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Preventing Repeat Hospitalisations in Patients With Chronic Obstructive Pulmonary Disease (COPD) (INCA R-ACE)

17 juli 2019 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Gedetailleerde beschrijving

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.

Studietype

Observationeel

Inschrijving (Werkelijk)

207

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Ierland
      • Dublin, Ierland
        • Beaumont Hospital

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

35 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

Patients admitted to hospital with an acute exacerbation of COPD

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
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.
Tijdsspanne: From admission to 90 days from hospitalisation with an exacerbation
From admission to 90 days from hospitalisation with an exacerbation

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Relationship between changes in IC and respiratory symptoms
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Beaumont Hospital

Medewerkers

Royal College of Surgeons, Ireland

Onderzoekers

  • Hoofdonderzoeker: Richard W Costello, Beaumont Hospital, Dublin, Ireland

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 oktober 2015

Primaire voltooiing (Werkelijk)

1 juli 2017

Studie voltooiing (Werkelijk)

1 september 2018

Studieregistratiedata

Eerst ingediend

10 december 2015

Eerst ingediend dat voldeed aan de QC-criteria

30 december 2015

Eerst geplaatst (Schatting)

1 januari 2016

Updates van studierecords

Laatste update geplaatst (Werkelijk)

18 juli 2019

Laatste update ingediend die voldeed aan QC-criteria

17 juli 2019

Laatst geverifieerd

1 juli 2019

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • INCA-R-ACE

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