Clinical trial NCT04433260: COVID19 and Physical and Emotional Wellbeing of HCP
Official title: Immediate and Mid-term Implications of the Covid-19 Pandemic on the Physical, Behavioural and Mental Health of Healthcare Workers: A Cohort Study of Doctor, Nurses and Other Health Care Workers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mental Health
Keywords: healthcare professionals
Personal protective equipment
covid-19
SARS-CoV2
Lead sponsor: Queen Mary University of London
Sponsor class: OTHER
First posted: 2020-06-16
Enrollment: 1721
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Doctors, nurses and other healthcares ≥ 18 years of age in direct contact with patients potentially infected with COVID-19 (n = minimum 800)

Healthcare /NHS Administrative staff who are working in the hospital, but not directly in contact with patients potentially infected with COVID-19 (minimum n= 125) (internal control)

Non-healthcare/non-NHS academic staff who are not working in the environment where patient exposure is expected (minimum n=125) (population control)

Brief summary: The current COVID-19 pandemic has affected more than 3 million people worldwide across more than 200 countries.

In the United Kingdom alone, at the end of April, there were almost 160,000 confirmed cases with more than 20,000 deaths. This has undoubtedly had significant physical and economical impact on the public.

Healthcare workers are at high risk of developing life-threatening infectious diseases with increased exposure to patients' blood and bodily fluids. As such, health care workers arguably experience heightened anxiety and are predisposed to greater negative psycho-social impact from the current COVID-19 pandemic.

The aim of this study is to evaluate the physical and psychological impact of COVID-19 on healthcare workers. This will be performed in two phases.

In phase 1, investigators will collect information to evaluate the current psychiatric symptom profile (in particular, screening for anxiety or depression related symptoms), alcohol use, sleep-related complaints and overall well-being among healthcare workers who participate in this survey (with a focus on junior doctors). In addition the association of these mental health and behavioural parameters with the prevalence of stressful occasions, such as long-hours, unpredictability of work / redeployment, availability of personal protection equipment and concerns regarding family/relationship and self will be assessed.

In phase 2, investigators will then reassess for the development or progression of psychiatric symptoms, use of alcohol and other substances, behavioural or interpersonal relationship changes as well as physical well-being at 6 weeks and 4- months. Physical well-being is assessed through the presence of suspected or confirmed COVID-19 infection and absence from work. Specifically, investigators will study the impact of variable provision of personal protection equipment (supply and training), extended working hours, and concern for well-being of family members, on work morale and anxiety levels.

Another aim is also study the longer term mental health consequences of the current pandemic on health care workers.


Eligibility criteria: Inclusion Criteria:

1. Aged \>=18
2. Electronic consent
3. Either:

a - healthcare workers in contact with patients with confirmed or suspected COVID-19 b - Healthcare staff not having direct patient contact c - Non-healthcare academic staff with no direct patient contact

Exclusion Criteria:

1. Age\<18
2. Individuals not belonging to the 3 cohorts of interest listed in the inclusion criteria.
3. Those who are not able to understand written English will be excluded, indeed by the design and methodology of the study, as the study invite and all other information provided is in English.

Primary outcomes:
measure: Presence of anxiety at baseline
timeFrame: baseline
measure: Presence of depression at baseline
timeFrame: baseline
measure: Proportion of those who report a combined outcome of presence of anxiety or depression at the baseline as determined by screening questionnaires used.
timeFrame: baseline
measure: Change in proportion of who report a combined outcome of either presence of anxiety or depression from baseline to the end of study
timeFrame: 4 months
measure: Change in the proportion of those who report signs and symptoms or evidence consistent with probable diagnosis of COVID-19 from baseline to the end of study
timeFrame: 4 months
Secondary outcomes:
measure: Change in prevalence of anxiety from baseline
timeFrame: 4 months
measure: Change in prevalence of depression from baseline
timeFrame: 4 months followup
measure: Prevalence of sleep-related issues at baseline
timeFrame: At baseline
measure: Change in prevalence of sleep-related issues from baseline
timeFrame: 4-month follow-up
measure: Prevalence of a combined outcome of presence of anyone of anxiety, depression or sleep related issues at baseline.
timeFrame: baseline
measure: Proportion of those with low mental wellbeing at baseline
timeFrame: baseline
measure: Change in proportion of those with low mental wellbeing from baseline to the end of study.
timeFrame: 4-month follow-up
measure: Prevalence of those who report concern related to work-place practices.
timeFrame: At baseline
measure: Change in the prevalence from baseline of those who report concern related to work-place practices.
timeFrame: 6-week
measure: Change in the prevalence from baseline of those who report concern related to work-place practices.
timeFrame: 4 months
measure: Change in behavioural habits, such as smoking and alcohol intake from baseline to the end of study
timeFrame: 4-month follow-up
measure: Proportion of those who report signs and symptoms or evidence consistent with probable diagnosis of COVID-19
timeFrame: Baseline
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Ajay K Gupta
Study officials:
affiliation: Queen Mary University London
name: Ajay Gupta, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Khanji MY, Maniero C, Ng S, Siddiqui I, Gupta J, Crosby L, Antoniou S, Khan R, Kapil V, Gupta A. Early and Mid-Term Implications of the COVID-19 Pandemic on the Physical, Behavioral and Mental Health of Healthcare Professionals: The CoPE-HCP Study Protocol. Front Psychol. 2021 Feb 2;12:616280. doi: 10.3389/fpsyg.2021.616280. eCollection 2021.