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 uppdaterad 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.
Studieöversikt
Status
Avslutad
Betingelser
Studietyp
Observationell
Inskrivning (Faktisk)
700
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Attiki
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Athina, Attiki, Grekland
- Research Site
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Kalithea, Attiki, Grekland
- Research Site
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Marousi, Attiki, Grekland
- Research Site
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Megara, Attiki, Grekland
- Research Site
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Nea Ionia, Attiki, Grekland
- Research Site
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Nea Makri, Attiki, Grekland
- Research Site
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Piraeus, Attiki, Grekland
- Research Site
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Dodekanisa
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Rodos, Dodekanisa, Grekland
- Research Site
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Eptanisa
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Kerkyra, Eptanisa, Grekland
- Research Site
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Ipiros
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Ioannina, Ipiros, Grekland
- Research Site
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Kriti
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Chania, Kriti, Grekland
- Research Site
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Heraklion, Kriti, Grekland
- Research Site
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Kyklades
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Larisa, Kyklades, Grekland
- Research Site
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Mykonos, Kyklades, Grekland
- Research Site
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Makedonia
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Alexandria, Makedonia, Grekland
- Research Site
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Drama, Makedonia, Grekland
- Research Site
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Florina, Makedonia, Grekland
- Research Site
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Katerini, Makedonia, Grekland
- Research Site
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Kavala, Makedonia, Grekland
- Research Site
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Kozani, Makedonia, Grekland
- Research Site
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Serres, Makedonia, Grekland
- Research Site
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Thesaloniki, Makedonia, Grekland
- Research Site
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Peloponisos
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Krestena, Peloponisos, Grekland
- Research Site
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Lechaina, Peloponisos, Grekland
- Research Site
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Patra, Peloponisos, Grekland
- Research Site
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Skala, Peloponisos, Grekland
- Research Site
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Sterea
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Agrinio, Sterea, Grekland
- Research Site
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Halkida, Sterea, Grekland
- Research Site
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Itea, Sterea, Grekland
- Research Site
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Livadia, Sterea, Grekland
- Research Site
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Thesalia
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Volos, Thesalia, Grekland
- Research Site
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Traki
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Xanthi, Traki, Grekland
- Research Site
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
45 år till 75 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Testmetod
Sannolikhetsprov
Studera befolkning
Patients with Chronic Obstructive Pulmonary Disease
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
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1
Patients with Chronic Obstructive Pulmonary Disease
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
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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.
Tidsram: End of recruitment (estimated timeframe :2.5 months)
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End of recruitment (estimated timeframe :2.5 months)
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Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
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Civilstånd
Tidsram: Slut på rekryteringen (beräknad tidsram: 2,5 månader)
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Slut på rekryteringen (beräknad tidsram: 2,5 månader)
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Ockupation
Tidsram: Slut på rekryteringen (beräknad tidsram: 2,5 månader)
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Slut på rekryteringen (beräknad tidsram: 2,5 månader)
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Age
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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.
Tidsram: End of recruitment (estimated timeframe :2.5 months)
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End of recruitment (estimated timeframe :2.5 months)
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Studierektor: Panagiotis Pontikis
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 oktober 2010
Primärt slutförande (Faktisk)
1 mars 2011
Avslutad studie (Faktisk)
1 mars 2011
Studieregistreringsdatum
Först inskickad
8 oktober 2010
Först inskickad som uppfyllde QC-kriterierna
12 oktober 2010
Första postat (Uppskatta)
13 oktober 2010
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
21 mars 2012
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
20 mars 2012
Senast verifierad
1 mars 2012
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- NIS-RGR-DUM-2010/1
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .