- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT02970422
Chronic Obstructive Pulmonary Disease Patient Preferences Survey
COPD Patient Preferences, Activities, and Participation Survey
Přehled studie
Postavení
Intervence / Léčba
Typ studie
Zápis (Aktuální)
Kontakty a umístění
Studijní místa
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Quebec
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Montreal, Quebec, Kanada, H4A 3J1
- Montreal Chest Institute of the McGill University Health Center (MUHC)
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
---|---|
Quartile 1 [Mild]
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Participants will answer an online survey and their medical chart information will be gathered to compare responses across disease severity.
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Quartile 2 [Moderate]
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Participants will answer an online survey and their medical chart information will be gathered to compare responses across disease severity.
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Quartile 3 [Severe]
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Participants will answer an online survey and their medical chart information will be gathered to compare responses across disease severity.
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Quartile 4 [Very Severe]
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Participants will answer an online survey and their medical chart information will be gathered to compare responses across disease severity.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Number of Participants Who Prioritized Healthcare Topics
Časové okno: Baseline
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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.
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Baseline
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Number of Participants Who Prioritized Research Topics
Časové okno: Baseline
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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.
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Baseline
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Number of Participants Who Were Not Satisfied With Their Participation in Daily and Social Activities
Časové okno: Baseline
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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
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Forced Expiratory Volume in 1-sec (FEV1)
Časové okno: Baseline
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Individuals forced expiratory volume in 1-sec (FEV1) as assessed by spirometry
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Baseline
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FEV1/FVC
Časové okno: Baseline
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Individuals FEV1-to-forced vital capacity (FVC) ratio
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Baseline
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Modified Medical Research Council Questionnaire on Breathlessness
Časové okno: Baseline
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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.
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Baseline
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COPD Assessment Test
Časové okno: Baseline
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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.
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Baseline
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Godin Leisure Time Physical Activity Questionnaire
Časové okno: Baseline
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Self-reported physical activity levels measured in length of bouts over the previous 7 days to determine physical activity frequency.
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Baseline
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Satisfaction of Life Questionnaire
Časové okno: Baseline
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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.
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Baseline
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Number of Participants With Exacerbations Due to COPD in the Preceding 12 Months
Časové okno: baseline
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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.
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baseline
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Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Shane N Sweet, Ph.D., McGill University
Publikace a užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 15-203-MUHC
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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