Preventing Repeat Hospitalisations in Patients With Chronic Obstructive Pulmonary Disease (COPD) (INCA R-ACE)
17. Juli 2019 aktualisiert von: 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.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Detaillierte Beschreibung
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.
Studientyp
Beobachtungs
Einschreibung (Tatsächlich)
207
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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Dublin, Irland
- Beaumont Hospital
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
35 Jahre und älter (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Probenahmeverfahren
Nicht-Wahrscheinlichkeitsprobe
Studienpopulation
Patients admitted to hospital with an acute exacerbation of COPD
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
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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.
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Relationship between changes in IC and respiratory symptoms
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
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Relationship between change in FVC and quality of life scores
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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.
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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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Mitarbeiter
Ermittler
- Hauptermittler: Richard W Costello, Beaumont Hospital, Dublin, Ireland
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
1. Oktober 2015
Primärer Abschluss (Tatsächlich)
1. Juli 2017
Studienabschluss (Tatsächlich)
1. September 2018
Studienanmeldedaten
Zuerst eingereicht
10. Dezember 2015
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
30. Dezember 2015
Zuerst gepostet (Schätzen)
1. Januar 2016
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
18. Juli 2019
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
17. Juli 2019
Zuletzt verifiziert
1. Juli 2019
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- INCA-R-ACE
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