Trial Outcomes & Findings for Chronic Obstructive Pulmonary Disease Patient Preferences Survey (NCT NCT02970422)
NCT ID: NCT02970422
Last Updated: 2020-12-24
Results Overview
Twenty-four healthcare topics were selected once again from a literature and expert panel review, as well as corroborated by individuals living with COPD in five focus groups. Example healthcare topics include: relief of breathlessness; increase maximal amount of exercise individuals living with COPD can do inside and outside their homes; and prevent-lung flare-ups. Participants were asked to indicate their preference of the topics by assigning a percentage of their time, in increments of 10%, to the various healthcare topics, for a total of 100% of their time. For the 24 healthcare topics, individuals could select up to 10 topics (10% times 10 topics, for 100% of their time). The top five topics are presented as the most important topics for the participants and are indicative of areas of focus for future healthcare and research. The top five were presented in accordance to the request from the working group who developed the survey and reviewed the results.
COMPLETED
200 participants
Baseline
2020-12-24
Participant Flow
200 participants completed the AHRPQ. Of those, 52 were missing spirometry in medical records, 148 completed with spirometry for Quartile 1-4 analysis \[groups\], and 130 of the 148 completed spirometry, exacerbation and mMRC for Group A-D analysis.
Participant milestones
| Measure |
All Participants
Participants answered an online survey and their medical chart information was gathered to compare responses across disease severity. This was a single arm study.
|
|---|---|
|
Overall Study
STARTED
|
200
|
|
Overall Study
COMPLETED
|
200
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Participants were missing data as data collected was voluntary to provide or the information was not included in their medical charts.
Baseline characteristics by cohort
| Measure |
All Participants
n=200 Participants
Participants answered an online survey and their medical chart information was gathered to compare responses across disease severity. This was a single arm study.
|
|---|---|
|
Age, Continuous
|
67.5 Years
STANDARD_DEVIATION 8.8 • n=200 Participants
|
|
Sex: Female, Male
Female
|
96 Participants
n=199 Participants • Participants were missing data as data collected was voluntary to provide or the information was not included in their medical charts.
|
|
Sex: Female, Male
Male
|
103 Participants
n=199 Participants • Participants were missing data as data collected was voluntary to provide or the information was not included in their medical charts.
|
|
Race/Ethnicity, Customized
Race · Other
|
12 Participants
n=193 Participants • Participants were missing data as data collected was voluntary to provide or the information was not included in their medical charts.
|
|
Race/Ethnicity, Customized
Race · White
|
181 Participants
n=193 Participants • Participants were missing data as data collected was voluntary to provide or the information was not included in their medical charts.
|
|
Region of Enrollment
Canada
|
200 Participants
n=200 Participants
|
|
Marital Status
Single/Divorced/Widowed
|
86 Participants
n=194 Participants • Participants were missing data as data collected was voluntary to provide or the information was not included in their medical charts.
|
|
Marital Status
Married/Common Law
|
108 Participants
n=194 Participants • Participants were missing data as data collected was voluntary to provide or the information was not included in their medical charts.
|
|
Education
Full-time/Part-time
|
86 Participants
n=194 Participants • Participants were missing data as data collected was voluntary to provide or the information was not included in their medical charts.
|
|
Education
Unemployed/Retired/Disability
|
108 Participants
n=194 Participants • Participants were missing data as data collected was voluntary to provide or the information was not included in their medical charts.
|
|
Household Income
Under $60,000
|
118 Participants
n=161 Participants • Participants were missing data as data collected was voluntary to provide or the information was not included in their medical charts.
|
|
Household Income
Above $60,000
|
43 Participants
n=161 Participants • Participants were missing data as data collected was voluntary to provide or the information was not included in their medical charts.
|
|
Smoking
Never smoked tobacco
|
9 Participants
n=193 Participants • Participants were missing data as data collected was voluntary to provide or the information was not included in their medical charts.
|
|
Smoking
Ever smoked tobacco
|
184 Participants
n=193 Participants • Participants were missing data as data collected was voluntary to provide or the information was not included in their medical charts.
|
|
CAT (COPD assessment test)
score <10 (less than normal burden of disease)
|
34 Participants
n=197 Participants • Participants were missing data as data collected was voluntary to provide or the information was not included in their medical charts.
|
|
CAT (COPD assessment test)
score ≥10 (higher than normal burden of disease )
|
163 Participants
n=200 Participants • Participants were missing data as data collected was voluntary to provide or the information was not included in their medical charts.
|
|
mMRC (Modified-Medical Research Council Questionnaire on breathlessness)
0-1 (mild breathlessnes)
|
67 Participants
n=196 Participants • Participants were missing data as data collected was voluntary to provide or the information was not included in their medical charts.
|
|
mMRC (Modified-Medical Research Council Questionnaire on breathlessness)
≥2 (increased breathlessness)
|
129 Participants
n=196 Participants • Participants were missing data as data collected was voluntary to provide or the information was not included in their medical charts.
|
|
Pulmonary Rehab Attendance
Yes
|
81 Participants
n=193 Participants • Participants were missing data as data collected was voluntary to provide or the information was not included in their medical charts.
|
|
Pulmonary Rehab Attendance
No
|
112 Participants
n=193 Participants • Participants were missing data as data collected was voluntary to provide or the information was not included in their medical charts.
|
|
Myocardial Infarction
|
11 Participants
n=200 Participants
|
|
Congestive heart failure
|
15 Participants
n=200 Participants
|
|
Peripheral vascular disease
|
7 Participants
n=200 Participants
|
|
Cerebrovascular disease
|
3 Participants
n=200 Participants
|
|
Dementia
|
1 Participants
n=200 Participants
|
|
Connective tissue disease
|
3 Participants
n=200 Participants
|
|
Diabetes Mellitus
|
18 Participants
n=200 Participants
|
|
Chronic kidney disease
|
5 Participants
n=200 Participants
|
|
Hemiplegia
|
0 Participants
n=200 Participants
|
|
Cancer
|
25 Participants
n=200 Participants
|
|
Liver disease
|
4 Participants
n=200 Participants
|
|
HIV/AIDS
|
1 Participants
n=200 Participants
|
|
Asthma
|
64 Participants
n=200 Participants
|
PRIMARY outcome
Timeframe: BaselinePopulation: Participants answered an online survey and their medical chart information was gathered to compare responses across disease severity. Of the 148 participants, 130 completed the online survey with spirometry \& exacerbation and mMRC for Group ABCD analysis.
Twenty-four healthcare topics were selected once again from a literature and expert panel review, as well as corroborated by individuals living with COPD in five focus groups. Example healthcare topics include: relief of breathlessness; increase maximal amount of exercise individuals living with COPD can do inside and outside their homes; and prevent-lung flare-ups. Participants were asked to indicate their preference of the topics by assigning a percentage of their time, in increments of 10%, to the various healthcare topics, for a total of 100% of their time. For the 24 healthcare topics, individuals could select up to 10 topics (10% times 10 topics, for 100% of their time). The top five topics are presented as the most important topics for the participants and are indicative of areas of focus for future healthcare and research. The top five were presented in accordance to the request from the working group who developed the survey and reviewed the results.
Outcome measures
| Measure |
Participation Differences by Individuals' Disease Severity
n=148 Participants
For airflow obstruction, individuals were divided into quartiles based on their FEV1%predicted. (mild, moderate, severe, and very severe)
|
Participation Differences by (GOLD) ABCD Classification
n=130 Participants
Individuals' ABCD classifications were based on the 2017 GOLD guidelines based on modified British Medical Research Council (mMRC) dyspnea scores and 12-month exacerbation history.
|
Quartile 1 - Mild Airflow Obstruction
n=37 Participants
FEV1%predicted range = 65.1-184.8
|
Quartile 2 - Moderate Airflow Obstruction
n=37 Participants
FEV1% predicted range = 48.4-64.3
|
Quartile 3 - Severe Airflow Obstruction
n=37 Participants
FEV1% predicted range = 31.7-46.8
|
Quartile 4 - Very Severe Airflow Obstruction
n=37 Participants
FEV1% predicted range = 14.7-31.5
|
Group A - Breathlessness Burden and Exacerbation Risk
n=26 Participants
FEV1%predicted range = 42.3-69.4
|
Group B - Breathlessness Burden and Exacerbation Risk
n=50 Participants
FEV1% predicted range = 28.0-65.9
|
Group C - Breathlessness Burden and Exacerbation Risk
n=14 Participants
FEV1% predicted range = 27.0-67.0
|
Group D - Breathlessness Burden and Exacerbation Risk
n=40 Participants
FEV1% predicted range = 27.0-67.7
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Who Prioritized Healthcare Topics
Relief of Breathlessness
|
90 participants
|
79 participants
|
23 participants
|
22 participants
|
21 participants
|
24 participants
|
11 participants
|
36 participants
|
5 participants
|
27 participants
|
|
Number of Participants Who Prioritized Healthcare Topics
Improve Your Ability to Improve Activities
|
79 participants
|
67 participants
|
20 participants
|
22 participants
|
15 participants
|
22 participants
|
12 participants
|
30 participants
|
6 participants
|
19 participants
|
|
Number of Participants Who Prioritized Healthcare Topics
Prevent Lung Flare-Ups
|
74 participants
|
64 participants
|
18 participants
|
18 participants
|
18 participants
|
20 participants
|
14 participants
|
23 participants
|
7 participants
|
20 participants
|
|
Number of Participants Who Prioritized Healthcare Topics
Discuss COPD
|
71 participants
|
61 participants
|
18 participants
|
19 participants
|
23 participants
|
11 participants
|
12 participants
|
27 participants
|
6 participants
|
16 participants
|
|
Number of Participants Who Prioritized Healthcare Topics
Improve Physical Well-Being
|
70 participants
|
62 participants
|
20 participants
|
15 participants
|
17 participants
|
18 participants
|
12 participants
|
26 participants
|
9 participants
|
15 participants
|
PRIMARY outcome
Timeframe: BaselinePopulation: Participants answered an online survey and their medical chart information was gathered to compare responses across disease severity. Of the 148 participants, 130 completed the online survey with spirometry \& exacerbation and mMRC for Group ABCD analysis.
Individuals were asked to indicate their research priorities from a list of research topics using a modified willingness-to-pay method (Kawata et al., 2014). The willingness-to-pay method allows individuals to assign preference to various topics by assigning a percentage of funds to the topic. A list of 22 research topics (e.g., to relieve breathlessness in individuals living with COPD, to increase access to lung transplantations) was created for this study through a literature review, expert consultation, and five focus groups with individuals living with COPD (n=23, 27% women). Individuals were asked to assign a percentage of funds, in increments of 10% of funding, to the 22 COPD research topics. Participants could assign anywhere between 10% of funding to 100% of funding to the topics. The top five were presented in accordance to the request from the working group who developed the survey and reviewed the results.
Outcome measures
| Measure |
Participation Differences by Individuals' Disease Severity
n=148 Participants
For airflow obstruction, individuals were divided into quartiles based on their FEV1%predicted. (mild, moderate, severe, and very severe)
|
Participation Differences by (GOLD) ABCD Classification
n=130 Participants
Individuals' ABCD classifications were based on the 2017 GOLD guidelines based on modified British Medical Research Council (mMRC) dyspnea scores and 12-month exacerbation history.
|
Quartile 1 - Mild Airflow Obstruction
n=37 Participants
FEV1%predicted range = 65.1-184.8
|
Quartile 2 - Moderate Airflow Obstruction
n=37 Participants
FEV1% predicted range = 48.4-64.3
|
Quartile 3 - Severe Airflow Obstruction
n=37 Participants
FEV1% predicted range = 31.7-46.8
|
Quartile 4 - Very Severe Airflow Obstruction
n=37 Participants
FEV1% predicted range = 14.7-31.5
|
Group A - Breathlessness Burden and Exacerbation Risk
n=26 Participants
FEV1%predicted range = 42.3-69.4
|
Group B - Breathlessness Burden and Exacerbation Risk
n=50 Participants
FEV1% predicted range = 28.0-65.9
|
Group C - Breathlessness Burden and Exacerbation Risk
n=14 Participants
FEV1% predicted range = 27.0-67.0
|
Group D - Breathlessness Burden and Exacerbation Risk
n=40 Participants
FEV1% predicted range = 27.0-67.7
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Who Prioritized Research Topics
To prevent the development of COPD
|
85 participants
|
74 participants
|
18 participants
|
26 participants
|
22 participants
|
19 participants
|
15 participants
|
30 participants
|
9 participants
|
20 participants
|
|
Number of Participants Who Prioritized Research Topics
To prevent lung flare ups
|
74 participants
|
62 participants
|
18 participants
|
18 participants
|
14 participants
|
24 participants
|
14 participants
|
24 participants
|
3 participants
|
21 participants
|
|
Number of Participants Who Prioritized Research Topics
To increase the ability to exercise
|
70 participants
|
61 participants
|
20 participants
|
14 participants
|
17 participants
|
19 participants
|
11 participants
|
29 participants
|
7 participants
|
14 participants
|
|
Number of Participants Who Prioritized Research Topics
To relieve breathlessness in COPD
|
113 participants
|
98 participants
|
28 participants
|
29 participants
|
26 participants
|
30 participants
|
20 participants
|
40 participants
|
7 participants
|
31 participants
|
|
Number of Participants Who Prioritized Research Topics
To improve maximal amount of exercise
|
68 participants
|
57 participants
|
21 participants
|
12 participants
|
15 participants
|
20 participants
|
6 participants
|
29 participants
|
4 participants
|
18 participants
|
PRIMARY outcome
Timeframe: BaselinePopulation: Participants answered an online survey and their medical chart information was gathered to compare responses across disease severity. Of the 148 participants, 130 completed the online survey with spirometry \& exacerbation and mMRC for Group ABCD analysis.
Participants will answer questions about their participation in 26 daily activities, as well as their desire to participate in each of the 26 daily activities. This is a measure of those who indicated they wanted to increase their participation. 10 of the 26 activities and their outcome measures are listed below. Activity 1: Walking from one place to another outside of your home on a flat surface. Activity 2: Moving from one place to another using motorized transportation. Activity 3: Climbing two or more flights of stairs. Activity 4: Walking up a hill. Activity 5: Participating in regular exercise. Activity 6: Walking from one place to another in your home. Activity 7: Carrying light objects on a flat surface. Activity 8: Carrying heavy objects on a flat surface. Activity 9: Carrying-out low intensity physical activities
Outcome measures
| Measure |
Participation Differences by Individuals' Disease Severity
n=148 Participants
For airflow obstruction, individuals were divided into quartiles based on their FEV1%predicted. (mild, moderate, severe, and very severe)
|
Participation Differences by (GOLD) ABCD Classification
n=130 Participants
Individuals' ABCD classifications were based on the 2017 GOLD guidelines based on modified British Medical Research Council (mMRC) dyspnea scores and 12-month exacerbation history.
|
Quartile 1 - Mild Airflow Obstruction
n=37 Participants
FEV1%predicted range = 65.1-184.8
|
Quartile 2 - Moderate Airflow Obstruction
n=37 Participants
FEV1% predicted range = 48.4-64.3
|
Quartile 3 - Severe Airflow Obstruction
n=37 Participants
FEV1% predicted range = 31.7-46.8
|
Quartile 4 - Very Severe Airflow Obstruction
n=37 Participants
FEV1% predicted range = 14.7-31.5
|
Group A - Breathlessness Burden and Exacerbation Risk
n=26 Participants
FEV1%predicted range = 42.3-69.4
|
Group B - Breathlessness Burden and Exacerbation Risk
n=50 Participants
FEV1% predicted range = 28.0-65.9
|
Group C - Breathlessness Burden and Exacerbation Risk
n=14 Participants
FEV1% predicted range = 27.0-67.0
|
Group D - Breathlessness Burden and Exacerbation Risk
n=40 Participants
FEV1% predicted range = 27.0-67.7
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Who Were Not Satisfied With Their Participation in Daily and Social Activities
Activity 10
|
90 participants
|
71 participants
|
5 participants
|
17 participants
|
30 participants
|
38 participants
|
0 participants
|
24 participants
|
14 participants
|
33 participants
|
|
Number of Participants Who Were Not Satisfied With Their Participation in Daily and Social Activities
Activity 1
|
108 participants
|
83 participants
|
8 participants
|
27 participants
|
30 participants
|
43 participants
|
8 participants
|
38 participants
|
7 participants
|
30 participants
|
|
Number of Participants Who Were Not Satisfied With Their Participation in Daily and Social Activities
Activity 2
|
17 participants
|
25 participants
|
5 participants
|
3 participants
|
3 participants
|
6 participants
|
15 participants
|
2 participants
|
0 participants
|
8 participants
|
|
Number of Participants Who Were Not Satisfied With Their Participation in Daily and Social Activities
Activity 3
|
114 participants
|
101 participants
|
24 participants
|
27 participants
|
22 participants
|
41 participants
|
12 participants
|
30 participants
|
21 participants
|
38 participants
|
|
Number of Participants Who Were Not Satisfied With Their Participation in Daily and Social Activities
Activity 4
|
142 participants
|
107 participants
|
24 participants
|
41 participants
|
39 participants
|
38 participants
|
19 participants
|
44 participants
|
0 participants
|
44 participants
|
|
Number of Participants Who Were Not Satisfied With Their Participation in Daily and Social Activities
Activity 5
|
117 participants
|
87 participants
|
22 participants
|
22 participants
|
32 participants
|
41 participants
|
8 participants
|
44 participants
|
7 participants
|
28 participants
|
|
Number of Participants Who Were Not Satisfied With Their Participation in Daily and Social Activities
Activity 6
|
3 participants
|
0 participants
|
0 participants
|
0 participants
|
3 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants Who Were Not Satisfied With Their Participation in Daily and Social Activities
Activity 7
|
19 participants
|
15 participants
|
5 participants
|
3 participants
|
3 participants
|
8 participants
|
4 participants
|
6 participants
|
0 participants
|
5 participants
|
|
Number of Participants Who Were Not Satisfied With Their Participation in Daily and Social Activities
Activity 8
|
99 participants
|
86 participants
|
11 participants
|
22 participants
|
28 participants
|
38 participants
|
7 participants
|
27 participants
|
14 participants
|
38 participants
|
|
Number of Participants Who Were Not Satisfied With Their Participation in Daily and Social Activities
Activity 9
|
30 participants
|
28 participants
|
5 participants
|
3 participants
|
3 participants
|
19 participants
|
8 participants
|
8 participants
|
7 participants
|
5 participants
|
SECONDARY outcome
Timeframe: BaselineIndividuals forced expiratory volume in 1-sec (FEV1) as assessed by spirometry
Outcome measures
| Measure |
Participation Differences by Individuals' Disease Severity
n=148 Participants
For airflow obstruction, individuals were divided into quartiles based on their FEV1%predicted. (mild, moderate, severe, and very severe)
|
Participation Differences by (GOLD) ABCD Classification
n=130 Participants
Individuals' ABCD classifications were based on the 2017 GOLD guidelines based on modified British Medical Research Council (mMRC) dyspnea scores and 12-month exacerbation history.
|
Quartile 1 - Mild Airflow Obstruction
n=37 Participants
FEV1%predicted range = 65.1-184.8
|
Quartile 2 - Moderate Airflow Obstruction
n=37 Participants
FEV1% predicted range = 48.4-64.3
|
Quartile 3 - Severe Airflow Obstruction
n=37 Participants
FEV1% predicted range = 31.7-46.8
|
Quartile 4 - Very Severe Airflow Obstruction
n=37 Participants
FEV1% predicted range = 14.7-31.5
|
Group A - Breathlessness Burden and Exacerbation Risk
n=26 Participants
FEV1%predicted range = 42.3-69.4
|
Group B - Breathlessness Burden and Exacerbation Risk
n=50 Participants
FEV1% predicted range = 28.0-65.9
|
Group C - Breathlessness Burden and Exacerbation Risk
n=14 Participants
FEV1% predicted range = 27.0-67.0
|
Group D - Breathlessness Burden and Exacerbation Risk
n=40 Participants
FEV1% predicted range = 27.0-67.7
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Forced Expiratory Volume in 1-sec (FEV1)
|
49.6 percent predicted
Standard Deviation 23.2
|
48.5 percent predicted
Standard Deviation 20.7
|
79.0 percent predicted
Standard Deviation 21.5
|
55.6 percent predicted
Standard Deviation 5.5
|
38.5 percent predicted
Standard Deviation 4.8
|
25.2 percent predicted
Standard Deviation 4.5
|
66.0 percent predicted
Standard Deviation 20.2
|
47.1 percent predicted
Standard Deviation 17.9
|
50.8 percent predicted
Standard Deviation 20.3
|
37.8 percent predicted
Standard Deviation 17.0
|
SECONDARY outcome
Timeframe: BaselineIndividuals FEV1-to-forced vital capacity (FVC) ratio
Outcome measures
| Measure |
Participation Differences by Individuals' Disease Severity
n=148 Participants
For airflow obstruction, individuals were divided into quartiles based on their FEV1%predicted. (mild, moderate, severe, and very severe)
|
Participation Differences by (GOLD) ABCD Classification
n=130 Participants
Individuals' ABCD classifications were based on the 2017 GOLD guidelines based on modified British Medical Research Council (mMRC) dyspnea scores and 12-month exacerbation history.
|
Quartile 1 - Mild Airflow Obstruction
n=37 Participants
FEV1%predicted range = 65.1-184.8
|
Quartile 2 - Moderate Airflow Obstruction
n=37 Participants
FEV1% predicted range = 48.4-64.3
|
Quartile 3 - Severe Airflow Obstruction
n=37 Participants
FEV1% predicted range = 31.7-46.8
|
Quartile 4 - Very Severe Airflow Obstruction
n=37 Participants
FEV1% predicted range = 14.7-31.5
|
Group A - Breathlessness Burden and Exacerbation Risk
n=26 Participants
FEV1%predicted range = 42.3-69.4
|
Group B - Breathlessness Burden and Exacerbation Risk
n=50 Participants
FEV1% predicted range = 28.0-65.9
|
Group C - Breathlessness Burden and Exacerbation Risk
n=14 Participants
FEV1% predicted range = 27.0-67.0
|
Group D - Breathlessness Burden and Exacerbation Risk
n=40 Participants
FEV1% predicted range = 27.0-67.7
|
|---|---|---|---|---|---|---|---|---|---|---|
|
FEV1/FVC
|
49.1 Measured ratio
Standard Deviation 11.8
|
49.0 Measured ratio
Standard Deviation 11.9
|
60.5 Measured ratio
Standard Deviation 8.5
|
53.8 Measured ratio
Standard Deviation 8.5
|
44.1 Measured ratio
Standard Deviation 8.9
|
38.1 Measured ratio
Standard Deviation 7.9
|
58.1 Measured ratio
Standard Deviation 7.3
|
47.9 Measured ratio
Standard Deviation 11.2
|
49.1 Measured ratio
Standard Deviation 12.8
|
44.5 Measured ratio
Standard Deviation 12.0
|
SECONDARY outcome
Timeframe: BaselineSelf-reported intensity of activity related breathlessness as assessed by the modified Medical Research Council (mMRC) dyspnea scale (0-4). This questionnaire was used to measure participants' breathlessness burden using a single item scale from 0 to 4, where a score of 0-1 indicated mild breathlessness and 2-4 indicated increased breathlessness.
Outcome measures
| Measure |
Participation Differences by Individuals' Disease Severity
n=148 Participants
For airflow obstruction, individuals were divided into quartiles based on their FEV1%predicted. (mild, moderate, severe, and very severe)
|
Participation Differences by (GOLD) ABCD Classification
n=130 Participants
Individuals' ABCD classifications were based on the 2017 GOLD guidelines based on modified British Medical Research Council (mMRC) dyspnea scores and 12-month exacerbation history.
|
Quartile 1 - Mild Airflow Obstruction
n=37 Participants
FEV1%predicted range = 65.1-184.8
|
Quartile 2 - Moderate Airflow Obstruction
n=37 Participants
FEV1% predicted range = 48.4-64.3
|
Quartile 3 - Severe Airflow Obstruction
n=37 Participants
FEV1% predicted range = 31.7-46.8
|
Quartile 4 - Very Severe Airflow Obstruction
n=37 Participants
FEV1% predicted range = 14.7-31.5
|
Group A - Breathlessness Burden and Exacerbation Risk
n=26 Participants
FEV1%predicted range = 42.3-69.4
|
Group B - Breathlessness Burden and Exacerbation Risk
n=50 Participants
FEV1% predicted range = 28.0-65.9
|
Group C - Breathlessness Burden and Exacerbation Risk
n=14 Participants
FEV1% predicted range = 27.0-67.0
|
Group D - Breathlessness Burden and Exacerbation Risk
n=40 Participants
FEV1% predicted range = 27.0-67.7
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Modified Medical Research Council Questionnaire on Breathlessness
mMRC 0-1
|
45 participants
|
40 participants
|
20 participants
|
15 participants
|
7 participants
|
3 participants
|
26 participants
|
0 participants
|
14 participants
|
0 participants
|
|
Modified Medical Research Council Questionnaire on Breathlessness
mMRC ≥2
|
101 participants
|
90 participants
|
15 participants
|
22 participants
|
30 participants
|
34 participants
|
0 participants
|
50 participants
|
0 participants
|
40 participants
|
|
Modified Medical Research Council Questionnaire on Breathlessness
Data missing
|
2 participants
|
0 participants
|
2 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: BaselineThis questionnaire measure the impact COPD is having on well being and daily life. The CAT is an eight-item semantic differential scale from 0 to 5, where 0 is no impact and 5 is extremely impactful. Items include: I never cough\| I cough all the time, I have no phlegm (mucus) in my chest at all \| My chest is completely full of phlegm (mucus), My chest does not feel tight at all \| My chest feels very tight, When I walk up a hill or one flight of stairs, I am not breathless \| When I walk up a hill or one flight of stairs, I am very breathless, I am not limited doing any activities at home\| I am very limited doing activities at home, I am confident leaving my home despite my lung condition\| I am not at all confident leaving my home because of my lung condition, I sleep soundly \| I don't sleep soundly because of my lung condition, I have lots of energy I have no energy at all. Participants' scores were totaled and a score of ≥ 10 indicated higher than normal burden of disease.
Outcome measures
| Measure |
Participation Differences by Individuals' Disease Severity
n=148 Participants
For airflow obstruction, individuals were divided into quartiles based on their FEV1%predicted. (mild, moderate, severe, and very severe)
|
Participation Differences by (GOLD) ABCD Classification
n=130 Participants
Individuals' ABCD classifications were based on the 2017 GOLD guidelines based on modified British Medical Research Council (mMRC) dyspnea scores and 12-month exacerbation history.
