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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04304898
Recruitment Status : Recruiting
First Posted : March 12, 2020
Last Update Posted : August 25, 2021
Sponsor:
Information provided by (Responsible Party):
Marlies Wijsenbeek, Erasmus Medical Center

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.

Condition or disease Intervention/treatment
Pulmonary Fibrosis 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 700 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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 700 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: An International Patient-led Registry in Fibrotic Interstitial Lung Diseases Using eHealth Technology: I-FILE
Actual Study Start Date : May 1, 2020
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : October 2023

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04304898


Contacts
Layout table for location contacts
Contact: Marlies Wijsenbeek, MD PhD +31107030323 m.wijsenbeek-lourens@erasmusmc.nl

Locations
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Netherlands
Erasmus MC Recruiting
Rotterdam, Zuid-Holland, Netherlands, 3015 CE
Contact: Marlies Wijsenbeek, MD PhD    +31107030323    m.wijsenbeek-lourens@erasmusmc.nl   
Erasmus MC Recruiting
Rotterdam, Netherlands
Contact: M.S. Wijsenbeek, dr         
Sponsors and Collaborators
Erasmus Medical Center
Investigators
Layout table for investigator information
Principal Investigator: Marlies Wijsenbeek, MD PhD Erasmus MC
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.
Layout table for additonal information
Responsible Party: Marlies Wijsenbeek, Principal investigator, Erasmus Medical Center
ClinicalTrials.gov Identifier: NCT04304898    
Other Study ID Numbers: MEC-2020-0029
First Posted: March 12, 2020    Key Record Dates
Last Update Posted: August 25, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Marlies Wijsenbeek, Erasmus Medical Center:
eHealth
home spirometry
Additional relevant MeSH terms:
Layout table for MeSH terms
Lung Diseases
Pulmonary Fibrosis
Lung Diseases, Interstitial
Respiratory Tract Diseases