<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/NCT03294057</url>
  </required_header>
  <id_info>
    <org_study_id>HI16C0455-2</org_study_id>
    <nct_id>NCT03294057</nct_id>
  </id_info>
  <brief_title>Collaborative Care With Smart Health Management Program for Patients With Chronic Illness</brief_title>
  <official_title>The Effectiveness of Collaborative Care With Smart Health Management Program 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>Korea Health Industry Development Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <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>Seoul National University Bundang Hospital</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 collaborative care with Smart Health Management Program&#xD;
      developed for patients with chronic illness. The aim of the study is to observe the changes&#xD;
      in clinical indicators, quality of life and health related behaviors when providing&#xD;
      self-management programs with ICT for chronic disease patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is to demonstrate that chronic disease patients receiving collaborative care with&#xD;
      ICT-based self-management and educational program can improve clinical outcomes and overall&#xD;
      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. The collaborative care management based Chronic&#xD;
      Care Model (CCM) have provided coaching by a medically supervised nurse, working with each&#xD;
      patient's physician. However, standard CCM have limitations in that they do not provide&#xD;
      self-management strategies of the patient in detail. Therefore, to improve the effectiveness&#xD;
      of the CCM model, it is required to propose a new approach to the utilization of IT-based&#xD;
      self-management program that is currently being developed to increase accessibility and&#xD;
      efficiency of health care service.&#xD;
&#xD;
      Primary outcomes of this study are as follow: Improvement of depression in patients with&#xD;
      osteoporosis, chronic respiratory disease and chronic arthritis.&#xD;
&#xD;
      Participants in this study will respond a baseline questionnaire about depressive mood,&#xD;
      health habits, health behavior patterns and quality of life, diet, exercise, etc. After that,&#xD;
      participants will be allocated equally into three groups - the intervention group 1,&#xD;
      intervention group 2 and the control group. The intervention group 1 will receive S Healthing&#xD;
      and a tele- coaching program conducted 12 times (one time for one week), and more than 20&#xD;
      minutes each by a trained nurse. The intervention group 2 will receive S Healthing while the&#xD;
      control group will receive basic educational material on the disease. Coaching content&#xD;
      consists specifically of: 1) evaluation, 2) facing and accepting the health crisis, 3)&#xD;
      setting up new goals, 4) making decisions and plans, and 5) practice. &quot;S Healthing&quot; is based&#xD;
      ICT- program and includes educational contents and self-management program based on Smart&#xD;
      Management Strategy for Health (SMASH). The intervention group 1, 2 will conduct&#xD;
      self-management for 3 months through smart phone application and web program. Participants&#xD;
      will receive a questionnaire about the quality of life and health habits with the clinical&#xD;
      examination 3 months after baseline survey was conducted. The result from two questionnaires&#xD;
      (baseline, 3 months post-intervention) and clinical outcome of baseline and 3 months will be&#xD;
      compiled and be compared with others.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 27, 2017</start_date>
  <completion_date type="Actual">June 30, 2019</completion_date>
  <primary_completion_date type="Actual">June 7, 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>
  </study_design_info>
  <primary_outcome>
    <measure>Depression</measure>
    <time_frame>Baseline, 3 months post-intervention</time_frame>
    <description>Improvement of depression (PHQ-9)</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>Health Management Strategies</measure>
    <time_frame>Baseline, 3 months post-intervention</time_frame>
    <description>Improvement of Health Management Strategies by SAT (We use Smart Management Strategy for Health Assessment Tool (SAT) to assess their self-management (SM) strategies of health by themselves).</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 (EuroQoL)</measure>
    <time_frame>Baseline, 3 months post-intervention</time_frame>
    <description>Improvement of quality of life (EuroQoL)</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>Physical activity</measure>
    <time_frame>Baseline, 3 months post-intervention</time_frame>
    <description>Changes in exercise (Godin's Leisure Time Exercise Questionnaire)</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">54</enrollment>
  <condition>Osteoporosis</condition>
  <condition>Chronic Respiratory Disease</condition>
  <condition>Arthritis</condition>
  <condition>Osteopenia</condition>
  <arm_group>
    <arm_group_label>ICT programs + Tele-coaching 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. And a trained nurse provides tele-coaching programs to subjects. After that, subjects will conduct self-management health care and tele-coaching programs for 12 weeks. After 3 months, they finish self-management ICT + coaching programs, and then they fill out the questionnaire.</description>
