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| Name | Class |
|---|---|
| patientMpower Ltd. | INDUSTRY |
| Imperial College London | OTHER |
| University College, London | OTHER |
| Action for Pulmonary Fibrosis |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Remote Monitoring | Experimental | 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. |
|
| Usual Care | No Intervention | Patients in this arm will undergo usual clinical care as planned by their medical team. They 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remote monitoring | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of clinical reviews per patient | Average for each study arm | 12 months |
| Proportion of clinical reviews which are virtual | Average for each study arm |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Melissa Wickremasinghe | Imperial College Healthcare NHS Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Basingstoke and North Hampshire Hospital | Basingstoke | United Kingdom | ||||
| Royal Papworth Hospital |
Aggregate participant data will be available to shared with other researchers only.
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| 12 months |
| Number of in-clinic lung function appointments per patient | Total number for each study arm | 12 months |
| Number of patients who have chest CT scans | Total number for each study arm | 12 months |
| Change in forced vital capacity (FVC) | Average for each study arm | 12 months |
| Number of patients with >10% decline in FVC | 12 months |
| Number of patients starting new treatments for their interstitial lung disease | 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. | 12 months |
| Number of patients recording measurements at least once/week on at least 66% study weeks | active study arm only. | 12 months |
| Number of unscheduled reviews per patient | Average for each study arm | 12 months |
| Number of hospital admissions per patient | Average for each study arm | 12 months |
| Change in patient recorded dyspnoea (mMRC) score | Average for each study arm | 12 months |
| Change in health-related quality of life (EQ-5D-5L) score | Average for each study arm | 12 months |
| Change in King's Brief Interstitial Lung Disease (K-BILD) score | Average for each study arm | 12 months |
| Change in Generalised Anxiety Disorder Assessment (GAD-7) | Average for each study arm | 12 months |
| Change in Patient Activation Measure (PAM-13) | Average for each study arm | 12 months |
| Cambridge |
| United Kingdom |
| Royal Devon University Healthcare NHS Trust | Exeter | EX2 5DW | 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 |
| New Cross Hospital, Royal Wolverhampton NHS Trust | Wolverhampton | United Kingdom |
| ID | Term |
|---|---|
| D017563 | Lung Diseases, Interstitial |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000098465 | Remote Patient Monitoring |
| ID | Term |
|---|---|
| D017216 | Telemedicine |
| D003695 | Delivery of Health Care |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
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