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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Pulmonary Fibrosis
• Intervention / Treatment: Other: Home spirometry

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.

• Study Type: Observational
• Enrollment (Estimated): 700

Contacts and Locations

• Study Contact: Name: Marlies Wijsenbeek, MD PhD; Phone Number: +31107030323; Email: m.wijsenbeek-lourens@erasmusmc.nl

Study Locations

• Netherlands
  • Rotterdam, Netherlands
    • Recruiting
    • Erasmus MC
    • Contact: M.S. Wijsenbeek, dr
  • Zuid-Holland
    • Rotterdam, Zuid-Holland, Netherlands, 3015 CE
      • Recruiting
      • Erasmus MC
      • Contact: Marlies Wijsenbeek, MD PhD; Phone Number: +31107030323; Email: m.wijsenbeek-lourens@erasmusmc.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

500 untreated patients with a diagnosis of F-ILD in ILD expert centers in 5 European countries

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Single Group Assignment; Intervention group without a control group

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Forced Vital Capacity (FVC) home spirometry	FVC change measured with home spirometry and saturation at 6 months (in % and L)	6 months after inclusion
Forced Vital Capacity (FVC) home spirometry	FVC change measured with home spirometry and saturation at 12 months (in % and L)	12 months after inclusion
Forced Vital Capacity (FVC) home spirometry	FVC change measured with home spirometry and saturation at 24 months (in % and L)	24 months after inclusion
Forced Vital Capacity (FVC) hospital spirometry	FVC change measured with hospital spirometry and saturation at 6 months (in % and L)	6 months after inclusion
Forced Vital Capacity (FVC) hospital spirometry	FVC change measured with hospital spirometry and saturation at 12 months (in % and L)	12 months after inclusion
Forced Vital Capacity (FVC) hospital spirometry	FVC change measured with hospital spirometry and saturation at 24 months (in % and L)	24 months after inclusion
Adherence to daily home spirometry	The percentage of patients completed daily home spirometry	3 months after inclusion
Adherence to weekly home spirometry	The percentage of patients completed weekly home spirometry	2 years after inclusion
L-PF Impacts	• Living with Pulmonary Fibrosis: 21-item questionnaire which assess the way pulmonary fibrosis has impact on quality of life. Total scores range from 0-4, with a higher score indicating more impact of lung fibrosis on the quality of life.	Baseline
K-BILD	• King's brief Interstitial Lung Disease Health Status: The K-BILD health status questionnaire is a 15 item validated, self-completed heath status questionnaire. It has three domains: breathlessness and activities, psychological and chest symptoms. The K-BILD domain and total score ranges are 0-100, with the higher scores corresponding with better HRQOL. It will take about 3 minutes to complete this questionnaire.	Baseline
EQ5D	• The EuroQol five dimensions 5-level questionnaire: 6-item questionnaire on five dimensions: The EuroQol five dimensions 5-level questionnaire is a standardized instrument to measures health outcomes in two components: health description and valuation. It comprises five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Higher score indicates a poorer health status.	Baseline
VAS	• Visual Analogue Scale: scores on fatigue, dyspnea, cough and general wellbeing on a scale ranging from 0-10. Higher score indicates more complaint.	Baseline
LCQ	• Leicester Cough Questionnaire: Cough-specific, health related quality of life is assessed with the Leicester Cough Questionnaire (LCQ), a 19-item questionnaire that has been validated in acute and chronic cough. The overall score ranges from 3 to 21 with a higher score indicating a better quality of life. It will take about 4 minutes to complete the questionnaire.	Baseline
FAS	• Fatigue Assessment Scale: 10-item questionnaire about fatigue FAS. The fatigue assessment scale (FAS) is a 10-item self-administered questionnaire about fatigue in patients with sarcoidosis. The score ranges from 5-50 points, with a score of ≥ 22 points as cut-off for fatigue. The minimal important difference (MID) is 4 points or a 10% lower score. It will take about 1-2 minutes to complete.	Baseline
WPAI	• Work Productivity and Activity Impairment Questionnaire: General Health (WPAI) All patients in the working age population will complete this questionnaire which assess loss of work productivity due to disease in six questions .It will take about 2-3 minutes to complete. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity.	Baseline
GRoC	• Global Rating of Change Scales: Global rating of change (GRC) scales provide a method of obtaining information about improving or deteriorated of health condition of patients over time. Patients are asked to make global ratings on changes in regards to their well-being on a 15-point self-report scale (from -7 to 7 ). It will take about 1 minute to complete. Higher score indicates a better health condition.	Baseline
L-PF Impacts	• Living with Pulmonary Fibrosis: 21-item questionnaire which assess the way pulmonary fibrosis has impact on quality of life. Total scores range from 0-4, with a higher score indicating more impact of lung fibrosis on the quality of life.	After 12 months
K-BILD	• King's brief Interstitial Lung Disease Health Status: The K-BILD health status questionnaire is a 15 item validated, self-completed heath status questionnaire. It has three domains: breathlessness and activities, psychological and chest symptoms. The K-BILD domain and total score ranges are 0-100, with the higher scores corresponding with better HRQOL. It will take about 3 minutes to complete this questionnaire.	After 12 months
EQ5D	• The EuroQol five dimensions 5-level questionnaire: 6-item questionnaire on five dimensions: The EuroQol five dimensions 5-level questionnaire is a standardized instrument to measures health outcomes in two components: health description and valuation. It comprises five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Higher score indicates a poorer health status.	After 12 months
VAS	• Visual Analogue Scale: scores on fatigue, dyspnea, cough and general wellbeing on a scale ranging from 0-10. Higher score indicates more complaint.	After 12 months
LCQ	• Leicester Cough Questionnaire: Cough-specific, health related quality of life is assessed with the Leicester Cough Questionnaire (LCQ), a 19-item questionnaire that has been validated in acute and chronic cough. The overall score ranges from 3 to 21 with a higher score indicating a better quality of life. It will take about 4 minutes to complete the questionnaire.	After 12 months
FAS	• Fatigue Assessment Scale: 10-item questionnaire about fatigue FAS. The fatigue assessment scale (FAS) is a 10-item self-administered questionnaire about fatigue in patients with sarcoidosis. The score ranges from 5-50 points, with a score of ≥ 22 points as cut-off for fatigue. The minimal important difference (MID) is 4 points or a 10% lower score. It will take about 1-2 minutes to complete.	After 12 months
