Sensor and Electronic Health Records (EHR) Integration Pilot Study

• Sponsor: GlaxoSmithKline (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03357341
• Collaborator: Geisinger HealthPlan (Other)
• Enrollment: 194
• Location: 1
• Actual Duration (Months): 14.2
• Patients Per Site Per Month: 13.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pulmonary Disease, Chronic Obstructive	Device: Mobile spirometer; Device: Device sensor; Drug: Salbutamol; Device: Activity monitor; Other: electronic diary card; Other: CAT; Other: ACT

Study Design

• Study Type: Observational
• Actual Enrollment: 194 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Enabling Innovative Respiratory Real World Evidence Generation: Sensor and EHR Integration Pilot Study
• Actual Study Start Date: Jul 23, 2018
• Actual Primary Completion Date: Sep 27, 2019
• Actual Study Completion Date: Sep 27, 2019

Arms and Interventions

Arm	Intervention/Treatment
COPD cohort Approximately 100 subjects with COPD identified through integrated EHR records will be enrolled.	Device: Mobile spirometer; Mobile spirometer will be used to measure FEV1 values weekly.; Device: Device sensor; Sensors will be attached to rescue and maintenance inhalers to measure use of rescue medication and maintenance therapy.; Drug: Salbutamol; Salbutamol MDI will be given as a rescue medication to be used on an as needed basis in this study.; Device: Activity monitor; Subjects will be required to wear activity monitors daily to record their physical activity.; Other: electronic diary card; Electronic diary card will be completed daily by subjects in COPD cohort.; Other: CAT; Subjects will be required to complete CAT monthly.
Asthma cohort Approximately 100 subjects with asthma identified through integrated EHR records will be enrolled.	Device: Mobile spirometer; Mobile spirometer will be used to measure FEV1 values weekly.; Device: Device sensor; Sensors will be attached to rescue and maintenance inhalers to measure use of rescue medication and maintenance therapy.; Drug: Salbutamol; Salbutamol MDI will be given as a rescue medication to be used on an as needed basis in this study.; Device: Activity monitor; Subjects will be required to wear activity monitors daily to record their physical activity.; Other: ACT; Subjects will be required to complete ACT monthly.

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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.

3. 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.

4. 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).

5. 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.

6. 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).

7. 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

8. 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.

9. 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.

10. 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

11. 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

12. 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

13. 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.

14. 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

15. 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.

16. 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.

17. 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.

18. 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.

19. 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.

20. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Danville	Pennsylvania	United States	17822

Sponsors and Collaborators

• GlaxoSmithKline
• Geisinger HealthPlan

Investigators

• Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Feb 22, 2018

More Information

Publications

None provided.

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT03357341
• Other Study ID Numbers: 207223; HO-17-17827
• First Posted: Nov 29, 2017
• Last Update Posted: Nov 24, 2020
• Last Verified: Oct 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Keywords provided by GlaxoSmithKline: electronic health record; Pilot; COPD; Sensor; Asthma
• Additional relevant MeSH terms: Pulmonary Disease, Chronic Obstructive; Albuterol

Study Results

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 Detail	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.

Arm/Group Title	Asthma Cohort	COPD Cohort
Arm/Group Description	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.	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.
Period Title: Overall Study
STARTED	96	98
COMPLETED	89	86
NOT COMPLETED	7	12

Baseline Characteristics

Arm/Group Title	Asthma Cohort	COPD Cohort	Total
Arm/Group Description	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.	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.	Total of all reporting groups
Overall Participants	96	98	194
Age (Years) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [Years]	59	64	62
Sex: Female, Male (Count of Participants)
Female	63 65.6%	66 67.3%	129 66.5%
Male	33 34.4%	32 32.7%	65 33.5%
Race/Ethnicity, Customized (Count of Participants)
Caucasian	93 96.9%	94 95.9%	187 96.4%
African-American	1 1%	4 4.1%	5 2.6%
South East Asian	1 1%	0 0%	1 0.5%
Unknown	1 1%	0 0%	1 0.5%

Outcome Measures

1. Primary Outcome

Title	Change From Baseline in Forced Expiratory Volume in One Second (FEV1)
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Asthma Cohort	COPD Cohort
Arm/Group Description	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.	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.
Measure Participants	73	68
Week 5, n=61, 44	-0.03	0.07
Week 9, n=61,39	-0.09	-0.08
Week 13, n=57, 40	-0.06	-0.10
Week 17, n=54, 38	-0.11	-0.15
Week 21, n=33, 28	-0.07	-0.19
Week 25, n=26, 14	-0.12	-0.10

2. Primary Outcome

Title	Median Number of Steps Per Day
Description	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

Outcome Measure Data

Analysis Population Description

All Enrolled Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).

Arm/Group Title	Asthma Cohort	COPD Cohort
Arm/Group Description	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.	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.
Measure Participants	72	68
Week 1, n=72, 68	3574	2186
Week 5, n=53, 54	4547	2446
Week 9, n=52,42	3270	2312
Week 13, n=52, 42	3124	2117
Week 17, n=47, 37	3962	1583
Week 21, n=34, 31	3816	1702
Week 25, n=23, 20	3431	2239

3. Primary Outcome

Title	Median Daily Activity Level Based on Vector Magnitude Counts.
Description	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

Outcome Measure Data

Analysis Population Description

All Enrolled Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).

Arm/Group Title	Asthma Cohort	COPD Cohort
Arm/Group Description	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.	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.
Measure Participants	72	68
Week 1, n=72, 68	512	378
Week 5, n=53, 54	475	415
Week 9, n=52, 42	483	389
Week 13, n=52, 42	469	384
Week 17, n=47, 37	490	342
Week 21, n=34, 31	525	359
Week 25, n=23, 20	446	412

4. Primary Outcome

Title	Patient Reported Outcome (PRO) Active Total Score
Description	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

Outcome Measure Data

Analysis Population Description

All Enrolled Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).

Arm/Group Title	Asthma Cohort	COPD Cohort
Arm/Group Description	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.	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.
Measure Participants	54	58
Week 2, n=54, 58	75	60.3
Week 6, n=40, 52	75	59
Week 10, n=35,36	73	62.5
Week 14, n=36, 36	73.5	58.5
Week 18, n=22, 22	75	57.5
Week 22, n=21, 23	76.5	56.5
Week 26, n=15, 12	75.5	58

5. Primary Outcome

Title	PROactive Amount Domain Score
Description	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

Outcome Measure Data

Analysis Population Description

All Enrolled Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).

Arm/Group Title	Asthma Cohort	COPD Cohort
Arm/Group Description	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.	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.
Measure Participants	54	58
Week 2, n=54, 58	61	52
Week 6, n=40, 52	61	54
Week 10, n=35,36	57	57
Week 14, n=36, 36	59	52
Week 18, n=22, 22	61	52
Week 22, n=21, 23	61	52
Week 26, n=15, 12	61	54

6. Primary Outcome

Title	PROactive Difficulty Domain Score
Description	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

Outcome Measure Data

Analysis Population Description

All Enrolled Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).

Arm/Group Title	Asthma Cohort	COPD Cohort
Arm/Group Description	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.	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.
Measure Participants	68	83
Week 2, n=68, 83	84.5	66
Week 6, n=57, 77	86	63
Week 10, n=54, 65	82	65
Week 14, n=49, 56	83	66
Week 18, n=39, 41	83	61
Week 22, n=47, 50	86	65.5
Week 26, n=28, 37	86	65

7. Primary Outcome

Title	Evaluating Respiratory Symptoms (E-RS) in COPD Total Score-COPD Cohort Only
Description	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

Outcome Measure Data

Analysis Population Description

All Enrolled Population.Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).

Arm/Group Title	COPD Cohort
Arm/Group Description	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.
Measure Participants	72
Week 1, n=72	16.5
Week 5, n=66	17.8
Week 9, n=60	17.1
Week 13, n=56	15.5
Week 17, n=52	15.8
Week 21, n=43	16.3
Week 25, n=41	15.3

8. Primary Outcome

Title	Exacerbations of Chronic Pulmonary Disease Tool (EXACT) Event Rate-COPD Cohort Only
Description	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

Outcome Measure Data

Analysis Population Description

All Enrolled Population.

Arm/Group Title	COPD Cohort
Arm/Group Description	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.
Measure Participants	98
Number [Events per participant per year]	2.06

9. Primary Outcome

Title	Number of Primary Care Visits for Asthma Conditions or COPD
Description	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

Outcome Measure Data

Analysis Population Description

All Enrolled Population.

Arm/Group Title	Asthma Cohort	COPD Cohort
Arm/Group Description	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.	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.
Measure Participants	96	98
Ambulatory	23	79
Home	1	21
Phone	4	17

10. Primary Outcome

Title	Number of Secondary Care Visits for Asthma Conditions or COPD
Description	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

Outcome Measure Data

Analysis Population Description

All Enrolled Population

Arm/Group Title	Asthma Cohort	COPD Cohort
Arm/Group Description	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.	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.
Measure Participants	96	98
Inpatient hospitalization	0	0
ED visits	0	0

11. Primary Outcome

Title	Number of All Primary Care Visits
Description	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

Outcome Measure Data

Analysis Population Description

All Enrolled Population

Arm/Group Title	Asthma Cohort	COPD Cohort
Arm/Group Description	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.	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.
Measure Participants	96	98
Ambulatory	426	598
Home	7	55
Phone	87	116

12. Primary Outcome

Title	Number of All Secondary Care Visits
Description	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

Outcome Measure Data

Analysis Population Description

All Enrolled Population

Arm/Group Title	Asthma Cohort	COPD Cohort
Arm/Group Description	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.	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.
Measure Participants	96	98
Inpatient hospitalization	0	0
ED visits	0	0

13. Primary Outcome

Title	Number of Participants With New Prescriptions
Description	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

Outcome Measure Data

Analysis Population Description

All Enrolled Population

Arm/Group Title	Asthma Cohort	COPD Cohort
Arm/Group Description	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.	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.
Measure Participants	96	98
SABA	85 88.5%	85 86.7%
ICS/LABA	59 61.5%	48 49%
OCS	33 34.4%	52 53.1%
LEUK	37 38.5%	14 14.3%
ICS	30 31.3%	15 15.3%
LAMA	6 6.3%	35 35.7%
SABA/SAMA	9 9.4%	22 22.4%
a-CHOL	2 2.1%	8 8.2%
LABA/LAMA	0 0%	9 9.2%
ICS/LABA/LAMA	0 0%	8 8.2%
PDE4	0 0%	8 8.2%
a-IgE	2 2.1%	1 1%
LABA	2 2.1%	1 1%
IL-5	2 2.1%	0 0%

14. Primary Outcome

Title	Number of Days in Hospital for Asthma and COPD
Description	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

Outcome Measure Data

Analysis Population Description

All Enrolled Population

Arm/Group Title	Asthma Cohort	COPD Cohort
Arm/Group Description	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.	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.
Measure Participants	96	98
Number [Days]	0	0

15. Primary Outcome

Title	Number of Participants Who Received Short-acting Beta-agonist Therapy
Description	Participants who received SABA were summarized using data from EHR-based healthcare utilization.
Time Frame	Up to 6 months

Outcome Measure Data

Analysis Population Description

All Enrolled Population

Arm/Group Title	Asthma Cohort	COPD Cohort
Arm/Group Description	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.	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.
Measure Participants	96	98
Count of Participants [Participants]	85 88.5%	85 86.7%

16. Primary Outcome

Title	Change From Baseline in COPD Assessment Test (CAT) Score-COPD Cohort Only
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	COPD Cohort
Arm/Group Description	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.
Measure Participants	92
Week 5, n=71	0
Week 9, n=67	0
Week 13, n=60	1
Week 17, n=56	0.5
Week 21, n=50	1.5
Week 25, n=48	0

17. Primary Outcome

Title	Change From Baseline in Asthma Control Test (ACT) Score-asthma Cohort Only
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Asthma Cohort
Arm/Group Description	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.
Measure Participants	95
Week 5, n=72	0
Week 9, n=54	0
Week 13, n=62	0
Week 17, n=59	0
Week 21, n=47	0
Week 25, n=46	0

18. Primary Outcome

Title	Median Rescue Medication Use
Description	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

Outcome Measure Data

Analysis Population Description

All Enrolled Population. Only those participants with rescue medication sensors were analyzed.

Arm/Group Title	Asthma Cohort	COPD Cohort
Arm/Group Description	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.	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.
Measure Participants	69	76
Week 1	0.3	0.6
Week 5	0.2	0.4
Week 9	0.1	0.3
Week 13	0.1	0.3
Week 17	0	0.3
Week 21	0	0.3
Week 25	0	0.3

19. Primary Outcome

Title	Percentage of Participants With Maintenance Compliance
Description	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

Outcome Measure Data

Analysis Population Description

All Enrolled Population. Only those participants with maintenance medication sensors were analyzed.

Arm/Group Title	Asthma Cohort	COPD Cohort
Arm/Group Description	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.	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.
Measure Participants	71	59
Week 1	68 70.8%	64 65.3%
Week 5	59 61.5%	56 57.1%
Week 9	54 56.3%	54 55.1%
Week 13	52 54.2%	50 51%
Week 17	48 50%	48 49%
Week 21	48 50%	49 50%
Week 25	46 47.9%	48 49%

20. Primary Outcome

Title	Number of Participants Who Completed Exit Interview
Description	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

Outcome Measure Data

Analysis Population Description

All Enrolled Population

Arm/Group Title	Asthma Cohort	COPD Cohort
Arm/Group Description	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.	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.
Measure Participants	96	98
Count of Participants [Participants]	96 100%	80 81.6%

Adverse Events

Time Frame	Up to 6 months
Adverse Event Reporting Description	Adverse events (AEs) and serious adverse events (SAEs) were observed in All Enrolled Population.
Arm/Group Title	Asthma Cohort		COPD Cohort
Arm/Group Description	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.		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.
All Cause Mortality
	Asthma Cohort		COPD Cohort
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/96 (0%)		1/98 (1%)
Serious Adverse Events
	Asthma Cohort		COPD Cohort
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/96 (0%)		0/98 (0%)
Other (Not Including Serious) Adverse Events
	Asthma Cohort		COPD Cohort
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/96 (0%)		0/98 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.