Clinical trial NCT06883448: Implementation of Home Monitoring in Patients with Pulmonary Fibrosis
Official title: The SUITS Study: Implementation of Home Monitoring in Patients with Pulmonary Fibrosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pulmonary Fibrosis
Interstitial Lung Disease (ILD)
Keywords: eHealth
Hybrid care
Self-management
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
Collaborators: name: Zuyderland Medisch Centrum, Sittard-Geleen, the Netherlands
name: Leiden University Medical Center, LUMC, Leiden, The Netherlands
name: UMC Utrecht, Utrecht, the Netherlands
name: Rijnstate, Arnhem, the Netherlands
name: Catharina, Eindhoven, the Netherlands
name: MC Leeuwarden, Leeuwarden, the Netherlands
name: OLVG, Amsterdam, the Netherlands
name: Medical Center Haaglanden, The Hague, The Netherlands
name: Amphia, Breda, the Netherlands
name: St. Antonius Hospital
First posted: 2025-03-19
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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).
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Patient self-management
timeFrame: Baseline to 12 months
Secondary outcomes:
measure: Patient self management
timeFrame: Baseline
measure: Patient self-management
timeFrame: Baseline to 6 months
measure: Living with Pulmonary Fibrosis (L-PF) questionnaire
timeFrame: Baseline
measure: Living with Pulmonary Fibrosis (L-PF) questionnaire
timeFrame: Baseline to 6 months
measure: Living with Pulmonary Fibrosis (L-PF) questionnaire
timeFrame: Baseline to 12 months
measure: King's brief Interstitial Lung Disease Health Status (K-BILD)
timeFrame: Baseline
measure: King's brief Interstitial Lung Disease Health Status (K-BILD)
timeFrame: Baseline to 6 months
measure: King's brief Interstitial Lung Disease Health Status (K-BILD)
timeFrame: Baseline to 12 months
measure: The EuroQol five dimensions 5-level plus respiratory bolt-on (EQ-5D-5L+R) questionnaire
timeFrame: Baseline
measure: The EuroQol five dimensions 5-level plus respiratory bolt-on (EQ-5D-5L+R) questionnaire
timeFrame: Baseline to 6 months
measure: The EuroQol five dimensions 5-level plus respiratory bolt-on (EQ-5D-5L+R) questionnaire
timeFrame: Baseline to 12 months
measure: Patient Experience and Satisfaction with Medication questionnaire
timeFrame: Baseline
measure: Patient Experience and Satisfaction with Medication questionnaire
timeFrame: Baseline to 6 months
measure: Patient Experience and Satisfaction with Medication questionnaire
timeFrame: Baseline to 12 months
measure: Forced vital capacity (FVC)
timeFrame: Baseline
measure: Forced vital capacity (FVC)
timeFrame: Baseline to 6 months
measure: Forced vital capacity (FVC)
timeFrame: Baseline to 12 months
measure: Forced vital capacity (FVC)
timeFrame: Baseline
measure: Forced vital capacity (FVC)
timeFrame: Baseline to 6 months
measure: Forced vital capacity (FVC)
timeFrame: Baseline to 12 months
measure: Diffusing capacity of the lung for carbon monoxide (DLCO)
timeFrame: Baseline
measure: Diffusing capacity of the lung for carbon monoxide (DLCO)
timeFrame: Baseline to 6 months
measure: Diffusing capacity of the lung for carbon monoxide (DLCO)
timeFrame: Baseline to 12 months
measure: Planned respiratory related hospital visits
timeFrame: Baseline to 12 months
measure: Unplanned respiratory related hospital visits
timeFrame: Baseline to 12 months
measure: Respiratory related hospitalisations
timeFrame: From baseline to 12 months
measure: Video consultations
timeFrame: Baseline to 12 months
measure: Mortality
timeFrame: Baseline to 12 months
measure: Patient adherence to home monitoring protocol
timeFrame: Baseline to 12 months
Other outcomes:
measure: Cost-effectiveness and cost-utility analyses of home monitoring
timeFrame: Baseline to 12 months
measure: Reliability and validity of home measured Forced vital capacity (FVC)
timeFrame: From baseline to 12 months
measure: Forced vital capacity (FVC) change and patient-reported outcome measures (PROMs) change
timeFrame: From baseline to 12 months
measure: Visual Analogue Scales (VAS) questionnaires
timeFrame: Baseline
measure: Visual Analogue Scales (VAS) questionnaires
timeFrame: Weekly
measure: Pulse-oximetry
timeFrame: Baseline to 12 months
measure: Travel movements
timeFrame: Baseline to 12 months
measure: Medication adjustments
timeFrame: Baseline to 12 months
measure: Adherence to home monitoring protocol for healthcare professionals
timeFrame: Baseline to 12 months
measure: Healthcare professional- and patient satisfaction
timeFrame: 12 months
Locations:
city: Amsterdam
country: Netherlands
facility: Department of Pulmonology, Onze Lieve Vrouwe Gasthuis
city: Arnhem
country: Netherlands
facility: Department of Pulmonary Diseases, Rijnstate Hospital
city: Breda
country: Netherlands
facility: Department of Respiratory Medicine, Amphia Hospital
city: Den Haag
country: Netherlands
facility: Department of Pulmonology, Haaglanden Medisch Centrum
city: Eindhoven
country: Netherlands
facility: Department of Respiratory Medicine, Catharina Hospital
city: Heerlen
country: Netherlands
facility: Department of Pulmonary Medicine, Zuyderland Medical Centre
city: Leeuwarden
country: Netherlands
facility: Department of Pulmonology, Medical Center Leeuwarden
city: Leiden
country: Netherlands
facility: Department of Pulmonology, Leiden University Medical Center
city: Nieuwegein
country: Netherlands
facility: Interstitial Lung Diseases Center of Excellence, Department of Pulmonology, St Antonius Hospital
city: Rotterdam
country: Netherlands
facility: Department of Respiratory Medicine, Center of Excellence for Interstitial Lung Disease, Erasmus University Medical Center
city: Utrecht
country: Netherlands
facility: Division of Heart and Lungs, University Medical Center Utrecht and Utrecht University
Study officials:
affiliation: Department of Respiratory Medicine, Center of Excellence for Interstitial Lung Disease, Erasmus University Medical Center, Rotterdam, The Netherlands
name: Marlies S. Wijsenbeek-Lourens, Prof Dr
role: PRINCIPAL_INVESTIGATOR
References: