search
Back to results

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

Primary Purpose

Pulmonary Disease, Chronic Obstructive

Status
Active
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Vivalink wearable device
Sponsored by
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Pulmonary Disease, Chronic Obstructive

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Research Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

COPD cohort

Calibration participants cohort

Arm Description

Outcomes

Primary Outcome Measures

Occurrence of COPD exacerbations
Severity of exacerbations
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

COPD Assessment Test (CAT) Questionnaire: Patients' health status and symptoms at baseline and study end
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 Forced Expiratory Volume in 1 second (FEV1) as assessed using body plethysmography
Lung function measuring FEV1 / Forced Vital Capacity (FVC) as assessed using body plethysmography
Number of COPD exacerbations

Full Information

First Posted
November 18, 2022
Last Updated
July 26, 2023
Sponsor
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
search

1. Study Identification

Unique Protocol Identification Number
NCT05655832
Brief Title
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
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 5, 2022 (Actual)
Primary Completion Date
November 27, 2023 (Anticipated)
Study Completion Date
November 27, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
77 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
COPD cohort
Arm Type
Experimental
Arm Title
Calibration participants cohort
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Vivalink wearable device
Intervention Description
a CE marked device modified to add a temperature measurement algorithm in addition to ECG and respiratory rate measurements
Primary Outcome Measure Information:
Title
Occurrence of COPD exacerbations
Time Frame
3 months
Title
Severity of exacerbations
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
COPD Assessment Test (CAT) Questionnaire: Patients' health status and symptoms at baseline and study end
Description
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
Time Frame
Baseline (Day 0) and at 3 months
Title
Lung function measuring Forced Expiratory Volume in 1 second (FEV1) as assessed using body plethysmography
Time Frame
Baseline (Day 0) and at 3 months
Title
Lung function measuring FEV1 / Forced Vital Capacity (FVC) as assessed using body plethysmography
Time Frame
Baseline (Day 0) and at 3 months
Title
Number of COPD exacerbations
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Responsible
Organizational Affiliation
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Heidelberg
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and the European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website http://bit.ly/IPD21

Learn more about this trial

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

We'll reach out to this number within 24 hrs