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/NCT05963828</url>
    </required_header>
    <id_info>
      <org_study_id>COMPLIANCE-MT</org_study_id>
      <nct_id>NCT05963828</nct_id>
    </id_info>
    <brief_title>Comprehensive Management of High-risk PopuLatIon of Stroke Based on Social Network</brief_title>
    <acronym>COMPLIANCE-MT</acronym>
    <official_title>COmprehensive Management of High-risk PopuLatIon of Stroke bAsed oN soCial nEtwork: a Multicenter, Parallel and Randomized Controlled sTudy</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Changhai Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Changhai 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>
        The purpose of this study is to evaluate the effectiveness of social network in improving&#xD;
        drug compliance and risk factors control rate of stroke high-risk population after discharge.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Stroke is the leading cause of death among residents in China, with the characteristics of&#xD;
        high morbidity, high mortality, high disability rate, high recurrence rate and so on, which&#xD;
        brings huge economic burden to the patients' families and society. Strengthening the&#xD;
        comprehensive management of the high-risk population of stroke, improving the medication&#xD;
        compliance of patients and the control rate of stroke risk factors play a key role in&#xD;
        reducing stroke recurrence.&#xD;
  &#xD;
        This study is a multicenter, prospective, randomized, single-blind study, which aims to use&#xD;
        the tool of WeChat Mini Programs to realize the post-hospital follow-up management of the&#xD;
        high-risk population of stroke. The follow-up time is 12 months. The main measurement result&#xD;
        was the change of patients' medication compliance after comprehensive management.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 1, 2023</start_date>
    <completion_date type="Anticipated">September 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">September 30, 2024</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>Prevention</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Good compliance rate of stroke prevention drugs at 12 months after discharge</measure>
      <time_frame>12 months after discharge.</time_frame>
      <description>Measured by The 8-Item Medication Adherence Scale ;The score of Morisky-8 medication compliance scale is greater than 6 as &quot;good compliance&quot;.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Good compliance rate of stroke prevention drugs at 1 month, 3 months and 6 months after discharge</measure>
      <time_frame>1 month, 3 months and 6 months after discharge.</time_frame>
      <description>Measured by The 8-Item Medication Adherence Scale ;The score of Morisky-8 medication compliance scale is greater than 6 as &quot;good compliance&quot;.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The attainment rate of stroke risk factors (blood glucose, blood pressure, blood lipid, BMI, waist circumference, hip circumference, smoking) at 1 month, 3 months, 6 months and 12 months after discharge.</measure>
      <time_frame>1 month, 3 months, 6 months and 12 months after discharge</time_frame>
      <description>The method of measurement is as follows:&#xD;
  Blood lipids: fasting blood sampling measurement Blood glucose: fasting fingertip blood glucose Blood pressure: using a sphygmomanometer to measure BMI: weight (kg) / height (m) ^ 2 Waist circumference, Hip circumference, Smoking: Patient self-report</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Knowledge of stroke</measure>
      <time_frame>1 month, 3 months, 6 months and 12 months after discharge</time_frame>
      <description>Measured by The Knowledge questionnaire on prevention and treatment of stroke</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Personal motivation</measure>
      <time_frame>1 month, 3 months, 6 months and 12 months after discharge</time_frame>
      <description>Measured by The Stroke Attitude Questionnaire</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Stroke health behavior improvement</measure>
      <time_frame>1 month, 3 months, 6 months and 12 months after discharge</time_frame>
      <description>Measured by The Stroke Prevention Health Behavior Scale</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Social motivation</measure>
      <time_frame>1 month, 3 months, 6 months and 12 months after discharge</time_frame>
      <description>Measured by Perceived Social Support Scale</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Health-related quality of life</measure>
      <time_frame>1 month, 3 months, 6 months and 12 months after discharge</time_frame>
      <description>Measured by The 5-level EQ-5D</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of anxiety</measure>
      <time_frame>1 month, 3 months, 6 months and 12 months after discharge</time_frame>
      <description>Measured by Generalized Anxiety Disorder-7</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of depression</measure>
      <time_frame>1 month, 3 months, 6 months and 12 months after discharge</time_frame>
      <description>Measured by Patient Health Questionnaire-9</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Self efficacy</measure>
      <time_frame>1 month, 3 months, 6 months and 12 months after discharge</time_frame>
      <description>Measured by Chronic Disease Self-Efficacy Scale</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of major cardiovascular events including stroke, acute coronary syndrome, and vascular death</measure>
      <time_frame>1 month, 3 months, 6 months and 12 months after discharge</time_frame>
      <description>Stroke: cerebral blood supply disorder caused by acute (focal) neurological syndrome, there is ischemic or hemorrhagic lesion in the corresponding area on brain imaging, or clinical evidence shows negative ischemic lesion on imaging, and the symptoms last longer than 24 hours.&#xD;
  Acute coronary syndrome: ①typical clinical symptoms (such as chest pain, heart failure, etc.) accompanied by typical electrocardiogram (ECG) abnormalities; ② typical clinical symptoms with troponin elevated more than 2 times the upper limit of normal;③ or Non-specific symptoms with elevated troponin more than 2 times the upper limit of normal; ④Asymptomatic myocardial infarction diagnosed by follow-up ECG compared with baseline ECG combined with corresponding results of echocardiography or coronary angiography.&#xD;
  Vascular death: including death within 30 days after stroke, death within 7 days after acute coronary syndrome, non-cerebral hemorrhage or necrotic death after peripheral artery occlusion or</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Delayed behavioral intention before hospitalization after stroke</measure>
      <time_frame>1 month, 3 months, 6 months and 12 months after discharge</time_frame>
      <description>Measured by Prehospital Delayed Behavior Intention Scale for Stroke</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">720</enrollment>
    <condition>Stroke</condition>
    <condition>Cerebrovascular Disorders</condition>
    <condition>Brain Diseases</condition>
    <condition>Central Nervous System Diseases</condition>
    <condition>Nervous System Diseases</condition>
    <condition>Vascular Diseases</condition>
    <condition>Cardiovascular Diseases</condition>
    <arm_group>
      <arm_group_label>Standard group</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Patients are managed according to the routine methods after enrollment.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Experimental group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients are managed by the social network platform.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Post-hospital management based on WeChat applet</intervention_name>
      <description>The brain and heart health manager uses the exclusive QR code in the WeChat applet to receive and manage patients. Patients can register and use the WeChat applet by scanning the QR code. The functions of WeChat applet include making medication plan for patients, daily medication reminder, targeted health education, health index monitoring, online consultation and so on.</description>
      <arm_group_label>Experimental group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Routine post-hospital follow-up management</intervention_name>
      <description>The brain and mental health managers routinely followed up the patients in the standard group for 1, 3, 6 and 12 months by telephone or outpatient follow-up, the main content of which was to inquire about the medication of patients and the management of stroke risk factors. Targeted health education was carried out according to the risk factors of patients.</description>
      <arm_group_label>Standard group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age ≥18 years&#xD;
  &#xD;
            -  High-risk population of stroke for hospitalization&#xD;
  &#xD;
            -  Modified Rankin Scale score≤ 2&#xD;
  &#xD;
            -  Patients or primary caregiver have smart phone and wechat accounts&#xD;
  &#xD;
            -  Patients take at least one drug for a long time (antihypertensive, hypoglycemic,&#xD;
               lipid-lowering, anticoagulant, antiplatelet drugs)&#xD;
  &#xD;
            -  Written informed consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients and their families are unable to operate smartphones&#xD;
  &#xD;
            -  Having other diseases that interfere with clinical follow-up assessment (such as&#xD;
               cancer, dementia, severe mental illness, etc.)&#xD;
  &#xD;
            -  Life expectancy is less than 12 months&#xD;
  &#xD;
            -  Patients living in the absence of network conditions&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Zhang lingjuan</last_name>
      <role>Study Director</role>
      <affiliation>Changhai Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Qiao mengting</last_name>
      <phone>15039464902</phone>
      <email>pour7788@163.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Changhai Hospital</name>
        <address>
          <city>Shanghai</city>
          <state>Shanghai</state>
          <zip>200433</zip>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Qiao mengting</last_name>
        <phone>15039464902</phone>
        <email>pour7788@163.com</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>April 14, 2023</study_first_submitted>
    <study_first_submitted_qc>July 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>July 25, 2023</last_update_submitted>
    <last_update_submitted_qc>July 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 27, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Stroke</keyword>
    <keyword>Management</keyword>
    <keyword>Social Networks</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Stroke</mesh_term>
      <mesh_term>Nervous System Diseases</mesh_term>
      <mesh_term>Brain Diseases</mesh_term>
      <mesh_term>Central Nervous System Diseases</mesh_term>
      <mesh_term>Cerebrovascular Disorders</mesh_term>
      <mesh_term>Cardiovascular Diseases</mesh_term>
      <mesh_term>Vascular Diseases</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</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/NCT05963828
  org study id: COMPLIANCE-MT
  nct id: NCT05963828
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this study is to evaluate the effectiveness of social network in improving
        drug compliance and risk factors control rate of stroke high-risk population after discharge.
  Stroke is the leading cause of death among residents in China, with the characteristics of
        high morbidity, high mortality, high disability rate, high recurrence rate and so on, which
        brings huge economic burden to the patients' families and society. Strengthening the
        comprehensive management of the high-risk population of stroke, improving the medication
        compliance of patients and the control rate of stroke risk factors play a key role in
        reducing stroke recurrence.
