Mechanisms of COPD Exacerbation Recurrence

NCT04024735 | Unknown

• 1 other identifier: 21022
• Study Type: observational
• Target: 166
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Disease, Chronic Obstructive; COPD Exacerbation; Patient Readmission; Recurrence

Outcome Measures

Primary Outcomes (1)

• The primary outcome is the factors that determine readmission to hospital within 30 and 90 days post discharge.

  30 and 90 days

Secondary Outcomes (24)

• 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

Interventions

Spirometry, Forced Oscillation Technique, Step-counter, sputum and blood samples DIAGNOSTIC_TEST

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 Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

COPD patients admitted to the hospital because of COPD exacerbation.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University College, London: lead

Study Sites (1)

Royal Free Hospital NHS

London, NW3 2PF, United Kingdom

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Recurrence

Interventions

Spirometry; Blood Specimen Collection

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Clinical Laboratory Techniques; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2019
• First Posted: July 18, 2019
• Study Start: June 1, 2019
• Primary Completion: February 1, 2022
• Study Completion: May 1, 2022
• Last Updated: July 18, 2019

Record last verified: 2019-07

Locations

GB (1)