Mechanisms of COPD Exacerbation Recurrence

July 16, 2019 updated by: University College, London

Chronic obstructive pulmonary disease (COPD) is a common smoking-related lung disease. Patients with COPD are at increased risk of readmission to hospitals within the following 30 days. Hospital readmissions of COPD contribute to clinical and economic burden on society. Understanding why some COPD patients are readmitted remains a key area of unmet need.

To our knowledge, no previous study has fully investigated both the social and clinical risk factors associated with these types of patients. The investigators want to prospectively and comprehensively explore the possible causes, whether clinical or social factors, that cause rehospitalisation. The investigators will be collecting demographic and clinical information including daily physical activity level, lung function, blood and sputum samples. These measurements will be collected at patient admission, discharge and at follow-up of 30 and 90 days. This process could lead to a better understanding of the reasons which prevent early hospital readmission for those patients.

Study Overview

Study Type

Observational

Enrollment (Anticipated)

166

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

COPD patients admitted to the hospital because of COPD exacerbation.

Description

Inclusion Criteria:

  • Patients who have a primary diagnosis of COPD
  • Patients admitted to hospital with an exacerbation.

Exclusion Criteria:

  • Patients in whom an initial diagnosis of an AECOPD is revised to an alternative at a later phase of the study.
  • Patients who have a predominant history of asthma
  • Patients with a confirmed active malignancy
  • Patients who have a predominant history of bronchiectasis.
  • Cognitive impairment patients with a Mental Test Score (MTS) of 6 or less.
  • Inability to give informed consent to take part in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The primary outcome is the factors that determine readmission to hospital within 30 and 90 days post discharge.
Time Frame: 30 and 90 days
30 and 90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Readmission rate at 30 days and at 3 months
Time Frame: 30 and 90 days
30 and 90 days
Prevalence of comorbidities between those who are and are not readmitted within 30 and 90 days.
Time Frame: 30 and 90 days
30 and 90 days
Changes in admission-to-discharge in within breath reactance (∆Xrs5Hz) between patients who are and are not readmitted to the hospital within 30 and 90 days.
Time Frame: 30 and 90 days
30 and 90 days
Change in the modified Medical Research Council scale (mMRC) at admission, discharge and after 30 days follow-up or at readmission.
Time Frame: 30 and 90 days
It is used to scale breathlessness, ranges from 0 to 4 which higher values represent a worse outcome.
30 and 90 days
Change in quality of life by measuring COPD assessment test (CAT) at admission, discharge and after 30 days follow-up or at readmission.
Time Frame: 30 and 90 days
It is used to scale patient's quality of life. Range of CAT scores from 0-40 which higher scores denote a more severe impact of COPD on a patient's life.
30 and 90 days
Change in Hospital Anxiety and Depression Scale (HADS) at admission, discharge and after 30 days follow-up or at readmission.
Time Frame: 30 and 90 days
It is used to scale patient's quality of life. The questionnaire comprises seven questions for anxiety and seven questions for depression. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression. The higher score indicates a worse outcome.
30 and 90 days
Prevalence of frailty between those who are and are not readmitted to the hospital within 30 and 90 days.
Time Frame: 30 and 90 days
30 and 90 days
Change in physical activity level (daily steps) following the discharge between patients who are and are not readmitted.
Time Frame: 30 days
Step counter (pedometer) will be given to wear throughout the 30 days period to measure the daily steps.
30 days
Changes in admission-to-discharge peak inspiration flow rate (PIFR) between patients who are and are not readmitted.
Time Frame: 30 and 90 days
The In-Check DIAL device will be used which is capable of measuring inspiratory flow rates between 0 and 120 L/min. Optimal PIFR, more than 60 L/min; and sub-optimal PIFR, 60 L/min or less).
30 and 90 days
Change in white cell count (WCC) blood biomarkers
Time Frame: 30 and 90 days
At admission, discharge and at readmission.
30 and 90 days
Change in C-reactive protein (CRP) blood biomarker
Time Frame: 30 and 90 days
At admission, discharge and at readmission.
30 and 90 days
Change in Eosinophils blood biomarker
Time Frame: 30 and 90 days
At admission, discharge and at readmission.
30 and 90 days
Change in Neutrophils blood biomarker
Time Frame: 30 and 90 days
At admission, discharge and at readmission.
30 and 90 days
Change in troponin blood biomarker
Time Frame: 30 and 90 days
At admission, discharge and at readmission.
30 and 90 days
Change in B-type Natriuretic Peptide (BNP) blood biomarker
Time Frame: 30 and 90 days
At admission, discharge and at readmission.
30 and 90 days
Change in procalcitonin blood biomarker
Time Frame: 30 and 90 days
At admission, discharge and at readmission.
30 and 90 days
Change in fibrinogen blood biomarker
Time Frame: 30 and 90 days
At admission, discharge and at readmission.
30 and 90 days
Change in sputum biomarkers
Time Frame: 30 and 90 days
This is used to assess bacteria species, load and resistance to antibiotics, and markers of inflammation such as IL-8.
30 and 90 days
Number of hospital admissions in the previous year.
Time Frame: 30 and 90 days
The investigators will record it to find the difference between patients who are and are not readmitted to the hospital within 30 and 90 days.
30 and 90 days
Number of exacerbations in the previous year.
Time Frame: 30 and 90 days
The investigators will record it to find the difference between patients who are and are not readmitted to the hospital within 30 and 90 days.
30 and 90 days
Use of long-term oxygen therapy (LTOT)
Time Frame: 30 and 90 days
The investigators will record it to find the difference between patients who are and are not readmitted to the hospital within 30 and 90 days.
30 and 90 days
Length of stay (LOS) in hospital
Time Frame: 30 and 90 days
The investigators will record it to find the difference between patients who are and are not readmitted to the hospital within 30 and 90 days.
30 and 90 days
Use of non-invasive ventilation (NIV)
Time Frame: 30 and 90 days
The investigators will record it to find the difference between patients who are and are not readmitted to the hospital within 30 and 90 days.
30 and 90 days
Previous admission to the ICU
Time Frame: 30 and 90 days
The investigators will record it to find the difference between patients who are and are not readmitted to the hospital within 30 and 90 days.
30 and 90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2019

Primary Completion (Anticipated)

February 1, 2022

Study Completion (Anticipated)

May 1, 2022

Study Registration Dates

First Submitted

April 4, 2019

First Submitted That Met QC Criteria

July 16, 2019

First Posted (Actual)

July 18, 2019

Study Record Updates

Last Update Posted (Actual)

July 18, 2019

Last Update Submitted That Met QC Criteria

July 16, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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