Interstitial lung disease (ILD) is a collective term for a group of diseases where the lungs become scarred causing breathlessness. This research project will assess if remote digital monitoring of frequent spirometry and pulse oximetry can provide an additional way to monitor ILD and provide information to support virtual consultations. Outcomes in the remote monitoring group will be compared with usual care alone over 12 months. Patients taking part will be randomly allocated to remote digital monitoring or to usual care (with an equal chance of either). Remote monitoring will be performed using an app provided by patientMpower Ltd which patients will be able to download onto a smartphone or tablet. The study team will provide a spirometer and oximeter for patients to measure their lung function (spirometry) and oxygen saturations. These devices link to the app via Bluetooth to record all measurements. Patients will be asked to do these measurements three times a week. Clinical teams will be asked to review all measurements at least once a fortnight. Health outcomes will be described and compared between the two groups.
This study hopes to understand more about how remote digital monitoring of spirometry and pulse oximetry fits within the clinical care of patients with interstitial lung disease. This study will randomise patients to either remote monitoring or usual care and then collect information about the trajectory of their interstitial lung disease treatment and monitoring for the next 12 months to understand the impact of remote monitoring.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
139
Patients will download the patientMpower app and be provided with a spirometer (Spirobank Smart, MIR) and oximeter (Nonin) to record their spirometry and pulse oximetry which will upload to the application via Bluetooth for clinical review. Patients will be asked to upload measurements three times per week.
Basingstoke and North Hampshire Hospital
Basingstoke, United Kingdom
Royal Papworth Hospital
Cambridge, United Kingdom
Royal Devon University Healthcare NHS Trust
Exeter, United Kingdom
Leeds Teaching Hospital NHS Trust
Leeds, United Kingdom
University Hospital of Leicester NHS Trust
Leicester, United Kingdom
Liverpool University Hospitals NHS Foundation Trust
Liverpool, United Kingdom
Imperial College Healthcare NHS Trust
London, United Kingdom
Royal Brompton Hospital
London, United Kingdom
St George's University Hospital NHS Foundation Trust
London, United Kingdom
Sheffield Teaching Hospitals NHS Trust
Sheffield, United Kingdom
...and 2 more locations
Spirometry availability at clinical review at first and last clinic appointments during the study observation period
Number of patients who have spirometry recorded with the preceding 2 weeks for review at the first and last clinical reviews during the observation period
Time frame: 12 months
Number of clinical reviews per patient
Average for each study arm
Time frame: 12 months
Proportion of clinical reviews which are virtual
Average for each study arm
Time frame: 12 months
Number of in-clinic lung function appointments per patient
Total number for each study arm
Time frame: 12 months
Number of patients who have chest CT scans
Total number for each study arm
Time frame: 12 months
Change in forced vital capacity (FVC)
Average for each study arm
Time frame: 12 months
Number of patients with >10% decline in FVC
Time frame: 12 months
Number of patients starting new treatments for their interstitial lung disease
Time frame: 12 months
Adherence to study measurements
Active study arm only, adherence calculated as number of days with recordings divded by 156 days, result will be an average.
Time frame: 12 months
Number of patients recording measurements at least once/week on at least 66% study weeks
active study arm only.
Time frame: 12 months
Number of unscheduled reviews per patient
Average for each study arm
Time frame: 12 months
Number of hospital admissions per patient
Average for each study arm
Time frame: 12 months
Change in patient recorded dyspnoea (mMRC) score
Average for each study arm
Time frame: 12 months
Change in health-related quality of life (EQ-5D-5L) score
Average for each study arm
Time frame: 12 months
Change in King's Brief Interstitial Lung Disease (K-BILD) score
Average for each study arm
Time frame: 12 months
Change in Generalised Anxiety Disorder Assessment (GAD-7)
Average for each study arm
Time frame: 12 months
Change in Patient Activation Measure (PAM-13)
Average for each study arm
Time frame: 12 months
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