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/NCT05974670</url>
    </required_header>
    <id_info>
      <org_study_id>2021397-20220703</org_study_id>
      <nct_id>NCT05974670</nct_id>
    </id_info>
    <brief_title>Early Warning Value of Consumer Wearable Devices in AECOPD</brief_title>
    <acronym>EWVCWDC</acronym>
    <official_title>Early Warning Value of Consumer Wearable Devices in Chronic Obstructive Pulmonary Disease Exacerbation: An Evaluation Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Peking University First Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Peking University First 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 is a prospective, multi-center cohort study. 150 subjects with COPD and in stable stage&#xD;
        will be included. Wearable device's physiological parameters will be continually collected,&#xD;
        the investigators aim to explore whether consumer wearable devices are useful for early&#xD;
        warning deterioration of COPD.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a prospective cohort study. 150 subjects aged 35～80y with stable COPD will be&#xD;
        recruited. After enrollment, subjects wear consumer wearable devices and install APP on their&#xD;
        mobile phones. The first 7 days of wearing are to evaluate the stability of data collection&#xD;
        and the subject compliance, and to correct the wrong wearing. The subjects are required to&#xD;
        fill in the COPD symptom diary every day, and conducted online or offline follow-up at the&#xD;
        4th, 8th, 12th, 16th, 20th, and 24th weeks after enrollment. The physiological parameters of&#xD;
        wearable devices, including pulse rate, blood oxygen saturation, physical activity,&#xD;
        electrocardiogram, and sleep, will be continuously collected during the study. The Department&#xD;
        of Respiratory and Critical Care of Peking University First Hospital is responsible for this&#xD;
        research. Primary outcome is the moderate or more severe COPD acute exacerbation events. The&#xD;
        purpose of this study is to use consumer wearable devices to monitor the changes of COPD, and&#xD;
        to establish a physiological parameters model of wearable device that can predict the acute&#xD;
        exacerbation of COPD.&#xD;
  &#xD;
        The study protocol has been approved by the Peking University First Hospital Institutional&#xD;
        Review Board (IRB) (2021-397). Any protocol modifications will be submitted for the IRB&#xD;
        review and approval.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 21, 2022</start_date>
    <completion_date type="Anticipated">September 30, 2023</completion_date>
    <primary_completion_date type="Anticipated">September 30, 2023</primary_completion_date>
    <study_type>Observational</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>
    <primary_outcome>
      <measure>Moderate or more severe COPD exacerbation</measure>
      <time_frame>6 months</time_frame>
      <description>Mild exacerbation: exacerbation requiring short-acting bronchodilator (SABD) therapy alone Moderate exacerbation: exacerbation requiring SABD and antimicrobials with or without oral corticosteroids Severe exacerbation: exacerbation requiring hospitalization or emergency, intensive care unit (ICU) treatment.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Changes in symptoms (assessed by COPD Assessment Test, CAT)</measure>
      <time_frame>6 months</time_frame>
      <description>The change in CAT score is calculated by the difference in CAT score during follow-up.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in symptoms (assessed by the modified Medical Research Council (mMRC) dyspnea scores)</measure>
      <time_frame>6 months</time_frame>
      <description>The change in mMRC score is calculated by the difference in CAT score during follow-up.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in post-bronchodilator FEV1</measure>
      <time_frame>6 months</time_frame>
      <description>Post-bronchodilator FEV1 is measured by trained staff. The change in post-bronchodilator FEV1 is defined as the difference in FEV1 between week 24 follow-up and enrollment.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in post-bronchodilator FEV1%</measure>
      <time_frame>6 months</time_frame>
      <description>Post-bronchodilator FEV1% is measured by trained staff. The change in post-bronchodilator FEV1% is defined as the difference in FEV1 between week 24 follow-up and enrollment.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in post-bronchodilator FVC</measure>
      <time_frame>6 months</time_frame>
      <description>Post-bronchodilator FVC is measured by trained staff. The change in post-bronchodilator FVC is defined as the difference in FEV1 between week 24 follow-up and enrollment.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in post-bronchodilator FVC%</measure>
      <time_frame>6 months</time_frame>
      <description>Post-bronchodilator FVC% is measured by trained staff. The change in post-bronchodilator FVC% is defined as the difference in FEV1 between week 24 follow-up and enrollment.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in post-bronchodilator FEV1/FVC</measure>
      <time_frame>6 months</time_frame>
      <description>Post-bronchodilator FEV1/FVC is measured by trained staff. The change in post-bronchodilator FEV1/FVC is defined as the difference in FEV1 between week 24 follow-up and enrollment.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Herat rate parameters</measure>
      <time_frame>6 months</time_frame>
      <description>A wearable device worn by the subject continuously monitors heart rate parameters, from which parameters such as heart rate can be obtained.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Blood oxygen saturation</measure>
      <time_frame>6 months</time_frame>
      <description>A wearable device worn by the subject continuously monitors blood oxygen saturation.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Physical parameters from wearable device</measure>
      <time_frame>6 months</time_frame>
      <description>A wearable device worn by the subject continuously monitors physical parameters, from which parameters such as steps can be obtained.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Sleep parameters from wearable device</measure>
      <time_frame>6 months</time_frame>
      <description>A wearable device worn by the subject continuously monitors sleep parameters, from which parameters such as sleep duration can be obtained.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Wearing compliance</measure>
      <time_frame>6 months</time_frame>
      <description>Compliance is defined as the ratio of the time of wearing a device to the total study time.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Data loss rate</measure>
      <time_frame>6 months</time_frame>
      <description>Data loss rate</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">150</enrollment>
    <condition>COPD</condition>
    <arm_group>
      <arm_group_label>Wearing device</arm_group_label>
      <description>The subjects are required to fill in the COPD symptom diary every day, and conducted online or offline follow-up at the 4th, 8th, 12th, 16th, 20th, and 24th weeks after enrollment. The physiological parameters of wearable devices, including pulse rate, blood oxygen saturation, physical activity, electrocardiogram, and sleep, will be continuously collected during the study.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Consumer wearable device</intervention_name>
      <description>The subjects are required to wear the consumer wearable devices continuously during the whole study period. The device can provided several physiological parameters, including pulse rate, blood oxygen saturation, physical activity, electrocardiogram, and sleep.</description>
      <arm_group_label>Wearing device</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Outpatients and inpatients from Peking University First Hospital&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients diagnosed with stable COPD (refer to 2021 GOLD guidelines);&#xD;
  &#xD;
            -  Age between 35 and 80 years (both 35 and 80), either gender;&#xD;
  &#xD;
            -  A post-bronchodilator forced expiratory volume in 1 second percentage (FEV1%)&#xD;
               predicted between 25%~80%;&#xD;
  &#xD;
            -  Having mobile phone which can install APP of wearable device;&#xD;
  &#xD;
            -  Able to engage in daily activities;&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  History of asthma, lung cancer, active pulmonary tuberculosis, bronchiectasis, diffuse&#xD;
               lung disease (interstitial pneumonia, pulmonary sarcoidosis, occupational lung&#xD;
               disease, sarcoidosis et al) and pleural disease;&#xD;
  &#xD;
            -  History of lobectomy and/or lung transplantation;&#xD;
  &#xD;
            -  Predicted life expectancy less than 3 years;&#xD;
  &#xD;
            -  History of serious underlying diseases (including severe psychiatric illnesses, mental&#xD;
               disorders, neurological disorders, malignant tumors, chronic liver disease, heart&#xD;
               failure, autoimmune diseases, chronic kidney disease);&#xD;
  &#xD;
            -  Alcoholism, drug or toxic solvents abuse;&#xD;
  &#xD;
            -  Moderate to severe anemia;&#xD;
  &#xD;
            -  Smoking or quitting smoking for less than 6 weeks;&#xD;
  &#xD;
            -  Skin pigmentation, deformity, arterial stenosis or occlusion of both upper limbs;&#xD;
  &#xD;
            -  Skin allergy to metal/plastic;&#xD;
  &#xD;
            -  Those who are participating in other clinical trials, cannot be followed up for a long&#xD;
               time or have poor compliance.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>35 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Guangfa Wang, MD.</last_name>
      <role>Study Chair</role>
      <affiliation>Peking University First Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Jiping Liao, MD.</last_name>
      <phone>13521714181</phone>
      <email>colorfulwing01@163.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Chunbo Zhang</last_name>
      <phone>13086645758</phone>
      <email>2399637945@qq.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Peking University First Hospital</name>
        <address>
          <city>Beijing</city>
          <state>Beijing</state>
          <zip>100034</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Jiping Liao, MD.</last_name>
        <phone>13521714181</phone>
        <email>colorfulwing01@163.com</email>
      </contact>
      <contact_backup>
        <last_name>Chunbo Zhang</last_name>
        <phone>13086645758</phone>
        <email>2399637945@qq.com</email>
      </contact_backup>
      <investigator>
