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

Depression Clinical Trial

— PSYCOV-CV  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04397835
• Other study ID #: RC31/20/0135
• Status: Completed
• Start date: April 17, 2020
• Est. completion date: July 17, 2021

Study information

• Verified date: April 2022
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 534
• Est. completion date: July 17, 2021
• Est. primary completion date: July 17, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• COVID-19
• Depression
• Stress

Locations

Country	Name	City	State
France	CHU de Toulouse	Toulouse	Occitanie

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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