Sensor and Electronic Health Records (EHR) Integration Pilot Study

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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