Clinical trial NCT04304898: An International Patient-led Registry in Fibrotic Interstitial Lung Diseases Using eHealth Technology
Official title: An International Patient-led Registry in Fibrotic Interstitial Lung Diseases Using eHealth Technology: I-FILE
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pulmonary Fibrosis
Keywords: eHealth
home spirometry
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
First posted: 2020-03-12
Enrollment: 700
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 500 untreated patients with a diagnosis of F-ILD in ILD expert centers in 5 European countries

Brief 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.

Eligibility 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

Primary outcomes:
measure: Forced Vital Capacity (FVC) home spirometry
timeFrame: 6 months after inclusion
measure: Forced Vital Capacity (FVC) home spirometry
timeFrame: 12 months after inclusion
measure: Forced Vital Capacity (FVC) home spirometry
timeFrame: 24 months after inclusion
measure: Forced Vital Capacity (FVC) hospital spirometry
timeFrame: 6 months after inclusion
measure: Forced Vital Capacity (FVC) hospital spirometry
timeFrame: 12 months after inclusion
measure: Forced Vital Capacity (FVC) hospital spirometry
timeFrame: 24 months after inclusion
measure: Adherence to daily home spirometry
timeFrame: 3 months after inclusion
measure: Adherence to weekly home spirometry
timeFrame: 2 years after inclusion
measure: L-PF Impacts
timeFrame: Baseline
measure: K-BILD
timeFrame: Baseline
measure: EQ5D
timeFrame: Baseline
measure: VAS
timeFrame: Baseline
measure: LCQ
timeFrame: Baseline
measure: FAS
timeFrame: Baseline
measure: WPAI
timeFrame: Baseline
measure: GRoC
timeFrame: Baseline
measure: L-PF Impacts
timeFrame: After 12 months
measure: K-BILD
timeFrame: After 12 months
measure: EQ5D
timeFrame: After 12 months
measure: VAS
timeFrame: After 12 months
measure: LCQ
timeFrame: After 12 months
measure: FAS
timeFrame: After 12 months
measure: WPAI
timeFrame: After 12 months
measure: GRoC
timeFrame: After 12 months
measure: L-PF Impacts
timeFrame: After 24 months
measure: K-BILD
timeFrame: After 24 months
measure: EQ5D
timeFrame: After 24 months
measure: VAS
timeFrame: After 24 months
measure: LCQ
timeFrame: After 24 months
measure: FAS
timeFrame: After 24 months
measure: WPAI
timeFrame: After 24 months
measure: GRoC
timeFrame: After 24 months
measure: Time to change of L-PF Impacts
timeFrame: 2 years
measure: Time to change of K-BILD
timeFrame: 2 years
measure: Time to change of EQ5D
timeFrame: 2 years
measure: Time to change of VAS
timeFrame: 2 years
measure: Time to change of LCQ
timeFrame: 2 years
measure: Time to change of FAS
timeFrame: 2 years
measure: Time to change of WPAI
timeFrame: 2 years
measure: Time to change of GRoC
timeFrame: 2 years
measure: Predictors
timeFrame: 2 years
measure: FVC change hospital-based and home spirometry
timeFrame: 2 years
measure: FVC change and HRQOL and symptom changes
timeFrame: 12 months
measure: FVC change and HRQOL and symptom changes
timeFrame: 24 months
measure: Differences in adherence between countries
timeFrame: 2 years
measure: Healthcare provider and patient satisfaction
timeFrame: 2 years
measure: Mortality
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Erasmus MC
state: Zuid-Holland
city: Rotterdam
country: Netherlands
facility: Erasmus MC
Study officials:
affiliation: Erasmus Medical Center
name: Marlies Wijsenbeek, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitair Ziekenhuis Leuven
name: Wim Wuyts, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Oslo University Hospital
name: Anna-Maria Hoffmann-Vold, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Interdisciplinary Center for Sarcoidosis, Thoraxklinik, University Hospital Heidelberg
name: Michael Kreuter, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Royal Brompton Hospital, Guys and St Thomas' Hospital NHS Foundation Trust.
name: Philip Molyneaux, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Service de pneumologie, hôpital Louis Pradel, Hospices Civils de Lyon
name: Vincent Cottin, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Laboratory of Molecular and Cellular Pneumonology, Respiratory Medicine Department, School of Medicine, University of Crete, Heraklion, Greece
name: Katarina Antoniou
role: PRINCIPAL_INVESTIGATOR
References: