CHU de Toulouse
Toulouse, Occitanie, 31062, France
NCT Number: NCT04397835
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.
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Notify Me50 year–89 year
All sexes
Observational
Toulouse, Occitanie, 31062, France
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 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:
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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:
Time frame: at 1, 6 and 12 month
" 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.
Time frame: at 1, 6 and 12 month
"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.
Time frame: at 1, 6 and 12 month
" Impact of Event Scale - Revised " (IES-R) :
University Hospital, Toulouse
Other
Psychological Impact of Quarantine During the COVID-19 Outbreak and Worsening of Cardiovascular Risk in the French General Population: a Prospective Cohort Study
Acronym: PSYCOV-CV
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