Trial Outcomes & Findings for Sensor and Electronic Health Records (EHR) Integration Pilot Study (NCT NCT03357341)
NCT ID: NCT03357341
Last Updated: 2020-11-24
Results Overview
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.
COMPLETED
194 participants
Baseline (Week 1) and Weeks 5, 9, 13, 17, 21 and 25
2020-11-24
Participant Flow
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.
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.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
96
|
98
|
|
Overall Study
COMPLETED
|
89
|
86
|
|
Overall Study
NOT COMPLETED
|
7
|
12
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
6
|
|
Overall Study
Lost to Follow-up
|
4
|
5
|
|
Overall Study
Death
|
0
|
1
|
Baseline Characteristics
Sensor and Electronic Health Records (EHR) Integration Pilot Study
Baseline characteristics by cohort
| Measure |
Asthma Cohort
n=96 Participants
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.
|
COPD Cohort
n=98 Participants
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
n=194 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59 Years
n=5 Participants
|
64 Years
n=7 Participants
|
62 Years
n=5 Participants
|
|
Sex: Female, Male
Female
|
63 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
129 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
93 Participants
n=5 Participants
|
94 Participants
n=7 Participants
|
187 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African-American
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
South East Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (Week 1) and Weeks 5, 9, 13, 17, 21 and 25Population: 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).
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.
Outcome measures
| Measure |
Asthma Cohort
n=73 Participants
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.
|
COPD Cohort
n=68 Participants
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.
|
|---|---|---|
|
Change From Baseline in Forced Expiratory Volume in One Second (FEV1)
Week 5, n=61, 44
|
-0.03 Liter
Interval -0.23 to 0.14
|
0.07 Liter
Interval -0.08 to 0.17
|
|
Change From Baseline in Forced Expiratory Volume in One Second (FEV1)
Week 9, n=61,39
|
-0.09 Liter
Interval -0.28 to 0.11
|
-0.08 Liter
Interval -0.26 to 0.03
|
|
Change From Baseline in Forced Expiratory Volume in One Second (FEV1)
Week 13, n=57, 40
|
-0.06 Liter
Interval -0.22 to 0.14
|
-0.10 Liter
Interval -0.22 to 0.06
|
|
Change From Baseline in Forced Expiratory Volume in One Second (FEV1)
Week 17, n=54, 38
|
-0.11 Liter
Interval -0.27 to 0.05
|
-0.15 Liter
Interval -0.23 to 0.09
|
|
Change From Baseline in Forced Expiratory Volume in One Second (FEV1)
Week 21, n=33, 28
|
-0.07 Liter
Interval -0.22 to 0.08
|
-0.19 Liter
Interval -0.51 to 0.0
|
|
Change From Baseline in Forced Expiratory Volume in One Second (FEV1)
Week 25, n=26, 14
|
-0.12 Liter
Interval -0.24 to 0.18
|
-0.10 Liter
Interval -0.27 to 0.01
|
PRIMARY outcome
Timeframe: Weeks 1, 5, 9, 13, 17, 21 and 25Population: All Enrolled Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).
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.
Outcome measures
| Measure |
Asthma Cohort
n=72 Participants
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.
|
COPD Cohort
n=68 Participants
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.
|
|---|---|---|
|
Median Number of Steps Per Day
Week 1, n=72, 68
|
3574 Steps per day
Interval 2321.0 to 5584.0
|
2186 Steps per day
Interval 1185.0 to 3320.0
|
|
Median Number of Steps Per Day
Week 5, n=53, 54
|
4547 Steps per day
Interval 1956.0 to 6021.0
|
2446 Steps per day
Interval 1281.0 to 3832.0
|
|
Median Number of Steps Per Day
Week 9, n=52,42
|
3270 Steps per day
Interval 2161.0 to 6358.0
|
2312 Steps per day
Interval 1335.0 to 3605.0
|
|
Median Number of Steps Per Day
Week 13, n=52, 42
|
3124 Steps per day
Interval 1944.0 to 6425.0
|
2117 Steps per day
Interval 1150.0 to 3390.0
|
|
Median Number of Steps Per Day
Week 17, n=47, 37
|
3962 Steps per day
Interval 2160.0 to 6637.0
|
1583 Steps per day
Interval 1148.0 to 2752.0
|
|
Median Number of Steps Per Day
Week 21, n=34, 31
|
3816 Steps per day
Interval 1498.0 to 6547.0
|
1702 Steps per day
Interval 912.0 to 3645.0
|
|
Median Number of Steps Per Day
Week 25, n=23, 20
|
3431 Steps per day
Interval 1822.0 to 6501.0
|
2239 Steps per day
Interval 1012.0 to 3139.0
|
PRIMARY outcome
Timeframe: Weeks 1, 5, 9, 13, 17, 21 and 25Population: All Enrolled Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).
