Pulmonary Disease, Chronic ObstructiveNCT02970422

Chronic Obstructive Pulmonary Disease Patient Preferences Survey

An observational study of Pulmonary Disease, Chronic Obstructive, run by McGill University at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 40 to 90 years
Conditions the study is for: Pulmonary Disease, Chronic Obstructive
What is being tested?: Patient Survey
How many people: 200 participants
Where: 1 siteCanada
Study dates: Nov 2016to 12 Dec 2018
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 to 90 years
All sexes
No healthy volunteers
Adult, Older adult

Study population: Adults living with chronic obstructive pulmonary disease (COPD).

Who may be able to join

Clinical diagnosis of COPD
English or French speaking
Patient at one of the three participating sites with medical chart

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Canada1 site

Montreal Chest Institute of the McGill University Health Center (MUHC)
Montreal, Quebec, H4A 3J1

Other trials in Canada

About this study

Official title: COPD Patient Preferences, Activities, and Participation Survey

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.

Conditions: Pulmonary Disease, Chronic Obstructive
Being tested: Patient Survey
Keywords: Survey, Priorities, Activities, Participation
Medical subject headings: Pulmonary Disease, Chronic Obstructive, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Patient SurveyOther
Participants will answer an online survey and their medical chart information will be gathered to compare responses across disease severity.

Study groups in NCT02970422
Study group	Role	What they receive
Quartile 1 [Mild]		Not described Receives: Other: Patient Survey
Quartile 2 [Moderate]		Not described Receives: Other: Patient Survey
Quartile 3 [Severe]		Not described Receives: Other: Patient Survey
Quartile 4 [Very Severe]		Not described Receives: Other: Patient Survey

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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
Measured: Baseline

Secondary outcomes (7)

Forced Expiratory Volume in 1-sec (FEV1)
Individuals forced expiratory volume in 1-sec (FEV1) as assessed by spirometry
Measured: Baseline
FEV1/FVC
Individuals FEV1-to-forced vital capacity (FVC) ratio
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 201612 Dec 2018

First posted22 Nov 2016 (estimated)
Study startNov 2016
Primary completionOct 2017
Study completion12 Dec 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Other
Time perspective: Cross-sectional
Enrolment: 200 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02970422
Sponsor's protocol ID: 15-203-MUHC
Status last verified: Dec 2020
First submitted: 26 Apr 2016
Last updated: 24 Dec 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 24 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: COPD Patient Preferences, Activities, and Participation Survey
ClinicalTrials.gov ID: NCT02970422
Acronym / sponsor ID: 15-203-MUHC
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: Survey, Priorities, Activities, Participation
Study type: Observational
Recruitment status: Completed
Enrolment: 200 participants (actual)
Lead sponsor: McGill UniversityUniversity, hospital or other
Collaborators: AstraZeneca
Study start: Nov 2016
Primary completion: Oct 2017 (actual)
Study completion: 12 Dec 2018 (actual)
First posted: 22 Nov 2016 (estimated)
Results: Posted 24 Dec 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Other
Time perspective: Cross-sectional
Number of arms: 4

Arm	Type	Receives
Quartile 1 [Mild]	–	Other: Patient Survey
Quartile 2 [Moderate]	–	Other: Patient Survey
Quartile 3 [Severe]	–	Other: Patient Survey
Quartile 4 [Very Severe]	–	Other: Patient Survey

Who may qualify

Ages: 40 to 90 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Adults living with chronic obstructive pulmonary disease (COPD).

Key inclusion criteria (3 listed)

Clinical diagnosis of COPD
English or French speaking
Patient at one of the three participating sites with medical chart

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Patient SurveyParticipants will answer an online survey and their medical chart information will be gathered to compare responses across disease severity.	Other	Quartile 1 [Mild], Quartile 2 [Moderate], Quartile 3 [Severe], Quartile 4 [Very Severe]

Primary outcome

Number of Participants Who Prioritized Healthcare Topics
Time frame: Baseline
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.
Number of Participants Who Prioritized Research Topics
Time frame: Baseline
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.
Number of Participants Who Were Not Satisfied With Their Participation in Daily and Social Activities
Time frame: Baseline
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

7 secondary outcomes

Forced Expiratory Volume in 1-sec (FEV1)
Time frame: Baseline
FEV1/FVC
Time frame: Baseline
Modified Medical Research Council Questionnaire on Breathlessness
Time frame: Baseline
COPD Assessment Test
Time frame: Baseline
Godin Leisure Time Physical Activity Questionnaire
Time frame: Baseline
Satisfaction of Life Questionnaire
Time frame: Baseline
Number of Participants With Exacerbations Due to COPD in the Preceding 12 Months
Time frame: baseline

Results and safety

Results posted to the registry on 24 Dec 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Participants	200	200

Primary outcome: Number of Participants Who Prioritized Healthcare Topics

Time frame: Baseline. Number. Unit: participants

Measure	Participation Differences by Individuals' Disease Severity n = 148	Participation Differences by (GOLD) ABCD Classification n = 130	Quartile 1 - Mild Airflow Obstruction n = 37	Quartile 2 - Moderate Airflow Obstruction n = 37	Quartile 3 - Severe Airflow Obstruction n = 37	Quartile 4 - Very Severe Airflow Obstruction n = 37	Group A - Breathlessness Burden and Exacerbation Risk n = 26	Group B - Breathlessness Burden and Exacerbation Risk n = 50	Group C - Breathlessness Burden and Exacerbation Risk n = 14	Group D - Breathlessness Burden and Exacerbation Risk n = 40
Relief of Breathlessness	90	79	23	22	21	24	11	36	5	27
Improve Your Ability to Improve Activities	79	67	20	22	15	22	12	30	6	19
Prevent Lung Flare-Ups	74	64	18	18	18	20	14	23	7	20
Discuss COPD	71	61	18	19	23	11	12	27	6	16
Improve Physical Well-Being	70	62	20	15	17	18	12	26	9	15

Participation Differences by Individuals' Disease Severity: p = .91, Chi-squared
Participation Differences by Individuals' Disease Severity: p = .31, Chi-squared
Participation Differences by Individuals' Disease Severity: p = .96, Chi-squared

Population analysed: 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.

Primary outcome: Number of Participants Who Prioritized Research Topics

Time frame: Baseline. Number. Unit: participants

Measure	Participation Differences by Individuals' Disease Severity n = 148	Participation Differences by (GOLD) ABCD Classification n = 130	Quartile 1 - Mild Airflow Obstruction n = 37	Quartile 2 - Moderate Airflow Obstruction n = 37	Quartile 3 - Severe Airflow Obstruction n = 37	Quartile 4 - Very Severe Airflow Obstruction n = 37	Group A - Breathlessness Burden and Exacerbation Risk n = 26	Group B - Breathlessness Burden and Exacerbation Risk n = 50	Group C - Breathlessness Burden and Exacerbation Risk n = 14	Group D - Breathlessness Burden and Exacerbation Risk n = 40
To relieve breathlessness in COPD	113	98	28	29	26	30	20	40	7	31
To prevent the development of COPD	85	74	18	26	22	19	15	30	9	20
To prevent lung flare ups	74	62	18	18	14	24	14	24	3	21
To increase the ability to exercise	70	61	20	14	17	19	11	29	7	14
To improve maximal amount of exercise	68	57	21	12	15	20	6	29	4	18

Participation Differences by Individuals' Disease Severity: p = .73, Chi-squared
Participation Differences by Individuals' Disease Severity: p = .23, Chi-squared
Participation Differences by Individuals' Disease Severity: p = .14, Chi-squared

Primary outcome: Number of Participants Who Were Not Satisfied With Their Participation in Daily and Social Activities

Time frame: Baseline. Number. Unit: participants

Measure	Participation Differences by Individuals' Disease Severity n = 148	Participation Differences by (GOLD) ABCD Classification n = 130	Quartile 1 - Mild Airflow Obstruction n = 37	Quartile 2 - Moderate Airflow Obstruction n = 37	Quartile 3 - Severe Airflow Obstruction n = 37	Quartile 4 - Very Severe Airflow Obstruction n = 37	Group A - Breathlessness Burden and Exacerbation Risk n = 26	Group B - Breathlessness Burden and Exacerbation Risk n = 50	Group C - Breathlessness Burden and Exacerbation Risk n = 14	Group D - Breathlessness Burden and Exacerbation Risk n = 40
Activity 1	108	83	8	27	30	43	8	38	7	30
Activity 2	17	25	5	3	3	6	15	2	0	8
Activity 3	114	101	24	27	22	41	12	30	21	38
Activity 4	142	107	24	41	39	38	19	44	0	44
Activity 5	117	87	22	22	32	41	8	44	7	28
Activity 6	3	0	0	0	3	0	0	0	0	0
Activity 7	19	15	5	3	3	8	4	6	0	5

7 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
All Participants	0 of 0	0 of 0	0

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Clinical Exercise and Respiratory Physiology Laboratory (CERPL)Link provided by the sponsor.
Theories and Interventions in Exercise and Health Psychology (TIE) LaboratoryLink provided by the sponsor.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Dennis Jensen, Ph.D. principal investigator

McGill University

Shane N Sweet, Ph.D. principal investigator

McGill University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Pulmonary Disease, Chronic Obstructive, run by McGill University at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Who Prioritized Healthcare Topics (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02970422.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2020.