<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/NCT02186067</url>
  </required_header>
  <id_info>
    <org_study_id>13102013FM</org_study_id>
    <nct_id>NCT02186067</nct_id>
  </id_info>
  <brief_title>Developing an Integrated System Approach for the Management of Hypertension: A Pilot Study</brief_title>
  <official_title>Developing an Integrated System Approach for the Management of Hypertension: A Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aga Khan University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Aga Khan University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Hypertension has become a public health concern worldwide due to its significant contribution&#xD;
      to the global health burden and its role as a prominent risk factor for the development of a&#xD;
      number of chronic diseases such as Cardiovascular diseases (CVD), the leading cause of&#xD;
      mortality in Pakistan and Worldwide. According to WHO, about 7.5 million deaths worldwide is&#xD;
      attributable to hypertension i.e. about 12.8% of the total of all deaths. This accounts for&#xD;
      57 million disability adjusted life years (DALYS) or 3.7% of total DALYS.&#xD;
&#xD;
      Studies suggest that hypertension is among the top five most common presenting complaints to&#xD;
      private general practice clinics. Therefore, primary care physicians/Family physicians are&#xD;
      the first line service providers and; thus it is important to manage hypertensive patients&#xD;
      early, through lifestyle and treatment interventions that may prevent the complications such&#xD;
      as development of CVDs etc.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To the best of authors' knowledge limited evidence is available from Pakistan on management&#xD;
      of hypertension through an integrated approach. Therefore, the aim of the trial is to develop&#xD;
      a health delivery system that effectively manages hypertension at primary care level.&#xD;
&#xD;
      Hypothesis: The development of an integrated management approach will be effective in&#xD;
      managing hypertension at all levels among hypertensive patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>February 2014</start_date>
  <completion_date type="Actual">March 2015</completion_date>
  <primary_completion_date type="Actual">March 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>At least an absolute 20% point greater proportion of participants in the intervention group achieving blood pressure targets ( SBP &lt;140 mmHg and DBP &lt; 90mmHg)</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adherence to life style modification</measure>
    <time_frame>6 months</time_frame>
    <description>Adherence to life style modification (exercise, diet, medication) by the patients: This will be assessed through self-report, anthropometric and blood pressure measurement and empty blister count at the follow up visits.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adherence by physicians to hypertension management guidelines</measure>
    <time_frame>6 months</time_frame>
    <description>Adherence by physicians to hypertension management guidelines: assessed through monthly audits conducted by the research medical officer.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost-Effectiveness</measure>
    <time_frame>6 months</time_frame>
    <description>Cost-Effectiveness: cost of medication (self-report by patient), cost of physician visit (clinic data) etc.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Satisfaction</measure>
    <time_frame>6 months</time_frame>
    <description>Patient Satisfaction: This would be assessed through PSQ-18.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">118</enrollment>
  <condition>Hypertension</condition>
  <arm_group>
    <arm_group_label>Referral System</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Referral System:&#xD;
Primary Level Secondary Level Tertiary Level</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Usual/routine care will be provided to the patients</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Referral System</intervention_name>
    <description>Primary Level:&#xD;
Refer patients to secondary care centre if Patients has complicated hypertension (Patients with target organ damage, CVD, CKD or more the 3 drugs)&#xD;
Secondary Level:&#xD;
Community health center at Aga Khan University will serve as the secondary care center.&#xD;
Family physician will manage patients with CVD, CKD or more than 3 drugs.&#xD;
Tertiary care:&#xD;
Cardiologist at the Aga Khan University will manage secondary, resistant and difficult to treat hypertension.&#xD;
Behavioral: Other Interventions CME session by Cardiologist/Consultant Family Physician : At start , and at two months Community screening by Family physicians at the primary care center (open house) once in three months Patient group education session. Once in three months</description>
    <arm_group_label>Referral System</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Individuals aged 40 years or over visiting the selected IMS centre with known&#xD;
             hypertension or with consistently elevated BP on two separate visits (mean of last two&#xD;
             of three measurements of systolic pressure ≥140 mm Hg or mean diastolic pressure ≥90&#xD;
             mm Hg) or already receiving treatment will be eligible for inclusion in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Those patients who require intensive care unit or coronary care unit admissions, or&#xD;
             are diagnosed to have cognitive impairment, are agitated due to severe pain,&#xD;
             non-resident of Karachi, or having language barrier will be excluded from the study.&#xD;
&#xD;
          -  A screening form will be designed for the collection of the above mentioned&#xD;
             information. The rationale of excluding all the participants with above mentioned&#xD;
             condition is that the participants having these health concerns will either not be&#xD;
             able to respond to our questionnaire or their presence may confound our results.&#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>Waris Qidwai</last_name>
    <role>Principal Investigator</role>
    <affiliation>Aga Khan University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Integrated Medical Services Clinics (IMS)</name>
      <address>
        <city>Karachi</city>
        <state>Sindh</state>
        <country>Pakistan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Pakistan</country>
  </location_countries>
  <verification_date>June 2015</verification_date>
  <study_first_submitted>July 8, 2014</study_first_submitted>
  <study_first_submitted_qc>July 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 10, 2014</study_first_posted>
  <last_update_submitted>June 24, 2015</last_update_submitted>
  <last_update_submitted_qc>June 24, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 25, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Aga Khan University</investigator_affiliation>
    <investigator_full_name>Waris Qidwai</investigator_full_name>
    <investigator_title>Professor and Chairman Department of Family Medicine</investigator_title>
  </responsible_party>
  <keyword>Hypertension</keyword>
  <keyword>Uncontrolled Hypertension</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension</mesh_term>
  </condition_browse>
  <!-- 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/NCT02186067
org study id: 13102013FM
nct id: NCT02186067
lead sponsor: 
has dmc: No
Hypertension has become a public health concern worldwide due to its significant contribution
      to the global health burden and its role as a prominent risk factor for the development of a
      number of chronic diseases such as Cardiovascular diseases (CVD), the leading cause of
      mortality in Pakistan and Worldwide. According to WHO, about 7.5 million deaths worldwide is
      attributable to hypertension i.e. about 12.8% of the total of all deaths. This accounts for
      57 million disability adjusted life years (DALYS) or 3.7% of total DALYS.

      Studies suggest that hypertension is among the top five most common presenting complaints to
      private general practice clinics. Therefore, primary care physicians/Family physicians are
      the first line service providers and; thus it is important to manage hypertensive patients
      early, through lifestyle and treatment interventions that may prevent the complications such
      as development of CVDs etc.
To the best of authors' knowledge limited evidence is available from Pakistan on management
      of hypertension through an integrated approach. Therefore, the aim of the trial is to develop
      a health delivery system that effectively manages hypertension at primary care level.

      Hypothesis: The development of an integrated management approach will be effective in
      managing hypertension at all levels among hypertensive patients.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: At least an absolute 20% point greater proportion of participants in the intervention group achieving blood pressure targets ( SBP <140 mmHg and DBP < 90mmHg)
time frame: 6 months
measure: Adherence to life style modification
time frame: 6 months
description: Adherence to life style modification (exercise, diet, medication) by the patients: This will be assessed through self-report, anthropometric and blood pressure measurement and empty blister count at the follow up visits.
measure: Adherence by physicians to hypertension management guidelines
time frame: 6 months
description: Adherence by physicians to hypertension management guidelines: assessed through monthly audits conducted by the research medical officer.
measure: Cost-Effectiveness
time frame: 6 months
description: Cost-Effectiveness: cost of medication (self-report by patient), cost of physician visit (clinic data) etc.
measure: Patient Satisfaction
time frame: 6 months
description: Patient Satisfaction: This would be assessed through PSQ-18.
arm group label: Referral System
arm group type: Experimental
description: Referral System:
Primary Level Secondary Level Tertiary Level
arm group label: Control
arm group type: No Intervention
description: Usual/routine care will be provided to the patients
intervention type: Other
intervention name: Referral System
description: Primary Level:
Refer patients to secondary care centre if Patients has complicated hypertension (Patients with target organ damage, CVD, CKD or more the 3 drugs)
Secondary Level:
Community health center at Aga Khan University will serve as the secondary care center.
Family physician will manage patients with CVD, CKD or more than 3 drugs.
Tertiary care:
Cardiologist at the Aga Khan University will manage secondary, resistant and difficult to treat hypertension.
Behavioral: Other Interventions CME session by Cardiologist/Consultant Family Physician : At start , and at two months Community screening by Family physicians at the primary care center (open house) once in three months Patient group education session. Once in three months
arm group label: Referral System
criteria: 
gender: All
minimum age: 40 Years
maximum age: N/A
healthy volunteers: No
last name: Waris Qidwai
role: Principal Investigator
affiliation: Aga Khan University
facility: 
country: Pakistan
responsible party type: Principal Investigator
investigator affiliation: Aga Khan University
investigator full name: Waris Qidwai
investigator title: Professor and Chairman Department of Family Medicine
mesh term: Hypertension