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

Pulmonary Disease, Chronic Obstructive Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05655832
• Other study ID #: MS202559_0001
• Status: Completed
• Phase: N/A
• Start date: December 5, 2022
• Est. completion date: October 31, 2023

Study information

• Verified date: November 2023
• Source: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: October 31, 2023
• Est. primary completion date: October 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Lung Diseases
• Pulmonary Disease, Chronic Obstructive

Intervention

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

Locations

Country	Name	City	State
Germany	Praxis an der Oper	Berlin
Germany	Lungenzentrum Darmstadt GmbH	Darmstadt
Germany	Städtische Kliniken Darmstadt	Darmstadt
Germany	Lungenzentrum Frankfurt	Frankfurt
Germany	Thoraxklinik Heidelberg gGmbH	Heidelberg
Germany	ZERO Praxen	Mannheim
Germany	Pneumologisches Studienzentrum München-West	München
Germany	Pneumologische Gemeinschaftspraxis Saarbrücken	Saarbrücken
Germany	RespiRatio / Lungenpraxis	Schleswig
Germany	Pneumologische Praxis Wiesbaden	Wiesbaden
Germany	Lungenpraxis Dr. Franz / Dr. Weber	Witten

Sponsors (1)

Lead Sponsor	Collaborator
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of COPD exacerbations		3 months
Primary	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.	3 months
Secondary	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	Baseline (Day 0) and at 3 months
Secondary	Lung function measuring Forced Expiratory Volume in 1 second (FEV1) as assessed using body plethysmography		Baseline (Day 0) and at 3 months
Secondary	Lung function measuring FEV1 / Forced Vital Capacity (FVC) as assessed using body plethysmography		Baseline (Day 0) and at 3 months
Secondary	Number of COPD exacerbations		3 months

External Links

•   Trial Awareness and Transparency website