<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02212145</url>
  </required_header>
  <id_info>
    <org_study_id>20100473</org_study_id>
    <secondary_id>2012/1172-31/1</secondary_id>
    <nct_id>NCT02212145</nct_id>
  </id_info>
  <brief_title>Follow-up of Sollentuna Prevention Program</brief_title>
  <acronym>SoPP</acronym>
  <official_title>Long-term Follow-up of an Individual and Population-based Program Aimed at Preventing Cardiovascular Disease in Sollentuna Municipality</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Karolinska Institutet</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Swedish Heart Lung Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Karolinska Institutet</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To evaluate long-term effects of one individual- and population-oriented cardiovascular&#xD;
      prevention programs in primary care.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In Sweden there are unique opportunities to create a relevant comparison group for this&#xD;
      study, which is of great importance to the value of this cohort study.&#xD;
&#xD;
      Of the three study populations two (2-3)will be created by using national registries.&#xD;
&#xD;
        1. The screened group consists of the individuals (n = 5938) who had direct contact with&#xD;
           the prevention program, ie undergone a voluntary opportunistic cardiovascular screening&#xD;
           (questionnaire, physical examination and testing in connection with visits to health&#xD;
           centers) and the rest of all individuals who lived in Sollentuna Municipality between&#xD;
           1988-1993.&#xD;
&#xD;
        2. Relatives of individuals included in the screened group who lived in Stockholm county at&#xD;
           the time of the intervention will be identified by the use of the Medical Birth Register&#xD;
           and the Multi-Generation Register. Family members are defined as parents, siblings and&#xD;
           children and husband / wife to those in thescreened group and will be analyzed in the&#xD;
           same way as those who participated in the intervention for risk of developing&#xD;
           cardiovascular disease and cancer.&#xD;
&#xD;
        3. The comparison group consists of the entire population of Stockholm County minus&#xD;
           Sollentuna 1988-93, taking into account population changes (migration, birth, death)&#xD;
           during the period.&#xD;
&#xD;
      This three populations will be followed-up in national registries and databases&#xD;
&#xD;
      All subjects will be monitored for example disease history, socio-economics and biochemical&#xD;
      risk factors presented below national registries and research databases. When all the matches&#xD;
      of national registers and a local register (AMORIS)have been done the database will&#xD;
      de-identified and anonymized data to be available for statistical processing.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>June 1988</start_date>
  <completion_date type="Anticipated">December 2016</completion_date>
  <primary_completion_date type="Anticipated">September 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Ecologic or Community</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence and mortality in acute myocardial infarction, stroke, cardiovascular disease, and overall mortality, a twenty year follow-up of a prevention program.</measure>
    <time_frame>24 years</time_frame>
    <description>Long term follow-up of a cardiovascular prevention program by using Swedish national patient registries</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>A follow-up of drug treatment of diabetes, dyslipidemia and hypertension</measure>
    <time_frame>24 years</time_frame>
    <description>By using the drug register in Sweden do a follow-up of drug treatment in the cohort</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Incidence and mortality in cancer</measure>
    <time_frame>24 years</time_frame>
    <description>Incidence and mortality in cancer - a twenty year follow-up by using the swedish cancer register</description>
  </other_outcome>
  <other_outcome>
    <measure>Consumption of medical care overall and for different diagnostic groups</measure>
    <time_frame>24 years</time_frame>
    <description>To study medical care consumption overall for different diagnostic groups by using different registers in Sweden</description>
  </other_outcome>
  <other_outcome>
    <measure>Health economic aspects</measure>
    <time_frame>24 years</time_frame>
    <description>Health economic aspects such as&#xD;
health care consumption in total and for different diagnostic groups&#xD;
care costs&#xD;
impact on indirect costs (lost working years and sick leave)&#xD;
intervention cost will be studied</description>
  </other_outcome>
  <other_outcome>
    <measure>Time trends of morbidity and mortality in acute myocardial infarction, stroke, cardiovascular disease and total mortality</measure>
    <time_frame>24 years</time_frame>
    <description>To study time trends of morbidity and mortality in acute myocardial infarction, stroke, cardiovascular disease and total mortality by use of National Swedish registries.</description>
  </other_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">1600000</enrollment>
  <condition>Cardiovascular Diseases</condition>
  <arm_group>
    <arm_group_label>Screened group</arm_group_label>
    <description>Screened group is defined as those individuals who were willing to participate in the cardiovascular prevention program and all the individuals who lived in Sollentuna during the intervention.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Relatives to the screened group</arm_group_label>
    <description>Relatives to individuals included in the screened group, who lived in Stockholm County at least during one year at the time of the intervention.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <description>Matched &quot;controls&quot; is going to be selected randomly from the population of Stockholm County minus Sollentuna Municipality with relevant background factors. The whole population will be used as a comparison group when evaluating the result from all the municipality of Sollentuna during 1988-1993.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        1. The screened group who participated in the cardiovascular prevention program:&#xD;
&#xD;
             (n=5938) and the rest of the population in Sollentuna Municipality.&#xD;
&#xD;
          2. To the screened group matched &quot;controls&quot; will be selected randomly from the population&#xD;
             of Stockholm County minus Sollentuna. The population in Sollentuna will compared to&#xD;
             the population of Stockholm County minus Sollentuna Municipality.&#xD;
&#xD;
          3. Relatives of individuals included in the intervention group and who lived in Stockholm&#xD;
             County at the time of the intervention will be identified by use of national&#xD;
             registers.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria in the risk intervention group:&#xD;
&#xD;
          -  Individuals 15 years of age or more who visited three (four) health care centres in&#xD;
             Sollentuna 1988-1993 were offered to participate in the prevention program&#xD;
&#xD;
        Exclusion Criteria in the screened intervention group:&#xD;
&#xD;
          -  Age &lt; 15 years&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gunilla Journath, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Karolinska Institutet</affiliation>
  </overall_official>
  <verification_date>January 2015</verification_date>
  <study_first_submitted>August 7, 2014</study_first_submitted>
  <study_first_submitted_qc>August 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 8, 2014</study_first_posted>
  <last_update_submitted>January 19, 2015</last_update_submitted>
  <last_update_submitted_qc>January 19, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 21, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Karolinska Institutet</investigator_affiliation>
    <investigator_full_name>Mai-Lis Hellénius, Professor</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>prevention</keyword>
  <keyword>cardiovascular disease</keyword>
  <keyword>risk factors</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiovascular Diseases</mesh_term>
  </condition_browse>
  <pending_results>
    <submitted>November 27, 2020</submitted>
    <returned>December 23, 2020</returned>
  </pending_results>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02212145
org study id: 20100473
secondary id: 2012/1172-31/1
nct id: NCT02212145
lead sponsor: 
collaborator: 
has dmc: No
To evaluate long-term effects of one individual- and population-oriented cardiovascular
      prevention programs in primary care.
In Sweden there are unique opportunities to create a relevant comparison group for this
      study, which is of great importance to the value of this cohort study.

      Of the three study populations two (2-3)will be created by using national registries.

        1. The screened group consists of the individuals (n = 5938) who had direct contact with
           the prevention program, ie undergone a voluntary opportunistic cardiovascular screening
           (questionnaire, physical examination and testing in connection with visits to health
           centers) and the rest of all individuals who lived in Sollentuna Municipality between
           1988-1993.

        2. Relatives of individuals included in the screened group who lived in Stockholm county at
           the time of the intervention will be identified by the use of the Medical Birth Register
           and the Multi-Generation Register. Family members are defined as parents, siblings and
           children and husband / wife to those in thescreened group and will be analyzed in the
           same way as those who participated in the intervention for risk of developing
           cardiovascular disease and cancer.

        3. The comparison group consists of the entire population of Stockholm County minus
           Sollentuna 1988-93, taking into account population changes (migration, birth, death)
           during the period.

      This three populations will be followed-up in national registries and databases

      All subjects will be monitored for example disease history, socio-economics and biochemical
      risk factors presented below national registries and research databases. When all the matches
      of national registers and a local register (AMORIS)have been done the database will
      de-identified and anonymized data to be available for statistical processing.
observational model: Ecologic or Community
time perspective: Retrospective
measure: Incidence and mortality in acute myocardial infarction, stroke, cardiovascular disease, and overall mortality, a twenty year follow-up of a prevention program.
time frame: 24 years
description: Long term follow-up of a cardiovascular prevention program by using Swedish national patient registries
measure: A follow-up of drug treatment of diabetes, dyslipidemia and hypertension
time frame: 24 years
description: By using the drug register in Sweden do a follow-up of drug treatment in the cohort
measure: Incidence and mortality in cancer
time frame: 24 years
description: Incidence and mortality in cancer - a twenty year follow-up by using the swedish cancer register
measure: Consumption of medical care overall and for different diagnostic groups
time frame: 24 years
description: To study medical care consumption overall for different diagnostic groups by using different registers in Sweden
measure: Health economic aspects
time frame: 24 years
description: Health economic aspects such as
health care consumption in total and for different diagnostic groups
care costs
impact on indirect costs (lost working years and sick leave)
intervention cost will be studied
measure: Time trends of morbidity and mortality in acute myocardial infarction, stroke, cardiovascular disease and total mortality
time frame: 24 years
description: To study time trends of morbidity and mortality in acute myocardial infarction, stroke, cardiovascular disease and total mortality by use of National Swedish registries.
arm group label: Screened group
description: Screened group is defined as those individuals who were willing to participate in the cardiovascular prevention program and all the individuals who lived in Sollentuna during the intervention.
arm group label: Relatives to the screened group
description: Relatives to individuals included in the screened group, who lived in Stockholm County at least during one year at the time of the intervention.
arm group label: Control group
description: Matched "controls" is going to be selected randomly from the population of Stockholm County minus Sollentuna Municipality with relevant background factors. The whole population will be used as a comparison group when evaluating the result from all the municipality of Sollentuna during 1988-1993.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 15 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Gunilla Journath, PhD
role: Principal Investigator
affiliation: Karolinska Institutet
responsible party type: Principal Investigator
investigator affiliation: Karolinska Institutet
investigator full name: Mai-Lis Hellénius, Professor
investigator title: Professor
mesh term: Cardiovascular Diseases
submitted: November 27, 2020
returned: December 23, 2020