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NCT Number: NCT01219946

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 (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.

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Key information

Age range

45 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Athens, Attica, Greece

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

    Time frame: End of recruitment (estimated timeframe :2.5 months)

Secondary outcomes

  1. Age

    Time frame: End of recruitment (estimated timeframe :2.5 months)

  2. Gender

    Time frame: End of recruitment (estimated timeframe :2.5 months)

  3. Place of residence

    Time frame: End of recruitment (estimated timeframe :2.5 months)

  4. Marital status

    Time frame: End of recruitment (estimated timeframe :2.5 months)

  5. Native language

    Time frame: End of recruitment (estimated timeframe :2.5 months)

  6. Educational level

    Time frame: End of recruitment (estimated timeframe :2.5 months)

  7. Occupation

    Time frame: End of recruitment (estimated timeframe :2.5 months)

  8. Co-morbidities

    Time frame: End of recruitment (estimated timeframe :2.5 months)

  9. Years / months since COPD diagnosis and years with COPD symptoms

    Time frame: End of recruitment (estimated timeframe :2.5 months)

  10. Smoking history

    Time frame: End of recruitment (estimated timeframe :2.5 months)

  11. Number of exacerbations during the last year

    Time frame: End of recruitment (estimated timeframe :2.5 months)

  12. Current therapy

    Time frame: End of recruitment (estimated timeframe :2.5 months)

  13. CCQ score

    Time frame: End of recruitment (estimated timeframe :2.5 months)

  14. Compliance with therapy

    Time frame: End of recruitment (estimated timeframe :2.5 months)

  15. 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)

  16. Scale for the assessment of the severity of the relevant symptoms

    Time frame: End of recruitment (estimated timeframe :2.5 months)

  17. Actions/therapeutic recommendations by the physician when any of the symptoms worsen

    Time frame: End of recruitment (estimated timeframe :2.5 months)

  18. 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)

  19. Related actions initiated by the patient regarding chronic daily symptoms

    Time frame: End of recruitment (estimated timeframe :2.5 months)

  20. Related actions initiated by the patient when the symptoms worsen.

    Time frame: End of recruitment (estimated timeframe :2.5 months)

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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.

Acronym: COPD Language

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Oct 13, 2010
Registry last updated
Mar 21, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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