COPD in the Time of COVID-19

• ClinicalTrials.gov Identifier: NCT04407598
• Recruitment Status: Active, not recruiting
• First Posted: May 29, 2020
• Last Update Posted: November 3, 2020
• Sponsor: University of Leicester
• Collaborator: University Hospitals, Leicester
• Information provided by (Responsible Party): University of Leicester

Study Description

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.

Condition or disease
COPD Exacerbation; COPD

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 160 participants
• Observational Model: Cohort
• Time Perspective: Cross-Sectional
• 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

Groups and Cohorts

Group/Cohort
Glenfield Complex COPD Clinic Cohort; Patients previously seen in the complex COPD clinic at the Glenfield Hospital.

Outcome Measures

Primary Outcome Measures :

1. 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 Outcome Measures :

1. Change in number of Severe AECOPD events during period of interest in 2020 from same period in 2019. [ Time Frame: 46 days ]
2. Change in Moderate AECOPD events during period of interest in 2020 from same period in 2019. [ Time Frame: 46 days ]
3. Social contact changes during i) pre-lockdown and ii) lockdown period [ Time Frame: 46 days ]
4. Household contacts during i) pre-lockdown and ii) lockdown period [ Time Frame: 46 days ]
5. Household visitors during i) pre-lockdown and ii) lockdown period [ Time Frame: 46 days ]
6. Regular shopping behaviour during i) pre-lockdown and ii) lockdown period [ Time Frame: 46 days ]
7. Medication changes during i) pre-lockdown and ii) lockdown period [ Time Frame: 46 days ]
8. Reported change in regular medication usage during i) pre-lockdown and ii) lockdown period [ Time Frame: 46 days ]
9. Change in physical activity levels during i) pre-lockdown and ii) lockdown period [ Time Frame: 46 days ]
10. Change in anxiety levels during i) pre-lockdown and ii) lockdown period [ Time Frame: 46 days ]
11. Perceived fear of hospitalisation during COVID-19 period [ Time Frame: 46 days ]
12. 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 ]
13. Association between changes in AECOPD event rate and changes in local air pollution during the COVID-19 lockdown [ Time Frame: 46 days ]

Eligibility Criteria

• Ages Eligible for Study: 40 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• 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.

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

Contacts and Locations

Locations

United Kingdom

NIHR Leicester Biomedical Research Centre (Respiratory), Glenfield Hospital

Leicester, United Kingdom, LE3 9QG

Sponsors and Collaborators

University of Leicester

University Hospitals, Leicester

Investigators

• Principal Investigator: Neil J Greening, PhD; University of Leicester

More Information

• Responsible Party: University of Leicester
• ClinicalTrials.gov Identifier: NCT04407598
• Other Study ID Numbers: 0778
• First Posted: May 29, 2020
• Last Update Posted: November 3, 2020
• Last Verified: May 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Leicester:

COPD; AECOPD; COVID-19

Additional relevant MeSH terms:

Pulmonary Disease, Chronic Obstructive; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases