Implementation of Home Monitoring in Patients With Pulmonary Fibrosis (SUITS)

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.

Study Overview

• Status: Recruiting
• Conditions: Pulmonary Fibrosis; Interstitial Lung Disease (ILD)
• Intervention / Treatment: Combination product: Home monitoring care

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 Type: Interventional
• Enrollment (Estimated): 220
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Catharina C. Moor; Email: c.moor@erasmusmc.nl
• Study Contact Backup: Name: Delian E. Hofman; Phone Number: +31650162675; Email: d.hofman@erasmusmc.nl

Study Locations

• Netherlands
  • Amsterdam, Netherlands
    • Recruiting
    • Department of Pulmonology, Onze Lieve Vrouwe Gasthuis
    • Contact: Paul Bresser
  • Arnhem, Netherlands
    • Recruiting
    • Department of Pulmonary Diseases, Rijnstate Hospital
    • Contact: Linda Moonen
  • Breda, Netherlands
    • Recruiting
    • Department of Respiratory Medicine, Amphia Hospital
    • Contact: Daan W. Loth
  • Eindhoven, Netherlands
    • Recruiting
    • Department of Respiratory Medicine, Catharina Hospital
    • Contact: Eveline Schakenraad
  • Heerlen, Netherlands
    • Recruiting
    • Department of Pulmonary Medicine, Zuyderland Medical Centre
    • Contact: Rémy L.M. Mostard
  • Leeuwarden, Netherlands
    • Recruiting
    • Department of Pulmonology, Medical Center Leeuwarden
    • Contact: Jan van der Maten
  • Leiden, Netherlands
    • Recruiting
    • Department of Pulmonology, Leiden University Medical Center
    • Contact: Kelly M.C. van Doorn-Hogervorst
  • Nieuwegein, Netherlands
    • Recruiting
    • Interstitial Lung Diseases Center of Excellence, Department of Pulmonology, St Antonius Hospital
    • Contact: Frouke van Beek
  • Rotterdam, Netherlands
    • Recruiting
    • Department of Respiratory Medicine, Center of Excellence for Interstitial Lung Disease, Erasmus University Medical Center
    • Contact: Delian E. Hofman; Email: d.hofman@erasmusmc.nl
  • The Hague, Netherlands
    • Recruiting
    • Department of Pulmonology, Haaglanden Medisch Centrum
    • Contact: Maria J. Overbeek
  • Utrecht, Netherlands
    • Recruiting
    • Division of Heart and Lungs, University Medical Center Utrecht and Utrecht University
    • Contact: Adriane D.M. Vorselaars

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Hospital-based care; Hospital-based care involves outpatient clinic visits every three months including in-hospital lung function testing.
Experimental: Home monitoring care; 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.	Combination product: Home monitoring care; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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 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
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
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
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
Respiratory related hospitalisations		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
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
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
Mortality or lung transplantation		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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Healthcare professional- and patient satisfaction	Healthcare providers and patients will be asked about their satisfaction and experiences on home monitoring.	12 months
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
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

Collaborators and Investigators

• Sponsor: Erasmus Medical Center
• Collaborators: St. Antonius Hospital; Amphia, Breda, the Netherlands; MC Leeuwarden, Leeuwarden, the Netherlands; OLVG, Amsterdam, the Netherlands; Rijnstate, Arnhem, the Netherlands; UMC Utrecht, Utrecht, the Netherlands; Zuyderland Medisch Centrum, Sittard-Geleen, the Netherlands; Medical Center Haaglanden, The Hague, The Netherlands; Leiden University Medical Center, LUMC, Leiden, The Netherlands; Catharina, Eindhoven, the Netherlands
• Investigators: Principal Investigator: Marlies S. Wijsenbeek-Lourens, Prof Dr, Department of Respiratory Medicine, Center of Excellence for Interstitial Lung Disease, Erasmus University Medical Center, Rotterdam, The Netherlands

Study record dates

Study Major Dates

• Study Start (Actual): October 2, 2024
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: March 13, 2025
• First Submitted That Met QC Criteria: March 13, 2025
• First Posted (Actual): March 19, 2025

Study Record Updates

• Last Update Posted (Actual): May 27, 2026
• Last Update Submitted That Met QC Criteria: May 22, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: eHealth; Self-management; Hybrid care
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Fibrosis; Pathological Conditions, Signs and Symptoms; Pulmonary Fibrosis; Lung Diseases, Interstitial
• Other Study ID Numbers: MEC-2024-0045; 10140292110006 (Other Grant/Funding Number: The Netherlands Organisation for Health Research and Development (ZonMw))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No