Patient-led registry for monitoring pulmonary fibrosis using eHealth technology
An International Patient-led Registry in Fibrotic Interstitial Lung Diseases Using eHealth Technology: I-FILE
This study is testing a new way for people with pulmonary fibrosis to track their symptoms and disease progression at home using technology to see if it helps improve their care.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 700 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Erasmus Medical Center Academic / other |
| Locations | 2 sites (Rotterdam, South Holland and 1 other locations) |
| Trial ID | NCT04304898 on ClinicalTrials.gov |
What this trial studies
The I-FILE study is a prospective multicenter, multinational observational study aimed at evaluating the feasibility of a patient-led registry that utilizes home monitoring to track disease progression in patients with pulmonary fibrosis. Participants will perform daily home spirometry for the first three months, followed by weekly measurements over a two-year follow-up period. Additionally, patient-reported outcomes will be collected online every six months to assess the impact of the disease and treatment. This innovative approach seeks to enhance the understanding of disease behavior and improve the identification of patients with progressive disease.
Who should consider this trial
Good fit: Ideal candidates are newly diagnosed patients with fibrotic interstitial lung diseases who have received a diagnosis within the last six months.
Not a fit: Patients who are unable to comply with the study protocol or lack internet access may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better monitoring and management of pulmonary fibrosis, ultimately improving patient outcomes.
How similar studies have performed: Other studies have shown promise in using eHealth technologies for monitoring chronic diseases, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Rotterdam, South Holland and 1 other locations
- Erasmus MC — Rotterdam, South Holland, Netherlands (Recruiting)
- Erasmus MC — Rotterdam, Netherlands (Recruiting)
Study contacts
- Principal investigator: Marlies Wijsenbeek, MD PhD — Erasmus Medical Center
- Study coordinator: Marlies Wijsenbeek, MD PhD
- Email: m.wijsenbeek-lourens@erasmusmc.nl
- Phone: +31107030323
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.