COPD in the Time of COVID-19
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|ClinicalTrials.gov Identifier: NCT04407598|
Recruitment Status : Active, not recruiting
First Posted : May 29, 2020
Last Update Posted : November 3, 2020
|Condition or disease|
|COPD Exacerbation COPD|
This study will be a cross-sectional observational study utilising a telephone survey.
After obtaining informed verbal consent participants will be asked to recall their symptoms, exacerbation events and exacerbation medication usage over the periods of 01/03/20 - 14/03/20 (pre-lockdown) and then 15/03/20 to 30/04/20 (lockdown).
A structured survey will follow on from this asking questions regarding behaviour including self-isolation, shielding, other household contacts, visitors to the home, arrangements for shopping, changes in smoking behaviour (including that of other smokers in the household), medication changes, self-reported change in use of preventer medication, self-reported change in walking/activity levels and self-reported changes in anxiety levels.
Baseline clinical data will subsequently also be collected from the comprehensive respiratory review previously performed in the complex COPD clinic (comprising both hospital and GP records.) This will include previous AECOPD phenotyping (eosinophil levels, sputum culture and viral PCR), previous lung function testing, prescribed medication, BMI and smoking status and history. Previous AECOPD events will be counted and graded based on GP antibiotic or steroid prescriptions and hospital admissions.
Participants will be contacted once as part of the main study following verbal informed consent (via telephone). This will be a brief survey as described above, lasting approximately 20 minutes. A second similar survey will take place up to 12 months after the initial contact to evaluate longitudinal changes associated with the lockdown (further details on this will be submitted as an amendment at a later date due the shifting and unpredictable nature of the COVID-19 pandemic and lockdown, this will be prior to initiating these second calls).
Additional clinical data will be collected from healthcare records to quantify disease severity. Participant postcodes will be collected to link results with changes in local air pollution as recorded or estimated during the COVID-19 lockdown.
|Study Type :||Observational|
|Actual Enrollment :||160 participants|
|Official Title:||Cross-Sectional Observation Telephone Survey Study to Understand the Changes in COPD Exacerbation Patterns and Potential Causes of These During the COVID-19 Pandemic|
|Actual Study Start Date :||May 1, 2020|
|Actual Primary Completion Date :||June 8, 2020|
|Estimated Study Completion Date :||June 2021|
Glenfield Complex COPD Clinic Cohort
Patients previously seen in the complex COPD clinic at the Glenfield Hospital.
- Change in COPD Exacerbation Rate [ Time Frame: 46 days ]The primary outcome will be the change in number of moderate or severe AECOPD events over the 46 days from the 15th March, 2020 to 30th April, 2020 compared to the same 46 day period in 2019.
- Change in number of Severe AECOPD events during period of interest in 2020 from same period in 2019. [ Time Frame: 46 days ]
- Change in Moderate AECOPD events during period of interest in 2020 from same period in 2019. [ Time Frame: 46 days ]
- Social contact changes during i) pre-lockdown and ii) lockdown period [ Time Frame: 46 days ]
- Household contacts during i) pre-lockdown and ii) lockdown period [ Time Frame: 46 days ]
- Household visitors during i) pre-lockdown and ii) lockdown period [ Time Frame: 46 days ]
- Regular shopping behaviour during i) pre-lockdown and ii) lockdown period [ Time Frame: 46 days ]
- Medication changes during i) pre-lockdown and ii) lockdown period [ Time Frame: 46 days ]
- Reported change in regular medication usage during i) pre-lockdown and ii) lockdown period [ Time Frame: 46 days ]
- Change in physical activity levels during i) pre-lockdown and ii) lockdown period [ Time Frame: 46 days ]
- Change in anxiety levels during i) pre-lockdown and ii) lockdown period [ Time Frame: 46 days ]
- Perceived fear of hospitalisation during COVID-19 period [ Time Frame: 46 days ]
- Patient reported changes in perception of symptoms, need for hospitalisation and availability and safety of healthcare resources thought semi-structured interviews in 20 patients (nested qualitative study) [ Time Frame: 46 days ]
- Association between changes in AECOPD event rate and changes in local air pollution during the COVID-19 lockdown [ Time Frame: 46 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04407598
|NIHR Leicester Biomedical Research Centre (Respiratory), Glenfield Hospital|
|Leicester, United Kingdom, LE3 9QG|
|Principal Investigator:||Neil J Greening, PhD||University of Leicester|