<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/NCT02223793</url>
  </required_header>
  <id_info>
    <org_study_id>2013/1660</org_study_id>
    <secondary_id>39255 (NSD)</secondary_id>
    <secondary_id>1660/2013</secondary_id>
    <nct_id>NCT02223793</nct_id>
  </id_info>
  <brief_title>Vascular Lifestyle-Intervention and Screening in Pharmacy</brief_title>
  <acronym>VISA</acronym>
  <official_title>Effects of Cardiovascular Risk Screening in Pharmacies: A Randomized Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Oslo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Tromso</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Minnesota</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Boots Norway AS</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Mills DA</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Oslo</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The overall goal of the present project is to contribute to new knowledge about the effect of&#xD;
      a low threshold population screening system for cardiovascular risk factors in Norway.&#xD;
      Further, this project aim to study if identifying high cardiovascular risk itself may lead to&#xD;
      beneficial changes in health behaviors such as physical activity, diet, tobacco and alcohol&#xD;
      behavior together with reduced risk score of cardiovascular disease, across socioeconomic&#xD;
      status. This fall, a nationwide, free screening of cardiovascular risk factors will be&#xD;
      conducted in 150 pharmacies in Norway. All participants that consent to participate will&#xD;
      measure full lipid-profile, blood pressure, HbA1c, body weight and height by health care&#xD;
      providers in pharmacies. Based on their measurement levels, participants will be stratified&#xD;
      into either a low or a high risk group. In the high risk group, participants will further be&#xD;
      randomized to either the intervention group or one of the two control groups. Participants in&#xD;
      the intervention group will be informed about all their measurement levels with comparison to&#xD;
      the recommended levels. Contrary, participants randomized to the two control groups will have&#xD;
      delayed information of their measured levels. Participants in the intervention group and the&#xD;
      first control groups will receive general oral and written information about how to lower&#xD;
      their measurement levels in 8 weeks. In the second control group, participants will not&#xD;
      receive any information at the first visit. In this way the investigators may be able to&#xD;
      isolate the effect of identifying high risk and high levels of the risk factors itself. All&#xD;
      groups will be given a diet- and physical activity questionnaire at visit 1, and will be&#xD;
      invited back after 8 weeks to once more perform the measurement screening and receive the&#xD;
      same questionnaire. At visit 2, all participants will, after the measurement screening, be&#xD;
      informed about their measured risk factors and receive information on how to lower their&#xD;
      levels. 1 year after inclusion, all participants in the three groups will be invited back for&#xD;
      a one-year follow up visit in pharmacy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      One year after inclusion, all participants that were not loss to follow up, or had their&#xD;
      consent withdrawn, were invited back to pharmacies to perform the same measurements for the&#xD;
      third time. However, at this third visit, pharmacies were randomized 1:2 to test an&#xD;
      additional intervention. Further, an extra blood sample, dried blood spot, was taken to&#xD;
      measure cholesterol, HbA1c and fatty acids.&#xD;
&#xD;
      About half of the pharmacies (n=23) communicated cardiovasular disease (CVD) risk factor&#xD;
      levels as Heart age compared to own age (British communication tool) together with tailored&#xD;
      lifestyle advices on how to reduce elevated levels. While the other 25 pharmacies&#xD;
      communicated CVD risk the usual way and gave general lifestyle advices on how to reduce CVD&#xD;
      risk. 4 weeks later, all participants took dried blood spot samples at home. We will compare&#xD;
      results from dried blood spot samples to study whether heart age and tailored lifestyle&#xD;
      advice is more effective than general information in reducing CVD risk.&#xD;
&#xD;
      The investigators will also record social security number to make connection to central&#xD;
      health registry as prescription registry, patient registry and cause of death registry after&#xD;
      2 years and 5 years.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">September 2014</start_date>
  <completion_date type="Anticipated">February 2022</completion_date>
  <primary_completion_date type="Actual">December 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Screening</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in ad Hoc Risk Score (Measure on a Scale From Min 4 to Max 14)</measure>
    <time_frame>Baseline and at 8 weeks</time_frame>
    <description>The (ad hoc) risk score was a summarization of points ranging from 0 (favorable measures) , 2 (slighly unfavourable) or 4 (very unfavorable measures) assigned for each of Total cholesterol, HDL-cholesterol, HbA1c, blood pressure, body mass index and age (age was included because presence of elevated cardiovascular disease risk factors is more alarming in younger age).&#xD;
Risk points for each risk factor was summarized into an total risk score ranging from 4 (min) to 14 (max). A total risk score of ≥4 served as inclusion criteria because it indicated moderately elevated risk of cardiovascular disease.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>8-week Change in Total Cholesterol</measure>
    <time_frame>At baseline and at 8 weeks</time_frame>
    <description>Change in total cholesterol, from date of randomization and until the end of the follow up after 8 weeks.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Effect of Heart Age and Tailord CVD Advice After 1 Year</measure>
    <time_frame>4 weeks</time_frame>
    <description>Comparing results from blood samples after 4 weeks in 23 pharmacies (enhanced CVD communication) versus 25 pharmacies (general communication of CVD risk).N</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">582</enrollment>
  <condition>Cardiovascular Diseases</condition>
  <condition>Hypercholesterolemia</condition>
  <condition>Dyslipidemia</condition>
  <condition>Hypertensive Disease</condition>
  <condition>Diabetes Mellitus, Type 2</condition>
  <arm_group>
    <arm_group_label>No information on high risk factor levels but lifestyle advice</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This arm of high risk participants will not be informed about their measured levels of the different cardiovascular risk factors at baseline. However, they will receive general information on how to lower risk factor levels in 8 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No information on high risk factor levels nor lifestyle advice</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In this arm, participants will not be informed about their measured levels of the different cardiovascular risk factors, nor receiving lifestyle advices at baseline</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Information on high risk factor levels and lifestyle advice</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This arm of high risk participants will not be informed about their measured levels of the different cardiovascular risk factors at baseline, and receive general information on how to lower risk factor levels in 8 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Information on high risk factor levels and lifestyle advice</intervention_name>
    <description>This arm of high risk participants will be informed about their measured levels of the different cardiovascular risk factors. They will also receive information on how to lower their levels in 8 weeks</description>
    <arm_group_label>Information on high risk factor levels and lifestyle advice</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>No information on high risk factor levels but lifestyle advice</intervention_name>
    <description>In this arm, participants will have delayed information on their risk factor levels, but they will receive general advices on how to lower levels in 8 weeks</description>
    <arm_group_label>No information on high risk factor levels but lifestyle advice</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>No information on high risk factor levels, nor lifestyle advice</intervention_name>
    <description>In this arm, participants will have delayed information on both their risk factor levels and general information on how to lower risk factor levels.</description>
    <arm_group_label>No information on high risk factor levels nor lifestyle advice</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Above18 years&#xD;
&#xD;
          -  Not pregnant or lactating&#xD;
&#xD;
          -  Not previous cardiovascular events nor treatment related to cardiovascular disease&#xD;
             ((myocardial infarction, stroke, angina pectoris, coronary artery bypass, -&#xD;
             Percutaneous coronary intervention, diabetes type 1 and 2)&#xD;
&#xD;
          -  No use of cholesterol lowering medication, bloodpressure lowering medication,&#xD;
             bloodsugar lowering medication or medication related to diabetes&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Below18 years&#xD;
&#xD;
          -  Pregnant or lactating&#xD;
&#xD;
          -  Previous cardiovascular events nor treatment related to cardiovascular disease&#xD;
             (myocardial infarction, stroke, angina pectoris, coronary artery bypass,&#xD;
&#xD;
          -  Percutaneous coronary intervention, diabetes type 1 and 2)&#xD;
&#xD;
          -  Use of cholesterol lowering medication, bloodpressure lowering medication, bloodsugar&#xD;
             lowering medication or medication related to diabetes&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Karianne Svendsen, M.Sc.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Oslo</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Oslo</name>
      <address>
        <city>Oslo</city>
        <state>P.B. 1046 Blinderen</state>
        <zip>0317</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>August 18, 2014</study_first_submitted>
  <study_first_submitted_qc>August 20, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 22, 2014</study_first_posted>
  <results_first_submitted>September 17, 2018</results_first_submitted>
  <results_first_submitted_qc>October 2, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">October 3, 2019</results_first_posted>
  <last_update_submitted>April 23, 2020</last_update_submitted>
  <last_update_submitted_qc>April 23, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 6, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Oslo</investigator_affiliation>
    <investigator_full_name>Karianne Svendsen</investigator_full_name>
    <investigator_title>PHD student</investigator_title>
  </responsible_party>
  <keyword>Vascular screening</keyword>
  <keyword>Cardiovascular risk factors</keyword>
  <keyword>Blood pressure</keyword>
  <keyword>Lipids</keyword>
  <keyword>Lifestyle</keyword>
  <keyword>Identifying unknown risk</keyword>
  <keyword>Low socioeconomic status</keyword>
  <keyword>low threshold</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiovascular Diseases</mesh_term>
    <mesh_term>Hypertension</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
    <mesh_term>Hypercholesterolemia</mesh_term>
    <mesh_term>Dyslipidemias</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>No Information on High Risk Factor Levels But Lifestyle Advice</title>
          <description>This arm of high risk participants will not be informed about their measured levels of the different cardiovascular risk factors at baseline. However, they will receive general information on how to lower risk factor levels in 8 weeks&#xD;
No information on high risk factor levels but lifestyle advice: In this arm, participants will have delayed information on their risk factor levels, but they will receive general advices on how to lower levels in 8 weeks</description>
        </group>
        <group group_id="P2">
          <title>No Information on High Risk Factor Levels Nor Lifestyle Advice</title>
          <description>In this arm, participants will not be informed about their measured levels of the different cardiovascular risk factors, nor receiving lifestyle advices at baseline&#xD;
No information on high risk factor levels, nor lifestyle advice: In this arm, participants will have delayed information on both their risk factor levels and general information on how to lower risk factor levels.</description>
        </group>
        <group group_id="P3">
          <title>Information on High Risk Factor Levels and Lifestyle Advice</title>
          <description>This arm of high risk participants will not be informed about their measured levels of the different cardiovascular risk factors at baseline, and receive general information on how to lower risk factor levels in 8 weeks&#xD;
Information on high risk factor levels and lifestyle advice: This arm of high risk participants will be informed about their measured levels of the different cardiovascular risk factors. They will also receive information on how to lower their levels in 8 weeks</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="185"/>
                <participants group_id="P2" count="199"/>
                <participants group_id="P3" count="198"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="168"/>
                <participants group_id="P2" count="190"/>
                <participants group_id="P3" count="185"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="17"/>
                <participants group_id="P2" count="9"/>
                <participants group_id="P3" count="13"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Moved/studycenter unable to participate</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="8"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>No Information on High Risk Factor Levels But Lifestyle Advice</title>
          <description>This arm of high risk participants will not be informed about their measured levels of the different cardiovascular risk factors at baseline. However, they will receive general information on how to lower risk factor levels in 8 weeks&#xD;
No information on high risk factor levels but lifestyle advice: In this arm, participants will have delayed information on their risk factor levels, but they will receive general advices on how to lower levels in 8 weeks</description>
        </group>
        <group group_id="B2">
          <title>No Information on High Risk Factor Levels Nor Lifestyle Advice</title>
          <description>In this arm, participants will not be informed about their measured levels of the different cardiovascular risk factors, nor receiving lifestyle advices at baseline&#xD;
No information on high risk factor levels, nor lifestyle advice: In this arm, participants will have delayed information on both their risk factor levels and general information on how to lower risk factor levels.</description>
        </group>
        <group group_id="B3">
          <title>Information on High Risk Factor Levels and Lifestyle Advice</title>
          <description>This arm of high risk participants will not be informed about their measured levels of the different cardiovascular risk factors at baseline, and receive general information on how to lower risk factor levels in 8 weeks&#xD;
Information on high risk factor levels and lifestyle advice: This arm of high risk participants will be informed about their measured levels of the different cardiovascular risk factors. They will also receive information on how to lower their levels in 8 weeks</description>
        </group>
        <group group_id="B4">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="185"/>
            <count group_id="B2" value="199"/>
            <count group_id="B3" value="198"/>
            <count group_id="B4" value="582"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="113"/>
                    <measurement group_id="B2" value="124"/>
                    <measurement group_id="B3" value="131"/>
                    <measurement group_id="B4" value="368"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="72"/>
                    <measurement group_id="B2" value="75"/>
                    <measurement group_id="B3" value="67"/>
                    <measurement group_id="B4" value="214"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="57.4" spread="14.6"/>
                    <measurement group_id="B2" value="56.5" spread="15.5"/>
                    <measurement group_id="B3" value="55.7" spread="14.4"/>
                    <measurement group_id="B4" value="56.5" spread="14.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="140"/>
                    <measurement group_id="B2" value="136"/>
                    <measurement group_id="B3" value="141"/>
                    <measurement group_id="B4" value="417"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="45"/>
                    <measurement group_id="B2" value="63"/>
                    <measurement group_id="B3" value="57"/>
                    <measurement group_id="B4" value="165"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Norway</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="185"/>
                    <measurement group_id="B2" value="199"/>
                    <measurement group_id="B3" value="198"/>
                    <measurement group_id="B4" value="582"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ad hoc risk score</title>
          <description>Ad hoc riskscore IS a summarization of scores ranging from zero (favorablemeasures) to four (very unfavorable measures), assigned for each of TC, HDL-C, HbA1c, blood pressure, BMI and age. A risk score of≥4 served as inclusion criteria because it indicated moderately elevated risk of CVD (minimum score). Maximum score was 14.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5.2" spread="1.3"/>
                    <measurement group_id="B2" value="5.4" spread="1.5"/>
                    <measurement group_id="B3" value="5.4" spread="1.5"/>
                    <measurement group_id="B4" value="5.3" spread="1.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in ad Hoc Risk Score (Measure on a Scale From Min 4 to Max 14)</title>
        <description>The (ad hoc) risk score was a summarization of points ranging from 0 (favorable measures) , 2 (slighly unfavourable) or 4 (very unfavorable measures) assigned for each of Total cholesterol, HDL-cholesterol, HbA1c, blood pressure, body mass index and age (age was included because presence of elevated cardiovascular disease risk factors is more alarming in younger age).&#xD;
Risk points for each risk factor was summarized into an total risk score ranging from 4 (min) to 14 (max). A total risk score of ≥4 served as inclusion criteria because it indicated moderately elevated risk of cardiovascular disease.</description>
        <time_frame>Baseline and at 8 weeks</time_frame>
        <population>Between groups analysis</population>
        <group_list>
          <group group_id="O1">
            <title>No Information on High Risk Factor Levels But Lifestyle Advice</title>
            <description>This arm of high risk participants will not be informed about their measured levels of the different cardiovascular risk factors at baseline. However, they will receive general information on how to lower risk factor levels in 8 weeks&#xD;
No information on high risk factor levels but lifestyle advice: In this arm, participants will have delayed information on their risk factor levels, but they will receive general advices on how to lower levels in 8 weeks</description>
          </group>
          <group group_id="O2">
            <title>No Information on High Risk Factor Levels Nor Lifestyle Advice</title>
            <description>In this arm, participants will not be informed about their measured levels of the different cardiovascular risk factors, nor receiving lifestyle advices at baseline&#xD;
No information on high risk factor levels, nor lifestyle advice: In this arm, participants will have delayed information on both their risk factor levels and general information on how to lower risk factor levels.</description>
          </group>
          <group group_id="O3">
            <title>Information on High Risk Factor Levels and Lifestyle Advice</title>
            <description>This arm of high risk participants will not be informed about their measured levels of the different cardiovascular risk factors at baseline, and receive general information on how to lower risk factor levels in 8 weeks&#xD;
Information on high risk factor levels and lifestyle advice: This arm of high risk participants will be informed about their measured levels of the different cardiovascular risk factors. They will also receive information on how to lower their levels in 8 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Change in ad Hoc Risk Score (Measure on a Scale From Min 4 to Max 14)</title>
          <description>The (ad hoc) risk score was a summarization of points ranging from 0 (favorable measures) , 2 (slighly unfavourable) or 4 (very unfavorable measures) assigned for each of Total cholesterol, HDL-cholesterol, HbA1c, blood pressure, body mass index and age (age was included because presence of elevated cardiovascular disease risk factors is more alarming in younger age).&#xD;
Risk points for each risk factor was summarized into an total risk score ranging from 4 (min) to 14 (max). A total risk score of ≥4 served as inclusion criteria because it indicated moderately elevated risk of cardiovascular disease.</description>
          <population>Between groups analysis</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="185"/>
                <count group_id="O2" value="199"/>
                <count group_id="O3" value="198"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.71" lower_limit="-0.99" upper_limit="-0.44"/>
                    <measurement group_id="O2" value="-0.76" lower_limit="-1.02" upper_limit="-0.5"/>
                    <measurement group_id="O3" value="-0.36" lower_limit="-0.62" upper_limit="-0.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>8-week Change in Total Cholesterol</title>
        <description>Change in total cholesterol, from date of randomization and until the end of the follow up after 8 weeks.</description>
        <time_frame>At baseline and at 8 weeks</time_frame>
        <population>Difference between three groups.</population>
        <group_list>
          <group group_id="O1">
            <title>No Information on High Risk Factor Levels But Lifestyle Advice</title>
            <description>This arm of high risk participants will not be informed about their measured levels of the different cardiovascular risk factors at baseline. However, they will receive general information on how to lower risk factor levels in 8 weeks&#xD;
No information on high risk factor levels but lifestyle advice: In this arm, participants will have delayed information on their risk factor levels, but they will receive general advices on how to lower levels in 8 weeks</description>
          </group>
          <group group_id="O2">
            <title>No Information on High Risk Factor Levels Nor Lifestyle Advice</title>
            <description>In this arm, participants will not be informed about their measured levels of the different cardiovascular risk factors, nor receiving lifestyle advices at baseline&#xD;
No information on high risk factor levels, nor lifestyle advice: In this arm, participants will have delayed information on both their risk factor levels and general information on how to lower risk factor levels.</description>
          </group>
          <group group_id="O3">
            <title>Information on High Risk Factor Levels and Lifestyle Advice</title>
            <description>This arm of high risk participants will not be informed about their measured levels of the different cardiovascular risk factors at baseline, and receive general information on how to lower risk factor levels in 8 weeks&#xD;
Information on high risk factor levels and lifestyle advice: This arm of high risk participants will be informed about their measured levels of the different cardiovascular risk factors. They will also receive information on how to lower their levels in 8 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>8-week Change in Total Cholesterol</title>
          <description>Change in total cholesterol, from date of randomization and until the end of the follow up after 8 weeks.</description>
          <population>Difference between three groups.</population>
          <units>mmol/L</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="168"/>
                <count group_id="O2" value="190"/>
                <count group_id="O3" value="185"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.12" lower_limit="-0.23" upper_limit="-0.06"/>
                    <measurement group_id="O2" value="-0.16" lower_limit="-0.31" upper_limit="-0.02"/>
                    <measurement group_id="O3" value="-0.08" lower_limit="-0.23" upper_limit="0.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Effect of Heart Age and Tailord CVD Advice After 1 Year</title>
        <description>Comparing results from blood samples after 4 weeks in 23 pharmacies (enhanced CVD communication) versus 25 pharmacies (general communication of CVD risk).N</description>
        <time_frame>4 weeks</time_frame>
        <posting_date>04/2020</posting_date>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse effects were collected during the study periode (1 year and 2 months)- between start of study (september 2014) and end of study (november 2015).</time_frame>
      <desc>Definition do not differ. adverse event collection was non-systematically where the subjects were adviced to contact PI or study coordinator.</desc>
      <group_list>
        <group group_id="E1">
          <title>No Information on High Risk Factor Levels But Lifestyle Advice</title>
          <description>This arm of high risk participants will not be informed about their measured levels of the different cardiovascular risk factors at baseline. However, they will receive general information on how to lower risk factor levels in 8 weeks&#xD;
No information on high risk factor levels but lifestyle advice: In this arm, participants will have delayed information on their risk factor levels, but they will receive general advices on how to lower levels in 8 weeks</description>
        </group>
        <group group_id="E2">
          <title>No Information on High Risk Factor Levels Nor Lifestyle Advice</title>
          <description>In this arm, participants will not be informed about their measured levels of the different cardiovascular risk factors, nor receiving lifestyle advices at baseline&#xD;
No information on high risk factor levels, nor lifestyle advice: In this arm, participants will have delayed information on both their risk factor levels and general information on how to lower risk factor levels.</description>
        </group>
        <group group_id="E3">
          <title>Information on High Risk Factor Levels and Lifestyle Advice</title>
          <description>This arm of high risk participants will not be informed about their measured levels of the different cardiovascular risk factors at baseline, and receive general information on how to lower risk factor levels in 8 weeks&#xD;
Information on high risk factor levels and lifestyle advice: This arm of high risk participants will be informed about their measured levels of the different cardiovascular risk factors. They will also receive information on how to lower their levels in 8 weeks</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="185"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="199"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="198"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="185"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="199"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="198"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="185"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="199"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="198"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Karianne Svendsen</name_or_title>
      <organization>University of Oslo</organization>
      <phone>+4795026445</phone>
      <email>karianne.svendsen@medisin.uio.no</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02223793
org study id: 2013/1660
secondary id: 39255 (NSD)
secondary id: 1660/2013
nct id: NCT02223793
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
The overall goal of the present project is to contribute to new knowledge about the effect of
      a low threshold population screening system for cardiovascular risk factors in Norway.
      Further, this project aim to study if identifying high cardiovascular risk itself may lead to
      beneficial changes in health behaviors such as physical activity, diet, tobacco and alcohol
      behavior together with reduced risk score of cardiovascular disease, across socioeconomic
      status. This fall, a nationwide, free screening of cardiovascular risk factors will be
      conducted in 150 pharmacies in Norway. All participants that consent to participate will
      measure full lipid-profile, blood pressure, HbA1c, body weight and height by health care
      providers in pharmacies. Based on their measurement levels, participants will be stratified
      into either a low or a high risk group. In the high risk group, participants will further be
      randomized to either the intervention group or one of the two control groups. Participants in
      the intervention group will be informed about all their measurement levels with comparison to
      the recommended levels. Contrary, participants randomized to the two control groups will have
      delayed information of their measured levels. Participants in the intervention group and the
      first control groups will receive general oral and written information about how to lower
      their measurement levels in 8 weeks. In the second control group, participants will not
      receive any information at the first visit. In this way the investigators may be able to
      isolate the effect of identifying high risk and high levels of the risk factors itself. All
      groups will be given a diet- and physical activity questionnaire at visit 1, and will be
      invited back after 8 weeks to once more perform the measurement screening and receive the
      same questionnaire. At visit 2, all participants will, after the measurement screening, be
      informed about their measured risk factors and receive information on how to lower their
      levels. 1 year after inclusion, all participants in the three groups will be invited back for
      a one-year follow up visit in pharmacy.
One year after inclusion, all participants that were not loss to follow up, or had their
      consent withdrawn, were invited back to pharmacies to perform the same measurements for the
      third time. However, at this third visit, pharmacies were randomized 1:2 to test an
      additional intervention. Further, an extra blood sample, dried blood spot, was taken to
      measure cholesterol, HbA1c and fatty acids.

      About half of the pharmacies (n=23) communicated cardiovasular disease (CVD) risk factor
      levels as Heart age compared to own age (British communication tool) together with tailored
      lifestyle advices on how to reduce elevated levels. While the other 25 pharmacies
      communicated CVD risk the usual way and gave general lifestyle advices on how to reduce CVD
      risk. 4 weeks later, all participants took dried blood spot samples at home. We will compare
      results from dried blood spot samples to study whether heart age and tailored lifestyle
      advice is more effective than general information in reducing CVD risk.

      The investigators will also record social security number to make connection to central
      health registry as prescription registry, patient registry and cause of death registry after
      2 years and 5 years.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Screening
masking: Single (Participant)
measure: Change in ad Hoc Risk Score (Measure on a Scale From Min 4 to Max 14)
time frame: Baseline and at 8 weeks
description: The (ad hoc) risk score was a summarization of points ranging from 0 (favorable measures) , 2 (slighly unfavourable) or 4 (very unfavorable measures) assigned for each of Total cholesterol, HDL-cholesterol, HbA1c, blood pressure, body mass index and age (age was included because presence of elevated cardiovascular disease risk factors is more alarming in younger age).
Risk points for each risk factor was summarized into an total risk score ranging from 4 (min) to 14 (max). A total risk score of ≥4 served as inclusion criteria because it indicated moderately elevated risk of cardiovascular disease.
measure: 8-week Change in Total Cholesterol
time frame: At baseline and at 8 weeks
description: Change in total cholesterol, from date of randomization and until the end of the follow up after 8 weeks.
measure: Effect of Heart Age and Tailord CVD Advice After 1 Year
time frame: 4 weeks
description: Comparing results from blood samples after 4 weeks in 23 pharmacies (enhanced CVD communication) versus 25 pharmacies (general communication of CVD risk).N
arm group label: No information on high risk factor levels but lifestyle advice
arm group type: Experimental
description: This arm of high risk participants will not be informed about their measured levels of the different cardiovascular risk factors at baseline. However, they will receive general information on how to lower risk factor levels in 8 weeks
arm group label: No information on high risk factor levels nor lifestyle advice
arm group type: Experimental
description: In this arm, participants will not be informed about their measured levels of the different cardiovascular risk factors, nor receiving lifestyle advices at baseline
arm group label: Information on high risk factor levels and lifestyle advice
arm group type: Experimental
description: This arm of high risk participants will not be informed about their measured levels of the different cardiovascular risk factors at baseline, and receive general information on how to lower risk factor levels in 8 weeks
intervention type: Behavioral
intervention name: Information on high risk factor levels and lifestyle advice
description: This arm of high risk participants will be informed about their measured levels of the different cardiovascular risk factors. They will also receive information on how to lower their levels in 8 weeks
arm group label: Information on high risk factor levels and lifestyle advice
intervention type: Behavioral
intervention name: No information on high risk factor levels but lifestyle advice
description: In this arm, participants will have delayed information on their risk factor levels, but they will receive general advices on how to lower levels in 8 weeks
arm group label: No information on high risk factor levels but lifestyle advice
intervention type: Behavioral
intervention name: No information on high risk factor levels, nor lifestyle advice
description: In this arm, participants will have delayed information on both their risk factor levels and general information on how to lower risk factor levels.
arm group label: No information on high risk factor levels nor lifestyle advice
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Karianne Svendsen, M.Sc.
role: Principal Investigator
affiliation: University of Oslo
facility: 
country: Norway
responsible party type: Principal Investigator
investigator affiliation: University of Oslo
investigator full name: Karianne Svendsen
investigator title: PHD student
mesh term: Cardiovascular Diseases
mesh term: Hypertension
mesh term: Diabetes Mellitus, Type 2
mesh term: Hypercholesterolemia
mesh term: Dyslipidemias
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 