Clinical trial NCT01219946: A Study for the Assessment of the Words Used by Patients and Physicians to Express the Symptoms of Chronic Obstructive Pulmonary Disease (COPD)
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Chronic Obstructive Pulmonary Disease, symptoms
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-10-13
Enrollment: 700
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with Chronic Obstructive Pulmonary Disease

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: End of recruitment (estimated timeframe :2.5 months)
Secondary outcomes:
measure: Age
timeFrame: End of recruitment (estimated timeframe :2.5 months)
measure: Gender
timeFrame: End of recruitment (estimated timeframe :2.5 months)
measure: Place of residence
timeFrame: End of recruitment (estimated timeframe :2.5 months)
measure: Marital status
timeFrame: End of recruitment (estimated timeframe :2.5 months)
measure: Native language
timeFrame: End of recruitment (estimated timeframe :2.5 months)
measure: Educational level
timeFrame: End of recruitment (estimated timeframe :2.5 months)
measure: Occupation
timeFrame: End of recruitment (estimated timeframe :2.5 months)
measure: Co-morbidities
timeFrame: End of recruitment (estimated timeframe :2.5 months)
measure: Years / months since COPD diagnosis and years with COPD symptoms
timeFrame: End of recruitment (estimated timeframe :2.5 months)
measure: Smoking history
timeFrame: End of recruitment (estimated timeframe :2.5 months)
measure: Number of exacerbations during the last year
timeFrame: End of recruitment (estimated timeframe :2.5 months)
measure: Current therapy
timeFrame: End of recruitment (estimated timeframe :2.5 months)
measure: CCQ score
timeFrame: End of recruitment (estimated timeframe :2.5 months)
measure: Compliance with therapy
timeFrame: End of recruitment (estimated timeframe :2.5 months)
measure: Actions/therapeutic recommendations by the physician associated with each chosen word that express the chronic daily symptoms
timeFrame: End of recruitment (estimated timeframe :2.5 months)
measure: Scale for the assessment of the severity of the relevant symptoms
timeFrame: End of recruitment (estimated timeframe :2.5 months)
measure: Actions/therapeutic recommendations by the physician when any of the symptoms worsen
timeFrame: End of recruitment (estimated timeframe :2.5 months)
measure: Severity scale regarding how the patient experiences each of the chosen words that express the chronic daily symptoms
timeFrame: End of recruitment (estimated timeframe :2.5 months)
measure: Related actions initiated by the patient regarding chronic daily symptoms
timeFrame: End of recruitment (estimated timeframe :2.5 months)
measure: Related actions initiated by the patient when the symptoms worsen.
timeFrame: End of recruitment (estimated timeframe :2.5 months)
Other outcomes:
Locations:
city: Athina
country: Greece
facility: Research Site
state: Attiki
city: Kalithea
country: Greece
facility: Research Site
state: Attiki
city: Marousi
country: Greece
facility: Research Site
state: Attiki
city: Megara
country: Greece
facility: Research Site
state: Attiki
city: Nea Ionia
country: Greece
facility: Research Site
state: Attiki
city: Nea Makri
country: Greece
facility: Research Site
state: Attiki
city: Piraeus
country: Greece
facility: Research Site
state: Attiki
city: Rodos
country: Greece
facility: Research Site
state: Dodekanisa
city: Kerkyra
country: Greece
facility: Research Site
state: Eptanisa
city: Ioannina
country: Greece
facility: Research Site
state: Ipiros
city: Chania
country: Greece
facility: Research Site
state: Kriti
city: Heraklion
country: Greece
facility: Research Site
state: Kriti
city: Larisa
country: Greece
facility: Research Site
state: Kyklades
city: Mykonos
country: Greece
facility: Research Site
state: Kyklades
city: Alexandria
country: Greece
facility: Research Site
state: Makedonia
city: Drama
country: Greece
facility: Research Site
state: Makedonia
city: Florina
country: Greece
facility: Research Site
state: Makedonia
city: Katerini
country: Greece
facility: Research Site
state: Makedonia
city: Kavala
country: Greece
facility: Research Site
state: Makedonia
city: Kozani
country: Greece
facility: Research Site
state: Makedonia
city: Serres
country: Greece
facility: Research Site
state: Makedonia
city: Thesaloniki
country: Greece
facility: Research Site
state: Makedonia
city: Krestena
country: Greece
facility: Research Site
state: Peloponisos
city: Lechaina
country: Greece
facility: Research Site
state: Peloponisos
city: Patra
country: Greece
facility: Research Site
state: Peloponisos
city: Skala
country: Greece
facility: Research Site
state: Peloponisos
city: Agrinio
country: Greece
facility: Research Site
state: Sterea
city: Halkida
country: Greece
facility: Research Site
state: Sterea
city: Itea
country: Greece
facility: Research Site
state: Sterea
city: Livadia
country: Greece
facility: Research Site
state: Sterea
city: Volos
country: Greece
facility: Research Site
state: Thesalia
city: Xanthi
country: Greece
facility: Research Site
state: Traki
Study officials:
name: Panagiotis Pontikis
role: STUDY_DIRECTOR
References: