Preventing Repeat Hospitalisations in Patients With Chronic Obstructive Pulmonary Disease (COPD) (INCA R-ACE)
17. juli 2019 opdateret af: Professor Richard Costello, Beaumont Hospital
Risk Factors for Re-exacerbation After a Chronic Obstructive Pulmonary Disease (COPD) Exacerbation
The purpose of this study is to determine whether the investigators can predict which patients are at risk of a re-exacerbation of COPD within 30 and 90 days using changes in lung capacity during the initial exacerbation.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
Patients admitted to hospital with an acute exacerbation of COPD will be approached to participate in the study.
The investigators will analyse changes in lung capacity (through measurement of spirometry and inspiratory capacity) and physical activity level over the first three days of admission, at discharge and at a day 30 follow-up visit. The investigators will record quality of life and symptom scores at these time points and again at a day 90 telephone visit. Data relating to the patients overall health status -disease severity, co-morbidity, cognition, psychological status, home environment and adherence to inhaled medication will be collected. The investigators will look for any relationship between these changes and a further exacerbations within 30 and 90 days.
The central hypothesis of this proposal is that the clinical course following an exacerbation of COPD may be monitored through measurement of inspiratory capacity(IC), a marker of lung hyperinflation. Resolution of an exacerbation is related to an increase in inspiratory capacity above a threshold level of improvement, after which the risk of re-exacerbation within the subsequent 30 and 90 days is low. The investigators will assess the accuracy of IC as a predictor of exacerbation and the feasibility of measuring IC during the early stages of a COPD exacerbation.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
207
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Dublin, Irland
- Beaumont Hospital
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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
35 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Patients admitted to hospital with an acute exacerbation of COPD
Beskrivelse
Inclusion Criteria:
- Within 72 hours of admission with an Acute Exacerbation of COPD (AE COPD) defined as "an acute change in a patient's baseline dyspnoea, cough and/or sputum beyond day-to-day variability sufficient to warrant a change in therapy" as per ATS/ERS consensus guidelines[ ] where "a change in therapy" includes the following: Prescription of antibiotics and / or systemic steroids
- Diagnosis of COPD based on GOLD criteria
- Able to give informed consent
- Willing to participate in the study
Exclusion Criteria:
- Admission reason other than AE COPD or breathlessness primarily caused by another pathology
- Already enrolled in the study
- Receiving palliative care
- Severe cognitive impairment or psychological disorder that results in inability to give informed consent or complete investigations required for the study
- Physical impairment resulting in inability to complete physiological tests
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
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The relationship between change in inspiratory capacity(IC), from admission with an exacerbation of COPD to hospital discharge, and the risk of 30-day and 90-day re-exacerbation is reduced.
Tidsramme: From admission to 90 days from hospitalisation with an exacerbation
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From admission to 90 days from hospitalisation with an exacerbation
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Relationship between changes in IC and respiratory symptoms
Tidsramme: From admission to 30 days from hospitalisation with an exacerbation
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Medical Research Council(MRC) and Borg breathlessness scores and IC will be measured at hospitalisation with an exacerbation of COPD and at 30 days post exacerbation and correlated.
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From admission to 30 days from hospitalisation with an exacerbation
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Relationship between changes in Forced Expiratory Volume in 1 second (FEV1) and respiratory symptoms
Tidsramme: From admission to 30 days from hospitalisation with an exacerbation
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Medical Research Council(MRC) and Borg breathlessness scores and FEV1 will be measured at hospitalisation with an exacerbation of COPD and at 30 days post exacerbation and correlated.
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From admission to 30 days from hospitalisation with an exacerbation
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Relationship between changes in Forced Vital Capacity and respiratory symptoms
Tidsramme: From admission to 30 days from hospitalisation with an exacerbation
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Medical Research Council(MRC) and Borg breathlessness scores and FVC will be measured at hospitalisation with an exacerbation of COPD and at 30 days post exacerbation and correlated.
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From admission to 30 days from hospitalisation with an exacerbation
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Relationship between change in IC and quality of life scores
Tidsramme: From admission to 30 days from hospitalisation with an exacerbation
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COPD Assessment Test (CAT) quality of life score and IC will be measured at hospitalisation with an exacerbation of COPD and at 30 days post exacerbation and correlated.
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From admission to 30 days from hospitalisation with an exacerbation
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Relationship between change in FEV1 and quality of life scores
Tidsramme: From admission to 30 days from hospitalisation with an exacerbation
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COPD Assessment Test (CAT) quality of life score and FEV1 will be measured at hospitalisation with an exacerbation of COPD and at 30 days post exacerbation and correlated.
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From admission to 30 days from hospitalisation with an exacerbation
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Relationship between change in FVC and quality of life scores
Tidsramme: From admission to 30 days from hospitalisation with an exacerbation
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COPD Assessment Test (CAT) quality of life score and FVC will be measured at hospitalisation with an exacerbation of COPD and at 30 days post exacerbation and correlated.
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From admission to 30 days from hospitalisation with an exacerbation
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Relationship between change in IC and gait speed
Tidsramme: From admission to 30 days from hospitalisation with an exacerbation
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4 metre gait speed test and IC will be measured at hospitalisation with an exacerbation of COPD and at 30 days post exacerbation and correlated.
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From admission to 30 days from hospitalisation with an exacerbation
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Relationship between change in FEV1 and gait speed
Tidsramme: From admission to 30 days from hospitalisation with an exacerbation
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4 metre gait speed test and FEV1 will be measured will be measured at hospitalisation with an exacerbation of COPD and at 30 days post exacerbation and correlated.
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From admission to 30 days from hospitalisation with an exacerbation
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Relationship between change in FVC and gait speed
Tidsramme: From admission to 30 days from hospitalisation with an exacerbation
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4 metre gait speed test and FVC will be measured at hospitalisation with an exacerbation of COPD and at 30 days post exacerbation and correlated.
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From admission to 30 days from hospitalisation with an exacerbation
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Relationship between patient factors and subsequent exacerbation
Tidsramme: 90 days from hospitalisation with an exacerbation
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The association between patient factors (to include baseline GOLD grade, Charlston co-morbidity index score, Katz index, Hospital Anxiety and Depression Scale (HADS) score, Montreal Cognitive Assessment (MOCA) score) and exacerbation in the entire cohort and in those who do and do not achieve a rise in IC compared to baseline values will be examined
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90 days from hospitalisation with an exacerbation
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Time to re-exacerbation
Tidsramme: 90 days from hospitalisation with an exacerbation
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90 days from hospitalisation with an exacerbation
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Sensitivity of vital capacity measures taken with a bedside portable spirometer compared with those performed in the pulmonary function test laboratory
Tidsramme: Day 3-7 of hospital admission
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Vital capacity will be measured at the bedside with a portable spirometer and using gold standard spirometry in a pulmonary function laboratory.
These two measurements will then be compared and correlated.
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Day 3-7 of hospital admission
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Sensitivity of FEV1 measures taken with a bedside portable spirometer compared with those performed in the pulmonary function test laboratory
Tidsramme: Day 3-7 of hospital admission
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FEV1 will be measured at the bedside with a portable spirometer and using gold standard spirometry in a pulmonary function laboratory.
These two measurements will then be compared and correlated.
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Day 3-7 of hospital admission
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Sensitivity of inspiratory capacity (IC) measured with a bedside portable spirometer and by the gold standard body plethysmography
Tidsramme: Day 3-7 of hospital admission
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IC will be measured at the bedside with a portable spirometer and by gold standard body plethysmography in a pulmonary function laboratory.
These two measurements will then be compared and correlated.
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Day 3-7 of hospital admission
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Change in vital capacity during an exacerbation and its relationship to re-exacerbation
Tidsramme: At days 1-3 of admission, hospital discharge and 30 days from hospitalisation with an exacerbation
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At days 1-3 of admission, hospital discharge and 30 days from hospitalisation with an exacerbation
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Change in FEV1 during an exacerbation and its relationship to re-exacerbation
Tidsramme: At days 1-3 of admission, hospital discharge and 30 days from hospitalisation with an exacerbation
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At days 1-3 of admission, hospital discharge and 30 days from hospitalisation with an exacerbation
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Relationship between Exacerbation factors and re-exacerbation
Tidsramme: 90 days from hospitalisation with an exacerbation
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The association between exacerbation severity as determined by DECAF score, need for non-invasive ventilation or critical care, length of hospital stay in the entire cohort and in those who do and do not achieve a rise in IC compared to baseline values will be examined
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90 days from hospitalisation with an exacerbation
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Relationship between Social and Environmental factors and subsequent exacerbation
Tidsramme: 90 days from hospitalisation with an exacerbation
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The impact of patients social environment as determined by living conditions, presence of home supports, socioeconomic group in the entire cohort and in those who do and do not achieve a rise in IC compared to baseline values will be examined
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90 days from hospitalisation with an exacerbation
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Richard W Costello, Beaumont Hospital, Dublin, Ireland
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 (Faktiske)
1. oktober 2015
Primær færdiggørelse (Faktiske)
1. juli 2017
Studieafslutning (Faktiske)
1. september 2018
Datoer for studieregistrering
Først indsendt
10. december 2015
Først indsendt, der opfyldte QC-kriterier
30. december 2015
Først opslået (Skøn)
1. januar 2016
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
18. juli 2019
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
17. juli 2019
Sidst verificeret
1. juli 2019
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- INCA-R-ACE
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