|
Quartile 1 - Mild Airflow Obstruction
n=37 Participants
FEV1%predicted range = 65.1-184.8
|
Quartile 2 - Moderate Airflow Obstruction
n=37 Participants
FEV1% predicted range = 48.4-64.3
|
Quartile 3 - Severe Airflow Obstruction
n=37 Participants
FEV1% predicted range = 31.7-46.8
|
Quartile 4 - Very Severe Airflow Obstruction
n=37 Participants
FEV1% predicted range = 14.7-31.5
|
Group A - Breathlessness Burden and Exacerbation Risk
n=26 Participants
FEV1%predicted range = 42.3-69.4
|
Group B - Breathlessness Burden and Exacerbation Risk
n=50 Participants
FEV1% predicted range = 28.0-65.9
|
Group C - Breathlessness Burden and Exacerbation Risk
n=14 Participants
FEV1% predicted range = 27.0-67.0
|
Group D - Breathlessness Burden and Exacerbation Risk
n=40 Participants
FEV1% predicted range = 27.0-67.7
|
|---|---|---|---|---|---|---|---|---|---|---|
|
COPD Assessment Test
CAT <10
|
24 participants
|
22 participants
|
10 participants
|
5 participants
|
6 participants
|
3 participants
|
8 participants
|
6 participants
|
5 participants
|
3 participants
|
|
COPD Assessment Test
Data missing
|
2 participants
|
1 participants
|
1 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
COPD Assessment Test
CAT ≥10
|
122 participants
|
107 participants
|
26 participants
|
32 participants
|
30 participants
|
34 participants
|
18 participants
|
44 participants
|
9 participants
|
36 participants
|
SECONDARY outcome
Timeframe: BaselinePopulation: Missing data n=8 for differences by individuals' disease severity and n=4 for differences by (GOLD) ABCD
Self-reported physical activity levels measured in length of bouts over the previous 7 days to determine physical activity frequency.
Outcome measures
| Measure |
Participation Differences by Individuals' Disease Severity
n=140 Participants
For airflow obstruction, individuals were divided into quartiles based on their FEV1%predicted. (mild, moderate, severe, and very severe)
|
Participation Differences by (GOLD) ABCD Classification
n=126 Participants
Individuals' ABCD classifications were based on the 2017 GOLD guidelines based on modified British Medical Research Council (mMRC) dyspnea scores and 12-month exacerbation history.
|
Quartile 1 - Mild Airflow Obstruction
n=34 Participants
FEV1%predicted range = 65.1-184.8
|
Quartile 2 - Moderate Airflow Obstruction
n=35 Participants
FEV1% predicted range = 48.4-64.3
|
Quartile 3 - Severe Airflow Obstruction
n=36 Participants
FEV1% predicted range = 31.7-46.8
|
Quartile 4 - Very Severe Airflow Obstruction
n=35 Participants
FEV1% predicted range = 14.7-31.5
|
Group A - Breathlessness Burden and Exacerbation Risk
n=23 Participants
FEV1%predicted range = 42.3-69.4
|
Group B - Breathlessness Burden and Exacerbation Risk
n=50 Participants
FEV1% predicted range = 28.0-65.9
|
Group C - Breathlessness Burden and Exacerbation Risk
n=14 Participants
FEV1% predicted range = 27.0-67.0
|
Group D - Breathlessness Burden and Exacerbation Risk
n=39 Participants
FEV1% predicted range = 27.0-67.7
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Godin Leisure Time Physical Activity Questionnaire
|
74.64 Total minutes of Moderate to Vigorous PA
Standard Deviation 138.59
|
101.86 Total minutes of Moderate to Vigorous PA
Standard Deviation 194.49
|
100.29 Total minutes of Moderate to Vigorous PA
Standard Deviation 170.08
|
117.06 Total minutes of Moderate to Vigorous PA
Standard Deviation 175.61
|
42.78 Total minutes of Moderate to Vigorous PA
Standard Deviation 90.57
|
40.06 Total minutes of Moderate to Vigorous PA
Standard Deviation 79.70
|
166.52 Total minutes of Moderate to Vigorous PA
Standard Deviation 204.52
|
33.38 Total minutes of Moderate to Vigorous PA
Standard Deviation 76.05
|
138.57 Total minutes of Moderate to Vigorous PA
Standard Deviation 149.35
|
39.10 Total minutes of Moderate to Vigorous PA
Standard Deviation 73.21
|
SECONDARY outcome
Timeframe: BaselinePopulation: Missing data n=6 for differences by individuals' disease severity and n=6 for differences by (GOLD) ABCD
This 5 item questionnaire was used to measure participants' level of life satisfaction. The higher the score, the higher the sense of life satisfaction. A score from 5-9 indicated extremely dissatisfied, 10-14 is dissatisfied, 15-19 indicated slightly below average life satisfaction. 20-24 is the average score, 25-29 is a high score indicative of higher life satisfaction and a score between 30-35 is a very high score and represent very high life satisfaction.
Outcome measures
| Measure |
Participation Differences by Individuals' Disease Severity
n=142 Participants
For airflow obstruction, individuals were divided into quartiles based on their FEV1%predicted. (mild, moderate, severe, and very severe)
|
Participation Differences by (GOLD) ABCD Classification
n=124 Participants
Individuals' ABCD classifications were based on the 2017 GOLD guidelines based on modified British Medical Research Council (mMRC) dyspnea scores and 12-month exacerbation history.
|
Quartile 1 - Mild Airflow Obstruction
n=35 Participants
FEV1%predicted range = 65.1-184.8
|
Quartile 2 - Moderate Airflow Obstruction
n=33 Participants
FEV1% predicted range = 48.4-64.3
|
Quartile 3 - Severe Airflow Obstruction
n=37 Participants
FEV1% predicted range = 31.7-46.8
|
Quartile 4 - Very Severe Airflow Obstruction
n=37 Participants
FEV1% predicted range = 14.7-31.5
|
Group A - Breathlessness Burden and Exacerbation Risk
n=26 Participants
FEV1%predicted range = 42.3-69.4
|
Group B - Breathlessness Burden and Exacerbation Risk
n=46 Participants
FEV1% predicted range = 28.0-65.9
|
Group C - Breathlessness Burden and Exacerbation Risk
n=12 Participants
FEV1% predicted range = 27.0-67.0
|
Group D - Breathlessness Burden and Exacerbation Risk
n=40 Participants
FEV1% predicted range = 27.0-67.7
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Satisfaction of Life Questionnaire
|
18.62 total score on a scale
Standard Deviation 8.16
|
18.38 total score on a scale
Standard Deviation 8.14
|
22.51 total score on a scale
Standard Deviation 7.78
|
20.94 total score on a scale
Standard Deviation 7.68
|
16.35 total score on a scale
Standard Deviation 7.23
|
15.1 total score on a scale
Standard Deviation 7.87
|
22.50 total score on a scale
Standard Deviation 6.83
|
17.33 total score on a scale
Standard Deviation 8.10
|
21.67 total score on a scale
Standard Deviation 6.73
|
15.95 total score on a scale
Standard Deviation 8.26
|
SECONDARY outcome
Timeframe: baselineAn exacerbation was defined as a change in medication due to a COPD exacerbation (i.e., the prescription of prednisone or a medical action plan) as indicated in the medical chart or hospital admission due to a COPD exacerbation.
Outcome measures
| Measure |
Participation Differences by Individuals' Disease Severity
n=148 Participants
For airflow obstruction, individuals were divided into quartiles based on their FEV1%predicted. (mild, moderate, severe, and very severe)
|
Participation Differences by (GOLD) ABCD Classification
n=130 Participants
Individuals' ABCD classifications were based on the 2017 GOLD guidelines based on modified British Medical Research Council (mMRC) dyspnea scores and 12-month exacerbation history.
|
Quartile 1 - Mild Airflow Obstruction
n=37 Participants
FEV1%predicted range = 65.1-184.8
|
Quartile 2 - Moderate Airflow Obstruction
n=37 Participants
FEV1% predicted range = 48.4-64.3
|
Quartile 3 - Severe Airflow Obstruction
n=37 Participants
FEV1% predicted range = 31.7-46.8
|
Quartile 4 - Very Severe Airflow Obstruction
n=37 Participants
FEV1% predicted range = 14.7-31.5
|
Group A - Breathlessness Burden and Exacerbation Risk
n=26 Participants
FEV1%predicted range = 42.3-69.4
|
Group B - Breathlessness Burden and Exacerbation Risk
n=50 Participants
FEV1% predicted range = 28.0-65.9
|
Group C - Breathlessness Burden and Exacerbation Risk
n=14 Participants
FEV1% predicted range = 27.0-67.0
|
Group D - Breathlessness Burden and Exacerbation Risk
n=40 Participants
FEV1% predicted range = 27.0-67.7
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Exacerbations Due to COPD in the Preceding 12 Months
Number of participants with 0-1 exacerbations
|
92 participants
|
76 participants
|
30 participants
|
27 participants
|
19 participants
|
16 participants
|
26 participants
|
50 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Exacerbations Due to COPD in the Preceding 12 Months
Number of participants with 2+ or 1 exacerbations leading to hospital admission
|
56 participants
|
54 participants
|
7 participants
|
10 participants
|
18 participants
|
21 participants
|
0 participants
|
0 participants
|
14 participants
|
40 participants
|
Adverse Events
All Participants
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
- Publication restrictions are in place