Covid19NCT04497246
Psychological Impact, Mental Health and Sleep Disorder Among Patients Hospitalized and Health Care Workers During the 2019 Coronavirus Outbreak (COVID-19)
An observational study of Covid19, run by Murielle Surquin at 1 site in Belgium.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- Questionnaire
- How many people
- 1,150 participants
- Where
- 1 siteBelgium
- Study dates
- 29 May 2020to 20 Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Incoherent patients
- Severe presbycusis
- Oral expression impairment
- Insurmountable language barrier
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Covid19
- Being tested
- Questionnaire
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
Data collection by means of various questionnaires
| Study group | Role | What they receive |
|---|---|---|
| Elderly patients | Elderly patients (over 65 years old) hospitalized for COVID-19 within the CHU Brugmann Hospital Receives: Other: Questionnaire | |
| Health Care professionals | Health Care professionals working within the CHU Brugmann Hospital Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 15 minutes
Secondary outcomes (6)
Demographic data
Age, gender, familial status, home status (living alone/family support/healthcare support/ retirement home).
Measured: 1 year
Hospitalization duration
Hospitalization duration
Measured: 1 year
ICU stay
Hospitalization within the intensive care unit (yes/no) with or without intubation
Measured: 1 year
Medical history
History of chronic diseases
Measured: 1 year
Alcohol consumption
Alcohol consumption : none - stable - increased - diminished
Measured: 1 year
Tobacco consumption
Tobacco consumption : none - stable - increased - diminished
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2020
- Study start29 May 2020
- Primary completion20 Aug 2021
- Study completion20 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Murielle Surquin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Murielle Surquin, Brugmann University Hospital
- Investigators
- Sophie Levy, MD, Principal investigator, CHU Brugmann
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04497246
- Sponsor's protocol ID
- CHU-COVIDIMPACT
- Status last verified
- Mar 2022
- First submitted
- 3 Aug 2020
- Last updated
- 6 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychological Impact, Mental Health and Sleep Disorder Among Patients Hospitalized and Health Care Workers During the 2019 Coronavirus Outbreak (COVID-19)
- ClinicalTrials.gov ID
- NCT04497246
- Acronym / sponsor ID
- CHU-COVIDIMPACT
- Conditions
- Covid19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,150 participants (actual)
- Lead sponsor
- Murielle SurquinUniversity, hospital or other
- Study start
- 29 May 2020 (actual)
- Primary completion
- 20 Aug 2021 (actual)
- Study completion
- 20 Aug 2021 (actual)
- First posted
- 4 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Elderly patients | – | Other: QuestionnaireElderly patients (over 65 years old) hospitalized for COVID-19 within the CHU Brugmann Hospital |
| Health Care professionals | – | Other: QuestionnaireHealth Care professionals working within the CHU Brugmann Hospital |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- Incoherent patients
- Severe presbycusis
- Oral expression impairment
- Insurmountable language barrier
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnaireData collection by means of various questionnaires | Other | Elderly patients, Health Care professionals |
Primary outcome
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.
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.
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.
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).
6 secondary outcomes
Demographic data
Time frame: 1 year
Hospitalization duration
Time frame: 1 year
ICU stay
Time frame: 1 year
Medical history
Time frame: 1 year
Alcohol consumption
Time frame: 1 year
Tobacco consumption
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sophie Levy, MD principal investigator
CHU Brugmann
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19, run by Murielle Surquin at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact Event Scale-Revised (IES-R) (time frame: 15 minutes). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2022; AzTrials last refreshed its copy on 8 Nov 2026.