Mechanisms of COPD Exacerbation Recurrence

Mechanisms of COPD Exacerbation Recurrence

Sponsors

Lead Sponsor: University College, London

Source University College, London
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.

Overall Status Recruiting
Start Date June 1, 2019
Completion Date May 1, 2022
Primary Completion Date February 1, 2022
Study Type Observational
Primary Outcome
Measure Time Frame
The primary outcome is the factors that determine readmission to hospital within 30 and 90 days post discharge. 30 and 90 days
Secondary Outcome
Measure Time Frame
Readmission rate at 30 days and at 3 months 30 and 90 days
Prevalence of comorbidities between those who are and are not readmitted within 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. 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. 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. 30 and 90 days
Change in Hospital Anxiety and Depression Scale (HADS) at admission, discharge and after 30 days follow-up or at readmission. 30 and 90 days
Prevalence of frailty between those who are and are not readmitted to the hospital within 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. 30 days
Changes in admission-to-discharge peak inspiration flow rate (PIFR) between patients who are and are not readmitted. 30 and 90 days
Change in white cell count (WCC) blood biomarkers 30 and 90 days
Change in C-reactive protein (CRP) blood biomarker 30 and 90 days
Change in Eosinophils blood biomarker 30 and 90 days
Change in Neutrophils blood biomarker 30 and 90 days
Change in troponin blood biomarker 30 and 90 days
Change in B-type Natriuretic Peptide (BNP) blood biomarker 30 and 90 days
Change in procalcitonin blood biomarker 30 and 90 days
Change in fibrinogen blood biomarker 30 and 90 days
Change in sputum biomarkers 30 and 90 days
Number of hospital admissions in the previous year. 30 and 90 days
Number of exacerbations in the previous year. 30 and 90 days
Use of long-term oxygen therapy (LTOT) 30 and 90 days
Length of stay (LOS) in hospital 30 and 90 days
Use of non-invasive ventilation (NIV) 30 and 90 days
Previous admission to the ICU 30 and 90 days
Enrollment 166
Condition
Intervention

Intervention Type: Diagnostic Test

Intervention Name: Spirometry, Forced Oscillation Technique, Step-counter, sputum and blood samples

Description: 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.

Eligibility

Sampling Method: Non-Probability Sample

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Location
Facility: Status: Contact: Royal Free Hospital NHS Jaber S Alqahtani, MSc +447846713703 [email protected]
Location Countries

United Kingdom

Verification Date

July 2019

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Patient Data Undecided
Study Design Info

Observational Model: Cohort

Time Perspective: Prospective

Source: ClinicalTrials.gov