Cross-Sectional Observation Telephone Survey Study to Understand the Changes in COPD Exacerbation Patterns and Potential Causes of These During the COVID-19 Pandemic
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- University of Leicester
- Enrollment
- 160
- Locations
- 1
- Primary Endpoint
- Change in COPD Exacerbation Rate
Study Overview
Brief Summary
This cross-sectional observational study will collect information about changes in exacerbation frequency and behaviour amongst a clinical cohort of severe or complex COPD clinic patients. This will be done through a combination of telephone survey and access to electronic heath records.
Detailed Description
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).
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 40 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Confirmed clinical diagnosis of COPD
- •Ability to provide informed verbal consent via English language telephone consultation
- •Adults aged over 40 years
Exclusion Criteria
- •Patients currently admitted to hospital
- •Unwilling/unable to provide informed consent
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- 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)(46 days)
- Change in number of Severe AECOPD events during period of interest in 2020 from same period in 2019.(46 days)
- Social contact changes during i) pre-lockdown and ii) lockdown period(46 days)
- Household visitors during i) pre-lockdown and ii) lockdown period(46 days)
- Regular shopping behaviour during i) pre-lockdown and ii) lockdown period(46 days)
- Medication changes during i) pre-lockdown and ii) lockdown period(46 days)
- Change in physical activity levels during i) pre-lockdown and ii) lockdown period(46 days)
- Change in anxiety levels during i) pre-lockdown and ii) lockdown period(46 days)
- Perceived fear of hospitalisation during COVID-19 period(46 days)
- Change in Moderate AECOPD events during period of interest in 2020 from same period in 2019.(46 days)
- Household contacts during i) pre-lockdown and ii) lockdown period(46 days)
- Reported change in regular medication usage during i) pre-lockdown and ii) lockdown period(46 days)
- Association between changes in AECOPD event rate and changes in local air pollution during the COVID-19 lockdown(46 days)