Condition category
Mental and Behavioural Disorders
Date applied
11/09/2020
Date assigned
30/09/2020
Last edited
30/09/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
COVID-19 is a condition caused by the coronavirus (called SARS-CoV-2) that was first identified in late 2019. This virus can infect the respiratory (breathing) system. Some people do not have symptoms but can carry the virus and pass it on to others. People who have developed the condition may develop a fever and/or a continuous cough among other symptoms. This can develop into pneumonia. Pneumonia is a chest infection where the small air pockets of the lungs, called alveoli, fill with liquid and make it more difficult to breathe.
In 2020, the virus has spread to many countries around the world and neither a vaccine against the virus or specific treatment for COVID-19 has yet been developed. As of April 2020, it is advised that people minimize travel and social contact, and regularly wash their hands to reduce the spread of the virus.
Groups who are at a higher risk from infection with the virus, and therefore of developing COVID-19, include people aged over 70 years, people who have long-term health conditions (such as asthma or diabetes), people who have a weakened immune system and people who are pregnant. People in these groups, and people who might come into contact with them, can reduce this risk by following the up-to-date advice to reduce the spread of the virus.
This study will investigate the impact of the COVID-19 pandemic on the psychological health and wellbeing of NHS staff in England.

Who can participate?
All staff working at or with a participating NHS Trust

What does the study involve?
A combination of online questionnaires and, with a smaller group of participants, more detailed telephone interviews. Participants will complete questionnaires about their health, distress, and work environment at the start of the study and 4 and 8 months later. The follow-up over time is to see whether the participants' mental health improves or worsens and to identify which groups of staff may need tailored support. The questionnaire has been produced alongside healthcare staff in local NHS Trusts. The researchers have formed a study steering panel consisting of representatives whose support they have already gained (e.g., unions, employers, and different staff groups). They will feedback emerging results to participating Trusts, networks, their partners, and NHS England, from which they have full encouragement, to help them prepare for future psychological health and workforce planning needs.

What are the possible benefits and risks of participating?
Although there are no immediate individual benefits of taking part, participants will have the unique opportunity to contribute to some innovative and valuable research which may later be used across the world. Individuals may also find it helpful to reflect on the current situation and anonymously express their feelings concerning a stressful and unprecedented global event. The results will feed directly into supporting the NHS workforce during the pandemic. It is hoped that this research will help bring about improvements in policies and practices for NHS colleagues now and in the future. The researchers do not foresee any risks occurring from participation but if the questions lead to any distress they direct all participants who would like emotional support or find completing the survey causes distress to reach out to someone they trust. They also provide suggestions of outside support which can be accessed.

Where is the study run from?
This study is a collaborative effort led by a research team at King’s College London and King’s Health Partners supported by expert clinicians, frontline staff and researchers across different NHS Trusts and Universities, and the NIHR Maudsley Biomedical Research Centre (UK)

When is the study starting and how long is it expected to run for?
April 2020 to April 2022

Who is funding the study?
1. King's College London (KCL) (UK)
2. NIHR Biomedical Research Centre at the Maudsley (UK)
3. Rosetrees Trust (UK)
4. University College London (UCL) (UK)
5. Medical Research Council (MRC) (UK)

Who is the main contact?
Rupa Bhundia
NHSCHECK@kcl.ac.uk

Trial website

https://www.nhscheck.org/

Contact information

Type

Scientific

Primary contact

Prof Simon Wessely

ORCID ID

https://orcid.org/0000-0002-6743-9929

Contact details

King's College London
London
SE5 9AF
United Kingdom
-
NHSCHECK@kcl.ac.uk

Type

Public

Additional contact

Miss Rupa Bhundia

ORCID ID

Contact details

King's College London
London
SE5 9AF
United Kingdom
-
NHSCHECK@kcl.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

IRAS 282686, CPMS 46176

Study information

Scientific title

NHS CHECK: The psychosocial impact of the COVID-19 pandemic on NHS affiliated staff – monitoring the response to the pandemic and the evaluation of local and national staff support programmes

Acronym

NHS CHECK

Study hypothesis

To establish a cohort of NHS-affiliated staff to investigate the short, medium- and longer-term psychosocial impact of the COVID-19 pandemic on staff performance and wellbeing.

Ethics approval

REC review not required as this study involves NHS staff
Approved 24/04/2020, Health Research Authority (HRA) (address and tel not provided; approvals@hra.nhs.uk), ref: 20/HRA/2107

Study design

Multicentre cohort study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Other

Patient information sheet

https://www.nhscheck.org/CHECK_participant_information_sheet.pdf

Condition

The psychosocial impact of the COVID-19 pandemic on NHS affiliated staff – monitoring response to the pandemic and the evaluation of local and national staff support programmes

Intervention

Baseline online survey launched in April 2020 followed by repeated surveys at month 4, 8 and 12. The 4-month survey includes an evaluation of staff support programmes. A subset of participants will also be invited to participate in psychiatric diagnostic interviews between month 4 and month 8.

Intervention type

Other

Phase

Drug names

Primary outcome measure

General (non-psychotic) psychiatric morbidity, resilience, anxiety, depression, wellbeing, moral injury and burnout measured using online survey at baseline, month 4 and 12

Secondary outcome measures

Tiered and tailored staff support programmes being implemented locally and nationally, evaluated using online survey at month 4

Overall trial start date

01/04/2020

Overall trial end date

23/04/2022

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Affiliated NHS member of staff, working at, or with, the participating NHS Trusts during the COVID-19 pandemic
2. Aged 18 and over
3. Able to give informed consent to take part in research
4. Able to understand and communicate in English
5. Have access to the internet to complete the surveys
6. Have access to an email address to facilitate survey registration and receive survey links

Participant type

Health professional

Age group

Adult

Gender

Both

Target number of participants

25% of the workforce at each participating sites, roughly 20,000

Participant exclusion criteria

1. If participants are not an affiliated NHS member of staff, working at, or with, the participating NHS Trusts
2. Aged under 18
3. Unable to give informed consent to take part in research
4. Unable to understand and communicate in English
5. No access to the internet to complete the surveys
6. No access to an email address to facilitate survey registration and receive survey links

Recruitment start date

24/04/2020

Recruitment end date

23/04/2022

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Guy's and St Thomas' NHS Foundation Trust
Westminster Bridge Rd
London
SE1 7EH
United Kingdom

Trial participating centre

King's College Hospital
Denmark Hill Brixton
London
SE5 9RS
United Kingdom

Trial participating centre

South London and Maudsley NHS Foundation Trust
Maudsley Hospital Denmark Hill
London
SE5 8AZ
United Kingdom

Trial participating centre

Avon and Wiltshire Mental Health Partnership NHS Trust
Avon and Wiltshire Mental Health Partnership NHS Trust
Bristol
BS16 2EW
United Kingdom

Trial participating centre

Gloucestershire Hospitals NHS Foundation Trust
GL1 2EL
United Kingdom

Trial participating centre

East Suffolk and North Essex NHS Foundation Trust
Turner Rd Mile End
Colchester
CO4 5JL
United Kingdom

Trial participating centre

University Hospitals of Derby and Burton NHS Foundation Trust
Uttoxeter Road
Derby
DE22 3NE
United Kingdom

Trial participating centre

Nottinghamshire Healthcare NHS Foundation Trust
Duncan Macmillan House Porchester Road
Nottingham
NG3 6AA
United Kingdom

Trial participating centre

University Hospitals of Leicester NHS Foundation Trust
Infirmary Square
Leicester
LE1 5WW
United Kingdom

Trial participating centre

Cambridgeshire and Peterborough NHS Foundation Trust
Cambridge
CB21 5EF
United Kingdom

Trial participating centre

Norfolk and Norwich University Hospitals NHS Foundation Trust
Colney Lane
Norwich
NR4 7UY
United Kingdom

Trial participating centre

Cambridge University Hospitals NHS Foundation Trust
Hills Road
Cambridge
CB2 0QQ
United Kingdom

Trial participating centre

Sheffield Health and Social Care Trust
Fulwood House Old Fulwood Road
Sheffield
S10 3TH
United Kingdom

Trial participating centre

Lancashire and South Cumbria NHS Foundation Trust
Sceptre Point Sceptre Way Walton Summit Rd Walton Summit Centre
Preston
PR5 6AW
United Kingdom

Trial participating centre

Tees Esk and Wear Valleys NHS Foundation Trust
Middlesborough
TS6 0SZ
United Kingdom

Trial participating centre

Devon Partnership NHS Trust
Wonford House Dryden Rd
Exeter
EX2 5AF
United Kingdom

Trial participating centre

Cornwall Partnership NHS Foundation Trust
Carew House, Beacon Technology Park Dunmere Rd Bodmin
Cornwall
PL31 2QN
United Kingdom

Trial participating centre

Royal Papworth Hospital NHS Foundation Trust
Papworth Rd Trumpington
Cambridge
CB2 0AY
United Kingdom

Sponsor information

Organisation

King's College London

Sponsor details

James Clerk Maxwell Building
57 Waterloo Road
London
SE1 8WA
United Kingdom
-
R&D@gstt.nhs.uk

Sponsor type

University/education

Website

http://www.kcl.ac.uk/index.aspx

Funders

Funder type

Charity

Funder name

Rosetrees Trust

Alternative name(s)

Teresa Rosenbaum Golden Charitable Trust, Rosetrees

Funding Body Type

private sector organisation

Funding Body Subtype

Trusts, charities, foundations (both public and private)

Location

United Kingdom

Funder name

Medical Research Council

Alternative name(s)

MRC

Funding Body Type

government organisation

Funding Body Subtype

National government

Location

United Kingdom

Funder name

University College London

Alternative name(s)

UCL

Funding Body Type

private sector organisation

Funding Body Subtype

Universities (academic only)

Location

United Kingdom

Funder name

King’s College London

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

Universities (academic only)

Location

United Kingdom

Funder name

NIHR Biomedical Research Centre at the Maudsley

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal. The researchers will feedback emerging results to participating Trusts, networks, their partners, and NHS England, from which they have full encouragement, to help them prepare for future psychological health and workforce planning needs. Additional documents are not currently available.

IPD sharing statement
The data-sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

01/01/2021

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

11/09/2020: Trial's existence confirmed by the NIHR.