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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04397835
Recruitment Status : Recruiting
First Posted : May 21, 2020
Last Update Posted : May 21, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

Brief 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.

Condition or disease
COVID-19 Anxiety Depression Stress

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.

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Study Type : Observational
Estimated Enrollment : 800 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : April 17, 2020
Estimated Primary Completion Date : April 20, 2021
Estimated Study Completion Date : April 20, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   50 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04397835


Contacts
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Contact: Emilie Bérard, MD PhD 5 61 14 59 52 ext +33 emilie.berard@univ-tlse3.fr

Locations
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France
CHU de Toulouse Recruiting
Toulouse, Occitanie, France, 31062
Contact: Emilie Bérard, MD, PHD    5 61 14 59 52 ext +33    emilie.berard@univ-tlse3.fr   
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
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Principal Investigator: Emilie Bérard Service d'Epidémiologie, CHU de Toulouse UMR 1027, INSERM
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Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT04397835    
Other Study ID Numbers: RC31/20/0135
First Posted: May 21, 2020    Key Record Dates
Last Update Posted: May 21, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Toulouse:
quarantine
psychological impact
cardiovascular disease
general population
Additional relevant MeSH terms:
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Depression
Behavioral Symptoms