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

Merck KGaA (EMD Serono)

Status: Completed

Conditions: Pulmonary Disease, Chronic Obstructive

Treatments: Device: Vivalink wearable device

Study type: Interventional

Funder types: Industry

Identifiers

NCT05655832

MS202559_0001

Details and patient eligibility

About

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.

Enrollment: 77 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

77 participants in 2 patient groups

COPD cohort

Experimental group

Treatment:

Device: Vivalink wearable device

Calibration participants cohort

Experimental group

Treatment:

Device: Vivalink wearable device