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

NCT04397835 | Completed

• 1 other identifier: RC31/20/0135
• Study Type: observational
• Target: 534
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19; Anxiety; Depression; Stress

Keywords

quarantine; psychological impact; cardiovascular disease; general population

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (3)

• psychological impact of the quarantine on anxiety

  at 1, 6 and 12 month

• psychological impact of the quarantine on health

  at 1, 6 and 12 month

• psychological impact of the quarantine on stress

  at 1, 6 and 12 month

Eligibility Criteria

• Age: 50 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• All participants of the MONALISA survey residing in south-western France (Toulouse area).

You may not qualify if:

• Opposition to participate in this new survey
• Pregnancy or breastfeeding
• Subject under guardianship, curatorship or safeguard of justice
• Lack of health insurance coverage

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

CHU de Toulouse

Toulouse, Occitanie, 31062, France

Location

MeSH Terms

Conditions

COVID-19; Anxiety Disorders; Depression; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Emilie Bérard

  Service d'Epidémiologie, CHU de Toulouse UMR 1027, INSERM

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2020
• First Posted: May 21, 2020
• Study Start: April 17, 2020
• Primary Completion: July 17, 2021
• Study Completion: July 17, 2021
• Last Updated: April 18, 2022

Record last verified: 2022-04

Locations

FR (1)