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/NCT06011213</url>
    </required_header>
    <id_info>
      <org_study_id>202361</org_study_id>
      <nct_id>NCT06011213</nct_id>
    </id_info>
    <brief_title>Early-warning Intervention for Heat Waves and Cold Spells in Older Hypertensive Patients</brief_title>
    <official_title>A Health-risk Early-warning Intervention for Heat Waves and Cold Spells in Older Hypertensive Patients in Tianjin, China: an Open, Cluster-randomised Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Tiantian Li</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Centers for Disease Control and Prevention, China</source>
    <oversight_info>
      <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 was designed to explore the impact of health-risk early-warning interventions for&#xD;
        heat waves and cold spells on older hypertensive patients.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        From June 15th 2023 to August 31st 2023, and December 1st 2023 to February 28th 2024,&#xD;
        researchers will conduct a double-blind, cluster randomised controlled trial involving 258&#xD;
        hypertensive patients aged 60 to 65 years in Wuqing District, Tianjin. For the sampling&#xD;
        stage, three communities will be randomly selected in Wuqing District. The geographical&#xD;
        distribution, urbanisation, population size, population structure, economic status, and&#xD;
        health service resources of each selected community are in equilibrium. Meanwhile, the&#xD;
        distance between the selected communities is greater than 5 km. Based on the list of chronic&#xD;
        disease management records, 86 older hypertensive patients (male: female = 1:1) in each&#xD;
        community will be involved in the intervention group, monitoring group, and blank control&#xD;
        group, respectively. Eligible individuals for this trial will be a mean untreated systolic&#xD;
        blood pressure of at least 140 mmHg or a mean untreated diastolic blood pressure of at least&#xD;
        90 mmHg, or a mean treated systolic blood pressure of at least 130 mmHg or a mean treated&#xD;
        diastolic blood pressure of at least 80 mmHg. Patients with a history of coronary heart&#xD;
        disease, heart failure, stroke or diabetes were exclueded. For the intervention stage,&#xD;
        different groups have different intervention modalities including heat waves or cold spells&#xD;
        warnings, monitoring of health indicators, questionnaire surveys, health checkups and&#xD;
        biological sample collection. According to the heat waves or cold spells health warning&#xD;
        systems conducted by National Institute of Environmental Health in the Chinese Center for&#xD;
        Disease Control and Prevention, whenever a health risk warning for a heat waves or cold&#xD;
        spells is issued, only the elderly in the intervention group will be alerted to the early&#xD;
        warning information through the Wechat Mini Programme. The exposure temperature,&#xD;
        electrocardiography (ECG), and blood pressure indicators will be monitored every day during&#xD;
        the study period in the intervention group and monitoring group, respectively. The blank&#xD;
        control group will only monitor the exposure temperature every day. Besides, the study period&#xD;
        will be divided into two parts including pre-intervention and intervention periods,&#xD;
        respectively, and all the patients will have questionnaire surveys, health checkups and&#xD;
        biological sample collections once in the pre-intervention period and three times in the&#xD;
        intervention period. Biological biomarkers of inflammation and oxidative stress in the&#xD;
        cardiovascular system will be tested. The content of the questionnaire will include&#xD;
        individual fundamental information, the perception of the health risk of heat waves and cold&#xD;
        spells, sleep quality, hypertension medication.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 15, 2023</start_date>
    <completion_date type="Anticipated">February 28, 2024</completion_date>
    <primary_completion_date type="Anticipated">February 28, 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>Double (Participant, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Observation indicators:Individual fundamental information</measure>
      <time_frame>six months</time_frame>
      <description>Weight and height will be combined to report BMI in kilogram/meter^2 (kg/m^2).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Observation indicators:Sleep quality</measure>
      <time_frame>six months</time_frame>
      <description>Sleep duration in hour.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Functional indicators:Blood pressure</measure>
      <time_frame>six months</time_frame>
      <description>Diastolic pressure and systolic pressure in millimetre of mercury (mmHg).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Functional indicators:Monitoring indicators of electrocardiogram-1</measure>
      <time_frame>six months</time_frame>
      <description>AverageHeartRate in beat per minute(bpm),MaxHeartRate in bpm,MinHeartRate in bpm.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Functional indicators:Monitoring indicators of electrocardiogram-2</measure>
      <time_frame>six months</time_frame>
      <description>ECG QT interval inMillisecond(ms),PR interval in ms.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Functional indicators:Monitoring indicators of electrocardiogram-3</measure>
      <time_frame>six months</time_frame>
      <description>QRS Electrical axis in degree.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Experimental test index:Biomarkers of inflammation in the cardiovascular system-1</measure>
      <time_frame>six months</time_frame>
      <description>Cardiac troponin in microgram/litre(μg/L),Heart fatty acid binding protein in μg/L.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Experimental test index:Biomarkers of inflammation in the cardiovascular system-2</measure>
      <time_frame>six months</time_frame>
      <description>C-reactiveprotein in milligram/litre(mg/L),D-dimer in mg/L.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Experimental test index:Biomarkers of inflammation in the cardiovascular system-3</measure>
      <time_frame>six months</time_frame>
      <description>Creatine kinase isoenzyme-MB in unit/liter(U/L).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Experimental test index:Biomarkers of inflammation in the cardiovascular system-4</measure>
      <time_frame>six months</time_frame>
      <description>NT-proBNP in picogram/milliLiter(pg/ml),Interleukin-6 in pg/ml.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Experimental test index:Biomarkers of inflammation in the cardiovascular system-5</measure>
      <time_frame>six months</time_frame>
      <description>Myoglobin in nanogram/milliliter(ng/mL).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Experimental test index:Biomarkers of inflammation in the cardiovascular system-6</measure>
      <time_frame>six months</time_frame>
      <description>B-type natriuretic peptides in picogram/Litre(pg/L).</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">258</enrollment>
    <condition>Hypertension</condition>
    <arm_group>
      <arm_group_label>Early-warning interventions</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The elderly in the intervention group will receive warning messages through WeChat mini programs and monitor daily exposure temperature, electrocardiogram (ECG), and blood pressure indicators</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Health monitoring</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>The exposure temperature, electrocardiography (ECG), and blood pressure indicators will be monitored every day during the study period in the monitoring group</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Blank control</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>The blank control group will only monitor the exposure temperature every day.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Information notification based on the health warning system for heat waves and cold spells</intervention_name>
      <description>Whenever a health risk warning for a heat waves or cold spells is issued, only the elderly in the intervention group will be alerted to the early warning information through the Wechat Mini Programme.</description>
      <arm_group_label>Early-warning interventions</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>The electrocardiography(ECG) and blood pressure monitoring</intervention_name>
      <description>The electrocardiography (ECG) and blood pressure indicators will be monitored every day during the study period in the intervention group and monitoring group, respectively.</description>
      <arm_group_label>Early-warning interventions</arm_group_label>
      <arm_group_label>Health monitoring</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  60 ≤ 65 years old&#xD;
  &#xD;
            -  Volunteer to participate in this study&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients with a history of coronary heart disease, heart failure, stroke or diabetes&#xD;
               were exclueded.&#xD;
  &#xD;
            -  Unable to cooperate with follow-up&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>60 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Tiantian Li</last_name>
      <role>Study Director</role>
      <affiliation>National lnstitute of Environmental Health, Chinese Center for Disease Controland Prevention</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Tiantian Li</last_name>
      <phone>010-50930213</phone>
      <email>litiantian@nieh.chinacdc.cn</email>
    </overall_contact>
    <location>
      <facility>
        <name>National Institute of Environmental Health, Chinese Center for Disease Control and Prevention</name>
        <address>
          <city>Beijing</city>
          <zip>100021</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>tiantian Li</last_name>
        <phone>010-50930213</phone>
        <email>litiantian@nieh.chinacdc.cn</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>June 4, 2023</study_first_submitted>
    <study_first_submitted_qc>August 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 25, 2023</study_first_posted>
    <last_update_submitted>August 28, 2023</last_update_submitted>
    <last_update_submitted_qc>August 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 30, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Centers for Disease Control and Prevention, China</investigator_affiliation>
      <investigator_full_name>Tiantian Li</investigator_full_name>
      <investigator_title>professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Hypertension</mesh_term>
    </condition_browse>
    <!-- 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/NCT06011213
  org study id: 202361
  nct id: NCT06011213
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  This study was designed to explore the impact of health-risk early-warning interventions for
        heat waves and cold spells on older hypertensive patients.
  From June 15th 2023 to August 31st 2023, and December 1st 2023 to February 28th 2024,
        researchers will conduct a double-blind, cluster randomised controlled trial involving 258
        hypertensive patients aged 60 to 65 years in Wuqing District, Tianjin. For the sampling
        stage, three communities will be randomly selected in Wuqing District. The geographical
        distribution, urbanisation, population size, population structure, economic status, and
        health service resources of each selected community are in equilibrium. Meanwhile, the
        distance between the selected communities is greater than 5 km. Based on the list of chronic
        disease management records, 86 older hypertensive patients (male: female = 1:1) in each
        community will be involved in the intervention group, monitoring group, and blank control
        group, respectively. Eligible individuals for this trial will be a mean untreated systolic
        blood pressure of at least 140 mmHg or a mean untreated diastolic blood pressure of at least
        90 mmHg, or a mean treated systolic blood pressure of at least 130 mmHg or a mean treated
        diastolic blood pressure of at least 80 mmHg. Patients with a history of coronary heart
        disease, heart failure, stroke or diabetes were exclueded. For the intervention stage,
        different groups have different intervention modalities including heat waves or cold spells
        warnings, monitoring of health indicators, questionnaire surveys, health checkups and
        biological sample collection. According to the heat waves or cold spells health warning
        systems conducted by National Institute of Environmental Health in the Chinese Center for
        Disease Control and Prevention, whenever a health risk warning for a heat waves or cold
        spells is issued, only the elderly in the intervention group will be alerted to the early
        warning information through the Wechat Mini Programme. The exposure temperature,
        electrocardiography (ECG), and blood pressure indicators will be monitored every day during
        the study period in the intervention group and monitoring group, respectively. The blank
        control group will only monitor the exposure temperature every day. Besides, the study period
        will be divided into two parts including pre-intervention and intervention periods,
        respectively, and all the patients will have questionnaire surveys, health checkups and
        biological sample collections once in the pre-intervention period and three times in the
        intervention period. Biological biomarkers of inflammation and oxidative stress in the
        cardiovascular system will be tested. The content of the questionnaire will include
        individual fundamental information, the perception of the health risk of heat waves and cold
        spells, sleep quality, hypertension medication.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: Double (Participant, Investigator)
  measure: Observation indicators:Individual fundamental information
  time frame: six months
  description: Weight and height will be combined to report BMI in kilogram/meter^2 (kg/m^2).
  measure: Observation indicators:Sleep quality
  time frame: six months
  description: Sleep duration in hour.
  measure: Functional indicators:Blood pressure
  time frame: six months
  description: Diastolic pressure and systolic pressure in millimetre of mercury (mmHg).
  measure: Functional indicators:Monitoring indicators of electrocardiogram-1
  time frame: six months
  description: AverageHeartRate in beat per minute(bpm),MaxHeartRate in bpm,MinHeartRate in bpm.
  measure: Functional indicators:Monitoring indicators of electrocardiogram-2
  time frame: six months
  description: ECG QT interval inMillisecond(ms),PR interval in ms.
  measure: Functional indicators:Monitoring indicators of electrocardiogram-3
  time frame: six months
  description: QRS Electrical axis in degree.
  measure: Experimental test index:Biomarkers of inflammation in the cardiovascular system-1
  time frame: six months
  description: Cardiac troponin in microgram/litre(μg/L),Heart fatty acid binding protein in μg/L.
  measure: Experimental test index:Biomarkers of inflammation in the cardiovascular system-2
  time frame: six months
  description: C-reactiveprotein in milligram/litre(mg/L),D-dimer in mg/L.
  measure: Experimental test index:Biomarkers of inflammation in the cardiovascular system-3
  time frame: six months
  description: Creatine kinase isoenzyme-MB in unit/liter(U/L).
  measure: Experimental test index:Biomarkers of inflammation in the cardiovascular system-4
  time frame: six months
  description: NT-proBNP in picogram/milliLiter(pg/ml),Interleukin-6 in pg/ml.
  measure: Experimental test index:Biomarkers of inflammation in the cardiovascular system-5
  time frame: six months
  description: Myoglobin in nanogram/milliliter(ng/mL).
  measure: Experimental test index:Biomarkers of inflammation in the cardiovascular system-6
  time frame: six months
  description: B-type natriuretic peptides in picogram/Litre(pg/L).
  arm group label: Early-warning interventions
  arm group type: Experimental
  description: The elderly in the intervention group will receive warning messages through WeChat mini programs and monitor daily exposure temperature, electrocardiogram (ECG), and blood pressure indicators
  arm group label: Health monitoring
  arm group type: Other
  description: The exposure temperature, electrocardiography (ECG), and blood pressure indicators will be monitored every day during the study period in the monitoring group
  arm group label: Blank control
  arm group type: No Intervention
  description: The blank control group will only monitor the exposure temperature every day.
  intervention type: Behavioral
  intervention name: Information notification based on the health warning system for heat waves and cold spells
  description: Whenever a health risk warning for a heat waves or cold spells is issued, only the elderly in the intervention group will be alerted to the early warning information through the Wechat Mini Programme.
  arm group label: Early-warning interventions
  intervention type: Device
  intervention name: The electrocardiography(ECG) and blood pressure monitoring
  description: The electrocardiography (ECG) and blood pressure indicators will be monitored every day during the study period in the intervention group and monitoring group, respectively.
  arm group label: Early-warning interventions
  arm group label: Health monitoring
  criteria: 
  gender: All
  minimum age: 60 Years
  maximum age: 65 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Tiantian Li
  role: Study Director
  affiliation: National lnstitute of Environmental Health, Chinese Center for Disease Controland Prevention
  last name: Tiantian Li
  phone: 010-50930213
  email: litiantian@nieh.chinacdc.cn
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Sponsor-Investigator
  investigator affiliation: Centers for Disease Control and Prevention, China
  investigator full name: Tiantian Li
  investigator title: professor
  mesh term: Hypertension