Psychological Impact of COVID-19 Quarantine and Worsening of Cardiovascular Risk in the French General Population
NCT ID: NCT04397835
Last Updated: 2022-04-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
534 participants
OBSERVATIONAL
2020-04-17
2021-07-17
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Pregnancy or breastfeeding
* Subject under guardianship, curatorship or safeguard of justice
* Lack of health insurance coverage
50 Years
89 Years
ALL
Yes
Sponsors
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University Hospital, Toulouse
OTHER
Responsible Party
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Principal Investigators
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Emilie Bérard
Role: PRINCIPAL_INVESTIGATOR
Service d'Epidémiologie, CHU de Toulouse UMR 1027, INSERM
Locations
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CHU de Toulouse
Toulouse, Occitanie, France
Countries
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Other Identifiers
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RC31/20/0135
Identifier Type: -
Identifier Source: org_study_id
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