Lung diseases (COPD, ILD, COVID19) Respiratory
Conditions
Interventions
This study will investigate the potential benefit and feasibility of multiparametric remote monitoring of patient symptoms and physiology using commercially available wearables sensors for heart rate,
spirometry, phone sensors, questionnaires and digital tests in patients with a range of pulmonary disorders.
Participants with lung diseases are enrolled and will wear wearable devices, use spiromete
Sponsors
South London and Maudsley NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: COPD cohort 1. Clinical Conditions: 20 patients with a diagnosis of COPD 2. Gender: M/F 3. Age range: 18+ years 4. Prior mobile phone use: required 5: Willingness to use monitoring devices and complete study questionnaires 6. History of exacerbation: 2 or more exacerbations in last 1 yr ILD cohort 1. Clinical Conditions: 20 patients with a diagnosis of interstitial lung disease 2. Gender: M/F 3. Age range: 18-90 4. Prior mobile phone use: required 5: Willingness to use monitoring devices and complete study questionnaires COVID-19 cohort 1. Clinical Conditions: a clinical diagnosis of COVID-19 (within 4-13 weeks of enrolment) who either and report symptoms interfering with day to day activity present for more than 28 days following the onset of COVID-19 2. Gender: M/F 3. Age range: 18+ 4. Prior mobile phone use: required 5: Willingness to use monitoring devices and complete study questionnaires
Exclusion criteria
Exclusion criteria: Non-English language Speaker
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Participant acceptability (TAMF, Interview) and drop-out rates at end of the study. The study will test the feasibility of tasks for participants. On completion of data collection periods a measurement of total available data as a function of a theoretical maximum and data quality measured by a range of criteria including missingness and contiguity 2. Detection of clinically important events such as exacerbations (inc. sub-clinical exacerbation) and disease progression, ERS, Sensor data, near real-time, 6 months. Detect exacerbation/symptom e.g. changes in wearable data (e.g. HR, SpO2, Activity) before, during and after the reported period of exacerbation (symptoms, FVC, death). A real-time algorithm will be included to predict exacerbations with patients notified with the Exacerbation Rating Scale (ERS) to confirm the prediction at or close to the time of the event 3. Quantification of symptoms (physical and mental health), various symptom questionnaires and scales, 6 months 4. Impact of disease on mood and wellbeing/QoL, GAD/PHQ8, weekly for 6 months 5. The trajectory-tracking of main outcome variables, symptom fluctuations, sub-clinical exacerbations and ordering 6. Report longitudinal mental health symptoms measures as reported by GAD7 and PHQ8 associated with the three diseases 7. Fatigue is the major reported symptom for those experiencing "long COVID". A range of modalities for evaluating fatigue are included 1) Garmin Body Battery value and 2) Fatigue Severity Scale (FSS), continuous/weekly respectively, duration of study 8. The assessment of novel phone based tests (Audio, Breathing Tests see: non-questionnaire Active App tests) for remote monitoring of respiratory health. The ubiquity of smartphones presents an opportunity to use the phone itself as a health measuring tool for both application in COVID-19 as part of this study but also wider application to other respiratory diseases. These phone based tests will be compared with other devices such as Pu | — |
Secondary
| Measure | Time frame |
|---|---|
| Measured at the end of the study using patient records and data recorded through wearable devices: 1. Proportion of participants that complete the study 2. Number of participants that experience one exacerbation within the stopping criteria for each group 3. Number of exacerbations that were detected by i) spirometry ii) PROMs iii) wearable data, within the stopping criteria for each group | — |
Countries
England, United Kingdom
Outcome results
None listed