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 de marzo de 2012 actualizado por: 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.
Descripción general del estudio
Estado
Terminado
Condiciones
Tipo de estudio
De observación
Inscripción (Actual)
700
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Attiki
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Athina, Attiki, Grecia
- Research Site
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Kalithea, Attiki, Grecia
- Research Site
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Marousi, Attiki, Grecia
- Research Site
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Megara, Attiki, Grecia
- Research Site
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Nea Ionia, Attiki, Grecia
- Research Site
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Nea Makri, Attiki, Grecia
- Research Site
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Piraeus, Attiki, Grecia
- Research Site
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Dodekanisa
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Rodos, Dodekanisa, Grecia
- Research Site
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Eptanisa
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Kerkyra, Eptanisa, Grecia
- Research Site
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Ipiros
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Ioannina, Ipiros, Grecia
- Research Site
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Kriti
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Chania, Kriti, Grecia
- Research Site
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Heraklion, Kriti, Grecia
- Research Site
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Kyklades
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Larisa, Kyklades, Grecia
- Research Site
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Mykonos, Kyklades, Grecia
- Research Site
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Makedonia
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Alexandria, Makedonia, Grecia
- Research Site
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Drama, Makedonia, Grecia
- Research Site
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Florina, Makedonia, Grecia
- Research Site
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Katerini, Makedonia, Grecia
- Research Site
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Kavala, Makedonia, Grecia
- Research Site
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Kozani, Makedonia, Grecia
- Research Site
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Serres, Makedonia, Grecia
- Research Site
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Thesaloniki, Makedonia, Grecia
- Research Site
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Peloponisos
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Krestena, Peloponisos, Grecia
- Research Site
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Lechaina, Peloponisos, Grecia
- Research Site
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Patra, Peloponisos, Grecia
- Research Site
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Skala, Peloponisos, Grecia
- Research Site
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Sterea
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Agrinio, Sterea, Grecia
- Research Site
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Halkida, Sterea, Grecia
- Research Site
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Itea, Sterea, Grecia
- Research Site
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Livadia, Sterea, Grecia
- Research Site
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Thesalia
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Volos, Thesalia, Grecia
- Research Site
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Traki
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Xanthi, Traki, Grecia
- Research Site
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
45 años a 75 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Método de muestreo
Muestra de probabilidad
Población de estudio
Patients with Chronic Obstructive Pulmonary Disease
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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1
Patients with Chronic Obstructive Pulmonary Disease
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
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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.
Periodo de tiempo: End of recruitment (estimated timeframe :2.5 months)
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End of recruitment (estimated timeframe :2.5 months)
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
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Estado civil
Periodo de tiempo: Fin de la contratación (plazo estimado: 2,5 meses)
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Fin de la contratación (plazo estimado: 2,5 meses)
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Ocupación
Periodo de tiempo: Fin de la contratación (plazo estimado: 2,5 meses)
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Fin de la contratación (plazo estimado: 2,5 meses)
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Age
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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.
Periodo de tiempo: End of recruitment (estimated timeframe :2.5 months)
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End of recruitment (estimated timeframe :2.5 months)
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Director de estudio: Panagiotis Pontikis
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de octubre de 2010
Finalización primaria (Actual)
1 de marzo de 2011
Finalización del estudio (Actual)
1 de marzo de 2011
Fechas de registro del estudio
Enviado por primera vez
8 de octubre de 2010
Primero enviado que cumplió con los criterios de control de calidad
12 de octubre de 2010
Publicado por primera vez (Estimar)
13 de octubre de 2010
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
21 de marzo de 2012
Última actualización enviada que cumplió con los criterios de control de calidad
20 de marzo de 2012
Última verificación
1 de marzo de 2012
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- NIS-RGR-DUM-2010/1
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .