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 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Studietype
Observasjonsmessig
Registrering (Faktiske)
700
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Attiki
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Athina, Attiki, Hellas
- Research Site
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Kalithea, Attiki, Hellas
- Research Site
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Marousi, Attiki, Hellas
- Research Site
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Megara, Attiki, Hellas
- Research Site
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Nea Ionia, Attiki, Hellas
- Research Site
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Nea Makri, Attiki, Hellas
- Research Site
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Piraeus, Attiki, Hellas
- Research Site
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Dodekanisa
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Rodos, Dodekanisa, Hellas
- Research Site
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Eptanisa
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Kerkyra, Eptanisa, Hellas
- Research Site
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Ipiros
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Ioannina, Ipiros, Hellas
- Research Site
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Kriti
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Chania, Kriti, Hellas
- Research Site
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Heraklion, Kriti, Hellas
- Research Site
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Kyklades
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Larisa, Kyklades, Hellas
- Research Site
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Mykonos, Kyklades, Hellas
- Research Site
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Makedonia
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Alexandria, Makedonia, Hellas
- Research Site
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Drama, Makedonia, Hellas
- Research Site
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Florina, Makedonia, Hellas
- Research Site
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Katerini, Makedonia, Hellas
- Research Site
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Kavala, Makedonia, Hellas
- Research Site
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Kozani, Makedonia, Hellas
- Research Site
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Serres, Makedonia, Hellas
- Research Site
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Thesaloniki, Makedonia, Hellas
- Research Site
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Peloponisos
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Krestena, Peloponisos, Hellas
- Research Site
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Lechaina, Peloponisos, Hellas
- Research Site
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Patra, Peloponisos, Hellas
- Research Site
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Skala, Peloponisos, Hellas
- Research Site
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Sterea
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Agrinio, Sterea, Hellas
- Research Site
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Halkida, Sterea, Hellas
- Research Site
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Itea, Sterea, Hellas
- Research Site
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Livadia, Sterea, Hellas
- Research Site
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Thesalia
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Volos, Thesalia, Hellas
- Research Site
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Traki
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Xanthi, Traki, Hellas
- Research Site
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
45 år til 75 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Sannsynlighetsprøve
Studiepopulasjon
Patients with Chronic Obstructive Pulmonary Disease
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
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1
Patients with Chronic Obstructive Pulmonary Disease
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
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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.
Tidsramme: End of recruitment (estimated timeframe :2.5 months)
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End of recruitment (estimated timeframe :2.5 months)
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Sekundære resultatmål
Resultatmål |
Tidsramme |
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Sivilstatus
Tidsramme: Slutt på rekruttering (estimert tidsramme: 2,5 måneder)
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Slutt på rekruttering (estimert tidsramme: 2,5 måneder)
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Okkupasjon
Tidsramme: Slutt på rekruttering (estimert tidsramme: 2,5 måneder)
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Slutt på rekruttering (estimert tidsramme: 2,5 måneder)
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Age
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.
Tidsramme: End of recruitment (estimated timeframe :2.5 months)
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End of recruitment (estimated timeframe :2.5 months)
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Studieleder: Panagiotis Pontikis
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. oktober 2010
Primær fullføring (Faktiske)
1. mars 2011
Studiet fullført (Faktiske)
1. mars 2011
Datoer for studieregistrering
Først innsendt
8. oktober 2010
Først innsendt som oppfylte QC-kriteriene
12. oktober 2010
Først lagt ut (Anslag)
13. oktober 2010
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
21. mars 2012
Siste oppdatering sendt inn som oppfylte QC-kriteriene
20. mars 2012
Sist bekreftet
1. mars 2012
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- NIS-RGR-DUM-2010/1
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