<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/NCT04450888</url>
  </required_header>
  <id_info>
    <org_study_id>610041</org_study_id>
    <nct_id>NCT04450888</nct_id>
  </id_info>
  <brief_title>Effects of Message Framing and Time Discounting on Health Communication for Optimum Cardiovascular Disease and Stroke Prevention</brief_title>
  <acronym>EMT-OCSP</acronym>
  <official_title>Effects of Message Framing and Time Discounting on Health Communication for Optimum Cardiovascular Disease and Stroke Prevention(EMT-OCSP): a Pragmatic,Multi-centre, Observer-blinded,12-month Randomised Controlled Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>West China Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Centers for Disease Control and Prevention, China</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Beijing Tiantan Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>First Affiliated Hospital of Chongqing Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>China Stroke Databank Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>West China Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Effects of Message framing and Time discounting on heath communication for Optimum&#xD;
      Cardiovascular disease and Stroke Prevention（EMT-OCSP）is a pragmatic, 2 × 2 factorial,&#xD;
      randomized, controlled, observer blinded, multicenter trial with four parallel groups. It&#xD;
      aims to determine if risk and intervention communication strategy（gain-framed versus&#xD;
      loss-frame, long-term context versus short-term context and the potential interaction）have&#xD;
      different effect on optimizing adherence to clinical preventive management （in the endpoint&#xD;
      of CVD risk reduction）for subjects with at least one moldable risk factor for CVD.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Scientific title Effects of Message framing and Time discounting on health communication for&#xD;
      Optimum Cardiovascular disease and Stroke Prevention(EMT-OCSP): a pragmatic randomised&#xD;
      controlled study&#xD;
&#xD;
      Principal Investigator Li He&#xD;
&#xD;
      Study period 2020-07-01-2022-01-21&#xD;
&#xD;
      Hypotheses and aims When communicating cardiovascular disease（CVD）risk to individuals,&#xD;
      different presentation of information carries its own connotations and biases. The one or the&#xD;
      other pattern of the presentation may affect individuals' decision making.This study aims to&#xD;
      determine if risk and intervention communication strategy（gain-framed versus loss-frame,&#xD;
      long-term context versus short-term context and the potential interaction）have different&#xD;
      effect on optimizing adherence to clinical preventive management （in the endpoint of CVD risk&#xD;
      reduction）for subjects with at least one moldable risk factor for CVD. We aim to provide&#xD;
      evidence for practitioners regarding messaging strategies that improve communication&#xD;
      effectiveness and further reduce the risk of CVD events in the population, as well as to&#xD;
      develop more effective communication strategies for groups of people with different&#xD;
      characteristics to maximise patient adherence to lifestyle modifications and medical&#xD;
      treatment.&#xD;
&#xD;
      Primary outcome Ten-year CVD risk, lifetime CVD risk and CVD-free life expectancy after 1&#xD;
      year according to the LIFE-CVD model.&#xD;
&#xD;
      Secondary outcomes CVD risk factors [blood pressure(BP) and serum cholesterol, low-density&#xD;
      lipoprotein (LDL), non-high-density lipoprotein (HDL), triglycerides and fasting glucose&#xD;
      levels],lifestyle factors (physical activity, tobacco use, alcohol use and eating habits),&#xD;
      pharmacological treatments for hypertension, dyslipidaemia and diabetes, and anti-thrombotic&#xD;
      drug prescriptions after 1 year.&#xD;
&#xD;
      Study design The EMT-OCSP trial is designed as a pragmatic, 2 × 2 factorial, randomized,&#xD;
      controlled, observer blinded, multicenter trial with four parallel groups. Randomization will&#xD;
      be performed as block randomization with a 1:1:1:1 allocation.&#xD;
&#xD;
      Study population and sample size Subjects with at least one moldable risk factor for CVD. The&#xD;
      sample size calculations revealed that the enrolment of 15,000 participants would be&#xD;
      sufficient, allowing for a 20% drop-out rate.&#xD;
&#xD;
      Follow-up period One year&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2020</start_date>
  <completion_date type="Actual">January 22, 2022</completion_date>
  <primary_completion_date type="Actual">January 22, 2022</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>Factorial Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>10-year CVD risk</measure>
    <time_frame>At the 1-year follow-up</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Lifetime CVD risk</measure>
    <time_frame>At the 1-year follow-up</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>CVD-free life expectancy</measure>
    <time_frame>At the 1-year follow-up</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in systolic and diastolic blood pressure</measure>
    <time_frame>At the 1-year follow-up</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in serum cholesterol level</measure>
    <time_frame>At the 1-year follow-up</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in serum LDL level</measure>
    <time_frame>At the 1-year follow-up</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in serum non-HDL level</measure>
    <time_frame>At the 1-year follow-up</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in serum triglycerides level</measure>
    <time_frame>At the 1-year follow-up</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in fasting glucose level</measure>
    <time_frame>At the 1-year follow-up</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in physical activity (International Physical Activity Questionnaire or International Physical Activity Questionnaire Short Version Modified for Elderly)</measure>
    <time_frame>At the 1-year follow-up</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in tobacco use</measure>
    <time_frame>At the 1-year follow-up</time_frame>
    <description>Tobacco use status (current, former, never) in the records at visits</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in alcohol use (AUDIT questionnaire)</measure>
    <time_frame>At the 1-year follow-up</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in dietary habits (food frequency questionnaire)</measure>
    <time_frame>At the 1-year follow-up</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes adherence to pharmacological treatments for hypertension (proportion of persistent medication user）</measure>
    <time_frame>At the 1-year follow-up</time_frame>
    <description>A persistent medication user is defined as a participant who has purchased the drug at least once during each 3-month interval during our study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes adherence to pharmacological treatments for dyslipidaemia (proportion of persistent medication user）</measure>
    <time_frame>At the 1-year follow-up</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes adherence to pharmacological treatments for diabetes (proportion of persistent medication user）</measure>
    <time_frame>At the 1-year follow-up</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes adherence to anti-thrombotic therapy (proportion of persistent medication user）</measure>
    <time_frame>At the 1-year follow-up</time_frame>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">13114</enrollment>
  <condition>Cardiovascular Disease</condition>
  <condition>Stroke</condition>
  <condition>Primary Prevention</condition>
  <arm_group>
    <arm_group_label>Model A</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Total cardiovascular disease (CVD)-free life expectancy gain in one's remaining life.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Model B</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Average CVD-free life expectancy gain per year.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Model C</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Total CVD-free life expectancy loss that can be reclaimed in one's remaining life.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Model D</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Average CVD-free life expectancy loss that can be reclaimed per year.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>The strategic use of messages in risk communication</intervention_name>
    <description>The interventions in the EMT-OCSP study are strategic health messages delivered (gain-framed vs.loss-framed and long-term vs.short-term contexts) to individuals based on their calculated CVD-free life expectancy and potential interventional benefits.</description>
    <arm_group_label>Model A</arm_group_label>
    <arm_group_label>Model B</arm_group_label>
    <arm_group_label>Model C</arm_group_label>
    <arm_group_label>Model D</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  aged 45-80 years,&#xD;
&#xD;
          -  personally own and use a smartphone (Apple or Android platform) with Internet access,&#xD;
&#xD;
          -  and have at least one of the following CVD risk factors: history of CVD at age &lt; 60&#xD;
             years in a first-degree relative, smoking, diabetes, hypertension, and low-density&#xD;
             lipoprotein (LDL)cholesterol ≥ 4.5 mmol/L.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  participants with histories of CVD, heart failure, or chronic kidney disease&#xD;
             (estimated glomerular filtration rate &lt; 30 mL/min/1.73m2);&#xD;
&#xD;
          -  those with terminal malignancy at baseline;&#xD;
&#xD;
          -  those with severe psychological or mental disorders&#xD;
&#xD;
          -  violation of the study protocol and participation in another clinical study during&#xD;
             follow-up&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Li He, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>West China Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Health center of Sipo town</name>
      <address>
        <city>Yibin</city>
        <state>Sichuan</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>June 11, 2020</study_first_submitted>
  <study_first_submitted_qc>June 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 30, 2020</study_first_posted>
  <last_update_submitted>March 9, 2022</last_update_submitted>
  <last_update_submitted_qc>March 9, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 10, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>West China Hospital</investigator_affiliation>
    <investigator_full_name>Li He</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
    <mesh_term>Cardiovascular Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Researchers affiliated with the EMT-OCSP study will have access to an internal webpage listing available aggregated datasets and variables; they will not have access to individual data or the original database.External researchers collaborating with at least one steering group member may submit standardised applications for data via this webpage.Upon steering group approval, the data manager will export anonymised aggregated data to authorised researchers.</ipd_description>
    <ipd_time_frame>6 months after publication</ipd_time_frame>
  </patient_data>
  <!-- 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/NCT04450888
org study id: 610041
nct id: NCT04450888
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Effects of Message framing and Time discounting on heath communication for Optimum
      Cardiovascular disease and Stroke Prevention（EMT-OCSP）is a pragmatic, 2 × 2 factorial,
      randomized, controlled, observer blinded, multicenter trial with four parallel groups. It
      aims to determine if risk and intervention communication strategy（gain-framed versus
      loss-frame, long-term context versus short-term context and the potential interaction）have
      different effect on optimizing adherence to clinical preventive management （in the endpoint
      of CVD risk reduction）for subjects with at least one moldable risk factor for CVD.
Scientific title Effects of Message framing and Time discounting on health communication for
      Optimum Cardiovascular disease and Stroke Prevention(EMT-OCSP): a pragmatic randomised
      controlled study

