<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04410016</url>
  </required_header>
  <id_info>
    <org_study_id>COVID-WELL_May20</org_study_id>
    <nct_id>NCT04410016</nct_id>
  </id_info>
  <brief_title>Evaluation of Staff COVID-19 Wellbeing Centres in a Healthcare Workplace: COVID-WELL Study</brief_title>
  <acronym>COVID-WELL</acronym>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Nottingham</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Nottingham University Hospitals NHS Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Nottingham</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Evaluation of a workplace intervention to implement supported wellbeing centres in a&#xD;
      healthcare workplace during and after the COVID-19 pandemic.&#xD;
&#xD;
      Mixed-Methods Evaluation study - including collection of service use monitoring data, online&#xD;
      survey and qualitative interviews.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Project Aims:&#xD;
&#xD;
        1. To describe the cost, reach and usage of the Staff Wellbeing Centres&#xD;
&#xD;
        2. To gather insight into experiences of those who access the facility ('service users') as&#xD;
           well as those of support workers ('wellbeing buddies').&#xD;
&#xD;
        3. To identify any facilitators, obstacles or barriers to accessing the facility.&#xD;
&#xD;
        4. To identify perceptions of facility users and non-users towards the value of the&#xD;
           facilities during and after the coronavirus pandemic.&#xD;
&#xD;
        5. To establish recommendations for longer-term sustainability of the wellbeing centres.&#xD;
&#xD;
      Interviews will be conducted with up to 45 interview participants (10-15 Wellbeing Buddies,&#xD;
      25-30 Staff).&#xD;
&#xD;
      Online survey will be conducted - all Nottingham University Hospitals National Health Service&#xD;
      (NHS) staff invited to take part (&gt;14,000).&#xD;
&#xD;
      The survey will include measures of mental wellbeing (Warwick-Edinburgh Wellbeing Scale,&#xD;
      14-item - license received), and single items measures of job stressfulness, job&#xD;
      satisfaction, presenteeism, turnover intentions and work engagement.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 25, 2020</start_date>
  <completion_date type="Actual">October 30, 2020</completion_date>
  <primary_completion_date type="Actual">July 31, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_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).</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>This is an evaluation of a service - the Wellbeing Centres at Nottingham University Hospitals National Health Service (NHS) Trust - which are a form of 'intervention' for staff provided during the coronavirus pandemic. Therefore the investigators will conduct interviews with people who have used the centres, or who have acted as support workers within them. The investigators will survey all staff in the Trust, and interview up to 45 participants.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Warwick-Edinburgh Mental Wellbeing Scale</measure>
    <time_frame>Baseline</time_frame>
    <description>14-item scale to measure mental wellbeing. Total scores range from 14 to 70 and higher scores indicate greater positive mental wellbeing.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Single Item Measure of Global Job Stressfulness (Houdmont et al, 2019)</measure>
    <time_frame>Baseline</time_frame>
    <description>Single-item measure. Scores range from 1 to 5 and higher scores indicated greater job stressfulness.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Single Item Global Job Satisfaction Measure (Dolbier et al, 2005)</measure>
    <time_frame>Baseline</time_frame>
    <description>Single-item measure. Scores range from 1 to 5 and higher scores indicated greater job satisfaction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Single Item Measure of Presenteeism (Aronsson &amp; Gustafsson, 2004)</measure>
    <time_frame>Baseline</time_frame>
    <description>Single-item measure. Scores range from 1 to 4, with higher scores indicating greater presenteeism.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Single Item Measure of Turnover intentions (Ryan et al, 2017)</measure>
    <time_frame>Baseline</time_frame>
    <description>Single-item measure. Scored 1=no intent to leave, 2=intent to leave</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Work Engagement (Shaufeli et al, 2006)</measure>
    <time_frame>Baseline</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Qualitative Interviews with Staff</measure>
    <time_frame>Once per study, telephone interview (during a 6-week interview period)</time_frame>
    <description>Users and non-users of Wellbeing Centres</description>
  </other_outcome>
  <other_outcome>
    <measure>Qualitative Interviews with Wellbeing Buddies</measure>
    <time_frame>Once per study, telephone interview (during a 6-week interview period)</time_frame>
    <description>Support Workers within the Wellbeing Centres</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">819</enrollment>
  <condition>Mental Health Wellness 1</condition>
  <arm_group>
    <arm_group_label>Staff Wellbeing Centre</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Staff Wellbeing Centres</intervention_name>
    <description>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.</description>
    <arm_group_label>Staff Wellbeing Centre</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  National Health Service staff which includes employees, volunteers or healthcare&#xD;
             students, as well as bank staff (all have access to the Staff Wellbeing Centres).&#xD;
&#xD;
          -  Ability to give informed consent. For survey element: Ability to access the internet&#xD;
             (to complete the online survey) For interview element: Ability to attend an individual&#xD;
             interview.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        • Inability to communicate in spoken English.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Nottingham University Hospitals NHS Trust</name>
      <address>
        <city>Nottingham</city>
        <state>Nottinghamshire</state>
        <zip>NG7 2UH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <link>
    <url>https://www.nottingham.ac.uk/healthsciences/news/the-covid-well-study.aspx</url>
    <description>departmental news item</description>
  </link>
  <results_reference>
    <citation>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.</citation>
    <PMID>33807306</PMID>
  </results_reference>
  <results_reference>
    <citation>Blake 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.</citation>
    <PMID>33333913</PMID>
  </results_reference>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>May 22, 2020</study_first_submitted>
  <study_first_submitted_qc>May 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 1, 2020</study_first_posted>
  <last_update_submitted>August 26, 2021</last_update_submitted>
  <last_update_submitted_qc>August 26, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 30, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Nottingham</investigator_affiliation>
    <investigator_full_name>Holly Blake</investigator_full_name>
    <investigator_title>Dr Holly Blake, Associate Professor of Behavioural Science</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Interview data will be made available on request (after study end).</ipd_description>
    <ipd_time_frame>Interview data will be available on request at study end (after publication of findings).</ipd_time_frame>
    <ipd_access_criteria>On request.</ipd_access_criteria>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04410016
org study id: COVID-WELL_May20
nct id: NCT04410016
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
Project Aims:

        1. To describe the cost, reach and usage of the Staff Wellbeing Centres

        2. To gather insight into experiences of those who access the facility ('service users') as
           well as those of support workers ('wellbeing buddies').

        3. To identify any facilitators, obstacles or barriers to accessing the facility.

        4. To identify perceptions of facility users and non-users towards the value of the
           facilities during and after the coronavirus pandemic.

        5. 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.
allocation: N/A
intervention model: Single Group Assignment
intervention 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).
primary purpose: Other
masking: None (Open Label)
masking description: This is an evaluation of a service - the Wellbeing Centres at Nottingham University Hospitals National Health Service (NHS) Trust - which are a form of 'intervention' for staff provided during the coronavirus pandemic. Therefore the investigators will conduct interviews with people who have used the centres, or who have acted as support workers within them. The investigators will survey all staff in the Trust, and interview up to 45 participants.
measure: Warwick-Edinburgh Mental Wellbeing Scale
time frame: Baseline
description: 14-item scale to measure mental wellbeing. Total scores range from 14 to 70 and higher scores indicate greater positive mental wellbeing.
measure: Single Item Measure of Global Job Stressfulness (Houdmont et al, 2019)
time frame: Baseline
description: Single-item measure. Scores range from 1 to 5 and higher scores indicated greater job stressfulness.
measure: Single Item Global Job Satisfaction Measure (Dolbier et al, 2005)
time frame: Baseline
description: Single-item measure. Scores range from 1 to 5 and higher scores indicated greater job satisfaction.
measure: Single Item Measure of Presenteeism (Aronsson & Gustafsson, 2004)
time frame: Baseline
description: Single-item measure. Scores range from 1 to 4, with higher scores indicating greater presenteeism.
measure: Single Item Measure of Turnover intentions (Ryan et al, 2017)
time frame: Baseline
description: Single-item measure. Scored 1=no intent to leave, 2=intent to leave
measure: Work Engagement (Shaufeli et al, 2006)
time frame: Baseline
description: 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.
measure: Qualitative Interviews with Staff
time frame: Once per study, telephone interview (during a 6-week interview period)
description: Users and non-users of Wellbeing Centres
measure: Qualitative Interviews with Wellbeing Buddies
time frame: Once per study, telephone interview (during a 6-week interview period)
description: Support Workers within the Wellbeing Centres
arm group label: Staff Wellbeing Centre
arm group type: Experimental
description: 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.
intervention type: Other
intervention name: Staff Wellbeing Centres
description: 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.
arm group label: Staff Wellbeing Centre
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United Kingdom
url: https://www.nottingham.ac.uk/healthsciences/news/the-covid-well-study.aspx
description: departmental news item
citation: 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.
PMID: 33807306
citation: Blake 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.
PMID: 33333913
responsible party type: Principal Investigator
investigator affiliation: University of Nottingham
investigator full name: Holly Blake
investigator title: Dr Holly Blake, Associate Professor of Behavioural Science
sharing ipd: Yes
ipd description: Interview data will be made available on request (after study end).
ipd time frame: Interview data will be available on request at study end (after publication of findings).
ipd access criteria: On request.