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.
Outcome measures
| Measure |
Asthma Cohort
n=72 Participants
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.
|
COPD Cohort
n=68 Participants
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.
|
|---|---|---|
|
Median Daily Activity Level Based on Vector Magnitude Counts.
Week 1, n=72, 68
|
512 Vector magnitude counts
Interval 407.0 to 658.0
|
378 Vector magnitude counts
Interval 288.0 to 492.0
|
|
Median Daily Activity Level Based on Vector Magnitude Counts.
Week 5, n=53, 54
|
475 Vector magnitude counts
Interval 375.0 to 669.0
|
415 Vector magnitude counts
Interval 302.0 to 578.0
|
|
Median Daily Activity Level Based on Vector Magnitude Counts.
Week 9, n=52, 42
|
483 Vector magnitude counts
Interval 348.0 to 629.0
|
389 Vector magnitude counts
Interval 290.0 to 523.0
|
|
Median Daily Activity Level Based on Vector Magnitude Counts.
Week 13, n=52, 42
|
469 Vector magnitude counts
Interval 342.0 to 685.0
|
384 Vector magnitude counts
Interval 268.0 to 541.0
|
|
Median Daily Activity Level Based on Vector Magnitude Counts.
Week 17, n=47, 37
|
490 Vector magnitude counts
Interval 375.0 to 670.0
|
342 Vector magnitude counts
Interval 272.0 to 434.0
|
|
Median Daily Activity Level Based on Vector Magnitude Counts.
Week 21, n=34, 31
|
525 Vector magnitude counts
Interval 359.0 to 683.0
|
359 Vector magnitude counts
Interval 242.0 to 608.0
|
|
Median Daily Activity Level Based on Vector Magnitude Counts.
Week 25, n=23, 20
|
446 Vector magnitude counts
Interval 343.0 to 661.0
|
412 Vector magnitude counts
Interval 311.0 to 648.0
|
PRIMARY outcome
Timeframe: Weeks 2, 6, 10, 14, 18, 22 and 26Population: All Enrolled Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).
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).
Outcome measures
| Measure |
Asthma Cohort
n=54 Participants
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.
|
COPD Cohort
n=58 Participants
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.
|
|---|---|---|
|
Patient Reported Outcome (PRO) Active Total Score
Week 2, n=54, 58
|
75 Scores on a scale
Interval 66.5 to 78.5
|
60.3 Scores on a scale
Interval 54.5 to 69.0
|
|
Patient Reported Outcome (PRO) Active Total Score
Week 6, n=40, 52
|
75 Scores on a scale
Interval 63.8 to 79.3
|
59 Scores on a scale
Interval 55.3 to 66.0
|
|
Patient Reported Outcome (PRO) Active Total Score
Week 10, n=35,36
|
73 Scores on a scale
Interval 63.5 to 78.5
|
62.5 Scores on a scale
Interval 53.5 to 69.5
|
|
Patient Reported Outcome (PRO) Active Total Score
Week 14, n=36, 36
|
73.5 Scores on a scale
Interval 65.5 to 79.3
|
58.5 Scores on a scale
Interval 49.5 to 68.3
|
|
Patient Reported Outcome (PRO) Active Total Score
Week 18, n=22, 22
|
75 Scores on a scale
Interval 70.0 to 78.5
|
57.5 Scores on a scale
Interval 52.5 to 61.5
|
|
Patient Reported Outcome (PRO) Active Total Score
Week 22, n=21, 23
|
76.5 Scores on a scale
Interval 67.0 to 81.0
|
56.5 Scores on a scale
Interval 48.5 to 63.5
|
|
Patient Reported Outcome (PRO) Active Total Score
Week 26, n=15, 12
|
75.5 Scores on a scale
Interval 67.0 to 79.0
|
58 Scores on a scale
Interval 56.3 to 67.8
|
PRIMARY outcome
Timeframe: Weeks 2, 6, 10, 14, 18, 22 and 26Population: All Enrolled Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).
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.
Outcome measures
| Measure |
Asthma Cohort
n=54 Participants
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.
|
COPD Cohort
n=58 Participants
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.
|
|---|---|---|
|
PROactive Amount Domain Score
Week 2, n=54, 58
|
61 Scores on a scale
Interval 52.0 to 70.0
|
52 Scores on a scale
Interval 48.0 to 57.0
|
|
PROactive Amount Domain Score
Week 6, n=40, 52
|
61 Scores on a scale
Interval 52.0 to 65.0
|
54 Scores on a scale
Interval 48.0 to 61.0
|
|
PROactive Amount Domain Score
Week 10, n=35,36
|
57 Scores on a scale
Interval 52.0 to 65.0
|
57 Scores on a scale
Interval 48.0 to 61.0
|
|
PROactive Amount Domain Score
Week 14, n=36, 36
|
59 Scores on a scale
Interval 52.0 to 70.0
|
52 Scores on a scale
Interval 44.0 to 63.0
|
|
PROactive Amount Domain Score
Week 18, n=22, 22
|
61 Scores on a scale
Interval 57.0 to 75.0
|
52 Scores on a scale
Interval 48.0 to 61.0
|
|
PROactive Amount Domain Score
Week 22, n=21, 23
|
61 Scores on a scale
Interval 57.0 to 75.0
|
52 Scores on a scale
Interval 39.0 to 61.0
|
|
PROactive Amount Domain Score
Week 26, n=15, 12
|
61 Scores on a scale
Interval 57.0 to 70.0
|
54 Scores on a scale
Interval 46.0 to 57.0
|
PRIMARY outcome
Timeframe: Weeks 2, 6, 10, 14, 18, 22 and 26Population: All Enrolled Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).
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).
Outcome measures
| Measure |
Asthma Cohort
n=68 Participants
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.
|
COPD Cohort
n=83 Participants
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.
|
|---|---|---|
|
PROactive Difficulty Domain Score
Week 2, n=68, 83
|
84.5 Scores on a scale
Interval 73.0 to 94.0
|
66 Scores on a scale
Interval 60.0 to 75.0
|
|
PROactive Difficulty Domain Score
Week 6, n=57, 77
|
86 Scores on a scale
Interval 68.0 to 94.0
|
63 Scores on a scale
Interval 56.0 to 77.0
|
|
PROactive Difficulty Domain Score
Week 10, n=54, 65
|
82 Scores on a scale
Interval 72.0 to 92.0
|
65 Scores on a scale
Interval 55.0 to 73.0
|
|
PROactive Difficulty Domain Score
Week 14, n=49, 56
|
83 Scores on a scale
Interval 79.0 to 94.0
|
66 Scores on a scale
Interval 56.5 to 83.0
|
|
PROactive Difficulty Domain Score
Week 18, n=39, 41
|
83 Scores on a scale
Interval 75.0 to 92.0
|
61 Scores on a scale
Interval 56.0 to 72.0
|
|
PROactive Difficulty Domain Score
Week 22, n=47, 50
|
86 Scores on a scale
Interval 77.0 to 92.0
|
65.5 Scores on a scale
Interval 53.0 to 70.0
|
|
PROactive Difficulty Domain Score
Week 26, n=28, 37
|
86 Scores on a scale
Interval 78.0 to 94.0
|
65 Scores on a scale
Interval 55.0 to 72.0
|
PRIMARY outcome
Timeframe: Weeks 1, 5, 9, 13, 17, 21 and 25Population: All Enrolled Population.Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).
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
Outcome measures
| Measure |
Asthma Cohort
n=72 Participants
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.
|
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.
|
|---|---|---|
|
Evaluating Respiratory Symptoms (E-RS) in COPD Total Score-COPD Cohort Only
Week 9, n=60
|
17.1 Scores on a scale
Interval 11.7 to 25.9
|
—
|
|
Evaluating Respiratory Symptoms (E-RS) in COPD Total Score-COPD Cohort Only
Week 1, n=72
|
16.5 Scores on a scale
Interval 11.5 to 22.3
|
—
|
|
Evaluating Respiratory Symptoms (E-RS) in COPD Total Score-COPD Cohort Only
Week 5, n=66
|
17.8 Scores on a scale
Interval 12.0 to 23.5
|
—
|
|
Evaluating Respiratory Symptoms (E-RS) in COPD Total Score-COPD Cohort Only
Week 13, n=56
|
15.5 Scores on a scale
Interval 12.4 to 23.4
|
—
|
|
Evaluating Respiratory Symptoms (E-RS) in COPD Total Score-COPD Cohort Only
Week 17, n=52
|
15.8 Scores on a scale
Interval 11.9 to 23.8
|
—
|
|
Evaluating Respiratory Symptoms (E-RS) in COPD Total Score-COPD Cohort Only
Week 21, n=43
|
16.3 Scores on a scale
Interval 11.5 to 23.0
|
—
|
|
Evaluating Respiratory Symptoms (E-RS) in COPD Total Score-COPD Cohort Only
Week 25, n=41
|
15.3 Scores on a scale
Interval 10.3 to 21.4
|
—
|
PRIMARY outcome
Timeframe: Up to 6 monthsPopulation: All Enrolled Population.
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.
Outcome measures
| Measure |
Asthma Cohort
n=98 Participants
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.
|
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.
|
|---|---|---|
|
Exacerbations of Chronic Pulmonary Disease Tool (EXACT) Event Rate-COPD Cohort Only
|
2.06 Events per participant per year
|
—
|
PRIMARY outcome
Timeframe: Up to 6 monthsPopulation: All Enrolled Population.
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.
Outcome measures
| Measure |
Asthma Cohort
n=96 Participants
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.
|
COPD Cohort
n=98 Participants
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.
|
|---|---|---|
|
Number of Primary Care Visits for Asthma Conditions or COPD
Ambulatory
|
23 Visits
|
79 Visits
|
|
Number of Primary Care Visits for Asthma Conditions or COPD
Home
|
1 Visits
|
21 Visits
|
|
Number of Primary Care Visits for Asthma Conditions or COPD
Phone
|
4 Visits
|
17 Visits
|
PRIMARY outcome
Timeframe: Up to 6 monthsPopulation: All Enrolled Population
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
Outcome measures
| Measure |
Asthma Cohort
n=96 Participants
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.
|
COPD Cohort
n=98 Participants
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.
|
|---|---|---|
|
Number of Secondary Care Visits for Asthma Conditions or COPD
Inpatient hospitalization
|
0 Visits
|
0 Visits
|
|
Number of Secondary Care Visits for Asthma Conditions or COPD
ED visits
|
0 Visits
|
0 Visits
|
PRIMARY outcome
Timeframe: Up to 6 monthsPopulation: All Enrolled Population
The number of all primary care visits (including ambulatory, home and phone) were summarized using data from EHR-based healthcare utilization
Outcome measures
| Measure |
Asthma Cohort
n=96 Participants
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.
|
COPD Cohort
n=98 Participants
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.
|
|---|---|---|
|
Number of All Primary Care Visits
Ambulatory
|
426 Visits
|
598 Visits
|
|
Number of All Primary Care Visits
Home
|
7 Visits
|
55 Visits
|
|
Number of All Primary Care Visits
Phone
|
87 Visits
|
116 Visits
|
PRIMARY outcome
Timeframe: Up to 6 monthsPopulation: All Enrolled Population
The number of all secondary care visits (that is, inpatient hospitalization and ED) were summarized using data from EHR-based healthcare utilization
Outcome measures
| Measure |
Asthma Cohort
n=96 Participants
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.
|
COPD Cohort
n=98 Participants
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.
|
|---|---|---|
|
Number of All Secondary Care Visits
Inpatient hospitalization
|
0 Visits
|
0 Visits
|
|
Number of All Secondary Care Visits
ED visits
|
0 Visits
|
0 Visits
|
PRIMARY outcome
Timeframe: Up to 6 monthsPopulation: All Enrolled Population
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.