      Principal Investigator Li He

      Study period 2020-07-01-2022-01-21

      Hypotheses and aims When communicating cardiovascular disease（CVD）risk to individuals,
      different presentation of information carries its own connotations and biases. The one or the
      other pattern of the presentation may affect individuals' decision making.This study aims to
      determine if risk and intervention communication strategy（gain-framed versus loss-frame,
      long-term context versus short-term context and the potential interaction）have different
      effect on optimizing adherence to clinical preventive management （in the endpoint of CVD risk
      reduction）for subjects with at least one moldable risk factor for CVD. We aim to provide
      evidence for practitioners regarding messaging strategies that improve communication
      effectiveness and further reduce the risk of CVD events in the population, as well as to
      develop more effective communication strategies for groups of people with different
      characteristics to maximise patient adherence to lifestyle modifications and medical
      treatment.

      Primary outcome Ten-year CVD risk, lifetime CVD risk and CVD-free life expectancy after 1
      year according to the LIFE-CVD model.

      Secondary outcomes CVD risk factors [blood pressure(BP) and serum cholesterol, low-density
      lipoprotein (LDL), non-high-density lipoprotein (HDL), triglycerides and fasting glucose
      levels],lifestyle factors (physical activity, tobacco use, alcohol use and eating habits),
      pharmacological treatments for hypertension, dyslipidaemia and diabetes, and anti-thrombotic
      drug prescriptions after 1 year.

      Study design The EMT-OCSP trial is designed as a pragmatic, 2 × 2 factorial, randomized,
      controlled, observer blinded, multicenter trial with four parallel groups. Randomization will
      be performed as block randomization with a 1:1:1:1 allocation.

      Study population and sample size Subjects with at least one moldable risk factor for CVD. The
      sample size calculations revealed that the enrolment of 15,000 participants would be
      sufficient, allowing for a 20% drop-out rate.

      Follow-up period One year
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: 10-year CVD risk
time frame: At the 1-year follow-up
measure: Lifetime CVD risk
time frame: At the 1-year follow-up
measure: CVD-free life expectancy
time frame: At the 1-year follow-up
measure: Changes in systolic and diastolic blood pressure
time frame: At the 1-year follow-up
measure: Changes in serum cholesterol level
time frame: At the 1-year follow-up
measure: Changes in serum LDL level
time frame: At the 1-year follow-up
measure: Changes in serum non-HDL level
time frame: At the 1-year follow-up
measure: Changes in serum triglycerides level
time frame: At the 1-year follow-up
measure: Changes in fasting glucose level
time frame: At the 1-year follow-up
measure: Changes in physical activity (International Physical Activity Questionnaire or International Physical Activity Questionnaire Short Version Modified for Elderly)
time frame: At the 1-year follow-up
measure: Changes in tobacco use
time frame: At the 1-year follow-up
description: Tobacco use status (current, former, never) in the records at visits
measure: Changes in alcohol use (AUDIT questionnaire)
time frame: At the 1-year follow-up
measure: Changes in dietary habits (food frequency questionnaire)
time frame: At the 1-year follow-up
measure: Changes adherence to pharmacological treatments for hypertension (proportion of persistent medication user）
time frame: At the 1-year follow-up
description: A persistent medication user is defined as a participant who has purchased the drug at least once during each 3-month interval during our study.
measure: Changes adherence to pharmacological treatments for dyslipidaemia (proportion of persistent medication user）
time frame: At the 1-year follow-up
measure: Changes adherence to pharmacological treatments for diabetes (proportion of persistent medication user）
time frame: At the 1-year follow-up
measure: Changes adherence to anti-thrombotic therapy (proportion of persistent medication user）
time frame: At the 1-year follow-up
arm group label: Model A
arm group type: Other
description: Total cardiovascular disease (CVD)-free life expectancy gain in one's remaining life.
arm group label: Model B
arm group type: Other
description: Average CVD-free life expectancy gain per year.
arm group label: Model C
arm group type: Other
description: Total CVD-free life expectancy loss that can be reclaimed in one's remaining life.
arm group label: Model D
arm group type: Other
description: Average CVD-free life expectancy loss that can be reclaimed per year.
intervention type: Other
intervention name: The strategic use of messages in risk communication
description: The interventions in the EMT-OCSP study are strategic health messages delivered (gain-framed vs.loss-framed and long-term vs.short-term contexts) to individuals based on their calculated CVD-free life expectancy and potential interventional benefits.
arm group label: Model A
arm group label: Model B
arm group label: Model C
arm group label: Model D
criteria: 
gender: All
minimum age: 45 Years
maximum age: 80 Years
healthy volunteers: No
last name: Li He, M.D.
role: Principal Investigator
affiliation: West China Hospital
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: West China Hospital
investigator full name: Li He
investigator title: Professor
mesh term: Stroke
mesh term: Cardiovascular Diseases
sharing ipd: Yes
ipd description: Researchers affiliated with the EMT-OCSP study will have access to an internal webpage listing available aggregated datasets and variables; they will not have access to individual data or the original database.External researchers collaborating with at least one steering group member may submit standardised applications for data via this webpage.Upon steering group approval, the data manager will export anonymised aggregated data to authorised researchers.
ipd time frame: 6 months after publication