Implementation of Home Monitoring in Patients With Pulmonary Fibrosis

NCT06883448 | Recruiting

• 2 other identifiers: MEC-2024-004510140292110006
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 11

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.

Conditions

Pulmonary Fibrosis; Interstitial Lung Disease (ILD)

Keywords

eHealth; Hybrid care; Self-management

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (28)

• Patient self-management

  Baseline

• Patient self-management

  Baseline to 6 months

• Living with Pulmonary Fibrosis (L-PF) questionnaire

  Baseline

• Living with Pulmonary Fibrosis (L-PF) questionnaire

  Baseline to 6 months

• Living with Pulmonary Fibrosis (L-PF) questionnaire

  Baseline to 12 months

Other Outcomes (4)

• Cost-effectiveness and cost-utility analyses

  Baseline to 12 months

• Healthcare professional- and patient satisfaction

  12 months

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

  Baseline to 12 months

Study Arms (2)

Hospital-based care

NO INTERVENTION

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

Home monitoring care

EXPERIMENTAL

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

Interventions

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.

Home monitoring care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (11)

Department of Pulmonology, Onze Lieve Vrouwe Gasthuis

Amsterdam, Netherlands

RECRUITING

Department of Pulmonary Diseases, Rijnstate Hospital

Arnhem, Netherlands

RECRUITING

Department of Respiratory Medicine, Amphia Hospital

Breda, Netherlands

RECRUITING

Department of Respiratory Medicine, Catharina Hospital

Eindhoven, Netherlands

RECRUITING

Department of Pulmonary Medicine, Zuyderland Medical Centre

Heerlen, Netherlands

RECRUITING

Department of Pulmonology, Medical Center Leeuwarden

Leeuwarden, Netherlands

RECRUITING

Department of Pulmonology, Leiden University Medical Center

Leiden, Netherlands

RECRUITING

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

Nieuwegein, Netherlands

RECRUITING

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

Rotterdam, Netherlands

RECRUITING

Department of Pulmonology, Haaglanden Medisch Centrum

The Hague, Netherlands

RECRUITING

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

Utrecht, Netherlands

RECRUITING

MeSH Terms

Conditions

Pulmonary Fibrosis; Lung Diseases, Interstitial

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Marlies S. Wijsenbeek-Lourens, Prof Dr

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Delian E. Hofman

CONTACT

+31650162675; d.hofman@erasmusmc.nl

Catharina C. Moor

CONTACT

c.moor@erasmusmc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Participants, health-care providers, and research staff will not be masked to group allocation.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr., MD

Model Details: 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).

Study Record Dates

• First Submitted: March 13, 2025
• First Posted: March 19, 2025
• Study Start: October 2, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: December 22, 2025

Record last verified: 2025-12

Locations

NL (11)