xml: <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/NCT06022575</url>
    </required_header>
    <id_info>
      <org_study_id>PekingUTH Telehealth</org_study_id>
      <nct_id>NCT06022575</nct_id>
    </id_info>
    <brief_title>Telehealth Integrated Care Model in Patients With Cardiometabolic Disease</brief_title>
    <official_title>Evaluation of the Telehealth Integrated Care Model in Patients With Hyperlipidemia and Other Cardiometabolic Disease</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Peking University Third Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Peking University Third Hospital</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 objective of this study is to evaluate the telehealth integrated care model for its&#xD;
        clinical efficacy, medical resource utilization, health economics measurement, and&#xD;
        satisfaction survey indicators in hyperlipidemia patients and other cardiometabolic diseases.&#xD;
        The result of the study will provide evidence for the value of integrated model in the&#xD;
        treatment of patients with cardiometabolic syndrome.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Efficacy evaluation is critical for understanding the practical application effect of&#xD;
        telehealth integrated mode in the therapy of cardiometabolic disease patients. We can&#xD;
        comprehend the influence of the combination of online and offline models on patients'&#xD;
        clinical curative effect, medication compliance, medical cost, and satisfaction by analyzing&#xD;
        the curative effect and finding a scientific basis for clinical practice and policy&#xD;
        formation. As a result, the purpose of this study is to assess the curative effect of&#xD;
        hyperlipidemia patients with other cardiometabolic disease using a telehealth integrated&#xD;
        model, as well as to investigate the potential benefits and risks of this model in the&#xD;
        management of cardiometabolic disease.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 20, 2023</start_date>
    <completion_date type="Anticipated">July 20, 2025</completion_date>
    <primary_completion_date type="Anticipated">June 20, 2024</primary_completion_date>
    <study_type>Observational [Patient Registry]</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <target_duration>12 Months</target_duration>
    <primary_outcome>
      <measure>changes of compliance rate of target treatment for hyperlipidemia</measure>
      <time_frame>12 month after recuitment</time_frame>
      <description>difference of compliance rate of target treatment for hyperlipidemia between endpoint with baseline</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>changes of blood pressure</measure>
      <time_frame>12 month after recuitment</time_frame>
      <description>difference of blood pressure（both systolic and diastolic blood pressure will be measured.） between endpoint with baseline</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>changes of glycosylated hemoglobin</measure>
      <time_frame>12 month after recuitment</time_frame>
      <description>difference of glycosylated hemoglobin between endpoint with baseline</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>changes of fasting glucose</measure>
      <time_frame>12 month after recuitment</time_frame>
      <description>difference of fasting glucose between endpoint with baseline</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>changes of LDL-c</measure>
      <time_frame>12 month after recuitment</time_frame>
      <description>difference of LDL-c between endpoint with baseline</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>changes of triglyceride</measure>
      <time_frame>12 month after recuitment</time_frame>
      <description>difference of triglyceride between endpoint with baseline</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>abnormal liver function</measure>
      <time_frame>12 month after recuitment</time_frame>
      <description>an increase above the 3-fold normal value for ALT or AST.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>abnormal kidney function</measure>
      <time_frame>12 month after recuitment</time_frame>
      <description>an increase in creatinine of ≥ 30%</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Rehospitalization</measure>
      <time_frame>12 month</time_frame>
      <description>Rehospitalization because of coronary heart disease, poor blood pressure control, and poor glycemic control</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cardiovascular death</measure>
      <time_frame>12 month</time_frame>
      <description>Death because of cardiovascular diseases and sudden death</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>medication adherence rate</measure>
      <time_frame>12 month</time_frame>
      <description>Difference of medication adherence between each group measured by Morisky Medication Adherence Scale-8</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>patients satisfaction</measure>
      <time_frame>12 month</time_frame>
      <description>patients will be asked to rate their satisfaction score in Likert form with 1 being the most unsatisfactory and 5 being the most satisfactory on the overall experience, the medical diagnosis process, service attitude and physician's professionalism.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>medical cost</measure>
      <time_frame>12 month</time_frame>
      <description>Health Economics on medical cost, transportation cost, accommodation cost, waiting time and lost work time</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>in person visit counts</measure>
      <time_frame>12 month after recuitment</time_frame>
      <description>total number of in person visits</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>telehealth visit counts</measure>
      <time_frame>12 month after recuitment</time_frame>
      <description>total number of telehealth visits</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">1302</enrollment>
    <condition>Cardiometabolic Disease</condition>
    <condition>Hyperlipidemia</condition>
    <arm_group>
      <arm_group_label>Telehealth Integrated Care Group</arm_group_label>
      <description>Followed up in online Internet hospital, estimated and adjusted treatment accroding to clinical efficacy, and send individualized health education messages regularly.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Conventional Group</arm_group_label>
      <description>Followed up face-to-face in cardiacmetabolic clinics, estimated and adjusted treatment accroding to clinical efficacy, and conducted health education.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Telehealth integrated care</intervention_name>
      <description>Followed up in online Internet hospital, estimated and adjusted treatment accroding to clinical efficacy, and send individualized health education messages regularly.</description>
      <arm_group_label>Telehealth Integrated Care Group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Conventional health care</intervention_name>
      <description>Followed up face-to-face in cardiacmetabolic clinics, estimated and adjusted treatment accroding to clinical efficacy, and conducted health education.</description>
      <arm_group_label>Conventional Group</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Cardiometabolic Disease&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age ≥ 16 years, and ≤ 85 years;&#xD;
  &#xD;
            -  Diagnosis as hyperlipidemia with at least one of the following disease: hypertension&#xD;
               or type 2 diabetes mellitus;&#xD;
  &#xD;
            -  Agreed to be enrolled in this study.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Undergone percutaneous coronary intervention within one year in our hospital;&#xD;
  &#xD;
            -  Severe LV dysfunction, such as LV ejection fraction &lt; 35%, or congestive heart failure&#xD;
               with New York Heart Association (NYHA) functional class IV or Killip class IV;&#xD;
  &#xD;
            -  Structural heart disease, or severe arrhythmia;&#xD;
  &#xD;
            -  Severe liver or kidney diseases, endocrinology diseases, hematologic diseases,&#xD;
               rheumatic immune system diseases, and malignancy;&#xD;
  &#xD;
            -  could not complete at least one-year-followup.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>16 Years</minimum_age>
      <maximum_age>85 Years</maximum_age>
    </eligibility>
    <overall_official>
      <last_name>Lin Zeng, Ph.D</last_name>
      <role>Principal Investigator</role>
      <affiliation>Peking University Third Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Lequn Zhou, Dr</last_name>
      <phone>+86 1082266280</phone>
      <email>zhoulequnde@126.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Yipei Wang, Ph.D</last_name>
      <phone>+86 1082266191</phone>
      <email>yipeiw@126.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Peking University Third Hospital</name>
        <address>
          <city>Beijing</city>
          <state>Beijing</state>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Lequn Zhou</last_name>
        <email>zhoulequnde@126.com</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>July 7, 2023</study_first_submitted>
    <study_first_submitted_qc>September 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 5, 2023</study_first_posted>
    <last_update_submitted>September 1, 2023</last_update_submitted>
    <last_update_submitted_qc>September 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 5, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Peking University Third Hospital</investigator_affiliation>
      <investigator_full_name>Zeng Lin, Ph. D.</investigator_full_name>
      <investigator_title>Deputy Director of Research Center of Clinical Epidemiology</investigator_title>
    </responsible_party>
    <keyword>Telehealth</keyword>
    <keyword>Cardiometabolic Disease</keyword>
    <keyword>Hyperlipidemia</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Hyperlipidemias</mesh_term>
      <mesh_term>Hyperlipoproteinemias</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06022575
  org study id: PekingUTH Telehealth
  nct id: NCT06022575
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The objective of this study is to evaluate the telehealth integrated care model for its
        clinical efficacy, medical resource utilization, health economics measurement, and
        satisfaction survey indicators in hyperlipidemia patients and other cardiometabolic diseases.
        The result of the study will provide evidence for the value of integrated model in the
        treatment of patients with cardiometabolic syndrome.
