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
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Keep this study
Lead
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Age
40–80
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | 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
