Interstitial Lung Disease (ILD), Pulmonary Fibrosis
Conditions
Keywords
eHealth, Hybrid care, Self-management
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. 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_PRODUCTHome 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.
Sponsors
Erasmus Medical Center
Zuyderland Medisch Centrum, Sittard-Geleen, the Netherlands
Leiden University Medical Center, LUMC, Leiden, The Netherlands
UMC Utrecht, Utrecht, the Netherlands
Rijnstate, Arnhem, the Netherlands
Catharina, Eindhoven, the Netherlands
MC Leeuwarden, Leeuwarden, the Netherlands
OLVG, Amsterdam, the Netherlands
Medical Center Haaglanden, The Hague, The Netherlands
Amphia, Breda, the Netherlands
St. Antonius Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Masking description
Participants, health-care providers, and research staff will not be masked to group allocation.
Intervention model description
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).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Living with Pulmonary Fibrosis (L-PF) questionnaire | Baseline | 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. |
| King's brief Interstitial Lung Disease Health Status (K-BILD) | Baseline | 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. |
| The EuroQol five dimensions 5-level plus respiratory bolt-on (EQ-5D-5L+R) questionnaire | Baseline | 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. |
| Scheduled respiratory related outpatient clinic visits | Baseline to 12 months | — |
| Unscheduled respiratory related outpatient clinic visits | Baseline to 12 months | — |
| Respiratory related remote consultations | Baseline to 12 months | Compare the number of remote consultations performed. |
| Respiratory related emergency visits | Baseline to 12 months | — |
| Respiratory related hospitalisations | From baseline to 12 months | — |
| Mortality or lung transplantation | Baseline to 12 months | — |
| Forced vital capacity (FVC) | Baseline | Forced vital capacity (FVC) measured with pulmonary function study (PFT) as ml and as percentage predicted of healthy standards (in %). |
| Diffusing capacity of the lung for carbon monoxide (DLCO) | Baseline | 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 %). |
| Correlation and agreement of home measured Forced vital capacity (FVC) | From baseline to 12 months | Correlations between home measured Forced vital capacity (FVC) and in-hospital FVC in ml in the home monitoring group. |
| 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). |
Countries
Netherlands
Contacts
CONTACTDelian E. Hofman
CONTACTCatharina C. Moor
PRINCIPAL_INVESTIGATORMarlies S. Wijsenbeek-Lourens, Prof Dr
Department of Respiratory Medicine, Center of Excellence for Interstitial Lung Disease, Erasmus University Medical Center, Rotterdam, The Netherlands
Outcome results
None listed