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| ID | Type | Description | Link |
|---|---|---|---|
| 10140292110006 | Other Grant/Funding Number | The Netherlands Organisation for Health Research and Development (ZonMw) |
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| Name | Class |
|---|---|
| Zuyderland Medisch Centrum, Sittard-Geleen, the Netherlands | UNKNOWN |
| Leiden University Medical Center, LUMC, Leiden, The Netherlands | UNKNOWN |
| UMC Utrecht, Utrecht, the Netherlands | UNKNOWN |
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The objective of this study is to evaluate the impact of structurally replacing half of the outpatient clinic visits for patients with pulmonary fibrosis by home monitoring and video consultations on patient self-management and health(care) outcomes.
Patients will be randomly assigned to receive either hospital-based care or a home monitoring program integrated into hospital-based care. Hospital-based care involves outpatient clinic visits every three months including lung function testing. Home monitoring involves weekly measurements of both physiological- and patient reported outcomes (PROs) in a mobile health care application with half of the outpatient clinic visits alternately being replaced by remote video consultations. The home monitoring program includes home spirometry, pulse-oximetry, PROs, video consultations, a medication coach, and an infotheque showing disease-specific information. Questionnaires will be filled out by both study groups at set time points. The total study duration for individual patients will be 12 months.
Trial Registration and Ethics Statement In the Netherlands, clinical trial registration is not mandatory for studies exempt from ethics review. As this study was exempt from ethics review, as approved by the IRB of Erasmus Medical Center in Rotterdam, the Netherlands, the study was not prospectively registered. During the enrollment phase, the study protocol was retrospectively registered on ClinicalTrials.gov to ensure public access to the study protocol and study outcomes. IRB approval was obtained prior to enrollment of the first participant. No changes were made to the IRB-approved study protocol (version 1, 11-01-2024) prior to registration on ClinicalTrials.gov.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hospital-based care | No Intervention | Hospital-based care involves outpatient clinic visits every three months including in-hospital lung function testing. | |
| Home monitoring care | Experimental | Patients in the home monitoring group will receive a home spirometer, pulse oximetry meter, and access to a smartphone or tablet app, where they can perform home based measurements weekly and complete PROMs. Furthermore, this app includes disease specific information and allows for direct communication with the hospital via eConsultation. In the home monitoring group, half of the outpatient clinic visits will alternately be replaced by remote visits via video consultation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Home monitoring care | Combination Product | Patients in the home monitoring group will receive a home spirometer, pulse oximetry meter, and access to a smartphone or tablet app, where they can perform home based measurements weekly and complete PROMs. Furthermore, this app includes disease specific information and allows for direct communication with the hospital via eConsultation. In the home monitoring group, half of the outpatient clinic visits will alternately be replaced by remote visits via video consultation. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient self-management | Delta score of the Patient Activation Measure (PAM) questionnaire. The PAM is a 13-item survey assessing levels of patient activation in terms of managing their own health and healthcare. Total score ranges are 0-100, with higher scores indicating greater patient activation. | Baseline to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Patient self-management | The Patient Activation Measure (PAM) questionnaire is a 13-item survey assessing levels of patient activation in terms of managing their own health and healthcare. Total score ranges are 0-100, with higher scores indicating greater patient activation. | Baseline |
| Patient self-management |
| Measure | Description | Time Frame |
|---|---|---|
| Cost-effectiveness and cost-utility analyses | The costs, cost-effectiveness and cost-utility analyses will be conducted from a healthcare system and societal perspective. | Baseline to 12 months |
| Healthcare professional- and patient satisfaction |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Delian E. Hofman | Contact | +31650162675 | d.hofman@erasmusmc.nl | |
| Catharina C. Moor | Contact | c.moor@erasmusmc.nl |
| Name | Affiliation | Role |
|---|---|---|
| Marlies S. Wijsenbeek-Lourens, Prof Dr | Department of Respiratory Medicine, Center of Excellence for Interstitial Lung Disease, Erasmus University Medical Center, Rotterdam, The Netherlands | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Pulmonology, Onze Lieve Vrouwe Gasthuis | Recruiting | Amsterdam | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42310732 | Derived | Hofman DE, Moor CC, van Beek FF, Vorselaars ADM, Overbeek MJ, van Doorn-Hogervorst K, Moonen LAA, van der Maten J, Bresser P, Loth DW, Schakenraad E, Kerstens R, van der Wal P, de Mul M, Mostard RLM, Wijsenbeek MS. Design of a randomized controlled trial comparing hybrid care with standard care for people with pulmonary fibrosis. Respir Res. 2026 Jun 17. doi: 10.1186/s12931-026-03716-0. Online ahead of print. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 15, 2026 | Apr 20, 2026 |
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| Rijnstate, Arnhem, the Netherlands | UNKNOWN |
| Catharina, Eindhoven, the Netherlands | UNKNOWN |
| MC Leeuwarden, Leeuwarden, the Netherlands | UNKNOWN |
| OLVG, Amsterdam, the Netherlands | UNKNOWN |
| Medical Center Haaglanden, The Hague, The Netherlands | UNKNOWN |
| Amphia, Breda, the Netherlands | UNKNOWN |
| St. Antonius Hospital | OTHER |
Patients will be randomly assigned in a 1:1 ratio to receive either hospital-based care or the home monitoring program integrated into hospital-based care. Randomisation will be done with a computer-generated schedule (ALEA Screening and Enrolment Application Software), using block-randomisation, stratified for study site and use of anti-fibrotic treatment (yes or no).
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Participants, health-care providers, and research staff will not be masked to group allocation.
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Delta score of the Patient Activation Measure (PAM) questionnaire. The PAM is a 13-item survey assessing levels of patient activation in terms of managing their own health and healthcare. Total score ranges are 0-100, with higher scores indicating greater patient activation. |
| Baseline to 6 months |
| Living with Pulmonary Fibrosis (L-PF) questionnaire | The Living with Pulmonary Fibrosis (L-PF) questionnaire is developed to assess symptoms and HRQOL in patients with Pulmonary Fibrosis. It consists of 44 items divided into two modules: symptoms (23 items) and impacts (21 items). The symptom module assesses shortness of breath, cough and fatigue. The impacts module assesses multiple aspects of HRQOL on a five-option numeric rating score. Overall scores range from 0 to 100, with higher numbers indicating a greater impairment. | Baseline |
| Living with Pulmonary Fibrosis (L-PF) questionnaire | Delta scores of all domains of the Living with Pulmonary Fibrosis (L-PF) questionnaire will be assessed. The L-PF questionnaire is developed to assess symptoms and HRQOL in patients with Pulmonary Fibrosis. It consists of 44 items divided into two modules: symptoms (23 items) and impacts (21 items). The symptom module assesses shortness of breath, cough and fatigue. The impacts module assesses multiple aspects of HRQOL on a five-option numeric rating score. Overall scores range from 0 to 100, with higher numbers indicating a greater impairment. | Baseline to 6 months |
| Living with Pulmonary Fibrosis (L-PF) questionnaire | Delta scores of all domains of the Living with Pulmonary Fibrosis (L-PF) questionnaire will be assessed. The L-PF questionnaire is developed to assess symptoms and HRQOL in patients with Pulmonary Fibrosis. It consists of 44 items divided into two modules: symptoms (23 items) and impacts (21 items). The symptom module assesses shortness of breath, cough and fatigue. The impacts module assesses multiple aspects of HRQOL on a five-option numeric rating score. Overall scores range from 0 to 100, with higher numbers indicating a greater impairment. | Baseline to 12 months |
| King's brief Interstitial Lung Disease Health Status (K-BILD) | The K-BILD health status questionnaire is a 15-item validated, self-completed heath status questionnaire. It contains three domains: breathlessness and activities, psychological and chest symptoms. The total score ranges are 0-100, with higher scores corresponding with better HRQOL. | Baseline |
| King's brief Interstitial Lung Disease Health Status (K-BILD) | Delta scores of all domains of the King's brief Interstitial Lung Disease Health Status (K-BILD) questionnaire will be assessed. The K-BILD health status questionnaire is a 15-item validated, self-completed heath status questionnaire. It contains three domains: breathlessness and activities, psychological and chest symptoms. The total score ranges are 0-100, with higher scores corresponding with better HRQOL. | Baseline to 6 months |
| King's brief Interstitial Lung Disease Health Status (K-BILD) | Delta scores of all domains of the King's brief Interstitial Lung Disease Health Status (K-BILD) questionnaire will be assessed. The K-BILD health status questionnaire is a 15-item validated, self-completed heath status questionnaire. It contains three domains: breathlessness and activities, psychological and chest symptoms. The total score ranges are 0-100, with higher scores corresponding with better HRQOL. | Baseline to 12 months |
| The EuroQol five dimensions 5-level plus respiratory bolt-on (EQ-5D-5L+R) questionnaire | The EQ-5D-5L+R questionnaire is a standardized instrument to measure health outcomes in two components: health description and valuation. It comprises six dimensions: mobility, self-care, usual activities, pain/discomfort, anxiety/depression, and respiratory complaints on a 5-point scale. From these 6 answers an index value is derived between 0 and 1, with a higher value corresponding with a better QoL. In the valuation part the patients' general health status is evaluated using a VAS-score from 0 to 100, with a higher score representing a better quality of life. | Baseline |
| The EuroQol five dimensions 5-level plus respiratory bolt-on (EQ-5D-5L+R) questionnaire | Delta scores of the EuroQol five dimensions 5-level plus respiratory bolt-on (EQ-5D-5L+R) questionnaire will be assessed. The EQ-5D-5L+R questionnaire is a standardized instrument to measure health outcomes in two components: health description and valuation. It comprises six dimensions: mobility, self-care, usual activities, pain/discomfort, anxiety/depression, and respiratory complaints on a 5-point scale. From these 6 answers an index value is derived between 0 and 1, with a higher value corresponding with a better QoL. In the valuation part the patients' general health status is evaluated using a VAS-score from 0 to 100, with a higher score representing a better quality of life. | Baseline to 6 months |
| The EuroQol five dimensions 5-level plus respiratory bolt-on (EQ-5D-5L+R) questionnaire | Delta scores of all dimensions of the The EuroQol five dimensions 5-level plus respiratory bolt-on (EQ-5D-5L+R) questionnaire will be assessed. The EQ-5D-5L+R questionnaire is a standardized instrument to measure health outcomes in two components: health description and valuation. It comprises six dimensions: mobility, self-care, usual activities, pain/discomfort, anxiety/depression, and respiratory complaints on a 5-point scale. From these 6 answers an index value is derived between 0 and 1, with a higher value corresponding with a better QoL. In the valuation part the patients' general health status is evaluated using a VAS-score from 0 to 100, with a higher score representing a better quality of life. | Baseline to 12 months |
| Scheduled respiratory related outpatient clinic visits | Baseline to 12 months |
| Unscheduled respiratory related outpatient clinic visits | Baseline to 12 months |
| Respiratory related remote consultations | Compare the number of remote consultations performed. | Baseline to 12 months |
| Respiratory related emergency visits | Baseline to 12 months |
| Respiratory related hospitalisations | From baseline to 12 months |
| Mortality or lung transplantation | Baseline to 12 months |
| Forced vital capacity (FVC) | Forced vital capacity (FVC) measured with pulmonary function study (PFT) as ml and as percentage predicted of healthy standards (in %). | Baseline |
| Forced vital capacity (FVC) | Delta forced vital capacity (FVC) measured with pulmonary function study (PFT) as ml and as percentage predicted of healthy standards (in %). | Baseline to 6 months |
| Forced vital capacity (FVC) | Delta forced vital capacity (FVC) measured with pulmonary function study (PFT) as ml and as percentage predicted of healthy standards (in %). | Baseline to 12 months |
| Diffusing capacity of the lung for carbon monoxide (DLCO) | Diffusing capacity of the lungs for carbon monoxide (DLCO) measured with pulmonary function study (PFT) as ml and as percentage predicted of healthy standards (in %). | Baseline |
| Diffusing capacity of the lung for carbon monoxide (DLCO) | Delta diffusing capacity of the lungs for carbon monoxide (DLCO) measured with pulmonary function study (PFT) as ml and as percentage predicted of healthy standards (in %). | Baseline to 6 months |
| Diffusing capacity of the lung for carbon monoxide (DLCO) | Delta diffusing capacity of the lungs for carbon monoxide (DLCO) measured with pulmonary function study (PFT) as ml and as percentage predicted of healthy standards (in %). | Baseline to 12 months |
| Forced vital capacity (FVC) | Forced vital capacity (FVC) measured with home measured pulmonary function study (PFT) as ml and as percentage predicted of healthy standards (in %). | Baseline |
| Forced vital capacity (FVC) | Delta forced vital capacity (FVC) measured with home measured pulmonary function study (PFT) as ml and as percentage predicted of healthy standards (in %). | Baseline to 6 months |
| Forced vital capacity (FVC) | Delta forced vital capacity (FVC) measured with home measured pulmonary function study (PFT) as ml and as percentage predicted of healthy standards (in %). | Baseline to 12 months |
| Correlation and agreement of home measured Forced vital capacity (FVC) | Correlations between home measured Forced vital capacity (FVC) and in-hospital FVC in ml in the home monitoring group. | From baseline to 12 months |
| Patient adherence to home monitoring protocol | Patients' adherence to home monitoring for home measured spirometry, pulse-oximetry, and patient-reported outcome measures (PROMs). | Baseline to 12 months |
Healthcare providers and patients will be asked about their satisfaction and experiences on home monitoring.
| 12 months |
| Time to detection of a decline of 10% in in-hospital versus home-based FVC | Baseline to 12 months |
| Travel movements | Explorative evaluation of the effect of home monitoring on travel movements. | Baseline to 12 months |
| Department of Pulmonary Diseases, Rijnstate Hospital | Recruiting | Arnhem | Netherlands |
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| Department of Respiratory Medicine, Amphia Hospital | Recruiting | Breda | Netherlands |
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| Department of Respiratory Medicine, Catharina Hospital | Recruiting | Eindhoven | Netherlands |
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| Department of Pulmonary Medicine, Zuyderland Medical Centre | Recruiting | Heerlen | Netherlands |
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| Department of Pulmonology, Medical Center Leeuwarden | Recruiting | Leeuwarden | Netherlands |
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| Department of Pulmonology, Leiden University Medical Center | Recruiting | Leiden | Netherlands |
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| Interstitial Lung Diseases Center of Excellence, Department of Pulmonology, St Antonius Hospital | Recruiting | Nieuwegein | Netherlands |
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| Department of Respiratory Medicine, Center of Excellence for Interstitial Lung Disease, Erasmus University Medical Center | Recruiting | Rotterdam | Netherlands |
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| Department of Pulmonology, Haaglanden Medisch Centrum | Recruiting | The Hague | Netherlands |
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| Division of Heart and Lungs, University Medical Center Utrecht and Utrecht University | Recruiting | Utrecht | Netherlands |
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| SAP_000.pdf |
| ID | Term |
|---|---|
| D011658 | Pulmonary Fibrosis |
| D017563 | Lung Diseases, Interstitial |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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