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

Abstract

Background Chronic lung disorders like chronic obstructive pulmonary disease (COPD) and idiopathic pulmonary fibrosis (IPF) are characterized by exacerbations. They are unpleasant for patients and sometimes severe enough to cause hospital admission and death. Moreover, due to the COVID-19 pandemic, vulnerable populations with these disorders are at high risk, and their routine care cannot be done properly. Remote monitoring offers a low cost and safe solution for gaining visibility into the health of people in their daily lives, making it useful for vulnerable populations. Objective The primary objective is to assess the feasibility and acceptability of remote monitoring using wearables and mobile phones in patients with pulmonary diseases. The secondary objective is to provide power calculations for future studies centered around understanding the number of exacerbations according to sample size and duration. Methods Twenty participants will be recruited in each of three cohorts (COPD, IPF, and posthospitalization COVID). Data collection will be done remotely using the RADAR-Base (Remote Assessment of Disease And Relapse) mobile health (mHealth) platform for different devices, including Garmin wearable devices and smart spirometers, mobile app questionnaires, surveys, and finger pulse oximeters. Passive data include wearable-derived continuous heart rate, oxygen saturation, respiration rate, activity, and sleep. Active data include disease-specific patient-reported outcome measures, mental health questionnaires, and symptom tracking to track disease trajectory. Analyses will assess the feasibility of lung disorder remote monitoring (including data quality, data completeness, system usability, and system acceptability). We will attempt to explore disease trajectory, patient stratification, and identification of acute clinical events such as exacerbations. A key aspect is understanding the potential of real-time data collection. We will simulate an intervention to acquire responses at the time of the event to assess model performance for exacerbation identification. Results The Remote Assessment of Lung Disease and Impact on Physical and Mental Health (RALPMH) study provides a unique opportunity to assess the use of remote monitoring in the evaluation of lung disorders. The study started in the middle of June 2021. The data collection apparatus, questionnaires, and wearable integrations were setup and tested by the clinical teams prior to the start of recruitment. While recruitment is ongoing, real-time exacerbation identification models are currently being constructed. The models will be pretrained daily on data of previous days, but the inference will be run in real time. Conclusions The RALPMH study will provide a reference infrastructure for remote monitoring of lung diseases. It specifically involves information regarding the feasibility and acceptability of remote monitoring and the potential of real-time data collection and analysis in the context of chronic lung disorders. It will help plan and inform decisions in future studies in the area of respiratory health. Trial Registration ISRCTN Registry ISRCTN16275601; https://www.isrctn.com/ISRCTN16275601 International Registered Report Identifier (IRRID) PRR1-10.2196/28873

The Innovative Medicines Initiative neurodegeneration portfolio: From individual projects to collaborative networks

“…The EQIPD Quality System, which includes a series of tools, guidance and requirements to support preclinical researchers ensure their work is robust and reliable, is being incorporated into the global Partnership for Assessment and Accreditation of Scientific Practice (PAASP) network ( https://paasp.net ). Together, the RADAR-CNS and RADAR-AD projects have developed and refined the RADAR-Base system ( https//radar-base.org ), an open-source platform for remote assessment using wearables and mobile applications, which is now also being used by external groups for studies on remote monitoring of lung diseases ( 8 ). While research and innovation efforts such as these have opened new commercial possibilities based on new services and products, IMI efforts have been especially beneficial in terms of scientific progress and publishable results.…”

Home monitoring of physiology and symptoms to detect interstitial lung disease exacerbations and progression: a systematic review

“…The potential of home monitoring of ILD patients was a consistent focus of the included studies, but the challenge of providing effective detection of exacerbation and/or progression has yet to be addressed. The published trials were mostly feasibility studies with a few ongoing studies [ 56 , 84 – 86 ] focusing on detection of AE-ILD using home spirometry. Researchers should conduct longitudinal studies of physiological parameters and symptoms with real-time feedback from integrated spirometry, pulse oximetry and wearable devices and smartphone applications to assess their ability to detect exacerbation and/or progression in patients with ILD.…”

Hypnosis for the management of COPD-related anxiety and dyspnoea in pulmonary rehabilitation: rationale and design for a cluster-randomised, active-control trial (HYPNOBPCO_2)

“…Second, because its implementation is fast, and its effects are both immediate and long-lasting: patients can be inconvenienced for as little as 15 min [ 10 ], either in person or online [ 33 ], and obtain a clinically significant relief that can be revisited through self-hypnosis at later times. This could significantly contribute to delocalising PRPs, conducting online PRPs [ 34 ] and reducing general rehabilitation duration without compromising output quality [ 35 ]. Finally, owing to the nature of its therapeutic mechanisms, hypnosis is always highly personalised, as it is based on a patients’ own memories, behaviours and proprioception [ 36 ].…”