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
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Interventions
- Device: Vivalink wearable device
- Registration Number
- NCT05655832
- Lead Sponsor
- Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 77
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
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description COPD cohort Vivalink wearable device - Calibration participants cohort Vivalink wearable device -
- Primary Outcome Measures
Name Time Method Occurrence of COPD exacerbations 3 months Severity of exacerbations 3 months 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.
- Secondary Outcome Measures
Name Time Method COPD Assessment Test (CAT) Questionnaire: Patients' health status and symptoms at baseline and study end Baseline (Day 0) and at 3 months 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
Lung function measuring FEV1 / Forced Vital Capacity (FVC) as assessed using body plethysmography 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 Number of COPD exacerbations 3 months
Trial Locations
- Locations (11)
Praxis an der Oper
🇩🇪Berlin, Germany
Lungenzentrum Darmstadt GmbH
🇩🇪Darmstadt, Germany
Städtische Kliniken Darmstadt
🇩🇪Darmstadt, Germany
Lungenzentrum Frankfurt
🇩🇪Frankfurt, Germany
Thoraxklinik Heidelberg gGmbH
🇩🇪Heidelberg, Germany
ZERO Praxen
🇩🇪Mannheim, Germany
Pneumologische Gemeinschaftspraxis Saarbrücken
🇩🇪Saarbrücken, Germany
Pneumologisches Studienzentrum München-West
🇩🇪München, Germany
RespiRatio / Lungenpraxis
🇩🇪Schleswig, Germany
Lungenpraxis Dr. Franz / Dr. Weber
🇩🇪Witten, Germany
Pneumologische Praxis Wiesbaden
🇩🇪Wiesbaden, Germany