Psychological Impact of Quarantine During the COVID-19 Outbreak and Worsening of Cardiovascular Risk in the French General Population: a Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 534
- 试验地点
- 1
- 主要终点
- worsening of cardiovascular risk (treatments)
研究概览
简要总结
In response to the COVID-19 outbreak, the French government put in place home quarantine of the general population in order to limit the transmission of the virus. It is obvious that quarantine at home have a psychological impact which could worsened cardiovascular risk. Our aim is to assess risk factors for severe stress, anxiety or depression, during and after quarantine, as well as risk factors (including stress, anxiety or depression), in the worsening of cardiovascular risk.
详细描述
In response to the COVID-19 outbreak, the French government put in place home quarantine of the general population in order to limit the transmission of the virus. It is obvious that quarantine at home have a psychological impact which could worsened cardiovascular risk. Our aim is to assess risk factors for severe stress, anxiety or depression, during and after quarantine, as well as risk factors (including stress, anxiety or depression), in the worsening of cardiovascular risk.
A prospective epidemiological observational cohort study will be carried out (in French general population aged 50 to 89 years) with data collection by telephone interviews (in agreement with the context of quarantine).
The telephone interviews will be carried out during quarantine (V1), in the month following the end of quarantine (V2) and then, at 6 (V3) and 12 (V4) months. At baseline, the questionnaire will focus on socio-demographic and contextual characteristics related to the COVID-19 outbreak, medical history, cardiovascular risk factors and treatments, anxiety and depression scales. Next (after the quarantine), the questionnaire will focus on the evolution of cardiovascular risk factors and the occurrence of acute cardiovascular events, the evolution of treatments and post-traumatic stress, anxiety or depression scales.
The assessment of risk factors for severe stress, anxiety or depression, during and after quarantine, as well as risk factors of the worsening of cardiovascular risk will be based on mixed logistic regression.
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
- 50 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All participants of the MONALISA survey residing in south-western France (Toulouse area).
排除标准
- •Opposition to participate in this new survey
- •Pregnancy or breastfeeding
- •Subject under guardianship, curatorship or safeguard of justice
- •Lack of health insurance coverage
结局指标
主要结局
worsening of cardiovascular risk (treatments)
时间窗: at 1, 6 and 12 month
The worsening of the cardiovascular risk factors during or after quarantine (versus before quarantine) will be considered in case of: - introduction or increase of antihypertensive, lipid-lowering or hypoglycaemic drug treatment on the prescription
worsening of cardiovascular risk (smoking consumption)
时间窗: at 1, 6 and 12 month
The worsening of the cardiovascular risk factors during or after quarantine (versus before quarantine) will be considered in case of increased smoking consumption
worsening of cardiovascular risk (food balance)
时间窗: at 1, 6 and 12 month
The worsening of the cardiovascular risk factors during or after quarantine (versus before quarantine) will be considered in case of alteration of the food balance
worsening of cardiovascular risk (weight gain)
时间窗: at 1, 6 and 12 month
The worsening of the cardiovascular risk factors during or after quarantine (versus before quarantine) will be considered in case of weight gain
worsening of cardiovascular risk (physical activity)
时间窗: at 1, 6 and 12 month
The worsening of the cardiovascular risk factors during or after quarantine (versus before quarantine) will be considered in case of: - reduction in the level of physical activity
次要结局
- psychological impact of the quarantine on anxiety(at 1, 6 and 12 month)
- psychological impact of the quarantine on health(at 1, 6 and 12 month)
- psychological impact of the quarantine on stress(at 1, 6 and 12 month)