<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/NCT03301194</url>
  </required_header>
  <id_info>
    <org_study_id>HKUCTR-2233</org_study_id>
    <nct_id>NCT03301194</nct_id>
  </id_info>
  <brief_title>Cost-effectiveness of RAMP-HT for Patients With Uncontrolled Hypertension in Hong Kong</brief_title>
  <official_title>In-depth Study of the Cost-effectiveness of the Risk Assessment and Management Programme for Hypertension (RAMP-HT) for Patients With Uncontrolled Hypertension in Primary Care in Hong Kong</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The University of Hong Kong</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The University of Hong Kong</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Hypertension (HT) is an important risk factor for stroke, coronary heart disease (CHD), heart&#xD;
      failure and renal diseases, and the leading risk factor of global disease burden. A multitude&#xD;
      of interventions have proven efficacy in lowering blood pressure and reducing long term HT&#xD;
      complications, including pharmacologic treatment, DASH diet (Dietary Approaches to Stop&#xD;
      Hypertension), exercise, weight reduction, smoking cessation, alcohol moderation and&#xD;
      self-monitoring of blood pressure.&#xD;
&#xD;
      Objectives:&#xD;
&#xD;
      To evaluate long-term effectiveness and cost-effectiveness of&#xD;
      Risk-Assessment-and-Management-Programme-for-Hypertension (RAMP-HT), a multi-disciplinary&#xD;
      structured service to enhance quality of hypertension care in primary care compared to usual&#xD;
      care&#xD;
&#xD;
      Hypotheses:&#xD;
&#xD;
        1. RAMP-HT is effective in reducing HT complications, based on previous results showing&#xD;
           RAMP-HT was effective in improving patients' blood pressure&#xD;
&#xD;
        2. RAMP-HT is cost-effective&#xD;
&#xD;
      Design and Subjects:&#xD;
&#xD;
      Retrospective study of 5-year longitudinal data on matched cohorts of public primary care&#xD;
      patients with uncontrolled HT under RAMP-HT and usual care will be conducted to evaluate&#xD;
      long-term effectiveness and direct medical costs. Results from the long-term effectiveness&#xD;
      and costing analyses will be applied to Markov modeling to determine the life time&#xD;
      cost-effectiveness of RAMP-HT.&#xD;
&#xD;
      Main outcome measures:&#xD;
&#xD;
        1. 5-year incidence of cardiovascular complications&#xD;
&#xD;
        2. Direct medical costs of RAMP-HT and usual care HT patients&#xD;
&#xD;
        3. Incremental cost-effectiveness ratio (ICER) of cost per quality-adjusted life year&#xD;
           (QALY) gained by RAMP-HT compared to usual care&#xD;
&#xD;
      Data analysis:&#xD;
&#xD;
      Cox regression will be performed to estimate the effect of RAMP-HT on the development of HT&#xD;
      complication adjusted for baseline covariates. Descriptive statistics will be used to&#xD;
      calculate costs of RAMP-HT and annual direct medical costs for HT patients. Markov modeling&#xD;
      will be used to simulate 2 patient cohorts (RAMP-HT versus usual care) to estimate the&#xD;
      respective lifetime direct medical costs and QALY gained/person. Cost/QALY of RAMP-HT will be&#xD;
      compared to that of usual care to determine the ICER.&#xD;
&#xD;
      Expected results:&#xD;
&#xD;
      The results can provide evidence on the effectiveness and cost-effectiveness of RAMP-HT for&#xD;
      primary care patients with uncontrolled HT, which can inform health policy and service&#xD;
      planning.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Aim and objectives:&#xD;
&#xD;
      The aim of this study is to evaluate the cost-effectiveness of the RAMP-HT of the HA in&#xD;
      primary care patients with uncontrolled hypertension.&#xD;
&#xD;
      The objectives are to:&#xD;
&#xD;
        1. Evaluate the long term (5-year) effectiveness of RAMP-HT compared to usual care in&#xD;
           reducing cardiovascular complications, end-stage renal disease and all-cause mortalities&#xD;
           in a cohort of primary care patients with uncontrolled hypertension at baseline&#xD;
&#xD;
        2. Estimate the direct medical cost of RAMP-HT and other health services among primary care&#xD;
           HT patients with or without complications&#xD;
&#xD;
        3. Evaluate the cost-effectiveness of RAMP-HT, compared to usual care, in gaining one QALY&#xD;
           in primary care patients with uncontrolled hypertension&#xD;
&#xD;
      Hypotheses:&#xD;
&#xD;
        1. RAMP-HT is more effective in reducing 5-year cardiovascular complications, end stage&#xD;
           renal disease and all-cause mortality among primary care patients with uncontrolled&#xD;
           hypertension compared to usual care&#xD;
&#xD;
        2. The direct medical cost of RAMP-HT patients, for the same disease complication status,&#xD;
           is not higher than that of usual care except for the RAMP-HT cost&#xD;
&#xD;
        3. The direct medical cost of HT patients with one or more complications is higher than&#xD;
           that of HT patients without any complication&#xD;
&#xD;
        4. RAMP-HT is cost-effective compared to usual care, i.e. ICER per QALY gained is below the&#xD;
           threshold value of 1 annual GDP (Gross Domestic Product) per capita of Hong Kong, which&#xD;
           is the benchmark recommended by the World Health Organization&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2016</start_date>
  <completion_date type="Actual">January 31, 2019</completion_date>
  <primary_completion_date type="Actual">January 31, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The 5-year incidence of CVD among RAMP-HT and usual care HT patients</measure>
    <time_frame>60-month</time_frame>
    <description>CVD is defined as the presence of any of coronary heart disease (CHD), heart failure or stroke. CHD includes all ischaemic heart disease, myocardial infarction, coronary death or sudden death as indicated by the ICPC-2 K74 to K76 or ICD-9-CM 410.x, 411.x to 414.x, 798.x codes. Heart failure is defined as the ICPC-2 K77 or ICD-9-CM 428.x codes. Stroke (fatal and non-fatal stroke) is defined by the ICPC-2 K89 to K91 or ICD-9-CM 430.x to 438.x codes.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The direct medical costs of RAMP-HT and usual care HT patients with and without complications</measure>
    <time_frame>12-month before baseline, baseline, 12, 24, 36, 48 and 60-month</time_frame>
    <description>Public medical costs will be estimated from products of the unit costs (published in the HKSAR Government Gazette and Hospital Authority (HA) ordinance (Chapter 113) of charges for non-entitled persons) and the utilization rates of 1) dispensed drugs, 2) laboratory tests and investigations, 3) healthcare services including general outpatient clinics (GOPC), specialist outpatient clinics (SOPC), allied health services (e.g. dietician, physiotherapist or occupational therapist), accident and emergency (A&amp;E) department and 4) admissions to hospital in the 12 months before baseline and at 12, 24, 36, 48 and 60 months after study enrolment for each patient in the study cohorts.&#xD;
Private direct medical costs include the cost of all private Western doctor and Chinese medicine practitioner consultations, private hospitalisation and self-medications inclusive of self-financed medications prescribed by the HA.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The ICER of cost per QALY gained by RAMP-HT compared to usual care group</measure>
    <time_frame>60-month</time_frame>
    <description>The ICER was the ratio of the incremental costs of RAMP-HT group over the incremental effectiveness compared to those of the usual care group. In this study, the ICER referred to 1) program cost per HT-related complication reduced by RAMP-HT, and 2) program cost per event-free year in the RAMP-HT group, compared to the usual care group.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The 5-year incidence of end stage renal disease (ESRD) and all-cause mortality among RAMP-HT and usual care HT patients</measure>
    <time_frame>60-month</time_frame>
    <description>ESRD is defined by any of ICD-9-CM 250.3x, 585.x, 586.x, or an estimated Glomerular Filtration Rate (eGFR) &lt; 15mL/min/1.73m2, according to the definition of the National Kidney Foundation. Mortality is defined by a documented death in the Hong Kong Death Registry.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The hazard ratio of CVD, ESRD and all-cause mortalities between RAMP-HT and usual care group</measure>
    <time_frame>60-month</time_frame>
    <description>Multivariable Cox proportional hazards regression will be performed to estimate the adjusted effect of RAMP-HT on the dependent variable of each first HT complication event, adjusting for all baseline covariates of patients.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Number-Need-to-Treat (NNT) to reduce one CVD, ESRD and mortality in 5 years by RAMP-HT</measure>
    <time_frame>60-month</time_frame>
    <description>NNT is the average number of patients who need to be treated to prevent one additional outcome event. It is defined as the inverse of the absolute risk reduction.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">158322</enrollment>
  <condition>Hypertension</condition>
  <condition>Cost Effectiveness</condition>
  <arm_group>
    <arm_group_label>RAMP-HT patients</arm_group_label>
    <description>HT patients who have enrolled into the RAMP-HT between 1 October 2011 and 31 March 2012 and fulfilled the inclusion criteria and without any exclusion criteria</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual care patients</arm_group_label>
    <description>HT patients receiving usual care in GOPCs who have never enrolled into RAMP-HT on or before 31 March 2017 and fulfilled the inclusion criteria and without any exclusion criteria</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>RAMP-HT</intervention_name>
    <description>RAMP-HT was launched since October 2011 by the Hospital Authority with the support from the Food and Health Bureau. Standardized cardiovascular risk factor assessment, hypertensive complication screening and assessment on patient adherence to treatment are carried out on enrolled patients. Patients are stratified into low, medium or high risk groups according to the 10-year cardiovascular disease (CVD) risk calculated from their relevant risk factors by the Joint British Society 2005 Equation. A multidisciplinary team comprised of doctors, nurses, dieticians, physiotherapists and/or occupational therapists would then deliver individualized management targeted to the patient's risk factors according to standardized risk-stratified guidelines.</description>
    <arm_group_label>RAMP-HT patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All patients who have enrolled into the RAMP-HT between 1 October 2011 and 31 March 2012,&#xD;
        fulfilled the inclusion criteria and without any exclusion criterion will be included in&#xD;
        the RAMP-HT cohort. The same number of matched patients receiving usual care in general&#xD;
        outpatient clinics (GOPCs) who have never enrolled into RAMP-HT on or before 31 March 2017,&#xD;
        fulfilled the inclusion criteria and without any exclusion criterion will be randomly&#xD;
        selected from the HA clinical management system (CMS) to form the usual care cohort.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          1. Age ≥ 18 years old and &lt; 80 years old&#xD;
&#xD;
          2. Coded with ICPC-2 of K86 on or before baseline*&#xD;
&#xD;
          3. Had uncontrolled blood pressure (i.e. average Systolic Blood Pressure (SBP) ≥ 140mmHg&#xD;
             OR Diastolic Blood Pressure (DBP) ≥ 90mmHg between 6 months before and 3 months after&#xD;
             baseline*)&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          1. Patients who had a diagnosis of any HT complications defined by relevant ICPC-2 and/or&#xD;
             ICD-9-CM diagnosis codes on or before baseline*&#xD;
&#xD;
          2. Patients diagnosed to have Diabetes Mellitus (DM) on or before 31 March 2017, defined&#xD;
             by ICPC-2 codes of T89 or T90&#xD;
&#xD;
          3. Patients exclusively managed by Specialist Out-Patient Clinic (SOPC) on or before&#xD;
             baseline*&#xD;
&#xD;
               -  Baseline: date of RAMP-HT enrolment for RAMP-HT cohort, and 31 March 2012 for&#xD;
                  usual care cohort&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>79 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Esther Yee Tak Yu</last_name>
    <role>Principal Investigator</role>
    <affiliation>The University of Hong Kong</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The University of Hong Kong</name>
      <address>
        <city>Hong Kong</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Hong Kong</country>
  </location_countries>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>September 27, 2017</study_first_submitted>
  <study_first_submitted_qc>October 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 4, 2017</study_first_posted>
  <last_update_submitted>May 1, 2019</last_update_submitted>
  <last_update_submitted_qc>May 1, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 3, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The University of Hong Kong</investigator_affiliation>
    <investigator_full_name>Dr. YU Yee Yak, Esther</investigator_full_name>
    <investigator_title>Clinical Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Hypertension</keyword>
  <keyword>Effectiveness</keyword>
  <keyword>Cost Effectiveness</keyword>
  <keyword>Cost</keyword>
  <keyword>Multi-disciplinary</keyword>
  <keyword>Risk Stratification</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>March 4, 2015</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/94/NCT03301194/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03301194
org study id: HKUCTR-2233
nct id: NCT03301194
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Hypertension (HT) is an important risk factor for stroke, coronary heart disease (CHD), heart
      failure and renal diseases, and the leading risk factor of global disease burden. A multitude
      of interventions have proven efficacy in lowering blood pressure and reducing long term HT
      complications, including pharmacologic treatment, DASH diet (Dietary Approaches to Stop
      Hypertension), exercise, weight reduction, smoking cessation, alcohol moderation and
      self-monitoring of blood pressure.

      Objectives:

      To evaluate long-term effectiveness and cost-effectiveness of
      Risk-Assessment-and-Management-Programme-for-Hypertension (RAMP-HT), a multi-disciplinary
      structured service to enhance quality of hypertension care in primary care compared to usual
      care

      Hypotheses:

        1. RAMP-HT is effective in reducing HT complications, based on previous results showing
           RAMP-HT was effective in improving patients' blood pressure

        2. RAMP-HT is cost-effective

      Design and Subjects:

      Retrospective study of 5-year longitudinal data on matched cohorts of public primary care
      patients with uncontrolled HT under RAMP-HT and usual care will be conducted to evaluate
      long-term effectiveness and direct medical costs. Results from the long-term effectiveness
      and costing analyses will be applied to Markov modeling to determine the life time
      cost-effectiveness of RAMP-HT.

      Main outcome measures:

        1. 5-year incidence of cardiovascular complications

        2. Direct medical costs of RAMP-HT and usual care HT patients

        3. Incremental cost-effectiveness ratio (ICER) of cost per quality-adjusted life year
           (QALY) gained by RAMP-HT compared to usual care

      Data analysis:

      Cox regression will be performed to estimate the effect of RAMP-HT on the development of HT
      complication adjusted for baseline covariates. Descriptive statistics will be used to
      calculate costs of RAMP-HT and annual direct medical costs for HT patients. Markov modeling
      will be used to simulate 2 patient cohorts (RAMP-HT versus usual care) to estimate the
      respective lifetime direct medical costs and QALY gained/person. Cost/QALY of RAMP-HT will be
      compared to that of usual care to determine the ICER.

      Expected results:

      The results can provide evidence on the effectiveness and cost-effectiveness of RAMP-HT for
      primary care patients with uncontrolled HT, which can inform health policy and service
      planning.
Aim and objectives:

      The aim of this study is to evaluate the cost-effectiveness of the RAMP-HT of the HA in
      primary care patients with uncontrolled hypertension.

      The objectives are to:

        1. Evaluate the long term (5-year) effectiveness of RAMP-HT compared to usual care in
           reducing cardiovascular complications, end-stage renal disease and all-cause mortalities
           in a cohort of primary care patients with uncontrolled hypertension at baseline

        2. Estimate the direct medical cost of RAMP-HT and other health services among primary care
           HT patients with or without complications

        3. Evaluate the cost-effectiveness of RAMP-HT, compared to usual care, in gaining one QALY
           in primary care patients with uncontrolled hypertension

      Hypotheses:

        1. RAMP-HT is more effective in reducing 5-year cardiovascular complications, end stage
           renal disease and all-cause mortality among primary care patients with uncontrolled
           hypertension compared to usual care

        2. The direct medical cost of RAMP-HT patients, for the same disease complication status,
           is not higher than that of usual care except for the RAMP-HT cost

        3. The direct medical cost of HT patients with one or more complications is higher than
           that of HT patients without any complication

        4. RAMP-HT is cost-effective compared to usual care, i.e. ICER per QALY gained is below the
           threshold value of 1 annual GDP (Gross Domestic Product) per capita of Hong Kong, which
           is the benchmark recommended by the World Health Organization
observational model: Cohort
time perspective: Retrospective
measure: The 5-year incidence of CVD among RAMP-HT and usual care HT patients
time frame: 60-month
description: CVD is defined as the presence of any of coronary heart disease (CHD), heart failure or stroke. CHD includes all ischaemic heart disease, myocardial infarction, coronary death or sudden death as indicated by the ICPC-2 K74 to K76 or ICD-9-CM 410.x, 411.x to 414.x, 798.x codes. Heart failure is defined as the ICPC-2 K77 or ICD-9-CM 428.x codes. Stroke (fatal and non-fatal stroke) is defined by the ICPC-2 K89 to K91 or ICD-9-CM 430.x to 438.x codes.
measure: The direct medical costs of RAMP-HT and usual care HT patients with and without complications
time frame: 12-month before baseline, baseline, 12, 24, 36, 48 and 60-month
description: Public medical costs will be estimated from products of the unit costs (published in the HKSAR Government Gazette and Hospital Authority (HA) ordinance (Chapter 113) of charges for non-entitled persons) and the utilization rates of 1) dispensed drugs, 2) laboratory tests and investigations, 3) healthcare services including general outpatient clinics (GOPC), specialist outpatient clinics (SOPC), allied health services (e.g. dietician, physiotherapist or occupational therapist), accident and emergency (A&E) department and 4) admissions to hospital in the 12 months before baseline and at 12, 24, 36, 48 and 60 months after study enrolment for each patient in the study cohorts.
Private direct medical costs include the cost of all private Western doctor and Chinese medicine practitioner consultations, private hospitalisation and self-medications inclusive of self-financed medications prescribed by the HA.
measure: The ICER of cost per QALY gained by RAMP-HT compared to usual care group
time frame: 60-month
description: The ICER was the ratio of the incremental costs of RAMP-HT group over the incremental effectiveness compared to those of the usual care group. In this study, the ICER referred to 1) program cost per HT-related complication reduced by RAMP-HT, and 2) program cost per event-free year in the RAMP-HT group, compared to the usual care group.
measure: The 5-year incidence of end stage renal disease (ESRD) and all-cause mortality among RAMP-HT and usual care HT patients
time frame: 60-month
description: ESRD is defined by any of ICD-9-CM 250.3x, 585.x, 586.x, or an estimated Glomerular Filtration Rate (eGFR) < 15mL/min/1.73m2, according to the definition of the National Kidney Foundation. Mortality is defined by a documented death in the Hong Kong Death Registry.
measure: The hazard ratio of CVD, ESRD and all-cause mortalities between RAMP-HT and usual care group
time frame: 60-month
description: Multivariable Cox proportional hazards regression will be performed to estimate the adjusted effect of RAMP-HT on the dependent variable of each first HT complication event, adjusting for all baseline covariates of patients.
measure: The Number-Need-to-Treat (NNT) to reduce one CVD, ESRD and mortality in 5 years by RAMP-HT
time frame: 60-month
description: NNT is the average number of patients who need to be treated to prevent one additional outcome event. It is defined as the inverse of the absolute risk reduction.
arm group label: RAMP-HT patients
description: HT patients who have enrolled into the RAMP-HT between 1 October 2011 and 31 March 2012 and fulfilled the inclusion criteria and without any exclusion criteria
arm group label: Usual care patients
description: HT patients receiving usual care in GOPCs who have never enrolled into RAMP-HT on or before 31 March 2017 and fulfilled the inclusion criteria and without any exclusion criteria
intervention type: Other
intervention name: RAMP-HT
description: RAMP-HT was launched since October 2011 by the Hospital Authority with the support from the Food and Health Bureau. Standardized cardiovascular risk factor assessment, hypertensive complication screening and assessment on patient adherence to treatment are carried out on enrolled patients. Patients are stratified into low, medium or high risk groups according to the 10-year cardiovascular disease (CVD) risk calculated from their relevant risk factors by the Joint British Society 2005 Equation. A multidisciplinary team comprised of doctors, nurses, dieticians, physiotherapists and/or occupational therapists would then deliver individualized management targeted to the patient's risk factors according to standardized risk-stratified guidelines.
arm group label: RAMP-HT patients
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 79 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Esther Yee Tak Yu
role: Principal Investigator
affiliation: The University of Hong Kong
facility: 
country: Hong Kong
responsible party type: Principal Investigator
investigator affiliation: The University of Hong Kong
investigator full name: Dr. YU Yee Yak, Esther
investigator title: Clinical Assistant Professor
mesh term: Hypertension
provided document: 