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Implementation of Home Monitoring in Patients With Pulmonary Fibrosis

NCT ID: NCT06883448

Last Updated: 2025-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-02

Study Completion Date

2026-09-01

Brief Summary

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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

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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.

Conditions

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Pulmonary Fibrosis Interstitial Lung Disease (ILD)

Keywords

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eHealth Hybrid care Self-management

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Participants, health-care providers, and research staff will not be masked to group allocation.

Study Groups

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Hospital-based care

Hospital-based care involves outpatient clinic visits every three months including in-hospital lung function testing.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Home monitoring care

Intervention Type 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.

Interventions

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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.

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zuyderland Medisch Centrum, Sittard-Geleen, the Netherlands

UNKNOWN

Sponsor Role collaborator

Leiden University Medical Center, LUMC, Leiden, The Netherlands

UNKNOWN

Sponsor Role collaborator

UMC Utrecht, Utrecht, the Netherlands

UNKNOWN

Sponsor Role collaborator

Rijnstate, Arnhem, the Netherlands

UNKNOWN

Sponsor Role collaborator

Catharina, Eindhoven, the Netherlands

UNKNOWN

Sponsor Role collaborator

MC Leeuwarden, Leeuwarden, the Netherlands

UNKNOWN

Sponsor Role collaborator

OLVG, Amsterdam, the Netherlands

UNKNOWN

Sponsor Role collaborator

Medical Center Haaglanden, The Hague, The Netherlands

UNKNOWN

Sponsor Role collaborator

Amphia, Breda, the Netherlands

UNKNOWN

Sponsor Role collaborator

St. Antonius Hospital

OTHER

Sponsor Role collaborator

Erasmus Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Marlies Wijsenbeek

Prof. Dr., MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marlies S. Wijsenbeek-Lourens, Prof Dr

Role: PRINCIPAL_INVESTIGATOR

Department of Respiratory Medicine, Center of Excellence for Interstitial Lung Disease, Erasmus University Medical Center, Rotterdam, The Netherlands

Locations

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Department of Pulmonology, Onze Lieve Vrouwe Gasthuis

Amsterdam, , Netherlands

Site Status RECRUITING

Department of Pulmonary Diseases, Rijnstate Hospital

Arnhem, , Netherlands

Site Status RECRUITING

Department of Respiratory Medicine, Amphia Hospital

Breda, , Netherlands

Site Status RECRUITING

Department of Respiratory Medicine, Catharina Hospital

Eindhoven, , Netherlands

Site Status RECRUITING

Department of Pulmonary Medicine, Zuyderland Medical Centre

Heerlen, , Netherlands

Site Status RECRUITING

Department of Pulmonology, Medical Center Leeuwarden

Leeuwarden, , Netherlands

Site Status RECRUITING

Department of Pulmonology, Leiden University Medical Center

Leiden, , Netherlands

Site Status RECRUITING

Interstitial Lung Diseases Center of Excellence, Department of Pulmonology, St Antonius Hospital

Nieuwegein, , Netherlands

Site Status RECRUITING

Department of Respiratory Medicine, Center of Excellence for Interstitial Lung Disease, Erasmus University Medical Center

Rotterdam, , Netherlands

Site Status RECRUITING

Department of Pulmonology, Haaglanden Medisch Centrum

The Hague, , Netherlands

Site Status RECRUITING

Division of Heart and Lungs, University Medical Center Utrecht and Utrecht University

Utrecht, , Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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Delian E. Hofman

Role: CONTACT

Phone: +31650162675

Email: [email protected]

Catharina C. Moor

Role: CONTACT

Email: [email protected]

Facility Contacts

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Paul Bresser

Role: primary

Linda Moonen

Role: primary

Daan W. Loth

Role: primary

Eveline Schakenraad

Role: primary

Rémy L.M. Mostard

Role: primary

Jan van der Maten

Role: primary

Kelly M.C. van Doorn-Hogervorst

Role: primary

Frouke van Beek

Role: primary

Delian E. Hofman

Role: primary

Maria J. Overbeek

Role: primary

Adriane D.M. Vorselaars

Role: primary

Other Identifiers

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MEC-2024-0045

Identifier Type: -

Identifier Source: org_study_id

10140292110006

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id