Study protocol of an international patient-led registry in patients with pulmonary fibrosis using online home monitoring: I-FILE

Gizal Nakshbandi; Catharina C. Moor; Katerina Antoniou; Vincent Cottin; Anna Maria Hoffmann-Vold; Edwin A. Koemans; Michael Kreuter; Philip L. Molyneaux; Wim A. Wuyts; Marlies S. Wijsenbeek

doi:10.1186/s12890-023-02336-4

Study protocol of an international patient-led registry in patients with pulmonary fibrosis using online home monitoring: I-FILE

Gizal Nakshbandi
, Catharina C. Moor
, Katerina Antoniou
, Vincent Cottin
, Anna Maria Hoffmann-Vold
, Edwin A. Koemans
, Michael Kreuter
, Philip L. Molyneaux
, Wim A. Wuyts
, Marlies S. Wijsenbeek^*

^*Corresponding author for this work

Pulmonary Medicine

Research output: Contribution to journal › Article › Academic › peer-review

7 Citations (Scopus)

56 Downloads (Pure)

Abstract

Background: Pulmonary fibrosis (PF) is caused by a heterogeneous group of diseases, with a high inter-individual variability in disease trajectory. Identifying disease progression in patients with PF has impact on clinical management decisions. However, strategies to early identify and predict disease progression for these patients are currently lacking. In this study, we aim to assess long-term FVC change in patients with PF measured with home spirometry, and evaluate the feasibility of a multinational patient-led registry in PF. In addition, we will assess validity of patient-reported outcomes (PROMs) for the different subgroups of patients with PF. Methods: In this international, prospective, multicenter, observational study, we aim to include 700 patients across seven European countries. Patients will monitor their disease course for a period of two years using an online home monitoring program (I-FILE), which includes home spirometry, pulse oximetry, and PROMs. Results will be directly sent to the hospital via the online application. Patients will be asked to perform daily home spirometry and pulse oximetry in the first three months, followed by once weekly measurements for a period of two years. PROMs will be completed in the online I-FILE application every six months, including the King’s brief Interstitial Lung Disease Health Status, The EuroQol five dimensions five-level, Visual Analogue Scales on cough, dyspnea, fatigue and general complaints, Leicester Cough Questionnaire, Fatigue Assessment Scale, Work Productivity and Activity Impairment Questionnaire, Global Rating of Change Scale, and Living with Pulmonary Fibrosis questionnaire. Discussion: This study will provide much needed insights in disease trajectories of the different subgroups of patients with PF. Simultaneously, the I-FILE study will yield valuable information on the use and feasibility of home-based data collection. This international patient-led registry will facilitate trans-border collaboration to further optimize care and research for patients with PF. Trial registration: The study was registered on the 12th of March 2020 in the International Clinical Trial Registry, www.clinicaltrials.gov; Identifier: NCT04304898.

Original language	English
Article number	51
Journal	BMC Pulmonary Medicine
Volume	23
Issue number	1
DOIs	https://doi.org/10.1186/s12890-023-02336-4
Publication status	Published - 2 Feb 2023

