Psychological Impact of COVID-19 Quarantine and Worsening of Cardiovascular Risk in the French General Population

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Psychological Impact of Quarantine During the COVID-19 Outbreak and Worsening of Cardiovascular Risk in the French General Population: a Prospective Cohort Study

Conditions
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COVID-19, Anxiety, Depression, Stress

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All participants of the MONALISA survey residing in south-western France (Toulouse area). Exclusion Criteria: Opposition to participate in this new survey Pregnancy or breastfeeding Subject under guardianship, curatorship or safeguard of justice Lack of health insurance coverage

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| worsening of cardiovascular risk (treatments) | 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 | at 1, 6 and 12 month | 
| worsening of cardiovascular risk (smoking consumption) | The worsening of the cardiovascular risk factors during or after quarantine (versus before quarantine) will be considered in case of increased smoking consumption | at 1, 6 and 12 month | 
| worsening of cardiovascular risk (food balance) | 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 | at 1, 6 and 12 month | 
| worsening of cardiovascular risk (weight gain) | The worsening of the cardiovascular risk factors during or after quarantine (versus before quarantine) will be considered in case of weight gain | at 1, 6 and 12 month | 
| worsening of cardiovascular risk (physical activity) | 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 | at 1, 6 and 12 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| psychological impact of the quarantine on anxiety |  Generalized Anxiety Disorder  (GAD-7) : Spitzer, R. L., Kroenke, K., Williams, J. B. W. et Löwe, B. (2006). A brief measure for assessing generalized anxiety disorder: The GAD-7. Archives of Internal Medicine, 166(10), 1092-1097. | at 1, 6 and 12 month | 
| psychological impact of the quarantine on health | Patient Health Questionnaire  (PHQ-9) : Kroenke, K., Spitzer, R. L. et Williams, J. B. W. (2001). The PHQ-9: Validity of a brief depression severity measure. J Gen Intern Med, 16(9), 606-613. | at 1, 6 and 12 month | 
| psychological impact of the quarantine on stress |  Impact of Event Scale - Revised  (IES-R) : Weiss, D. S. et Marmar, C. R. (1996). The Impact of Event Scale-Revised. Dans J. P. Wilson et T. M. Keane (dir.). Assessing psychological trauma and PTSD. New York : Guildford Press. Brunet, A., St-Hilaire, A., Jehel, L. et King, S. (2003). Validation of a French Version of the Impact of Event Scale-Revised. | at 1, 6 and 12 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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quarantine, psychological impact, cardiovascular disease, general population