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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01219946
First received: October 8, 2010
Last updated: March 20, 2012
Last verified: March 2012
  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
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.

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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
Study Population

Patients with Chronic Obstructive Pulmonary Disease

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01219946

Locations
Greece
Research Site
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
Rodos, Dodekanisa, Greece
Research Site
Kerkyra, Eptanisa, Greece
Research Site
Ioannina, Ipiros, Greece
Research Site
Chania, Kriti, Greece
Research Site
Heraklion, Kriti, Greece
Research Site
Larisa, Kyklades, Greece
Research Site
Mykonos, Kyklades, Greece
Research Site
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
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
Sponsors and Collaborators
AstraZeneca
Investigators
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, Obstructive
Pulmonary Disease, Chronic Obstructive
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 22, 2014