Outcome measures
| Measure |
Asthma Cohort
n=96 Participants
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.
|
COPD Cohort
n=98 Participants
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.
|
|---|---|---|
|
Number of Participants With New Prescriptions
SABA
|
85 Participants
|
85 Participants
|
|
Number of Participants With New Prescriptions
ICS/LABA
|
59 Participants
|
48 Participants
|
|
Number of Participants With New Prescriptions
OCS
|
33 Participants
|
52 Participants
|
|
Number of Participants With New Prescriptions
LEUK
|
37 Participants
|
14 Participants
|
|
Number of Participants With New Prescriptions
ICS
|
30 Participants
|
15 Participants
|
|
Number of Participants With New Prescriptions
LAMA
|
6 Participants
|
35 Participants
|
|
Number of Participants With New Prescriptions
SABA/SAMA
|
9 Participants
|
22 Participants
|
|
Number of Participants With New Prescriptions
a-CHOL
|
2 Participants
|
8 Participants
|
|
Number of Participants With New Prescriptions
LABA/LAMA
|
0 Participants
|
9 Participants
|
|
Number of Participants With New Prescriptions
ICS/LABA/LAMA
|
0 Participants
|
8 Participants
|
|
Number of Participants With New Prescriptions
PDE4
|
0 Participants
|
8 Participants
|
|
Number of Participants With New Prescriptions
a-IgE
|
2 Participants
|
1 Participants
|
|
Number of Participants With New Prescriptions
LABA
|
2 Participants
|
1 Participants
|
|
Number of Participants With New Prescriptions
IL-5
|
2 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 6 monthsPopulation: All Enrolled Population
The number of days for which the participant was hospitalized for asthma and COPD was summarized using data from EHR-based healthcare utilization
Outcome measures
| Measure |
Asthma Cohort
n=96 Participants
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.
|
COPD Cohort
n=98 Participants
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.
|
|---|---|---|
|
Number of Days in Hospital for Asthma and COPD
|
0 Days
|
0 Days
|
PRIMARY outcome
Timeframe: Up to 6 monthsPopulation: All Enrolled Population
Participants who received SABA were summarized using data from EHR-based healthcare utilization.
Outcome measures
| Measure |
Asthma Cohort
n=96 Participants
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.
|
COPD Cohort
n=98 Participants
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.
|
|---|---|---|
|
Number of Participants Who Received Short-acting Beta-agonist Therapy
|
85 Participants
|
85 Participants
|
PRIMARY outcome
Timeframe: Baseline (Week 1) and Weeks 5, 9, 13, 17, 21 and 25Population: 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).
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.
Outcome measures
| Measure |
Asthma Cohort
n=92 Participants
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.
|
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.
|
|---|---|---|
|
Change From Baseline in COPD Assessment Test (CAT) Score-COPD Cohort Only
Week 5, n=71
|
0 Scores on a scale
Interval -4.0 to 4.0
|
—
|
|
Change From Baseline in COPD Assessment Test (CAT) Score-COPD Cohort Only
Week 9, n=67
|
0 Scores on a scale
Interval -3.0 to 3.0
|
—
|
|
Change From Baseline in COPD Assessment Test (CAT) Score-COPD Cohort Only
Week 13, n=60
|
1 Scores on a scale
Interval -3.0 to 3.0
|
—
|
|
Change From Baseline in COPD Assessment Test (CAT) Score-COPD Cohort Only
Week 17, n=56
|
0.5 Scores on a scale
Interval -3.0 to 4.0
|
—
|
|
Change From Baseline in COPD Assessment Test (CAT) Score-COPD Cohort Only
Week 21, n=50
|
1.5 Scores on a scale
Interval -2.0 to 4.0
|
—
|
|
Change From Baseline in COPD Assessment Test (CAT) Score-COPD Cohort Only
Week 25, n=48
|
0 Scores on a scale
Interval -3.0 to 4.0
|
—
|
PRIMARY outcome
Timeframe: Baseline (Week 1) and Weeks 5, 9, 13, 17, 21 and 25Population: 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).
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.
Outcome measures
| Measure |
Asthma Cohort
n=95 Participants
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.
|
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.
|
|---|---|---|
|
Change From Baseline in Asthma Control Test (ACT) Score-asthma Cohort Only
Week 5, n=72
|
0 Scores on a scale
Interval -1.0 to 2.0
|
—
|
|
Change From Baseline in Asthma Control Test (ACT) Score-asthma Cohort Only
Week 9, n=54
|
0 Scores on a scale
Interval -2.0 to 1.0
|
—
|
|
Change From Baseline in Asthma Control Test (ACT) Score-asthma Cohort Only
Week 13, n=62
|
0 Scores on a scale
Interval -1.0 to 2.0
|
—
|
|
Change From Baseline in Asthma Control Test (ACT) Score-asthma Cohort Only
Week 17, n=59
|
0 Scores on a scale
Interval -2.0 to 2.0
|
—
|
|
Change From Baseline in Asthma Control Test (ACT) Score-asthma Cohort Only
Week 21, n=47
|
0 Scores on a scale
Interval -1.0 to 2.0
|
—
|
|
Change From Baseline in Asthma Control Test (ACT) Score-asthma Cohort Only
Week 25, n=46
|
0 Scores on a scale
Interval -1.0 to 2.0
|
—
|
PRIMARY outcome
Timeframe: Weeks 1, 5, 9, 13, 17, 21, 25Population: All Enrolled Population. Only those participants with rescue medication sensors were analyzed.
The use of rescue medication by participants were monitored by attaching a sensor to rescue inhaler.
Outcome measures
| Measure |
Asthma Cohort
n=69 Participants
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.
|
COPD Cohort
n=76 Participants
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.
|
|---|---|---|
|
Median Rescue Medication Use
Week 1
|
0.3 Occasions per day
Interval 0.1 to 1.3
|
0.6 Occasions per day
Interval 0.1 to 1.7
|
|
Median Rescue Medication Use
Week 5
|
0.2 Occasions per day
Interval 0.0 to 1.0
|
0.4 Occasions per day
Interval 0.1 to 1.3
|
|
Median Rescue Medication Use
Week 9
|
0.1 Occasions per day
Interval 0.0 to 0.6
|
0.3 Occasions per day
Interval 0.0 to 0.9
|
|
Median Rescue Medication Use
Week 13
|
0.1 Occasions per day
Interval 0.0 to 0.9
|
0.3 Occasions per day
Interval 0.0 to 0.9
|
|
Median Rescue Medication Use
Week 17
|
0 Occasions per day
Interval 0.0 to 0.5
|
0.3 Occasions per day
Interval 0.0 to 0.9
|
|
Median Rescue Medication Use
Week 21
|
0 Occasions per day
Interval 0.0 to 0.3
|
0.3 Occasions per day
Interval 0.0 to 0.7
|
|
Median Rescue Medication Use
Week 25
|
0 Occasions per day
Interval 0.0 to 0.3
|
0.3 Occasions per day
Interval 0.0 to 1.0
|
PRIMARY outcome
Timeframe: Weeks 1, 5, 9, 13, 17, 21 and 25Population: All Enrolled Population. Only those participants with maintenance medication sensors were analyzed.
The use of maintenance therapy by participants were monitored by attaching a sensor to maintenance inhaler.
Outcome measures
| Measure |
Asthma Cohort
n=71 Participants
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.
|
COPD Cohort
n=59 Participants
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.
|
|---|---|---|
|
Percentage of Participants With Maintenance Compliance
Week 1
|
68 Percentage of Participants
|
64 Percentage of Participants
|
|
Percentage of Participants With Maintenance Compliance
Week 5
|
59 Percentage of Participants
|
56 Percentage of Participants
|
|
Percentage of Participants With Maintenance Compliance
Week 9
|
54 Percentage of Participants
|
54 Percentage of Participants
|
|
Percentage of Participants With Maintenance Compliance
Week 13
|
52 Percentage of Participants
|
50 Percentage of Participants
|
|
Percentage of Participants With Maintenance Compliance
Week 17
|
48 Percentage of Participants
|
48 Percentage of Participants
|
|
Percentage of Participants With Maintenance Compliance
Week 21
|
48 Percentage of Participants
|
49 Percentage of Participants
|
|
Percentage of Participants With Maintenance Compliance
Week 25
|
46 Percentage of Participants
|
48 Percentage of Participants
|
PRIMARY outcome
Timeframe: Up to 6 MonthsPopulation: All Enrolled Population
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.
Outcome measures
| Measure |
Asthma Cohort
n=96 Participants
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.
|
COPD Cohort
n=98 Participants
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.
|
|---|---|---|
|
Number of Participants Who Completed Exit Interview
|
96 Participants
|
80 Participants
|
Adverse Events
Asthma Cohort
COPD Cohort
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER