- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01219946
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)
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.
연구 개요
상태
정황
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Attiki
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Athina, Attiki, 그리스
- Research Site
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Kalithea, Attiki, 그리스
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Marousi, Attiki, 그리스
- Research Site
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Megara, Attiki, 그리스
- Research Site
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Nea Ionia, Attiki, 그리스
- Research Site
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Nea Makri, Attiki, 그리스
- Research Site
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Piraeus, Attiki, 그리스
- Research Site
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Dodekanisa
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Rodos, Dodekanisa, 그리스
- Research Site
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Eptanisa
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Kerkyra, Eptanisa, 그리스
- Research Site
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Ipiros
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Ioannina, Ipiros, 그리스
- Research Site
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Kriti
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Chania, Kriti, 그리스
- Research Site
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Heraklion, Kriti, 그리스
- Research Site
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Kyklades
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Larisa, Kyklades, 그리스
- Research Site
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Mykonos, Kyklades, 그리스
- Research Site
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Makedonia
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Alexandria, Makedonia, 그리스
- Research Site
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Drama, Makedonia, 그리스
- Research Site
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Florina, Makedonia, 그리스
- Research Site
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Katerini, Makedonia, 그리스
- Research Site
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Kavala, Makedonia, 그리스
- Research Site
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Kozani, Makedonia, 그리스
- Research Site
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Serres, Makedonia, 그리스
- Research Site
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Thesaloniki, Makedonia, 그리스
- Research Site
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Peloponisos
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Krestena, Peloponisos, 그리스
- Research Site
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Lechaina, Peloponisos, 그리스
- Research Site
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Patra, Peloponisos, 그리스
- Research Site
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Skala, Peloponisos, 그리스
- Research Site
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Sterea
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Agrinio, Sterea, 그리스
- Research Site
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Halkida, Sterea, 그리스
- Research Site
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Itea, Sterea, 그리스
- Research Site
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Livadia, Sterea, 그리스
- Research Site
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Thesalia
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Volos, Thesalia, 그리스
- Research Site
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Traki
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Xanthi, Traki, 그리스
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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1
Patients with Chronic Obstructive Pulmonary Disease
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
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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.
기간: End of recruitment (estimated timeframe :2.5 months)
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End of recruitment (estimated timeframe :2.5 months)
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2차 결과 측정
결과 측정 |
기간 |
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혼인 여부
기간: 채용 종료(예상 기간: 2.5개월)
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채용 종료(예상 기간: 2.5개월)
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직업
기간: 채용 종료(예상 기간: 2.5개월)
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채용 종료(예상 기간: 2.5개월)
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Age
기간: End of recruitment (estimated timeframe :2.5 months)
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End of recruitment (estimated timeframe :2.5 months)
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Gender
기간: End of recruitment (estimated timeframe :2.5 months)
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End of recruitment (estimated timeframe :2.5 months)
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Place of residence
기간: End of recruitment (estimated timeframe :2.5 months)
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End of recruitment (estimated timeframe :2.5 months)
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Native language
기간: End of recruitment (estimated timeframe :2.5 months)
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End of recruitment (estimated timeframe :2.5 months)
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Educational level
기간: End of recruitment (estimated timeframe :2.5 months)
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End of recruitment (estimated timeframe :2.5 months)
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Co-morbidities
기간: End of recruitment (estimated timeframe :2.5 months)
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End of recruitment (estimated timeframe :2.5 months)
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Years / months since COPD diagnosis and years with COPD symptoms
기간: End of recruitment (estimated timeframe :2.5 months)
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End of recruitment (estimated timeframe :2.5 months)
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Smoking history
기간: End of recruitment (estimated timeframe :2.5 months)
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End of recruitment (estimated timeframe :2.5 months)
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Number of exacerbations during the last year
기간: End of recruitment (estimated timeframe :2.5 months)
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End of recruitment (estimated timeframe :2.5 months)
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Current therapy
기간: End of recruitment (estimated timeframe :2.5 months)
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End of recruitment (estimated timeframe :2.5 months)
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CCQ score
기간: End of recruitment (estimated timeframe :2.5 months)
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End of recruitment (estimated timeframe :2.5 months)
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Compliance with therapy
기간: End of recruitment (estimated timeframe :2.5 months)
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End of recruitment (estimated timeframe :2.5 months)
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Actions/therapeutic recommendations by the physician associated with each chosen word that express the chronic daily symptoms
기간: End of recruitment (estimated timeframe :2.5 months)
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End of recruitment (estimated timeframe :2.5 months)
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Scale for the assessment of the severity of the relevant symptoms
기간: End of recruitment (estimated timeframe :2.5 months)
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End of recruitment (estimated timeframe :2.5 months)
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Actions/therapeutic recommendations by the physician when any of the symptoms worsen
기간: End of recruitment (estimated timeframe :2.5 months)
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End of recruitment (estimated timeframe :2.5 months)
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Severity scale regarding how the patient experiences each of the chosen words that express the chronic daily symptoms
기간: End of recruitment (estimated timeframe :2.5 months)
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End of recruitment (estimated timeframe :2.5 months)
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Related actions initiated by the patient regarding chronic daily symptoms
기간: End of recruitment (estimated timeframe :2.5 months)
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End of recruitment (estimated timeframe :2.5 months)
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Related actions initiated by the patient when the symptoms worsen.
기간: End of recruitment (estimated timeframe :2.5 months)
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End of recruitment (estimated timeframe :2.5 months)
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공동 작업자 및 조사자
스폰서
수사관
- 연구 책임자: Panagiotis Pontikis
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- NIS-RGR-DUM-2010/1
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