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

NCT ID: NCT02644772

Last Updated: 2019-07-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 207 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2018-09-30

Brief 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.

Detailed 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.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Royal College of Surgeons, Ireland

OTHER

Sponsor Role: collaborator

Beaumont Hospital

OTHER

Sponsor Role: lead

Responsible Party

Professor Richard Costello

Professor Richard W Costello

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Richard W Costello

Role: PRINCIPAL_INVESTIGATOR

Beaumont Hospital, Dublin, Ireland

Locations

Beaumont Hospital

Dublin, , Ireland

Countries

Ireland

Other Identifiers

INCA-R-ACE

Identifier Type: -

Identifier Source: org_study_id