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NCT Number: NCT04397835

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

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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Key information

About this 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.

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. worsening of cardiovascular risk (treatments)

    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:

    • introduction or increase of antihypertensive, lipid-lowering or hypoglycaemic drug treatment on the prescription
  2. worsening of cardiovascular risk (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 increased smoking consumption

  3. worsening of cardiovascular risk (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 alteration of the food balance

  4. worsening of cardiovascular risk (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 weight gain

  5. worsening of cardiovascular risk (physical activity)

    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:

    • reduction in the level of physical activity

Secondary outcomes

  1. psychological impact of the quarantine on anxiety

    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.

  2. psychological impact of the quarantine on health

    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.

  3. psychological impact of the quarantine on stress

    Time frame: at 1, 6 and 12 month

    " 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
May 21, 2020
Registry last updated
Apr 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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