NCT04304898

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 700 (estimated)
• Sponsor: Erasmus Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Pulmonary Fibrosis

Interventions

Type	Name	Description
OTHER	Home 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.

Timeline

• Start date: 2020-05-01
• Primary completion: 2025-07-01
• Completion: 2026-07-01
• First posted: 2020-03-12
• Last updated: 2024-03-20

Locations

2 sites across 1 country: Netherlands