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

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04497246
• Other study ID #: CHU-COVIDIMPACT
• Status: Completed
• Start date: May 29, 2020
• Est. completion date: August 20, 2021

Study information

• Verified date: March 2022
• Source: Brugmann University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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), 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1150
• Est. completion date: August 20, 2021
• Est. primary completion date: August 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Covid19
• Parasomnias
• Sleep Wake Disorders

Intervention

Other:
• Questionnaire
Data collection by means of various questionnaires

Locations

Country	Name	City	State
Belgium	CHU Brugmann	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Murielle Surquin

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	Demographic data	Age, gender, familial status, home status (living alone/family support/healthcare support/ retirement home).	1 year
Secondary	Hospitalization duration	Hospitalization duration	1 year
Secondary	ICU stay	Hospitalization within the intensive care unit (yes/no) with or without intubation	1 year
Secondary	Medical history	History of chronic diseases	1 year
Secondary	Alcohol consumption	Alcohol consumption : none - stable - increased - diminished	1 year
Secondary	Tobacco consumption	Tobacco consumption : none - stable - increased - diminished	1 year