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| Name | Class |
|---|---|
| AstraZeneca | INDUSTRY |
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The purpose of this study is to distribute a questionnaire created for individuals living with chronic obstructive pulmonary disease (COPD) to assess their activities, participation, and healthcare and COPD-related research priorities. The data collected will be compared across diagnosed COPD stages and disease severity to determine the extent to which adults with COPD participate in the listed activities and identify their primary research and healthcare related priorities. The questionnaire was originally developed based on past research then verified by a panel of COPD and participation experts; as well as, individuals living with COPD in the form of focus groups. The questionnaire will now be administered to 200 individuals living COPD (50 in each GOLD stage) at three sites across Montreal where clinical data for each participant will be available. This phase will help establish the reliability of the questionnaire.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Quartile 1 [Mild] |
| ||
| Quartile 2 [Moderate] |
| ||
| Quartile 3 [Severe] |
| ||
| Quartile 4 [Very Severe] |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patient Survey | Other | Participants will answer an online survey and their medical chart information will be gathered to compare responses across disease severity. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Prioritized Healthcare Topics | 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. | Baseline |
| Number of Participants Who Prioritized Research Topics | 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. | Baseline |
| Number of Participants Who Were Not Satisfied With Their Participation in Daily and Social Activities | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Forced Expiratory Volume in 1-sec (FEV1) | Individuals forced expiratory volume in 1-sec (FEV1) as assessed by spirometry | Baseline |
| FEV1/FVC | Individuals FEV1-to-forced vital capacity (FVC) ratio |
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Inclusion Criteria:
Exclusion Criteria:
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Adults living with chronic obstructive pulmonary disease (COPD).
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| Name | Affiliation | Role |
|---|---|---|
| Dennis Jensen, Ph.D. | McGill University | Principal Investigator |
| Shane N Sweet, Ph.D. | McGill University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montreal Chest Institute of the McGill University Health Center (MUHC) | Montreal | Quebec | H4A 3J1 | Canada |
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| Label | URL |
|---|---|
| Clinical Exercise and Respiratory Physiology Laboratory (CERPL) | View source |
| Theories and Interventions in Exercise and Health Psychology (TIE) Laboratory | View source |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Who Prioritized Healthcare Topics | 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. | 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. | Posted | Number | participants | Baseline |
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All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not assessed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Emilie Michalovic, Ph.D. Candidate | McGill University | 514-941-6450 | emilie.michalovic@mail.mcgill.ca |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Oct 12, 2016 | Jun 12, 2020 | ICF_000.pdf |
| Prot | Yes | No | No | Study Protocol | Oct 12, 2016 | Jul 2, 2020 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 13, 2019 | Oct 16, 2020 | SAP_002.pdf |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| Baseline |
| Baseline |
| Modified Medical Research Council Questionnaire on Breathlessness | Self-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. | Baseline |
| COPD Assessment Test | This 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. | Baseline |
| Godin Leisure Time Physical Activity Questionnaire | Self-reported physical activity levels measured in length of bouts over the previous 7 days to determine physical activity frequency. | Baseline |
| Satisfaction of Life Questionnaire | 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. | Baseline |
| Number of Participants With Exacerbations Due to COPD in the Preceding 12 Months | An 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. | baseline |
| Years |
|
| Sex: Female, Male | Participants were missing data as data collected was voluntary to provide or the information was not included in their medical charts. | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Participants were missing data as data collected was voluntary to provide or the information was not included in their medical charts. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Marital Status | Participants were missing data as data collected was voluntary to provide or the information was not included in their medical charts. | Count of Participants | Participants |
|
| Education | Participants were missing data as data collected was voluntary to provide or the information was not included in their medical charts. | Count of Participants | Participants |
|
| Household Income | Participants were missing data as data collected was voluntary to provide or the information was not included in their medical charts. | Count of Participants | Participants |
|
| Smoking | Participants were missing data as data collected was voluntary to provide or the information was not included in their medical charts. | Count of Participants | Participants |
|
| CAT (COPD assessment test) | This questionnaire helps 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. Individuals are asked to rate the impact of 8 items on their COPD disease burden. Their total score is calculated. A score of <10 is representative of lower disease burden; whereas, a score >= 10 is indicative of higher disease burden. | Participants were missing data as data collected was voluntary to provide or the information was not included in their medical charts. | Count of Participants | Participants |
|
| mMRC (Modified-Medical Research Council Questionnaire on breathlessness) | 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. | Participants were missing data as data collected was voluntary to provide or the information was not included in their medical charts. | Count of Participants | Participants |
|
| Pulmonary Rehab Attendance | Participants were missing data as data collected was voluntary to provide or the information was not included in their medical charts. | Count of Participants | Participants |
|
| Myocardial Infarction | Count of Participants | Participants |
|
| Congestive heart failure | Count of Participants | Participants |
|
| Peripheral vascular disease | Count of Participants | Participants |
|
| Cerebrovascular disease | Count of Participants | Participants |
|
| Dementia | Count of Participants | Participants |
|
| Connective tissue disease | Count of Participants | Participants |
|
| Diabetes Mellitus | Count of Participants | Participants |
|
| Chronic kidney disease | Count of Participants | Participants |
|
| Hemiplegia | Count of Participants | Participants |
|
| Cancer | Count of Participants | Participants |
|
| Liver disease | Count of Participants | Participants |
|
| HIV/AIDS | Count of Participants | Participants |
|
| Asthma | Count of Participants | Participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | Participation Differences by Individuals' Disease Severity | For airflow obstruction, individuals were divided into quartiles based on their FEV1%predicted. (mild, moderate, severe, and very severe) |
| OG001 | Participation Differences by (GOLD) ABCD Classification | 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. |
| OG002 | Quartile 1 - Mild Airflow Obstruction | FEV1%predicted range = 65.1-184.8 |
| OG003 | Quartile 2 - Moderate Airflow Obstruction | FEV1% predicted range = 48.4-64.3 |
| OG004 | Quartile 3 - Severe Airflow Obstruction | FEV1% predicted range = 31.7-46.8 |
| OG005 | Quartile 4 - Very Severe Airflow Obstruction | FEV1% predicted range = 14.7-31.5 |
| OG006 | Group A - Breathlessness Burden and Exacerbation Risk | FEV1%predicted range = 42.3-69.4 |
| OG007 | Group B - Breathlessness Burden and Exacerbation Risk | FEV1% predicted range = 28.0-65.9 |
| OG008 | Group C - Breathlessness Burden and Exacerbation Risk | FEV1% predicted range = 27.0-67.0 |
| OG009 | Group D - Breathlessness Burden and Exacerbation Risk | FEV1% predicted range = 27.0-67.7 |
|
|
|
| Primary | Number of Participants Who Prioritized Research Topics | 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. | 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. | Posted | Number | participants | Baseline |
|
|
|
|
| Primary | Number of Participants Who Were Not Satisfied With Their Participation in Daily and Social Activities | 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 | 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. | Posted | Number | participants | Baseline |
|
|
|
|
| Secondary | Forced Expiratory Volume in 1-sec (FEV1) | Individuals forced expiratory volume in 1-sec (FEV1) as assessed by spirometry | Posted | Mean | Standard Deviation | percent predicted | Baseline |
|
|
|
|
| Secondary | FEV1/FVC | Individuals FEV1-to-forced vital capacity (FVC) ratio | Posted | Mean | Standard Deviation | Measured ratio | Baseline |
|
|
|
|
| Secondary | Modified Medical Research Council Questionnaire on Breathlessness | Self-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. | Posted | Number | participants | Baseline |
|
|
|
|
| Secondary | COPD Assessment Test | This 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. | Posted | Number | participants | Baseline |
|
|
|
|
| Secondary | Godin Leisure Time Physical Activity Questionnaire | Self-reported physical activity levels measured in length of bouts over the previous 7 days to determine physical activity frequency. | Missing data n=8 for differences by individuals' disease severity and n=4 for differences by (GOLD) ABCD | Posted | Mean | Standard Deviation | Total minutes of Moderate to Vigorous PA | Baseline |
|
|
|
|
| Secondary | Satisfaction of Life Questionnaire | 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. | Missing data n=6 for differences by individuals' disease severity and n=6 for differences by (GOLD) ABCD | Posted | Mean | Standard Deviation | total score on a scale | Baseline |
|
|
|
|
| Secondary | Number of Participants With Exacerbations Due to COPD in the Preceding 12 Months | An 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. | Posted | Number | participants | baseline |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
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| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
| To prevent the development of COPD |
|
| To prevent lung flare ups |
|
| To increase the ability to exercise |
|
| To improve maximal amount of exercise |
|
Chi-squared value= 4.28 |
| .23 |
| Other |
| To prevent lung flare-ups in adults living with COPD | Chi-squared | Chi-squared value= 5.51 | .14 | Other |
| To increase the ability of adults living with COPD to exercise | Chi-squared | Chi-squared value= 2.28 | .52 | Other |
| To improve the maximal amount of exercise of adults living with COPD in and out of the home | Chi-squared | Chi-squared value= 5.88 | .11 | Other |
| To relieve breathlessness in adults living with COPD | Chi-squared | Chi-squared value= 5.57 | .14 | Other |
| To prevent the development of COPD | Chi-squared | Chi-squared value= 1.29 | .73 | Other |
| To prevent lung flare-ups in adults living with COPD | Chi-squared | Chi-squared value= 4.64 | .20 | Other |
| To increase the ability of adults living with COPD to exercise | Chi-squared | Chi-squared value= 5.02 | .17 | Other |
| To improve the maximal amount of exercise of adults living with COPD in and out of the home | Chi-squared | Chi-square value= 9.97 | .02 | Other |
| Activity 2 |
|
| Activity 3 |
|
| Activity 4 |
|
| Activity 5 |
|
| Activity 6 |
|
| Activity 7 |
|
| Activity 8 |
|
| Activity 9 |
|
| Activity 10 |
|
| Chi-squared |
Chi-squared value= 4.56 |
| .87 |
| Other |
| Activity 3: Climbing two or more flights of stairs | Chi-squared | Chi-squared value= 6.85 | .65 | Other |
| Activity 4: Walking up a hill | Chi-squared | Chi-squared value= 10.00 | .35 | Other |
| Activity 5: Participating in regular exercise requiring physical effort, to maintain or improve health or fitness | Chi-squared | Chi-squared value= 18.75 | .03 | Other |
| Activity 1: Walking from one place to another outside of your home on a flat surface | Chi-squared | Chi-squared value= 35.52 | .00 | Other |
| Activity 2: Moving from one place to another using motorized transportation | Chi-squared | Chi-squared value= 10.23 | .33 | Other |
| Activity 3: Climbing two or more flights of stairs | Chi-squared | Chi-squared value= 23.94 | .00 | Other |
| Activity 4: Walking up a hill | Chi-squared | Chi-squared value= 22.80 | .01 | Other |
| Activity 5: Participating in regular exercise requiring physical effort, to maintain or improve health or fitness | Chi-squared | Chi-squared value= 20.43 | .02 | Other |
| mMRC ≥2 |
|
| Data missing |
|
| CAT ≥10 |
|
| Data missing |
|
| Number of participants with 2+ or 1 exacerbations leading to hospital admission |
|