Mental Health Wellness 1COVID-WELLNCT04410016
Evaluation of Staff COVID-19 Wellbeing Centres in a Healthcare Workplace: COVID-WELL Study
A study testing Staff Wellbeing Centres in people with Mental Health Wellness 1, run by University of Nottingham at 1 site in United Kingdom.
Trial summary
Evaluation of a workplace intervention to implement supported wellbeing centres in a healthcare workplace during and after the COVID-19 pandemic. Mixed-Methods Evaluation study - including collection of service use monitoring data, online survey and qualitative interviews. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Mental Health Wellness 1
- What is being tested?
- Staff Wellbeing Centres
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 819 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 25 May 2020to 30 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- National Health Service staff which includes employees, volunteers or healthcare students, as well as bank staff (all have access to the Staff Wellbeing Centres).
- Ability to give informed consent. For survey element: Ability to access the internet (to complete the online survey) For interview element: Ability to attend an individual interview.
Who cannot join
- Inability to communicate in spoken English.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Nottingham University Hospitals NHS Trust
Nottingham, Nottinghamshire, NG7 2UH
About this study
Official title: Evaluation of a Workplace Intervention to Implement Supported COVID-19 Wellbeing Centres in a Healthcare Workplace During and After the Coronavirus Pandemic: The COVID-WELL Study
Evaluation of a workplace intervention to implement supported wellbeing centres in a healthcare workplace during and after the COVID-19 pandemic.
Mixed-Methods Evaluation study - including collection of service use monitoring data, online survey and qualitative interviews.
Read the detailed description
Project Aims:
- To describe the cost, reach and usage of the Staff Wellbeing Centres
- To gather insight into experiences of those who access the facility ('service users') as well as those of support workers ('wellbeing buddies').
- To identify any facilitators, obstacles or barriers to accessing the facility.
- To identify perceptions of facility users and non-users towards the value of the facilities during and after the coronavirus pandemic.
- To establish recommendations for longer-term sustainability of the wellbeing centres.
Interviews will be conducted with up to 45 interview participants (10-15 Wellbeing Buddies, 25-30 Staff).
Online survey will be conducted - all Nottingham University Hospitals National Health Service (NHS) staff invited to take part (>14,000).
The survey will include measures of mental wellbeing (Warwick-Edinburgh Wellbeing Scale, 14-item - license received), and single items measures of job stressfulness, job satisfaction, presenteeism, turnover intentions and work engagement.
- Conditions
- Mental Health Wellness 1
- Being tested
- Staff Wellbeing Centres
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Staff Wellbeing CentresOther
2 Centres (rooms) accessible to staff for rest and relaxation, work breaks, supports advice and signposting. They are manned by support workers called Wellbeing Buddies.
| Study group | Role | What they receive |
|---|---|---|
| Staff Wellbeing Centre | Experimental | Wellbeing Centres are rooms where staff employed at the hospital trust can go for a break, rest, relaxation, quiet time out, advice support or signposting. They are manned by Wellbeing Buddies who are support workers who offer advice and signposting services. The Centres are accessible to all staff at the Trust. Receives: Other: Staff Wellbeing Centres |
What is being measured
The primary outcome is the main question the study is designed to answer.
Warwick-Edinburgh Mental Wellbeing Scale
14-item scale to measure mental wellbeing. Total scores range from 14 to 70 and higher scores indicate greater positive mental wellbeing.
Measured: Baseline
Secondary outcomes (5)
Single Item Measure of Global Job Stressfulness (Houdmont et al, 2019)
Single-item measure. Scores range from 1 to 5 and higher scores indicated greater job stressfulness.
Measured: Baseline
Single Item Global Job Satisfaction Measure (Dolbier et al, 2005)
Single-item measure. Scores range from 1 to 5 and higher scores indicated greater job satisfaction.
Measured: Baseline
Single Item Measure of Presenteeism (Aronsson & Gustafsson, 2004)
Single-item measure. Scores range from 1 to 4, with higher scores indicating greater presenteeism.
Measured: Baseline
Single Item Measure of Turnover intentions (Ryan et al, 2017)
Single-item measure. Scored 1=no intent to leave, 2=intent to leave
Measured: Baseline
Work Engagement (Shaufeli et al, 2006)
Dedication subscale of the 9-item Utrecht Work Engagement Scale (3 items will be used: 2, 3 and 4). Scores range from 0 to 6, with higher scores indicating greater work engagement.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2020
- Study start25 May 2020
- Primary completion31 Jul 2020
- Study completion30 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Mental Health Wellness 1Studies of the same condition, open and under way.
- More trials run by University of NottinghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All staff have access to the Staff Wellbeing Centres (usual practice). In this study the investigators will conduct a questionnaire survey with all Nottingham University Hospitals National Health Service (NHS) staff about their mental wellbeing, and use of this facility. The investigators will conduct qualitative interviews with users and non-users of the Wellbeing Centres (staff) as well as the Wellbeing Buddies (support workers).
- Masking
- None (open label)
- Enrolment
- 819 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Collaborators
- Nottingham University Hospitals NHS Trust
- Responsible party
- Principal investigator, Holly Blake, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04410016
- Sponsor's protocol ID
- COVID-WELL_May20
- Acronym
- COVID-WELL
- Status last verified
- Aug 2021
- First submitted
- 22 May 2020
- Last updated
- 30 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Interview data will be made available on request (after study end).
Publications
Blake H, Gupta A, Javed M, Wood B, Knowles S, Coyne E, Cooper J. COVID-Well Study: Qualitative Evaluation of Supported Wellbeing Centres and Psychological First Aid for Healthcare Workers during the COVID-19 Pandemic. Int J Environ Res Public Health. 2021 Mar 31;18(7):3626. doi: 10.3390/ijerph18073626.
PubMed 33807306Blake H, Yildirim M, Wood B, Knowles S, Mancini H, Coyne E, Cooper J. COVID-Well: Evaluation of the Implementation of Supported Wellbeing Centres for Hospital Employees during the COVID-19 Pandemic. Int J Environ Res Public Health. 2020 Dec 15;17(24):9401. doi: 10.3390/ijerph17249401.
PubMed 33333913
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Workplace Intervention to Implement Supported COVID-19 Wellbeing Centres in a Healthcare Workplace During and After the Coronavirus Pandemic: The COVID-WELL Study
- ClinicalTrials.gov ID
- NCT04410016
- Acronym / sponsor ID
- COVID-WELL / COVID-WELL_May20
- Conditions
- Mental Health Wellness 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 819 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Collaborators
- Nottingham University Hospitals NHS Trust
- Study start
- 25 May 2020 (actual)
- Primary completion
- 31 Jul 2020 (actual)
- Study completion
- 30 Oct 2020 (actual)
- First posted
- 1 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluation of a workplace intervention to implement supported wellbeing centres in a healthcare workplace during and after the COVID-19 pandemic.
Mixed-Methods Evaluation study - including collection of service use monitoring data, online survey and qualitative interviews.
Detailed description
Project Aims:
- To describe the cost, reach and usage of the Staff Wellbeing Centres
- To gather insight into experiences of those who access the facility ('service users') as well as those of support workers ('wellbeing buddies').
- To identify any facilitators, obstacles or barriers to accessing the facility.
- To identify perceptions of facility users and non-users towards the value of the facilities during and after the coronavirus pandemic.
- To establish recommendations for longer-term sustainability of the wellbeing centres.
Interviews will be conducted with up to 45 interview participants (10-15 Wellbeing Buddies, 25-30 Staff).
Online survey will be conducted - all Nottingham University Hospitals National Health Service (NHS) staff invited to take part (>14,000).
The survey will include measures of mental wellbeing (Warwick-Edinburgh Wellbeing Scale, 14-item - license received), and single items measures of job stressfulness, job satisfaction, presenteeism, turnover intentions and work engagement.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All staff have access to the Staff Wellbeing Centres (usual practice). In this study the investigators will conduct a questionnaire survey with all Nottingham University Hospitals National Health Service (NHS) staff about their mental wellbeing, and use of this facility. The investigators will conduct qualitative interviews with users and non-users of the Wellbeing Centres (staff) as well as the Wellbeing Buddies (support workers).
| Arm | Type | Receives |
|---|---|---|
| Staff Wellbeing Centre | Experimental | Other: Staff Wellbeing CentresWellbeing Centres are rooms where staff employed at the hospital trust can go for a break, rest, relaxation, quiet time out, advice support or signposting. They are manned by Wellbeing Buddies who are support workers who offer advice and signposting services. The Centres are accessible to all staff at the Trust. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- National Health Service staff which includes employees, volunteers or healthcare students, as well as bank staff (all have access to the Staff Wellbeing Centres).
- Ability to give informed consent. For survey element: Ability to access the internet (to complete the online survey) For interview element: Ability to attend an individual interview.
Key exclusion criteria (1 listed)
- Inability to communicate in spoken English.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Staff Wellbeing Centres2 Centres (rooms) accessible to staff for rest and relaxation, work breaks, supports advice and signposting. They are manned by support workers called Wellbeing Buddies. | Other | Staff Wellbeing Centre |
Primary outcome
Warwick-Edinburgh Mental Wellbeing Scale
Time frame: Baseline
14-item scale to measure mental wellbeing. Total scores range from 14 to 70 and higher scores indicate greater positive mental wellbeing.
5 secondary outcomes
Single Item Measure of Global Job Stressfulness (Houdmont et al, 2019)
Time frame: Baseline
Single Item Global Job Satisfaction Measure (Dolbier et al, 2005)
Time frame: Baseline
Single Item Measure of Presenteeism (Aronsson & Gustafsson, 2004)
Time frame: Baseline
Single Item Measure of Turnover intentions (Ryan et al, 2017)
Time frame: Baseline
Work Engagement (Shaufeli et al, 2006)
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2021.
- Results publication: PubMed 33807306Blake H, Gupta A, Javed M, Wood B, Knowles S, Coyne E, Cooper J. COVID-Well Study: Qualitative Evaluation of Supported Wellbeing Centres and Psychological First Aid for Healthcare Workers during the COVID-19 Pandemic. Int J Environ Res Public Health. 2021 Mar 31;18(7):3626. doi: 10.3390/ijerph18073626.
- Results publication: PubMed 33333913Blake H, Yildirim M, Wood B, Knowles S, Mancini H, Coyne E, Cooper J. COVID-Well: Evaluation of the Implementation of Supported Wellbeing Centres for Hospital Employees during the COVID-19 Pandemic. Int J Environ Res Public Health. 2020 Dec 15;17(24):9401. doi: 10.3390/ijerph17249401.
- departmental news itemLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Interview data will be made available on request (after study end).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Staff Wellbeing Centres in people with Mental Health Wellness 1, run by University of Nottingham at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Warwick-Edinburgh Mental Wellbeing Scale (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04410016, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2021.