<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/NCT03294044</url>
  </required_header>
  <id_info>
    <org_study_id>HI16C0455-1</org_study_id>
    <nct_id>NCT03294044</nct_id>
  </id_info>
  <brief_title>The Effectiveness of Smart Health Management Program for Patients With Chronic Illness</brief_title>
  <official_title>The Effectiveness of Smart Health Management Program With Proactive Overcoming for Patients With Chronic Illness: Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Evidence-Based Healthcare Collaborating Agency</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute of Health, Korea</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Clinical Research Coordination Center, Seoul, Korea</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Korea Health Industry Development Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Seoul National University Hospital</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 verifies efficacy of Smart Health Management Program developed for patients with&#xD;
      chronic illness. The aim of the study is to observe the changes in clinical indicators,&#xD;
      quality of life and health related behaviors when providing self-management programs with ICT&#xD;
      for chronic disease patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is to demonstrate that chronic disease patients (hypertension, diabetes and&#xD;
      dyslipidemia) with ICT-based self-management and educational program can improve clinical&#xD;
      outcomes and overall health status, including quality of life and health habits.&#xD;
&#xD;
      In addition to the economic burden, people with chronic disease experience various&#xD;
      psychosocial crises such as anxiety and depression, which causes the deterioration of overall&#xD;
      quality of life and increases social burden. However, standard Chronic Care Model (CCM) have&#xD;
      limitations in that they do not provide self-management strategies of the patient in detail.&#xD;
      Therefore, to improve the effectiveness of the CCM model, it is required to propose a new&#xD;
      approach to the utilization of IT-based self-management program that is currently being&#xD;
      developed to increase accessibility and efficiency of health care service.&#xD;
&#xD;
      Primary outcomes of this study are as follow: Improvement of clinical indicators in patients&#xD;
      with hypertension, diabetes and hyperlipidemia.&#xD;
&#xD;
      Participants in this study will respond a baseline questionnaire about health habits, health&#xD;
      behavior patterns and quality of life, diet, exercise, etc. After that, participants will be&#xD;
      allocated randomly into the intervention group and the control group. The intervention group&#xD;
      will receive self-management and educational program with ICT (&quot;S Healthing&quot;) while the&#xD;
      control group will receive basic educational material with same contents on the disease. &quot;S&#xD;
      Healthing&quot; is based ICT- program and includes educational contents and self-management&#xD;
      program based on Smart Management Strategy for Health (SMASH). The intervention group will&#xD;
      conduct self-management for 3 months through smart phone application and web program.&#xD;
      Participants will receive a questionnaire about the quality of life and health habits with&#xD;
      the clinical examination 3 months after baseline survey was conducted. The result from two&#xD;
      questionnaires (baseline, post-intervention) and clinical outcomes will be compiled and be&#xD;
      compared with each other.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 27, 2017</start_date>
  <completion_date type="Actual">July 31, 2018</completion_date>
  <primary_completion_date type="Actual">March 26, 2018</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>
    <intervention_model_description>Parallel Assignment</intervention_model_description>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>No masking</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Success in clinical outcomes of Hypertension from baseline to 3 months</measure>
    <time_frame>Baseline, 3 months post-intervention</time_frame>
    <description>Change in Systolic blood pressure(mmHg)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Success in clinical outcomes of Dyslipidemia from baseline to 3 months</measure>
    <time_frame>Baseline, 3 months post-intervention</time_frame>
    <description>Change in LDL Cholesterol (mg/dL)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Success in clinical outcomes of primary disease Diabetes from baseline to 3 months</measure>
    <time_frame>Baseline, 3 months post-intervention</time_frame>
    <description>Change in HbA1c (%)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Health behavior patterns</measure>
    <time_frame>Baseline, 3 months post-intervention</time_frame>
    <description>We identify health habits by dividing into five steps according to the TTM stage. We evaluate increase in maintenance rate of health behavior patterns.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depression</measure>
    <time_frame>Baseline, 3 months post-intervention</time_frame>
    <description>Change in depression score (PHQ-9)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health Management Strategies</measure>
    <time_frame>Baseline, 3 months post-intervention</time_frame>
    <description>We use Smart Management Strategy for Health Assessment Tool (SAT) to assess their self-management (SM) strategies of health by themselves. We evaluate improvement of Health Management Strategies.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life (SF-12)</measure>
    <time_frame>Baseline, 3 months post-intervention</time_frame>
    <description>Improvement of quality of life (SF-12)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life (Mcgill QOL)</measure>
    <time_frame>Baseline, 3 months post-intervention</time_frame>
    <description>Improvement of quality of life (Mcgill QOL)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life (Euro-QoL)</measure>
    <time_frame>Baseline, 3 months post-intervention</time_frame>
    <description>Improvement of quality of life (Euro-QoL)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">106</enrollment>
  <condition>Hypertension</condition>
  <condition>Dyslipidemias</condition>
  <condition>Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>ICT programs</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ICT programs that include health information learning by disease, and self-management based on Smart Management Strategy for Health (SMASH) are provided. After that, subjects will conduct self-management health care for 12 weeks. After 3 months, they finish self-management ICT programs, and then they fill out the questionnaire.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>A book about chronic disease</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects in the group get a book about chronic disease for patients. After 3 months, they finish reading the materials, they fill out the questionnaire.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>ICT programs</intervention_name>
    <description>ICT programs that include health information learning by disease and self-management based on Smart Management Strategy for Health (SMASH).</description>
    <arm_group_label>ICT programs</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>A book about chronic disease</intervention_name>
    <description>A Take-home book about chronic disease are provided for self-education</description>
    <arm_group_label>A book about chronic disease</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject 19 years old and more&#xD;
&#xD;
          -  Subject who understands the purpose of the study and signs with informed consent form&#xD;
&#xD;
          -  Subject with chronic disease (hypertension, diabetes, dyslipidemia)&#xD;
&#xD;
          -  Subject with more than one Poor Disease Control Indicator&#xD;
&#xD;
               1. HbA1C 7.0% or more&#xD;
&#xD;
               2. Systolic BP 140mmHg or more&#xD;
&#xD;
               3. LDL-cholesterol 130mg/dL or more&#xD;
&#xD;
          -  Subjects who use smart phones and PCs (those who can use ICT-based health care&#xD;
             programs)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to speak, understand, or write Korean&#xD;
&#xD;
          -  Inability to understand the contents of the provided materials due to poor eyesight&#xD;
             and hearing&#xD;
&#xD;
          -  Medical conditions that would limit adherence to participation of the clinical trial&#xD;
             (as confirmed by their referring physician; e.g. dyspnea, severe depression and other&#xD;
             mental disorders)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Young Ho Yun, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seoul National University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Seoul National University</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>September 19, 2017</study_first_submitted>
  <study_first_submitted_qc>September 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 26, 2017</study_first_posted>
  <last_update_submitted>October 22, 2018</last_update_submitted>
  <last_update_submitted_qc>October 22, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 24, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seoul National University Hospital</investigator_affiliation>
    <investigator_full_name>Young Ho Yun</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Self-Management IT Program</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dyslipidemias</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/NCT03294044
org study id: HI16C0455-1
nct id: NCT03294044
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study verifies efficacy of Smart Health Management Program developed for patients with
      chronic illness. The aim of the study is to observe the changes in clinical indicators,
      quality of life and health related behaviors when providing self-management programs with ICT
      for chronic disease patients.
This study is to demonstrate that chronic disease patients (hypertension, diabetes and
      dyslipidemia) with ICT-based self-management and educational program can improve clinical
      outcomes and overall health status, including quality of life and health habits.

      In addition to the economic burden, people with chronic disease experience various
      psychosocial crises such as anxiety and depression, which causes the deterioration of overall
      quality of life and increases social burden. However, standard Chronic Care Model (CCM) have
      limitations in that they do not provide self-management strategies of the patient in detail.
      Therefore, to improve the effectiveness of the CCM model, it is required to propose a new
      approach to the utilization of IT-based self-management program that is currently being
      developed to increase accessibility and efficiency of health care service.

      Primary outcomes of this study are as follow: Improvement of clinical indicators in patients
      with hypertension, diabetes and hyperlipidemia.

      Participants in this study will respond a baseline questionnaire about health habits, health
      behavior patterns and quality of life, diet, exercise, etc. After that, participants will be
      allocated randomly into the intervention group and the control group. The intervention group
      will receive self-management and educational program with ICT ("S Healthing") while the
      control group will receive basic educational material with same contents on the disease. "S
      Healthing" is based ICT- program and includes educational contents and self-management
      program based on Smart Management Strategy for Health (SMASH). The intervention group will
      conduct self-management for 3 months through smart phone application and web program.
      Participants will receive a questionnaire about the quality of life and health habits with
      the clinical examination 3 months after baseline survey was conducted. The result from two
      questionnaires (baseline, post-intervention) and clinical outcomes will be compiled and be
      compared with each other.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
masking description: No masking
measure: Success in clinical outcomes of Hypertension from baseline to 3 months
time frame: Baseline, 3 months post-intervention
description: Change in Systolic blood pressure(mmHg)
measure: Success in clinical outcomes of Dyslipidemia from baseline to 3 months
time frame: Baseline, 3 months post-intervention
description: Change in LDL Cholesterol (mg/dL)
measure: Success in clinical outcomes of primary disease Diabetes from baseline to 3 months
time frame: Baseline, 3 months post-intervention
description: Change in HbA1c (%)
measure: Health behavior patterns
time frame: Baseline, 3 months post-intervention
description: We identify health habits by dividing into five steps according to the TTM stage. We evaluate increase in maintenance rate of health behavior patterns.
measure: Depression
time frame: Baseline, 3 months post-intervention
description: Change in depression score (PHQ-9)
measure: Health Management Strategies
time frame: Baseline, 3 months post-intervention
description: We use Smart Management Strategy for Health Assessment Tool (SAT) to assess their self-management (SM) strategies of health by themselves. We evaluate improvement of Health Management Strategies.
measure: Quality of life (SF-12)
time frame: Baseline, 3 months post-intervention
description: Improvement of quality of life (SF-12)
measure: Quality of life (Mcgill QOL)
time frame: Baseline, 3 months post-intervention
description: Improvement of quality of life (Mcgill QOL)
measure: Quality of life (Euro-QoL)
time frame: Baseline, 3 months post-intervention
description: Improvement of quality of life (Euro-QoL)
arm group label: ICT programs
arm group type: Experimental
description: ICT programs that include health information learning by disease, and self-management based on Smart Management Strategy for Health (SMASH) are provided. After that, subjects will conduct self-management health care for 12 weeks. After 3 months, they finish self-management ICT programs, and then they fill out the questionnaire.
arm group label: A book about chronic disease
arm group type: Active Comparator
description: Subjects in the group get a book about chronic disease for patients. After 3 months, they finish reading the materials, they fill out the questionnaire.
intervention type: Behavioral
intervention name: ICT programs
description: ICT programs that include health information learning by disease and self-management based on Smart Management Strategy for Health (SMASH).
arm group label: ICT programs
intervention type: Behavioral
intervention name: A book about chronic disease
description: A Take-home book about chronic disease are provided for self-education
arm group label: A book about chronic disease
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
last name: Young Ho Yun, MD, PhD
role: Principal Investigator
affiliation: Seoul National University Hospital
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Seoul National University Hospital
investigator full name: Young Ho Yun
investigator title: Principal Investigator
mesh term: Dyslipidemias
mesh term: Chronic Disease