Clinical trial NCT04024735: Mechanisms of COPD Exacerbation Recurrence
Official title: Mechanisms of COPD Exacerbation Recurrence
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pulmonary Disease, Chronic Obstructive
COPD Exacerbation
Patient Readmission
Recurrence
Lead sponsor: University College, London
Sponsor class: OTHER
First posted: 2019-07-18
Enrollment: 166
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: COPD patients admitted to the hospital because of COPD exacerbation.

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: The primary outcome is the factors that determine readmission to hospital within 30 and 90 days post discharge.
timeFrame: 30 and 90 days
Secondary outcomes:
measure: Readmission rate at 30 days and at 3 months
timeFrame: 30 and 90 days
measure: Prevalence of comorbidities between those who are and are not readmitted within 30 and 90 days.
timeFrame: 30 and 90 days
measure: 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.
timeFrame: 30 and 90 days
measure: Change in the modified Medical Research Council scale (mMRC) at admission, discharge and after 30 days follow-up or at readmission.
timeFrame: 30 and 90 days
measure: Change in quality of life by measuring COPD assessment test (CAT) at admission, discharge and after 30 days follow-up or at readmission.
timeFrame: 30 and 90 days
measure: Change in Hospital Anxiety and Depression Scale (HADS) at admission, discharge and after 30 days follow-up or at readmission.
timeFrame: 30 and 90 days
measure: Prevalence of frailty between those who are and are not readmitted to the hospital within 30 and 90 days.
timeFrame: 30 and 90 days
measure: Change in physical activity level (daily steps) following the discharge between patients who are and are not readmitted.
timeFrame: 30 days
measure: Changes in admission-to-discharge peak inspiration flow rate (PIFR) between patients who are and are not readmitted.
timeFrame: 30 and 90 days
measure: Change in white cell count (WCC) blood biomarkers
timeFrame: 30 and 90 days
measure: Change in C-reactive protein (CRP) blood biomarker
timeFrame: 30 and 90 days
measure: Change in Eosinophils blood biomarker
timeFrame: 30 and 90 days
measure: Change in Neutrophils blood biomarker
timeFrame: 30 and 90 days
measure: Change in troponin blood biomarker
timeFrame: 30 and 90 days
measure: Change in B-type Natriuretic Peptide (BNP) blood biomarker
timeFrame: 30 and 90 days
measure: Change in procalcitonin blood biomarker
timeFrame: 30 and 90 days
measure: Change in fibrinogen blood biomarker
timeFrame: 30 and 90 days
measure: Change in sputum biomarkers
timeFrame: 30 and 90 days
measure: Number of hospital admissions in the previous year.
timeFrame: 30 and 90 days
measure: Number of exacerbations in the previous year.
timeFrame: 30 and 90 days
measure: Use of long-term oxygen therapy (LTOT)
timeFrame: 30 and 90 days
measure: Length of stay (LOS) in hospital
timeFrame: 30 and 90 days
measure: Use of non-invasive ventilation (NIV)
timeFrame: 30 and 90 days
measure: Previous admission to the ICU
timeFrame: 30 and 90 days
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Royal Free Hospital NHS
Study officials:
References: