A Study for the Assessment of the Words Used by Patients and Physicians to Express the Symptoms of Chronic Obstructive Pulmonary Disease (COPD)
COPD Language
A Cross Sectional Study for the Assessment of the Words Used by Patients and Physicians to Express the Symptoms of Chronic Obstructive Pulmonary Disease and the Limitations of Patients' Activities in Primary Care.
1 other identifier
observational
700
1 country
32
Brief Summary
Chronic obstructive pulmonary disease (COPD) is characterized by a progressive decline in lung function and increased symptoms such as breathlessness/dyspnoea, cough and expectoration. Even though subjective in nature, the symptomatology of COPD and mainly that of breathlessness/dyspnoea has been studied with the use of objective measurement tools. Taking into consideration that the symptoms experienced by the patient who suffers from a progressive disease such as COPD can only be perceived and interpreted by the patient him- or herself, and thus difficult to be quantified, COPD remains a challenge in clinical research. Therefore, there is a need to carry out qualitative studies that will provide insight into the wide spectrum of COPD symptomatology from the patient's perspective. In addition, a further mapping of the impact that COPD symptoms' perception has on a patient's life is required, as well as of the different pathways through which symptoms' perception is interpreted regarding the limitations of daily living activities, and the subsequent impact on disease management. The more the physician learns on the embodied experience of COPD, the better he/she may assist the patient in achieving optimal COPD management. Thus this cross-sectional observational study was designed aiming to obtain these data. Specifically, the study aims to evaluate the most frequently used words by the patients and the physicians to express the symptoms of COPD as well as the limitation of activities that it causes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2010
Shorter than P25 for all trials
32 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2010
CompletedFirst Submitted
Initial submission to the registry
October 8, 2010
CompletedFirst Posted
Study publicly available on registry
October 13, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2011
CompletedMarch 21, 2012
March 1, 2012
5 months
October 8, 2010
March 20, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Words used by the patients and the physicians to express the symptoms of COPD as well as the limitations of patients' daily living activities caused by COPD.
End of recruitment (estimated timeframe :2.5 months)
Secondary Outcomes (20)
Age
End of recruitment (estimated timeframe :2.5 months)
Gender
End of recruitment (estimated timeframe :2.5 months)
Place of residence
End of recruitment (estimated timeframe :2.5 months)
Marital status
End of recruitment (estimated timeframe :2.5 months)
Native language
End of recruitment (estimated timeframe :2.5 months)
- +15 more secondary outcomes
Study Arms (1)
1
Patients with Chronic Obstructive Pulmonary Disease
Eligibility Criteria
Patients with Chronic Obstructive Pulmonary Disease
You may qualify if:
- Aged 45-75 years
- Current or former smokers
- Known history of COPD for at least 6 months before enrolment into the study documented by spirometry (FEV1 /FVC \<70%)
- Patients with stable COPD (no exacerbation within the last month before enrolment into the study) under treatment with a long-acting inhaled bronchodilator (LABA and/or LAMA) alone or in combination with an inhaled corticosteroid
- Written consent for participation in the study
- Patients who are able to complete by themselves in Greek a questionnaire on COPD.
You may not qualify if:
- Patients with diagnosed Asthma
- Patients with any psychiatric, neurological or other disorder render them unable to complete the COPD questionnaire by themselves
- The patient participates in another study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (32)
Research Site
Athens, Attica, Greece
Research Site
Kallithea, Attica, Greece
Research Site
Marousi, Attica, Greece
Research Site
Megara, Attica, Greece
Research Site
Nea Ionia, Attica, Greece
Research Site
Nea Makri, Attica, Greece
Research Site
Piraeus, Attica, Greece
Research Site
Chania, Crete, Greece
Research Site
Heraklion, Crete, Greece
Research Site
Rhodes, Dodekanisa, Greece
Research Site
Corfu, Eptanisa, Greece
Research Site
Ioannina, Ipiros, Greece
Research Site
Larissa, Kyklades, Greece
Research Site
Mykonos, Kyklades, Greece
Research Site
Alexándreia, Makedonia, Greece
Research Site
Drama, Makedonia, Greece
Research Site
Florina, Makedonia, Greece
Research Site
Katerini, Makedonia, Greece
Research Site
Kavala, Makedonia, Greece
Research Site
Kozani, Makedonia, Greece
Research Site
Serres, Makedonia, Greece
Research Site
Thesaloniki, Makedonia, Greece
Research Site
Krestena, Peloponisos, Greece
Research Site
Lechainá, Peloponisos, Greece
Research Site
Pátrai, Peloponisos, Greece
Research Site
Skála, Peloponisos, Greece
Research Site
Agrinio, Sterea, Greece
Research Site
Halkida, Sterea, Greece
Research Site
Itea, Sterea, Greece
Research Site
Livadia, Sterea, Greece
Research Site
Volos, Thesalia, Greece
Research Site
Xánthi, Traki, Greece
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Panagiotis Pontikis
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 8, 2010
First Posted
October 13, 2010
Study Start
October 1, 2010
Primary Completion
March 1, 2011
Study Completion
March 1, 2011
Last Updated
March 21, 2012
Record last verified: 2012-03