Pandemic tracking of healthcare workers cohort and questionnaire study

ISRCTN	ISRCTN15677965
DOI	https://doi.org/10.1186/ISRCTN15677965
IRAS number	285436
Secondary identifying numbers	CPMS 47035, IRAS 285436

Submission date: 19/01/2021
Registration date: 14/04/2021
Last edited: 15/02/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
The WHO characterised COVID-19 as a pandemic after 118,000 cases and 4,291 deaths. Cases have continued to rise and now 400,000 deaths have been reported. National guidance has recommended physical distancing to reduce transmission of the virus, although healthcare workers are expected to continue with normal patterns of working in order to care for those with the virus. There is early evidence that there is up to a 12-fold increased risk of SARS-CoV-2 infection in healthcare workers, and there have been 245 reported fatalities in UK healthcare workers.

In an environment where there is increased exposure, it is important to understand the occupational, personal, medical and genetics factors which predispose healthcare workers to contracting the virus and make individuals at risk of poor outcomes. There have been a number of epidemiological and serological studies which have identified risk factors such as age, gender and certain pre-existing conditions, but there is less evidence looking evidence in the healthcare worker population.

We set up a study under the Human Tissue Authority licence at the Nottingham Tissue Bank (PANTHER Tissue study) to allow healthcare workers (and their household contacts) to donate samples for testing for research purposes. As of June 2020, 640 participants have consented to donate tissue and over 3000 samples have been collected. This tissue will be subjected to antibody testing, and genetic sequencing to help understand the prevalence of COVID-19 in the healthcare worker population and genetic factors which influence COVID-19.

We would now like to contact participants to invite them to take part in a linked questionnaire study to enrich the human tissue authority study date by providing details about whether they experienced COVID-19 symptoms, their general health and wellbeing (including comorbidities), health related quality of life, and personal and occupational exposure along with questions related to their home circumstances.

Who can participate?
Healthcare workers and their household contacts who have donated blood to the Nottingham Tissue Bank for use in COVID research

What does the study involve?
Participants will complete sets of questionnaires at baseline and 12 weeks later.

What are the possible benefits and risks of participating?
None

Where is the study run from?
1. University of Nottingham (UK)
2. Nottingham University Hospitals (UK)

When is the study starting and how long is it expected to run for?
April 2020 to November 2021

Who is funding the study?
1. The Medical Research Council (UK)
2. UK Research and Innovation
3. Nottingham Biomedical Research Centre (UK)

Who is the main contact?
1. Jessica Nightingale, jessica.nightingale@nuh.nhs.uk.
2. Professor Ana Valdes, ana.valdes@nottingham.ac.uk
3. Professor Ben Ollivere, benjamin.ollivere@nottingham.ac.uk

Study website

Contact information

Miss Jess Nightingale
Scientific

Research Manager
Trauma and Orthopaedics
Nottingham University Hospitals
T&O Audit Office, C-West (1285), QMC
Nottingham
NG7 2UH
United Kingdom

