Pulmonary Disease, Chronic Obstructive Clinical Trial
Official title:
COPD Patient Preferences, Activities, and Participation Survey
NCT number | NCT02970422 |
Other study ID # | 15-203-MUHC |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | November 2016 |
Est. completion date | December 12, 2018 |
Verified date | December 2020 |
Source | McGill University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 200 |
Est. completion date | December 12, 2018 |
Est. primary completion date | October 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 90 Years |
Eligibility | Inclusion Criteria: - Clinical diagnosis of COPD - English or French speaking - Patient at one of the three participating sites with medical chart Exclusion Criteria: - No diagnosis of COPD by a healthcare professional - Unable to communicate in English or French - Unable to provide informed consent - No medical chart information at one of the three participating sites |
Country | Name | City | State |
---|---|---|---|
Canada | Montreal Chest Institute of the McGill University Health Center (MUHC) | Montreal | Quebec |
Lead Sponsor | Collaborator |
---|---|
McGill University | AstraZeneca |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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. | Baseline | |
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. | 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 |
Baseline | |
Secondary | Forced Expiratory Volume in 1-sec (FEV1) | Individuals forced expiratory volume in 1-sec (FEV1) as assessed by spirometry | Baseline | |
Secondary | FEV1/FVC | Individuals FEV1-to-forced vital capacity (FVC) 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. | 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. | 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. | 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. | 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. | baseline |
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