ILD: Health Outcomes in Remote Digital Monitoring Versus Usual Care
- Conditions
- Interstitial Lung Disease
- Interventions
- Other: Remote monitoring
- Registration Number
- NCT05662124
- Lead Sponsor
- Imperial College Healthcare NHS Trust
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 139
- Diagnosis of fibrotic interstitial lung disease
- Aged at least 18 years
- Owns a smartphone or tablet device
- Has a mobile telephone number, email address and access to the internet at home
- In clinic lung function assessment within 6 months prior to study entry including spirometry and gas transfer measurement
- Intention to have at least two outpatient clinical reviews (either in person or virtual) within the study observation period of 12 months
- Willing to allow home monitoring of their health including spirometry and pulse oximetry data
- Understands how to use mobile technology (eg. has downloaded and used other "apps" on their mobile device; uses email)
- Demonstrates willingness to measure spirometry and pulse oximetry three times weekly for the duration of the observation period
- Fluent in English language
- Written or electronic informed consent
- Unable to fulfil all inclusion criteria
- Cognitive impairment
- History of difficulties performing spirometry at previous clinic testing
- Contraindications to spirometry (for example previous pneumothorax, unstable cardiac status, known aortic or cerebral aneurysm)
- Serious concomitant conditions which place the patient at high risk of respiratory distress making them unsuitable to be managed at home.
- Current or recent (within the last 6 weeks before baseline) participation in another research project
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Remote Monitoring Remote monitoring Patients in this arm will be asked to record their spirometry and oximetry three times weekly. This will be performed using a spirometer and oximeter which upload the results via bluetooth to the patientMpower app on their smartphones/tablets. These results are immediately available for review by their clinical teams who will be asked to review them at least once a fortnight. All patients will be asked to complete surveys at baseline, 3, 6, and 12 months and for clinical outcome data during the observation period to be collected.
- Primary Outcome Measures
Name Time Method Spirometry availability at clinical review at first and last clinic appointments during the study observation period 12 months 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
- Secondary Outcome Measures
Name Time Method Number of patients who have chest CT scans 12 months Total number for each study arm
Change in forced vital capacity (FVC) 12 months Average for each study arm
Number of patients with >10% decline in FVC 12 months Number of in-clinic lung function appointments per patient 12 months Total number for each study arm
Number of patients starting new treatments for their interstitial lung disease 12 months Number of hospital admissions per patient 12 months Average for each study arm
Change in health-related quality of life (EQ-5D-5L) score 12 months Average for each study arm
Change in Generalised Anxiety Disorder Assessment (GAD-7) 12 months Average for each study arm
Proportion of clinical reviews which are virtual 12 months Average for each study arm
Number of patients recording measurements at least once/week on at least 66% study weeks 12 months active study arm only.
Number of unscheduled reviews per patient 12 months Average for each study arm
Number of clinical reviews per patient 12 months Average for each study arm
Adherence to study measurements 12 months Active study arm only, adherence calculated as number of days with recordings divded by 156 days, result will be an average.
Change in patient recorded dyspnoea (mMRC) score 12 months Average for each study arm
Change in King's Brief Interstitial Lung Disease (K-BILD) score 12 months Average for each study arm
Change in Patient Activation Measure (PAM-13) 12 months Average for each study arm
Trial Locations
- Locations (12)
New Cross Hospital, Royal Wolverhampton NHS Trust
🇬🇧Wolverhampton, United Kingdom
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
Royal Hampshire County Hospital
🇬🇧Winchester, United Kingdom