An observational study in Pulmonary Disease, Chronic Obstructive, COPD Exacerbation and Patient Readmission, sponsored by University College, London. Status unknown at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-07-18.
Sponsored by University College, London · Observational
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.
4,131 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 697 are open to participants now.
This study's planned enrollment of 166 is close to the median of 180 across 1,066 observational studies indexed under Pulmonary Disease, Chronic Obstructive.
Browse Pulmonary Disease, Chronic Obstructive studies →University College, London is the lead sponsor of 632 studies on the registry; 145 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.
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COPD patients admitted to the hospital because of COPD exacerbation.
Exclusion Criteria:
We 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.
The primary outcome is the factors that determine readmission to hospital within 30 and 90 days post discharge.
Time frame: 30 and 90 days
Readmission rate at 30 days and at 3 months
Time frame: 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
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
Change in the modified Medical Research Council scale (mMRC) at admission, discharge and after 30 days follow-up or at readmission.
It is used to scale breathlessness, ranges from 0 to 4 which higher values represent a worse outcome.
Time frame: 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.
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.
Time frame: 30 and 90 days
Change in Hospital Anxiety and Depression Scale (HADS) at admission, discharge and after 30 days follow-up or at readmission.
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.
Time frame: 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
Change in physical activity level (daily steps) following the discharge between patients who are and are not readmitted.
Step counter (pedometer) will be given to wear throughout the 30 days period to measure the daily steps.
Time frame: 30 days
Changes in admission-to-discharge peak inspiration flow rate (PIFR) between patients who are and are not readmitted.
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).
Time frame: 30 and 90 days
Change in white cell count (WCC) blood biomarkers
At admission, discharge and at readmission.
Time frame: 30 and 90 days
Change in C-reactive protein (CRP) blood biomarker
At admission, discharge and at readmission.
Time frame: 30 and 90 days
Change in Eosinophils blood biomarker
At admission, discharge and at readmission.
Time frame: 30 and 90 days
Change in Neutrophils blood biomarker
At admission, discharge and at readmission.
Time frame: 30 and 90 days
Change in troponin blood biomarker
At admission, discharge and at readmission.
Time frame: 30 and 90 days
Change in B-type Natriuretic Peptide (BNP) blood biomarker
At admission, discharge and at readmission.
Time frame: 30 and 90 days
Change in procalcitonin blood biomarker
At admission, discharge and at readmission.
Time frame: 30 and 90 days
Change in fibrinogen blood biomarker
At admission, discharge and at readmission.
Time frame: 30 and 90 days
Change in sputum biomarkers
This is used to assess bacteria species, load and resistance to antibiotics, and markers of inflammation such as IL-8.
Time frame: 30 and 90 days
Number of hospital admissions in the previous year.
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.
Time frame: 30 and 90 days
Number of exacerbations in the previous year.
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.
Time frame: 30 and 90 days
Use of long-term oxygen therapy (LTOT)
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.
Time frame: 30 and 90 days
Length of stay (LOS) in hospital
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.
Time frame: 30 and 90 days
Use of non-invasive ventilation (NIV)
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.
Time frame: 30 and 90 days
Previous admission to the ICU
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.
Time frame: 30 and 90 days
Plan to share: Undecided
No publications or documents are linked to this record.
This study is status unknown, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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Pulmonary Disease, Chronic Obstructive→
University College, London