Preventing Repeat Hospitalisations in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

— INCA R-ACE  

Official title:

Risk Factors for Re-exacerbation After a Chronic Obstructive Pulmonary Disease (COPD) Exacerbation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02644772
• Other study ID #: INCA-R-ACE
• Status: Completed
• Start date: October 2015
• Est. completion date: September 2018

Study information

• Verified date: July 2019
• Source: Beaumont Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 207
• Est. completion date: September 2018
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease (COPD)
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Locations

Country	Name	City	State
Ireland	Beaumont Hospital	Dublin

Sponsors (2)

Lead Sponsor	Collaborator
Beaumont Hospital	Royal College of Surgeons, Ireland

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		From admission to 90 days from hospitalisation with an exacerbation
Secondary	Relationship between changes in IC and respiratory symptoms	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
Secondary	Relationship between changes in Forced Expiratory Volume in 1 second (FEV1) and respiratory symptoms	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
Secondary	Relationship between changes in Forced Vital Capacity and respiratory symptoms	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
Secondary	Relationship between change in IC and quality of life scores	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
Secondary	Relationship between change in FEV1 and quality of life scores	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
Secondary	Relationship between change in FVC and quality of life scores	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
Secondary	Relationship between change in IC and gait speed	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
Secondary	Relationship between change in FEV1 and gait speed	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
Secondary	Relationship between change in FVC and gait speed	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
Secondary	Relationship between patient factors and subsequent 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
Secondary	Time to re-exacerbation		90 days from hospitalisation with an exacerbation
Secondary	Sensitivity of vital capacity measures taken with a bedside portable spirometer compared with those performed in the pulmonary function test laboratory	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
Secondary	Sensitivity of FEV1 measures taken with a bedside portable spirometer compared with those performed in the pulmonary function test laboratory	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
Secondary	Sensitivity of inspiratory capacity (IC) measured with a bedside portable spirometer and by the gold standard body plethysmography	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
Secondary	Change in vital capacity during an exacerbation and its relationship to re-exacerbation		At days 1-3 of admission, hospital discharge and 30 days from hospitalisation with an exacerbation
Secondary	Change in FEV1 during an exacerbation and its relationship to re-exacerbation		At days 1-3 of admission, hospital discharge and 30 days from hospitalisation with an exacerbation
Secondary	Relationship between Exacerbation factors and re-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
Secondary	Relationship between Social and Environmental factors and subsequent 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