<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/NCT04429828</url>
  </required_header>
  <id_info>
    <org_study_id>PoWerS_June2020</org_study_id>
    <nct_id>NCT04429828</nct_id>
  </id_info>
  <brief_title>COVID-19 Psychological Wellbeing for Healthcare Students</brief_title>
  <acronym>PoWerS</acronym>
  <official_title>PoWerS Study: Psychological Wellbeing for Healthcare Students: Evaluation of a COVID-19 Digital Learning Package</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Nottingham</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </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>
      We have developed an online learning resource designed to support healthcare staff during and&#xD;
      after the COVID-19 pandemic. This resource has been produced in anticipation of the&#xD;
      psychological effect of working during this time. This is an open access, free, online&#xD;
      resource available here: https://www.nottingham.ac.uk/toolkits/play_22794 It is designed to&#xD;
      be relevant for healthcare staff, and we are evaluating it now with healthcare students as&#xD;
      our next generation of healthcare staff. We are interested in knowing more about your views&#xD;
      of healthcare students towards this package. This will help us to determine its value as a&#xD;
      learning resource to support psychological wellbeing in healthcare students, alongside other&#xD;
      welfare supports. The aim is to describe the views of healthcare students towards an&#xD;
      e-learning package developed in response to COVID-19 on Psychological Wellbeing for&#xD;
      Healthcare Workers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators aim to:&#xD;
&#xD;
        -  gather insight into the emotional highs and lows of being a healthcare student during&#xD;
           the pandemic&#xD;
&#xD;
        -  identify any facilitators, obstacles or barriers to accessing the e-package.&#xD;
&#xD;
        -  identify perceptions of healthcare students towards the value of the e-package during&#xD;
           and after the COVID19 pandemic.&#xD;
&#xD;
        -  establish recommendations for longer-term support for psychological wellbeing in&#xD;
           healthcare students.&#xD;
&#xD;
      Qualitative interviews will be conducted with up to 45 purposively sampled healthcare&#xD;
      students who have accessed the e-learning resource. The interview will be semi-structured and&#xD;
      include a measure of mental wellbeing (Warwick-Edinburgh Wellbeing Scale, 14-item - license&#xD;
      received), and single items measures of job stressfulness, job satisfaction, presenteeism,&#xD;
      turnover intentions and work engagement.&#xD;
&#xD;
      Findings will inform future supportive interventions for healthcare students.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 13, 2020</start_date>
  <completion_date type="Actual">December 30, 2020</completion_date>
  <primary_completion_date type="Actual">September 30, 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 students have access to the COVID-19 educational package to support psychological wellbeing in healthcare students (usual practice). In this study the investigators will conduct semi-structured qualitative interviews with healthcare students about their mental wellbeing, and use of this e-package.</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>This is an evaluation of an educational learning package, which is a form of 'supportive intervention' for students provided during the coronavirus pandemic. Therefore the investigators will conduct interviews with people who have used the e-package. The investigators will interview up to 45 participants.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Qualitative Interviews with Healthcare Students</measure>
    <time_frame>Once per study, telephone interview (during a 6-week interview period)</time_frame>
    <description>Users of the e-package</description>
  </primary_outcome>
  <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</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>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">42</enrollment>
  <condition>Psychological Wellbeing</condition>
  <arm_group>
    <arm_group_label>e-package: psychological wellbeing for healthcare workers</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A COVID-19 educational package on psychological wellbeing for healthcare workers, accessible to all healthcare students.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>COVID-19 e-package: Psychological wellbeing for healthcare workers</intervention_name>
    <description>All healthcare students have access to a COVID-19 educational learning package around psychological wellbeing (usual practice). In this study the investigators will conduct semi-structured qualitative interviews with healthcare students about their mental wellbeing, and use of this e-package.</description>
    <arm_group_label>e-package: psychological wellbeing for healthcare workers</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Healthcare students (e.g. any students who are registered on a healthcare course).&#xD;
&#xD;
          -  Ability to give informed consent.&#xD;
&#xD;
          -  Ability to attend an individual interview (remotely).&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
        • Not a registered healthcare student.&#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>University of Nottingham</name>
      <address>
        <city>Nottingham</city>
        <zip>NG7 2HA</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>June 11, 2020</study_first_submitted>
  <study_first_submitted_qc>June 11, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 12, 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 27, 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>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/NCT04429828
org study id: PoWerS_June2020
nct id: NCT04429828
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
We have developed an online learning resource designed to support healthcare staff during and
      after the COVID-19 pandemic. This resource has been produced in anticipation of the
      psychological effect of working during this time. This is an open access, free, online
      resource available here: https://www.nottingham.ac.uk/toolkits/play_22794 It is designed to
      be relevant for healthcare staff, and we are evaluating it now with healthcare students as
      our next generation of healthcare staff. We are interested in knowing more about your views
      of healthcare students towards this package. This will help us to determine its value as a
      learning resource to support psychological wellbeing in healthcare students, alongside other
      welfare supports. The aim is to describe the views of healthcare students towards an
      e-learning package developed in response to COVID-19 on Psychological Wellbeing for
      Healthcare Workers.
The investigators aim to:

        -  gather insight into the emotional highs and lows of being a healthcare student during
           the pandemic

        -  identify any facilitators, obstacles or barriers to accessing the e-package.

        -  identify perceptions of healthcare students towards the value of the e-package during
           and after the COVID19 pandemic.

        -  establish recommendations for longer-term support for psychological wellbeing in
           healthcare students.

      Qualitative interviews will be conducted with up to 45 purposively sampled healthcare
      students who have accessed the e-learning resource. The interview will be semi-structured and
      include a measure 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.

      Findings will inform future supportive interventions for healthcare students.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: All students have access to the COVID-19 educational package to support psychological wellbeing in healthcare students (usual practice). In this study the investigators will conduct semi-structured qualitative interviews with healthcare students about their mental wellbeing, and use of this e-package.
primary purpose: Supportive Care
masking: None (Open Label)
masking description: This is an evaluation of an educational learning package, which is a form of 'supportive intervention' for students provided during the coronavirus pandemic. Therefore the investigators will conduct interviews with people who have used the e-package. The investigators will interview up to 45 participants.
measure: Qualitative Interviews with Healthcare Students
time frame: Once per study, telephone interview (during a 6-week interview period)
description: Users of the e-package
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
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.
arm group label: e-package: psychological wellbeing for healthcare workers
arm group type: Experimental
description: A COVID-19 educational package on psychological wellbeing for healthcare workers, accessible to all healthcare students.
intervention type: Other
intervention name: COVID-19 e-package: Psychological wellbeing for healthcare workers
description: All healthcare students have access to a COVID-19 educational learning package around psychological wellbeing (usual practice). In this study the investigators will conduct semi-structured qualitative interviews with healthcare students about their mental wellbeing, and use of this e-package.
arm group label: e-package: psychological wellbeing for healthcare workers
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United Kingdom
responsible party type: Principal Investigator
investigator affiliation: University of Nottingham
investigator full name: Holly Blake
investigator title: 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.