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. marts 2012 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
700
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Attiki
-
Athina, Attiki, Grækenland
- Research Site
-
Kalithea, Attiki, Grækenland
- Research Site
-
Marousi, Attiki, Grækenland
- Research Site
-
Megara, Attiki, Grækenland
- Research Site
-
Nea Ionia, Attiki, Grækenland
- Research Site
-
Nea Makri, Attiki, Grækenland
- Research Site
-
Piraeus, Attiki, Grækenland
- Research Site
-
-
Dodekanisa
-
Rodos, Dodekanisa, Grækenland
- Research Site
-
-
Eptanisa
-
Kerkyra, Eptanisa, Grækenland
- Research Site
-
-
Ipiros
-
Ioannina, Ipiros, Grækenland
- Research Site
-
-
Kriti
-
Chania, Kriti, Grækenland
- Research Site
-
Heraklion, Kriti, Grækenland
- Research Site
-
-
Kyklades
-
Larisa, Kyklades, Grækenland
- Research Site
-
Mykonos, Kyklades, Grækenland
- Research Site
-
-
Makedonia
-
Alexandria, Makedonia, Grækenland
- Research Site
-
Drama, Makedonia, Grækenland
- Research Site
-
Florina, Makedonia, Grækenland
- Research Site
-
Katerini, Makedonia, Grækenland
- Research Site
-
Kavala, Makedonia, Grækenland
- Research Site
-
Kozani, Makedonia, Grækenland
- Research Site
-
Serres, Makedonia, Grækenland
- Research Site
-
Thesaloniki, Makedonia, Grækenland
- Research Site
-
-
Peloponisos
-
Krestena, Peloponisos, Grækenland
- Research Site
-
Lechaina, Peloponisos, Grækenland
- Research Site
-
Patra, Peloponisos, Grækenland
- Research Site
-
Skala, Peloponisos, Grækenland
- Research Site
-
-
Sterea
-
Agrinio, Sterea, Grækenland
- Research Site
-
Halkida, Sterea, Grækenland
- Research Site
-
Itea, Sterea, Grækenland
- Research Site
-
Livadia, Sterea, Grækenland
- Research Site
-
-
Thesalia
-
Volos, Thesalia, Grækenland
- Research Site
-
-
Traki
-
Xanthi, Traki, Grækenland
- Research Site
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
45 år til 75 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Sandsynlighedsprøve
Studiebefolkning
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
|---|
|
1
Patients with Chronic Obstructive Pulmonary Disease
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
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)
|
End of recruitment (estimated timeframe :2.5 months)
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Civilstand
Tidsramme: Slut på rekruttering (estimeret tidsramme: 2,5 måneder)
|
Slut på rekruttering (estimeret tidsramme: 2,5 måneder)
|
|
Beskæftigelse
Tidsramme: Slut på rekruttering (estimeret tidsramme: 2,5 måneder)
|
Slut på rekruttering (estimeret tidsramme: 2,5 måneder)
|
|
Age
Tidsramme: End of recruitment (estimated timeframe :2.5 months)
|
End of recruitment (estimated timeframe :2.5 months)
|
|
Gender
Tidsramme: End of recruitment (estimated timeframe :2.5 months)
|
End of recruitment (estimated timeframe :2.5 months)
|
|
Place of residence
Tidsramme: End of recruitment (estimated timeframe :2.5 months)
|
End of recruitment (estimated timeframe :2.5 months)
|
|
Native language
Tidsramme: End of recruitment (estimated timeframe :2.5 months)
|
End of recruitment (estimated timeframe :2.5 months)
|
|
Educational level
Tidsramme: End of recruitment (estimated timeframe :2.5 months)
|
End of recruitment (estimated timeframe :2.5 months)
|
|
Co-morbidities
Tidsramme: End of recruitment (estimated timeframe :2.5 months)
|
End of recruitment (estimated timeframe :2.5 months)
|
|
Years / months since COPD diagnosis and years with COPD symptoms
Tidsramme: End of recruitment (estimated timeframe :2.5 months)
|
End of recruitment (estimated timeframe :2.5 months)
|
|
Smoking history
Tidsramme: End of recruitment (estimated timeframe :2.5 months)
|
End of recruitment (estimated timeframe :2.5 months)
|
|
Number of exacerbations during the last year
Tidsramme: End of recruitment (estimated timeframe :2.5 months)
|
End of recruitment (estimated timeframe :2.5 months)
|
|
Current therapy
Tidsramme: End of recruitment (estimated timeframe :2.5 months)
|
End of recruitment (estimated timeframe :2.5 months)
|
|
CCQ score
Tidsramme: End of recruitment (estimated timeframe :2.5 months)
|
End of recruitment (estimated timeframe :2.5 months)
|
|
Compliance with therapy
Tidsramme: End of recruitment (estimated timeframe :2.5 months)
|
End of recruitment (estimated timeframe :2.5 months)
|
|
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)
|
End of recruitment (estimated timeframe :2.5 months)
|
|
Scale for the assessment of the severity of the relevant symptoms
Tidsramme: End of recruitment (estimated timeframe :2.5 months)
|
End of recruitment (estimated timeframe :2.5 months)
|
|
Actions/therapeutic recommendations by the physician when any of the symptoms worsen
Tidsramme: End of recruitment (estimated timeframe :2.5 months)
|
End of recruitment (estimated timeframe :2.5 months)
|
|
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)
|
End of recruitment (estimated timeframe :2.5 months)
|
|
Related actions initiated by the patient regarding chronic daily symptoms
Tidsramme: End of recruitment (estimated timeframe :2.5 months)
|
End of recruitment (estimated timeframe :2.5 months)
|
|
Related actions initiated by the patient when the symptoms worsen.
Tidsramme: End of recruitment (estimated timeframe :2.5 months)
|
End of recruitment (estimated timeframe :2.5 months)
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studieleder: Panagiotis Pontikis
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. oktober 2010
Primær færdiggørelse (Faktiske)
1. marts 2011
Studieafslutning (Faktiske)
1. marts 2011
Datoer for studieregistrering
Først indsendt
8. oktober 2010
Først indsendt, der opfyldte QC-kriterier
12. oktober 2010
Først opslået (Skøn)
13. oktober 2010
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
21. marts 2012
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
20. marts 2012
Sidst verificeret
1. marts 2012
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- NIS-RGR-DUM-2010/1
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .