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

Erasmus University

Status: Enrolling

Conditions: Pulmonary Fibrosis

Treatments: Other: Home spirometry

Study type: Observational

Funder types: Other

Identifiers

NCT04304898

MEC-2020-0029

Details and patient eligibility

About

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.

Full description

Nowadays, identifying disease progression will have direct treatment implications in patients with fibrotic Interstitial lung diseases (F-ILDs). eHealth could be a possible solution for close monitoring and detecting disease progression, at a low burden for patients and healthcare providers. The main aim of the I-FILE study will be to evaluate feasibility of a patient-led registry using home spirometry to monitor disease progression in patients with F-ILD. The secondary aim will be to better validate existing health-related quality of life questionnaires to assess the impact of disease and treatment in these patients.

In total 500 patients with newly diagnosed F-ILD will be included. Patients will perform daily home spirometry in the first three months followed by once weekly measurements with a follow up period of 2 years. In addition, patient-reported outcomes (PROMs) will be completed online every 6 months. Results are encrypted and directly sent to a secured server through the online I-FILE application.

Enrollment: 700 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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 criteria

• 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

Trial design

700 participants in 1 patient group

Single Group Assignment

Description:

Intervention group without a control group

Treatment:

Other: Home spirometry