WPAI	• Work Productivity and Activity Impairment Questionnaire: General Health (WPAI) All patients in the working age population will complete this questionnaire which assess loss of work productivity due to disease in six questions .It will take about 2-3 minutes to complete. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity.	After 12 months
GRoC	• Global Rating of Change Scales: Global rating of change (GRC) scales provide a method of obtaining information about improving or deteriorated of health condition of patients over time. Patients are asked to make global ratings on changes in regards to their well-being on a 15-point self-report scale (from -7 to 7 ). It will take about 1 minute to complete. Higher score indicates a better health condition.	After 12 months
L-PF Impacts	• Living with Pulmonary Fibrosis: 21-item questionnaire which assess the way pulmonary fibrosis has impact on quality of life. Total scores range from 0-4, with a higher score indicating more impact of lung fibrosis on the quality of life.	After 24 months
K-BILD	• King's brief Interstitial Lung Disease Health Status: The K-BILD health status questionnaire is a 15 item validated, self-completed heath status questionnaire. It has three domains: breathlessness and activities, psychological and chest symptoms. The K-BILD domain and total score ranges are 0-100, with the higher scores corresponding with better HRQOL. It will take about 3 minutes to complete this questionnaire.	After 24 months
EQ5D	• The EuroQol five dimensions 5-level questionnaire: 6-item questionnaire on five dimensions: The EuroQol five dimensions 5-level questionnaire is a standardized instrument to measures health outcomes in two components: health description and valuation. It comprises five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Higher score indicates a poorer health status.	After 24 months
VAS	• Visual Analogue Scale: scores on fatigue, dyspnea, cough and general wellbeing on a scale ranging from 0-10. Higher score indicates more complaint.	After 24 months
LCQ	• Leicester Cough Questionnaire: Cough-specific, health related quality of life is assessed with the Leicester Cough Questionnaire (LCQ), a 19-item questionnaire that has been validated in acute and chronic cough. The overall score ranges from 3 to 21 with a higher score indicating a better quality of life. It will take about 4 minutes to complete the questionnaire.	After 24 months
FAS	• Fatigue Assessment Scale: 10-item questionnaire about fatigue FAS. The fatigue assessment scale (FAS) is a 10-item self-administered questionnaire about fatigue in patients with sarcoidosis. The score ranges from 5-50 points, with a score of ≥ 22 points as cut-off for fatigue. The minimal important difference (MID) is 4 points or a 10% lower score. It will take about 1-2 minutes to complete.	After 24 months
WPAI	• Work Productivity and Activity Impairment Questionnaire: General Health (WPAI) All patients in the working age population will complete this questionnaire which assess loss of work productivity due to disease in six questions .It will take about 2-3 minutes to complete. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity.	After 24 months
GRoC	• Global Rating of Change Scales: Global rating of change (GRC) scales provide a method of obtaining information about improving or deteriorated of health condition of patients over time. Patients are asked to make global ratings on changes in regards to their well-being on a 15-point self-report scale (from -7 to 7 ). It will take about 1 minute to complete. Higher score indicates a better health condition.	After 24 months
Time to change of L-PF Impacts	• Living with Pulmonary Fibrosis: 21-item questionnaire which assess the way pulmonary fibrosis has impact on quality of life. Total scores range from 0-4, with a higher score indicating more impact of lung fibrosis on the quality of life.	2 years
Time to change of K-BILD	• King's brief Interstitial Lung Disease Health Status: The K-BILD health status questionnaire is a 15 item validated, self-completed heath status questionnaire. It has three domains: breathlessness and activities, psychological and chest symptoms. The K-BILD domain and total score ranges are 0-100, with the higher scores corresponding with better HRQOL. It will take about 3 minutes to complete this questionnaire.	2 years
Time to change of EQ5D	• The EuroQol five dimensions 5-level questionnaire: 6-item questionnaire on five dimensions: The EuroQol five dimensions 5-level questionnaire is a standardized instrument to measures health outcomes in two components: health description and valuation. It comprises five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Higher score indicates a poorer health status.	2 years
Time to change of VAS	• Visual Analogue Scale: scores on fatigue, dyspnea, cough and general wellbeing on a scale ranging from 0-10. Higher score indicates more complaint.	2 years
Time to change of LCQ	• Leicester Cough Questionnaire: Cough-specific, health related quality of life is assessed with the Leicester Cough Questionnaire (LCQ), a 19-item questionnaire that has been validated in acute and chronic cough. The overall score ranges from 3 to 21 with a higher score indicating a better quality of life. It will take about 4 minutes to complete the questionnaire.	2 years
Time to change of FAS	• Fatigue Assessment Scale: 10-item questionnaire about fatigue FAS. The fatigue assessment scale (FAS) is a 10-item self-administered questionnaire about fatigue in patients with sarcoidosis. The score ranges from 5-50 points, with a score of ≥ 22 points as cut-off for fatigue. The minimal important difference (MID) is 4 points or a 10% lower score. It will take about 1-2 minutes to complete.	2 years
Time to change of WPAI	• Work Productivity and Activity Impairment Questionnaire: General Health (WPAI) All patients in the working age population will complete this questionnaire which assess loss of work productivity due to disease in six questions .It will take about 2-3 minutes to complete. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity.	2 years
Time to change of GRoC	• Global Rating of Change Scales: Global rating of change (GRC) scales provide a method of obtaining information about improving or deteriorated of health condition of patients over time. Patients are asked to make global ratings on changes in regards to their well-being on a 15-point self-report scale (from -7 to 7 ). It will take about 1 minute to complete. Higher score indicates a better health condition.	2 years
Predictors	Predictors of disease progression and mortality	2 years
FVC change hospital-based and home spirometry	Correlations between FVC change between home and hospital-based spirometry	2 years
FVC change and HRQOL and symptom changes	Correlations between FVC change and HRQOL and symptom changes	12 months
FVC change and HRQOL and symptom changes	Correlations between FVC change and HRQOL and symptom changes	24 months
Differences in adherence between countries	Differences in adherence, FVC change, HRQOL and mortality between countries	2 years
Healthcare provider and patient satisfaction	Healthcare provider and patient satisfaction and experience with the online application. Patients and healthcare providers are asked about their experiences and opinions on homemonitoring.	2 years
Mortality	Mortality	2 years

Collaborators and Investigators

• Sponsor: Erasmus Medical Center
• Investigators: Principal Investigator: Marlies Wijsenbeek, MD PhD, Erasmus Medical Center; Principal Investigator: Wim Wuyts, MD PhD, Universitair Ziekenhuis Leuven; Principal Investigator: Anna-Maria Hoffmann-Vold, MD PhD, Oslo University Hospital; Principal Investigator: Michael Kreuter, MD PhD, Interdisciplinary Center for Sarcoidosis, Thoraxklinik, University Hospital Heidelberg; Principal Investigator: Philip Molyneaux, MD PhD, Royal Brompton Hospital, Guys and St Thomas' Hospital NHS Foundation Trust.; Principal Investigator: Vincent Cottin, MD PhD, Service de pneumologie, hôpital Louis Pradel, Hospices Civils de Lyon; Principal Investigator: Katarina Antoniou, Laboratory of Molecular and Cellular Pneumonology, Respiratory Medicine Department, School of Medicine, University of Crete, Heraklion, Greece

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2020
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: March 9, 2020
• First Submitted That Met QC Criteria: March 9, 2020
• First Posted (Actual): March 12, 2020

Study Record Updates

• Last Update Posted (Actual): March 20, 2024
• Last Update Submitted That Met QC Criteria: March 19, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: eHealth; home spirometry
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Fibrosis; Lung Diseases; Pulmonary Fibrosis; Lung Diseases, Interstitial
• Other Study ID Numbers: MEC-2020-0029

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No