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)

March 20, 2012 updated by: AstraZeneca

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.

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

700

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
    • Attiki
      • Athina, Attiki, Greece
        • Research Site
      • Kalithea, Attiki, Greece
        • Research Site
      • Marousi, Attiki, Greece
        • Research Site
      • Megara, Attiki, Greece
        • Research Site
      • Nea Ionia, Attiki, Greece
        • Research Site
      • Nea Makri, Attiki, Greece
        • Research Site
      • Piraeus, Attiki, Greece
        • Research Site
    • Dodekanisa
      • Rodos, Dodekanisa, Greece
        • Research Site
    • Eptanisa
      • Kerkyra, Eptanisa, Greece
        • Research Site
    • Ipiros
      • Ioannina, Ipiros, Greece
        • Research Site
    • Kriti
      • Chania, Kriti, Greece
        • Research Site
      • Heraklion, Kriti, Greece
        • Research Site
    • Kyklades
      • Larisa, Kyklades, Greece
        • Research Site
      • Mykonos, Kyklades, Greece
        • Research Site
    • Makedonia
      • Alexandria, 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
    • Peloponisos
      • Krestena, Peloponisos, Greece
        • Research Site
      • Lechaina, Peloponisos, Greece
        • Research Site
      • Patra, Peloponisos, Greece
        • Research Site
      • Skala, Peloponisos, Greece
        • Research Site
    • Sterea
      • Agrinio, Sterea, Greece
        • Research Site
      • Halkida, Sterea, Greece
        • Research Site
      • Itea, Sterea, Greece
        • Research Site
      • Livadia, Sterea, Greece
        • Research Site
    • Thesalia
      • Volos, Thesalia, Greece
        • Research Site
    • Traki
      • Xanthi, Traki, Greece
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with Chronic Obstructive Pulmonary Disease

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
1
Patients with Chronic Obstructive Pulmonary Disease

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
End of recruitment (estimated timeframe :2.5 months)

Secondary Outcome Measures

Outcome Measure
Time Frame
Marital status
Time Frame: End of recruitment (estimated timeframe :2.5 months)
End of recruitment (estimated timeframe :2.5 months)
Occupation
Time Frame: End of recruitment (estimated timeframe :2.5 months)
End of recruitment (estimated timeframe :2.5 months)
Age
Time Frame: End of recruitment (estimated timeframe :2.5 months)
End of recruitment (estimated timeframe :2.5 months)
Gender
Time Frame: End of recruitment (estimated timeframe :2.5 months)
End of recruitment (estimated timeframe :2.5 months)
Place of residence
Time Frame: End of recruitment (estimated timeframe :2.5 months)
End of recruitment (estimated timeframe :2.5 months)
Native language
Time Frame: End of recruitment (estimated timeframe :2.5 months)
End of recruitment (estimated timeframe :2.5 months)
Educational level
Time Frame: End of recruitment (estimated timeframe :2.5 months)
End of recruitment (estimated timeframe :2.5 months)
Co-morbidities
Time Frame: End of recruitment (estimated timeframe :2.5 months)
End of recruitment (estimated timeframe :2.5 months)
Years / months since COPD diagnosis and years with COPD symptoms
Time Frame: End of recruitment (estimated timeframe :2.5 months)
End of recruitment (estimated timeframe :2.5 months)
Smoking history
Time Frame: End of recruitment (estimated timeframe :2.5 months)
End of recruitment (estimated timeframe :2.5 months)
Number of exacerbations during the last year
Time Frame: End of recruitment (estimated timeframe :2.5 months)
End of recruitment (estimated timeframe :2.5 months)
Current therapy
Time Frame: End of recruitment (estimated timeframe :2.5 months)
End of recruitment (estimated timeframe :2.5 months)
CCQ score
Time Frame: End of recruitment (estimated timeframe :2.5 months)
End of recruitment (estimated timeframe :2.5 months)
Compliance with therapy
Time Frame: End of recruitment (estimated timeframe :2.5 months)
End of recruitment (estimated timeframe :2.5 months)
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)
End of recruitment (estimated timeframe :2.5 months)
Scale for the assessment of the severity of the relevant symptoms
Time Frame: End of recruitment (estimated timeframe :2.5 months)
End of recruitment (estimated timeframe :2.5 months)
Actions/therapeutic recommendations by the physician when any of the symptoms worsen
Time Frame: End of recruitment (estimated timeframe :2.5 months)
End of recruitment (estimated timeframe :2.5 months)
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)
End of recruitment (estimated timeframe :2.5 months)
Related actions initiated by the patient regarding chronic daily symptoms
Time Frame: End of recruitment (estimated timeframe :2.5 months)
End of recruitment (estimated timeframe :2.5 months)
Related actions initiated by the patient when the symptoms worsen.
Time Frame: End of recruitment (estimated timeframe :2.5 months)
End of recruitment (estimated timeframe :2.5 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Study Director: Panagiotis Pontikis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

October 8, 2010

First Submitted That Met QC Criteria

October 12, 2010

First Posted (Estimate)

October 13, 2010

Study Record Updates

Last Update Posted (Estimate)

March 21, 2012

Last Update Submitted That Met QC Criteria

March 20, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIS-RGR-DUM-2010/1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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