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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

77 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-05

Study Completion Date

2023-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Pulmonary Disease, Chronic Obstructive

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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COPD cohort

Group Type EXPERIMENTAL

Vivalink wearable device

Intervention Type DEVICE

a CE marked device modified to add a temperature measurement algorithm in addition to ECG and respiratory rate measurements

Calibration participants cohort

Group Type EXPERIMENTAL

Vivalink wearable device

Intervention Type DEVICE

a CE marked device modified to add a temperature measurement algorithm in addition to ECG and respiratory rate measurements

Interventions

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Vivalink wearable device

a CE marked device modified to add a temperature measurement algorithm in addition to ECG and respiratory rate measurements

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No