Pulmonary Disease, Chronic Obstructive
Conditions
Keywords
electronic health record, Pilot, COPD, Sensor, Asthma
Brief summary
This is a pilot study that will evaluate the feasibility of collecting increasing amounts of clinical study data from subjects through sensor and web/app based methods and integrating it with data from their EHR to facilitate more efficient and meaningful research with acceptable quality. Approximately 100 subjects with asthma and 100 subjects with chronic obstructive pulmonary disease (COPD) will be enrolled in this prospective study. The subjects will be identified through integrated EHR records following which eligible subjects will receive study devices and training on proper use of the devices at Baseline visit. Data will be collected remotely from subject reports, devices and sensors over six months.
Interventions
DEVICEMobile spirometer
Mobile spirometer will be used to measure FEV1 values weekly.
DEVICEDevice sensor
Sensors will be attached to rescue and maintenance inhalers to measure use of rescue medication and maintenance therapy.
DRUGSalbutamol
Salbutamol MDI will be given as a rescue medication to be used on an as needed basis in this study.
DEVICEActivity monitor
Subjects will be required to wear activity monitors daily to record their physical activity.
OTHERelectronic diary card
Electronic diary card will be completed daily by subjects in COPD cohort.
OTHERCAT
Subjects will be required to complete CAT monthly.
OTHERACT
Subjects will be required to complete ACT monthly.
Sponsors
Geisinger HealthPlan
GlaxoSmithKline
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
COPD cohort * Provide signed and dated informed consent form. * Be willing to comply with all study procedures and be available for the duration of the study. * Age \>=40 years * Diagnosed with COPD, defined as COPD listed on the subject's problem list and one of the following: a) At least one inpatient hospitalization with a COPD diagnosis listed as the primary or secondary diagnosis (J41.x, J42.x, J44.x \[chronic bronchitis\], J43.9 \[emphysema\] or J44.9 \[Chronic obstructive pulmonary disease, unspecified\]) in the last 12 months b) At least two outpatient encounters with a diagnosis of COPD exacerbation (J44.1), Acute bronchitis (J20.x), or bronchitis (J40) listed as the primary or secondary diagnosis, with different dates of service in the last 12 months c) At least one emergency room encounter with a COPD diagnosis (J41.x, J42.x, J44.x, J43.9, J44.9) listed as the primary or secondary diagnosis in the last 12 months d) At least two urgent care encounters with different dates of service, with a COPD diagnosis (J41.x, J42.x, J44.x, J43.9, J44.9) listed as the primary or secondary diagnosis in the last 12 months. * At least one order for an inhaled COPD medication during the prior year. * More than 12 months of data available in the integrated EHR data prior to date of screening. Asthma cohort * Provide signed and dated informed consent form. * Be willing to comply with all study procedures and be available for the duration of the study. * Age \>=18 years * Diagnosed with asthma, defined as asthma listed on the subject's problem list and one of the following: a) At least one inpatient hospitalization with an asthma diagnosis (J45.x) listed as the primary or secondary diagnosis in the last 12 months. b) At least one emergency room encounter with an asthma diagnosis (J45.x) listed as the primary or secondary diagnosis in the last 12 months c) at least two urgent care encounters, with different dates of service, with an asthma diagnosis (J45.x) listed as the primary or secondary diagnosis in the last 12 months d) At least three or more prescriptions or prescription refills in the past 12 months for any combination of the following: an inhaled glucocorticoid with or without a second controller (Montelukast, Theophylline, a long-acting beta agonist \[LABA\] alone) or a combination drug with a LABA and an inhaled glucocorticoid. * More than 12 months of data available in the integrated EHR data prior to date of screening.
Exclusion criteria
COPD cohort * Inability/Unwillingness to use the required devices, or * Inability to read and understand English Asthma cohort * Inability/Unwillingness to use the required devices * Inability to read and understand English * Diagnosis of COPD listed on problem list
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Forced Expiratory Volume in One Second (FEV1) | Baseline (Week 1) and Weeks 5, 9, 13, 17, 21 and 25 | FEV1 is an important measure of pulmonary function and is the maximum amount of air that can be forced out in one second after taking a deep breath. FEV1 was measured using spirometry. Participants were given a hand-held spirometer with instructions on its proper use. Baseline (Week 1) measurement was taken in clinic and the participants were instructed to perform home spirometry on a weekly basis for the remainder of the study. The spirometry use was linked to the Propeller Health application on the iPad, which provided visual cues for the spirometry and sent the data to the central database after completion of the session. Change from Baseline was calculated as the value at specified time point minus Baseline value. Change from Baseline in FEV1 at 4-weekly intervals is presented. |
| Median Number of Steps Per Day | Weeks 1, 5, 9, 13, 17, 21 and 25 | The physical activity was captured using a waist-worn accelerometer. A valid day was defined as a day where the activity monitor detected that it was worn for at least 8 hours during that day. Data for three or more valid days were required to generate data for weekly step counts. |
| Median Daily Activity Level Based on Vector Magnitude Counts. | Weeks 1, 5, 9, 13, 17, 21 and 25 | The physical activity was captured using a waist-worn accelerometer. Vector magnitude in counts are accelerations in 3 dimensions that indicate activity. More counts is associated with more activity. |
| Patient Reported Outcome (PRO) Active Total Score | Weeks 2, 6, 10, 14, 18, 22 and 26 | The PROactive tool is used to investigate dimensions of physical activity (symptoms, distress, difficulties, amount etc.) that are judged as being essential by participants living with COPD. The clinic visit version of PRO was used, and was offered via the participant's electronic PRO application every 28 days. This version of PRO includes 14 items, measuring a physical activity 'Total Score' with 2 domains ('amount' and 'difficulty'). The 'amount' domain is covered by 2 items (amount of walking outside and chores outside) and by 2 activity monitor outputs (vector magnitude units per minute \[VMU/min\] and steps per day). The 'difficulty' domain is covered by 10 items. Each domain score is based on the simple addition of items (scale ranging from 0 to 15 for amount domain and 0 to 40 for difficulty domain), and then scaled from 0 to 100. 'Total Score' is calculated as the sum of the two domains (amount and difficulty) divided by two, thus scored from 0 (worse) to 100 (much better). |
| PROactive Amount Domain Score | Weeks 2, 6, 10, 14, 18, 22 and 26 | The PROactive tool is used to investigate dimensions of physical activity (symptoms, distress, difficulties, amount etc.) that are judged as being essential by participants living with COPD. The clinic visit version of the PRO was used in this study, and was offered via the participant's electronic PRO application every 28 days. This version of the PRO includes 14 items, measuring a physical activity 'Total Score' with 2 domains (amount and difficulty). The amount domain is covered by 2 items (amount of walking outside and chores outside) and by 2 activity monitor outputs (vector magnitude units per minute \[VMU/min\] and steps per day). Amount domain score is based on the simple addition of items (scale ranging from 0 to 15) and then scaled from 0 to 100. |
| PROactive Difficulty Domain Score | Weeks 2, 6, 10, 14, 18, 22 and 26 | The PROactive tool is used to investigate dimensions of physical activity (symptoms, distress, difficulties, amount etc.) that are judged as being essential by participants living with COPD. The clinic visit version of the PRO was used in this study, and was offered via the participant's electronic PRO application every 28 days. This version of the PRO includes 14 items, measuring a physical activity 'Total Score' with 2 domains ('amount' and 'difficulty'). The 'difficulty' domain is covered by 10 items. The difficulty domain score is based on the simple addition of items (0 to 40), which is then scaled from 0 (worse) to 100 (much better). |
| Evaluating Respiratory Symptoms (E-RS) in COPD Total Score-COPD Cohort Only | Weeks 1, 5, 9, 13, 17, 21 and 25 | The E-RS: COPD scale is a derivative instrument used to measure the effect of treatment on the severity of respiratory symptoms in stable COPD. The E-RS utilizes the 11 respiratory symptom items contained in the 14-item Exacerbations of Chronic pulmonary disease Tool (EXACT). For the COPD cohort specifically, the daily EXACT was offered each evening. The domains included: respiratory symptoms (RS)-breathlessness (RS-BRL comprised of 5 items, score range \[0-17\]), RS-cough and sputum (RS-CSP comprised of 3 items, score range \[0-11\]), and RS-chest symptoms (RS-CSY comprised of 3 items, score range \[0-12\]). The total score was derived by summing the 11-item scores and ranged between 0-40 with higher values indicating severe respiratory symptoms. Scores for the week were summarized for each COPD participant where they completed the questionnaire on three or more days during the study week |
| Exacerbations of Chronic Pulmonary Disease Tool (EXACT) Event Rate-COPD Cohort Only | Up to 6 months | EXACT is a 14-item diary that measures respiratory symptoms and function. The total score for EXACT ranges from 0-100, higher scores indicate more severe symptoms. EXACT events are considered worsening of symptom scores above the individual's Baseline value over multiple consecutive days. |
| Number of Primary Care Visits for Asthma Conditions or COPD | Up to 6 months | The number of primary care visits (including ambulatory, home and phone) for asthma conditions or COPD were summarized using data from EHR-based healthcare utilization. |
| Number of Secondary Care Visits for Asthma Conditions or COPD | Up to 6 months | The number of secondary care visits (that is, inpatient hospitalization and emergency department \[ED\]) for asthma conditions or COPD were summarized using data from EHR-based healthcare utilization |
| Number of All Primary Care Visits | Up to 6 months | The number of all primary care visits (including ambulatory, home and phone) were summarized using data from EHR-based healthcare utilization |
| Number of All Secondary Care Visits | Up to 6 months | The number of all secondary care visits (that is, inpatient hospitalization and ED) were summarized using data from EHR-based healthcare utilization |
| Number of Participants With New Prescriptions | Up to 6 months | New treatments that were prescribed for respiratory-related conditions (Short-acting beta-agonists \[SABA\], Inhaled corticosteroid (ICS)/long-acting beta-agonist \[LABA\] combinations, Oral corticosteroids \[OCS\], Leukotriene modifiers \[LEUK\], ICS, Long-acting muscarinic antagonists \[LAMA\], SABA/short-acting muscarinic antagonist \[SAMA\] combinations, Anti-cholinergics \[a-CHOL\], LABA/LAMA, ICS/LABA/LAMA, Phosphodiesterase type 4 inhibitors \[PDE4\], Anti-immunoglobulin E \[a-IgE\], LABA, and Interleukin-5 inhibitors \[IL-5\]) were summarized using data from EHR-based healthcare utilization. Some participants may have received prescriptions in more than one medication category. |
| Number of Days in Hospital for Asthma and COPD | Up to 6 months | The number of days for which the participant was hospitalized for asthma and COPD was summarized using data from EHR-based healthcare utilization |
| Number of Participants Who Received Short-acting Beta-agonist Therapy | Up to 6 months | Participants who received SABA were summarized using data from EHR-based healthcare utilization. |
| Change From Baseline in COPD Assessment Test (CAT) Score-COPD Cohort Only | Baseline (Week 1) and Weeks 5, 9, 13, 17, 21 and 25 | The CAT is an 8 item questionnaire (cough, sputum, chest tightness, breathlessness, going up hills/stairs, activity limitation at home, confidence leaving the home, and sleep and energy) that measures health status of participants with COPD. Participants completed each question by rating their experience on a 6 point scale ranging from 0 (maximum impairment) to 5 (no impairment). Total score was calculated by summing the non-missing scores on the eight items and ranged from 0-40. Higher scores indicated greater disease impact. Week 1 was considered as Baseline. Change from Baseline was calculated as value at the specified time point minus Baseline value. |
| Change From Baseline in Asthma Control Test (ACT) Score-asthma Cohort Only | Baseline (Week 1) and Weeks 5, 9, 13, 17, 21 and 25 | The ACT is a validated self-administered questionnaire utilizing 5 questions to assess asthma control on a 5-point categorical scale (1 to 5). Total score was calculated as the sum of scores from 5 questions and ranged from 5 to 25. Higher scores indicated better control of asthma. Week 1 was considered as Baseline. Change from Baseline was calculated as value at the specified time point minus Baseline value. |
| Median Rescue Medication Use | Weeks 1, 5, 9, 13, 17, 21, 25 | The use of rescue medication by participants were monitored by attaching a sensor to rescue inhaler. |
| Percentage of Participants With Maintenance Compliance | Weeks 1, 5, 9, 13, 17, 21 and 25 | The use of maintenance therapy by participants were monitored by attaching a sensor to maintenance inhaler. |
| Number of Participants Who Completed Exit Interview | Up to 6 Months | An exit interview were conducted to obtain relevant feedback from participants regarding the study, study devices and electronic PRO platform. Exit surveys were triggered via the study-supplied iPad to each participant when they completed (or withdrew from) the study. |
Countries
United States
Participant flow
Recruitment details
This was a prospective observational study that included two cohorts of participants identified through electronic health records (EHR) within the Geisinger Health System (GHS) database. The study was conducted at a single center in the United States.
Pre-assignment details
A total of 194 participants were enrolled and followed up for six months. The study data was captured remotely via sensors and devices provided by GlaxoSmithKline (GSK) to the participants, or via extraction of EHR data.
Participants by arm
| Arm | Count |
|---|---|
| Asthma Cohort Asthma participants were identified via EHR database analyses, study provider referral (asthma diagnoses with and without specialist confirmation) or recruited from sites of usual care. Participants attended two visits at the Baseline (Visit 1) and approximately six months later (Visit 2). At Visit 2, the participants returned the study devices and attended exit interview to provide relevant feedback. | 96 |
| COPD Cohort Participants with chronic obstructive pulmonary disease (COPD) were identified via EHR database analyses, study provider referral (COPD diagnoses with and without specialist confirmation) or recruited from sites of usual care. Participants attended two visits at the Baseline (Visit 1) and approximately six months later (Visit 2). At Visit 2, the participants returned the study devices and attended exit interview to provide relevant feedback. | 98 |
| Total | 194 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 0 | 1 |
| Overall Study | Lost to Follow-up | 4 | 5 |
| Overall Study | Withdrawal by Subject | 3 | 6 |
Baseline characteristics
| Characteristic | Asthma Cohort | COPD Cohort | Total |
|---|---|---|---|
| Age, Continuous | 59 Years | 64 Years | 62 Years |
| Race/Ethnicity, Customized African-American | 1 Participants | 4 Participants | 5 Participants |
| Race/Ethnicity, Customized Caucasian | 93 Participants | 94 Participants | 187 Participants |
| Race/Ethnicity, Customized South East Asian | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Unknown | 1 Participants | 0 Participants | 1 Participants |
| Sex: Female, Male Female | 63 Participants | 66 Participants | 129 Participants |
| Sex: Female, Male Male | 33 Participants | 32 Participants | 65 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 96 | 1 / 98 |
| other Total, other adverse events | 0 / 96 | 0 / 98 |
| serious Total, serious adverse events | 0 / 96 | 0 / 98 |
Outcome results
Primary
Change From Baseline in Asthma Control Test (ACT) Score-asthma Cohort Only
The ACT is a validated self-administered questionnaire utilizing 5 questions to assess asthma control on a 5-point categorical scale (1 to 5). Total score was calculated as the sum of scores from 5 questions and ranged from 5 to 25. Higher scores indicated better control of asthma. Week 1 was considered as Baseline. Change from Baseline was calculated as value at the specified time point minus Baseline value.
Time frame: Baseline (Week 1) and Weeks 5, 9, 13, 17, 21 and 25
Population: All Enrolled Population. A total of 95 participants were included in the analysis; however, only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Asthma Cohort | Change From Baseline in Asthma Control Test (ACT) Score-asthma Cohort Only | Week 5, n=72 | 0 Scores on a scale |
| Asthma Cohort | Change From Baseline in Asthma Control Test (ACT) Score-asthma Cohort Only | Week 9, n=54 | 0 Scores on a scale |
| Asthma Cohort | Change From Baseline in Asthma Control Test (ACT) Score-asthma Cohort Only | Week 13, n=62 | 0 Scores on a scale |
| Asthma Cohort | Change From Baseline in Asthma Control Test (ACT) Score-asthma Cohort Only | Week 17, n=59 | 0 Scores on a scale |
| Asthma Cohort | Change From Baseline in Asthma Control Test (ACT) Score-asthma Cohort Only | Week 21, n=47 | 0 Scores on a scale |
| Asthma Cohort | Change From Baseline in Asthma Control Test (ACT) Score-asthma Cohort Only | Week 25, n=46 | 0 Scores on a scale |
Primary
Change From Baseline in COPD Assessment Test (CAT) Score-COPD Cohort Only
The CAT is an 8 item questionnaire (cough, sputum, chest tightness, breathlessness, going up hills/stairs, activity limitation at home, confidence leaving the home, and sleep and energy) that measures health status of participants with COPD. Participants completed each question by rating their experience on a 6 point scale ranging from 0 (maximum impairment) to 5 (no impairment). Total score was calculated by summing the non-missing scores on the eight items and ranged from 0-40. Higher scores indicated greater disease impact. Week 1 was considered as Baseline. Change from Baseline was calculated as value at the specified time point minus Baseline value.
Time frame: Baseline (Week 1) and Weeks 5, 9, 13, 17, 21 and 25
Population: All Enrolled Population. A total of 92 participants were included in the analysis; however, only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Asthma Cohort | Change From Baseline in COPD Assessment Test (CAT) Score-COPD Cohort Only | Week 13, n=60 | 1 Scores on a scale |
| Asthma Cohort | Change From Baseline in COPD Assessment Test (CAT) Score-COPD Cohort Only | Week 17, n=56 | 0.5 Scores on a scale |
| Asthma Cohort | Change From Baseline in COPD Assessment Test (CAT) Score-COPD Cohort Only | Week 21, n=50 | 1.5 Scores on a scale |
| Asthma Cohort | Change From Baseline in COPD Assessment Test (CAT) Score-COPD Cohort Only | Week 5, n=71 | 0 Scores on a scale |
| Asthma Cohort | Change From Baseline in COPD Assessment Test (CAT) Score-COPD Cohort Only | Week 9, n=67 | 0 Scores on a scale |
| Asthma Cohort | Change From Baseline in COPD Assessment Test (CAT) Score-COPD Cohort Only | Week 25, n=48 | 0 Scores on a scale |
Primary
Change From Baseline in Forced Expiratory Volume in One Second (FEV1)
FEV1 is an important measure of pulmonary function and is the maximum amount of air that can be forced out in one second after taking a deep breath. FEV1 was measured using spirometry. Participants were given a hand-held spirometer with instructions on its proper use. Baseline (Week 1) measurement was taken in clinic and the participants were instructed to perform home spirometry on a weekly basis for the remainder of the study. The spirometry use was linked to the Propeller Health application on the iPad, which provided visual cues for the spirometry and sent the data to the central database after completion of the session. Change from Baseline was calculated as the value at specified time point minus Baseline value. Change from Baseline in FEV1 at 4-weekly intervals is presented.
Time frame: Baseline (Week 1) and Weeks 5, 9, 13, 17, 21 and 25
Population: All Enrolled Population: Includes participants with asthma and COPD identified via EHR database. Total of 73 and 68 participants were included in the analysis; however only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Asthma Cohort | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) | Week 5, n=61, 44 | -0.03 Liter |
| Asthma Cohort | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) | Week 9, n=61,39 | -0.09 Liter |
| Asthma Cohort | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) | Week 13, n=57, 40 | -0.06 Liter |
| Asthma Cohort | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) | Week 17, n=54, 38 | -0.11 Liter |
| Asthma Cohort | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) | Week 25, n=26, 14 | -0.12 Liter |
| Asthma Cohort | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) | Week 21, n=33, 28 | -0.07 Liter |
| COPD Cohort | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) | Week 17, n=54, 38 | -0.15 Liter |
| COPD Cohort | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) | Week 5, n=61, 44 | 0.07 Liter |
| COPD Cohort | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) | Week 21, n=33, 28 | -0.19 Liter |
| COPD Cohort | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) | Week 9, n=61,39 | -0.08 Liter |
| COPD Cohort | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) | Week 25, n=26, 14 | -0.10 Liter |
| COPD Cohort | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) | Week 13, n=57, 40 | -0.10 Liter |
Primary
Evaluating Respiratory Symptoms (E-RS) in COPD Total Score-COPD Cohort Only
The E-RS: COPD scale is a derivative instrument used to measure the effect of treatment on the severity of respiratory symptoms in stable COPD. The E-RS utilizes the 11 respiratory symptom items contained in the 14-item Exacerbations of Chronic pulmonary disease Tool (EXACT). For the COPD cohort specifically, the daily EXACT was offered each evening. The domains included: respiratory symptoms (RS)-breathlessness (RS-BRL comprised of 5 items, score range \[0-17\]), RS-cough and sputum (RS-CSP comprised of 3 items, score range \[0-11\]), and RS-chest symptoms (RS-CSY comprised of 3 items, score range \[0-12\]). The total score was derived by summing the 11-item scores and ranged between 0-40 with higher values indicating severe respiratory symptoms. Scores for the week were summarized for each COPD participant where they completed the questionnaire on three or more days during the study week
Time frame: Weeks 1, 5, 9, 13, 17, 21 and 25
Population: All Enrolled Population.Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Asthma Cohort | Evaluating Respiratory Symptoms (E-RS) in COPD Total Score-COPD Cohort Only | Week 1, n=72 | 16.5 Scores on a scale |
| Asthma Cohort | Evaluating Respiratory Symptoms (E-RS) in COPD Total Score-COPD Cohort Only | Week 5, n=66 | 17.8 Scores on a scale |
| Asthma Cohort | Evaluating Respiratory Symptoms (E-RS) in COPD Total Score-COPD Cohort Only | Week 9, n=60 | 17.1 Scores on a scale |
| Asthma Cohort | Evaluating Respiratory Symptoms (E-RS) in COPD Total Score-COPD Cohort Only | Week 17, n=52 | 15.8 Scores on a scale |
| Asthma Cohort | Evaluating Respiratory Symptoms (E-RS) in COPD Total Score-COPD Cohort Only | Week 21, n=43 | 16.3 Scores on a scale |
| Asthma Cohort | Evaluating Respiratory Symptoms (E-RS) in COPD Total Score-COPD Cohort Only | Week 13, n=56 | 15.5 Scores on a scale |
| Asthma Cohort | Evaluating Respiratory Symptoms (E-RS) in COPD Total Score-COPD Cohort Only | Week 25, n=41 | 15.3 Scores on a scale |
Primary
Exacerbations of Chronic Pulmonary Disease Tool (EXACT) Event Rate-COPD Cohort Only
EXACT is a 14-item diary that measures respiratory symptoms and function. The total score for EXACT ranges from 0-100, higher scores indicate more severe symptoms. EXACT events are considered worsening of symptom scores above the individual's Baseline value over multiple consecutive days.
Time frame: Up to 6 months
Population: All Enrolled Population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Asthma Cohort | Exacerbations of Chronic Pulmonary Disease Tool (EXACT) Event Rate-COPD Cohort Only | 2.06 Events per participant per year |
Primary
Median Daily Activity Level Based on Vector Magnitude Counts.
The physical activity was captured using a waist-worn accelerometer. Vector magnitude in counts are accelerations in 3 dimensions that indicate activity. More counts is associated with more activity.
Time frame: Weeks 1, 5, 9, 13, 17, 21 and 25
Population: All Enrolled Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Asthma Cohort | Median Daily Activity Level Based on Vector Magnitude Counts. | Week 25, n=23, 20 | 446 Vector magnitude counts |
| Asthma Cohort | Median Daily Activity Level Based on Vector Magnitude Counts. | Week 1, n=72, 68 | 512 Vector magnitude counts |
| Asthma Cohort | Median Daily Activity Level Based on Vector Magnitude Counts. | Week 5, n=53, 54 | 475 Vector magnitude counts |
| Asthma Cohort | Median Daily Activity Level Based on Vector Magnitude Counts. | Week 9, n=52, 42 | 483 Vector magnitude counts |
| Asthma Cohort | Median Daily Activity Level Based on Vector Magnitude Counts. | Week 13, n=52, 42 | 469 Vector magnitude counts |
| Asthma Cohort | Median Daily Activity Level Based on Vector Magnitude Counts. | Week 17, n=47, 37 | 490 Vector magnitude counts |
| Asthma Cohort | Median Daily Activity Level Based on Vector Magnitude Counts. | Week 21, n=34, 31 | 525 Vector magnitude counts |
| COPD Cohort | Median Daily Activity Level Based on Vector Magnitude Counts. | Week 25, n=23, 20 | 412 Vector magnitude counts |
| COPD Cohort | Median Daily Activity Level Based on Vector Magnitude Counts. | Week 13, n=52, 42 | 384 Vector magnitude counts |
| COPD Cohort | Median Daily Activity Level Based on Vector Magnitude Counts. | Week 1, n=72, 68 | 378 Vector magnitude counts |
| COPD Cohort | Median Daily Activity Level Based on Vector Magnitude Counts. | Week 21, n=34, 31 | 359 Vector magnitude counts |
| COPD Cohort | Median Daily Activity Level Based on Vector Magnitude Counts. | Week 5, n=53, 54 | 415 Vector magnitude counts |
| COPD Cohort | Median Daily Activity Level Based on Vector Magnitude Counts. | Week 17, n=47, 37 | 342 Vector magnitude counts |
| COPD Cohort | Median Daily Activity Level Based on Vector Magnitude Counts. | Week 9, n=52, 42 | 389 Vector magnitude counts |
Primary
Median Number of Steps Per Day
The physical activity was captured using a waist-worn accelerometer. A valid day was defined as a day where the activity monitor detected that it was worn for at least 8 hours during that day. Data for three or more valid days were required to generate data for weekly step counts.
Time frame: Weeks 1, 5, 9, 13, 17, 21 and 25
Population: All Enrolled Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Asthma Cohort | Median Number of Steps Per Day | Week 13, n=52, 42 | 3124 Steps per day |
| Asthma Cohort | Median Number of Steps Per Day | Week 17, n=47, 37 | 3962 Steps per day |
| Asthma Cohort | Median Number of Steps Per Day | Week 5, n=53, 54 | 4547 Steps per day |
| Asthma Cohort | Median Number of Steps Per Day | Week 21, n=34, 31 | 3816 Steps per day |
| Asthma Cohort | Median Number of Steps Per Day | Week 9, n=52,42 | 3270 Steps per day |
| Asthma Cohort | Median Number of Steps Per Day | Week 25, n=23, 20 | 3431 Steps per day |
| Asthma Cohort | Median Number of Steps Per Day | Week 1, n=72, 68 | 3574 Steps per day |
| COPD Cohort | Median Number of Steps Per Day | Week 25, n=23, 20 | 2239 Steps per day |
| COPD Cohort | Median Number of Steps Per Day | Week 13, n=52, 42 | 2117 Steps per day |
| COPD Cohort | Median Number of Steps Per Day | Week 5, n=53, 54 | 2446 Steps per day |
| COPD Cohort | Median Number of Steps Per Day | Week 9, n=52,42 | 2312 Steps per day |
| COPD Cohort | Median Number of Steps Per Day | Week 17, n=47, 37 | 1583 Steps per day |
| COPD Cohort | Median Number of Steps Per Day | Week 21, n=34, 31 | 1702 Steps per day |
| COPD Cohort | Median Number of Steps Per Day | Week 1, n=72, 68 | 2186 Steps per day |
Primary
Median Rescue Medication Use
The use of rescue medication by participants were monitored by attaching a sensor to rescue inhaler.
Time frame: Weeks 1, 5, 9, 13, 17, 21, 25
Population: All Enrolled Population. Only those participants with rescue medication sensors were analyzed.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Asthma Cohort | Median Rescue Medication Use | Week 5 | 0.2 Occasions per day |
| Asthma Cohort | Median Rescue Medication Use | Week 17 | 0 Occasions per day |
| Asthma Cohort | Median Rescue Medication Use | Week 9 | 0.1 Occasions per day |
| Asthma Cohort | Median Rescue Medication Use | Week 21 | 0 Occasions per day |
| Asthma Cohort | Median Rescue Medication Use | Week 1 | 0.3 Occasions per day |
| Asthma Cohort | Median Rescue Medication Use | Week 25 | 0 Occasions per day |
| Asthma Cohort | Median Rescue Medication Use | Week 13 | 0.1 Occasions per day |
| COPD Cohort | Median Rescue Medication Use | Week 25 | 0.3 Occasions per day |
| COPD Cohort | Median Rescue Medication Use | Week 9 | 0.3 Occasions per day |
| COPD Cohort | Median Rescue Medication Use | Week 13 | 0.3 Occasions per day |
| COPD Cohort | Median Rescue Medication Use | Week 1 | 0.6 Occasions per day |
| COPD Cohort | Median Rescue Medication Use | Week 17 | 0.3 Occasions per day |
| COPD Cohort | Median Rescue Medication Use | Week 21 | 0.3 Occasions per day |
| COPD Cohort | Median Rescue Medication Use | Week 5 | 0.4 Occasions per day |
Primary
Number of All Primary Care Visits
The number of all primary care visits (including ambulatory, home and phone) were summarized using data from EHR-based healthcare utilization
Time frame: Up to 6 months
Population: All Enrolled Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Asthma Cohort | Number of All Primary Care Visits | Ambulatory | 426 Visits |
| Asthma Cohort | Number of All Primary Care Visits | Home | 7 Visits |
| Asthma Cohort | Number of All Primary Care Visits | Phone | 87 Visits |
| COPD Cohort | Number of All Primary Care Visits | Ambulatory | 598 Visits |
| COPD Cohort | Number of All Primary Care Visits | Home | 55 Visits |
| COPD Cohort | Number of All Primary Care Visits | Phone | 116 Visits |
Primary
Number of All Secondary Care Visits
The number of all secondary care visits (that is, inpatient hospitalization and ED) were summarized using data from EHR-based healthcare utilization
Time frame: Up to 6 months
Population: All Enrolled Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Asthma Cohort | Number of All Secondary Care Visits | Inpatient hospitalization | 0 Visits |
| Asthma Cohort | Number of All Secondary Care Visits | ED visits | 0 Visits |
| COPD Cohort | Number of All Secondary Care Visits | Inpatient hospitalization | 0 Visits |
| COPD Cohort | Number of All Secondary Care Visits | ED visits | 0 Visits |
Primary
Number of Days in Hospital for Asthma and COPD
The number of days for which the participant was hospitalized for asthma and COPD was summarized using data from EHR-based healthcare utilization
Time frame: Up to 6 months
Population: All Enrolled Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Asthma Cohort | Number of Days in Hospital for Asthma and COPD | 0 Days |
| COPD Cohort | Number of Days in Hospital for Asthma and COPD | 0 Days |
Primary
Number of Participants Who Completed Exit Interview
An exit interview were conducted to obtain relevant feedback from participants regarding the study, study devices and electronic PRO platform. Exit surveys were triggered via the study-supplied iPad to each participant when they completed (or withdrew from) the study.
Time frame: Up to 6 Months
Population: All Enrolled Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Asthma Cohort | Number of Participants Who Completed Exit Interview | 96 Participants |
| COPD Cohort | Number of Participants Who Completed Exit Interview | 80 Participants |
Primary
Number of Participants Who Received Short-acting Beta-agonist Therapy
Participants who received SABA were summarized using data from EHR-based healthcare utilization.
Time frame: Up to 6 months
Population: All Enrolled Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Asthma Cohort | Number of Participants Who Received Short-acting Beta-agonist Therapy | 85 Participants |
| COPD Cohort | Number of Participants Who Received Short-acting Beta-agonist Therapy | 85 Participants |
Primary
Number of Participants With New Prescriptions
New treatments that were prescribed for respiratory-related conditions (Short-acting beta-agonists \[SABA\], Inhaled corticosteroid (ICS)/long-acting beta-agonist \[LABA\] combinations, Oral corticosteroids \[OCS\], Leukotriene modifiers \[LEUK\], ICS, Long-acting muscarinic antagonists \[LAMA\], SABA/short-acting muscarinic antagonist \[SAMA\] combinations, Anti-cholinergics \[a-CHOL\], LABA/LAMA, ICS/LABA/LAMA, Phosphodiesterase type 4 inhibitors \[PDE4\], Anti-immunoglobulin E \[a-IgE\], LABA, and Interleukin-5 inhibitors \[IL-5\]) were summarized using data from EHR-based healthcare utilization. Some participants may have received prescriptions in more than one medication category.
Time frame: Up to 6 months
Population: All Enrolled Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Asthma Cohort | Number of Participants With New Prescriptions | SABA/SAMA | 9 Participants |
| Asthma Cohort | Number of Participants With New Prescriptions | PDE4 | 0 Participants |
| Asthma Cohort | Number of Participants With New Prescriptions | a-CHOL | 2 Participants |
| Asthma Cohort | Number of Participants With New Prescriptions | LEUK | 37 Participants |
| Asthma Cohort | Number of Participants With New Prescriptions | LABA/LAMA | 0 Participants |
| Asthma Cohort | Number of Participants With New Prescriptions | ICS/LABA | 59 Participants |
| Asthma Cohort | Number of Participants With New Prescriptions | ICS/LABA/LAMA | 0 Participants |
| Asthma Cohort | Number of Participants With New Prescriptions | ICS | 30 Participants |
| Asthma Cohort | Number of Participants With New Prescriptions | a-IgE | 2 Participants |
| Asthma Cohort | Number of Participants With New Prescriptions | SABA | 85 Participants |
| Asthma Cohort | Number of Participants With New Prescriptions | LABA | 2 Participants |
| Asthma Cohort | Number of Participants With New Prescriptions | LAMA | 6 Participants |
| Asthma Cohort | Number of Participants With New Prescriptions | IL-5 | 2 Participants |
| Asthma Cohort | Number of Participants With New Prescriptions | OCS | 33 Participants |
| COPD Cohort | Number of Participants With New Prescriptions | IL-5 | 0 Participants |
| COPD Cohort | Number of Participants With New Prescriptions | SABA | 85 Participants |
| COPD Cohort | Number of Participants With New Prescriptions | ICS/LABA | 48 Participants |
| COPD Cohort | Number of Participants With New Prescriptions | OCS | 52 Participants |
| COPD Cohort | Number of Participants With New Prescriptions | LEUK | 14 Participants |
| COPD Cohort | Number of Participants With New Prescriptions | ICS | 15 Participants |
| COPD Cohort | Number of Participants With New Prescriptions | LAMA | 35 Participants |
| COPD Cohort | Number of Participants With New Prescriptions | SABA/SAMA | 22 Participants |
| COPD Cohort | Number of Participants With New Prescriptions | a-CHOL | 8 Participants |
| COPD Cohort | Number of Participants With New Prescriptions | LABA/LAMA | 9 Participants |
| COPD Cohort | Number of Participants With New Prescriptions | PDE4 | 8 Participants |
| COPD Cohort | Number of Participants With New Prescriptions | a-IgE | 1 Participants |
| COPD Cohort | Number of Participants With New Prescriptions | LABA | 1 Participants |
| COPD Cohort | Number of Participants With New Prescriptions | ICS/LABA/LAMA | 8 Participants |
Primary
Number of Primary Care Visits for Asthma Conditions or COPD
The number of primary care visits (including ambulatory, home and phone) for asthma conditions or COPD were summarized using data from EHR-based healthcare utilization.
