Psychological Impact, Mental Health and Sleep Disorder Among Patients Hospitalized and Health Care Workers During the 2019 Coronavirus Outbreak (COVID-19)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,150
- 试验地点
- 1
- 主要终点
- Patient Health Questionnaire-9 (PHQ-9)
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Incoherent patients
- •Severe presbycusis
- •Oral expression impairment
- •Insurmountable language barrier
结局指标
主要结局
Patient Health Questionnaire-9 (PHQ-9)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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.
次要结局
- Hospitalization duration(1 year)
- Medical history(1 year)
- Tobacco consumption(1 year)
- Demographic data(1 year)
- Alcohol consumption(1 year)
- ICU stay(1 year)
研究者
Murielle Surquin
Head of geriatry department
Brugmann University Hospital