<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/NCT03274089</url>
  </required_header>
  <id_info>
    <org_study_id>1629027001</org_study_id>
    <nct_id>NCT03274089</nct_id>
  </id_info>
  <brief_title>Health Outcomes of Patients With Stable Chronic Disease Managed With a Healthcare Kiosk</brief_title>
  <official_title>A Randomized Controlled Trial to Evaluate the Health Outcomes of Patients With Stable Chronic Disease Managed With a Healthcare Kiosk</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>SingHealth Polyclinics</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Agency for Science, Technology and Research</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>SingHealth Polyclinics</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>
      The chronic disease burden is increasing worldwide leading to a rise in the demand for&#xD;
      primary healthcare and a shortage of primary care physicians. Addressing this shortage&#xD;
      entails a multi-prong approach with innovations in care delivery, greater use of healthcare&#xD;
      technology, and more efficient use of all healthcare providers on the care team.&#xD;
&#xD;
      We previously developed an interactive self-service healthcare kiosk (Self-empowering and&#xD;
      enabling kiosk - SEEK® MyHealthKiosk) for the management of patients with stable chronic&#xD;
      disease in the primary care setting. A feasibility study using SEEK showed high levels of&#xD;
      acceptance and satisfaction from patients and healthcare providers.&#xD;
&#xD;
      The aim of this follow-up study is to evaluate the health outcomes of patients with stable&#xD;
      chronic disease who are on kiosk management compared to patients who are on routine&#xD;
      management by nurse clinicians. We hypothesize that patients who are managed by the kiosk&#xD;
      continue to maintain good disease control that are comparable to patients who are managed by&#xD;
      a nurse clinician.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients who seek primary healthcare vary in their time and resource requirements. Patients&#xD;
      with acute medical conditions or poorly controlled chronic disease typically require more&#xD;
      time and attention compared to patients with stable chronic disease.&#xD;
&#xD;
      Patients with chronic disease routinely make follow-up visits to their primary care provider&#xD;
      for assessment of their chronic disease status and for changes to their medications as&#xD;
      necessary. Patients with well-controlled stable chronic disease may go through several visits&#xD;
      to their primary care provider in 3 or 4-monthly intervals with little or no change to their&#xD;
      medication regimen. These patients have to wait in line with the rest of the patient crowd&#xD;
      for a doctor's consultation before getting their regular supply of medications. We hence saw&#xD;
      the potential of replacing some of these physician visits with an automated healthcare kiosk&#xD;
      so that if the disease condition of such patients remained stable, they can continue on their&#xD;
      current medications without having to see a doctor.&#xD;
&#xD;
      We previously described the feasibility of using an automated healthcare kiosk (SEEK®&#xD;
      MyHealthKiosk) for the management of patients with stable chronic disease in the primary care&#xD;
      setting. We propose a follow-up study to show equivalence of health outcomes for patients&#xD;
      managed with SEEK compared to the current standard of care. The study will be a 2-armed&#xD;
      randomized controlled trial of 120 patients with stable chronic disease on 4-monthly&#xD;
      follow-up visits over a 12-month period. Patients will be assigned randomly to intervention&#xD;
      or control groups to receive kiosk or nurse management respectively. The main primary outcome&#xD;
      measure is the overall chronic disease control of the patients. Other primary outcome&#xD;
      measures are the blood pressure and low-density lipoprotein cholesterol levels for patients&#xD;
      without diabetes; and blood pressure, low-density lipoprotein cholesterol and hemoglobin A1c&#xD;
      levels for patients with diabetes. Secondary outcome measures are visit duration, patient&#xD;
      satisfaction with the management process, health-related quality of life, and the occurrence&#xD;
      of any adverse event.&#xD;
&#xD;
      The potential benefits from the use of SEEK are:&#xD;
&#xD;
        1. Appropriate stratification of patient care needs so that more time and resources can be&#xD;
           channeled to patients with complex or acute needs;&#xD;
&#xD;
        2. Patient empowerment in the management of their chronic health conditions, with&#xD;
           flexibility of self-care and monitoring and decreased dependency on healthcare&#xD;
           providers;&#xD;
&#xD;
        3. Substitution of nurse clinicians for the management of stable chronic disease;&#xD;
&#xD;
        4. Reduction in the number of doctor visits per year for patients with stable chronic&#xD;
           disease.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 21, 2018</start_date>
  <completion_date type="Anticipated">September 2019</completion_date>
  <primary_completion_date type="Anticipated">September 2019</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>Disease control</measure>
    <time_frame>12 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Blood pressure</measure>
    <time_frame>12 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Low-density lipoprotein cholesterol</measure>
    <time_frame>12 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Hemoglobin A1c</measure>
    <time_frame>12 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Visit duration</measure>
    <time_frame>8 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient satisfaction questionnaire</measure>
    <time_frame>12 months</time_frame>
    <description>The following areas of patient satisfaction will be scored on a Likert scale: convenience of visit schedule, location of kiosk or nurse consultation, appropriateness of management, duration of time spent in kiosk usage or nurse consultation, and the replacement of a doctor's visit by the kiosk or nurse clinician. Qualitative feedback will be captured via free-text inputs.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health-related quality of life questionnaire</measure>
    <time_frame>12 months</time_frame>
    <description>Health-related quality of life will be assessed using the EQ-5D-5L questionnaire.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Hypertension</condition>
  <condition>Hyperlipidemia; Mixed</condition>
  <condition>Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>Kiosk intervention group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Nurse clinician control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Kiosk intervention group</intervention_name>
    <description>SEEK automates the management of patients with stable well-controlled chronic disease. SEEK has the following capabilities:&#xD;
Collects patient information using patient-specific identification&#xD;
Prompts the user for answers to screening questions for acute conditions&#xD;
Measures relevant physiological parameters: blood pressure, height, weight; and calculates body mass index&#xD;
Triages patients based on responses to screening questions, physiological parameters and blood test results&#xD;
Provides recommendations to the patient on the care plan, self management and lifestyle choices</description>
    <arm_group_label>Kiosk intervention group</arm_group_label>
    <other_name>SEEK® MyHealthKiosk</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  are between the ages of 21 and 75 years&#xD;
&#xD;
          -  have at least one chronic medical condition that includes hypertension,&#xD;
             hyperlipidemia, diabetes mellitus&#xD;
&#xD;
          -  have blood pressure, low-density lipoprotein cholesterol (LDL-C) and HbA1c levels&#xD;
             within the recommended targets according to the Ministry of Health Singapore clinical&#xD;
             practice guidelines for their current and last follow-up visits&#xD;
&#xD;
          -  are able to provide informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  have serum creatinine more than 140 mmol/L (from tests done within the past year)&#xD;
&#xD;
          -  have serum potassium less than 3.5 mmol/L or more than 5 mmol/L (from tests done&#xD;
             within the past year)&#xD;
&#xD;
          -  have overt proteinuria (urine protein:creatinine ratio more than 0.5)&#xD;
&#xD;
          -  were discharged from hospital or specialist follow-up within the last 6 months&#xD;
&#xD;
          -  have any pending laboratory or investigation result&#xD;
&#xD;
          -  are scheduled for any laboratory investigation within the next 4 months (except HbA1c&#xD;
             or panel test)&#xD;
&#xD;
          -  have any new complaint related to their chronic medical conditions&#xD;
&#xD;
          -  have a known history of white coat hypertension&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Grace Ng</last_name>
    <phone>+65 6377 8771</phone>
    <email>grace.ng.b.h@singhealth.com.sg</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Caris Tan</last_name>
    <phone>+65 6377 7107</phone>
    <email>tan.yang.thong@singhealth.com.sg</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>SingHealth Polyclinics - Punggol</name>
      <address>
        <city>Singapore</city>
        <country>Singapore</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Executive</last_name>
      <phone>6643 6969</phone>
    </contact>
  </location>
  <location_countries>
    <country>Singapore</country>
  </location_countries>
  <verification_date>June 2018</verification_date>
  <study_first_submitted>September 4, 2017</study_first_submitted>
  <study_first_submitted_qc>September 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 6, 2017</study_first_posted>
  <last_update_submitted>June 21, 2018</last_update_submitted>
  <last_update_submitted_qc>June 21, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">June 26, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>SingHealth Polyclinics</investigator_affiliation>
    <investigator_full_name>Grace Ng Beng Hua</investigator_full_name>
    <investigator_title>Family Physician</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hyperlipidemias</mesh_term>
    <mesh_term>Chronic Disease</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/NCT03274089
org study id: 1629027001
nct id: NCT03274089
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The chronic disease burden is increasing worldwide leading to a rise in the demand for
      primary healthcare and a shortage of primary care physicians. Addressing this shortage
      entails a multi-prong approach with innovations in care delivery, greater use of healthcare
      technology, and more efficient use of all healthcare providers on the care team.

      We previously developed an interactive self-service healthcare kiosk (Self-empowering and
      enabling kiosk - SEEK® MyHealthKiosk) for the management of patients with stable chronic
      disease in the primary care setting. A feasibility study using SEEK showed high levels of
      acceptance and satisfaction from patients and healthcare providers.

      The aim of this follow-up study is to evaluate the health outcomes of patients with stable
      chronic disease who are on kiosk management compared to patients who are on routine
      management by nurse clinicians. We hypothesize that patients who are managed by the kiosk
      continue to maintain good disease control that are comparable to patients who are managed by
      a nurse clinician.
Patients who seek primary healthcare vary in their time and resource requirements. Patients
      with acute medical conditions or poorly controlled chronic disease typically require more
      time and attention compared to patients with stable chronic disease.

      Patients with chronic disease routinely make follow-up visits to their primary care provider
      for assessment of their chronic disease status and for changes to their medications as
      necessary. Patients with well-controlled stable chronic disease may go through several visits
      to their primary care provider in 3 or 4-monthly intervals with little or no change to their
      medication regimen. These patients have to wait in line with the rest of the patient crowd
      for a doctor's consultation before getting their regular supply of medications. We hence saw
      the potential of replacing some of these physician visits with an automated healthcare kiosk
      so that if the disease condition of such patients remained stable, they can continue on their
      current medications without having to see a doctor.

      We previously described the feasibility of using an automated healthcare kiosk (SEEK®
      MyHealthKiosk) for the management of patients with stable chronic disease in the primary care
      setting. We propose a follow-up study to show equivalence of health outcomes for patients
      managed with SEEK compared to the current standard of care. The study will be a 2-armed
      randomized controlled trial of 120 patients with stable chronic disease on 4-monthly
      follow-up visits over a 12-month period. Patients will be assigned randomly to intervention
      or control groups to receive kiosk or nurse management respectively. The main primary outcome
      measure is the overall chronic disease control of the patients. Other primary outcome
      measures are the blood pressure and low-density lipoprotein cholesterol levels for patients
      without diabetes; and blood pressure, low-density lipoprotein cholesterol and hemoglobin A1c
      levels for patients with diabetes. Secondary outcome measures are visit duration, patient
      satisfaction with the management process, health-related quality of life, and the occurrence
      of any adverse event.

      The potential benefits from the use of SEEK are:

        1. Appropriate stratification of patient care needs so that more time and resources can be
           channeled to patients with complex or acute needs;

        2. Patient empowerment in the management of their chronic health conditions, with
           flexibility of self-care and monitoring and decreased dependency on healthcare
           providers;

        3. Substitution of nurse clinicians for the management of stable chronic disease;

        4. Reduction in the number of doctor visits per year for patients with stable chronic
           disease.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Disease control
time frame: 12 months
measure: Blood pressure
time frame: 12 months
measure: Low-density lipoprotein cholesterol
time frame: 12 months
measure: Hemoglobin A1c
time frame: 12 months
measure: Visit duration
time frame: 8 months
measure: Patient satisfaction questionnaire
time frame: 12 months
description: The following areas of patient satisfaction will be scored on a Likert scale: convenience of visit schedule, location of kiosk or nurse consultation, appropriateness of management, duration of time spent in kiosk usage or nurse consultation, and the replacement of a doctor's visit by the kiosk or nurse clinician. Qualitative feedback will be captured via free-text inputs.
measure: Adverse events
time frame: 12 months
measure: Health-related quality of life questionnaire
time frame: 12 months
description: Health-related quality of life will be assessed using the EQ-5D-5L questionnaire.
arm group label: Kiosk intervention group
arm group type: Experimental
arm group label: Nurse clinician control group
arm group type: No Intervention
intervention type: Device
intervention name: Kiosk intervention group
description: SEEK automates the management of patients with stable well-controlled chronic disease. SEEK has the following capabilities:
Collects patient information using patient-specific identification
Prompts the user for answers to screening questions for acute conditions
Measures relevant physiological parameters: blood pressure, height, weight; and calculates body mass index
Triages patients based on responses to screening questions, physiological parameters and blood test results
Provides recommendations to the patient on the care plan, self management and lifestyle choices
arm group label: Kiosk intervention group
other name: SEEK® MyHealthKiosk
criteria: 
gender: All
minimum age: 21 Years
maximum age: 75 Years
healthy volunteers: No
last name: Grace Ng
phone: +65 6377 8771
email: grace.ng.b.h@singhealth.com.sg
last name: Caris Tan
phone: +65 6377 7107
email: tan.yang.thong@singhealth.com.sg
facility: 
status: Recruiting
contact: 
country: Singapore
responsible party type: Principal Investigator
investigator affiliation: SingHealth Polyclinics
investigator full name: Grace Ng Beng Hua
investigator title: Family Physician
mesh term: Hyperlipidemias
mesh term: Chronic Disease