Clinical trial NCT04407598: COPD in the Time of COVID-19
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COPD Exacerbation
COPD
Keywords: COPD
AECOPD
COVID-19
Lead sponsor: University of Leicester
Sponsor class: OTHER
Collaborators: name: University Hospitals, Leicester
First posted: 2020-05-29
Enrollment: 160
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients known to have COPD and previously seen in the Complex COPD Clinic at the Glenfield Hospital, Leicester.

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).

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.

Eligibility criteria: Inclusion Criteria:

1. Confirmed clinical diagnosis of COPD
2. Ability to provide informed verbal consent via English language telephone consultation
3. Adults aged over 40 years

Exclusion Criteria:

1. Patients currently admitted to hospital
2. Unwilling/unable to provide informed consent

Primary outcomes:
measure: Change in COPD Exacerbation Rate
timeFrame: 46 days
Secondary outcomes:
measure: Change in number of Severe AECOPD events during period of interest in 2020 from same period in 2019.
timeFrame: 46 days
measure: Change in Moderate AECOPD events during period of interest in 2020 from same period in 2019.
timeFrame: 46 days
measure: Social contact changes during i) pre-lockdown and ii) lockdown period
timeFrame: 46 days
measure: Household contacts during i) pre-lockdown and ii) lockdown period
timeFrame: 46 days
measure: Household visitors during i) pre-lockdown and ii) lockdown period
timeFrame: 46 days
measure: Regular shopping behaviour during i) pre-lockdown and ii) lockdown period
timeFrame: 46 days
measure: Medication changes during i) pre-lockdown and ii) lockdown period
timeFrame: 46 days
measure: Reported change in regular medication usage during i) pre-lockdown and ii) lockdown period
timeFrame: 46 days
measure: Change in physical activity levels during i) pre-lockdown and ii) lockdown period
timeFrame: 46 days
measure: Change in anxiety levels during i) pre-lockdown and ii) lockdown period
timeFrame: 46 days
measure: Perceived fear of hospitalisation during COVID-19 period
timeFrame: 46 days
measure: 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)
timeFrame: 46 days
measure: Association between changes in AECOPD event rate and changes in local air pollution during the COVID-19 lockdown
timeFrame: 46 days
Other outcomes:
Locations:
city: Leicester
country: United Kingdom
facility: NIHR Leicester Biomedical Research Centre (Respiratory), Glenfield Hospital
Study officials:
affiliation: University of Leicester
name: Neil J Greening, PhD
role: PRINCIPAL_INVESTIGATOR
References: