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)
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Purpose
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.
| Condition |
|---|
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Chronic Obstructive Pulmonary Disease |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Cross-Sectional |
| Official Title: | 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. |
- 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. [ Time Frame: End of recruitment (estimated timeframe :2.5 months) ] [ Designated as safety issue: No ]
- Age [ Time Frame: End of recruitment (estimated timeframe :2.5 months) ] [ Designated as safety issue: No ]
- Gender [ Time Frame: End of recruitment (estimated timeframe :2.5 months) ] [ Designated as safety issue: No ]
- Place of residence [ Time Frame: End of recruitment (estimated timeframe :2.5 months) ] [ Designated as safety issue: No ]
- Marital status [ Time Frame: End of recruitment (estimated timeframe :2.5 months) ] [ Designated as safety issue: No ]
- Native language [ Time Frame: End of recruitment (estimated timeframe :2.5 months) ] [ Designated as safety issue: No ]
- Educational level [ Time Frame: End of recruitment (estimated timeframe :2.5 months) ] [ Designated as safety issue: No ]
- Occupation [ Time Frame: End of recruitment (estimated timeframe :2.5 months) ] [ Designated as safety issue: No ]
- Co-morbidities [ Time Frame: End of recruitment (estimated timeframe :2.5 months) ] [ Designated as safety issue: No ]
- Years / months since COPD diagnosis and years with COPD symptoms [ Time Frame: End of recruitment (estimated timeframe :2.5 months) ] [ Designated as safety issue: No ]
- Smoking history [ Time Frame: End of recruitment (estimated timeframe :2.5 months) ] [ Designated as safety issue: No ]
- Number of exacerbations during the last year [ Time Frame: End of recruitment (estimated timeframe :2.5 months) ] [ Designated as safety issue: No ]
- Current therapy [ Time Frame: End of recruitment (estimated timeframe :2.5 months) ] [ Designated as safety issue: No ]
- CCQ score [ Time Frame: End of recruitment (estimated timeframe :2.5 months) ] [ Designated as safety issue: No ]
- Compliance with therapy [ Time Frame: End of recruitment (estimated timeframe :2.5 months) ] [ Designated as safety issue: No ]
- Actions/therapeutic recommendations by the physician associated with each chosen word that express the chronic daily symptoms [ Time Frame: End of recruitment (estimated timeframe :2.5 months) ] [ Designated as safety issue: No ]
- Scale for the assessment of the severity of the relevant symptoms [ Time Frame: End of recruitment (estimated timeframe :2.5 months) ] [ Designated as safety issue: No ]
- Actions/therapeutic recommendations by the physician when any of the symptoms worsen [ Time Frame: End of recruitment (estimated timeframe :2.5 months) ] [ Designated as safety issue: No ]
- Severity scale regarding how the patient experiences each of the chosen words that express the chronic daily symptoms [ Time Frame: End of recruitment (estimated timeframe :2.5 months) ] [ Designated as safety issue: No ]
- Related actions initiated by the patient regarding chronic daily symptoms [ Time Frame: End of recruitment (estimated timeframe :2.5 months) ] [ Designated as safety issue: No ]
- Related actions initiated by the patient when the symptoms worsen. [ Time Frame: End of recruitment (estimated timeframe :2.5 months) ] [ Designated as safety issue: No ]
| Enrollment: | 700 |
| Study Start Date: | October 2010 |
| Study Completion Date: | March 2011 |
| Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
1
Patients with Chronic Obstructive Pulmonary Disease
|
Eligibility| Ages Eligible for Study: | 45 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Patients with Chronic Obstructive Pulmonary Disease
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Contacts and Locations| Greece | |
| Research Site | |
| Athina, Attiki, Greece | |
| Research Site | |
| Kalithea, Attiki, Greece | |
| Research Site | |
| Marousi, Attiki, Greece | |
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| Megara, Attiki, Greece | |
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| Nea Ionia, Attiki, Greece | |
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| Nea Makri, Attiki, Greece | |
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| Piraeus, Attiki, Greece | |
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| Rodos, Dodekanisa, Greece | |
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| Kerkyra, Eptanisa, Greece | |
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| Ioannina, Ipiros, Greece | |
| Research Site | |
| Chania, Kriti, Greece | |
| Research Site | |
| Heraklion, Kriti, Greece | |
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| Larisa, Kyklades, Greece | |
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| Mykonos, Kyklades, Greece | |
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| Alexandria, Makedonia, Greece | |
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| Drama, Makedonia, Greece | |
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| Florina, Makedonia, Greece | |
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| Katerini, Makedonia, Greece | |
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| Kavala, Makedonia, Greece | |
| Research Site | |
| Kozani, Makedonia, Greece | |
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| Serres, Makedonia, Greece | |
| Research Site | |
| Thesaloniki, Makedonia, Greece | |
| Research Site | |
| Krestena, Peloponisos, Greece | |
| Research Site | |
| Lechaina, Peloponisos, Greece | |
| Research Site | |
| Patra, Peloponisos, Greece | |
| Research Site | |
| Skala, 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 | |
| Xanthi, Traki, Greece | |
| Study Director: | Panagiotis Pontikis |
More Information
No publications provided
| Responsible Party: | AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT01219946 History of Changes |
| Other Study ID Numbers: | NIS-RGR-DUM-2010/1 |
| Study First Received: | October 8, 2010 |
| Last Updated: | March 20, 2012 |
| Health Authority: | Greece: National Organization of Medicines |
Keywords provided by AstraZeneca:
|
Chronic Obstructive Pulmonary Disease, symptoms |
Additional relevant MeSH terms:
|
Lung Diseases Respiration Disorders Pulmonary Disease, Chronic Obstructive Lung Diseases, Obstructive Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 21, 2013