A Study for the Assessment of the Words Used by Patients and Physicians to Express the Symptoms of Chronic Obstructive Pulmonary Disease (COPD)

Chronic Obstructive Pulmonary Disease Clinical Trial

— COPD Language  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01219946
• Other study ID #: NIS-RGR-DUM-2010/1
• Status: Completed
• Phase: N/A
• First received: October 8, 2010
• Last updated: March 20, 2012
• Start date: October 2010
• Est. completion date: March 2011

Study information

• Verified date: March 2012
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: National Organization of Medicines
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 700
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years to 75 Years

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Locations

Country	Name	City	State
Greece	Research Site	Agrinio	Sterea
Greece	Research Site	Alexandria	Makedonia
Greece	Research Site	Athina	Attiki
Greece	Research Site	Chania	Kriti
Greece	Research Site	Drama	Makedonia
Greece	Research Site	Florina	Makedonia
Greece	Research Site	Halkida	Sterea
Greece	Research Site	Heraklion	Kriti
Greece	Research Site	Ioannina	Ipiros
Greece	Research Site	Itea	Sterea
Greece	Research Site	Kalithea	Attiki
Greece	Research Site	Katerini	Makedonia
Greece	Research Site	Kavala	Makedonia
Greece	Research Site	Kerkyra	Eptanisa
Greece	Research Site	Kozani	Makedonia
Greece	Research Site	Krestena	Peloponisos
Greece	Research Site	Larisa	Kyklades
Greece	Research Site	Lechaina	Peloponisos
Greece	Research Site	Livadia	Sterea
Greece	Research Site	Marousi	Attiki
Greece	Research Site	Megara	Attiki
Greece	Research Site	Mykonos	Kyklades
Greece	Research Site	Nea Ionia	Attiki
Greece	Research Site	Nea Makri	Attiki
Greece	Research Site	Patra	Peloponisos
Greece	Research Site	Piraeus	Attiki
Greece	Research Site	Rodos	Dodekanisa
Greece	Research Site	Serres	Makedonia
Greece	Research Site	Skala	Peloponisos
Greece	Research Site	Thesaloniki	Makedonia
Greece	Research Site	Volos	Thesalia
Greece	Research Site	Xanthi	Traki

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	Age		End of recruitment (estimated timeframe :2.5 months)	No
Secondary	Gender		End of recruitment (estimated timeframe :2.5 months)	No
Secondary	Place of residence		End of recruitment (estimated timeframe :2.5 months)	No
Secondary	Marital status		End of recruitment (estimated timeframe :2.5 months)	No
Secondary	Native language		End of recruitment (estimated timeframe :2.5 months)	No
Secondary	Educational level		End of recruitment (estimated timeframe :2.5 months)	No
Secondary	Occupation		End of recruitment (estimated timeframe :2.5 months)	No
Secondary	Co-morbidities		End of recruitment (estimated timeframe :2.5 months)	No
Secondary	Years / months since COPD diagnosis and years with COPD symptoms		End of recruitment (estimated timeframe :2.5 months)	No
Secondary	Smoking history		End of recruitment (estimated timeframe :2.5 months)	No
Secondary	Number of exacerbations during the last year		End of recruitment (estimated timeframe :2.5 months)	No
Secondary	Current therapy		End of recruitment (estimated timeframe :2.5 months)	No
Secondary	CCQ score		End of recruitment (estimated timeframe :2.5 months)	No
Secondary	Compliance with therapy		End of recruitment (estimated timeframe :2.5 months)	No
Secondary	Actions/therapeutic recommendations by the physician associated with each chosen word that express the chronic daily symptoms		End of recruitment (estimated timeframe :2.5 months)	No
Secondary	Scale for the assessment of the severity of the relevant symptoms		End of recruitment (estimated timeframe :2.5 months)	No
Secondary	Actions/therapeutic recommendations by the physician when any of the symptoms worsen		End of recruitment (estimated timeframe :2.5 months)	No
Secondary	Severity scale regarding how the patient experiences each of the chosen words that express the chronic daily symptoms		End of recruitment (estimated timeframe :2.5 months)	No
Secondary	Related actions initiated by the patient regarding chronic daily symptoms		End of recruitment (estimated timeframe :2.5 months)	No
Secondary	Related actions initiated by the patient when the symptoms worsen.		End of recruitment (estimated timeframe :2.5 months)	No