NCT04407598

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2020

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

May 27, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 29, 2020

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 8, 2020

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

November 3, 2020

Status Verified

May 1, 2020

Enrollment Period

1 month

First QC Date

May 27, 2020

Last Update Submit

November 2, 2020

Conditions

Keywords

COPDAECOPDCOVID-19

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (13)

  • Change in number of Severe AECOPD events during period of interest in 2020 from same period in 2019.

    46 days

  • Change in Moderate 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 contacts during i) pre-lockdown and ii) lockdown period

    46 days

  • Household visitors during i) pre-lockdown and ii) lockdown period

    46 days

  • +8 more secondary outcomes

Study Arms (1)

Glenfield Complex COPD Clinic Cohort

Patients previously seen in the complex COPD clinic at the Glenfield Hospital.

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients known to have COPD and previously seen in the Complex COPD Clinic at the Glenfield Hospital, Leicester.

You may qualify if:

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

You may not qualify if:

  • Patients currently admitted to hospital
  • Unwilling/unable to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NIHR Leicester Biomedical Research Centre (Respiratory), Glenfield Hospital

Leicester, LE3 9QG, United Kingdom

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveCOVID-19

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus Infections

Study Officials

  • Neil J Greening, PhD

    University of Leicester

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 27, 2020

First Posted

May 29, 2020

Study Start

May 1, 2020

Primary Completion

June 8, 2020

Study Completion

June 1, 2021

Last Updated

November 3, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations