<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/NCT02972619</url>
  </required_header>
  <id_info>
    <org_study_id>NMRC/CSA-SI/0005/2015</org_study_id>
    <nct_id>NCT02972619</nct_id>
  </id_info>
  <brief_title>Management of Hypertension and Multiple Risk Factors to Enhance Cardiovascular Health</brief_title>
  <official_title>Management of Hypertension and Multiple Risk Factors to Enhance Cardiovascular Health - A Cluster Randomized Trial in Singapore Polyclinics</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Duke-NUS Graduate Medical School</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>SingHealth Polyclinics</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Duke-NUS Graduate Medical School</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background: Hypertension is a serious public health problem responsible for significant&#xD;
      mortality and morbidity from cardiovascular disease. In Singapore, 1 in 4 adults age 30 years&#xD;
      or older suffer from hypertension. Nearly half of these patients have uncontrolled&#xD;
      hypertension and only 50% of individuals are on antihypertensive treatment. Our study aims to&#xD;
      evaluate the effectiveness, cost effectiveness and impact on medication adherence of a&#xD;
      well-structured program using multicomponent intervention for hypertension control aimed at&#xD;
      overall cardiovascular risk reduction among individuals with hypertension attending the&#xD;
      polyclinics in Singapore, compared to existing services. Such a program is expected to be&#xD;
      cost-effective in terms of improving hypertensive individuals' outcomes, and to be&#xD;
      potentially scalable and sustainable.&#xD;
&#xD;
      Methods/design: Cluster randomized trial of 8 of the nine SingHealth Polyclinics randomized&#xD;
      to intervention or usual care (4 each) and followed up for 2 years post randomization&#xD;
&#xD;
      Intervention: The structured multicomponent primary care program comprises of: 1)&#xD;
      algorithm-driven antihypertensive treatment for all hypertensive individuals and using&#xD;
      fixed-dose combination (FDC) and lipid-lowering medication for high-risk hypertensive&#xD;
      individuals, 2) motivational conversation for high-risk hypertensive individuals, 3)&#xD;
      Follow-up of all hypertensive individuals on improving blood pressure (BP) as a primary&#xD;
      outcome and other cardiovascular risk factors as a secondary outcome, and 4) discounts on FDC&#xD;
      antihypertensive medication&#xD;
&#xD;
      Usual care: The participants attending polyclinics randomized to usual care will continue to&#xD;
      receive treatment from the health providers according to existing practices. The hypertensive&#xD;
      individuals will also continue to pay for the services (physician or nurse consultation) as&#xD;
      per their existing model of reimbursement.&#xD;
&#xD;
      Participants: A total of 1000 participants will be recruited, 125 from each of the 8&#xD;
      polyclinics. Recruitment will be in batches of 4 and 4 clinics sequentially (balanced by&#xD;
      randomization group).&#xD;
&#xD;
      Outcomes: All hypertensive individuals will be assessed by trained outcomes assessors&#xD;
      independent to treatment at baseline, 1-year and 2-yeat post randomization. The primary&#xD;
      outcome will be the change in systolic blood pressure from baseline to 2 years. Primary&#xD;
      Cost-Effectiveness measures will be- 1) Incremental cost per mm Hg systolic BP reduction from&#xD;
      baseline to end of follow-up at two years post randomization; 2) incremental cost per&#xD;
      projected CVD disability adjusted life years (DALYs) averted and quality adjusted life years&#xD;
      (QALYs) saved, and 3) incremental cost per change in cardiovascular risk score from baseline&#xD;
      to final follow-up at two-year post. The impact of effect on adherence to antihypertensive&#xD;
      and lipid medication will be measured using data on adherence obtained from polyclinic&#xD;
      pharmacy records and clinic notes. An average of percent adherence to antihypertensive and&#xD;
      lipid lowering will be computed as a composite score. The change in percent composite&#xD;
      adherence to antihypertensive and lipid medications from baseline to follow up will be&#xD;
      compared between the intervention and control groups.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 15, 2017</start_date>
  <completion_date type="Anticipated">March 15, 2020</completion_date>
  <primary_completion_date type="Anticipated">March 15, 2020</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>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Systolic Blood Pressure from baseline to final follow-up at 24 months</measure>
    <time_frame>Baseline to 2 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in serum LDL from baseline to final follow-up at 24 months</measure>
    <time_frame>Baseline to 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of hypertensive individuals with BP controlled to target or &gt; 5 mm Hg decrease in systolic BP</measure>
    <time_frame>Baseline to 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of hypertensive individuals with decrease in LDL cholesterol by &gt;0.4 mmol/L (&gt;15 mg/dl).</measure>
    <time_frame>Baseline to 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Composite outcome of death or hospital admission due to Coronary heart disease (CHD), heart failure, or stroke</measure>
    <time_frame>2years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Individual outcomes of all-cause mortality, Cardiovascular disease (CVD) deaths, and hospital admission due to CHD, heart failure, or stroke</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Decrease of &gt; 0.5 percent in glycated hemoglobin or change in proportion of hypertensive individuals with glycated hemoglobin &lt;7% in hypertensive individuals with diabetes</measure>
    <time_frame>Baseline to 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in albuminuria from baseline to follow-up at 24 months</measure>
    <time_frame>Baseline to 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in estimated CKD-EPI GFR from baseline to follow-up at 24 months</measure>
    <time_frame>Baseline - 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in cardiovascular disease (CVD) risk score</measure>
    <time_frame>Baseline - 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Individual outcomes of change in a) diastolic BP and b) total cholesterol from baseline to end of follow-up at 24 months</measure>
    <time_frame>Baseline to follow-up 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in lifestyle (diet, physical activity based on self-report) or BMI between groups</measure>
    <time_frame>Baseline to 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in systolic blood pressure from baseline to 12 months</measure>
    <time_frame>Baseline to 1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in serum LDL cholesterol from baseline to 12 months</measure>
    <time_frame>Baseline to 1 year</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">1000</enrollment>
  <condition>Hypertension</condition>
  <condition>Cardiovascular Disease</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Structured multicomponent intervention (MCI)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Control group receive usual care in the polyclinics</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Structured Multicomponent Intervention (MCI)</intervention_name>
    <description>Multicomponent Intervention (MCI) includes 1) algorithm-driven antihypertensive treatment for all hypertensive individuals using fixed-dose combination (FDC) and lipid lowering for high risk hypertensive individuals, 2) motivational conversation for high-risk hypertensive individuals and 3) telephone based follow-ups of all hypertensive individuals by a team of physician supervised nurse, and 4) discounts on FDC antihypertensive medications</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  40 years or older&#xD;
&#xD;
          -  Singapore citizens or Permanent Residents&#xD;
&#xD;
          -  Visiting the recruiting polyclinic at least twice during the last 1 year&#xD;
&#xD;
          -  Individuals with a diagnosis of hypertension (systolic BP ≥ 140 mm Hg or diastolic BP&#xD;
             ≥ 90 mm Hg on two or more prior visits; physician diagnosed hypertension, or on&#xD;
             antihypertensive medications) and uncontrolled blood pressure (systolic BP ≥ 140 mm Hg&#xD;
             or diastolic BP ≥ 90 mm Hg)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Active systemic illness including fever, recent hospitalization (i.e. during last 4&#xD;
             months),&#xD;
&#xD;
          -  Clinically unstable heart failure or advanced kidney disease {estimated CKD-Epi&#xD;
             glomerular filtration rate (GFR) &lt;40 ml/min/1.73m2 or nephrotic range proteinuria&#xD;
             (i.e. 3g/d or more)},&#xD;
&#xD;
          -  Known liver disease,&#xD;
&#xD;
          -  Pregnancy or breastfeeding&#xD;
&#xD;
          -  Any other major debilitating disease or mental illness that precludes validity of&#xD;
             informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dr Tazeen Jafar, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Duke-NUS Graduate Medical School</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Dr Tazeen Jafar, MD</last_name>
    <phone>+6566012582</phone>
    <email>tazeen.jafar@duke-nus.edu.sg</email>
  </overall_contact>
  <location>
    <facility>
      <name>SingHealth Polyclinics (SHP)</name>
      <address>
        <city>Singapore</city>
        <zip>150167</zip>
        <country>Singapore</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dr Ngaip Chuan Tan</last_name>
      <email>tan.ngiap.chuan@singhealth.com.sg</email>
    </contact>
  </location>
  <location_countries>
    <country>Singapore</country>
  </location_countries>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>November 20, 2016</study_first_submitted>
  <study_first_submitted_qc>November 21, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 23, 2016</study_first_posted>
  <last_update_submitted>January 30, 2018</last_update_submitted>
  <last_update_submitted_qc>January 30, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 1, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Duke-NUS Graduate Medical School</investigator_affiliation>
    <investigator_full_name>Professor Tazeen Jafar</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Blood Pressure</keyword>
  <keyword>Lipids</keyword>
  <keyword>Cardiovascular</keyword>
  <keyword>Health Services</keyword>
  <keyword>Hypertension</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension</mesh_term>
    <mesh_term>Cardiovascular Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT02972619
org study id: NMRC/CSA-SI/0005/2015
nct id: NCT02972619
lead sponsor: 
collaborator: 
has dmc: Yes
Background: Hypertension is a serious public health problem responsible for significant
      mortality and morbidity from cardiovascular disease. In Singapore, 1 in 4 adults age 30 years
      or older suffer from hypertension. Nearly half of these patients have uncontrolled
      hypertension and only 50% of individuals are on antihypertensive treatment. Our study aims to
      evaluate the effectiveness, cost effectiveness and impact on medication adherence of a
      well-structured program using multicomponent intervention for hypertension control aimed at
      overall cardiovascular risk reduction among individuals with hypertension attending the
      polyclinics in Singapore, compared to existing services. Such a program is expected to be
      cost-effective in terms of improving hypertensive individuals' outcomes, and to be
      potentially scalable and sustainable.

      Methods/design: Cluster randomized trial of 8 of the nine SingHealth Polyclinics randomized
      to intervention or usual care (4 each) and followed up for 2 years post randomization

      Intervention: The structured multicomponent primary care program comprises of: 1)
      algorithm-driven antihypertensive treatment for all hypertensive individuals and using
      fixed-dose combination (FDC) and lipid-lowering medication for high-risk hypertensive
      individuals, 2) motivational conversation for high-risk hypertensive individuals, 3)
      Follow-up of all hypertensive individuals on improving blood pressure (BP) as a primary
      outcome and other cardiovascular risk factors as a secondary outcome, and 4) discounts on FDC
      antihypertensive medication

      Usual care: The participants attending polyclinics randomized to usual care will continue to
      receive treatment from the health providers according to existing practices. The hypertensive
      individuals will also continue to pay for the services (physician or nurse consultation) as
      per their existing model of reimbursement.

      Participants: A total of 1000 participants will be recruited, 125 from each of the 8
      polyclinics. Recruitment will be in batches of 4 and 4 clinics sequentially (balanced by
      randomization group).

      Outcomes: All hypertensive individuals will be assessed by trained outcomes assessors
      independent to treatment at baseline, 1-year and 2-yeat post randomization. The primary
      outcome will be the change in systolic blood pressure from baseline to 2 years. Primary
      Cost-Effectiveness measures will be- 1) Incremental cost per mm Hg systolic BP reduction from
      baseline to end of follow-up at two years post randomization; 2) incremental cost per
      projected CVD disability adjusted life years (DALYs) averted and quality adjusted life years
      (QALYs) saved, and 3) incremental cost per change in cardiovascular risk score from baseline
      to final follow-up at two-year post. The impact of effect on adherence to antihypertensive
      and lipid medication will be measured using data on adherence obtained from polyclinic
      pharmacy records and clinic notes. An average of percent adherence to antihypertensive and
      lipid lowering will be computed as a composite score. The change in percent composite
      adherence to antihypertensive and lipid medications from baseline to follow up will be
      compared between the intervention and control groups.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Change in Systolic Blood Pressure from baseline to final follow-up at 24 months
time frame: Baseline to 2 years
measure: Change in serum LDL from baseline to final follow-up at 24 months
time frame: Baseline to 2 years
measure: Proportion of hypertensive individuals with BP controlled to target or > 5 mm Hg decrease in systolic BP
time frame: Baseline to 2 years
measure: Proportion of hypertensive individuals with decrease in LDL cholesterol by >0.4 mmol/L (>15 mg/dl).
time frame: Baseline to 2 years
measure: Composite outcome of death or hospital admission due to Coronary heart disease (CHD), heart failure, or stroke
time frame: 2years
measure: Individual outcomes of all-cause mortality, Cardiovascular disease (CVD) deaths, and hospital admission due to CHD, heart failure, or stroke
time frame: 2 years
measure: Decrease of > 0.5 percent in glycated hemoglobin or change in proportion of hypertensive individuals with glycated hemoglobin <7% in hypertensive individuals with diabetes
time frame: Baseline to 2 years
measure: Change in albuminuria from baseline to follow-up at 24 months
time frame: Baseline to 2 years
measure: Change in estimated CKD-EPI GFR from baseline to follow-up at 24 months
time frame: Baseline - 2 years
measure: Change in cardiovascular disease (CVD) risk score
time frame: Baseline - 2 years
measure: Individual outcomes of change in a) diastolic BP and b) total cholesterol from baseline to end of follow-up at 24 months
time frame: Baseline to follow-up 2 years
measure: Change in lifestyle (diet, physical activity based on self-report) or BMI between groups
time frame: Baseline to 2 years
measure: Change in systolic blood pressure from baseline to 12 months
time frame: Baseline to 1 year
measure: Change in serum LDL cholesterol from baseline to 12 months
time frame: Baseline to 1 year
arm group label: Intervention
arm group type: Experimental
description: Structured multicomponent intervention (MCI)
arm group label: Usual Care
arm group type: No Intervention
description: Control group receive usual care in the polyclinics
intervention type: Other
intervention name: Structured Multicomponent Intervention (MCI)
description: Multicomponent Intervention (MCI) includes 1) algorithm-driven antihypertensive treatment for all hypertensive individuals using fixed-dose combination (FDC) and lipid lowering for high risk hypertensive individuals, 2) motivational conversation for high-risk hypertensive individuals and 3) telephone based follow-ups of all hypertensive individuals by a team of physician supervised nurse, and 4) discounts on FDC antihypertensive medications
arm group label: Intervention
criteria: 
gender: All
minimum age: 40 Years
maximum age: N/A
healthy volunteers: No
last name: Dr Tazeen Jafar, MD, MPH
role: Principal Investigator
affiliation: Duke-NUS Graduate Medical School
last name: Dr Tazeen Jafar, MD
phone: +6566012582
email: tazeen.jafar@duke-nus.edu.sg
facility: 
status: Recruiting
contact: 
country: Singapore
responsible party type: Principal Investigator
investigator affiliation: Duke-NUS Graduate Medical School
investigator full name: Professor Tazeen Jafar
investigator title: Professor
mesh term: Hypertension
mesh term: Cardiovascular Diseases
sharing ipd: No