Pulmonary Disease, Chronic Obstructive
Conditions
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.
Interventions
DEVICEVivalink wearable device
a CE marked device modified to add a temperature measurement algorithm in addition to ECG and respiratory rate measurements
Sponsors
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Chronic Obstructive Pulmonary Disease (COPD) Exacerbations of Sensor-collected Parameters During Observation Period - Physical Activity | Day 0(Baseline) and Day 8 to Day 14 | An activity flag is extracted from the accelerometer by Vivalink, by using a predefined threshold for adult movement. For stair climbing, first periodic movement was determined, by using frequency analysis on specific time windows, and generating a ratio to the total spectrum indicating periodic activity over a certain threshold. |
| Chronic Obstructive Pulmonary Disease (COPD) Exacerbations of Sensor-collected Parameters During Observation Period - Heart Rate | Day 0(Baseline) and Day 8 to Day 14 | Heart rate is provided by Vivalink. |
| Chronic Obstructive Pulmonary Disease (COPD) Exacerbations of Sensor-collected Parameters During Observation Period - Heart Rate Variability (SDRR, SDNN, SDNNI, RMSSD, ln(RMSSD)) | Day 0(Baseline) and Day 8 to Day 14 | Heart rate variability reflecting differences in time intervals between 2 R-waves in the ECG (milliseconds) SDRR (Standard Deviation of Intervals between Heartbeats), SDNN (Standard Deviation of Intervals between Heartbeats, after removing abnormal Beats), SDNNI (Mean of the Standard Deviations of all the NN intervals for each 5 min Segment of a 24-h HRV Recording), and RMSSD (Mean of the Standard Deviations of all the NN intervals for each 5 min Segment of a 24-hour HRV Recording) and In(RMSDD) |
| Chronic Obstructive Pulmonary Disease (COPD) Exacerbations of Sensor-collected Parameters During Observation Period - Heart Rate Variability (pNN50) | Day 0(Baseline) and Day 8 to Day 14 | pNN50 is the percentage of adjacent NN intervals that differ from each other by more than 50 milliseconds. |
| Chronic Obstructive Pulmonary Disease (COPD) Exacerbations of Sensor-collected Parameters During Observation Period - Heart Rate Variability (Stress Index) | Day 0(Baseline) and Day 8 to Day 14 | Baevsky's Stress Index is a heart rate variability (HRV) measure used to assess autonomic nervous system activity and physiological stress, especially in monitoring chronic obstructive pulmonary disease (COPD) exacerbations. It is calculated as: amplitude of the mode (AMo) divided by two times the mode (Mo) multiplied by the difference between the maximum and minimum RR intervals (MxDMn). AMo is the percentage of RR intervals at the most frequent value, Mo is the most common RR interval, and MxDMn is the range of RR intervals. The index typically ranges from 50 to over 900. Lower values (50-150) indicate low stress and better autonomic balance, while higher values (above 500) reflect increased stress and sympathetic activity. Values above 900 are considered very high stress. This is a single composite score with no subscales; higher scores represent worse outcomes. |
| Chronic Obstructive Pulmonary Disease (COPD) Exacerbations of Sensor-collected Parameters During Observation Period - Heart Rate Variability (LF and HF) | Day 0(Baseline) and Day 8 to Day 14 | Applying a Fast Fourier Transformation (FFT) or autoregressive (AR) modeling one can separate Heart rate variability (HRV) into its component ultra-low-frequency (ULF), very low frequency (VLF), Low-Frequency power (LF), and High-Frequency power (HF) rhythms that operate within different frequency ranges. Given in absolute values of power (milliseconds squared). LF power, low frequency power (0.04-0.15 Hz). HF power, high frequency power (0.15-0.40 Hz). LF/HF Ratio, spectral HRV index computed as (LF/HF). |
| Chronic Obstructive Pulmonary Disease (COPD) Exacerbations of Sensor-collected Parameters During Observation Period - Heart Rate Variability (LF/HF) | Day 0(Baseline) and Day 8 to Day 14 | Applying a Fast Fourier Transformation (FFT) or autoregressive (AR) modeling one can separate Heart rate variability (HRV) into its component ultra-low-frequency (ULF), very low frequency (VLF), Low-Frequency power (LF), and High-Frequency power (HF) rhythms that operate within different frequency ranges. Given in absolute values of power (milliseconds squared). LF power, low frequency power (0.04-0.15 Hz). HF power, high frequency power (0.15-0.40 Hz). LF/HF Ratio, spectral HRV index computed as (LF/HF). |
| Chronic Obstructive Pulmonary Disease (COPD) Exacerbations of Sensor-collected Parameters During Observation Period - Temperature | Day 0(Baseline) and Day 8 to Day 14 | Temperature is provided by Vivalink. The value for temperature is derived by Vivalink from the display temperature and then calibrated using initial calibration values, in an IP protected process. The sensor temperature is considered only as a relative value to evaluate changes in the temperature, and not as an objective human body temperature value, meaning no thresholds relative to normal human body temperature are considered, and it will not be used as a marker for fever or hypothermia. |
| Chronic Obstructive Pulmonary Disease (COPD) Exacerbations of Sensor-collected Parameters During Observation Period - Respiratory Rate | Day 0(Baseline) and Day 8 to Day 14 | Respiration rate is provided by Vivalink. |
| Chronic Obstructive Pulmonary Disease (COPD) Exacerbations of Sensor-collected Parameters During Observation Period - Cough Frequency | Day 0(Baseline) and Day 8 to Day 14 | Cough Frequency was provided by vivalink. |
| Chronic Obstructive Pulmonary Disease (COPD) Exacerbations of Sensor-collected Parameters During Observation Period - Sleep Patterns | Day 0(Baseline) and Day 8 to Day 14 | The basis of the sleep pattern calculations is the self-reported bedtimes. With the same technique as the cough frequency prediction, inactivity signals can be predicted from the labeled data to improve the bedtime accuracy, and the changes in accelerometer (step detection algorithms) can be used to quantify the number of clear breaks in the sleep (standing up, strong cough, etc.). |
| Chronic Obstructive Pulmonary Disease (COPD) Exacerbations of Sensor-collected Parameters During Observation Period - Resting Heart Rate | Day 0(Baseline) and Day 8 to Day 14 | Resting Heart Rate is provided by Vivalink. |
| Chronic Obstructive Pulmonary Disease (COPD) Exacerbations of Sensor-collected Parameters During Observation Period - Inspiration vs Expiration Time Ratio | Day 0(Baseline) and Day 8 to Day 14 | Using the breathing signal one can determine the inspiration and expiration peaks. The difference between said peaks in milliseconds can be used to determine the ratio of inspiration (distance from lower point to next peak) vs expiration (distance from peak to next lower point). |
| Chronic Obstructive Pulmonary Disease (COPD) Exacerbations of Sensor-collected Parameters During Observation Period - Frequency of Additional Medication | Day 0(Basseline) and Day 8 to Day 14 | Count of the number of times the use of additional medication as a log activity is reported per day. |
| Prediction of Moderate or Severe COPD Exacerbations by Building a Statistical Model Employing Sensor-Derived Data and Demographic and Medical Covariates - Accuracy | Up to 3 months | Accuracy was calculated as (True Positives + True Negatives) / Total Population. True Positives (TP) are events correctly predicted as exacerbations. True Negatives (TN) are events correctly predicted as non-exacerbations. Total Population refers to the total number of events evaluated. Accuracy scores reflect XGBoost algorithm performance using random and time-based 70/30 data splits. The values were calculated in form of percentage where 100% is the ideal scenario for perfect predictability. |
| Prediction of Moderate or Severe COPD Exacerbations by Building a Statistical Model Employing Sensor-Derived Data and Demographic and Medical Covariates - Precision | Up to 3 months | Precision was calculated as True Positives / (True Positives + False Positives). True Positives (TP) are events correctly predicted as exacerbations. False Positives (FP) are events incorrectly predicted as exacerbations. Total Population refers to the total number of events evaluated. Precision scores reflect XGBoost algorithm performance using random and time-based 70/30 data splits. The values were calculated in form of percentage where 100% is the ideal scenario for perfect predictability. |
| Prediction of Moderate or Severe COPD Exacerbations by Building a Statistical Model Employing Sensor-Derived Data and Demographic and Medical Covariates - Recall | Up to 3 months | Recall was calculated as True Positives / (True Positives + False Negatives). True Positives (TP) are events correctly predicted as exacerbations. False Negatives (FN) are events incorrectly predicted as non-exacerbations. Total Population refers to the total number of events evaluated. Recall scores reflect XGBoost algorithm performance using random and time-based 70/30 data splits. The values were calculated in form of percentage where 100% is the ideal scenario for perfect predictability. |
| Prediction of Moderate or Severe COPD Exacerbations by Building a Statistical Model Employing Sensor-Derived Data and Demographic and Medical Covariates - Specificity | Up to 3 months | Specificity was calculated as True Negatives / (True Negatives + False Positives). True Negatives (TN) are events correctly predicted as non-exacerbations. False Positives (FP) are events incorrectly predicted as exacerbations. Total Population refers to the total number of events evaluated. Specificity scores reflect XGBoost algorithm performance using random and time-based 70/30 data splits. The values were calculated in form of percentage where 100% is the ideal scenario for perfect predictability. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Participants Health Status and Symptoms at Baseline and Study End | Baseline (Day 0) and at 3 months | Participants 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. |
| Predicting the CAT Score by Building a Statistical Model Employing Sensor-Derived Data and Demographic and Medical Covariates | Up to 3 months | Patients' health status and symptoms at baseline (Day 0) were measured using the CAT questionnaire, an 8-item tool with scores ranging from 0 to 5 per item. CAT scores were collected daily via a digital application during the observation period. Various machine learning algorithms were evaluated for predictive performance using metrics including accuracy, specificity, sensitivity, precision, positive predictive value (PPV), negative predictive value (NPV), and area under the ROC curve. R² (coefficient of determination) was computed for CAT score prediction models, defined as R² = 1 - (SS\_res / SS\_tot), where SS\_res is the residual sum of squares and SS\_tot is the total sum of squares. R² values range from 0 to 1, with higher values indicating better model fit. |
| Correlation of Sensor-Collected Data With Lung Function (FEV1) at Baseline and Study End | Baseline (Day 0) and at 3 months | Lung function was assessed using plethysmography. |
| Correlation of Sensor-Collected Data With Lung Function (FVC) at Baseline and Study End | Baseline (Day 0) and at 3 months | Lung function was assessed using plethysmography. |
| Correlation of Sensor-Collected Data With Lung Function (FEV1/FVC) at Baseline and Study End | Baseline (Day 0) and at 3 months | Lung function was assessed using plethysmography. |
| Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (White Blood Cells Count) | Baseline (Day 0) and at 3 months | Lung function was assessed using plethysmography and lab values including Complete Blood Count with differential, Blood Gas Analysis, procalcitonin and CRP will be assessed as per standard practice at baseline (Day 0) and at study end |
| Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Erythrocytes Count) | Baseline (Day 0) and at 3 months | Lung function was assessed using plethysmography and lab values including Complete Blood Count with differential, Blood Gas Analysis, procalcitonin and CRP will be assessed as per standard practice at baseline (Day 0) and at study end |
| Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Oxygen (pO2)) | Baseline (Day 0) and at 3 months | Lung function was assessed using plethysmography and lab values including Complete Blood Count with differential, Blood Gas Analysis, procalcitonin and CRP will be assessed as per standard practice at baseline (Day 0) and at study end |
| Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Carbon Dioxide (pCO2)) | Baseline (Day 0) and at 3 months | Lung function was assessed using plethysmography and lab values including Complete Blood Count with differential, Blood Gas Analysis, procalcitonin and CRP will be assessed as per standard practice at baseline (Day 0) and at study end |
| Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (O2 Saturation) | Baseline (Day 0) and at 3 months | Lung function was assessed using plethysmography and lab values including Complete Blood Count with differential, Blood Gas Analysis, procalcitonin and CRP will be assessed as per standard practice at baseline (Day 0) and at study end |
| Correlation of Sensor-Collected Data With Number, Date of Onset, and Duration of Mild, Moderate, and Severe Exacerbations | Up to 3 months | Exacerbations are classified as mild if they are treated with short-acting bronchodilators only, moderate if they are treated additionally with antibiotics or oral corticosteroids, or severe if the patient visits the emergency room or requires hospitalization because of an exacerbation. |
| Association Between Sensor Parameters (Heart Rate and Resting Heart Rate) and CAT Score | 7 days before Severe/Moderate Excarbations(S/M E) (7-day window period) | During the observation period the CAT score was obtained via a digital application daily. The daily CAT questionnaire summary score was computed. The fixed effect estimate represents the change in CAT score per unit change in the corresponding parameter. Linear mixed models were performed to assess the association between the CAT score and each sensor parameter (Heart Rate and Resting Heart Rate). Data was calculated through linear mixed model; reported as fixed effect estimate with measure type as number and measure dispersion as 95% CI. |
| Association Between Sensor Parameters (Respiration Rate) and CAT Score | 7 days before Severe/Moderate Excarbations(S/M E) (7-day window period) and 14 days before S/M E (1 day window period) | During the observation period the CAT score was obtained via a digital application daily. The daily CAT questionnaire summary score was computed. The fixed effect estimate represents the change in CAT score per unit change in the corresponding parameter. Linear mixed models were performed to assess the association between the CAT score and each sensor parameter (Respiration Rate). Data was calculated through linear mixed model; reported as fixed effect estimate with measure type as number and measure dispersion as 95% CI. |
| Association Between Sensor Parameters (SDRR, SDNN, SDNNI, RMSSD, In(RMSSD)) and CAT Score | 7 days before Severe/Moderate Excarbations(S/M E) (7-day window period) and 14 days before S/M E (1 day window period) | During the observation period the CAT score was obtained via a digital application daily. The daily CAT questionnaire summary score was computed. The fixed effect estimate represents the change in CAT score per unit change in the corresponding parameter. Linear mixed models were performed to assess the association between the CAT score and each sensor parameter (SDRR, SDNN, SDNNI, RMSSD, In(RMSSD)). Data was calculated through linear mixed model; reported as fixed effect estimate with measure type as number and measure dispersion as 95% CI. |
| Association Between Sensor Parameters (Stress Index, LF/HF) and CAT Score | 7 days before Severe/Moderate Excarbations(S/M E) (7-day window period) and 14 days before S/M E (1 day window period) | During the observation period, participants completed the CAT questionnaire daily via a digital app. Stress Index, based on heart rate variability (HRV), assessed autonomic activity and physiological stress. It was calculated as AMo/(2 \* Mo \* MxDMn), where AMo is the % of RR intervals at the most frequent value, Mo is the most common RR interval, and MxDMn is the RR interval range. Stress Index values range from 50-900; lower values (50-150) indicate low stress and better autonomic balance, while higher values (\>500) reflect increased stress and sympathetic activity. LF power reflects sympathetic activity; HF power reflects parasympathetic activity. Linear mixed models assessed associations between CAT score and each sensor parameters. Fixed effect estimates represent change in CAT score per unit change in each parameter. Data was calculated through linear mixed model; reported as fixed effect estimate with measure type as number and measure dispersion as 95% CI. |
| Association Between Sensor Parameters (pNN50) and CAT Score | 7 days before Severe/Moderate Excarbations(S/M E) (7-day window period) and 14 days before S/M E (1 day window period) | During the observation period the CAT score was obtained via a digital application daily. The daily CAT questionnaire summary score was computed. The fixed effect estimate represents the change in CAT score per unit change in the corresponding parameter. Linear mixed models were performed to assess the association between the CAT score and each sensor parameter (pNN50). Data was calculated through linear mixed model; reported as fixed effect estimate with measure type as number and measure dispersion as 95% CI. |
| Association Between Sensor Parameters (Temperature) and CAT Score | 14 days before S/M E (1 day window period) | During the observation period the CAT score was obtained via a digital application daily. The daily CAT questionnaire summary score was computed. The fixed effect estimate represents the change in CAT score per unit change in the corresponding parameter. Linear mixed models were performed to assess the association between the CAT score and each sensor parameter (Temperature). Data was calculated through linear mixed model; reported as fixed effect estimate with measure type as number and measure dispersion as 95% CI. |
| Association Between Sensor Parameters (Physical Activity) and CAT Score | 14 days before S/M E (1 day window period) | During the observation period the CAT score was obtained via a digital application daily. The daily CAT questionnaire summary score was computed. The fixed effect estimate represents the change in CAT score per unit change in the corresponding parameter. Linear mixed models were performed to assess the association between the CAT score and each sensor parameter (Physical activity). Data was calculated through linear mixed model; reported as fixed effect estimate with measure type as number and measure dispersion as 95% CI. |
| Association Between Sensor Parameters (Sleep Pattern) and CAT Score | 14 days before S/M E (1 day window period) | During the observation period the CAT score was obtained via a digital application daily. The daily CAT questionnaire summary score was computed. The fixed effect estimate represents the change in CAT score per unit change in the corresponding parameter. Linear mixed models were performed to assess the association between the CAT score and each sensor parameter (Sleep pattern). Data was calculated through linear mixed model; reported as fixed effect estimate with measure type as number and measure dispersion as 95% CI. |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Calibration Cohort Participants in this group did not have COPD and wore a Vivalink wearable device and were observed for a period of 2 weeks | 10 |
| COPD Cohort Participants in this group wore a Vivalink wearable device and were observed for a period of 3 months | 67 |
| Total | 77 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Not mentioned | 0 | 1 |
| Overall Study | Protocol non-compliance | 0 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | COPD Cohort | Total | Calibration Cohort |
|---|---|---|---|
| Age, Continuous | 67 years | 66 years | 52 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 67 Participants | 77 Participants | 10 Participants |
| Sex: Female, Male Female | 37 Participants | 45 Participants | 8 Participants |
| Sex: Female, Male Male | 30 Participants | 32 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 67 | 0 / 67 |
| other Total, other adverse events | 0 / 67 | 3 / 67 |
| serious Total, serious adverse events | 0 / 67 | 3 / 67 |
Outcome results
Primary
Chronic Obstructive Pulmonary Disease (COPD) Exacerbations of Sensor-collected Parameters During Observation Period - Cough Frequency
Cough Frequency was provided by vivalink.
Time frame: Day 0(Baseline) and Day 8 to Day 14
Population: COPD cohort consists of all participants with COPD fulfilling all of the inclusion criteria and none of the exclusion criteria. Here, Number analyzed signifies those participants who were evaluable at specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| COPD Cohort | Chronic Obstructive Pulmonary Disease (COPD) Exacerbations of Sensor-collected Parameters During Observation Period - Cough Frequency | Day 0 | 56.82 count per day | Standard Deviation 48.46 |
| COPD Cohort | Chronic Obstructive Pulmonary Disease (COPD) Exacerbations of Sensor-collected Parameters During Observation Period - Cough Frequency | Day 8 to Day 14 | 72.46 count per day | Standard Deviation 58.62 |
Primary
Chronic Obstructive Pulmonary Disease (COPD) Exacerbations of Sensor-collected Parameters During Observation Period - Frequency of Additional Medication
Count of the number of times the use of additional medication as a log activity is reported per day.
Time frame: Day 0(Basseline) and Day 8 to Day 14
Population: COPD cohort consisted of all participants with COPD fulfilling all of the inclusion criteria and none of the exclusion criteria.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| COPD Cohort | Chronic Obstructive Pulmonary Disease (COPD) Exacerbations of Sensor-collected Parameters During Observation Period - Frequency of Additional Medication | Day 0 | 0.37 count per day | Standard Deviation 0.714 |
| COPD Cohort | Chronic Obstructive Pulmonary Disease (COPD) Exacerbations of Sensor-collected Parameters During Observation Period - Frequency of Additional Medication | Day 8 to Day 14 | 0.82 count per day | Standard Deviation 0.859 |
Primary
Chronic Obstructive Pulmonary Disease (COPD) Exacerbations of Sensor-collected Parameters During Observation Period - Heart Rate
Heart rate is provided by Vivalink.
Time frame: Day 0(Baseline) and Day 8 to Day 14
Population: COPD cohort consists of all participants with COPD fulfilling all of the inclusion criteria and none of the exclusion criteria. Here, Number analyzed signifies those participants who were evaluable at specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| COPD Cohort | Chronic Obstructive Pulmonary Disease (COPD) Exacerbations of Sensor-collected Parameters During Observation Period - Heart Rate | Day 8 to Day 14 | 81.26 beats per minute | Standard Deviation 9.237 |
| COPD Cohort | Chronic Obstructive Pulmonary Disease (COPD) Exacerbations of Sensor-collected Parameters During Observation Period - Heart Rate | Day 0 | 86.4 beats per minute | Standard Deviation 7.953 |
Primary
Chronic Obstructive Pulmonary Disease (COPD) Exacerbations of Sensor-collected Parameters During Observation Period - Heart Rate Variability (LF and HF)
Applying a Fast Fourier Transformation (FFT) or autoregressive (AR) modeling one can separate Heart rate variability (HRV) into its component ultra-low-frequency (ULF), very low frequency (VLF), Low-Frequency power (LF), and High-Frequency power (HF) rhythms that operate within different frequency ranges. Given in absolute values of power (milliseconds squared). LF power, low frequency power (0.04-0.15 Hz). HF power, high frequency power (0.15-0.40 Hz). LF/HF Ratio, spectral HRV index computed as (LF/HF).
Time frame: Day 0(Baseline) and Day 8 to Day 14
Population: COPD cohort consists of all participants with COPD fulfilling all of the inclusion criteria and none of the exclusion criteria. Here, Number analyzed signifies those participants who were evaluable at specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| COPD Cohort | Chronic Obstructive Pulmonary Disease (COPD) Exacerbations of Sensor-collected Parameters During Observation Period - Heart Rate Variability (LF and HF) | LF: Day 0 | 320.32 hertz | Standard Deviation 456.411 |
| COPD Cohort | Chronic Obstructive Pulmonary Disease (COPD) Exacerbations of Sensor-collected Parameters During Observation Period - Heart Rate Variability (LF and HF) | LF: Day 8-14 | 287.19 hertz | Standard Deviation 399.897 |
| COPD Cohort | Chronic Obstructive Pulmonary Disease (COPD) Exacerbations of Sensor-collected Parameters During Observation Period - Heart Rate Variability (LF and HF) | HF: Day 0 | 646.3 hertz | Standard Deviation 1234.891 |
| COPD Cohort | Chronic Obstructive Pulmonary Disease (COPD) Exacerbations of Sensor-collected Parameters During Observation Period - Heart Rate Variability (LF and HF) | HF: Day 8-14 | 612.6 hertz | Standard Deviation 1542.947 |
Primary
Chronic Obstructive Pulmonary Disease (COPD) Exacerbations of Sensor-collected Parameters During Observation Period - Heart Rate Variability (LF/HF)
Applying a Fast Fourier Transformation (FFT) or autoregressive (AR) modeling one can separate Heart rate variability (HRV) into its component ultra-low-frequency (ULF), very low frequency (VLF), Low-Frequency power (LF), and High-Frequency power (HF) rhythms that operate within different frequency ranges. Given in absolute values of power (milliseconds squared). LF power, low frequency power (0.04-0.15 Hz). HF power, high frequency power (0.15-0.40 Hz). LF/HF Ratio, spectral HRV index computed as (LF/HF).
