusion Criteria3

Not able to speak, read or write in the native language of the country where the patient is included
Not able to comply to the study protocol, according to the judgement of the investigator and/or patient
No access to internet

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Interventions

OTHERHome spirometry

* Patients will perform daily home spirometry for three months with a Bluetooth-enabled validated, CE-marked home spirometer (Spiro bank Smart, MIR, Italy). Subsequently, patients will perform weekly home spirometry for two years in total. During this period, patients will be asked to perform three measurements each week on the same day. * Hospital-based spirometry will be performed according to international guidelines. * Patients will complete patient-reported outcomes (PROMs) online in the secured application every six months.