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

Sponsor
Murielle Surquin (Other)
Overall Status
Completed
CT.gov ID
NCT04497246
Collaborator
(none)
1,150
1
14.7
78.1

Study Details

Study Description

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 Phase
  • Other: Questionnaire

Study Design

Study Type:
Observational
Actual Enrollment :
1150 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
Actual Primary Completion Date :
Aug 20, 2021
Actual Study Completion Date :
Aug 20, 2021

Arms and Interventions

Arm 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

Primary Outcome Measures

  1. Impact Event Scale-Revised (IES-R) [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) [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) [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) [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 [1 year]

    Age, gender, familial status, home status (living alone/family support/healthcare support/ retirement home).

  2. Hospitalization duration [1 year]

    Hospitalization duration

  3. ICU stay [1 year]

    Hospitalization within the intensive care unit (yes/no) with or without intubation

  4. Medical history [1 year]

    History of chronic diseases

  5. Alcohol consumption [1 year]

    Alcohol consumption : none - stable - increased - diminished

  6. Tobacco consumption [1 year]

    Tobacco consumption : none - stable - increased - diminished

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 CHU Brugmann Brussels Belgium

Sponsors and Collaborators

  • Murielle Surquin

Investigators

  • Principal Investigator: Sophie Levy, MD, CHU Brugmann

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Murielle Surquin, Head of geriatry department, Brugmann University Hospital
ClinicalTrials.gov Identifier:
NCT04497246
Other Study ID Numbers:
  • CHU-COVIDIMPACT
First Posted:
Aug 4, 2020
Last Update Posted:
Apr 6, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 6, 2022