Preventing Repeat Hospitalisations in Patients With Chronic Obstructive Pulmonary Disease (COPD) (INCA R-ACE)
17. července 2019 aktualizováno: 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.
Přehled studie
Postavení
Dokončeno
Detailní popis
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.
Typ studie
Pozorovací
Zápis (Aktuální)
207
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
-
-
-
Dublin, Irsko
- Beaumont Hospital
-
-
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
35 let a starší (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Metoda odběru vzorků
Vzorek nepravděpodobnosti
Studijní populace
Patients admitted to hospital with an acute exacerbation of COPD
Popis
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
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Časové okno |
|---|---|
|
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.
Časové okno: From admission to 90 days from hospitalisation with an exacerbation
|
From admission to 90 days from hospitalisation with an exacerbation
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Relationship between changes in IC and respiratory symptoms
Časové okno: From admission to 30 days from hospitalisation with an exacerbation
|
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.
|
From admission to 30 days from hospitalisation with an exacerbation
|
|
Relationship between changes in Forced Expiratory Volume in 1 second (FEV1) and respiratory symptoms
Časové okno: From admission to 30 days from hospitalisation with an exacerbation
|
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.
|
From admission to 30 days from hospitalisation with an exacerbation
|
|
Relationship between changes in Forced Vital Capacity and respiratory symptoms
Časové okno: From admission to 30 days from hospitalisation with an exacerbation
|
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.
|
From admission to 30 days from hospitalisation with an exacerbation
|
|
Relationship between change in IC and quality of life scores
Časové okno: From admission to 30 days from hospitalisation with an exacerbation
|
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.
|
From admission to 30 days from hospitalisation with an exacerbation
|
|
Relationship between change in FEV1 and quality of life scores
Časové okno: From admission to 30 days from hospitalisation with an exacerbation
|
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.
|
From admission to 30 days from hospitalisation with an exacerbation
|
|
Relationship between change in FVC and quality of life scores
Časové okno: From admission to 30 days from hospitalisation with an exacerbation
|
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.
|
From admission to 30 days from hospitalisation with an exacerbation
|
|
Relationship between change in IC and gait speed
Časové okno: From admission to 30 days from hospitalisation with an exacerbation
|
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.
|
From admission to 30 days from hospitalisation with an exacerbation
|
|
Relationship between change in FEV1 and gait speed
Časové okno: From admission to 30 days from hospitalisation with an exacerbation
|
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.
|
From admission to 30 days from hospitalisation with an exacerbation
|
|
Relationship between change in FVC and gait speed
Časové okno: From admission to 30 days from hospitalisation with an exacerbation
|
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.
|
From admission to 30 days from hospitalisation with an exacerbation
|
|
Relationship between patient factors and subsequent exacerbation
Časové okno: 90 days from hospitalisation with an exacerbation
|
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
|
90 days from hospitalisation with an exacerbation
|
|
Time to re-exacerbation
Časové okno: 90 days from hospitalisation with an exacerbation
|
90 days from hospitalisation with an exacerbation
|
|
|
Sensitivity of vital capacity measures taken with a bedside portable spirometer compared with those performed in the pulmonary function test laboratory
Časové okno: Day 3-7 of hospital admission
|
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.
|
Day 3-7 of hospital admission
|
|
Sensitivity of FEV1 measures taken with a bedside portable spirometer compared with those performed in the pulmonary function test laboratory
Časové okno: Day 3-7 of hospital admission
|
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.
|
Day 3-7 of hospital admission
|
|
Sensitivity of inspiratory capacity (IC) measured with a bedside portable spirometer and by the gold standard body plethysmography
Časové okno: Day 3-7 of hospital admission
|
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.
|
Day 3-7 of hospital admission
|
|
Change in vital capacity during an exacerbation and its relationship to re-exacerbation
Časové okno: At days 1-3 of admission, hospital discharge and 30 days from hospitalisation with an exacerbation
|
At days 1-3 of admission, hospital discharge and 30 days from hospitalisation with an exacerbation
|
|
|
Change in FEV1 during an exacerbation and its relationship to re-exacerbation
Časové okno: At days 1-3 of admission, hospital discharge and 30 days from hospitalisation with an exacerbation
|
At days 1-3 of admission, hospital discharge and 30 days from hospitalisation with an exacerbation
|
|
|
Relationship between Exacerbation factors and re-exacerbation
Časové okno: 90 days from hospitalisation with an exacerbation
|
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
|
90 days from hospitalisation with an exacerbation
|
|
Relationship between Social and Environmental factors and subsequent exacerbation
Časové okno: 90 days from hospitalisation with an exacerbation
|
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
|
90 days from hospitalisation with an exacerbation
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Richard W Costello, Beaumont Hospital, Dublin, Ireland
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
1. října 2015
Primární dokončení (Aktuální)
1. července 2017
Dokončení studie (Aktuální)
1. září 2018
Termíny zápisu do studia
První předloženo
10. prosince 2015
První předloženo, které splnilo kritéria kontroly kvality
30. prosince 2015
První zveřejněno (Odhad)
1. ledna 2016
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
18. července 2019
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
17. července 2019
Naposledy ověřeno
1. července 2019
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- INCA-R-ACE
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .