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/NCT05966597</url>
    </required_header>
    <id_info>
      <org_study_id>MUHREC38735</org_study_id>
      <nct_id>NCT05966597</nct_id>
    </id_info>
    <brief_title>Written Behavioural Persuasion Technique Intervention for Hypertension Management</brief_title>
    <official_title>Effectiveness of Written Behavioural Persuasion Technique Intervention for Hypertension Management Among The Untreated Hypertension Population of The Community Observatory in Segamat, Johor: a 2-arm Randomised Controlled Trial Within Cohort</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Monash University Malaysia</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Monash University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Monash University Malaysia</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>
        This study aims to examine the feasibility and effectiveness of written behavioural&#xD;
        persuasion techniques intervention to encourage treatment initiation and follow-up for&#xD;
        hypertension management among the untreated hypertension population of the SEACO cohort.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Each household is given a unique identifier called house_id in the SEACO database. The&#xD;
        randomisation will be computer-generated according to their house_id with a ratio of 1:1.&#xD;
        During the house visit, participants' blood pressure will be taken three times, and the final&#xD;
        reading will be the average of the second and third readings. Participants will be assessed&#xD;
        based on the inclusion and exclusion criteria, i.e., age 35 years and above, blood pressure&#xD;
        reading and reported not being diagnosed with or treated for hypertension. At the end of the&#xD;
        house visit, all participants will receive a standard referral leaflet, and participants&#xD;
        randomised to the intervention group will receive an additional written behavioural&#xD;
        persuasion leaflet.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">March 2024</completion_date>
    <primary_completion_date type="Anticipated">March 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 see a doctor because of high blood pressure at Week 4</measure>
      <time_frame>Follow-up after 4 weeks receiving the leaflet</time_frame>
      <description>The number of participants who see a doctor because of high blood pressure within 4</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Time taken for clinic visit (week)</measure>
      <time_frame>Follow-up after 4 weeks of receiving the leaflet</time_frame>
      <description>Time taken (week) for participants to go see a doctor because of high blood pressure after receiving the leaflet</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Blood pressure status during clinic visit</measure>
      <time_frame>Follow-up after 4 weeks of receiving the leaflet</time_frame>
      <description>Participants' self-reported blood pressure status during the visit to the clinic/doctor (low, normal, high)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>12-item Health Literacy score</measure>
      <time_frame>Follow-up after 4 weeks of receiving the leaflet</time_frame>
      <description>12-item Health Literacy is a validated, self-reported instrument used to measure health literacy (HL). The index value for HL is obtained where 0 represents the lowest HL and 50 the highest HL</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Feedback on the intervention leaflet</measure>
      <time_frame>Follow-up after 4 weeks of receiving the leaflet</time_frame>
      <description>Participants in the intervention group will be asked if they remember receiving the intervention leaflet and if they find the leaflet useful to motivate them to go to the doctor for their high blood pressure. One open-ended question is added to ask which aspect of the intervention leaflet encourages them to see the doctor for high blood pressure.</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">830</enrollment>
    <condition>Hypertension</condition>
    <condition>Behavior and Behavior Mechanisms</condition>
    <arm_group>
      <arm_group_label>Written persuasive leaflet</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive a written persuasive leaflet in addition to the standard referral leaflet.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Standard referral leaflet</arm_group_label>
      <arm_group_type>Sham Comparator</arm_group_type>
      <description>Participants will receive a standard referral leaflet.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Written persuasive leaflet</intervention_name>
      <description>Additional written behavioural persuasive technique leaflet and a standard referral leaflet provided at the end of the home-based health screening.</description>
      <arm_group_label>Written persuasive leaflet</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Standard referral leaflet</intervention_name>
      <description>Standard referral leaflet provided at the end of the home-based health screening.</description>
      <arm_group_label>Standard referral leaflet</arm_group_label>
      <arm_group_label>Written persuasive leaflet</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age 35 and above&#xD;
  &#xD;
            -  Systolic blood pressure equal to or more than 140 mmHg&#xD;
  &#xD;
            -  Diastolic blood pressure equal to or more than 90 mmHg&#xD;
  &#xD;
            -  reported not being diagnosed with hypertension OR not being treated for hypertension&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Involve in other research projects&#xD;
  &#xD;
            -  decline to participate/reject&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>35 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Tin Tin Su</last_name>
      <role>Principal Investigator</role>
      <affiliation>Monash University Malaysia</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Chiew Way Ang</last_name>
      <phone>+6079310240</phone>
      <email>ang.chiewway@monash.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Hanoor Syahirah Zahari</last_name>
      <phone>+60197159359</phone>
      <email>hanoor.zahari@monash.edu</email>
    </overall_contact_backup>
    <reference>
      <citation>Duong TV, Aringazina A, Kayupova G, Nurjanah, Pham TV, Pham KM, Truong TQ, Nguyen KT, Oo WM, Su TT, Majid HA, Sorensen K, Lin IF, Chang Y, Yang SH, Chang PWS. Development and Validation of a New Short-Form Health Literacy Instrument (HLS-SF12) for the General Public in Six Asian Countries. Health Lit Res Pract. 2019 Apr 10;3(2):e91-e102. doi: 10.3928/24748307-20190225-01. eCollection 2019 Apr.</citation>
      <PMID>31294310</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 20, 2023</study_first_submitted>
    <study_first_submitted_qc>July 20, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 28, 2023</study_first_posted>
    <last_update_submitted>August 16, 2023</last_update_submitted>
    <last_update_submitted_qc>August 16, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Monash University Malaysia</investigator_affiliation>
      <investigator_full_name>Tin Tin Su</investigator_full_name>
      <investigator_title>Director of SEACO &amp; Professor Global Public Health</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Hypertension</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>There is no plan to make IPD available. The MUHREC requirement to comply with the term &quot;Retention and storage of data - The Chief Investigator is responsible for the storage and retention of the original data pertaining to the project for a minimum period of five years&quot;.</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/NCT05966597
  org study id: MUHREC38735
  nct id: NCT05966597
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  This study aims to examine the feasibility and effectiveness of written behavioural
        persuasion techniques intervention to encourage treatment initiation and follow-up for
        hypertension management among the untreated hypertension population of the SEACO cohort.
  Each household is given a unique identifier called house_id in the SEACO database. The
        randomisation will be computer-generated according to their house_id with a ratio of 1:1.
        During the house visit, participants' blood pressure will be taken three times, and the final
        reading will be the average of the second and third readings. Participants will be assessed
        based on the inclusion and exclusion criteria, i.e., age 35 years and above, blood pressure
        reading and reported not being diagnosed with or treated for hypertension. At the end of the
        house visit, all participants will receive a standard referral leaflet, and participants
        randomised to the intervention group will receive an additional written behavioural
        persuasion leaflet.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Other
  masking: None (Open Label)
  measure: Number of participants who see a doctor because of high blood pressure at Week 4
  time frame: Follow-up after 4 weeks receiving the leaflet
  description: The number of participants who see a doctor because of high blood pressure within 4
  measure: Time taken for clinic visit (week)
  time frame: Follow-up after 4 weeks of receiving the leaflet
  description: Time taken (week) for participants to go see a doctor because of high blood pressure after receiving the leaflet
  measure: Blood pressure status during clinic visit
  time frame: Follow-up after 4 weeks of receiving the leaflet
  description: Participants' self-reported blood pressure status during the visit to the clinic/doctor (low, normal, high)
  measure: 12-item Health Literacy score
  time frame: Follow-up after 4 weeks of receiving the leaflet
  description: 12-item Health Literacy is a validated, self-reported instrument used to measure health literacy (HL). The index value for HL is obtained where 0 represents the lowest HL and 50 the highest HL
  measure: Feedback on the intervention leaflet
  time frame: Follow-up after 4 weeks of receiving the leaflet
  description: Participants in the intervention group will be asked if they remember receiving the intervention leaflet and if they find the leaflet useful to motivate them to go to the doctor for their high blood pressure. One open-ended question is added to ask which aspect of the intervention leaflet encourages them to see the doctor for high blood pressure.
  arm group label: Written persuasive leaflet
  arm group type: Experimental
  description: Participants will receive a written persuasive leaflet in addition to the standard referral leaflet.
  arm group label: Standard referral leaflet
  arm group type: Sham Comparator
  description: Participants will receive a standard referral leaflet.
  intervention type: Behavioral
  intervention name: Written persuasive leaflet
  description: Additional written behavioural persuasive technique leaflet and a standard referral leaflet provided at the end of the home-based health screening.
  arm group label: Written persuasive leaflet
  intervention type: Behavioral
  intervention name: Standard referral leaflet
  description: Standard referral leaflet provided at the end of the home-based health screening.
  arm group label: Standard referral leaflet
  arm group label: Written persuasive leaflet
  criteria: 
  gender: All
  minimum age: 35 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Tin Tin Su
  role: Principal Investigator
  affiliation: Monash University Malaysia
  last name: Chiew Way Ang
  phone: +6079310240
  email: ang.chiewway@monash.edu
  last name: Hanoor Syahirah Zahari
  phone: +60197159359
  email: hanoor.zahari@monash.edu
  citation: Duong TV, Aringazina A, Kayupova G, Nurjanah, Pham TV, Pham KM, Truong TQ, Nguyen KT, Oo WM, Su TT, Majid HA, Sorensen K, Lin IF, Chang Y, Yang SH, Chang PWS. Development and Validation of a New Short-Form Health Literacy Instrument (HLS-SF12) for the General Public in Six Asian Countries. Health Lit Res Pract. 2019 Apr 10;3(2):e91-e102. doi: 10.3928/24748307-20190225-01. eCollection 2019 Apr.
  PMID: 31294310
  responsible party type: Principal Investigator
  investigator affiliation: Monash University Malaysia
  investigator full name: Tin Tin Su
  investigator title: Director of SEACO & Professor Global Public Health
  mesh term: Hypertension
  sharing ipd: No
  ipd description: There is no plan to make IPD available. The MUHREC requirement to comply with the term "Retention and storage of data - The Chief Investigator is responsible for the storage and retention of the original data pertaining to the project for a minimum period of five years".