Time frame: Up to 6 months
Population: All Enrolled Population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Asthma Cohort | Number of Primary Care Visits for Asthma Conditions or COPD | Ambulatory | 23 Visits |
| Asthma Cohort | Number of Primary Care Visits for Asthma Conditions or COPD | Home | 1 Visits |
| Asthma Cohort | Number of Primary Care Visits for Asthma Conditions or COPD | Phone | 4 Visits |
| COPD Cohort | Number of Primary Care Visits for Asthma Conditions or COPD | Ambulatory | 79 Visits |
| COPD Cohort | Number of Primary Care Visits for Asthma Conditions or COPD | Home | 21 Visits |
| COPD Cohort | Number of Primary Care Visits for Asthma Conditions or COPD | Phone | 17 Visits |
Primary
Number of Secondary Care Visits for Asthma Conditions or COPD
The number of secondary care visits (that is, inpatient hospitalization and emergency department \[ED\]) for asthma conditions or COPD were summarized using data from EHR-based healthcare utilization
Time frame: Up to 6 months
Population: All Enrolled Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Asthma Cohort | Number of Secondary Care Visits for Asthma Conditions or COPD | ED visits | 0 Visits |
| Asthma Cohort | Number of Secondary Care Visits for Asthma Conditions or COPD | Inpatient hospitalization | 0 Visits |
| COPD Cohort | Number of Secondary Care Visits for Asthma Conditions or COPD | ED visits | 0 Visits |
| COPD Cohort | Number of Secondary Care Visits for Asthma Conditions or COPD | Inpatient hospitalization | 0 Visits |
Primary
Patient Reported Outcome (PRO) Active Total Score
The PROactive tool is used to investigate dimensions of physical activity (symptoms, distress, difficulties, amount etc.) that are judged as being essential by participants living with COPD. The clinic visit version of PRO was used, and was offered via the participant's electronic PRO application every 28 days. This version of PRO includes 14 items, measuring a physical activity 'Total Score' with 2 domains ('amount' and 'difficulty'). The 'amount' domain is covered by 2 items (amount of walking outside and chores outside) and by 2 activity monitor outputs (vector magnitude units per minute \[VMU/min\] and steps per day). The 'difficulty' domain is covered by 10 items. Each domain score is based on the simple addition of items (scale ranging from 0 to 15 for amount domain and 0 to 40 for difficulty domain), and then scaled from 0 to 100. 'Total Score' is calculated as the sum of the two domains (amount and difficulty) divided by two, thus scored from 0 (worse) to 100 (much better).
Time frame: Weeks 2, 6, 10, 14, 18, 22 and 26
Population: All Enrolled Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Asthma Cohort | Patient Reported Outcome (PRO) Active Total Score | Week 10, n=35,36 | 73 Scores on a scale |
| Asthma Cohort | Patient Reported Outcome (PRO) Active Total Score | Week 26, n=15, 12 | 75.5 Scores on a scale |
| Asthma Cohort | Patient Reported Outcome (PRO) Active Total Score | Week 18, n=22, 22 | 75 Scores on a scale |
| Asthma Cohort | Patient Reported Outcome (PRO) Active Total Score | Week 2, n=54, 58 | 75 Scores on a scale |
| Asthma Cohort | Patient Reported Outcome (PRO) Active Total Score | Week 14, n=36, 36 | 73.5 Scores on a scale |
| Asthma Cohort | Patient Reported Outcome (PRO) Active Total Score | Week 6, n=40, 52 | 75 Scores on a scale |
| Asthma Cohort | Patient Reported Outcome (PRO) Active Total Score | Week 22, n=21, 23 | 76.5 Scores on a scale |
| COPD Cohort | Patient Reported Outcome (PRO) Active Total Score | Week 22, n=21, 23 | 56.5 Scores on a scale |
| COPD Cohort | Patient Reported Outcome (PRO) Active Total Score | Week 10, n=35,36 | 62.5 Scores on a scale |
| COPD Cohort | Patient Reported Outcome (PRO) Active Total Score | Week 14, n=36, 36 | 58.5 Scores on a scale |
| COPD Cohort | Patient Reported Outcome (PRO) Active Total Score | Week 18, n=22, 22 | 57.5 Scores on a scale |
| COPD Cohort | Patient Reported Outcome (PRO) Active Total Score | Week 6, n=40, 52 | 59 Scores on a scale |
| COPD Cohort | Patient Reported Outcome (PRO) Active Total Score | Week 26, n=15, 12 | 58 Scores on a scale |
| COPD Cohort | Patient Reported Outcome (PRO) Active Total Score | Week 2, n=54, 58 | 60.3 Scores on a scale |
Primary
Percentage of Participants With Maintenance Compliance
The use of maintenance therapy by participants were monitored by attaching a sensor to maintenance inhaler.
Time frame: Weeks 1, 5, 9, 13, 17, 21 and 25
Population: All Enrolled Population. Only those participants with maintenance medication sensors were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Asthma Cohort | Percentage of Participants With Maintenance Compliance | Week 9 | 54 Percentage of Participants |
| Asthma Cohort | Percentage of Participants With Maintenance Compliance | Week 17 | 48 Percentage of Participants |
| Asthma Cohort | Percentage of Participants With Maintenance Compliance | Week 5 | 59 Percentage of Participants |
| Asthma Cohort | Percentage of Participants With Maintenance Compliance | Week 21 | 48 Percentage of Participants |
| Asthma Cohort | Percentage of Participants With Maintenance Compliance | Week 13 | 52 Percentage of Participants |
| Asthma Cohort | Percentage of Participants With Maintenance Compliance | Week 25 | 46 Percentage of Participants |
| Asthma Cohort | Percentage of Participants With Maintenance Compliance | Week 1 | 68 Percentage of Participants |
| COPD Cohort | Percentage of Participants With Maintenance Compliance | Week 25 | 48 Percentage of Participants |
| COPD Cohort | Percentage of Participants With Maintenance Compliance | Week 1 | 64 Percentage of Participants |
| COPD Cohort | Percentage of Participants With Maintenance Compliance | Week 5 | 56 Percentage of Participants |
| COPD Cohort | Percentage of Participants With Maintenance Compliance | Week 9 | 54 Percentage of Participants |
| COPD Cohort | Percentage of Participants With Maintenance Compliance | Week 13 | 50 Percentage of Participants |
| COPD Cohort | Percentage of Participants With Maintenance Compliance | Week 17 | 48 Percentage of Participants |
| COPD Cohort | Percentage of Participants With Maintenance Compliance | Week 21 | 49 Percentage of Participants |
Primary
PROactive Amount Domain Score
The PROactive tool is used to investigate dimensions of physical activity (symptoms, distress, difficulties, amount etc.) that are judged as being essential by participants living with COPD. The clinic visit version of the PRO was used in this study, and was offered via the participant's electronic PRO application every 28 days. This version of the PRO includes 14 items, measuring a physical activity 'Total Score' with 2 domains (amount and difficulty). The amount domain is covered by 2 items (amount of walking outside and chores outside) and by 2 activity monitor outputs (vector magnitude units per minute \[VMU/min\] and steps per day). Amount domain score is based on the simple addition of items (scale ranging from 0 to 15) and then scaled from 0 to 100.
Time frame: Weeks 2, 6, 10, 14, 18, 22 and 26
Population: All Enrolled Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Asthma Cohort | PROactive Amount Domain Score | Week 2, n=54, 58 | 61 Scores on a scale |
| Asthma Cohort | PROactive Amount Domain Score | Week 6, n=40, 52 | 61 Scores on a scale |
| Asthma Cohort | PROactive Amount Domain Score | Week 10, n=35,36 | 57 Scores on a scale |
| Asthma Cohort | PROactive Amount Domain Score | Week 14, n=36, 36 | 59 Scores on a scale |
| Asthma Cohort | PROactive Amount Domain Score | Week 18, n=22, 22 | 61 Scores on a scale |
| Asthma Cohort | PROactive Amount Domain Score | Week 22, n=21, 23 | 61 Scores on a scale |
| Asthma Cohort | PROactive Amount Domain Score | Week 26, n=15, 12 | 61 Scores on a scale |
| COPD Cohort | PROactive Amount Domain Score | Week 14, n=36, 36 | 52 Scores on a scale |
| COPD Cohort | PROactive Amount Domain Score | Week 2, n=54, 58 | 52 Scores on a scale |
| COPD Cohort | PROactive Amount Domain Score | Week 22, n=21, 23 | 52 Scores on a scale |
| COPD Cohort | PROactive Amount Domain Score | Week 6, n=40, 52 | 54 Scores on a scale |
| COPD Cohort | PROactive Amount Domain Score | Week 18, n=22, 22 | 52 Scores on a scale |
| COPD Cohort | PROactive Amount Domain Score | Week 10, n=35,36 | 57 Scores on a scale |
| COPD Cohort | PROactive Amount Domain Score | Week 26, n=15, 12 | 54 Scores on a scale |
Primary
PROactive Difficulty Domain Score
The PROactive tool is used to investigate dimensions of physical activity (symptoms, distress, difficulties, amount etc.) that are judged as being essential by participants living with COPD. The clinic visit version of the PRO was used in this study, and was offered via the participant's electronic PRO application every 28 days. This version of the PRO includes 14 items, measuring a physical activity 'Total Score' with 2 domains ('amount' and 'difficulty'). The 'difficulty' domain is covered by 10 items. The difficulty domain score is based on the simple addition of items (0 to 40), which is then scaled from 0 (worse) to 100 (much better).
Time frame: Weeks 2, 6, 10, 14, 18, 22 and 26
Population: All Enrolled Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Asthma Cohort | PROactive Difficulty Domain Score | Week 2, n=68, 83 | 84.5 Scores on a scale |
| Asthma Cohort | PROactive Difficulty Domain Score | Week 6, n=57, 77 | 86 Scores on a scale |
| Asthma Cohort | PROactive Difficulty Domain Score | Week 10, n=54, 65 | 82 Scores on a scale |
| Asthma Cohort | PROactive Difficulty Domain Score | Week 14, n=49, 56 | 83 Scores on a scale |
| Asthma Cohort | PROactive Difficulty Domain Score | Week 22, n=47, 50 | 86 Scores on a scale |
| Asthma Cohort | PROactive Difficulty Domain Score | Week 26, n=28, 37 | 86 Scores on a scale |
| Asthma Cohort | PROactive Difficulty Domain Score | Week 18, n=39, 41 | 83 Scores on a scale |
| COPD Cohort | PROactive Difficulty Domain Score | Week 14, n=49, 56 | 66 Scores on a scale |
| COPD Cohort | PROactive Difficulty Domain Score | Week 2, n=68, 83 | 66 Scores on a scale |
| COPD Cohort | PROactive Difficulty Domain Score | Week 18, n=39, 41 | 61 Scores on a scale |
| COPD Cohort | PROactive Difficulty Domain Score | Week 6, n=57, 77 | 63 Scores on a scale |
| COPD Cohort | PROactive Difficulty Domain Score | Week 26, n=28, 37 | 65 Scores on a scale |
| COPD Cohort | PROactive Difficulty Domain Score | Week 10, n=54, 65 | 65 Scores on a scale |
| COPD Cohort | PROactive Difficulty Domain Score | Week 22, n=47, 50 | 65.5 Scores on a scale |