A Study to Investigate the Association of Real-world Sensor-derived Biometric Data With Clinical Parameters and Patient-reported Outcomes for Monitoring Disease Activity in Patients With COPD

Study Overview
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Brief Summary
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The purpose of this multicenter, prospective cohort study is to investigate the correlation of real-world sensor-derived biometric data obtained via a wearable device with clinical parameters and patient-reported outcomes (PROs) for monitoring disease activity and predicting exacerbations for participants with Chronic Obstructive Pulmonary Disease (COPD). The cohort of participants with COPD will be followed for 3 months. A calibration cohort with non-COPD participants will be included and followed for 2 weeks.

Official Title
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A Study to Investigate the Association of Real-world Sensor-derived Biometric Data With Clinical Parameters and Patient-reported Outcomes for Monitoring Disease Activity in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Conditions
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Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
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* Device: Vivalink wearable device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: For participants with COPD: Participants ≥40 and ≤80 years at baseline Diagnosis of COPD stage II to IV History of moderate or severe exacerbations (≥2 moderate exacerbations or ≥1 severe exacerbations in any 12-month time window during last 3 years prior to inclusion and ≥1 moderate or severe exacerbations in the last 12 months prior to inclusion, considering that the last 12 months may reflect lower exacerbation rate due to Covid-19 measures) For participants in the calibration cohort: • Participants ≥40 and ≤80 years at baseline Exclusion Criteria: For participants with COPD: Clinically relevant and/or serious concurrent medical conditions including, but not limited to visual problems, severe mental illness or cognitive impairment, musculoskeletal or movement disorders, cardiac disease (e.g., heart failure, arrythmia [esp. atrial fibrillation and conduction blocks]), lung cancer (currently treated) that in the opinion of the Investigator, would interfere with participant's ability to participate in the study or draw meaningful conclusions from the study Participants with a cardiac pacemaker, defibrillators, or other implanted electronic devices Participants with known allergies or sensitivity to silicon or hydrogel Less than 6 weeks since previous moderate/severe exacerbation For participants in the calibration cohort: Participants with a cardiac pacemaker, defibrillators, or other implanted electronic devices Participants with known allergies or sensitivity to silicon or hydrogel Diagnosis of pulmonary disease including, but not limited to COPD, asthma, pulmonary fibrosis, with impact on the lung function and exercise capacity

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: COPD cohort<br> | Device: Vivalink wearable device<br>* a CE marked device modified to add a temperature measurement algorithm in addition to ECG and respiratory rate measurements<br>|
| Experimental: Calibration participants cohort<br> | Device: Vivalink wearable device<br>* a CE marked device modified to add a temperature measurement algorithm in addition to ECG and respiratory rate measurements<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of COPD exacerbations |  | 3 months | 
| Severity of exacerbations | Severity of acute exacerbations of COPD (AECOPD) are defined using the GOLD definitions based on treatment consequences (event-based): 1) mild if they are treated with short-acting bronchodilators only; 2) moderate if they are treated with short-acting bronchodilators plus antibiotics and/or oral corticosteroids; or 3) severe if the patient visits the emergency room or requires hospitalization because of an exacerbation. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| COPD Assessment Test (CAT) Questionnaire: Patients' health status and symptoms at baseline and study end | Patients' health status and symptoms at baseline (Day 0) and study end will be measured as the summary score across items of the CAT questionnaire that consists of 8-items in which participants can choose a score from 0 to 5, for each visit | Baseline (Day 0) and at 3 months | 
| Lung function measuring Forced Expiratory Volume in 1 second (FEV1) as assessed using body plethysmography |  | Baseline (Day 0) and at 3 months | 
| Lung function measuring FEV1 / Forced Vital Capacity (FVC) as assessed using body plethysmography |  | Baseline (Day 0) and at 3 months | 
| Number of COPD exacerbations |  | 3 months |