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
| ISRCTN | ISRCTN18395399 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18395399 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 282686 |
| Protocol serial number | IRAS 282686, CPMS 46176 |
| Sponsor | King's College London |
| Funders | Rosetrees Trust, Medical Research Council, University College London, King’s College London, NIHR Biomedical Research Centre at the Maudsley |
- Submission date
- 11/09/2020
- Registration date
- 30/09/2020
- Last edited
- 30/08/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
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
Contact information
Scientific
King's College London
London
SE5 9AF
United Kingdom
| 0000-0002-6743-9929 | |
| NHSCHECK@kcl.ac.uk |
Public
King's College London
London
SE5 9AF
United Kingdom
| NHSCHECK@kcl.ac.uk |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Multicentre cohort study |
| Secondary study design | Cohort study |
| Study type | Participant information sheet |
| 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 |
| Study acronym | NHS CHECK |
| Study objectives | 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(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
General (non-psychotic) psychiatric morbidity, resilience, anxiety, depression, wellbeing, moral injury and burnout measured using online survey at baseline, month 4 and 12 |
| Key secondary outcome measure(s) |
Tiered and tailored staff support programmes being implemented locally and nationally, evaluated using online survey at month 4 |
| Completion date | 23/04/2022 |
Eligibility
| Participant type(s) | Health professional |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 20000 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 24/04/2020 |
| Date of final enrolment | 23/04/2022 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centres
London
SE1 7EH
United Kingdom
Brixton
London
SE5 9RS
United Kingdom
Denmark Hill
London
SE5 8AZ
United Kingdom
Bristol
BS16 2EW
United Kingdom
United Kingdom
Mile End
Colchester
CO4 5JL
United Kingdom
Derby
DE22 3NE
United Kingdom
Porchester Road
Nottingham
NG3 6AA
United Kingdom
Leicester
LE1 5WW
United Kingdom
CB21 5EF
United Kingdom
Norwich
NR4 7UY
United Kingdom
Cambridge
CB2 0QQ
United Kingdom
Old Fulwood Road
Sheffield
S10 3TH
United Kingdom
Sceptre Way
Walton Summit Rd
Walton Summit Centre
Preston
PR5 6AW
United Kingdom
TS6 0SZ
United Kingdom
Dryden Rd
Exeter
EX2 5AF
United Kingdom
Dunmere Rd
Bodmin
Cornwall
PL31 2QN
United Kingdom
Trumpington
Cambridge
CB2 0AY
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Preprint results | non-peer-reviewed baseline mental health survey results in preprint | 22/01/2021 | 19/03/2021 | No | No |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
30/08/2022: An embedded RCT within NHSCHECK testing a smartphone app aiming to support the mental health of healthcare workers has been registered on EudraCT as 2021-001279-18.
19/03/2021: Preprint reference added.
11/09/2020: Trial's existence confirmed by the NIHR.