Remote monitoring ILD feasibility assessment
Research type
Research Study
Full title
Remote monitoring of interstitial lung disease to provide continuity of care and shielding from risks associated with in-clinic assessment
IRAS ID
286521
Contact name
Melissa Wikremasinghe
Contact email
Sponsor organisation
Quiddity Health Ltd
Duration of Study in the UK
0 years, 5 months, 15 days
Research summary
Research Summary
As in-clinic pulmonary function testing is greatly restricted due to COVID19, alternative approaches to monitoring patients with long-term respiratory conditions need to be developed and assessed. This project will evaluate the feasibility of a remote monitoring programme designed for interstitial lung disease (ILD) [including idiopathic pulmonary fibrosis (IPF)] patients which includes patient-reported spirometry & pulse oximetry (to estimate lung airflow and oxygen levels in the blood). This will be assessed in two groups of patients, one in an urban (London) and the other in a more rural setting (Nottingham region).
Patients with a confirmed diagnosis of ILD will be asked to measure spirometry & pulse oximetry once/day for approximately three months. Each patient will be supplied with a spirometer & pulse oximeter for home use. There will be no other changes to patients’ care. The clinical teams responsible for care of the patients will be able to view all patient-recorded data immediately after data are recorded by the patient. Feasibility of remote monitoring will be assessed by determining the proportion of patients who provide measurements at least 3 times/week and on at least 70% of days in the observation period. Patient engagement (Patient Activation Measure), changes in spirometry measurements over time and healthcare resource utilisation (e.g. number of in-clinic visits) will also be assessed. Other outcomes assessed will include estimation of the proportion of patients with significant decreases in lung function, number of occasions where critical alert values of physiological parameters are reported and number of interventions by healthcare professionals in response to observations or alerts from remote monitoring. Feedback from patients and healthcare providers on user experience will also be sought.
Learnings from this project will be used to assess the wider application of delivery of digitally-based remote monitoring in management of long-term respiratory conditions.
Summary of Results
We wanted to know if monitoring your breathing at home is helpful if you have interstitial lung disease (ILD), including pulmonary fibrosis. We can monitor how well your lungs are working by measuring the amount of air you can breathe in and out (spirometry) and recording the amount of oxygen in your blood.
In the past, we could only monitor your lungs at the hospital, but now digital applications have been developed which can help record your spirometry and oxygen levels (oximetry) at home. We wanted to ask whether this is useful for patients with ILD.
Who participated in the study?
The study took place in 4 hospital sites across England between October 2021 and July 2022.
60 patients were recruited, gave consent to participate and provided at least one spirometry reading.
Average age: 68 years (range 24 – 83 years), 60% male ILD subtype: Idiopathic Pulmonary Fibrosis: 33/60 (55%); Other types of ILD 27/60 (45%) including Chronic Hypersensitivity Pneumonitis, Connective Tissue Disease associated-ILD, Rheumatoid Arthritis-ILD and others Average baseline forced vital capacity (FVC): 84% predicted What was the study?
Participants installed the patientMpower app on their smartphones or tablets. They were asked to record their oximetry and spirometry using the app every day for 3 months. Their clinical teams were asked to review these measurements weekly.
Participants were asked to complete questionnaires at the beginning and end of the study.
Did anything go wrong?
One participant reported a dizzy episode during spirometry.
2 patients were advised to stop recording spirometry for medical reasons. The medical reasons were not caused by home monitoring.
2 patients were admitted to hospital during the study but this was not related to them taking part in the study.
What were the results of the study?
68% of participants recorded spirometry at least 3 times every week and 72% recorded their oximetry at least 3 times every week.
On average, participants recorded spirometry on 71 days and oximetry measurements on 74 days during the 91 day study.
Participants were more likely to record spirometry and oximetry if they were older or had more severe lung disease. We did not find any other reasons to explain how often people recorded measurements.
33 participants out of 60 answered a questionnaire about their opinions. Participants who answered the questionnaire were more likely to have less severe disease and carried out more measurements compared to participants who did not fill out the questionnaire. Everyone who responded thought that home spirometry and oximetry were easy to perform and record. 75% wished to continue to monitor their lungs at home.
What does this mean?
These results suggest that it is possible for patients with interstitial lung disease to monitor their breathing at home.
The findings suggest that it is acceptable to most patients with ILD and useful for some patients to do this. However, it may not suit everyone. We need more research to understand which patients find it helpful.
Healthcare professionals need more research to understand how to respond to changes in home spirometry and make this information more useful in the caring for patients.
What next?
Our next step is to understand if remote monitoring should become a regular part of how we monitor and care for all patients with ILD usual care and the best way of using it in the care of ILD.REC name
East Midlands - Derby Research Ethics Committee
REC reference
21/EM/0004
Date of REC Opinion
2 Feb 2021
REC opinion
Further Information Favourable Opinion