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Psychological Impact, Mental Health and Sleep Disorder Among Patients Hospitalized and Health Care Workers During the 2019 Coronavirus Outbreak (COVID-19)

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ClinicalTrials.gov Identifier: NCT04497246
Recruitment Status : Recruiting
First Posted : August 4, 2020
Last Update Posted : August 4, 2020
Sponsor:
Information provided by (Responsible Party):
Murielle Surquin, Brugmann University Hospital

Study Description
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Brief Summary:

COVID-19 is an infectious disease caused by the last coronavirus discovered, called SARS-CoV-2. Symptoms encountered in COVID-19 are: cough, breathing difficulties (dyspnea, chest pain, etc.), pyrexia, anosmia (loss of smell) and/or dysgeusia (loss of taste), but also ENT symptoms (rhinitis type, odynophagia), headaches, asthenia, muscle pain, confusion and diarrhea. Infection with SARS-CoV-2 can also be asymptomatic. COVID-19 can be passed from person to person by respiratory droplets expelled when a person speaks, coughs or sneezes. The currently estimated incubation period ranges from 1 to 14 days, and most often this is around 5 days.

According to a literature review, there is strong evidence that COVID-19 has an impact on mental health (anxiety being the most common symptom) whether in the general population, healthcare workers or vulnerable populations. The objective of this project is to assess mental health and sleep disorders within two populations: elderly patients and nursing staff.


Condition or disease Intervention/treatment
Covid19 Other: Questionnaire

Study Design
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Study Type : Observational
Estimated Enrollment : 5000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Psychological Impact, Mental Health and Sleep Disorder Among Patients Hospitalized and Health Care Workers During the 2019 Coronavirus Outbreak (COVID-19)
Actual Study Start Date : May 29, 2020
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Elderly patients
Elderly patients (over 65 years old) hospitalized for COVID-19 within the CHU Brugmann Hospital
 Other: Questionnaire
Data collection by means of various questionnaires
Health Care professionals
Health Care professionals working within the CHU Brugmann Hospital
 Other: Questionnaire
Data collection by means of various questionnaires


Outcome Measures
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Primary Outcome Measures :
  1. Impact Event Scale-Revised (IES-R) [ Time Frame: 15 minutes ]
    The IES-R is a 22-item self-report measure that assesses subjective distress caused by traumatic events.Items are rated on a 5-point scale ranging from 0 ("not at all") to 4 ("extremely"). The IES-R yields a total score (ranging from 0 to 88) and subscale scores can also be calculated for the Intrusion, Avoidance, and Hyperarousal subscales.

  2. Generalised Anxiety Disorder-7 (GAD-7) [ Time Frame: 15 minutes ]
    Self-administered patient questionnaire used as a screening tool and severity measure for generalised anxiety disorder (GAD).The GAD-7 score is calculated by assigning scores of 0, 1, 2, and 3, to the response categories of 'not at all', 'several days', 'more than half the days', and 'nearly every day', respectively, and adding together the scores for the seven questions. Scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate and severe anxiety, respectively. When used as a screening tool, further evaluation is recommended when the score is 10 or greater.

  3. Patient Health Questionnaire-9 (PHQ-9) [ Time Frame: 15 minutes ]
    The PHQ-9 is the depression module, which scores each of the nine DSM-IV criteria as "0" (not at all) to "3" (nearly every day). It has been validated for use in primary care. It is not a screening tool for depression but it is used to monitor the severity of depression and response to treatment.

  4. Insomnia severity index (ISI) [ Time Frame: 15 minutes ]
    The ISI is a 7-item self-report questionnaire assessing the nature, severity, and impact of insomnia.The dimensions evaluated are: severity of sleep onset, sleep maintenance, and early morning awakening problems, sleep dissatisfaction, interference of sleep difficulties with daytime functioning, noticeability of sleep problems by others, and distress caused by the sleep difficulties. A 5-point Likert scale is used to rate each item (e.g., 0 = no problem; 4 = very severe problem), yielding a total score ranging from 0 to 28. The total score is interpreted as follows: absence of insomnia (0-7); sub-threshold insomnia (8-14); moderate insomnia (15-21); and severe insomnia (22-28).


Secondary Outcome Measures :
  1. Demographic data [ Time Frame: 1 year ]
    Age, gender, familial status, home status (living alone/family support/healthcare support/ retirement home).

  2. Hospitalization duration [ Time Frame: 1 year ]
    Hospitalization duration

  3. ICU stay [ Time Frame: 1 year ]
    Hospitalization within the intensive care unit (yes/no) with or without intubation

  4. Medical history [ Time Frame: 1 year ]
    History of chronic diseases

  5. Alcohol consumption [ Time Frame: 1 year ]
    Alcohol consumption : none - stable - increased - diminished

  6. Tobacco consumption [ Time Frame: 1 year ]
    Tobacco consumption : none - stable - increased - diminished


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
  • Subjects 65 years of age or older, having been hospitalized for COVID-19 within the CHU Brugmann Hospital
  • People aged 18 or over, member of the nursing staff of the CHU Brugmann Hospital, having worked during COVID-19.
Criteria

Inclusion Criteria:

  • Subjects 65 years of age or older, having been hospitalized for COVID-19 within the CHU Brugmann Hospital
  • People aged 18 or over, member of the nursing staff of the CHU Brugmann Hospital, having worked during COVID-19.

Exclusion Criteria:

  • Incoherent patients
  • Severe presbycusis
  • Oral expression impairment
  • Insurmountable language barrier
Contacts and Locations
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Information from the National Library of Medicine

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): NCT04497246


Contacts
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Contact: Sophie Levy, MD 0498165331 Sophie.LEVY@chu-brugmann.be
Contact: Maxime Windal Maxime.WINDAL@chu-brugmann.be

Locations
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Belgium
CHU Brugmann Recruiting
Brussels, Belgium
Contact: Sophie Levy       Sophie.LEVY@chu-brugmann.be   
Sponsors and Collaborators
Murielle Surquin
Investigators
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Principal Investigator: Sophie Levy, MD CHU Brugmann
More Information
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Responsible Party: Murielle Surquin, Head of geriatry department, Brugmann University Hospital
ClinicalTrials.gov Identifier: NCT04497246    
Other Study ID Numbers: CHU-COVIDIMPACT
First Posted: August 4, 2020    Key Record Dates
Last Update Posted: August 4, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sleep Wake Disorders
Parasomnias
Nervous System Diseases
Neurologic Manifestations
Mental Disorders