xml: <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/NCT06030726</url>
    </required_header>
    <id_info>
      <org_study_id>NUDGE-FLU-2</org_study_id>
      <nct_id>NCT06030726</nct_id>
    </id_info>
    <brief_title>Nationwide Utilization of Danish Government Electronic Letter System for Confirming the Effectiveness of Behavioral Nudges in Increasing InFLUenza Vaccine Uptake Among Older Adults</brief_title>
    <acronym>NUDGE-FLU-2</acronym>
    <official_title>Nationwide Utilization of Danish Government Electronic Letter System for Confirming the Effectiveness of Behavioral Nudges in Increasing InFLUenza Vaccine Uptake Among Older Adults</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Tor Biering-Sørensen</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Statens Serum Institut</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Herlev and Gentofte Hospital</source>
    <oversight_info>
      <has_dmc>No</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>
        In randomized clinical trials and observational studies, influenza vaccination has been shown&#xD;
        to be effective in reducing influenza-related illness, hospitalizations, cardiovascular&#xD;
        events, and mortality in select populations. However, the real-world effectiveness of&#xD;
        influenza vaccination is limited by its uptake. Conducted during the 2022/2023 influenza&#xD;
        season, the first NUDGE-FLU trial demonstrated the effectiveness of two electronic behavioral&#xD;
        nudging letter strategies in increasing influenza vaccination rates among older adults in&#xD;
        Denmark - a letter highlighting potential cardiovascular benefits of vaccination and a&#xD;
        standard informational letter sent at baseline and repeated at day 14. This present study&#xD;
        will once again investigate whether digital behavioral nudges delivered via the official,&#xD;
        mandatory Danish electronic letter system can increase influenza vaccine uptake among older&#xD;
        adults including whether the effectiveness of previously successful strategies can be&#xD;
        confirmed during a subsequent influenza season.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The study is a prospective, randomized, open-label implementation trial. The study population&#xD;
        will consist of persons aged &gt;=65 years at January 15, 2024 - this age group is eligible for&#xD;
        free-of-charge influenza vaccination in the official Danish vaccination program. Subjects&#xD;
        will be identified through Danish nationwide health registries including the Danish Civil&#xD;
        Registration System. Individuals will be randomized to 1 of 7 arms (1 usual care arm and 6&#xD;
        intervention arms) with each testing different nudging strategies employing various&#xD;
        behavioural economic principles. The interventions will be delivered through the official,&#xD;
        mandatory Danish electronic letter system. All subject data will be retrieved from the Danish&#xD;
        nationwide registries with the exception of information on intervention allocation. Endpoints&#xD;
        will be retrieved at prespecified dates using prespecified search algorithms.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">September 15, 2023</start_date>
    <completion_date type="Anticipated">May 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">January 1, 2024</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>Other</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Number of participants who received an influenza vaccine</measure>
      <time_frame>Up to 3 months</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Time from intervention delivery to influenza vaccination</measure>
      <time_frame>Up to 3 months</time_frame>
    </secondary_outcome>
    <other_outcome>
      <measure>Number of participants with laboratory-confirmed influenza</measure>
      <time_frame>Up to 8 months</time_frame>
    </other_outcome>
    <other_outcome>
      <measure>Number of participants with a hospitalization for influenza or pneumonia</measure>
      <time_frame>Up to 8 months</time_frame>
    </other_outcome>
    <other_outcome>
      <measure>Number of participants with a hospitalization for any respiratory disease</measure>
      <time_frame>Up to 8 months</time_frame>
    </other_outcome>
    <other_outcome>
      <measure>Number of participants with a hospitalization for any cardio-respiratory disease</measure>
      <time_frame>Up to 8 months</time_frame>
    </other_outcome>
    <other_outcome>
      <measure>Number of participants with a hospitalization for any cardiovascular disease</measure>
      <time_frame>Up to 8 months</time_frame>
    </other_outcome>
    <other_outcome>
      <measure>Number of participants with any hospitalization</measure>
      <time_frame>Up to 8 months</time_frame>
    </other_outcome>
    <other_outcome>
      <measure>Total number of hospitalizations (first and recurrent)</measure>
      <time_frame>Up to 8 months</time_frame>
    </other_outcome>
    <other_outcome>
      <measure>All-cause mortality</measure>
      <time_frame>Up to 8 months</time_frame>
    </other_outcome>
    <other_outcome>
      <measure>Composite of incident heart failure, heart failure hospitalization, or cardiovascular death</measure>
      <time_frame>Up to 8 months</time_frame>
    </other_outcome>
    <other_outcome>
      <measure>Composite of myocardial infarction, stroke, or cardiovascular death</measure>
      <time_frame>Up to 8 months</time_frame>
    </other_outcome>
    <other_outcome>
      <measure>Composite of myocardial infarction, coronary revascularization, stroke, or cardiovascular death</measure>
      <time_frame>Up to 8 months</time_frame>
    </other_outcome>
    <other_outcome>
      <measure>Number of participants with incident heart failure or heart failure hospitalization</measure>
      <time_frame>Up to 8 months</time_frame>
    </other_outcome>
    <other_outcome>
      <measure>Total number of heart failure events (incident heart failure and first and recurrent heart failure hospitalizations)</measure>
      <time_frame>Up to 8 months</time_frame>
    </other_outcome>
    <other_outcome>
      <measure>Cardiovascular death</measure>
      <time_frame>Up to 8 months</time_frame>
    </other_outcome>
    <other_outcome>
      <measure>Number of participants with myocardial infarction</measure>
      <time_frame>Up to 8 months</time_frame>
    </other_outcome>
    <other_outcome>
      <measure>Number of participants with coronary revascularization</measure>
      <time_frame>Up to 8 months</time_frame>
    </other_outcome>
    <other_outcome>
      <measure>Number of participants with stroke</measure>
      <time_frame>Up to 8 months</time_frame>
    </other_outcome>
    <other_outcome>
      <measure>Number of participants with incident atrial fibrillation or atrial fibrillation hospitalization</measure>
      <time_frame>Up to 8 months</time_frame>
    </other_outcome>
    <other_outcome>
      <measure>Number of contacts to general practitioner (excluding vaccination visit)</measure>
      <time_frame>Up to 8 months</time_frame>
    </other_outcome>
    <other_outcome>
      <measure>Number of participants with laboratory-confirmed COVID-19</measure>
      <time_frame>Up to 8 months</time_frame>
    </other_outcome>
    <other_outcome>
      <measure>Number of participants with a hospitalization for COVID-19</measure>
      <time_frame>Up to 8 months</time_frame>
    </other_outcome>
    <other_outcome>
      <measure>Number of participants who received a COVID-19 vaccine</measure>
      <time_frame>Up to 3 months</time_frame>
    </other_outcome>
    <other_outcome>
      <measure>Number of participants who filled a prescription for any guideline-directed medical therapy for heart failure</measure>
      <time_frame>Up to 8 months</time_frame>
    </other_outcome>
    <other_outcome>
      <measure>Total number of filled prescriptions for guideline-directed medical therapy for heart failure</measure>
      <time_frame>Up to 8 months</time_frame>
    </other_outcome>
    <other_outcome>
      <measure>Number of participants who filled a prescription for a sodium-glucose cotransporter 2 inhibitor or glucagon-like peptide 1 receptor agonist</measure>
      <time_frame>Up to 8 months</time_frame>
    </other_outcome>
    <number_of_arms>7</number_of_arms>
    <enrollment type="Anticipated">1000000</enrollment>
    <condition>Influenza</condition>
    <condition>Behavior and Behavior Mechanisms</condition>
    <arm_group>
      <arm_group_label>Usual Care</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>No letter</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Standard Letter</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>This group will receive a standard letter on the benefits of influenza vaccination without behavioral economic enhancement</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Repeated Letter</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The standard letter sent out two times instead of once</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Cardiovascular Gain-Framing Letter</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Text added to the standard letter highlighting potential cardiovascular benefits of influenza vaccination</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Respiratory Gain-Framing Letter</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Text added to the standard letter highlighting potential respiratory disease-related benefits of influenza vaccination</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Implementation Intention Prompt Letter</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Implementation intention prompt added to the standard letter</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Loss-Framing Letter</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Text added to the standard letter highlighting potential risks of not receiving influenza vaccination</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Behavioral Economic Principles</intervention_name>
      <description>The control arm will receive no letter to reflect the background vaccination uptake. Intervention arms will test the effects of different letters developed using behavioral economic principles.</description>
      <arm_group_label>Cardiovascular Gain-Framing Letter</arm_group_label>
      <arm_group_label>Implementation Intention Prompt Letter</arm_group_label>
      <arm_group_label>Loss-Framing Letter</arm_group_label>
      <arm_group_label>Repeated Letter</arm_group_label>
      <arm_group_label>Respiratory Gain-Framing Letter</arm_group_label>
      <arm_group_label>Standard Letter</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Age &gt;=65 years at January 15, 2024 (eligible for free-of-charge influenza vaccination&#xD;
               in the Danish public health system)&#xD;
  &#xD;
            2. Access to the official, mandatory Danish electronic mailbox system&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Persons living in nursing homes (approximated as any person living at an address with&#xD;
               &gt;=6 inhabitants aged 80 years and above)&#xD;
  &#xD;
            2. Known to have already scheduled influenza vaccination appointment&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>65 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Tor Biering-Sørensen, MD, MSc, MPH, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Niklas Dyrby Johansen, MD</last_name>
      <phone>+4520204794</phone>
      <email>niklas.dyrby.johansen@regionh.dk</email>
    </overall_contact>
    <location>
      <facility>
        <name>Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte</name>
        <address>
          <city>Hellerup</city>
          <state>Hovedstaden</state>
          <zip>2900</zip>
          <country>Denmark</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Niklas Dyrby Johansen, MD</last_name>
        <phone>+4520204794</phone>
        <email>niklas.dyrby.johansen@regionh.dk</email>
      </contact>
      <contact_backup>
        <last_name>Tor Biering-Sørensen, MD, MSc, MPH, PhD</last_name>
        <phone>+4528933590</phone>
        <email>tor.biering-soerensen@regionh.dk</email>
      </contact_backup>
      <investigator>
        <last_name>Tor Biering-Sørensen, MD, MSc, MPH, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Denmark</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 31, 2023</study_first_submitted>
    <study_first_submitted_qc>September 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 11, 2023</study_first_posted>
    <last_update_submitted>September 8, 2023</last_update_submitted>
    <last_update_submitted_qc>September 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 11, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Herlev and Gentofte Hospital</investigator_affiliation>
      <investigator_full_name>Tor Biering-Sørensen</investigator_full_name>
      <investigator_title>Professor, MD, MSc, MPH, PhD</investigator_title>
    </responsible_party>
    <keyword>Influenza</keyword>
    <keyword>Vaccination</keyword>
    <keyword>Nudging</keyword>
    <keyword>Behavioral Science</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Influenza, Human</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Data will be collected from Danish administrative health registries, which are subject to Danish legislation and can only be made available to a third party under certain conditions. Please contact the sponsor-investigator in case of any inquiries.</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06030726
  org study id: NUDGE-FLU-2
  nct id: NCT06030726
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  In randomized clinical trials and observational studies, influenza vaccination has been shown
        to be effective in reducing influenza-related illness, hospitalizations, cardiovascular
        events, and mortality in select populations. However, the real-world effectiveness of
        influenza vaccination is limited by its uptake. Conducted during the 2022/2023 influenza
        season, the first NUDGE-FLU trial demonstrated the effectiveness of two electronic behavioral
        nudging letter strategies in increasing influenza vaccination rates among older adults in
        Denmark - a letter highlighting potential cardiovascular benefits of vaccination and a
        standard informational letter sent at baseline and repeated at day 14. This present study
        will once again investigate whether digital behavioral nudges delivered via the official,
        mandatory Danish electronic letter system can increase influenza vaccine uptake among older
        adults including whether the effectiveness of previously successful strategies can be
        confirmed during a subsequent influenza season.
  The study is a prospective, randomized, open-label implementation trial. The study population
        will consist of persons aged >=65 years at January 15, 2024 - this age group is eligible for
        free-of-charge influenza vaccination in the official Danish vaccination program. Subjects
        will be identified through Danish nationwide health registries including the Danish Civil
        Registration System. Individuals will be randomized to 1 of 7 arms (1 usual care arm and 6
        intervention arms) with each testing different nudging strategies employing various
        behavioural economic principles. The interventions will be delivered through the official,
        mandatory Danish electronic letter system. All subject data will be retrieved from the Danish
        nationwide registries with the exception of information on intervention allocation. Endpoints
        will be retrieved at prespecified dates using prespecified search algorithms.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Other
  masking: None (Open Label)
  measure: Number of participants who received an influenza vaccine
  time frame: Up to 3 months
  measure: Time from intervention delivery to influenza vaccination
  time frame: Up to 3 months
  measure: Number of participants with laboratory-confirmed influenza
  time frame: Up to 8 months
  measure: Number of participants with a hospitalization for influenza or pneumonia
  time frame: Up to 8 months
  measure: Number of participants with a hospitalization for any respiratory disease
  time frame: Up to 8 months
  measure: Number of participants with a hospitalization for any cardio-respiratory disease
  time frame: Up to 8 months
  measure: Number of participants with a hospitalization for any cardiovascular disease
  time frame: Up to 8 months
  measure: Number of participants with any hospitalization
  time frame: Up to 8 months
  measure: Total number of hospitalizations (first and recurrent)
  time frame: Up to 8 months
  measure: All-cause mortality
  time frame: Up to 8 months
  measure: Composite of incident heart failure, heart failure hospitalization, or cardiovascular death
  time frame: Up to 8 months
  measure: Composite of myocardial infarction, stroke, or cardiovascular death
  time frame: Up to 8 months
  measure: Composite of myocardial infarction, coronary revascularization, stroke, or cardiovascular death
  time frame: Up to 8 months
  measure: Number of participants with incident heart failure or heart failure hospitalization
  time frame: Up to 8 months
  measure: Total number of heart failure events (incident heart failure and first and recurrent heart failure hospitalizations)
  time frame: Up to 8 months
  measure: Cardiovascular death
  time frame: Up to 8 months
  measure: Number of participants with myocardial infarction
  time frame: Up to 8 months
  measure: Number of participants with coronary revascularization
  time frame: Up to 8 months
  measure: Number of participants with stroke
  time frame: Up to 8 months
  measure: Number of participants with incident atrial fibrillation or atrial fibrillation hospitalization
  time frame: Up to 8 months
  measure: Number of contacts to general practitioner (excluding vaccination visit)
  time frame: Up to 8 months
  measure: Number of participants with laboratory-confirmed COVID-19
  time frame: Up to 8 months
  measure: Number of participants with a hospitalization for COVID-19
  time frame: Up to 8 months
  measure: Number of participants who received a COVID-19 vaccine
  time frame: Up to 3 months
  measure: Number of participants who filled a prescription for any guideline-directed medical therapy for heart failure
  time frame: Up to 8 months
  measure: Total number of filled prescriptions for guideline-directed medical therapy for heart failure
  time frame: Up to 8 months
  measure: Number of participants who filled a prescription for a sodium-glucose cotransporter 2 inhibitor or glucagon-like peptide 1 receptor agonist
  time frame: Up to 8 months
  arm group label: Usual Care
  arm group type: No Intervention
  description: No letter
  arm group label: Standard Letter
  arm group type: Experimental
  description: This group will receive a standard letter on the benefits of influenza vaccination without behavioral economic enhancement
  arm group label: Repeated Letter
  arm group type: Experimental
  description: The standard letter sent out two times instead of once
  arm group label: Cardiovascular Gain-Framing Letter
  arm group type: Experimental
  description: Text added to the standard letter highlighting potential cardiovascular benefits of influenza vaccination
  arm group label: Respiratory Gain-Framing Letter
  arm group type: Experimental
  description: Text added to the standard letter highlighting potential respiratory disease-related benefits of influenza vaccination
  arm group label: Implementation Intention Prompt Letter
  arm group type: Experimental
  description: Implementation intention prompt added to the standard letter
  arm group label: Loss-Framing Letter
  arm group type: Experimental
  description: Text added to the standard letter highlighting potential risks of not receiving influenza vaccination
  intervention type: Behavioral
  intervention name: Behavioral Economic Principles
  description: The control arm will receive no letter to reflect the background vaccination uptake. Intervention arms will test the effects of different letters developed using behavioral economic principles.
  arm group label: Cardiovascular Gain-Framing Letter
  arm group label: Implementation Intention Prompt Letter
  arm group label: Loss-Framing Letter
  arm group label: Repeated Letter
  arm group label: Respiratory Gain-Framing Letter
  arm group label: Standard Letter
  criteria: 
  gender: All
  minimum age: 65 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Tor Biering-Sørensen, MD, MSc, MPH, PhD
  role: Principal Investigator
  affiliation: Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte
  last name: Niklas Dyrby Johansen, MD
  phone: +4520204794
  email: niklas.dyrby.johansen@regionh.dk
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  country: Denmark
  responsible party type: Sponsor-Investigator
  investigator affiliation: Herlev and Gentofte Hospital
  investigator full name: Tor Biering-Sørensen
  investigator title: Professor, MD, MSc, MPH, PhD
  mesh term: Influenza, Human
  sharing ipd: Yes
  ipd description: Data will be collected from Danish administrative health registries, which are subject to Danish legislation and can only be made available to a third party under certain conditions. Please contact the sponsor-investigator in case of any inquiries.