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NCT Number: NCT04304898

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

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.

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Key information

Conditions

Pulmonary Fibrosis Fibrosis Lung Diseases Lung Diseases, Interstitial Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Erasmus MC, Rotterdam, South Holland, Netherlands

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Home spirometry

Other
  • 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.

Primary outcomes

  1. Forced Vital Capacity (FVC) home spirometry

    Time frame: 6 months after inclusion

    FVC change measured with home spirometry and saturation at 6 months (in % and L)

  2. Forced Vital Capacity (FVC) home spirometry

    Time frame: 12 months after inclusion

    FVC change measured with home spirometry and saturation at 12 months (in % and L)

  3. Forced Vital Capacity (FVC) home spirometry

    Time frame: 24 months after inclusion

    FVC change measured with home spirometry and saturation at 24 months (in % and L)

  4. Forced Vital Capacity (FVC) hospital spirometry

    Time frame: 6 months after inclusion

    FVC change measured with hospital spirometry and saturation at 6 months (in % and L)

  5. Forced Vital Capacity (FVC) hospital spirometry

    Time frame: 12 months after inclusion

    FVC change measured with hospital spirometry and saturation at 12 months (in % and L)

  6. Forced Vital Capacity (FVC) hospital spirometry

    Time frame: 24 months after inclusion

    FVC change measured with hospital spirometry and saturation at 24 months (in % and L)

  7. Adherence to daily home spirometry

    Time frame: 3 months after inclusion

    The percentage of patients completed daily home spirometry

  8. Adherence to weekly home spirometry

    Time frame: 2 years after inclusion

    The percentage of patients completed weekly home spirometry

  9. L-PF Impacts

    Time frame: Baseline

    • 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.

  10. K-BILD

    Time frame: Baseline

    • 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.

  11. EQ5D

    Time frame: Baseline

    • 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.

  12. VAS

    Time frame: Baseline

    • Visual Analogue Scale: scores on fatigue, dyspnea, cough and general wellbeing on a scale ranging from 0-10. Higher score indicates more complaint.

  13. LCQ

    Time frame: Baseline

    • 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.

  14. FAS

    Time frame: Baseline

    • 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.

  15. WPAI

    Time frame: Baseline

    • 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.

  16. GRoC

    Time frame: Baseline

    • 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.

  17. L-PF Impacts

    Time frame: After 12 months

    • 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.

  18. K-BILD

    Time frame: After 12 months

    • 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.

  19. EQ5D

    Time frame: After 12 months

    • 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.

  20. VAS

    Time frame: After 12 months

    • Visual Analogue Scale: scores on fatigue, dyspnea, cough and general wellbeing on a scale ranging from 0-10. Higher score indicates more complaint.

  21. LCQ

    Time frame: After 12 months

    • 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.

  22. FAS

    Time frame: After 12 months

    • 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.

  23. WPAI

    Time frame: After 12 months

    • 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.

  24. GRoC

    Time frame: After 12 months

    • 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.

  25. L-PF Impacts

    Time frame: After 24 months

    • 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.

  26. K-BILD

    Time frame: After 24 months

    • 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.

  27. EQ5D

    Time frame: After 24 months

    • 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.

  28. VAS

    Time frame: After 24 months

    • Visual Analogue Scale: scores on fatigue, dyspnea, cough and general wellbeing on a scale ranging from 0-10. Higher score indicates more complaint.

  29. LCQ

    Time frame: After 24 months

    • 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.

  30. FAS

    Time frame: After 24 months

    • 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.

  31. WPAI

    Time frame: After 24 months

    • 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.

  32. GRoC

    Time frame: After 24 months

    • 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.

  33. Time to change of L-PF Impacts

    Time frame: 2 years

    • 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.

  34. Time to change of K-BILD

    Time frame: 2 years

    • 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.

  35. Time to change of EQ5D

    Time frame: 2 years

    • 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.

  36. Time to change of VAS

    Time frame: 2 years

    • Visual Analogue Scale: scores on fatigue, dyspnea, cough and general wellbeing on a scale ranging from 0-10. Higher score indicates more complaint.

  37. Time to change of LCQ

    Time frame: 2 years

    • 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.

  38. Time to change of FAS

    Time frame: 2 years

    • 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.

  39. Time to change of WPAI

    Time frame: 2 years

    • 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.

  40. Time to change of GRoC

    Time frame: 2 years

    • 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.

  41. Predictors

    Time frame: 2 years

    Predictors of disease progression and mortality

  42. FVC change hospital-based and home spirometry

    Time frame: 2 years

    Correlations between FVC change between home and hospital-based spirometry

  43. FVC change and HRQOL and symptom changes

    Time frame: 12 months

    Correlations between FVC change and HRQOL and symptom changes

  44. FVC change and HRQOL and symptom changes

    Time frame: 24 months

    Correlations between FVC change and HRQOL and symptom changes

  45. Differences in adherence between countries

    Time frame: 2 years

    Differences in adherence, FVC change, HRQOL and mortality between countries

  46. Healthcare provider and patient satisfaction

    Time frame: 2 years

    Healthcare provider and patient satisfaction and experience with the online application. Patients and healthcare providers are asked about their experiences and opinions on homemonitoring.

  47. Mortality

    Time frame: 2 years

    Mortality

Study contacts

Contact information is provided by the study sponsor or research team.

Marlies Wijsenbeek, MD PhD

CONTACT

[email protected]

+31107030323

Sponsors and collaborators

Lead sponsor

Erasmus Medical Center

Other

Registry information

Official study title

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

Acronym: I-FILE

Important dates

Study start
2020
Primary completion
2025
Study completion
2026
First posted
Mar 12, 2020
Registry last updated
Mar 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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