An International Patient-led Registry in Fibrotic Interstitial Lung Diseases Using eHealth Technology
NCT ID: NCT04304898
Last Updated: 2024-03-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
700 participants
OBSERVATIONAL
2020-05-01
2026-07-31
Brief Summary
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Detailed Description
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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
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Single Group Assignment
Intervention group without a control group
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* MDT diagnosis ≤ 6 months before inclusion
* Treatment for F-ILD ≤ than 1 month
Exclusion Criteria
* Not able to comply to the study protocol, according to the judgement of the investigator and/or patient
* No access to internet
18 Years
ALL
No
Sponsors
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Erasmus Medical Center
OTHER
Responsible Party
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Marlies Wijsenbeek
Principal investigator
Principal Investigators
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Marlies Wijsenbeek, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Erasmus Medical Center
Wim Wuyts, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Universitair Ziekenhuis Leuven
Anna-Maria Hoffmann-Vold, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Oslo University Hospital
Michael Kreuter, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Interdisciplinary Center for Sarcoidosis, Thoraxklinik, University Hospital Heidelberg
Philip Molyneaux, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Royal Brompton Hospital, Guys and St Thomas' Hospital NHS Foundation Trust.
Vincent Cottin, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Service de pneumologie, hôpital Louis Pradel, Hospices Civils de Lyon
Katarina Antoniou
Role: PRINCIPAL_INVESTIGATOR
Laboratory of Molecular and Cellular Pneumonology, Respiratory Medicine Department, School of Medicine, University of Crete, Heraklion, Greece
Locations
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Erasmus MC
Rotterdam, South Holland, Netherlands
Erasmus MC
Rotterdam, , Netherlands
Countries
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Central Contacts
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Facility Contacts
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M.S. Wijsenbeek, dr
Role: primary
References
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Nakshbandi G, Moor CC, Antoniou K, Cottin V, Hoffmann-Vold AM, Koemans EA, Kreuter M, Molyneaux PL, Wuyts WA, Wijsenbeek MS. Study protocol of an international patient-led registry in patients with pulmonary fibrosis using online home monitoring: I-FILE. BMC Pulm Med. 2023 Feb 2;23(1):51. doi: 10.1186/s12890-023-02336-4.
Other Identifiers
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MEC-2020-0029
Identifier Type: -
Identifier Source: org_study_id
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