  </arm_group>
  <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>Tele-coaching programs</intervention_name>
    <description>Tele-coaching program conducted 12 times (one time for one week), and more than 20 minutes each by a trained nurse. Coaching content specifically, 1) evaluation, 2) facing and accepting the health crisis, 3) setting up new goals, 4) making decisions and plans, and 5) practice.</description>
    <arm_group_label>ICT programs + Tele-coaching programs</arm_group_label>
  </intervention>
  <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>
    <arm_group_label>ICT programs + Tele-coaching 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 (osteoporosis, chronic pulmonary disease, chronic&#xD;
             arthritis)&#xD;
&#xD;
          -  Subject with METs less than 12.5 hours per week&#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 Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>03080</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>March 2021</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>March 15, 2021</last_update_submitted>
  <last_update_submitted_qc>March 15, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 17, 2021</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>Osteoporosis</mesh_term>
    <mesh_term>Bone Diseases, Metabolic</mesh_term>
    <mesh_term>Respiratory Tract Diseases</mesh_term>
    <mesh_term>Respiration Disorders</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/NCT03294057
org study id: HI16C0455-2
nct id: NCT03294057
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study verifies efficacy of collaborative care with 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 receiving collaborative care 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. The collaborative care management based Chronic
      Care Model (CCM) have provided coaching by a medically supervised nurse, working with each
      patient's physician. However, standard 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 depression in patients with
      osteoporosis, chronic respiratory disease and chronic arthritis.

      Participants in this study will respond a baseline questionnaire about depressive mood,
      health habits, health behavior patterns and quality of life, diet, exercise, etc. After that,
      participants will be allocated equally into three groups - the intervention group 1,
      intervention group 2 and the control group. The intervention group 1 will receive S Healthing
      and a tele- coaching program conducted 12 times (one time for one week), and more than 20
      minutes each by a trained nurse. The intervention group 2 will receive S Healthing while the
      control group will receive basic educational material on the disease. Coaching content
      consists specifically of: 1) evaluation, 2) facing and accepting the health crisis, 3)
      setting up new goals, 4) making decisions and plans, and 5) practice. "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 1, 2 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, 3 months post-intervention) and clinical outcome of baseline and 3 months will be
      compiled and be compared with others.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Depression
time frame: Baseline, 3 months post-intervention
description: Improvement of depression (PHQ-9)
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: Health Management Strategies
time frame: Baseline, 3 months post-intervention
description: Improvement of Health Management Strategies by SAT (We use Smart Management Strategy for Health Assessment Tool (SAT) to assess their self-management (SM) strategies of health by themselves).
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 (EuroQoL)
time frame: Baseline, 3 months post-intervention
description: Improvement of quality of life (EuroQoL)
measure: Quality of life (SF-12)
time frame: Baseline, 3 months post-intervention
description: Improvement of quality of life (SF-12)
measure: Physical activity
time frame: Baseline, 3 months post-intervention
description: Changes in exercise (Godin's Leisure Time Exercise Questionnaire)
arm group label: ICT programs + Tele-coaching 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. And a trained nurse provides tele-coaching programs to subjects. After that, subjects will conduct self-management health care and tele-coaching programs for 12 weeks. After 3 months, they finish self-management ICT + coaching programs, and then they fill out the questionnaire.
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: Tele-coaching programs
description: Tele-coaching program conducted 12 times (one time for one week), and more than 20 minutes each by a trained nurse. Coaching content specifically, 1) evaluation, 2) facing and accepting the health crisis, 3) setting up new goals, 4) making decisions and plans, and 5) practice.
arm group label: ICT programs + Tele-coaching programs
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
arm group label: ICT programs + Tele-coaching 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: Osteoporosis
mesh term: Bone Diseases, Metabolic
mesh term: Respiratory Tract Diseases
mesh term: Respiration Disorders
mesh term: Chronic Disease