COVID19 and Physical and Emotional Wellbeing of HCP (CoPE-HCP)
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| ClinicalTrials.gov Identifier: NCT04433260 |
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Recruitment Status :
Completed
First Posted : June 16, 2020
Last Update Posted : February 8, 2022
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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.
| Condition or disease | Intervention/treatment |
|---|---|
| Mental Health | Other: Questionnaire including validated tools such as Patient Health Questionnaire (PHQ-9), the 7-item Generalised Anxiety Disorder (GAD- 7), the 7-item insomnia severity index Other: Questionnaire, same tools as before, with inclusion of PCL5 questionnaire too. Other: Informed consent |
| Study Type : | Observational |
| Actual Enrollment : | 1721 participants |
| Observational Model: | Cohort |
| Time Perspective: | Cross-Sectional |
| 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 |
| Actual Study Start Date : | July 25, 2020 |
| Actual Primary Completion Date : | March 31, 2021 |
| Actual Study Completion Date : | March 31, 2021 |
| Group/Cohort | Intervention/treatment |
|---|---|
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Cases
Doctors, nurses and other healthcares ≥ 18 years of age in direct contact with patients potentially infected with COVID-19
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Other: Questionnaire including validated tools such as Patient Health Questionnaire (PHQ-9), the 7-item Generalised Anxiety Disorder (GAD- 7), the 7-item insomnia severity index
The electronic survey for phase 1 detailing questions regarding affective symptoms, behaviour and ongoing concerns will be sent and implied consent assumed from responders. A proportion of these patients who give consent to be repeatedly contacted throughout the study period will be recruited into phase 2 of the study at 6 weeks and 4 months
Other Names:
Other: Questionnaire, same tools as before, with inclusion of PCL5 questionnaire too. Follow-up electronic surveys including questions regarding affective symptoms, behavioural changes and mental well-being will be sent at 6-weeks and 4-months following the initial survey. This will be sent to participants from Groups 1-3 that provided consent to receive these follow-up questionnaires. Other: Informed consent Participants will need to give their consent to participate to the survey after reading PIS |
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Internal Control
Healthcare /NHS Administrative staff who are working in the hospital, but not directly in contact with patients potentially infected with COVID-19.
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Other: Questionnaire including validated tools such as Patient Health Questionnaire (PHQ-9), the 7-item Generalised Anxiety Disorder (GAD- 7), the 7-item insomnia severity index
The electronic survey for phase 1 detailing questions regarding affective symptoms, behaviour and ongoing concerns will be sent and implied consent assumed from responders. A proportion of these patients who give consent to be repeatedly contacted throughout the study period will be recruited into phase 2 of the study at 6 weeks and 4 months
Other Names:
Other: Questionnaire, same tools as before, with inclusion of PCL5 questionnaire too. Follow-up electronic surveys including questions regarding affective symptoms, behavioural changes and mental well-being will be sent at 6-weeks and 4-months following the initial survey. This will be sent to participants from Groups 1-3 that provided consent to receive these follow-up questionnaires. Other: Informed consent Participants will need to give their consent to participate to the survey after reading PIS |
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Population Control
Non-healthcare/non-NHS academic staff who are not working in the environment where patient exposure is expected.
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Other: Questionnaire including validated tools such as Patient Health Questionnaire (PHQ-9), the 7-item Generalised Anxiety Disorder (GAD- 7), the 7-item insomnia severity index
The electronic survey for phase 1 detailing questions regarding affective symptoms, behaviour and ongoing concerns will be sent and implied consent assumed from responders. A proportion of these patients who give consent to be repeatedly contacted throughout the study period will be recruited into phase 2 of the study at 6 weeks and 4 months
Other Names:
Other: Questionnaire, same tools as before, with inclusion of PCL5 questionnaire too. Follow-up electronic surveys including questions regarding affective symptoms, behavioural changes and mental well-being will be sent at 6-weeks and 4-months following the initial survey. This will be sent to participants from Groups 1-3 that provided consent to receive these follow-up questionnaires. Other: Informed consent Participants will need to give their consent to participate to the survey after reading PIS |
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Follow-up cases
Doctors, nurses and other healthcare workers ≥ 18 years of age in direct contact with patients potentially infected with COVID-19 consenting to receive follow-up surveys (n ~ 400)
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Other: Questionnaire including validated tools such as Patient Health Questionnaire (PHQ-9), the 7-item Generalised Anxiety Disorder (GAD- 7), the 7-item insomnia severity index
The electronic survey for phase 1 detailing questions regarding affective symptoms, behaviour and ongoing concerns will be sent and implied consent assumed from responders. A proportion of these patients who give consent to be repeatedly contacted throughout the study period will be recruited into phase 2 of the study at 6 weeks and 4 months
Other Names:
Other: Questionnaire, same tools as before, with inclusion of PCL5 questionnaire too. Follow-up electronic surveys including questions regarding affective symptoms, behavioural changes and mental well-being will be sent at 6-weeks and 4-months following the initial survey. This will be sent to participants from Groups 1-3 that provided consent to receive these follow-up questionnaires. Other: Informed consent Participants will need to give their consent to participate to the survey after reading PIS |
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Follow-up controls
Healthcare Administrative staff who are working in the hospital, not at risk of work-related exposure to patients potentially infected with COVID-19 (n~80)
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Other: Questionnaire including validated tools such as Patient Health Questionnaire (PHQ-9), the 7-item Generalised Anxiety Disorder (GAD- 7), the 7-item insomnia severity index
The electronic survey for phase 1 detailing questions regarding affective symptoms, behaviour and ongoing concerns will be sent and implied consent assumed from responders. A proportion of these patients who give consent to be repeatedly contacted throughout the study period will be recruited into phase 2 of the study at 6 weeks and 4 months
Other Names:
Other: Questionnaire, same tools as before, with inclusion of PCL5 questionnaire too. Follow-up electronic surveys including questions regarding affective symptoms, behavioural changes and mental well-being will be sent at 6-weeks and 4-months following the initial survey. This will be sent to participants from Groups 1-3 that provided consent to receive these follow-up questionnaires. Other: Informed consent Participants will need to give their consent to participate to the survey after reading PIS |
- Presence of anxiety at baseline [ Time Frame: baseline ]
Symptoms of anxiety will be investigated using the 7-item Generalised Anxiety Disorder (GAD- 7) Scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate and severe anxiety, respectively.
Higher score corresponding to more severe degree of anxiety.
- Presence of depression at baseline [ Time Frame: baseline ]
Symptoms of depression will be investigated using the 9- item Patient Health Questionnaire (PHQ-9).
Min score of severity: 0-4 none, 20-27 severe. Higher score corresponding to more severe degree of depression
- Proportion of those who report a combined outcome of presence of anxiety or depression at the baseline as determined by screening questionnaires used. [ Time Frame: baseline ]
Anxiety will be investigated by 7-item Generalised Anxiety Disorder and depression will be investigated by 9-item patient health questionnaire. Presence of either one of those or both will be taken as the combined outcome.
For anxiety, 7-item Generalized anxiety disorder score (GAD- 7) Scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate and severe anxiety, respectively.
Higher score corresponding to more severe degree of anxiety. For depression, the 9- item Patient Health Questionnaire (PHQ-9). Min score of severity: 0-4 none, 20-27 severe. Higher score corresponding to more severe degree of depression
Higher score corresponding to more severe degree of anxiety.
- Change in proportion of who report a combined outcome of either presence of anxiety or depression from baseline to the end of study [ Time Frame: 4 months ]
Anxiety will be investigated by 7-item Generalised Anxiety Disorder and depression will be investigated by 9-item patient health questionnaire. Presence of either one of those or both will be taken as the combined outcome.
For anxiety, 7-item Generalized anxiety disorder score (GAD- 7) Scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate and severe anxiety, respectively.
Higher score corresponding to more severe degree of anxiety. For depression, the 9- item Patient Health Questionnaire (PHQ-9). Min score of severity: 0-4 none, 20-27 severe. Higher score corresponding to more severe degree of depression
- 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 [ Time Frame: 4 months ]Self reported, assessed based on the questions regarding the presence of symptoms with presence of either self reported positive test, or self-isolation of 7 or more days.
- Change in prevalence of anxiety from baseline [ Time Frame: 4 months ]
Symptoms of anxiety will be investigated using the 7-item Generalised Anxiety Disorder (GAD- 7) Scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate and severe anxiety, respectively.
Higher score corresponding to more severe degree of anxiety.
- Change in prevalence of depression from baseline [ Time Frame: 4 months followup ]
Symptoms of depression will be investigated using the 9- item Patient Health Questionnaire (PHQ-9).
Min score of severity: 0-4 none, 20-27 severe. Higher score corresponding to more severe degree of depression
- Prevalence of sleep-related issues at baseline [ Time Frame: At baseline ]This is based on questions derived from the Insomnia Severity Index Total score categories: 0-7 = No clinically significant insomnia 8-14 = Subthreshold insomnia 15-21 = Clinical insomnia (moderate severity) 22-28 = Clinical insomnia (severe)
- Change in prevalence of sleep-related issues from baseline [ Time Frame: 4-month follow-up ]
Insomnia Severity Index
Total score categories: 0-7 = No clinically significant insomnia 8-14 = Subthreshold insomnia 15-21 = Clinical insomnia (moderate severity) 22-28 = Clinical insomnia (severe)
- Prevalence of a combined outcome of presence of anyone of anxiety, depression or sleep related issues at baseline. [ Time Frame: baseline ]
Symptoms of depression will be investigated using the 9- item Patient Health Questionnaire (PHQ-9).
Min score of severity: 0-4 none, 20-27 severe. Higher score corresponding to more severe degree of depression
Symptoms of anxiety will be investigated using the 7-item Generalised Anxiety Disorder (GAD- 7) Scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate and severe anxiety, respectively.
Higher score corresponding to more severe degree of anxiety.
Total score categories: 0-7 = No clinically significant insomnia 8-14 = Subthreshold insomnia 15-21 = Clinical insomnia (moderate severity) 22-28 = Clinical insomnia (severe)
- Proportion of those with low mental wellbeing at baseline [ Time Frame: baseline ]This is based on questions derived from the Short Warwick-Edinburgh Mental Well-being Scale (SWEMWBS). Scores of 7-17 represent probable depression or anxiety; Scores of 18-20 suggest possible depression or anxiety.
- Change in proportion of those with low mental wellbeing from baseline to the end of study. [ Time Frame: 4-month follow-up ]Short Warwick-Edinburgh Mental Well-being Scale (SWEMWBS). Scores of 7-17 represent probable depression or anxiety; Scores of 18-20 suggest possible depression or anxiety
- Prevalence of those who report concern related to work-place practices. [ Time Frame: At baseline ]Self-reported measures through responses to direct questions relevant to work-related practices in the survey
- Change in the prevalence from baseline of those who report concern related to work-place practices. [ Time Frame: 6-week ]Self-reported measures through responses to direct questions relevant to work-related practices in the survey
- Change in the prevalence from baseline of those who report concern related to work-place practices. [ Time Frame: 4 months ]Self-reported measures through responses to direct questions relevant to work-related practices in the survey
- Change in behavioural habits, such as smoking and alcohol intake from baseline to the end of study [ Time Frame: 4-month follow-up ]Self-reported measures through responses to survey questions
- Proportion of those who report signs and symptoms or evidence consistent with probable diagnosis of COVID-19 [ Time Frame: Baseline ]Self reported, based on the presence of symptoms with either self reported positive test, or self-isolation of 7 or more days.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
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)
Inclusion Criteria:
- Aged >=18
- Electronic consent
- 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:
- Age<18
- Individuals not belonging to the 3 cohorts of interest listed in the inclusion criteria.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04433260
| United Kingdom | |
| Ajay K Gupta | |
| London, United Kingdom, EC1M 6BQ | |
| Principal Investigator: | Ajay Gupta, MD, PhD | Queen Mary University London |
| Responsible Party: | Queen Mary University of London |
| ClinicalTrials.gov Identifier: | NCT04433260 |
| Other Study ID Numbers: |
284686 |
| First Posted: | June 16, 2020 Key Record Dates |
| Last Update Posted: | February 8, 2022 |
| Last Verified: | February 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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healthcare professionals Personal protective equipment covid-19 SARS-CoV2 |
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COVID-19 Respiratory Tract Infections Infections Pneumonia, Viral Pneumonia Virus Diseases |
Coronavirus Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases |