COPD in the Time of COVID-19

COPD Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04407598
• Other study ID #: 0778
• Status: Active, not recruiting
• Start date: May 1, 2020
• Est. completion date: June 2021

Study information

• Verified date: May 2020
• Source: University of Leicester
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 160
• Est. completion date: June 2021
• Est. primary completion date: June 8, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COPD
• COPD Exacerbation
• Pulmonary Disease, Chronic Obstructive

Locations

Country	Name	City	State
United Kingdom	NIHR Leicester Biomedical Research Centre (Respiratory), Glenfield Hospital	Leicester

Sponsors (2)

Lead Sponsor	Collaborator
University of Leicester	University Hospitals, Leicester

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in COPD Exacerbation Rate	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.	46 days
Secondary	Change in number of Severe AECOPD events during period of interest in 2020 from same period in 2019.		46 days
Secondary	Change in Moderate AECOPD events during period of interest in 2020 from same period in 2019.		46 days
Secondary	Social contact changes during i) pre-lockdown and ii) lockdown period		46 days
Secondary	Household contacts during i) pre-lockdown and ii) lockdown period		46 days
Secondary	Household visitors during i) pre-lockdown and ii) lockdown period		46 days
Secondary	Regular shopping behaviour during i) pre-lockdown and ii) lockdown period		46 days
Secondary	Medication changes during i) pre-lockdown and ii) lockdown period		46 days
Secondary	Reported change in regular medication usage during i) pre-lockdown and ii) lockdown period		46 days
Secondary	Change in physical activity levels during i) pre-lockdown and ii) lockdown period		46 days
Secondary	Change in anxiety levels during i) pre-lockdown and ii) lockdown period		46 days
Secondary	Perceived fear of hospitalisation during COVID-19 period		46 days
Secondary	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
Secondary	Association between changes in AECOPD event rate and changes in local air pollution during the COVID-19 lockdown		46 days