Psychological Impact, Mental Health and Sleep Disorder Among Patients Hospitalized and Health Care Workers During the 2019 Coronavirus Outbreak (COVID-19)
1 other identifier
observational
1,150
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 29, 2020
CompletedFirst Submitted
Initial submission to the registry
August 3, 2020
CompletedFirst Posted
Study publicly available on registry
August 4, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 20, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 20, 2021
CompletedApril 6, 2022
March 1, 2022
1.2 years
August 3, 2020
March 28, 2022
Conditions
Outcome Measures
Primary Outcomes (4)
Impact Event Scale-Revised (IES-R)
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.
15 minutes
Generalised Anxiety Disorder-7 (GAD-7)
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.
15 minutes
Patient Health Questionnaire-9 (PHQ-9)
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.
15 minutes
Insomnia severity index (ISI)
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).
15 minutes
Secondary Outcomes (6)
Demographic data
1 year
Hospitalization duration
1 year
ICU stay
1 year
Medical history
1 year
Alcohol consumption
1 year
- +1 more secondary outcomes
Study Arms (2)
Elderly patients
Elderly patients (over 65 years old) hospitalized for COVID-19 within the CHU Brugmann Hospital
Health Care professionals
Health Care professionals working within the CHU Brugmann Hospital
Interventions
Data collection by means of various questionnaires
Eligibility 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.
You may qualify if:
- 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.
You may not qualify if:
- Incoherent patients
- Severe presbycusis
- Oral expression impairment
- Insurmountable language barrier
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Murielle Surquinlead
Study Sites (1)
CHU Brugmann
Brussels, Belgium
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sophie Levy, MD
CHU Brugmann
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Head of geriatry department
Study Record Dates
First Submitted
August 3, 2020
First Posted
August 4, 2020
Study Start
May 29, 2020
Primary Completion
August 20, 2021
Study Completion
August 20, 2021
Last Updated
April 6, 2022
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will not share