Phone	+44 (0)115 924 9924 (ext. 67502)
Email	jessica.nightingale@nuh.nhs.uk

Study information

Study design	Observational cohort study
Primary study design	Observational
Secondary study design	Cohort study
Study setting(s)	Internet/virtual
Study type	Other
Participant information sheet	https://pantherstudy.org.uk/participant-information/
Scientific title	PANdemic Tracking of HEalthcare woRkers Cohort and Questionnaire study
Study acronym	PANTHER Cohort
Study objectives	Healthcare workers are more likely to develop COVID than non-healthcare workers. It is anticipated that certain characteristics (age, gender, ethnicity, occupational exposure) confer an increased risk of infection, and severe disease.
Ethics approval(s)	Approved 27/10/2020 North West - Greater Manchester South Research Ethics Committee (Barlow House, 3rd Floor, 4 Minshull Street, Manchester, M1 3DZ, UK; +44 (0)207 104 8063; gmsouth.rec@hra.nhs.uk), ref: 20/NW/0395
Health condition(s) or problem(s) studied	COVID-19 (SARS-CoV-2 infection)
Intervention	We set up a study under the Human Tissue Authority licence at the Nottingham Tissue Bank (Licence holder: Nottingham University Hospitals Trust, Licenced Tissue Bank (no. 11035)) to allow healthcare workers (and their household contacts) to donate blood samples for COVID research. We would now like to contact participants to invite them to take part in a linked questionnaire study to enrich the data collected under the human tissue authority licence by providing details about whether they experienced COVID symptoms, their general health and wellbeing (including comorbidities), health related quality of life, and personal and occupational exposure. Participants will be asked to complete two questionnaires to provide health and wellbeing information. The first questionnaire will ask about their health and behaviour prior to lockdown and their health and behaviour during lockdown to the point of the first questionnaire. The second questionnaire will be sent at 12 weeks after recruitment and will ask participants to reflect on their health and behaviours in the previous 12 weeks. The questionnaire will ask the individual to provide details of their general health and wellbeing (including PHQ-9 and comorbidities), health related quality of life (EQ-5D-5L), and personal and occupational exposure (These questionnaires and questions are included in the questionnaire attached to the checklist). It will also ask individuals whether they have experienced COVID symptoms, had a positive COVID test or episodes of self-isolation. Participants will initially be sent the questionnaire by post. The postal communication will include a covering letter, participant information sheet, CRF and SAE. Individuals who fail to respond on the 1st attempt will be sent a reminder letter and second copy of the questionnaire.
Intervention type	Other
Primary outcome measure	Health-related quality of life (EQ-5D) at baseline and 12 weeks
Secondary outcome measures	1. Development of COVID symptoms and antibodies during COVID pandemic, based on self-reporting and blood serology. This was measured during the first national lockdown, at the end of the first national lockdown, and in April 2021 2. Mood assessment measured using PHQ9 during the first national lockdown, at the end of the first national lockdown, and in April 2021
Overall study start date	01/04/2020
Completion date	01/11/2021

Eligibility

Participant type(s)	Mixed
Age group	Adult
Sex	Both
Target number of participants	Planned Sample Size: 500; UK Sample Size: 500
Key inclusion criteria	1. Healthcare workers and their household contacts who have donated blood to the Nottingham Tissue Bank for use in COVID research 2. Capacity to consent 3. Speak English 4. Minimum age 16 years, no upper age limit
Key exclusion criteria	Declined to be contacted for future research
Date of first enrolment	01/12/2020
Date of final enrolment	01/08/2021

Locations

Countries of recruitment

England
United Kingdom

Study participating centres

Queen's Medical Centre

Nottingham University Hospitals NHS Trust
Derby Road
Nottingham
NG7 2UH
United Kingdom

Nottingham University Hospital

The Queen's Medical Centre Campus
Derby Road
Nottingham
NG7 2UH
United Kingdom

Sponsor information

University of Nottingham
University/education

Room East Atrium Jubilee Conference centre
Jubilee Campus
Nottingham
NG8 1DH
England
United Kingdom

Phone	+44(0)115 8467906
Email	sponsor@nottingham.ac.uk
Website	http://www.nottingham.ac.uk/
"ROR"	https://ror.org/01ee9ar58

Funders

Funder type

Government

UK Research and Innovation; Grant Codes: MR/V027883/1
Government organisation / National government

Alternative name(s): UKRI
Location: United Kingdom

Medical Research Council
Government organisation / National government

Alternative name(s): Medical Research Council (United Kingdom), UK Medical Research Council, MRC
Location: United Kingdom

Nottingham Biomedical Research Centre

No information available

Results and Publications

Intention to publish date	01/11/2022
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Stored in repository
Publication and dissemination plan	Planned publication in a high-impact peer-reviewed journal.
IPD sharing plan	The datasets generated during and/or analysed during the current study will be stored in a publically available repository.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		14/02/2022	15/02/2022	Yes	No
HRA research summary			28/06/2023	No	No

Editorial Notes

15/02/2022: Publication reference added.
19/01/2021: Trial’s existence confirmed by National Institute for Health Research (NIHR)