Bibliographical note

Funding Information:
GN: Financial grant from Boehringer Ingelheim paid to institution. CM: Financial grant from Boehringer Ingelheim, Astra—Zeneca, Daiichi-Sankyo paid to institution. Payments for presentations/lectures from Boehringer-Ingelheim and Hoffman—la Roche paid to institution. KA: Consulting fees from Boehringer Ingelheim, Hoffman—la Roche and GSK. Payments for presentations/lectures from Boehringer Ingelheim, Hoffman—la Roche, Chiesi, Menarini, GSK, AstraZeneca. VC: Financial grant from Boehringer Ingelheim paid to institution. Consulting fees from Astra Zeneca, Boehringer Ingelheim, Celgene/BMS, CSL Behring, GSK, Pliant, Pure Tech, RedX, Hoffman—la Roche, Sanofi, Shionogi, United Therapeutics/Ferrer. Payments for presentations/lectures from Boehringer Ingelheim and Hoffman—La Roche. Support for attending meetings from Boehringer Ingelheim and Hoffman—La Roche. Participation on data and safety monitoring board of Galapagos and Galecto. Leadership role in Fibrogen adjudication committee. AV: Grants from ARXX therapeutics, Boehringer Ingelheim, Hoffman—la Roche, Bayer, Merck Sharp&Dohme, Lilly and Medscape. Consulting fees from ARXX therapeutics, Boehringer Ingelheim, Roche, Merck Sharp&Dohme, Lilly, Medscape, Genentech. Payments for presentations/lectures from ARXX therapeutics, Boehringer Ingelheim, Roche, Bayer, Merck Sharp&Dohme, Lilly and Medscape. Support for attending meetings from Boehringer Ingelheim and Janssen. Leadership role in EULAR convenor for ERS/EULAR CTD-ILD guideline, EULAR quality of care committee, PH Nordic group. MK: Financial grant from Boehringer Ingelheim and Hoffman—la Roche. Consulting fees from Boehringer Ingelheim and Hoffman—la Roche. Payments for presentations/lectures from Boehringer Ingelheim and Hoffman—la Roche. Leadership role in ERS and DGP. PM: Financial grant from Astra Zeneca and Action for Pulmonary Fibrosis payed to institution. Advisory board fees from Hoffman—la Roche, Boehringer Ingelheim, Qureight, Trevi, AstraZeneca. Speakers fees from Astra Zeneca, Boehringer Ingelheim, Hoffman—La Roche. WW: Financial grant from Hoffman—la Roche, Boehringer Ingelheim, Galapagos paid to institution. Consulting fees from Hoffman—la Roche, Boehringer Ingelheim, Galpagos paid to institution. Payments for presentations/lectures from Boehringer Ingelheim paid to institution. Participation on Advisory board by Boehringer Ingelheim, Galapagos, Hoffman—La–Roche paid to institution. MW: Financial grant from Boehringer Ingelheim, Hoffman—La Roche, The Netherlands Organization for Health Research and Development; The Dutch Lung Foundation; The Dutch Pulmonary Fibrosis, all paid to institution. Consulting fees from Bristol Myers Squibb, Boehringer Ingelheim, Galapagos, Galecto, Hoffman la Roche, Horizon therapeutics, Kinevant Sciences, Molecure, Nerre Therapeutics, Novartis, PureTech Health, and Respivant, all paid to institution. Support for attending meeting from Boehringer Ingelheim, Hoffman la Roche, Galapagos. Participation on advisory board from Savara, Galapagos, all paid to institution. Leadership role as Chair of the Idiopathic Interstitial Pneumonia group of the European Respiratory Society, Member of the board of the Netherlands Respiratory Society, Member of the scientific advisory board of the European Idiopathic Pulmonary Fibrosis and related disorders federation, Chair of the educational committee of the European Reference Network for rare Lung Diseases, Advisory board of the Dutch Lung fibrosis and Sarcoidosis patient associations.

Funding Information:
The I-FILE study is sponsored by the Erasmus Medical Center and funded by Boehringer Ingelheim. Boehringer Ingelheim has no influence on the study design, procedures and has no access to the study data.

Publisher Copyright:
© 2023, The Author(s).

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Study protocol of an international patient-led registry in patients with pulmonary fibrosis using online home monitoringFinal published version, 991 KBLicence: CC BY

Cite this

Nakshbandi, G., Moor, C. C., Antoniou, K., Cottin, V., Hoffmann-Vold, A. M., Koemans, E. A., Kreuter, M., Molyneaux, P. L., Wuyts, W. A., & Wijsenbeek, M. S. (2023). Study protocol of an international patient-led registry in patients with pulmonary fibrosis using online home monitoring: I-FILE. BMC Pulmonary Medicine, 23(1), Article 51. https://doi.org/10.1186/s12890-023-02336-4

@article{42ab09b2e0b844baaf002d56143b1072,

title = "Study protocol of an international patient-led registry in patients with pulmonary fibrosis using online home monitoring: I-FILE",

abstract = "Background: Pulmonary fibrosis (PF) is caused by a heterogeneous group of diseases, with a high inter-individual variability in disease trajectory. Identifying disease progression in patients with PF has impact on clinical management decisions. However, strategies to early identify and predict disease progression for these patients are currently lacking. In this study, we aim to assess long-term FVC change in patients with PF measured with home spirometry, and evaluate the feasibility of a multinational patient-led registry in PF. In addition, we will assess validity of patient-reported outcomes (PROMs) for the different subgroups of patients with PF. Methods: In this international, prospective, multicenter, observational study, we aim to include 700 patients across seven European countries. Patients will monitor their disease course for a period of two years using an online home monitoring program (I-FILE), which includes home spirometry, pulse oximetry, and PROMs. Results will be directly sent to the hospital via the online application. Patients will be asked to perform daily home spirometry and pulse oximetry in the first three months, followed by once weekly measurements for a period of two years. PROMs will be completed in the online I-FILE application every six months, including the King{\textquoteright}s brief Interstitial Lung Disease Health Status, The EuroQol five dimensions five-level, Visual Analogue Scales on cough, dyspnea, fatigue and general complaints, Leicester Cough Questionnaire, Fatigue Assessment Scale, Work Productivity and Activity Impairment Questionnaire, Global Rating of Change Scale, and Living with Pulmonary Fibrosis questionnaire. Discussion: This study will provide much needed insights in disease trajectories of the different subgroups of patients with PF. Simultaneously, the I-FILE study will yield valuable information on the use and feasibility of home-based data collection. This international patient-led registry will facilitate trans-border collaboration to further optimize care and research for patients with PF. Trial registration: The study was registered on the 12th of March 2020 in the International Clinical Trial Registry, www.clinicaltrials.gov; Identifier: NCT04304898.",

author = "Gizal Nakshbandi and Moor, \{Catharina C.\} and Katerina Antoniou and Vincent Cottin and Hoffmann-Vold, \{Anna Maria\} and Koemans, \{Edwin A.\} and Michael Kreuter and Molyneaux, \{Philip L.\} and Wuyts, \{Wim A.\} and Wijsenbeek, \{Marlies S.\}",

note = "Funding Information: GN: Financial grant from Boehringer Ingelheim paid to institution. CM: Financial grant from Boehringer Ingelheim, Astra—Zeneca, Daiichi-Sankyo paid to institution. Payments for presentations/lectures from Boehringer-Ingelheim and Hoffman—la Roche paid to institution. KA: Consulting fees from Boehringer Ingelheim, Hoffman—la Roche and GSK. Payments for presentations/lectures from Boehringer Ingelheim, Hoffman—la Roche, Chiesi, Menarini, GSK, AstraZeneca. VC: Financial grant from Boehringer Ingelheim paid to institution. Consulting fees from Astra Zeneca, Boehringer Ingelheim, Celgene/BMS, CSL Behring, GSK, Pliant, Pure Tech, RedX, Hoffman—la Roche, Sanofi, Shionogi, United Therapeutics/Ferrer. Payments for presentations/lectures from Boehringer Ingelheim and Hoffman—La Roche. Support for attending meetings from Boehringer Ingelheim and Hoffman—La Roche. Participation on data and safety monitoring board of Galapagos and Galecto. Leadership role in Fibrogen adjudication committee. AV: Grants from ARXX therapeutics, Boehringer Ingelheim, Hoffman—la Roche, Bayer, Merck Sharp\&Dohme, Lilly and Medscape. Consulting fees from ARXX therapeutics, Boehringer Ingelheim, Roche, Merck Sharp\&Dohme, Lilly, Medscape, Genentech. Payments for presentations/lectures from ARXX therapeutics, Boehringer Ingelheim, Roche, Bayer, Merck Sharp\&Dohme, Lilly and Medscape. Support for attending meetings from Boehringer Ingelheim and Janssen. Leadership role in EULAR convenor for ERS/EULAR CTD-ILD guideline, EULAR quality of care committee, PH Nordic group. MK: Financial grant from Boehringer Ingelheim and Hoffman—la Roche. Consulting fees from Boehringer Ingelheim and Hoffman—la Roche. Payments for presentations/lectures from Boehringer Ingelheim and Hoffman—la Roche. Leadership role in ERS and DGP. PM: Financial grant from Astra Zeneca and Action for Pulmonary Fibrosis payed to institution. Advisory board fees from Hoffman—la Roche, Boehringer Ingelheim, Qureight, Trevi, AstraZeneca. Speakers fees from Astra Zeneca, Boehringer Ingelheim, Hoffman—La Roche. WW: Financial grant from Hoffman—la Roche, Boehringer Ingelheim, Galapagos paid to institution. Consulting fees from Hoffman—la Roche, Boehringer Ingelheim, Galpagos paid to institution. Payments for presentations/lectures from Boehringer Ingelheim paid to institution. Participation on Advisory board by Boehringer Ingelheim, Galapagos, Hoffman—La–Roche paid to institution. MW: Financial grant from Boehringer Ingelheim, Hoffman—La Roche, The Netherlands Organization for Health Research and Development; The Dutch Lung Foundation; The Dutch Pulmonary Fibrosis, all paid to institution. Consulting fees from Bristol Myers Squibb, Boehringer Ingelheim, Galapagos, Galecto, Hoffman la Roche, Horizon therapeutics, Kinevant Sciences, Molecure, Nerre Therapeutics, Novartis, PureTech Health, and Respivant, all paid to institution. Support for attending meeting from Boehringer Ingelheim, Hoffman la Roche, Galapagos. Participation on advisory board from Savara, Galapagos, all paid to institution. Leadership role as Chair of the Idiopathic Interstitial Pneumonia group of the European Respiratory Society, Member of the board of the Netherlands Respiratory Society, Member of the scientific advisory board of the European Idiopathic Pulmonary Fibrosis and related disorders federation, Chair of the educational committee of the European Reference Network for rare Lung Diseases, Advisory board of the Dutch Lung fibrosis and Sarcoidosis patient associations. Funding Information: The I-FILE study is sponsored by the Erasmus Medical Center and funded by Boehringer Ingelheim. Boehringer Ingelheim has no influence on the study design, procedures and has no access to the study data. Publisher Copyright: {\textcopyright} 2023, The Author(s).",

year = "2023",

month = feb,

day = "2",

doi = "10.1186/s12890-023-02336-4",

language = "English",

volume = "23",

journal = "BMC Pulmonary Medicine",

issn = "1471-2466",

publisher = "BioMed Central Ltd.",

number = "1",

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TY - JOUR

T1 - Study protocol of an international patient-led registry in patients with pulmonary fibrosis using online home monitoring

T2 - I-FILE

AU - Nakshbandi, Gizal

AU - Moor, Catharina C.

AU - Antoniou, Katerina

AU - Cottin, Vincent

AU - Hoffmann-Vold, Anna Maria

AU - Koemans, Edwin A.

AU - Kreuter, Michael

AU - Molyneaux, Philip L.

AU - Wuyts, Wim A.

AU - Wijsenbeek, Marlies S.

N1 - Funding Information: GN: Financial grant from Boehringer Ingelheim paid to institution. CM: Financial grant from Boehringer Ingelheim, Astra—Zeneca, Daiichi-Sankyo paid to institution. Payments for presentations/lectures from Boehringer-Ingelheim and Hoffman—la Roche paid to institution. KA: Consulting fees from Boehringer Ingelheim, Hoffman—la Roche and GSK. Payments for presentations/lectures from Boehringer Ingelheim, Hoffman—la Roche, Chiesi, Menarini, GSK, AstraZeneca. VC: Financial grant from Boehringer Ingelheim paid to institution. Consulting fees from Astra Zeneca, Boehringer Ingelheim, Celgene/BMS, CSL Behring, GSK, Pliant, Pure Tech, RedX, Hoffman—la Roche, Sanofi, Shionogi, United Therapeutics/Ferrer. Payments for presentations/lectures from Boehringer Ingelheim and Hoffman—La Roche. Support for attending meetings from Boehringer Ingelheim and Hoffman—La Roche. Participation on data and safety monitoring board of Galapagos and Galecto. Leadership role in Fibrogen adjudication committee. AV: Grants from ARXX therapeutics, Boehringer Ingelheim, Hoffman—la Roche, Bayer, Merck Sharp&Dohme, Lilly and Medscape. Consulting fees from ARXX therapeutics, Boehringer Ingelheim, Roche, Merck Sharp&Dohme, Lilly, Medscape, Genentech. Payments for presentations/lectures from ARXX therapeutics, Boehringer Ingelheim, Roche, Bayer, Merck Sharp&Dohme, Lilly and Medscape. Support for attending meetings from Boehringer Ingelheim and Janssen. Leadership role in EULAR convenor for ERS/EULAR CTD-ILD guideline, EULAR quality of care committee, PH Nordic group. MK: Financial grant from Boehringer Ingelheim and Hoffman—la Roche. Consulting fees from Boehringer Ingelheim and Hoffman—la Roche. Payments for presentations/lectures from Boehringer Ingelheim and Hoffman—la Roche. Leadership role in ERS and DGP. PM: Financial grant from Astra Zeneca and Action for Pulmonary Fibrosis payed to institution. Advisory board fees from Hoffman—la Roche, Boehringer Ingelheim, Qureight, Trevi, AstraZeneca. Speakers fees from Astra Zeneca, Boehringer Ingelheim, Hoffman—La Roche. WW: Financial grant from Hoffman—la Roche, Boehringer Ingelheim, Galapagos paid to institution. Consulting fees from Hoffman—la Roche, Boehringer Ingelheim, Galpagos paid to institution. Payments for presentations/lectures from Boehringer Ingelheim paid to institution. Participation on Advisory board by Boehringer Ingelheim, Galapagos, Hoffman—La–Roche paid to institution. MW: Financial grant from Boehringer Ingelheim, Hoffman—La Roche, The Netherlands Organization for Health Research and Development; The Dutch Lung Foundation; The Dutch Pulmonary Fibrosis, all paid to institution. Consulting fees from Bristol Myers Squibb, Boehringer Ingelheim, Galapagos, Galecto, Hoffman la Roche, Horizon therapeutics, Kinevant Sciences, Molecure, Nerre Therapeutics, Novartis, PureTech Health, and Respivant, all paid to institution. Support for attending meeting from Boehringer Ingelheim, Hoffman la Roche, Galapagos. Participation on advisory board from Savara, Galapagos, all paid to institution. Leadership role as Chair of the Idiopathic Interstitial Pneumonia group of the European Respiratory Society, Member of the board of the Netherlands Respiratory Society, Member of the scientific advisory board of the European Idiopathic Pulmonary Fibrosis and related disorders federation, Chair of the educational committee of the European Reference Network for rare Lung Diseases, Advisory board of the Dutch Lung fibrosis and Sarcoidosis patient associations. Funding Information: The I-FILE study is sponsored by the Erasmus Medical Center and funded by Boehringer Ingelheim. Boehringer Ingelheim has no influence on the study design, procedures and has no access to the study data. Publisher Copyright: © 2023, The Author(s).

PY - 2023/2/2

Y1 - 2023/2/2

N2 - Background: Pulmonary fibrosis (PF) is caused by a heterogeneous group of diseases, with a high inter-individual variability in disease trajectory. Identifying disease progression in patients with PF has impact on clinical management decisions. However, strategies to early identify and predict disease progression for these patients are currently lacking. In this study, we aim to assess long-term FVC change in patients with PF measured with home spirometry, and evaluate the feasibility of a multinational patient-led registry in PF. In addition, we will assess validity of patient-reported outcomes (PROMs) for the different subgroups of patients with PF. Methods: In this international, prospective, multicenter, observational study, we aim to include 700 patients across seven European countries. Patients will monitor their disease course for a period of two years using an online home monitoring program (I-FILE), which includes home spirometry, pulse oximetry, and PROMs. Results will be directly sent to the hospital via the online application. Patients will be asked to perform daily home spirometry and pulse oximetry in the first three months, followed by once weekly measurements for a period of two years. PROMs will be completed in the online I-FILE application every six months, including the King’s brief Interstitial Lung Disease Health Status, The EuroQol five dimensions five-level, Visual Analogue Scales on cough, dyspnea, fatigue and general complaints, Leicester Cough Questionnaire, Fatigue Assessment Scale, Work Productivity and Activity Impairment Questionnaire, Global Rating of Change Scale, and Living with Pulmonary Fibrosis questionnaire. Discussion: This study will provide much needed insights in disease trajectories of the different subgroups of patients with PF. Simultaneously, the I-FILE study will yield valuable information on the use and feasibility of home-based data collection. This international patient-led registry will facilitate trans-border collaboration to further optimize care and research for patients with PF. Trial registration: The study was registered on the 12th of March 2020 in the International Clinical Trial Registry, www.clinicaltrials.gov; Identifier: NCT04304898.

AB - Background: Pulmonary fibrosis (PF) is caused by a heterogeneous group of diseases, with a high inter-individual variability in disease trajectory. Identifying disease progression in patients with PF has impact on clinical management decisions. However, strategies to early identify and predict disease progression for these patients are currently lacking. In this study, we aim to assess long-term FVC change in patients with PF measured with home spirometry, and evaluate the feasibility of a multinational patient-led registry in PF. In addition, we will assess validity of patient-reported outcomes (PROMs) for the different subgroups of patients with PF. Methods: In this international, prospective, multicenter, observational study, we aim to include 700 patients across seven European countries. Patients will monitor their disease course for a period of two years using an online home monitoring program (I-FILE), which includes home spirometry, pulse oximetry, and PROMs. Results will be directly sent to the hospital via the online application. Patients will be asked to perform daily home spirometry and pulse oximetry in the first three months, followed by once weekly measurements for a period of two years. PROMs will be completed in the online I-FILE application every six months, including the King’s brief Interstitial Lung Disease Health Status, The EuroQol five dimensions five-level, Visual Analogue Scales on cough, dyspnea, fatigue and general complaints, Leicester Cough Questionnaire, Fatigue Assessment Scale, Work Productivity and Activity Impairment Questionnaire, Global Rating of Change Scale, and Living with Pulmonary Fibrosis questionnaire. Discussion: This study will provide much needed insights in disease trajectories of the different subgroups of patients with PF. Simultaneously, the I-FILE study will yield valuable information on the use and feasibility of home-based data collection. This international patient-led registry will facilitate trans-border collaboration to further optimize care and research for patients with PF. Trial registration: The study was registered on the 12th of March 2020 in the International Clinical Trial Registry, www.clinicaltrials.gov; Identifier: NCT04304898.

UR - https://www.scopus.com/pages/publications/85147306320

U2 - 10.1186/s12890-023-02336-4

DO - 10.1186/s12890-023-02336-4

M3 - Article

C2 - 36732734

AN - SCOPUS:85147306320

SN - 1471-2466

VL - 23

JO - BMC Pulmonary Medicine

JF - BMC Pulmonary Medicine

IS - 1

M1 - 51

ER -

Study protocol of an international patient-led registry in patients with pulmonary fibrosis using online home monitoring: I-FILE

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