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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)

2012年3月20日 更新者：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.

研究概览

地位

完全的

条件

研究类型

观察性的

注册 (实际的)

700

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

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

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

45年 至 75年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

概率样本

研究人群

Patients with Chronic Obstructive Pulmonary Disease

描述

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

队列和干预

团体/队列
1
Patients with Chronic Obstructive Pulmonary Disease

研究衡量的是什么？

主要结果指标

结果测量
大体时间
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.
大体时间：End of recruitment (estimated timeframe :2.5 months)
End of recruitment (estimated timeframe :2.5 months)

次要结果测量

结果测量
大体时间
婚姻状况
大体时间：招聘结束（预计时间：2.5 个月）
招聘结束（预计时间：2.5 个月）
职业
大体时间：招聘结束（预计时间：2.5 个月）
招聘结束（预计时间：2.5 个月）
Age
大体时间：End of recruitment (estimated timeframe :2.5 months)
End of recruitment (estimated timeframe :2.5 months)
Gender
大体时间：End of recruitment (estimated timeframe :2.5 months)
End of recruitment (estimated timeframe :2.5 months)
Place of residence
大体时间：End of recruitment (estimated timeframe :2.5 months)
End of recruitment (estimated timeframe :2.5 months)
Native language
大体时间：End of recruitment (estimated timeframe :2.5 months)
End of recruitment (estimated timeframe :2.5 months)
Educational level
大体时间：End of recruitment (estimated timeframe :2.5 months)
End of recruitment (estimated timeframe :2.5 months)
Co-morbidities
大体时间：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
大体时间：End of recruitment (estimated timeframe :2.5 months)
End of recruitment (estimated timeframe :2.5 months)
Smoking history
大体时间：End of recruitment (estimated timeframe :2.5 months)
End of recruitment (estimated timeframe :2.5 months)
Number of exacerbations during the last year
大体时间：End of recruitment (estimated timeframe :2.5 months)
End of recruitment (estimated timeframe :2.5 months)
Current therapy
大体时间：End of recruitment (estimated timeframe :2.5 months)
End of recruitment (estimated timeframe :2.5 months)
CCQ score
大体时间：End of recruitment (estimated timeframe :2.5 months)
End of recruitment (estimated timeframe :2.5 months)
Compliance with therapy
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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.
大体时间：End of recruitment (estimated timeframe :2.5 months)
End of recruitment (estimated timeframe :2.5 months)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

AstraZeneca

调查人员

  • 研究主任：Panagiotis Pontikis

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2010年10月1日

初级完成 (实际的)

2011年3月1日

研究完成 (实际的)

2011年3月1日

研究注册日期

首次提交

2010年10月8日

首先提交符合 QC 标准的

2010年10月12日

首次发布 (估计)

2010年10月13日

研究记录更新

最后更新发布 (估计)

2012年3月21日

上次提交的符合 QC 标准的更新

2012年3月20日

最后验证

2012年3月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • NIS-RGR-DUM-2010/1

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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