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Cognitive Status in Chronic Obstructive Pulmonary Disease's Patients (COPD)

17. maj 2014 opdateret af: Marie Carmen Valenza, Universidad de Granada

Clinical Profile and Cognitive Status in Chronic Obstructive Pulmonary Disease's Patients

Chronic obstructive pulmonary disease (COPD) is a chronic condition involving an impairment in functionality and in the execution of activities of daily life. The hypothesis of this study is to examine the relationship between cognitive status and clinical profile (respiratory, sleep quality, nutritional status) in patients with chronic obstructive pulmonary disease in two different moments: exacerbation or stable situation.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Chronic obstructive pulmonary disease is a pathology with a systemic impact with a progressive evolution that is characterized by the presence of chronic airflow obstruction.

Patients with COPD may have problems with cognitive functioning, either globally or in single cognitive domains, such as information processing, attention and concentration, memory, executive functioning and self-regulation.

Several studies have determined the prevalence of cognitive impairment in COPD compared to healthy control subjects, reaching very high levels, 36% of COPD patients with mild cognitive impairment compared with 12 % non- COPD subjects.

Undersøgelsestype

Observationel

Tilmelding (Forventet)

60

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Spanien
      • Granada, Spanien, 18071
        • Rekruttering
        • Department of Physical Therapy

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

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Patients diagnosed of chronic obstructive pulmonary disease.

Beskrivelse

Inclusion Criteria:

  • Clinical diagnosis of chronic obstructive pulmonary disease with exacerbation or stable.
  • Signed written consent.
  • Medical approval for inclusion

Exclusion Criteria:

  • Heart disease.
  • Neurological patients.
  • Severe cognitive impairment in order not to complete the assessment.

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
Intervention / Behandling
Stable and exacerbated patients
Patients diagnosed of chronic obstructive pulmonary disease in a stable or exacerbated situation. Cognitive assessment of these patients will be performed.
Andet: Cognitive assessment
Patients are going to be assessed regarding the outcome measures
Andre navne:
  • observation
  • vurdering
  • evaluering

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Cognitive impairment
Tidsramme: Baseline
The cognitive impairment will be measured using the Montreal Cognitive Assessment. The Montreal Cognitive Assessment is a test designed as a rapid screening instrument for mild cognitive dysfunction. It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation.
Baseline

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Sleep quality
Tidsramme: Baseline
Participants are going to complete the Pittsburgh Quality of Sleep Index. This is a self-rating questionnaire with seven subscores that result in a global score between 0 and 21.
Baseline
Activity monitoring
Tidsramme: Baseline
The accelerometer Armband is going to be used for activity monitoring. It measures the intensity of the activity during 12 hours.
Baseline
Nutritional state
Tidsramme: Baseline
Mini Nutritional Assessment has been designed and validated to provide a single, rapid assessment of nutritional status in elderly patients in outpatient clinics, hospitals, and nursing homes. It is composed of simple measurements and brief questions that can be completed in about 10 min
Baseline
Quality of life
Tidsramme: Baseline
Quality of life associated with health is going to be measured with two questionnaires: the EuroQol-5 questionnaire and the Health Questionnaire St. George
Baseline
Cough
Tidsramme: Baseline
The Leicester Cough Questionnaire-acute is a validated cough-related health status questionnaire designed for patients with chronic cough.
Baseline
Comorbidities
Tidsramme: Baseline
Comorbidities are going to be measured with the Charlson comorbidity index. The Charlson comorbidity index predicts the ten-year mortality for a patient who may have a range of comorbid conditions, such as heart disease, AIDS, or cancer (a total of 22 conditions). Each condition is assigned a score of 1, 2, 3, or 6, depending on the risk of dying associated with each one.
Baseline
Anxiety and depression
Tidsramme: Baseline
Patients are going to completed the Hospital Anxiety and Depression Scale composed of statements relevant to either generalized anxiety or depression.
Baseline
Cognitive flexibility
Tidsramme: Baseline
The cognitive flexibility of patients is measured using the Trial Making Test. This test explores visual-conceptual and visual-motor tracking, and it is a frequently used neuropsychological test.
Baseline
Forced vital capacity
Tidsramme: Baseline
Forced vital capacity is going to be measured with a spirometer as recommended by the American Thoracic Society
Baseline
Forced expiratory volume in the first second
Tidsramme: Baseline
Forced expiratory volume in the first second is going to be measured with a spirometer as recommended by the American Thoracic Society
Baseline

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Universidad de Granada

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. april 2014

Primær færdiggørelse (Forventet)

1. august 2014

Studieafslutning (Forventet)

1. december 2014

Datoer for studieregistrering

Først indsendt

17. maj 2014

Først indsendt, der opfyldte QC-kriterier

17. maj 2014

Først opslået (Skøn)

21. maj 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

21. maj 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

17. maj 2014

Sidst verificeret

1. maj 2014

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • DF0051UG

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 .

Kliniske forsøg med Cognitive assessment

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Sponsorer og samarbejdspartnere

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Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner