Clinical trial NCT04397835: Psychological Impact of COVID-19 Quarantine and Worsening of Cardiovascular Risk in the French General Population
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Anxiety
Depression
Stress
Keywords: quarantine
psychological impact
cardiovascular disease
general population
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2020-05-21
Enrollment: 534
Sex: ALL
Minimum age (years): 50
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility 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

Primary outcomes:
measure: worsening of cardiovascular risk (treatments)
timeFrame: at 1, 6 and 12 month
measure: worsening of cardiovascular risk (smoking consumption)
timeFrame: at 1, 6 and 12 month
measure: worsening of cardiovascular risk (food balance)
timeFrame: at 1, 6 and 12 month
measure: worsening of cardiovascular risk (weight gain)
timeFrame: at 1, 6 and 12 month
measure: worsening of cardiovascular risk (physical activity)
timeFrame: at 1, 6 and 12 month
Secondary outcomes:
measure: psychological impact of the quarantine on anxiety
timeFrame: at 1, 6 and 12 month
measure: psychological impact of the quarantine on health
timeFrame: at 1, 6 and 12 month
measure: psychological impact of the quarantine on stress
timeFrame: at 1, 6 and 12 month
Other outcomes:
Locations:
city: Toulouse
country: France
facility: CHU de Toulouse
state: Occitanie
Study officials:
affiliation: Service d'Epidémiologie, CHU de Toulouse UMR 1027, INSERM
name: Emilie Bérard
role: PRINCIPAL_INVESTIGATOR
References: