Implementation of Home Monitoring in Patients with Pulmonary Fibrosis

Not Applicable

Recruiting

• Conditions: Pulmonary Fibrosis; Interstitial Lung Disease (ILD)

• Registration Number: NCT06883448
• Lead Sponsor: Erasmus Medical Center

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.

Study Timeline

• Study Start: 2024-10-02
• Status Verified: 2025-03
• Study First Submitted: 2025-03-13
• Study First Submitted QC: 2025-03-13
• Last Update Submitted: 2025-03-13
• Study First Posted: 2025-03-19
• Last Update Posted: 2025-03-19
• Primary Completion: 2026-09-01
• Study Completion: 2026-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 220

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Patient self-management	Baseline to 12 months	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.

Secondary Outcome Measures

Name	Time	Method
Forced vital capacity (FVC)	Baseline to 12 months	Delta forced vital capacity (FVC) measured with home measured pulmonary function study (PFT) as ml and as percentage predicted of healthy standards (in %).
Patient self management	Baseline	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.
Patient self-management	Baseline to 6 months	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.
Living with Pulmonary Fibrosis (L-PF) questionnaire	Baseline to 12 months	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.
King's brief Interstitial Lung Disease Health Status (K-BILD)	Baseline to 12 months	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.
Diffusing capacity of the lung for carbon monoxide (DLCO)	Baseline to 12 months	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 %).
Planned respiratory related hospital visits	Baseline to 12 months
Unplanned respiratory related hospital visits	Baseline to 12 months
Respiratory related hospitalisations	From baseline to 12 months
The EuroQol five dimensions 5-level plus respiratory bolt-on (EQ-5D-5L+R) questionnaire	Baseline to 12 months	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.
Patient Experience and Satisfaction with Medication questionnaire	Baseline to 12 months	Delta scores of all domains of the Patient Experience and Satisfaction with Medication (PESaM) questionnaire will be assessed. PESaM assesses patients' experiences and satisfaction of antifibrotic therapy. PESaM will be used to gain more insights into patients' perceived effectiveness of medication. The questionnaire consists of 10 items related to domains effectiveness, side effects, and ease of use of anti-fibrotic treatment. Higher scores in the domain of effectiveness represent higher positive experiences with therapy. In the domains side effects and ease of use, higher scores represent higher patient burden.
Video consultations	Baseline to 12 months	Compare the number of video consultations performed.
Mortality	Baseline to 12 months
Patient adherence to home monitoring protocol	Baseline to 12 months	Patients' adherence to home monitoring for home measured spirometry, pulse-oximetry, and patient-reported outcome measures (PROMs).

Trial Locations

Locations (11)

Department of Pulmonology, Onze Lieve Vrouwe Gasthuis; 🇳🇱 Amsterdam, Netherlands

Department of Pulmonary Diseases, Rijnstate Hospital; 🇳🇱 Arnhem, Netherlands

Department of Respiratory Medicine, Amphia Hospital; 🇳🇱 Breda, Netherlands

Department of Pulmonology, Haaglanden Medisch Centrum; 🇳🇱 Den Haag, Netherlands

Department of Respiratory Medicine, Catharina Hospital; 🇳🇱 Eindhoven, Netherlands

Department of Pulmonary Medicine, Zuyderland Medical Centre; 🇳🇱 Heerlen, Netherlands

Department of Pulmonology, Medical Center Leeuwarden; 🇳🇱 Leeuwarden, Netherlands

Department of Pulmonology, Leiden University Medical Center; 🇳🇱 Leiden, Netherlands

Interstitial Lung Diseases Center of Excellence, Department of Pulmonology, St Antonius Hospital; 🇳🇱 Nieuwegein, Netherlands

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

Division of Heart and Lungs, University Medical Center Utrecht and Utrecht University; 🇳🇱 Utrecht, Netherlands