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<docDscr>
  <citation>
    <titlStmt>
      <titl>Case-Control Study on Individual and Collective Therapeutic Education for At-Risk Cardiovascular Patients in General Medicine</titl>
      <IDNo>FRESH-PEF8543-en</IDNo>
    </titlStmt>
    <prodStmt>
      <producer abbr="" affiliation="UNIVERSITE DE BORDEAUX" role="">Bernard GAY</producer>
    </prodStmt>
    <verStmt>
      <version></version>
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  </citation>
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<stdyDscr>
  <citation>
    <titlStmt>
      <titl>
                Case-Control Study on Individual and Collective Therapeutic Education for At-Risk Cardiovascular Patients in General Medicine            </titl>
      <altTitl>
                    ETHICCAR                </altTitl>
      <IDNo agency="FReSH-lang">
                FRESH-PEF8543-en            </IDNo>
      <IDNo agency="PEF">
                    8543                </IDNo>
      <IDNo agency="FReSH">
                    FRESH-PEF8543                </IDNo>
    </titlStmt>
    <rspStmt>
      <AuthEnty>
                    Jean-Louis DEMEAUX                                                                                                                            </AuthEnty>
      <AuthEnty affiliation="UNIVERSITE DE BORDEAUX">
        <ExtLink title="ROR" URI="https://ror.org/057qpr032" role="organisation id"/>
        <ExtLink title="SIREN" URI="130018351" role="organisation id"/>
      </AuthEnty>
      <AuthEnty>
                    Bernard GAY                                                                                                                            </AuthEnty>
      <AuthEnty affiliation="UNIVERSITE DE BORDEAUX">
        <ExtLink title="ROR" URI="https://ror.org/057qpr032" role="organisation id"/>
        <ExtLink title="SIREN" URI="130018351" role="organisation id"/>
      </AuthEnty>
      <othId affiliation="" type="">
                                    </othId>
    </rspStmt>
    <prodStmt>
      <producer role="sponsor">
                                            INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)                    
                                    </producer>
      <producer role="sponsor">
                                            UNIVERSITE DE BORDEAUX                    
                                    </producer>
      <prodPlac>
                Epidemiology France Portal (PEF)            </prodPlac>
      <fundAg>
                                            HAUTE AUTORITE DE SANTE (HAS)                    
                                    </fundAg>
      <fundAg>
                                            SANTE PUBLIQUE FRANCE                    
                                    </fundAg>
      <fundAg>
                                            GROUPEMENT REGIONAL DE SANTE PUBLIQUE                    
                                    </fundAg>
    </prodStmt>
    <distStmt>
      <distrbtr abbr="null">
                    null</distrbtr>
      <contact affiliation="UNIVERSITE DE BORDEAUX" email="bernard.gay@u-bordeaux.fr">
                    Bernard;GAY
                                            <ExtLink title="ROR" URI="https://ror.org/057qpr032" role="organisation id"/>
                                            <ExtLink title="SIREN" URI="130018351" role="organisation id"/>
                                    </contact>
      <depDate date="2026-06-16"/>
      <distDate date="2026-06-16"/>
    </distStmt>
    <biblCit format="">
            </biblCit>
    <holdings URI="null"/>
    <notes> </notes>
  </citation>
  <stdyInfo>
    <studyBudget/>
    <subject>
      <keyword vocab="" vocabURI="">
                    therapeutic</keyword>
      <keyword vocab="" vocabURI="">
                    individual</keyword>
      <keyword vocab="" vocabURI="">
                    collective</keyword>
      <keyword vocab="" vocabURI="">
                    profile</keyword>
      <keyword vocab="" vocabURI="">
                    psychosocial</keyword>
      <keyword vocab="" vocabURI="">
                    cardiovascular risk</keyword>
      <keyword vocab="" vocabURI="">
                    nutrition</keyword>
      <keyword vocab="" vocabURI="">
                    alcohol</keyword>
      <keyword vocab="" vocabURI="">
                    tobacco</keyword>
      <keyword vocab="" vocabURI="">
                    physical activity</keyword>
      <topcClas vocab="health theme">
                        Cardiology and vascular medicine                                                        <ExtLink title="ESV" URI="http://data.europa.eu/8mn/euroscivoc/4455c187-2f2f-4cd1-a4dd-449f59d73b39"/>
                                                            <ExtLink title="ESV" URI="http://data.europa.eu/8mn/euroscivoc/c42fc6ec-b216-4a24-9e9d-f5e781c175a0"/>
                                                            <ExtLink title="MeSH" URI="http://id.nlm.nih.gov/mesh/D002309"/>
                                                </topcClas>
      <topcClas vocab="health theme">
                        Addiction medicine                                                        <ExtLink title="ESV" URI="http://data.europa.eu/8mn/euroscivoc/42d645e0-f58d-40ed-9917-5b227ff41a92"/>
                                                            <ExtLink title="MeSH" URI="http://id.nlm.nih.gov/mesh/D000073316"/>
                                                </topcClas>
      <topcClas vocab="cim-11">
                        Essential hypertension                                            </topcClas>
      <topcClas vocab="health determinant">
                        Behavioral determinants: Addiction                    </topcClas>
      <topcClas vocab="health determinant">
                        Behavioral determinants: Eating habits                    </topcClas>
      <topcClas vocab="health determinant">
                        Behavioral determinants                    </topcClas>
      <topcClas vocab="health determinant">
                        Socio-demographic and economic determinants                    </topcClas>
    </subject>
    <abstract contentType="purpose">To assesses the impact of therapeutic education on reducing the risk and/or cardiovascular morbidity and mortality for hypertensive patients compared to regular follow-up. Secondary objectives: - To describe the development of cardiovascular risk score in the three groups over 5 years: individual education, collective education and control group (regular follow-up); - To compare morbidity and mortality in the 3 groups; - To compare the impact of individual or collective action against standard follow-up; - To compare the results of individual action to collective action; - To analyse the psychosocial profile of respondents to either method; - To identify factors justifying the choice of either method or association; - To describe and compare the quality of life of patients in the 3 groups.</abstract>
    <abstract contentType="abstract">null</abstract>
    <sumDscr>
      <collDate event="start" date="2009-01-01"/>
      <nation abbr="fr">
                    France
                                            <concept vocab="ISO" vocabURI="fr"/>
                                    </nation>
      <geogCover>Nouvelle-Aquitaine</geogCover>
      <geogUnit/>
      <anlyUnit>
                Individuals            </anlyUnit>
      <universe level="type" clusion="I">General population                    </universe>
      <universe level="sex" clusion="I">Male                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D008297"/>
                                                    </universe>
      <universe level="sex" clusion="I">Female                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D005260"/>
                                                    </universe>
      <universe level="age" clusion="I">Middle Aged (45 to 64 years)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D008875"/>
                                                    </universe>
      <universe level="age" clusion="I">Aged (65 to 79 years)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D000368"/>
                                                    </universe>
      <universe clusion="I">Inclusion criteria: - Men over 50 and women over 60 years old (&lt;75 years old); - Individuals with essential arterial hypertension (systolic pressure ≥140 mmHg, diastolic pressure ≥90 mmHg); -  With another risk factor: smoking, diabetes, dyslipidemia (i.e., at least 3 cardiovascular risk factors); - No history of cardiovascular accident (primary prevention).                      </universe>
      <universe clusion="E">Previous history of cardiovascular accident; - Secondary arterial hypertension; - Type 1 diabetes; - Short-term life-threatening disease; - Social or cultural situation making educational process impossible; - Cannot be monitored for at least two years; - Patient included in another study that could affect treatment (cohort study, therapeutic trial, etc.).                    </universe>
      <dataKind>Clinical data</dataKind>
      <dataKind>Participant-reported health data</dataKind>
      <dataKind>Biological data</dataKind>
    </sumDscr>
  </stdyInfo>
  <studyDevelopment>
    <developmentActivity type="primary evaluation">
      <description>Health event/morbidity
Health event/mortality
Health care consumption and services
Quality of life/health perception
Others</description>
    </developmentActivity>
  </studyDevelopment>
  <method>
    <dataColl>
      <sampProc>Other                                                            <concept vocab="CESSDA" vocabURI="Other"/>
                                                    </sampProc>
      <sampleFrame>
        <frameUnit>
          <unitType>Through independent healthcare practitioners</unitType>
        </frameUnit>
      </sampleFrame>
      <targetSampleSize>
        <sampleSizeFormula>&lt; 500 individuals                        </sampleSizeFormula>
      </targetSampleSize>
      <collMode>Other                                                            <concept vocab="CESSDA" vocabURI="Other"/>
                                                    </collMode>
    </dataColl>
    <notes>Observational Study</notes>
    <notes subject="research type">
                        Observational Study                    </notes>
    <notes subject="observational study method">
                        Case-control study                    </notes>
    <anlyInfo>
      <respRate>188 patients included: 66 in the collective action group, 68 in the individual action group and 54 in the control group.</respRate>
    </anlyInfo>
    <stdyClas>Unknown</stdyClas>
  </method>
  <dataAccs>
    <setAvail>
      <avlStatus>
                            Restricted access                                                    </avlStatus>
    </setAvail>
    <useStmt>
      <conditions>Contact the principal investigator</conditions>
    </useStmt>
  </dataAccs>
  <othrStdyMat>
    <relMat>Access on specific project only</relMat>
  </othrStdyMat>
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<dataDscr>
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