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临床试验/NCT04506632
NCT04506632进行中(未招募)不适用

COST-NHS: COvid Burden in STaff Working in the NHS: a Study to Assess the Mental Health Burden of the COVID-19 Pandemic on NHS Healthcare Staff

Sheffield Teaching Hospitals NHS Foundation Trust1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年6月2日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
100
试验地点
1
主要终点
Changes in feelings of paranoia

研究概览

简要总结

The COVID-19 crisis began in China in December 2019 and was declared a pandemic by the World Health Organisation on March 11th 2020. The pandemic has changed the way that clinicians interact with and treat patients overnight. Staff within the NHS will be under high levels of stress due to the increased needs and worse outcomes of work as they are shielding or self-isolating and may feel helpless and guilty. The psychological impact of the pandemic will be prolonged and varied. It is vital that Investigators increase understanding as much as possible to support NHS staff.

The aim of this survey is to examine the possible mental health burden on NHS staff as a result of the COVID-19 pandemic and how these change as the pandemic progresses. By understanding these effects, it will allow researchers to identify recommendations to allow support mechanisms to be put in place for NHS staff, to better manage this and future pandemics and similar crises.

Investigators are aiming to sample several cohorts of NHS staff including a subset of staff who are shielding. Staff will be asked to complete a series of online surveys at multiple timepoint: on study initiation, 1 month later and then 3 months after the pandemic has ceased in the UK. Additional timepoints may be added depending on the length and severity of the pandemic.

The main outcomes will be tracking changes in mental health measurements at the pre-defined timepoints. This work will allow Investigators to produce recommendations about the increased mental health support that NHS staff will need. If a need is demonstrated then an interventional research project will be designed and implemented.

详细描述

The aim of this survey is to examine the possible mental health burden on NHS staff as a results of the coronavirus COVID-19 pandemic and how these change as the pandemic progresses. By understanding these effects, it will allow Investigators to identify recommendations to allow appropriate support mechanisms to be put in place for NHS staff, to better manage this and future pandemics and similar crises.

Method:

Investigators aim to sample several cohorts of staff across the NHS. A subset of participants will include NHS staff that are currently shielding - they are self-isolating due to being identified as part of the at-risk/vulnerable members of society. The aim will be to survey a minimum of 100 members of staff. Introductory emails will be sent out to NHS staff using the hospital email system. Potential participants will be asked to read a participant information sheet and provide informed consent to participate in the subsequent survey.

Staff within the NHS will be asked to complete a series of surveys at multiple timepoints. The survey link will be circulated to staff with the introductory email. It will be sent at the following time points with a reminder to all on each occasion after 5 days: on study initiation, 1 month later and then 3 months after the pandemic has ceased in the UK. Additional timepoints may be added depending on the length and severity of the pandemic.

Qualtrics software will be used to host and administer the survey. The variables to be measured are:

研究设计

研究类型
Observational
观察模型
Ecologic Or Community
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Participants aged 16 years or over
  • Participants must be working in the NHS
  • NHS staff that are shielding will be eligible to participate
  • NHS staff that are self-isolating will be eligible to participate
  • Able and willing to provide informed consent
  • Able to read and understand English

排除标准

  • Participants will not be excluded on any other basis

结局指标

主要结局

Changes in feelings of paranoia

时间窗: UP to 3 months after the pandemic ends in the UK

measured by the short Green paranoia scale

conspiracy mentality and social interactions

时间窗: UP to 3 months after the pandemic ends in the UK

as measured by the loneliness scale

Changes in Depression

时间窗: UP to 3 months after the pandemic ends in the UK

We will assess depression with 9 items (PHQ-9);

Changes in Anxiety

时间窗: UP to 3 months after the pandemic ends in the UK

measured by GAD-7

Traumatic Stress

时间窗: UP to 3 months after the pandemic ends in the UK

As measured by PHQ-15

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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