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

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

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.

Study Overview

• Status: Completed
• Conditions: Depression; COVID-19; Stress; Anxiety

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 534

Contacts and Locations

Study Locations

• France
  • Occitanie
    • Toulouse, Occitanie, France, 31062
      • CHU de Toulouse

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

A sample of 1600 subjects was randomly recruited from the general population to participate in the MONALISA cross-sectional surveys on the prevalence of cardiovascular risk factors in 2005. Men and women aged 35-74, living in Toulouse area, were recruited between 2005 and 2008.

The participants of the MONALISA population survey had agreed to be contacted, after the end of the MONALISA study, to take news of their state of health.

Considering that the participation rate of the people contacted will be high (greater than 70%, taking into account the quarantine context), more than 800 participants (now aged 50 to 89 years) should be able to be included.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Investigators: Principal Investigator: Emilie Bérard, Service d'Epidémiologie, CHU de Toulouse UMR 1027, INSERM

Study record dates

Study Major Dates

• Study Start (Actual): April 17, 2020
• Primary Completion (Actual): July 17, 2021
• Study Completion (Actual): July 17, 2021

Study Registration Dates

• First Submitted: April 21, 2020
• First Submitted That Met QC Criteria: May 19, 2020
• First Posted (Actual): May 21, 2020

Study Record Updates

• Last Update Posted (Actual): April 18, 2022
• Last Update Submitted That Met QC Criteria: April 15, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: cardiovascular disease; psychological impact; quarantine; general population
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: RC31/20/0135

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No