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Clinical Trials/NCT04497246
NCT04497246
Completed
Not Applicable

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

Murielle Surquin1 site in 1 country1,150 target enrollmentMay 29, 2020
ConditionsCovid19

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Covid19
Sponsor
Murielle Surquin
Enrollment
1150
Locations
1
Primary Endpoint
Patient Health Questionnaire-9 (PHQ-9)
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 29, 2020
End Date
August 20, 2021
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor Investigator
Principal Investigator

Murielle Surquin

Head of geriatry department

Brugmann University Hospital

Eligibility 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

Outcomes

Primary Outcomes

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.

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.

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).

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.

Secondary Outcomes

  • Hospitalization duration(1 year)
  • Medical history(1 year)
  • Tobacco consumption(1 year)
  • Demographic data(1 year)
  • Alcohol consumption(1 year)
  • ICU stay(1 year)

Study Sites (1)

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