Pulmonary FibrosisSUITSNCT06883448
Implementation of Home Monitoring in Patients With Pulmonary Fibrosis
A study testing Home monitoring care in people with Pulmonary Fibrosis and Interstitial Lung Disease (ILD), run by Erasmus Medical Center at 11 sites in Netherlands.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Fibrosis, Interstitial Lung Disease (ILD)
- What is being tested?
- Home monitoring care
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 11 sitesNetherlands
- Study dates
- 2 Oct 2024to 1 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A multidisciplinary ILD team diagnosis of pulmonary fibrosis according to ATS/ERS/JRS/ALAT guidelines;
- Adults (=/>18 years).
Who cannot join
- Patients who are not able to speak, read and/or write in Dutch;
- Patients with no access to the internet;
- Patients with a life expectancy of less than 1 year as determined by the treating healthcare provider;
- Patients who are or have been using a home monitoring program for PF.
Trial locations and contacts
11 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Catharina C. Moor contact
11 sites in 1 country
Netherlands11 sites, 11 recruiting
- Recruiting
Department of Pulmonology, Onze Lieve Vrouwe Gasthuis
Amsterdam
Paul Bresser
- Recruiting
Department of Pulmonary Diseases, Rijnstate Hospital
Arnhem
Linda Moonen
- Recruiting
Department of Respiratory Medicine, Amphia Hospital
Breda
Daan W. Loth
- Recruiting
Department of Respiratory Medicine, Catharina Hospital
Eindhoven
Eveline Schakenraad
- Recruiting
Department of Pulmonary Medicine, Zuyderland Medical Centre
Heerlen
Rémy L.M. Mostard
- Recruiting
Department of Pulmonology, Medical Center Leeuwarden
Leeuwarden
Jan van der Maten
- Recruiting
Department of Pulmonology, Leiden University Medical Center
Leiden
Kelly M.C. van Doorn-Hogervorst
- Recruiting
Interstitial Lung Diseases Center of Excellence, Department of Pulmonology, St Antonius Hospital
Nieuwegein
Frouke van Beek
- Recruiting
Department of Respiratory Medicine, Center of Excellence for Interstitial Lung Disease, Erasmus University Medical Center
Rotterdam
Delian E. Hofman, d.hofman@erasmusmc.nl
- Recruiting
Department of Pulmonology, Haaglanden Medisch Centrum
The Hague
Maria J. Overbeek
- Recruiting
Division of Heart and Lungs, University Medical Center Utrecht and Utrecht University
Utrecht
Adriane D.M. Vorselaars
About this study
Official title: The SUITS Study: Implementation of Home Monitoring in Patients With Pulmonary Fibrosis
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.
Read the detailed description
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.
- Being tested
- Home monitoring care
- Keywords
- eHealth, Hybrid care, Self-management
- Medical subject headings
- Pulmonary Fibrosis, Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home monitoring careCombination 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Combination Product: Home monitoring care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 12 months
Secondary outcomes (28)
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.
Measured: Baseline
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline to 12 months
Scheduled respiratory related outpatient clinic visits
Measured: Baseline to 12 months
Unscheduled respiratory related outpatient clinic visits
Measured: Baseline to 12 months
Respiratory related remote consultations
Compare the number of remote consultations performed.
Measured: Baseline to 12 months
Respiratory related emergency visits
Measured: Baseline to 12 months
Respiratory related hospitalisations
Measured: From baseline to 12 months
Mortality or lung transplantation
Measured: 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 %).
Measured: 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 %).
Measured: 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 %).
Measured: 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 %).
Measured: 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 %).
Measured: 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 %).
Measured: 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 %).
Measured: 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 %).
Measured: 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 %).
Measured: 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.
Measured: 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).
Measured: Baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2025
- Study start2 Oct 2024
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary FibrosisStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- None (open label)
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Zuyderland Medisch Centrum, Sittard-Geleen, the Netherlands, Leiden University Medical Center, LUMC, Leiden, The Netherlands, UMC Utrecht, Utrecht, the Netherlands, Rijnstate, Arnhem, the Netherlands, Catharina, Eindhoven, the Netherlands, MC Leeuwarden, Leeuwarden, the Netherlands, OLVG, Amsterdam, the Netherlands, Medical Center Haaglanden, The Hague, The Netherlands, Amphia, Breda, the Netherlands, St. Antonius Hospital
- Responsible party
- Principal investigator, Marlies Wijsenbeek, Erasmus Medical Center
- Investigators
- Marlies S. Wijsenbeek-Lourens, Prof Dr, Principal investigator, Department of Respiratory Medicine, Center of Excellence for Interstitial Lung Disease, Erasmus University Medical Center, Rotterdam, The Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06883448
- Sponsor's protocol ID
- MEC-2024-0045
- Other IDs
- 10140292110006
- Acronym
- SUITS
- Status last verified
- Dec 2025
- First submitted
- 13 Mar 2025
- Last updated
- 27 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 42310732
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The SUITS Study: Implementation of Home Monitoring in Patients With Pulmonary Fibrosis
- ClinicalTrials.gov ID
- NCT06883448
- Acronym / sponsor ID
- SUITS / MEC-2024-0045
- Keywords
- eHealth, Hybrid care, Self-management
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Collaborators
- Zuyderland Medisch Centrum, Sittard-Geleen, the Netherlands, Leiden University Medical Center, LUMC, Leiden, The Netherlands, UMC Utrecht, Utrecht, the Netherlands, Rijnstate, Arnhem, the Netherlands, Catharina, Eindhoven, the Netherlands, MC Leeuwarden, Leeuwarden, the Netherlands, OLVG, Amsterdam, the Netherlands, Medical Center Haaglanden, The Hague, The Netherlands, Amphia, Breda, the Netherlands, St. Antonius Hospital
- Study start
- 2 Oct 2024 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 19 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| 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 | Combination Product: Home monitoring carePatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- A multidisciplinary ILD team diagnosis of pulmonary fibrosis according to ATS/ERS/JRS/ALAT guidelines;
- Adults (=/>18 years).
Key exclusion criteria (4 listed)
- Patients who are not able to speak, read and/or write in Dutch;
- Patients with no access to the internet;
- Patients with a life expectancy of less than 1 year as determined by the treating healthcare provider;
- Patients who are or have been using a home monitoring program for PF.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home monitoring carePatients 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. | Combination product | Home monitoring care |
Primary outcome
Patient self-management
Time frame: Baseline to 12 months
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.
28 secondary outcomes
Patient self-management
Time frame: Baseline
Patient self-management
Time frame: Baseline to 6 months
Living with Pulmonary Fibrosis (L-PF) questionnaire
Time frame: Baseline
Living with Pulmonary Fibrosis (L-PF) questionnaire
Time frame: Baseline to 6 months
Living with Pulmonary Fibrosis (L-PF) questionnaire
Time frame: Baseline to 12 months
King's brief Interstitial Lung Disease Health Status (K-BILD)
Time frame: Baseline
King's brief Interstitial Lung Disease Health Status (K-BILD)
Time frame: Baseline to 6 months
King's brief Interstitial Lung Disease Health Status (K-BILD)
Time frame: Baseline to 12 months
The EuroQol five dimensions 5-level plus respiratory bolt-on (EQ-5D-5L+R) questionnaire
Time frame: Baseline
The EuroQol five dimensions 5-level plus respiratory bolt-on (EQ-5D-5L+R) questionnaire
Time frame: Baseline to 6 months
The EuroQol five dimensions 5-level plus respiratory bolt-on (EQ-5D-5L+R) questionnaire
Time frame: Baseline to 12 months
Scheduled respiratory related outpatient clinic visits
Time frame: Baseline to 12 months
Unscheduled respiratory related outpatient clinic visits
Time frame: Baseline to 12 months
Respiratory related remote consultations
Time frame: Baseline to 12 months
Respiratory related emergency visits
Time frame: Baseline to 12 months
Respiratory related hospitalisations
Time frame: From baseline to 12 months
Mortality or lung transplantation
Time frame: Baseline to 12 months
Forced vital capacity (FVC)
Time frame: Baseline
Forced vital capacity (FVC)
Time frame: Baseline to 6 months
Forced vital capacity (FVC)
Time frame: Baseline to 12 months
Diffusing capacity of the lung for carbon monoxide (DLCO)
Time frame: Baseline
Diffusing capacity of the lung for carbon monoxide (DLCO)
Time frame: Baseline to 6 months
Diffusing capacity of the lung for carbon monoxide (DLCO)
Time frame: Baseline to 12 months
Forced vital capacity (FVC)
Time frame: Baseline
Forced vital capacity (FVC)
Time frame: Baseline to 6 months
Forced vital capacity (FVC)
Time frame: Baseline to 12 months
Correlation and agreement of home measured Forced vital capacity (FVC)
Time frame: From baseline to 12 months
Patient adherence to home monitoring protocol
Time frame: Baseline to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2026.
- Derived from this study: PubMed 42310732Hofman 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Catharina C. Moor contact
Marlies S. Wijsenbeek-Lourens, Prof Dr principal investigator
Department of Respiratory Medicine, Center of Excellence for Interstitial Lung Disease, Erasmus University Medical Center, Rotterdam, The Netherlands
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home monitoring care in people with Pulmonary Fibrosis and Interstitial Lung Disease (ILD), run by Erasmus Medical Center at 11 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Delian E. Hofman (+31650162675, d.hofman@erasmusmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient self-management (time frame: Baseline to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06883448, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2026; AzTrials last refreshed its copy on 8 Nov 2026.