At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A clinical study evaluating Vivalink wearable device for Pulmonary Disease, Chronic Obstructive. Completed, enrolled 77 participants across 11 sites.
Detailed 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.
Study Details
Timeline
Interventions
a CE marked device modified to add a temperature measurement algorithm in addition to ECG and respiratory rate measurements