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NCT Number: NCT06883448

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.

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Key information

Conditions

Pulmonary Fibrosis Fibrosis Interstitial Lung Disease (ILD) Lung Diseases Lung Diseases, Interstitial Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Pulmonology, Onze Lieve Vrouwe Gasthuis, Amsterdam, Netherlands

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About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • A multidisciplinary ILD team diagnosis of pulmonary fibrosis according to ATS/ERS/JRS/ALAT guidelines;
  • Adults (=/>18 years).

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Patient self-management

    Time frame: Baseline

    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.

  2. Patient self-management

    Time frame: Baseline to 6 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.

  3. Living with Pulmonary Fibrosis (L-PF) questionnaire

    Time frame: Baseline

    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.

  4. Living with Pulmonary Fibrosis (L-PF) questionnaire

    Time frame: Baseline to 6 months

    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.

  5. Living with Pulmonary Fibrosis (L-PF) questionnaire

    Time frame: Baseline to 12 months

    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.

  6. King's brief Interstitial Lung Disease Health Status (K-BILD)

    Time frame: Baseline

    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.

  7. King's brief Interstitial Lung Disease Health Status (K-BILD)

    Time frame: Baseline to 6 months

    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.

  8. King's brief Interstitial Lung Disease Health Status (K-BILD)

    Time frame: Baseline to 12 months

    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.

  9. The EuroQol five dimensions 5-level plus respiratory bolt-on (EQ-5D-5L+R) questionnaire

    Time frame: Baseline

    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.

  10. The EuroQol five dimensions 5-level plus respiratory bolt-on (EQ-5D-5L+R) questionnaire

    Time frame: Baseline to 6 months

    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.

  11. The EuroQol five dimensions 5-level plus respiratory bolt-on (EQ-5D-5L+R) questionnaire

    Time frame: Baseline to 12 months

    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.

  12. Scheduled respiratory related outpatient clinic visits

    Time frame: Baseline to 12 months

  13. Unscheduled respiratory related outpatient clinic visits

    Time frame: Baseline to 12 months

  14. Respiratory related remote consultations

    Time frame: Baseline to 12 months

    Compare the number of remote consultations performed.

  15. Respiratory related emergency visits

    Time frame: Baseline to 12 months

  16. Respiratory related hospitalisations

    Time frame: From baseline to 12 months

  17. Mortality or lung transplantation

    Time frame: Baseline to 12 months

  18. Forced vital capacity (FVC)

    Time frame: Baseline

    Forced vital capacity (FVC) measured with pulmonary function study (PFT) as ml and as percentage predicted of healthy standards (in %).

  19. Forced vital capacity (FVC)

    Time frame: Baseline to 6 months

    Delta forced vital capacity (FVC) measured with pulmonary function study (PFT) as ml and as percentage predicted of healthy standards (in %).

  20. Forced vital capacity (FVC)

    Time frame: Baseline to 12 months

    Delta forced vital capacity (FVC) measured with pulmonary function study (PFT) as ml and as percentage predicted of healthy standards (in %).

  21. Diffusing capacity of the lung for carbon monoxide (DLCO)

    Time frame: Baseline

    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 %).

  22. Diffusing capacity of the lung for carbon monoxide (DLCO)

    Time frame: Baseline to 6 months

    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 %).

  23. Diffusing capacity of the lung for carbon monoxide (DLCO)

    Time frame: Baseline to 12 months

    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 %).

  24. Forced vital capacity (FVC)

    Time frame: Baseline

    Forced vital capacity (FVC) measured with home measured pulmonary function study (PFT) as ml and as percentage predicted of healthy standards (in %).

  25. Forced vital capacity (FVC)

    Time frame: Baseline to 6 months

    Delta forced vital capacity (FVC) measured with home measured pulmonary function study (PFT) as ml and as percentage predicted of healthy standards (in %).

  26. Forced vital capacity (FVC)

    Time frame: Baseline to 12 months

    Delta forced vital capacity (FVC) measured with home measured pulmonary function study (PFT) as ml and as percentage predicted of healthy standards (in %).

  27. Correlation and agreement of home measured Forced vital capacity (FVC)

    Time frame: From baseline to 12 months

    Correlations between home measured Forced vital capacity (FVC) and in-hospital FVC in ml in the home monitoring group.

  28. Patient adherence to home monitoring protocol

    Time frame: Baseline to 12 months

    Patients' adherence to home monitoring for home measured spirometry, pulse-oximetry, and patient-reported outcome measures (PROMs).

Other outcomes

  1. Cost-effectiveness and cost-utility analyses

    Time frame: Baseline to 12 months

    The costs, cost-effectiveness and cost-utility analyses will be conducted from a healthcare system and societal perspective.

  2. Healthcare professional- and patient satisfaction

    Time frame: 12 months

    Healthcare providers and patients will be asked about their satisfaction and experiences on home monitoring.

  3. Time to detection of a decline of 10% in in-hospital versus home-based FVC

    Time frame: Baseline to 12 months

  4. Travel movements

    Time frame: Baseline to 12 months

    Explorative evaluation of the effect of home monitoring on travel movements.

Study contacts

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

Catharina C. Moor

CONTACT

[email protected]

Delian E. Hofman

CONTACT

[email protected]

+31650162675

Sponsors and collaborators

Lead sponsor

Erasmus Medical Center

Other

Collaborators

  • Amphia, Breda, the Netherlands
  • Catharina, Eindhoven, the Netherlands
  • Leiden University Medical Center, LUMC, Leiden, The Netherlands
  • MC Leeuwarden, Leeuwarden, the Netherlands
  • Medical Center Haaglanden, The Hague, The Netherlands
  • OLVG, Amsterdam, the Netherlands
  • Rijnstate, Arnhem, the Netherlands
  • St. Antonius Hospital
  • UMC Utrecht, Utrecht, the Netherlands
  • Zuyderland Medisch Centrum, Sittard-Geleen, the Netherlands

Registry information

Official study title

The SUITS Study: Implementation of Home Monitoring in Patients With Pulmonary Fibrosis

Acronym: SUITS

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Mar 19, 2025
Registry last updated
May 27, 2026

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

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

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

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