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 mars 2012 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Type d'étude
Observationnel
Inscription (Réel)
700
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Attiki
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Athina, Attiki, Grèce
- Research Site
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Kalithea, Attiki, Grèce
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Marousi, Attiki, Grèce
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Megara, Attiki, Grèce
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Nea Ionia, Attiki, Grèce
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Nea Makri, Attiki, Grèce
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Piraeus, Attiki, Grèce
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Dodekanisa
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Rodos, Dodekanisa, Grèce
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Eptanisa
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Kerkyra, Eptanisa, Grèce
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Ipiros
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Ioannina, Ipiros, Grèce
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Kriti
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Chania, Kriti, Grèce
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Heraklion, Kriti, Grèce
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Kyklades
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Larisa, Kyklades, Grèce
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Mykonos, Kyklades, Grèce
- Research Site
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Makedonia
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Alexandria, Makedonia, Grèce
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Drama, Makedonia, Grèce
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Florina, Makedonia, Grèce
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Katerini, Makedonia, Grèce
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Kavala, Makedonia, Grèce
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Kozani, Makedonia, Grèce
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Serres, Makedonia, Grèce
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Thesaloniki, Makedonia, Grèce
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Peloponisos
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Krestena, Peloponisos, Grèce
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Lechaina, Peloponisos, Grèce
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Patra, Peloponisos, Grèce
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Skala, Peloponisos, Grèce
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Sterea
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Agrinio, Sterea, Grèce
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Halkida, Sterea, Grèce
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Itea, Sterea, Grèce
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Livadia, Sterea, Grèce
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Thesalia
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Volos, Thesalia, Grèce
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Traki
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Xanthi, Traki, Grèce
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
45 ans à 75 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
Méthode d'échantillonnage
Échantillon de probabilité
Population étudiée
Patients with Chronic Obstructive Pulmonary Disease
La description
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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
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1
Patients with Chronic Obstructive Pulmonary Disease
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
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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.
Délai: End of recruitment (estimated timeframe :2.5 months)
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End of recruitment (estimated timeframe :2.5 months)
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
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État civil
Délai: Fin du recrutement (délai estimé : 2,5 mois)
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Fin du recrutement (délai estimé : 2,5 mois)
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Profession
Délai: Fin du recrutement (délai estimé : 2,5 mois)
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Fin du recrutement (délai estimé : 2,5 mois)
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Age
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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.
Délai: End of recruitment (estimated timeframe :2.5 months)
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End of recruitment (estimated timeframe :2.5 months)
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Directeur d'études: Panagiotis Pontikis
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 octobre 2010
Achèvement primaire (Réel)
1 mars 2011
Achèvement de l'étude (Réel)
1 mars 2011
Dates d'inscription aux études
Première soumission
8 octobre 2010
Première soumission répondant aux critères de contrôle qualité
12 octobre 2010
Première publication (Estimation)
13 octobre 2010
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
21 mars 2012
Dernière mise à jour soumise répondant aux critères de contrôle qualité
20 mars 2012
Dernière vérification
1 mars 2012
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- NIS-RGR-DUM-2010/1
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .