Issue in Remote Assessment of Lung Disease and Impact on Physical and Mental Health (RALPMH): Protocol for Prospective Observational Study.

Background Chronic Lung disorders like Chronic obstructive pulmonary disease (COPD) and Idiopathic pulmonary fibrosis (IPF) are characterised by exacerbations which are a significant problem: unpleasant for patients, and sometimes severe enough to cause hospital admission (and therefore National Health Service (NHS) pressures) and death. Reducing the impact of exacerbations is very important. Moreover, due to the coronavirus disease (COVID-19) pandemic, the vulnerable populations with these disorders are at high risk and hence their routine care cannot be done properly. Remote monitoring offers a low cost and safe solution of gaining visibility into the health of people in their daily life. Thus, remote monitoring of patients in their daily lives using mobile and wearable devices could be useful especially in high vulnerability groups. A scenario we consider here is to monitor patients and detect disease exacerbation and progression and investigate the opportunity of detecting exacerbations in real time with a future goal of real time intervention. Objective The primary objective is to assess the feasibility and acceptability of remote monitoring using wearable and mobile phones in patients with pulmonary diseases. The aims will be evaluated over these areas: Participant acceptability, drop-out rates and interpretation of data, Detection of clinically important events such as exacerbations and disease progression, Quantification of symptoms (physical and mental health), Impact of disease on mood and wellbeing/Quality-of-Life(QoL) and The trajectory-tracking of main outcome variables, symptom fluctuations and order. The secondary objective of this study is to provide power calculations for a larger longitudinal follow-up study. Power calculations will be centered around understanding the number of exacerbations according to sample size and duration. Methods Participants will be recruited from 2 NHS sites in 3 different cohorts - COPD, IPF and Post hospitalised Covid. A total of 60 participants will be recruited, 20 in each cohort. Data collection will be done remotely using the RADAR-Base (Remote Assessment of Disease And Relapse) mHealth (mobile health) platform for different devices - Garmin wearable devices, smart spirometers, mobile app questionnaires, surveys and finger pulse oximeters. Passive data collected includes wearable derived continuous heart rate, oxygen saturation (SpO2), respiration rate, activity, and sleep. Active data collected includes disease-specific Patient Reported Outcome Measures (PROMs), mental health questionnaires and symptoms tracking to track disease trajectory in addition to speech sampling, spirometry and finger Pulse Oximetry. Analyses are intended to assess the feasibility of RADAR-Base for lung disorder remote monitoring (include quality of data, cross-section of passive and active data, data completeness, the usability of the system, acceptability of the system). Where adequate data is collected, we will attempt to explore disease trajectory, patient stratification and identification of acute clinically interesting events such as exacerbations. A key part of this study is understanding the potential of real-time data collection, here we will simulate an intervention using the Exacerbation Rating Scale (ERS) to acquire responses at-time-of-event to assess the performance of a model for exacerbation identification from passive data collected. Results RALPMH study provides a unique opportunity to assess the use of remote monitoring in the study of lung disorders. The study is set to be started in mid-June 2021. The data collection apparatus, questionnaires and wearable integrations have been set up and tested by clinical teams as of 24th April 2021. While waiting for ethics approval, real-time exacerbation identification models are currently being constructed. The models will be pre-trained daily on previous days data but the inference will be run in real-time (with inputs from the wearable sensor data collected which is real-time) to acquire responses at-time-of-event to assess the performance of a model. Conclusions Remote Assessment of Lung Disease and Impact on Physical and Mental Health (RALPMH) will provide a reference infrastructure for the use of wearable data for monitoring lung diseases. Specifically information regarding the feasibility and acceptability of remote monitoring and the potential of real-time remote data collection and analysis in the context of chronic lung disorders. Moreover, it provides a unique standpoint to look into the specifics of novel coronavirus without burdensome interventions. It will help plan and inform decisions in any future studies that make use of remote monitoring in the area of Respiratory health. Clinicaltrial Isrctn.com ISRCTN16275601, https://www.isrctn.com/ISRCTN16275601.