Implementation of Home Monitoring in Patients With Pulmonary Fibrosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Home monitoring care.
- Who it may be relevant to
- Registry conditions: Pulmonary Fibrosis, Interstitial Lung Disease (ILD). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The SUITS Study: Implementation of Home Monitoring in Patients With Pulmonary Fibrosis
Overview
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.
Interventions
- 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.
Primary outcome measures
- Patient self-management [Time frame: Baseline to 12 months]
Secondary outcome measures (12)
- 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]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Health services research
Study locations
Netherlands · 11 centers
- Department of Pulmonology, Onze Lieve Vrouwe Gasthuis — Amsterdam
- Department of Pulmonary Diseases, Rijnstate Hospital — Arnhem
- Department of Respiratory Medicine, Amphia Hospital — Breda
- Department of Respiratory Medicine, Catharina Hospital — Eindhoven
- Department of Pulmonary Medicine, Zuyderland Medical Centre — Heerlen
- Department of Pulmonology, Medical Center Leeuwarden — Leeuwarden
- Department of Pulmonology, Leiden University Medical Center — Leiden
- Interstitial Lung Diseases Center of Excellence, Department of Pulmonology, St Antonius Ho — Nieuwegein
- … and 3 more centers
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 ahe PMID 42310732
Identifiers
NCT: NCT06883448 · MEC-2024-0045 · 10140292110006