  Efficacy evaluation is critical for understanding the practical application effect of
        telehealth integrated mode in the therapy of cardiometabolic disease patients. We can
        comprehend the influence of the combination of online and offline models on patients'
        clinical curative effect, medication compliance, medical cost, and satisfaction by analyzing
        the curative effect and finding a scientific basis for clinical practice and policy
        formation. As a result, the purpose of this study is to assess the curative effect of
        hyperlipidemia patients with other cardiometabolic disease using a telehealth integrated
        model, as well as to investigate the potential benefits and risks of this model in the
        management of cardiometabolic disease.
  observational model: Cohort
  time perspective: Prospective
  measure: changes of compliance rate of target treatment for hyperlipidemia
  time frame: 12 month after recuitment
  description: difference of compliance rate of target treatment for hyperlipidemia between endpoint with baseline
  measure: changes of blood pressure
  time frame: 12 month after recuitment
  description: difference of blood pressure（both systolic and diastolic blood pressure will be measured.） between endpoint with baseline
  measure: changes of glycosylated hemoglobin
  time frame: 12 month after recuitment
  description: difference of glycosylated hemoglobin between endpoint with baseline
  measure: changes of fasting glucose
  time frame: 12 month after recuitment
  description: difference of fasting glucose between endpoint with baseline
  measure: changes of LDL-c
  time frame: 12 month after recuitment
  description: difference of LDL-c between endpoint with baseline
  measure: changes of triglyceride
  time frame: 12 month after recuitment
  description: difference of triglyceride between endpoint with baseline
  measure: abnormal liver function
  time frame: 12 month after recuitment
  description: an increase above the 3-fold normal value for ALT or AST.
  measure: abnormal kidney function
  time frame: 12 month after recuitment
  description: an increase in creatinine of ≥ 30%
  measure: Rehospitalization
  time frame: 12 month
  description: Rehospitalization because of coronary heart disease, poor blood pressure control, and poor glycemic control
  measure: Cardiovascular death
  time frame: 12 month
  description: Death because of cardiovascular diseases and sudden death
  measure: medication adherence rate
  time frame: 12 month
  description: Difference of medication adherence between each group measured by Morisky Medication Adherence Scale-8
  measure: patients satisfaction
  time frame: 12 month
  description: patients will be asked to rate their satisfaction score in Likert form with 1 being the most unsatisfactory and 5 being the most satisfactory on the overall experience, the medical diagnosis process, service attitude and physician's professionalism.
  measure: medical cost
  time frame: 12 month
  description: Health Economics on medical cost, transportation cost, accommodation cost, waiting time and lost work time
  measure: in person visit counts
  time frame: 12 month after recuitment
  description: total number of in person visits
  measure: telehealth visit counts
  time frame: 12 month after recuitment
  description: total number of telehealth visits
  arm group label: Telehealth Integrated Care Group
  description: Followed up in online Internet hospital, estimated and adjusted treatment accroding to clinical efficacy, and send individualized health education messages regularly.
  arm group label: Conventional Group
  description: Followed up face-to-face in cardiacmetabolic clinics, estimated and adjusted treatment accroding to clinical efficacy, and conducted health education.
  intervention type: Procedure
  intervention name: Telehealth integrated care
  description: Followed up in online Internet hospital, estimated and adjusted treatment accroding to clinical efficacy, and send individualized health education messages regularly.
  arm group label: Telehealth Integrated Care Group
  intervention type: Procedure
  intervention name: Conventional health care
  description: Followed up face-to-face in cardiacmetabolic clinics, estimated and adjusted treatment accroding to clinical efficacy, and conducted health education.
  arm group label: Conventional Group
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 16 Years
  maximum age: 85 Years
  last name: Lin Zeng, Ph.D
  role: Principal Investigator
  affiliation: Peking University Third Hospital
  last name: Lequn Zhou, Dr
  phone: +86 1082266280
  email: zhoulequnde@126.com
  last name: Yipei Wang, Ph.D
  phone: +86 1082266191
  email: yipeiw@126.com
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: Peking University Third Hospital
  investigator full name: Zeng Lin, Ph. D.
  investigator title: Deputy Director of Research Center of Clinical Epidemiology
  mesh term: Hyperlipidemias
  mesh term: Hyperlipoproteinemias
  sharing ipd: Undecided