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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
220
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.
Department of Pulmonology, Onze Lieve Vrouwe Gasthuis
Amsterdam, Netherlands
RECRUITINGDepartment of Pulmonary Diseases, Rijnstate Hospital
Arnhem, Netherlands
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.
Time frame: Baseline to 12 months
Patient self-management
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.
Time frame: Baseline
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.
Time frame: Baseline to 6 months
Living with Pulmonary Fibrosis (L-PF) questionnaire
The Living with Pulmonary Fibrosis (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.
Time frame: Baseline
Living with Pulmonary Fibrosis (L-PF) questionnaire
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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Department of Respiratory Medicine, Amphia Hospital
Breda, Netherlands
RECRUITINGDepartment of Respiratory Medicine, Catharina Hospital
Eindhoven, Netherlands
RECRUITINGDepartment of Pulmonary Medicine, Zuyderland Medical Centre
Heerlen, Netherlands
RECRUITINGDepartment of Pulmonology, Medical Center Leeuwarden
Leeuwarden, Netherlands
RECRUITINGDepartment of Pulmonology, Leiden University Medical Center
Leiden, Netherlands
RECRUITINGInterstitial Lung Diseases Center of Excellence, Department of Pulmonology, St Antonius Hospital
Nieuwegein, Netherlands
RECRUITINGDepartment of Respiratory Medicine, Center of Excellence for Interstitial Lung Disease, Erasmus University Medical Center
Rotterdam, Netherlands
RECRUITINGDepartment of Pulmonology, Haaglanden Medisch Centrum
The Hague, Netherlands
RECRUITING...and 1 more locations
Time frame: Baseline to 6 months
Living with Pulmonary Fibrosis (L-PF) questionnaire
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.
Time frame: Baseline to 12 months
King's brief Interstitial Lung Disease Health Status (K-BILD)
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.
Time frame: Baseline
King's brief Interstitial Lung Disease Health Status (K-BILD)
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.
Time frame: Baseline to 6 months
King's brief Interstitial Lung Disease Health Status (K-BILD)
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.
Time frame: Baseline to 12 months
The EuroQol five dimensions 5-level plus respiratory bolt-on (EQ-5D-5L+R) questionnaire
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.
Time frame: Baseline
The EuroQol five dimensions 5-level plus respiratory bolt-on (EQ-5D-5L+R) questionnaire
Delta scores of 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.
Time frame: Baseline to 6 months
The EuroQol five dimensions 5-level plus respiratory bolt-on (EQ-5D-5L+R) questionnaire
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.
Time frame: Baseline to 12 months
Scheduled respiratory related outpatient clinic visits
Time frame: Baseline to 12 months
Unscheduled respiratory related outpatient clinic visits
Time frame: Baseline to 12 months
Respiratory related remote consultations
Compare the number of remote consultations performed.
Time frame: Baseline to 12 months
Respiratory related emergency visits
Time frame: Baseline to 12 months
Respiratory related hospitalisations
Time frame: From baseline to 12 months
Mortality or lung transplantation
Time frame: Baseline to 12 months
Forced vital capacity (FVC)
Forced vital capacity (FVC) measured with pulmonary function study (PFT) as ml and as percentage predicted of healthy standards (in %).
Time frame: Baseline
Forced vital capacity (FVC)
Delta forced vital capacity (FVC) measured with pulmonary function study (PFT) as ml and as percentage predicted of healthy standards (in %).
Time frame: Baseline to 6 months
Forced vital capacity (FVC)
Delta forced vital capacity (FVC) measured with pulmonary function study (PFT) as ml and as percentage predicted of healthy standards (in %).
Time frame: Baseline to 12 months
Diffusing capacity of the lung for carbon monoxide (DLCO)
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 %).
Time frame: Baseline
Diffusing capacity of the lung for carbon monoxide (DLCO)
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 %).
Time frame: Baseline to 6 months
Diffusing capacity of the lung for carbon monoxide (DLCO)
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 %).
Time frame: Baseline to 12 months
Forced vital capacity (FVC)
Forced vital capacity (FVC) measured with home measured pulmonary function study (PFT) as ml and as percentage predicted of healthy standards (in %).
Time frame: Baseline
Forced vital capacity (FVC)
Delta forced vital capacity (FVC) measured with home measured pulmonary function study (PFT) as ml and as percentage predicted of healthy standards (in %).
Time frame: Baseline to 6 months
Forced vital capacity (FVC)
Delta forced vital capacity (FVC) measured with home measured pulmonary function study (PFT) as ml and as percentage predicted of healthy standards (in %).
Time frame: Baseline to 12 months
Correlation and agreement of home measured Forced vital capacity (FVC)
Correlations between home measured Forced vital capacity (FVC) and in-hospital FVC in ml in the home monitoring group.
Time frame: From baseline to 12 months
Patient adherence to home monitoring protocol
Patients' adherence to home monitoring for home measured spirometry, pulse-oximetry, and patient-reported outcome measures (PROMs).
Time frame: Baseline to 12 months