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)
20. März 2012 aktualisiert von: 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.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Studientyp
Beobachtungs
Einschreibung (Tatsächlich)
700
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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Attiki
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Athina, Attiki, Griechenland
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Kalithea, Attiki, Griechenland
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Marousi, Attiki, Griechenland
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Megara, Attiki, Griechenland
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Nea Ionia, Attiki, Griechenland
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Nea Makri, Attiki, Griechenland
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Piraeus, Attiki, Griechenland
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Dodekanisa
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Rodos, Dodekanisa, Griechenland
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Eptanisa
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Kerkyra, Eptanisa, Griechenland
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Ipiros
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Ioannina, Ipiros, Griechenland
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Kriti
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Chania, Kriti, Griechenland
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Heraklion, Kriti, Griechenland
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Kyklades
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Larisa, Kyklades, Griechenland
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Mykonos, Kyklades, Griechenland
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Makedonia
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Alexandria, Makedonia, Griechenland
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Drama, Makedonia, Griechenland
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Florina, Makedonia, Griechenland
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Katerini, Makedonia, Griechenland
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Kavala, Makedonia, Griechenland
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Kozani, Makedonia, Griechenland
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Serres, Makedonia, Griechenland
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Thesaloniki, Makedonia, Griechenland
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Peloponisos
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Krestena, Peloponisos, Griechenland
- Research Site
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Lechaina, Peloponisos, Griechenland
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Patra, Peloponisos, Griechenland
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Skala, Peloponisos, Griechenland
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Sterea
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Agrinio, Sterea, Griechenland
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Halkida, Sterea, Griechenland
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Itea, Sterea, Griechenland
- Research Site
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Livadia, Sterea, Griechenland
- Research Site
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Thesalia
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Volos, Thesalia, Griechenland
- Research Site
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Traki
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Xanthi, Traki, Griechenland
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
45 Jahre bis 75 Jahre (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Probenahmeverfahren
Wahrscheinlichkeitsstichprobe
Studienpopulation
Patients with Chronic Obstructive Pulmonary Disease
Beschreibung
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.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
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1
Patients with Chronic Obstructive Pulmonary Disease
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
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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.
Zeitfenster: End of recruitment (estimated timeframe :2.5 months)
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End of recruitment (estimated timeframe :2.5 months)
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
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Familienstand
Zeitfenster: Ende der Rekrutierung (geschätzter Zeitrahmen: 2,5 Monate)
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Ende der Rekrutierung (geschätzter Zeitrahmen: 2,5 Monate)
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Beruf
Zeitfenster: Ende der Rekrutierung (geschätzter Zeitrahmen: 2,5 Monate)
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Ende der Rekrutierung (geschätzter Zeitrahmen: 2,5 Monate)
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Age
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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.
Zeitfenster: End of recruitment (estimated timeframe :2.5 months)
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End of recruitment (estimated timeframe :2.5 months)
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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Ermittler
- Studienleiter: Panagiotis Pontikis
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn
1. Oktober 2010
Primärer Abschluss (Tatsächlich)
1. März 2011
Studienabschluss (Tatsächlich)
1. März 2011
Studienanmeldedaten
Zuerst eingereicht
8. Oktober 2010
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
12. Oktober 2010
Zuerst gepostet (Schätzen)
13. Oktober 2010
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
21. März 2012
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
20. März 2012
Zuletzt verifiziert
1. März 2012
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- NIS-RGR-DUM-2010/1
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