Time frame: Day 0(Baseline) and Day 8 to Day 14
Population: COPD cohort consists of all participants with COPD fulfilling all of the inclusion criteria and none of the exclusion criteria. Here, Number analyzed signifies those participants who were evaluable at specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| COPD Cohort | Chronic Obstructive Pulmonary Disease (COPD) Exacerbations of Sensor-collected Parameters During Observation Period - Heart Rate Variability (LF/HF) | LF/HF: Day 0 | 1.38 ratio | Standard Deviation 1.211 |
| COPD Cohort | Chronic Obstructive Pulmonary Disease (COPD) Exacerbations of Sensor-collected Parameters During Observation Period - Heart Rate Variability (LF/HF) | LF/HF: Day 8-14 | 1.51 ratio | Standard Deviation 1.204 |
Primary
Chronic Obstructive Pulmonary Disease (COPD) Exacerbations of Sensor-collected Parameters During Observation Period - Heart Rate Variability (pNN50)
pNN50 is the percentage of adjacent NN intervals that differ from each other by more than 50 milliseconds.
Time frame: Day 0(Baseline) and Day 8 to Day 14
Population: COPD cohort consists of all participants with COPD fulfilling all of the inclusion criteria and none of the exclusion criteria. Here, Number analyzed signifies those participants who were evaluable at specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| COPD Cohort | Chronic Obstructive Pulmonary Disease (COPD) Exacerbations of Sensor-collected Parameters During Observation Period - Heart Rate Variability (pNN50) | Day 0 | 0.12 percentage | Standard Deviation 0.198 |
| COPD Cohort | Chronic Obstructive Pulmonary Disease (COPD) Exacerbations of Sensor-collected Parameters During Observation Period - Heart Rate Variability (pNN50) | Day 8-14 | 0.11 percentage | Standard Deviation 0.197 |
Primary
Chronic Obstructive Pulmonary Disease (COPD) Exacerbations of Sensor-collected Parameters During Observation Period - Heart Rate Variability (SDRR, SDNN, SDNNI, RMSSD, ln(RMSSD))
Heart rate variability reflecting differences in time intervals between 2 R-waves in the ECG (milliseconds) SDRR (Standard Deviation of Intervals between Heartbeats), SDNN (Standard Deviation of Intervals between Heartbeats, after removing abnormal Beats), SDNNI (Mean of the Standard Deviations of all the NN intervals for each 5 min Segment of a 24-h HRV Recording), and RMSSD (Mean of the Standard Deviations of all the NN intervals for each 5 min Segment of a 24-hour HRV Recording) and In(RMSDD)
Time frame: Day 0(Baseline) and Day 8 to Day 14
Population: COPD cohort consists of all participants with COPD fulfilling all of the inclusion criteria and none of the exclusion criteria. Here, Number analyzed signifies those participants who were evaluable at specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| COPD Cohort | Chronic Obstructive Pulmonary Disease (COPD) Exacerbations of Sensor-collected Parameters During Observation Period - Heart Rate Variability (SDRR, SDNN, SDNNI, RMSSD, ln(RMSSD)) | SDRR: Day 0 | 26.83 milliseconds | Standard Deviation 11.37 |
| COPD Cohort | Chronic Obstructive Pulmonary Disease (COPD) Exacerbations of Sensor-collected Parameters During Observation Period - Heart Rate Variability (SDRR, SDNN, SDNNI, RMSSD, ln(RMSSD)) | SDRR: Day 8-14 | 23.34 milliseconds | Standard Deviation 10.867 |
| COPD Cohort | Chronic Obstructive Pulmonary Disease (COPD) Exacerbations of Sensor-collected Parameters During Observation Period - Heart Rate Variability (SDRR, SDNN, SDNNI, RMSSD, ln(RMSSD)) | SDNN: Day 0 | 58.71 milliseconds | Standard Deviation 47.79 |
| COPD Cohort | Chronic Obstructive Pulmonary Disease (COPD) Exacerbations of Sensor-collected Parameters During Observation Period - Heart Rate Variability (SDRR, SDNN, SDNNI, RMSSD, ln(RMSSD)) | SDNN: Day 8-14 | 52.82 milliseconds | Standard Deviation 39.419 |
| COPD Cohort | Chronic Obstructive Pulmonary Disease (COPD) Exacerbations of Sensor-collected Parameters During Observation Period - Heart Rate Variability (SDRR, SDNN, SDNNI, RMSSD, ln(RMSSD)) | SDNNI: Day 0 | 69.51 milliseconds | Standard Deviation 63.18 |
| COPD Cohort | Chronic Obstructive Pulmonary Disease (COPD) Exacerbations of Sensor-collected Parameters During Observation Period - Heart Rate Variability (SDRR, SDNN, SDNNI, RMSSD, ln(RMSSD)) | SDNNI: Day 8-14 | 63.18 milliseconds | Standard Deviation 33.537 |
| COPD Cohort | Chronic Obstructive Pulmonary Disease (COPD) Exacerbations of Sensor-collected Parameters During Observation Period - Heart Rate Variability (SDRR, SDNN, SDNNI, RMSSD, ln(RMSSD)) | RMSSD: Day 0 | 55.37 milliseconds | Standard Deviation 59.658 |
| COPD Cohort | Chronic Obstructive Pulmonary Disease (COPD) Exacerbations of Sensor-collected Parameters During Observation Period - Heart Rate Variability (SDRR, SDNN, SDNNI, RMSSD, ln(RMSSD)) | RMSSD: Day 8-14 | 53.73 milliseconds | Standard Deviation 73.024 |
| COPD Cohort | Chronic Obstructive Pulmonary Disease (COPD) Exacerbations of Sensor-collected Parameters During Observation Period - Heart Rate Variability (SDRR, SDNN, SDNNI, RMSSD, ln(RMSSD)) | In (RMSSD): Day 0 | 3.59 milliseconds | Standard Deviation 0.883 |
| COPD Cohort | Chronic Obstructive Pulmonary Disease (COPD) Exacerbations of Sensor-collected Parameters During Observation Period - Heart Rate Variability (SDRR, SDNN, SDNNI, RMSSD, ln(RMSSD)) | In (RMSSD): Day 8-14 | 3.51 milliseconds | Standard Deviation 0.813 |
Primary
Chronic Obstructive Pulmonary Disease (COPD) Exacerbations of Sensor-collected Parameters During Observation Period - Heart Rate Variability (Stress Index)
Baevsky's Stress Index is a heart rate variability (HRV) measure used to assess autonomic nervous system activity and physiological stress, especially in monitoring chronic obstructive pulmonary disease (COPD) exacerbations. It is calculated as: amplitude of the mode (AMo) divided by two times the mode (Mo) multiplied by the difference between the maximum and minimum RR intervals (MxDMn). AMo is the percentage of RR intervals at the most frequent value, Mo is the most common RR interval, and MxDMn is the range of RR intervals. The index typically ranges from 50 to over 900. Lower values (50-150) indicate low stress and better autonomic balance, while higher values (above 500) reflect increased stress and sympathetic activity. Values above 900 are considered very high stress. This is a single composite score with no subscales; higher scores represent worse outcomes.
Time frame: Day 0(Baseline) and Day 8 to Day 14
Population: COPD cohort consists of all participants with COPD fulfilling all of the inclusion criteria and none of the exclusion criteria. Here, Number analyzed signifies those participants who were evaluable at specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| COPD Cohort | Chronic Obstructive Pulmonary Disease (COPD) Exacerbations of Sensor-collected Parameters During Observation Period - Heart Rate Variability (Stress Index) | Day 0 | 108.43 ratio | Standard Deviation 94.236 |
| COPD Cohort | Chronic Obstructive Pulmonary Disease (COPD) Exacerbations of Sensor-collected Parameters During Observation Period - Heart Rate Variability (Stress Index) | Day 8-14 | 99.86 ratio | Standard Deviation 81.076 |
Primary
Chronic Obstructive Pulmonary Disease (COPD) Exacerbations of Sensor-collected Parameters During Observation Period - Inspiration vs Expiration Time Ratio
Using the breathing signal one can determine the inspiration and expiration peaks. The difference between said peaks in milliseconds can be used to determine the ratio of inspiration (distance from lower point to next peak) vs expiration (distance from peak to next lower point).
Time frame: Day 0(Baseline) and Day 8 to Day 14
Population: COPD cohort consisted of all participants with COPD fulfilling all of the inclusion criteria and none of the exclusion criteria. Here, Number analyzed signifies those participants who were evaluable at specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| COPD Cohort | Chronic Obstructive Pulmonary Disease (COPD) Exacerbations of Sensor-collected Parameters During Observation Period - Inspiration vs Expiration Time Ratio | Day 0 | 0.96 ratio | Standard Deviation 0.078 |
| COPD Cohort | Chronic Obstructive Pulmonary Disease (COPD) Exacerbations of Sensor-collected Parameters During Observation Period - Inspiration vs Expiration Time Ratio | Day 8 to Day 14 | 0.98 ratio | Standard Deviation 0.068 |
Primary
Chronic Obstructive Pulmonary Disease (COPD) Exacerbations of Sensor-collected Parameters During Observation Period - Physical Activity
An activity flag is extracted from the accelerometer by Vivalink, by using a predefined threshold for adult movement. For stair climbing, first periodic movement was determined, by using frequency analysis on specific time windows, and generating a ratio to the total spectrum indicating periodic activity over a certain threshold.
Time frame: Day 0(Baseline) and Day 8 to Day 14
Population: COPD cohort consisted of all participants with COPD fulfilling all of the inclusion criteria and none of the exclusion criteria. Here, Number analyzed signifies those participants who were evaluable at specified time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| COPD Cohort | Chronic Obstructive Pulmonary Disease (COPD) Exacerbations of Sensor-collected Parameters During Observation Period - Physical Activity | Day 0 | 41.98 minutes | Standard Deviation 22.89 |
| COPD Cohort | Chronic Obstructive Pulmonary Disease (COPD) Exacerbations of Sensor-collected Parameters During Observation Period - Physical Activity | Day 8 to Day 14 | 58.93 minutes | Standard Deviation 33.026 |
Primary
Chronic Obstructive Pulmonary Disease (COPD) Exacerbations of Sensor-collected Parameters During Observation Period - Respiratory Rate
Respiration rate is provided by Vivalink.
Time frame: Day 0(Baseline) and Day 8 to Day 14
Population: COPD cohort consists of all participants with COPD fulfilling all of the inclusion criteria and none of the exclusion criteria. Here, Number analyzed signifies those participants who were evaluable at specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| COPD Cohort | Chronic Obstructive Pulmonary Disease (COPD) Exacerbations of Sensor-collected Parameters During Observation Period - Respiratory Rate | Day 8 to Day 14 | 20.92 breaths per minute | Standard Deviation 2.247 |
| COPD Cohort | Chronic Obstructive Pulmonary Disease (COPD) Exacerbations of Sensor-collected Parameters During Observation Period - Respiratory Rate | Day 0 | 21.42 breaths per minute | Standard Deviation 1.903 |
Primary
Chronic Obstructive Pulmonary Disease (COPD) Exacerbations of Sensor-collected Parameters During Observation Period - Resting Heart Rate
Resting Heart Rate is provided by Vivalink.
Time frame: Day 0(Baseline) and Day 8 to Day 14
Population: COPD cohort consists of all participants with COPD fulfilling all of the inclusion criteria and none of the exclusion criteria. Here, Number analyzed signifies those participants who were evaluable at specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| COPD Cohort | Chronic Obstructive Pulmonary Disease (COPD) Exacerbations of Sensor-collected Parameters During Observation Period - Resting Heart Rate | Day 0 | 85.02 beats per minute | Standard Deviation 8.003 |
| COPD Cohort | Chronic Obstructive Pulmonary Disease (COPD) Exacerbations of Sensor-collected Parameters During Observation Period - Resting Heart Rate | Day 8 to Day 14 | 79.9 beats per minute | Standard Deviation 9.126 |
Primary
Chronic Obstructive Pulmonary Disease (COPD) Exacerbations of Sensor-collected Parameters During Observation Period - Sleep Patterns
The basis of the sleep pattern calculations is the self-reported bedtimes. With the same technique as the cough frequency prediction, inactivity signals can be predicted from the labeled data to improve the bedtime accuracy, and the changes in accelerometer (step detection algorithms) can be used to quantify the number of clear breaks in the sleep (standing up, strong cough, etc.).
Time frame: Day 0(Baseline) and Day 8 to Day 14
Population: COPD cohort consists of all participants with COPD fulfilling all of the inclusion criteria and none of the exclusion criteria. Here, Number analyzed signifies those participants who were evaluable at specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| COPD Cohort | Chronic Obstructive Pulmonary Disease (COPD) Exacerbations of Sensor-collected Parameters During Observation Period - Sleep Patterns | Day 0 | 8.7 hours | Standard Deviation 1.892 |
| COPD Cohort | Chronic Obstructive Pulmonary Disease (COPD) Exacerbations of Sensor-collected Parameters During Observation Period - Sleep Patterns | Day 8 to Day 14 | 8.48 hours | Standard Deviation 1.491 |
Primary
Chronic Obstructive Pulmonary Disease (COPD) Exacerbations of Sensor-collected Parameters During Observation Period - Temperature
Temperature is provided by Vivalink. The value for temperature is derived by Vivalink from the display temperature and then calibrated using initial calibration values, in an IP protected process. The sensor temperature is considered only as a relative value to evaluate changes in the temperature, and not as an objective human body temperature value, meaning no thresholds relative to normal human body temperature are considered, and it will not be used as a marker for fever or hypothermia.
Time frame: Day 0(Baseline) and Day 8 to Day 14
Population: COPD cohort consists of all participants with COPD fulfilling all of the inclusion criteria and none of the exclusion criteria. Here, Number analyzed signifies those participants who were evaluable at specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| COPD Cohort | Chronic Obstructive Pulmonary Disease (COPD) Exacerbations of Sensor-collected Parameters During Observation Period - Temperature | Day 0 | 36.77 celsius | Standard Deviation 1.155 |
| COPD Cohort | Chronic Obstructive Pulmonary Disease (COPD) Exacerbations of Sensor-collected Parameters During Observation Period - Temperature | Day 8 to 14 | 37.14 celsius | Standard Deviation 1.239 |
Primary
Prediction of Moderate or Severe COPD Exacerbations by Building a Statistical Model Employing Sensor-Derived Data and Demographic and Medical Covariates - Accuracy
Accuracy was calculated as (True Positives + True Negatives) / Total Population. True Positives (TP) are events correctly predicted as exacerbations. True Negatives (TN) are events correctly predicted as non-exacerbations. Total Population refers to the total number of events evaluated. Accuracy scores reflect XGBoost algorithm performance using random and time-based 70/30 data splits. The values were calculated in form of percentage where 100% is the ideal scenario for perfect predictability.
Time frame: Up to 3 months
Population: COPD cohort consisted of all participants with COPD fulfilling all of the inclusion criteria and none of the exclusion criteria.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| COPD Cohort | Prediction of Moderate or Severe COPD Exacerbations by Building a Statistical Model Employing Sensor-Derived Data and Demographic and Medical Covariates - Accuracy | 70-30 | 0.56 percentage of predictability |
| COPD Cohort | Prediction of Moderate or Severe COPD Exacerbations by Building a Statistical Model Employing Sensor-Derived Data and Demographic and Medical Covariates - Accuracy | Random | 0.56 percentage of predictability |
Primary
Prediction of Moderate or Severe COPD Exacerbations by Building a Statistical Model Employing Sensor-Derived Data and Demographic and Medical Covariates - Precision
Precision was calculated as True Positives / (True Positives + False Positives). True Positives (TP) are events correctly predicted as exacerbations. False Positives (FP) are events incorrectly predicted as exacerbations. Total Population refers to the total number of events evaluated. Precision scores reflect XGBoost algorithm performance using random and time-based 70/30 data splits. The values were calculated in form of percentage where 100% is the ideal scenario for perfect predictability.
Time frame: Up to 3 months
Population: COPD cohort consisted of all participants with COPD fulfilling all of the inclusion criteria and none of the exclusion criteria.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| COPD Cohort | Prediction of Moderate or Severe COPD Exacerbations by Building a Statistical Model Employing Sensor-Derived Data and Demographic and Medical Covariates - Precision | 70-30 | 0.53 percentage of predictability |
| COPD Cohort | Prediction of Moderate or Severe COPD Exacerbations by Building a Statistical Model Employing Sensor-Derived Data and Demographic and Medical Covariates - Precision | Random | 0.62 percentage of predictability |
Primary
Prediction of Moderate or Severe COPD Exacerbations by Building a Statistical Model Employing Sensor-Derived Data and Demographic and Medical Covariates - Recall
Recall was calculated as True Positives / (True Positives + False Negatives). True Positives (TP) are events correctly predicted as exacerbations. False Negatives (FN) are events incorrectly predicted as non-exacerbations. Total Population refers to the total number of events evaluated. Recall scores reflect XGBoost algorithm performance using random and time-based 70/30 data splits. The values were calculated in form of percentage where 100% is the ideal scenario for perfect predictability.
Time frame: Up to 3 months
Population: COPD cohort consisted of all participants with COPD fulfilling all of the inclusion criteria and none of the exclusion criteria.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| COPD Cohort | Prediction of Moderate or Severe COPD Exacerbations by Building a Statistical Model Employing Sensor-Derived Data and Demographic and Medical Covariates - Recall | 70-30 | 0.63 percentage of predictability |
| COPD Cohort | Prediction of Moderate or Severe COPD Exacerbations by Building a Statistical Model Employing Sensor-Derived Data and Demographic and Medical Covariates - Recall | Random | 0.46 percentage of predictability |
Primary
Prediction of Moderate or Severe COPD Exacerbations by Building a Statistical Model Employing Sensor-Derived Data and Demographic and Medical Covariates - Specificity
Specificity was calculated as True Negatives / (True Negatives + False Positives). True Negatives (TN) are events correctly predicted as non-exacerbations. False Positives (FP) are events incorrectly predicted as exacerbations. Total Population refers to the total number of events evaluated. Specificity scores reflect XGBoost algorithm performance using random and time-based 70/30 data splits. The values were calculated in form of percentage where 100% is the ideal scenario for perfect predictability.
Time frame: Up to 3 months
Population: COPD cohort consisted of all participants with COPD fulfilling all of the inclusion criteria and none of the exclusion criteria.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| COPD Cohort | Prediction of Moderate or Severe COPD Exacerbations by Building a Statistical Model Employing Sensor-Derived Data and Demographic and Medical Covariates - Specificity | 70-30 | 0.53 percentage of predictability |
| COPD Cohort | Prediction of Moderate or Severe COPD Exacerbations by Building a Statistical Model Employing Sensor-Derived Data and Demographic and Medical Covariates - Specificity | Random | 0.63 percentage of predictability |
Secondary
Association Between Sensor Parameters (Heart Rate and Resting Heart Rate) and CAT Score
During the observation period the CAT score was obtained via a digital application daily. The daily CAT questionnaire summary score was computed. The fixed effect estimate represents the change in CAT score per unit change in the corresponding parameter. Linear mixed models were performed to assess the association between the CAT score and each sensor parameter (Heart Rate and Resting Heart Rate). Data was calculated through linear mixed model; reported as fixed effect estimate with measure type as number and measure dispersion as 95% CI.
Time frame: 7 days before Severe/Moderate Excarbations(S/M E) (7-day window period)
Population: COPD cohort consisted of all participants with COPD fulfilling all of the inclusion criteria and none of the exclusion criteria.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| COPD Cohort | Association Between Sensor Parameters (Heart Rate and Resting Heart Rate) and CAT Score | 7days<S/M E:Heart Rate | 0.039 scores on a scale/beats per minute |
| COPD Cohort | Association Between Sensor Parameters (Heart Rate and Resting Heart Rate) and CAT Score | 7days<S/M E:Resting Heart Rate | 0.039 scores on a scale/beats per minute |
Secondary
Association Between Sensor Parameters (Physical Activity) and CAT Score
During the observation period the CAT score was obtained via a digital application daily. The daily CAT questionnaire summary score was computed. The fixed effect estimate represents the change in CAT score per unit change in the corresponding parameter. Linear mixed models were performed to assess the association between the CAT score and each sensor parameter (Physical activity). Data was calculated through linear mixed model; reported as fixed effect estimate with measure type as number and measure dispersion as 95% CI.
Time frame: 14 days before S/M E (1 day window period)
Population: COPD cohort consisted of all participants with COPD fulfilling all of the inclusion criteria and none of the exclusion criteria.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| COPD Cohort | Association Between Sensor Parameters (Physical Activity) and CAT Score | -0.016 scores on a scale/minute |
Secondary
Association Between Sensor Parameters (pNN50) and CAT Score
During the observation period the CAT score was obtained via a digital application daily. The daily CAT questionnaire summary score was computed. The fixed effect estimate represents the change in CAT score per unit change in the corresponding parameter. Linear mixed models were performed to assess the association between the CAT score and each sensor parameter (pNN50). Data was calculated through linear mixed model; reported as fixed effect estimate with measure type as number and measure dispersion as 95% CI.
Time frame: 7 days before Severe/Moderate Excarbations(S/M E) (7-day window period) and 14 days before S/M E (1 day window period)
Population: COPD cohort consisted of all participants with COPD fulfilling all of the inclusion criteria and none of the exclusion criteria.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| COPD Cohort | Association Between Sensor Parameters (pNN50) and CAT Score | 7days<S/M E:pNN50 | 2.259 scores on a scale/percent of heartbeats |
| COPD Cohort | Association Between Sensor Parameters (pNN50) and CAT Score | 14days<S/M E:pNN50 | 5.483 scores on a scale/percent of heartbeats |
Secondary
Association Between Sensor Parameters (Respiration Rate) and CAT Score
During the observation period the CAT score was obtained via a digital application daily. The daily CAT questionnaire summary score was computed. The fixed effect estimate represents the change in CAT score per unit change in the corresponding parameter. Linear mixed models were performed to assess the association between the CAT score and each sensor parameter (Respiration Rate). Data was calculated through linear mixed model; reported as fixed effect estimate with measure type as number and measure dispersion as 95% CI.
Time frame: 7 days before Severe/Moderate Excarbations(S/M E) (7-day window period) and 14 days before S/M E (1 day window period)
Population: COPD cohort consisted of all participants with COPD fulfilling all of the inclusion criteria and none of the exclusion criteria.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| COPD Cohort | Association Between Sensor Parameters (Respiration Rate) and CAT Score | 7days<S/M E:Respiration Rate | 0.370 scores on a scale/ breaths per minute |
| COPD Cohort | Association Between Sensor Parameters (Respiration Rate) and CAT Score | 14days<S/M E:RespirationRate | 0.789 scores on a scale/ breaths per minute |
Secondary
Association Between Sensor Parameters (SDRR, SDNN, SDNNI, RMSSD, In(RMSSD)) and CAT Score
During the observation period the CAT score was obtained via a digital application daily. The daily CAT questionnaire summary score was computed. The fixed effect estimate represents the change in CAT score per unit change in the corresponding parameter. Linear mixed models were performed to assess the association between the CAT score and each sensor parameter (SDRR, SDNN, SDNNI, RMSSD, In(RMSSD)). Data was calculated through linear mixed model; reported as fixed effect estimate with measure type as number and measure dispersion as 95% CI.
Time frame: 7 days before Severe/Moderate Excarbations(S/M E) (7-day window period) and 14 days before S/M E (1 day window period)
Population: COPD cohort consisted of all participants with COPD fulfilling all of the inclusion criteria and none of the exclusion criteria.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| COPD Cohort | Association Between Sensor Parameters (SDRR, SDNN, SDNNI, RMSSD, In(RMSSD)) and CAT Score | 7days<S/M E:In (RMSSD) | 0.576 scores on a scale/millimeter |
| COPD Cohort | Association Between Sensor Parameters (SDRR, SDNN, SDNNI, RMSSD, In(RMSSD)) and CAT Score | 7days<S/M E:SDRR | 0.030 scores on a scale/millimeter |
| COPD Cohort | Association Between Sensor Parameters (SDRR, SDNN, SDNNI, RMSSD, In(RMSSD)) and CAT Score | 7days<S/M E:SDNN | 0.010 scores on a scale/millimeter |
| COPD Cohort | Association Between Sensor Parameters (SDRR, SDNN, SDNNI, RMSSD, In(RMSSD)) and CAT Score | 14days<S/M E:SDNN | 0.029 scores on a scale/millimeter |
| COPD Cohort | Association Between Sensor Parameters (SDRR, SDNN, SDNNI, RMSSD, In(RMSSD)) and CAT Score | 7days<S/M E:SDNNI | 0.011 scores on a scale/millimeter |
| COPD Cohort | Association Between Sensor Parameters (SDRR, SDNN, SDNNI, RMSSD, In(RMSSD)) and CAT Score | 14days<S/M E:SDNNI | 0.045 scores on a scale/millimeter |
| COPD Cohort | Association Between Sensor Parameters (SDRR, SDNN, SDNNI, RMSSD, In(RMSSD)) and CAT Score | 7days<S/M E:RMSSD | 0.006 scores on a scale/millimeter |
| COPD Cohort | Association Between Sensor Parameters (SDRR, SDNN, SDNNI, RMSSD, In(RMSSD)) and CAT Score | 14days<S/M E:RMSSD | 0.016 scores on a scale/millimeter |
| COPD Cohort | Association Between Sensor Parameters (SDRR, SDNN, SDNNI, RMSSD, In(RMSSD)) and CAT Score | 14days<S/M E:In(RMSSD) | 1.893 scores on a scale/millimeter |
Secondary
Association Between Sensor Parameters (Sleep Pattern) and CAT Score
During the observation period the CAT score was obtained via a digital application daily. The daily CAT questionnaire summary score was computed. The fixed effect estimate represents the change in CAT score per unit change in the corresponding parameter. Linear mixed models were performed to assess the association between the CAT score and each sensor parameter (Sleep pattern). Data was calculated through linear mixed model; reported as fixed effect estimate with measure type as number and measure dispersion as 95% CI.
Time frame: 14 days before S/M E (1 day window period)
Population: COPD cohort consisted of all participants with COPD fulfilling all of the inclusion criteria and none of the exclusion criteria.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| COPD Cohort | Association Between Sensor Parameters (Sleep Pattern) and CAT Score | -0.292 scores on a scale/hours per day |
Secondary
Association Between Sensor Parameters (Stress Index, LF/HF) and CAT Score
During the observation period, participants completed the CAT questionnaire daily via a digital app. Stress Index, based on heart rate variability (HRV), assessed autonomic activity and physiological stress. It was calculated as AMo/(2 \* Mo \* MxDMn), where AMo is the % of RR intervals at the most frequent value, Mo is the most common RR interval, and MxDMn is the RR interval range. Stress Index values range from 50-900; lower values (50-150) indicate low stress and better autonomic balance, while higher values (\>500) reflect increased stress and sympathetic activity. LF power reflects sympathetic activity; HF power reflects parasympathetic activity. Linear mixed models assessed associations between CAT score and each sensor parameters. Fixed effect estimates represent change in CAT score per unit change in each parameter. Data was calculated through linear mixed model; reported as fixed effect estimate with measure type as number and measure dispersion as 95% CI.
Time frame: 7 days before Severe/Moderate Excarbations(S/M E) (7-day window period) and 14 days before S/M E (1 day window period)
Population: COPD cohort consisted of all participants with COPD fulfilling all of the inclusion criteria and none of the exclusion criteria.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| COPD Cohort | Association Between Sensor Parameters (Stress Index, LF/HF) and CAT Score | 7days<S/M E:Stress Index | 0.003 fixed effect estimate |
| COPD Cohort | Association Between Sensor Parameters (Stress Index, LF/HF) and CAT Score | 14days<S/M E:StressIndex | -0.006 fixed effect estimate |
| COPD Cohort | Association Between Sensor Parameters (Stress Index, LF/HF) and CAT Score | 7days<S/M E:LF/HF | -0.441 fixed effect estimate |
| COPD Cohort | Association Between Sensor Parameters (Stress Index, LF/HF) and CAT Score | 14days<S/M E:LF/HF | -0.963 fixed effect estimate |
Secondary
Association Between Sensor Parameters (Temperature) and CAT Score
During the observation period the CAT score was obtained via a digital application daily. The daily CAT questionnaire summary score was computed. The fixed effect estimate represents the change in CAT score per unit change in the corresponding parameter. Linear mixed models were performed to assess the association between the CAT score and each sensor parameter (Temperature). Data was calculated through linear mixed model; reported as fixed effect estimate with measure type as number and measure dispersion as 95% CI.
Time frame: 14 days before S/M E (1 day window period)
Population: COPD cohort consisted of all participants with COPD fulfilling all of the inclusion criteria and none of the exclusion criteria.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| COPD Cohort | Association Between Sensor Parameters (Temperature) and CAT Score | 0.943 scores on a scale/degree Celsius |
Secondary
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Erythrocytes Count)
Lung function was assessed using plethysmography and lab values including Complete Blood Count with differential, Blood Gas Analysis, procalcitonin and CRP will be assessed as per standard practice at baseline (Day 0) and at study end
Time frame: Baseline (Day 0) and at 3 months
Population: COPD cohort consisted of all participants with COPD fulfilling all of the inclusion criteria and none of the exclusion criteria.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Erythrocytes Count) | Baseline: Heart Rate | 0.01 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Erythrocytes Count) | End of Study: Heart Rate | 0.11 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Erythrocytes Count) | Baseline: Resting Heart Rate | 0.02 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Erythrocytes Count) | End of Study: Resting Heart Rate | 0.1 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Erythrocytes Count) | Baseline: Temperature | 0.48 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Erythrocytes Count) | End of Study: Temperature | 0.21 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Erythrocytes Count) | Baseline: Temperature (normalized) | 0.08 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Erythrocytes Count) | End of Study: Temperature (normalized) | 0.02 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Erythrocytes Count) | Baseline: Respiration Rate | -0.23 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Erythrocytes Count) | End of Study: Respiration Rate | -0.14 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Erythrocytes Count) | Baseline: SDRR | 0.11 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Erythrocytes Count) | End of Study: SDRR | 0.39 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Erythrocytes Count) | Baseline: SDNN | 0.17 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Erythrocytes Count) | End of Study: SDNN | 0.41 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Erythrocytes Count) | Baseline: SDNNI | 0.24 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Erythrocytes Count) | End of Study: SDNNI | 0.43 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Erythrocytes Count) | Baseline: RMSSD | 0.13 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Erythrocytes Count) | End of Study: RMSSD | 0.25 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Erythrocytes Count) | Baseline: In (RMSSD) | 0.04 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Erythrocytes Count) | End of Study: In (RMSSD) | 0.28 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Erythrocytes Count) | Baseline: pNN50 | 0.08 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Erythrocytes Count) | End of Study: pNN50 | 0.41 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Erythrocytes Count) | Baseline: Stress Index | -0.11 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Erythrocytes Count) | End of Study: Stress Index | -0.32 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Erythrocytes Count) | Baseline: LF | 0.08 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Erythrocytes Count) | End of Study: LF | 0.3 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Erythrocytes Count) | Baseline: HF | 0.24 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Erythrocytes Count) | End of Study: HF | 0.13 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Erythrocytes Count) | Baseline: LF/HF | 0.25 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Erythrocytes Count) | End of Study: LF/ HF | 0.16 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Erythrocytes Count) | Baseline: Physical Activity | -0.26 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Erythrocytes Count) | End of Study: Physical Activity | -0.05 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Erythrocytes Count) | Baseline: Physical Activity (normalized) | -0.16 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Erythrocytes Count) | End of Study: Physical Activity (normalized) | 0.13 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Erythrocytes Count) | Baseline: In- vs. Expiration Time Ratio | -0.34 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Erythrocytes Count) | End of Study: In- vs. Expiration Time Ratio | -0.21 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Erythrocytes Count) | Baseline: Cough Frequency | -0.53 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Erythrocytes Count) | End of Study: Cough Frequency | -0.06 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Erythrocytes Count) | Baseline: Cough Frequency (normalized) | 0.24 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Erythrocytes Count) | End of Study: Cough Frequency (normalized) | 0.4 correlation coefficient |
Secondary
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (O2 Saturation)
Lung function was assessed using plethysmography and lab values including Complete Blood Count with differential, Blood Gas Analysis, procalcitonin and CRP will be assessed as per standard practice at baseline (Day 0) and at study end
Time frame: Baseline (Day 0) and at 3 months
Population: COPD cohort consisted of all participants with COPD fulfilling all of the inclusion criteria and none of the exclusion criteria.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (O2 Saturation) | Baseline: Heart Rate | -0.33 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (O2 Saturation) | End of Study: Heart Rate | -0.32 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (O2 Saturation) | Baseline: Resting Heart Rate | -0.35 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (O2 Saturation) | End of Study: Resting Heart Rate | -0.33 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (O2 Saturation) | Baseline: Temperature | -0.29 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (O2 Saturation) | End of Study: Temperature | 0.03 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (O2 Saturation) | Baseline: Temperature (normalized) | -0.28 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (O2 Saturation) | End of Study: Temperature (normalized) | 0.04 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (O2 Saturation) | Baseline: Respiration Rate | -0.28 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (O2 Saturation) | End of Study: Respiration Rate | -0.28 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (O2 Saturation) | Baseline: SDRR | -0.46 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (O2 Saturation) | End of Study: SDRR | -0.37 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (O2 Saturation) | Baseline: SDNN | -0.13 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (O2 Saturation) | End of Study: SDNN | -0.35 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (O2 Saturation) | Baseline: SDNNI | -0.22 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (O2 Saturation) | End of Study: SDNNI | -0.39 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (O2 Saturation) | Baseline: RMSSD | -0.11 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (O2 Saturation) | End of Study: RMSSD | -0.3 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (O2 Saturation) | Baseline: In (RMSSD) | -0.22 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (O2 Saturation) | End of Study: In (RMSSD) | -0.36 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (O2 Saturation) | Baseline: pNN50 | -0.03 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (O2 Saturation) | End of Study: pNN50 | -0.3 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (O2 Saturation) | Baseline: Stress Index | -0.36 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (O2 Saturation) | End of Study: Stress Index | 0.13 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (O2 Saturation) | Baseline: LF | 0.1 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (O2 Saturation) | End of Study: LF | -0.11 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (O2 Saturation) | Baseline: HF | -0.1 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (O2 Saturation) | End of Study: HF | -0.16 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (O2 Saturation) | Baseline: LF/HF | 0.29 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (O2 Saturation) | End of Study: LF/ HF | -0.02 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (O2 Saturation) | Baseline: Physical Activity | 0.44 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (O2 Saturation) | End of Study: Physical Activity | 0.1 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (O2 Saturation) | Baseline: Physical Activity (normalized) | 0.17 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (O2 Saturation) | End of Study: Physical Activity (normalized) | -0.07 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (O2 Saturation) | Baseline: In- vs. Expiration Time Ratio | 0.45 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (O2 Saturation) | End of Study: In- vs. Expiration Time Ratio | 0.41 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (O2 Saturation) | Baseline: Cough Frequency | 0.04 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (O2 Saturation) | End of Study: Cough Frequency | 0.28 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (O2 Saturation) | Baseline: Cough Frequency (normalized) | -0.11 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (O2 Saturation) | End of Study: Cough Frequency (normalized) | -0.32 correlation coefficient |
Secondary
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Carbon Dioxide (pCO2))
Lung function was assessed using plethysmography and lab values including Complete Blood Count with differential, Blood Gas Analysis, procalcitonin and CRP will be assessed as per standard practice at baseline (Day 0) and at study end
Time frame: Baseline (Day 0) and at 3 months
Population: COPD cohort consisted of all participants with COPD fulfilling all of the inclusion criteria and none of the exclusion criteria.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Carbon Dioxide (pCO2)) | Baseline: Heart Rate | 0.16 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Carbon Dioxide (pCO2)) | End of Study: Heart Rate | 0.32 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Carbon Dioxide (pCO2)) | Baseline: Resting Heart Rate | 0.18 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Carbon Dioxide (pCO2)) | End of Study: Resting Heart Rate | 0.3 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Carbon Dioxide (pCO2)) | Baseline: Temperature | 0.13 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Carbon Dioxide (pCO2)) | End of Study: Temperature | -0.26 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Carbon Dioxide (pCO2)) | Baseline: Temperature (normalized) | 0.54 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Carbon Dioxide (pCO2)) | End of Study: Temperature (normalized) | -0.55 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Carbon Dioxide (pCO2)) | Baseline: Respiration Rate | 0.09 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Carbon Dioxide (pCO2)) | End of Study: Respiration Rate | 0.15 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Carbon Dioxide (pCO2)) | Baseline: SDRR | -0.04 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Carbon Dioxide (pCO2)) | End of Study: SDRR | 0.14 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Carbon Dioxide (pCO2)) | Baseline: SDNN | -0.13 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Carbon Dioxide (pCO2)) | End of Study: SDNN | -0.12 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Carbon Dioxide (pCO2)) | Baseline: SDNNI | -0.16 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Carbon Dioxide (pCO2)) | End of Study: SDNNI | -0.04 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Carbon Dioxide (pCO2)) | Baseline: RMSSD | -0.14 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Carbon Dioxide (pCO2)) | End of Study: RMSSD | -0.32 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Carbon Dioxide (pCO2)) | Baseline: In (RMSSD) | -0.21 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Carbon Dioxide (pCO2)) | End of Study: In (RMSSD) | -0.29 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Carbon Dioxide (pCO2)) | Baseline: pNN50 | -0.14 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Carbon Dioxide (pCO2)) | End of Study: pNN50 | -0.14 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Carbon Dioxide (pCO2)) | Baseline: Stress Index | 0.45 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Carbon Dioxide (pCO2)) | End of Study: Stress Index | 0.14 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Carbon Dioxide (pCO2)) | Baseline: LF | -0.24 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Carbon Dioxide (pCO2)) | End of Study: LF | -0.4 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Carbon Dioxide (pCO2)) | Baseline: HF | -0.1 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Carbon Dioxide (pCO2)) | End of Study: HF | -0.5 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Carbon Dioxide (pCO2)) | Baseline: LF/HF | -0.04 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Carbon Dioxide (pCO2)) | End of Study: LF/ HF | 0.23 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Carbon Dioxide (pCO2)) | Baseline: Physical Activity | -0.41 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Carbon Dioxide (pCO2)) | End of Study: Physical Activity | 0.01 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Carbon Dioxide (pCO2)) | Baseline: Physical Activity (normalized) | -0.13 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Carbon Dioxide (pCO2)) | End of Study: Physical Activity (normalized) | 0.2 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Carbon Dioxide (pCO2)) | Baseline: In- vs. Expiration Time Ratio | -0.3 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Carbon Dioxide (pCO2)) | End of Study: In- vs. Expiration Time Ratio | -0.27 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Carbon Dioxide (pCO2)) | Baseline: Cough Frequency | -0.27 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Carbon Dioxide (pCO2)) | End of Study: Cough Frequency | 0.15 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Carbon Dioxide (pCO2)) | Baseline: Cough Frequency (normalized) | 0 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Carbon Dioxide (pCO2)) | End of Study: Cough Frequency (normalized) | 0.32 correlation coefficient |
Secondary
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Oxygen (pO2))
Lung function was assessed using plethysmography and lab values including Complete Blood Count with differential, Blood Gas Analysis, procalcitonin and CRP will be assessed as per standard practice at baseline (Day 0) and at study end
Time frame: Baseline (Day 0) and at 3 months
Population: COPD cohort consisted of all participants with COPD fulfilling all of the inclusion criteria and none of the exclusion criteria.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Oxygen (pO2)) | Baseline: Heart Rate | -0.39 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Oxygen (pO2)) | End of Study: Heart Rate | -0.3 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Oxygen (pO2)) | Baseline: Resting Heart Rate | -0.41 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Oxygen (pO2)) | End of Study: Resting Heart Rate | -0.3 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Oxygen (pO2)) | Baseline: Temperature | -0.3 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Oxygen (pO2)) | End of Study: Temperature | -0.24 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Oxygen (pO2)) | Baseline: Temperature (normalized) | 0.02 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Oxygen (pO2)) | End of Study: Temperature (normalized) | -0.07 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Oxygen (pO2)) | Baseline: Respiration Rate | -0.54 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Oxygen (pO2)) | End of Study: Respiration Rate | -0.3 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Oxygen (pO2)) | Baseline: SDRR | -0.32 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Oxygen (pO2)) | End of Study: SDRR | -0.27 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Oxygen (pO2)) | Baseline: SDNN | -0.13 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Oxygen (pO2)) | End of Study: SDNN | -0.15 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Oxygen (pO2)) | Baseline: SDNNI | -0.2 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Oxygen (pO2)) | End of Study: SDNNI | -0.22 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Oxygen (pO2)) | Baseline: RMSSD | -0.16 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Oxygen (pO2)) | End of Study: RMSSD | -0.08 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Oxygen (pO2)) | Baseline: In (RMSSD) | -0.24 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Oxygen (pO2)) | End of Study: In (RMSSD) | -0.27 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Oxygen (pO2)) | Baseline: pNN50 | -0.14 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Oxygen (pO2)) | End of Study: pNN50 | -0.26 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Oxygen (pO2)) | Baseline: Stress Index | -0.27 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Oxygen (pO2)) | End of Study: Stress Index | 0.37 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Oxygen (pO2)) | Baseline: LF | -0.04 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Oxygen (pO2)) | End of Study: LF | -0.35 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Oxygen (pO2)) | Baseline: HF | -0.09 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Oxygen (pO2)) | End of Study: HF | -0.17 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Oxygen (pO2)) | Baseline: LF/HF | 0.2 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Oxygen (pO2)) | End of Study: LF/ HF | -0.17 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Oxygen (pO2)) | Baseline: Physical Activity | 0.47 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Oxygen (pO2)) | End of Study: Physical Activity | -0.05 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Oxygen (pO2)) | Baseline: Physical Activity (normalized) | 0.24 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Oxygen (pO2)) | End of Study: Physical Activity (normalized) | -0.17 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Oxygen (pO2)) | Baseline: In- vs. Expiration Time Ratio | 0.34 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Oxygen (pO2)) | End of Study: In- vs. Expiration Time Ratio | 0.28 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Oxygen (pO2)) | Baseline: Cough Frequency | 0.16 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Oxygen (pO2)) | End of Study: Cough Frequency | 0.24 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Oxygen (pO2)) | Baseline: Cough Frequency (normalized) | 0.03 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Oxygen (pO2)) | End of Study: Cough Frequency (normalized) | -0.28 correlation coefficient |
Secondary
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (White Blood Cells Count)
Lung function was assessed using plethysmography and lab values including Complete Blood Count with differential, Blood Gas Analysis, procalcitonin and CRP will be assessed as per standard practice at baseline (Day 0) and at study end
Time frame: Baseline (Day 0) and at 3 months
Population: COPD cohort consisted of all participants with COPD fulfilling all of the inclusion criteria and none of the exclusion criteria.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (White Blood Cells Count) | Baseline: Heart Rate | 0.2 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (White Blood Cells Count) | End of Study: Heart Rate | -0.07 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (White Blood Cells Count) | Baseline: Resting Heart Rate | 0.21 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (White Blood Cells Count) | End of Study: Resting Heart Rate | -0.04 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (White Blood Cells Count) | Baseline: Temperature | 0.19 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (White Blood Cells Count) | End of Study: Temperature | 0.34 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (White Blood Cells Count) | Baseline: Temperature (normalized) | -0.29 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (White Blood Cells Count) | End of Study: Temperature (normalized) | 0.38 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (White Blood Cells Count) | Baseline: Respiration Rate | 0.42 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (White Blood Cells Count) | End of Study: Respiration Rate | -0.06 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (White Blood Cells Count) | Baseline: SDRR | 0.12 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (White Blood Cells Count) | End of Study: SDRR | -0.01 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (White Blood Cells Count) | Baseline: SDNN | 0.22 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (White Blood Cells Count) | End of Study: SDNN | 0.21 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (White Blood Cells Count) | Baseline: SDNNI | 0.28 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (White Blood Cells Count) | End of Study: SDNNI | 0.12 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (White Blood Cells Count) | Baseline: RMSSD | 0.31 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (White Blood Cells Count) | End of Study: RMSSD | 0.25 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (White Blood Cells Count) | Baseline: In (RMSSD) | 0.25 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (White Blood Cells Count) | End of Study: In (RMSSD) | 0.32 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (White Blood Cells Count) | Baseline: pNN50 | 0.4 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (White Blood Cells Count) | End of Study: pNN50 | 0.34 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (White Blood Cells Count) | Baseline: Stress Index | 0.02 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (White Blood Cells Count) | End of Study: Stress Index | -0.23 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (White Blood Cells Count) | Baseline: LF | -0.1 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (White Blood Cells Count) | End of Study: LF | 0.37 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (White Blood Cells Count) | Baseline: HF | -0.1 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (White Blood Cells Count) | End of Study: HF | 0.42 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (White Blood Cells Count) | Baseline: LF/HF | -0.07 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (White Blood Cells Count) | End of Study: LF/ HF | -0.3 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (White Blood Cells Count) | Baseline: Physical Activity | -0.41 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (White Blood Cells Count) | End of Study: Physical Activity | -0.19 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (White Blood Cells Count) | Baseline: Physical Activity (normalized) | -0.36 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (White Blood Cells Count) | End of Study: Physical Activity (normalized) | 0.13 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (White Blood Cells Count) | Baseline: In- vs. Expiration Time Ratio | -0.17 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (White Blood Cells Count) | End of Study: In- vs. Expiration Time Ratio | -0.05 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (White Blood Cells Count) | Baseline: Cough Frequency | 0.02 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (White Blood Cells Count) | End of Study: Cough Frequency | 0.26 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (White Blood Cells Count) | Baseline: Cough Frequency (normalized) | -0.27 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (White Blood Cells Count) | End of Study: Cough Frequency (normalized) | -0.31 correlation coefficient |
Secondary
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Participants Health Status and Symptoms at Baseline and Study End
Participants 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
Population: COPD cohort consisted of all participants with COPD fulfilling all of the inclusion criteria and none of the exclusion criteria.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Participants Health Status and Symptoms at Baseline and Study End | Baseline: Heart Rate | 0.19 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Participants Health Status and Symptoms at Baseline and Study End | End of Study: Heart Rate | 0.45 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Participants Health Status and Symptoms at Baseline and Study End | Baseline: Resting Heart Rate | 0.19 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Participants Health Status and Symptoms at Baseline and Study End | End of Study: Resting Heart Rate | 0.46 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Participants Health Status and Symptoms at Baseline and Study End | Baseline: Temperature | 0.07 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Participants Health Status and Symptoms at Baseline and Study End | End of Study: Temperature | 0.02 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Participants Health Status and Symptoms at Baseline and Study End | Baseline: Temperature (normalized) | 0.12 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Participants Health Status and Symptoms at Baseline and Study End | End of Study: Temperature (normalized) | -0.13 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Participants Health Status and Symptoms at Baseline and Study End | Baseline: Respiration Rate | 0.21 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Participants Health Status and Symptoms at Baseline and Study End | End of Study: Respiration Rate | 0.3 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Participants Health Status and Symptoms at Baseline and Study End | Baseline: SDRR | 0.04 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Participants Health Status and Symptoms at Baseline and Study End | End of Study: SDRR | 0.39 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Participants Health Status and Symptoms at Baseline and Study End | Baseline: SDNN | -0.06 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Participants Health Status and Symptoms at Baseline and Study End | End of Study: SDNN | 0.38 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Participants Health Status and Symptoms at Baseline and Study End | Baseline: SDNNI | 0.02 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Participants Health Status and Symptoms at Baseline and Study End | End of Study: SDNNI | 0.41 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Participants Health Status and Symptoms at Baseline and Study End | Baseline: RMSSD | -0.04 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Participants Health Status and Symptoms at Baseline and Study End | End of Study: RMSSD | 0.42 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Participants Health Status and Symptoms at Baseline and Study End | Baseline: In (RMSSD) | 0.04 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Participants Health Status and Symptoms at Baseline and Study End | End of Study: In (RMSSD) | 0.44 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Participants Health Status and Symptoms at Baseline and Study End | Baseline: pNN50 | -0.06 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Participants Health Status and Symptoms at Baseline and Study End | End of Study: pNN50 | 0.4 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Participants Health Status and Symptoms at Baseline and Study End | Baseline: Stress Index | -0.01 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Participants Health Status and Symptoms at Baseline and Study End | End of Study: Stress Index | -0.21 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Participants Health Status and Symptoms at Baseline and Study End | Baseline: LF | -0.28 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Participants Health Status and Symptoms at Baseline and Study End | End of Study: LF | 0.15 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Participants Health Status and Symptoms at Baseline and Study End | Baseline: HF | -0.09 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Participants Health Status and Symptoms at Baseline and Study End | End of Study: HF | 0.18 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Participants Health Status and Symptoms at Baseline and Study End | Baseline: LF/HF | -0.12 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Participants Health Status and Symptoms at Baseline and Study End | End of Study: LF/ HF | -0.34 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Participants Health Status and Symptoms at Baseline and Study End | Baseline: Physical Activity | -0.11 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Participants Health Status and Symptoms at Baseline and Study End | End of Study: Physical Activity | -0.11 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Participants Health Status and Symptoms at Baseline and Study End | Baseline: Physical Activity (normalized) | 0.06 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Participants Health Status and Symptoms at Baseline and Study End | End of Study: Physical Activity (normalized) | 0.11 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Participants Health Status and Symptoms at Baseline and Study End | Baseline: In- vs. Expiration Time Ratio | -0.04 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Participants Health Status and Symptoms at Baseline and Study End | End of Study: In- vs. Expiration Time Ratio | -0.21 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Participants Health Status and Symptoms at Baseline and Study End | Baseline: Cough Frequency | -0.2 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Participants Health Status and Symptoms at Baseline and Study End | End of Study: Cough Frequency | -0.21 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Participants Health Status and Symptoms at Baseline and Study End | Baseline: Cough Frequency (normalized) | 0.06 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Participants Health Status and Symptoms at Baseline and Study End | End of Study: Cough Frequency (normalized) | 0.27 correlation coefficient |
Secondary
Correlation of Sensor-Collected Data With Lung Function (FEV1) at Baseline and Study End
Lung function was assessed using plethysmography.
Time frame: Baseline (Day 0) and at 3 months
Population: COPD cohort consisted of all participants with COPD fulfilling all of the inclusion criteria and none of the exclusion criteria. Here, Number analyzed signifies those participants who were evaluable at specified time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| COPD Cohort | Correlation of Sensor-Collected Data With Lung Function (FEV1) at Baseline and Study End | Baseline: Heart Rate | 0.07 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With Lung Function (FEV1) at Baseline and Study End | End of Study: Heart Rate | -0.36 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With Lung Function (FEV1) at Baseline and Study End | Baseline: Resting Heart Rate | 0.08 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With Lung Function (FEV1) at Baseline and Study End | End of Study: Resting Heart Rate | -0.32 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With Lung Function (FEV1) at Baseline and Study End | Baseline: Temperature | -0.29 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With Lung Function (FEV1) at Baseline and Study End | End of Study: Temperature | -0.12 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With Lung Function (FEV1) at Baseline and Study End | Baseline: Temperature (normalized) | -0.18 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With Lung Function (FEV1) at Baseline and Study End | End of Study: Temperature (normalized) | 0.1 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With Lung Function (FEV1) at Baseline and Study End | Baseline: Respiration Rate | -0.25 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With Lung Function (FEV1) at Baseline and Study End | End of Study: Respiration Rate | -0.24 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With Lung Function (FEV1) at Baseline and Study End | Baseline: SDRR | -0.28 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With Lung Function (FEV1) at Baseline and Study End | End of Study: SDRR | -0.31 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With Lung Function (FEV1) at Baseline and Study End | Baseline: SDNN | 0.15 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With Lung Function (FEV1) at Baseline and Study End | End of Study: SDNN | -0.17 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With Lung Function (FEV1) at Baseline and Study End | Baseline: SDNNI | -0.02 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With Lung Function (FEV1) at Baseline and Study End | End of Study: SDNNI | -0.25 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With Lung Function (FEV1) at Baseline and Study End | Baseline: RMSSD | 0.08 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With Lung Function (FEV1) at Baseline and Study End | End of Study: RMSSD | -0.19 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With Lung Function (FEV1) at Baseline and Study End | Baseline: In (RMSSD) | 0.02 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With Lung Function (FEV1) at Baseline and Study End | End of Study: In (RMSSD) | -0.17 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With Lung Function (FEV1) at Baseline and Study End | Baseline: pNN50 | 0.05 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With Lung Function (FEV1) at Baseline and Study End | End of Study: pNN50 | -0.16 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With Lung Function (FEV1) at Baseline and Study End | Baseline: Stress Index | -0.04 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With Lung Function (FEV1) at Baseline and Study End | End of Study: Stress Index | -0.09 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With Lung Function (FEV1) at Baseline and Study End | Baseline: LF | 0.35 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With Lung Function (FEV1) at Baseline and Study End | End of Study: LF | -0.11 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With Lung Function (FEV1) at Baseline and Study End | Baseline: HF | 0.18 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With Lung Function (FEV1) at Baseline and Study End | End of Study: HF | -0.14 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With Lung Function (FEV1) at Baseline and Study End | Baseline: LF/HF | 0.14 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With Lung Function (FEV1) at Baseline and Study End | End of Study: LF/ HF | 0.04 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With Lung Function (FEV1) at Baseline and Study End | Baseline: Physical Activity | 0.11 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With Lung Function (FEV1) at Baseline and Study End | End of Study: Physical Activity | -0.03 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With Lung Function (FEV1) at Baseline and Study End | Baseline: Physical Activity (normalized) | -0.09 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With Lung Function (FEV1) at Baseline and Study End | End of Study: Physical Activity (normalized) | -0.24 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With Lung Function (FEV1) at Baseline and Study End | Baseline: In- vs. Expiration Time Ratio | 0.29 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With Lung Function (FEV1) at Baseline and Study End | End of Study: In- vs. Expiration Time Ratio | 0.13 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With Lung Function (FEV1) at Baseline and Study End | Baseline: Cough Frequency | 0.18 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With Lung Function (FEV1) at Baseline and Study End | End of Study: Cough Frequency | -0.05 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With Lung Function (FEV1) at Baseline and Study End | Baseline: Cough Frequency (normalized) | 0.02 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With Lung Function (FEV1) at Baseline and Study End | End of Study: Cough Frequency (normalized) | -0.2 correlation coefficient |
Secondary
Correlation of Sensor-Collected Data With Lung Function (FEV1/FVC) at Baseline and Study End
Lung function was assessed using plethysmography.
Time frame: Baseline (Day 0) and at 3 months
Population: COPD cohort consisted of all participants with COPD fulfilling all of the inclusion criteria and none of the exclusion criteria. Here, Number analyzed signifies those participants who were evaluable at specified time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| COPD Cohort | Correlation of Sensor-Collected Data With Lung Function (FEV1/FVC) at Baseline and Study End | Baseline: Heart Rate | -0.07 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With Lung Function (FEV1/FVC) at Baseline and Study End | End of Study: Heart Rate | -0.3 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With Lung Function (FEV1/FVC) at Baseline and Study End | Baseline: Resting Heart Rate | -0.08 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With Lung Function (FEV1/FVC) at Baseline and Study End | End of Study: Resting Heart Rate | -0.29 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With Lung Function (FEV1/FVC) at Baseline and Study End | Baseline: Temperature | -0.16 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With Lung Function (FEV1/FVC) at Baseline and Study End | End of Study: Temperature | 0.15 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With Lung Function (FEV1/FVC) at Baseline and Study End | Baseline: Temperature (normalized) | 0.07 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With Lung Function (FEV1/FVC) at Baseline and Study End | End of Study: Temperature (normalized) | 0.28 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With Lung Function (FEV1/FVC) at Baseline and Study End | Baseline: Respiration Rate | 0 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With Lung Function (FEV1/FVC) at Baseline and Study End | End of Study: Respiration Rate | -0.22 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With Lung Function (FEV1/FVC) at Baseline and Study End | Baseline: SDRR | -0.27 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With Lung Function (FEV1/FVC) at Baseline and Study End | End of Study: SDRR | -0.42 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With Lung Function (FEV1/FVC) at Baseline and Study End | Baseline: SDNN | -0.08 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With Lung Function (FEV1/FVC) at Baseline and Study End | End of Study: SDNN | -0.28 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With Lung Function (FEV1/FVC) at Baseline and Study End | Baseline: SDNNI | -0.17 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With Lung Function (FEV1/FVC) at Baseline and Study End | End of Study: SDNNI | -0.35 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With Lung Function (FEV1/FVC) at Baseline and Study End | Baseline: RMSSD | -0.09 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With Lung Function (FEV1/FVC) at Baseline and Study End | End of Study: RMSSD | -0.36 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With Lung Function (FEV1/FVC) at Baseline and Study End | Baseline: In (RMSSD) | -0.13 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With Lung Function (FEV1/FVC) at Baseline and Study End | End of Study: In (RMSSD) | -0.23 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With Lung Function (FEV1/FVC) at Baseline and Study End | Baseline: pNN50 | -0.09 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With Lung Function (FEV1/FVC) at Baseline and Study End | End of Study: pNN50 | -0.33 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With Lung Function (FEV1/FVC) at Baseline and Study End | Baseline: Stress Index | 0.09 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With Lung Function (FEV1/FVC) at Baseline and Study End | End of Study: Stress Index | -0.31 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With Lung Function (FEV1/FVC) at Baseline and Study End | Baseline: LF | 0.07 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With Lung Function (FEV1/FVC) at Baseline and Study End | End of Study: LF | -0.31 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With Lung Function (FEV1/FVC) at Baseline and Study End | Baseline: HF | 0.02 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With Lung Function (FEV1/FVC) at Baseline and Study End | End of Study: HF | -0.36 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With Lung Function (FEV1/FVC) at Baseline and Study End | Baseline: LF/HF | -0.06 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With Lung Function (FEV1/FVC) at Baseline and Study End | End of Study: LF/ HF | 0.03 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With Lung Function (FEV1/FVC) at Baseline and Study End | Baseline: Physical Activity | 0.2 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With Lung Function (FEV1/FVC) at Baseline and Study End | End of Study: Physical Activity | -0.15 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With Lung Function (FEV1/FVC) at Baseline and Study End | Baseline: Physical Activity (normalized) | -0.02 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With Lung Function (FEV1/FVC) at Baseline and Study End | End of Study: Physical Activity (normalized) | -0.37 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With Lung Function (FEV1/FVC) at Baseline and Study End | Baseline: In- vs. Expiration Time Ratio | 0.2 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With Lung Function (FEV1/FVC) at Baseline and Study End | End of Study: In- vs. Expiration Time Ratio | 0.17 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With Lung Function (FEV1/FVC) at Baseline and Study End | Baseline: Cough Frequency | -0.02 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With Lung Function (FEV1/FVC) at Baseline and Study End | End of Study: Cough Frequency | 0.1 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With Lung Function (FEV1/FVC) at Baseline and Study End | Baseline: Cough Frequency (normalized) | -0.18 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With Lung Function (FEV1/FVC) at Baseline and Study End | End of Study: Cough Frequency (normalized) | -0.29 correlation coefficient |
Secondary
Correlation of Sensor-Collected Data With Lung Function (FVC) at Baseline and Study End
Lung function was assessed using plethysmography.
Time frame: Baseline (Day 0) and at 3 months
Population: COPD cohort consisted of all participants with COPD fulfilling all of the inclusion criteria and none of the exclusion criteria. Here, Number analyzed signifies those participants who were evaluable at specified time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| COPD Cohort | Correlation of Sensor-Collected Data With Lung Function (FVC) at Baseline and Study End | Baseline: Heart Rate | 0.11 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With Lung Function (FVC) at Baseline and Study End | End of Study: Heart Rate | -0.15 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With Lung Function (FVC) at Baseline and Study End | Baseline: Resting Heart Rate | 0.13 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With Lung Function (FVC) at Baseline and Study End | End of Study: Resting Heart Rate | -0.11 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With Lung Function (FVC) at Baseline and Study End | Baseline: Temperature | -0.21 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With Lung Function (FVC) at Baseline and Study End | End of Study: Temperature | -0.28 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With Lung Function (FVC) at Baseline and Study End | Baseline: Temperature (normalized) | -0.32 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With Lung Function (FVC) at Baseline and Study End | End of Study: Temperature (normalized) | -0.1 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With Lung Function (FVC) at Baseline and Study End | Baseline: Respiration Rate | -0.28 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With Lung Function (FVC) at Baseline and Study End | End of Study: Respiration Rate | -0.09 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With Lung Function (FVC) at Baseline and Study End | Baseline: SDRR | -0.2 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With Lung Function (FVC) at Baseline and Study End | End of Study: SDRR | -0.04 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With Lung Function (FVC) at Baseline and Study End | Baseline: SDNN | 0.16 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With Lung Function (FVC) at Baseline and Study End | End of Study: SDNN | 0.09 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With Lung Function (FVC) at Baseline and Study End | Baseline: SDNNI | 0.03 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With Lung Function (FVC) at Baseline and Study End | End of Study: SDNNI | 0.04 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With Lung Function (FVC) at Baseline and Study End | Baseline: RMSSD | 0.1 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With Lung Function (FVC) at Baseline and Study End | End of Study: RMSSD | 0.19 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With Lung Function (FVC) at Baseline and Study End | Baseline: In (RMSSD) | 0.04 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With Lung Function (FVC) at Baseline and Study End | End of Study: In (RMSSD) | 0.03 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With Lung Function (FVC) at Baseline and Study End | Baseline: pNN50 | 0.07 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With Lung Function (FVC) at Baseline and Study End | End of Study: pNN50 | 0.21 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With Lung Function (FVC) at Baseline and Study End | Baseline: Stress Index | -0.09 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With Lung Function (FVC) at Baseline and Study End | End of Study: Stress Index | 0.25 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With Lung Function (FVC) at Baseline and Study End | Baseline: LF | 0.31 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With Lung Function (FVC) at Baseline and Study End | End of Study: LF | 0.29 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With Lung Function (FVC) at Baseline and Study End | Baseline: HF | 0.15 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With Lung Function (FVC) at Baseline and Study End | End of Study: HF | 0.32 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With Lung Function (FVC) at Baseline and Study End | Baseline: LF/HF | 0.25 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With Lung Function (FVC) at Baseline and Study End | End of Study: LF/ HF | 0.04 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With Lung Function (FVC) at Baseline and Study End | Baseline: Physical Activity | 0.02 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With Lung Function (FVC) at Baseline and Study End | End of Study: Physical Activity | 0.11 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With Lung Function (FVC) at Baseline and Study End | Baseline: Physical Activity (normalized) | -0.07 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With Lung Function (FVC) at Baseline and Study End | End of Study: Physical Activity (normalized) | 0.09 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With Lung Function (FVC) at Baseline and Study End | Baseline: In- vs. Expiration Time Ratio | 0.22 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With Lung Function (FVC) at Baseline and Study End | End of Study: In- vs. Expiration Time Ratio | 0.02 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With Lung Function (FVC) at Baseline and Study End | Baseline: Cough Frequency | 0.16 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With Lung Function (FVC) at Baseline and Study End | End of Study: Cough Frequency | -0.16 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With Lung Function (FVC) at Baseline and Study End | Baseline: Cough Frequency (normalized) | 0.12 correlation coefficient |
| COPD Cohort | Correlation of Sensor-Collected Data With Lung Function (FVC) at Baseline and Study End | End of Study: Cough Frequency (normalized) | 0.06 correlation coefficient |
Secondary
Correlation of Sensor-Collected Data With Number, Date of Onset, and Duration of Mild, Moderate, and Severe Exacerbations
Exacerbations are classified as mild if they are treated with short-acting bronchodilators only, moderate if they are treated additionally with antibiotics or oral corticosteroids, or severe if the patient visits the emergency room or requires hospitalization because of an exacerbation.
Time frame: Up to 3 months
Population: COPD cohort consisted of all participants with COPD fulfilling all of the inclusion criteria and none of the exclusion criteria.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| COPD Cohort | Correlation of Sensor-Collected Data With Number, Date of Onset, and Duration of Mild, Moderate, and Severe Exacerbations | NA correlation coefficient |
Secondary
Predicting the CAT Score by Building a Statistical Model Employing Sensor-Derived Data and Demographic and Medical Covariates
Patients' health status and symptoms at baseline (Day 0) were measured using the CAT questionnaire, an 8-item tool with scores ranging from 0 to 5 per item. CAT scores were collected daily via a digital application during the observation period. Various machine learning algorithms were evaluated for predictive performance using metrics including accuracy, specificity, sensitivity, precision, positive predictive value (PPV), negative predictive value (NPV), and area under the ROC curve. R² (coefficient of determination) was computed for CAT score prediction models, defined as R² = 1 - (SS\_res / SS\_tot), where SS\_res is the residual sum of squares and SS\_tot is the total sum of squares. R² values range from 0 to 1, with higher values indicating better model fit.
Time frame: Up to 3 months
Population: COPD cohort consisted of all participants with COPD fulfilling all of the inclusion criteria and none of the exclusion criteria. Data was not derived due to low number of exacerbations.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| COPD Cohort | Predicting the CAT Score by Building a Statistical Model Employing Sensor-Derived Data and Demographic and Medical Covariates | Time-Split Model | 82.7 coefficient of determination (R^2) |
| COPD Cohort | Predicting the CAT Score by Building a Statistical Model Employing Sensor-Derived Data and Demographic and Medical Covariates | XGBoost regressor model | 82.6 coefficient of determination (R^2) |