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

Sponsor
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Study ID
NCT05655832
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
40 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Vivalink wearable device — DEVICE
    a CE marked device modified to add a temperature measurement algorithm in addition to ECG and respiratory rate measurements

Study Details

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.

Key Dates

Start date
Dec 5, 2022
Status verified
Dec 2025
Primary completion
Oct 31, 2023
Completion
Oct 31, 2023

Study Design

Enrollment
77 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: COPD cohort
  • Experimental: Calibration participants cohort

Primary Outcome Measure

Chronic Obstructive Pulmonary Disease (COPD) Exacerbations of Sensor-collected Parameters During Observation Period - Physical Activity [ Time Frame: Day 0(Baseline) and Day 8 to Day 14 ]

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