  
        This study is a multicenter, prospective, randomized, single-blind study, which aims to use
        the tool of WeChat Mini Programs to realize the post-hospital follow-up management of the
        high-risk population of stroke. The follow-up time is 12 months. The main measurement result
        was the change of patients' medication compliance after comprehensive management.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: Single (Outcomes Assessor)
  measure: Good compliance rate of stroke prevention drugs at 12 months after discharge
  time frame: 12 months after discharge.
  description: Measured by The 8-Item Medication Adherence Scale ;The score of Morisky-8 medication compliance scale is greater than 6 as "good compliance".
  measure: Good compliance rate of stroke prevention drugs at 1 month, 3 months and 6 months after discharge
  time frame: 1 month, 3 months and 6 months after discharge.
  description: Measured by The 8-Item Medication Adherence Scale ;The score of Morisky-8 medication compliance scale is greater than 6 as "good compliance".
  measure: The attainment rate of stroke risk factors (blood glucose, blood pressure, blood lipid, BMI, waist circumference, hip circumference, smoking) at 1 month, 3 months, 6 months and 12 months after discharge.
  time frame: 1 month, 3 months, 6 months and 12 months after discharge
  description: The method of measurement is as follows:
  Blood lipids: fasting blood sampling measurement Blood glucose: fasting fingertip blood glucose Blood pressure: using a sphygmomanometer to measure BMI: weight (kg) / height (m) ^ 2 Waist circumference, Hip circumference, Smoking: Patient self-report
  measure: Knowledge of stroke
  time frame: 1 month, 3 months, 6 months and 12 months after discharge
  description: Measured by The Knowledge questionnaire on prevention and treatment of stroke
  measure: Personal motivation
  time frame: 1 month, 3 months, 6 months and 12 months after discharge
  description: Measured by The Stroke Attitude Questionnaire
  measure: Stroke health behavior improvement
  time frame: 1 month, 3 months, 6 months and 12 months after discharge
  description: Measured by The Stroke Prevention Health Behavior Scale
  measure: Social motivation
  time frame: 1 month, 3 months, 6 months and 12 months after discharge
  description: Measured by Perceived Social Support Scale
  measure: Health-related quality of life
  time frame: 1 month, 3 months, 6 months and 12 months after discharge
  description: Measured by The 5-level EQ-5D
  measure: Incidence of anxiety
  time frame: 1 month, 3 months, 6 months and 12 months after discharge
  description: Measured by Generalized Anxiety Disorder-7
  measure: Incidence of depression
  time frame: 1 month, 3 months, 6 months and 12 months after discharge
  description: Measured by Patient Health Questionnaire-9
  measure: Self efficacy
  time frame: 1 month, 3 months, 6 months and 12 months after discharge
  description: Measured by Chronic Disease Self-Efficacy Scale
  measure: Incidence of major cardiovascular events including stroke, acute coronary syndrome, and vascular death
  time frame: 1 month, 3 months, 6 months and 12 months after discharge
  description: Stroke: cerebral blood supply disorder caused by acute (focal) neurological syndrome, there is ischemic or hemorrhagic lesion in the corresponding area on brain imaging, or clinical evidence shows negative ischemic lesion on imaging, and the symptoms last longer than 24 hours.
  Acute coronary syndrome: ①typical clinical symptoms (such as chest pain, heart failure, etc.) accompanied by typical electrocardiogram (ECG) abnormalities; ② typical clinical symptoms with troponin elevated more than 2 times the upper limit of normal;③ or Non-specific symptoms with elevated troponin more than 2 times the upper limit of normal; ④Asymptomatic myocardial infarction diagnosed by follow-up ECG compared with baseline ECG combined with corresponding results of echocardiography or coronary angiography.
  Vascular death: including death within 30 days after stroke, death within 7 days after acute coronary syndrome, non-cerebral hemorrhage or necrotic death after peripheral artery occlusion or
  measure: Delayed behavioral intention before hospitalization after stroke
  time frame: 1 month, 3 months, 6 months and 12 months after discharge
  description: Measured by Prehospital Delayed Behavior Intention Scale for Stroke
  arm group label: Standard group
  arm group type: Other
  description: Patients are managed according to the routine methods after enrollment.
  arm group label: Experimental group
  arm group type: Experimental
  description: Patients are managed by the social network platform.
  intervention type: Behavioral
  intervention name: Post-hospital management based on WeChat applet
  description: The brain and heart health manager uses the exclusive QR code in the WeChat applet to receive and manage patients. Patients can register and use the WeChat applet by scanning the QR code. The functions of WeChat applet include making medication plan for patients, daily medication reminder, targeted health education, health index monitoring, online consultation and so on.
  arm group label: Experimental group
  intervention type: Behavioral
  intervention name: Routine post-hospital follow-up management
  description: The brain and mental health managers routinely followed up the patients in the standard group for 1, 3, 6 and 12 months by telephone or outpatient follow-up, the main content of which was to inquire about the medication of patients and the management of stroke risk factors. Targeted health education was carried out according to the risk factors of patients.
  arm group label: Standard group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Zhang lingjuan
  role: Study Director
  affiliation: Changhai Hospital
  last name: Qiao mengting
  phone: 15039464902
  email: pour7788@163.com
  facility: 
  contact: 
  country: China
  responsible party type: Sponsor
  mesh term: Stroke
  mesh term: Nervous System Diseases
  mesh term: Brain Diseases
  mesh term: Central Nervous System Diseases
  mesh term: Cerebrovascular Disorders
  mesh term: Cardiovascular Diseases
  mesh term: Vascular Diseases
  sharing ipd: No