        <last_name>Jiping Liao, MD.</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Guangfa Wang, MD.</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Zhe Jin, MD.</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Meng Zhang</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Yan Hu, MD.</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Chunbo Zhang</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Xueying Li</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Jian Chen</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Aerospace 731 Hospital</name>
        <address>
          <city>Beijing</city>
          <state>Beijing</state>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Fengzhen Zhang</last_name>
        <email>zfz731hx@163.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Beijing Miyun Hospital</name>
        <address>
          <city>Beijing</city>
          <state>Beijing</state>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Chunhong Wang</last_name>
        <email>13701387739@163.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Civil Aviation General Hospital</name>
        <address>
          <city>Beijing</city>
          <state>Beijing</state>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Xiaosen Qian</last_name>
        <email>qian186@sohu.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>People's Hospital of Beijing Daxing District</name>
        <address>
          <city>Beijing</city>
          <state>Beijing</state>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Yongxiang Zhang</last_name>
        <email>zyx8669@163.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Shichahai Community Health Service Center</name>
        <address>
          <city>Beijing</city>
          <state>Beijing</state>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Lina Zhang</last_name>
        <email>10027698@qq.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>The Hospital of Shunyi District Beijing</name>
        <address>
          <city>Beijing</city>
          <state>Beijing</state>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Xisheng Chen</last_name>
        <email>syhx2011@163.com</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>September 27, 2022</study_first_submitted>
    <study_first_submitted_qc>July 26, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 3, 2023</study_first_posted>
    <last_update_submitted>July 26, 2023</last_update_submitted>
    <last_update_submitted_qc>July 26, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 3, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>COPD</keyword>
    <keyword>AECOPD</keyword>
    <keyword>Consumer wearable device</keyword>
    <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/NCT05974670
  org study id: 2021397-20220703
  nct id: NCT05974670
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  This is a prospective, multi-center cohort study. 150 subjects with COPD and in stable stage
        will be included. Wearable device's physiological parameters will be continually collected,
        the investigators aim to explore whether consumer wearable devices are useful for early
        warning deterioration of COPD.
  This is a prospective cohort study. 150 subjects aged 35～80y with stable COPD will be
        recruited. After enrollment, subjects wear consumer wearable devices and install APP on their
        mobile phones. The first 7 days of wearing are to evaluate the stability of data collection
        and the subject compliance, and to correct the wrong wearing. The subjects are required to
        fill in the COPD symptom diary every day, and conducted online or offline follow-up at the
        4th, 8th, 12th, 16th, 20th, and 24th weeks after enrollment. The physiological parameters of
        wearable devices, including pulse rate, blood oxygen saturation, physical activity,
        electrocardiogram, and sleep, will be continuously collected during the study. The Department
        of Respiratory and Critical Care of Peking University First Hospital is responsible for this
        research. Primary outcome is the moderate or more severe COPD acute exacerbation events. The
        purpose of this study is to use consumer wearable devices to monitor the changes of COPD, and
        to establish a physiological parameters model of wearable device that can predict the acute
        exacerbation of COPD.
  
        The study protocol has been approved by the Peking University First Hospital Institutional
        Review Board (IRB) (2021-397). Any protocol modifications will be submitted for the IRB
        review and approval.
  observational model: Cohort
  time perspective: Prospective
  measure: Moderate or more severe COPD exacerbation
  time frame: 6 months
  description: Mild exacerbation: exacerbation requiring short-acting bronchodilator (SABD) therapy alone Moderate exacerbation: exacerbation requiring SABD and antimicrobials with or without oral corticosteroids Severe exacerbation: exacerbation requiring hospitalization or emergency, intensive care unit (ICU) treatment.
  measure: Changes in symptoms (assessed by COPD Assessment Test, CAT)
  time frame: 6 months
  description: The change in CAT score is calculated by the difference in CAT score during follow-up.
  measure: Changes in symptoms (assessed by the modified Medical Research Council (mMRC) dyspnea scores)
  time frame: 6 months
  description: The change in mMRC score is calculated by the difference in CAT score during follow-up.
  measure: Changes in post-bronchodilator FEV1
  time frame: 6 months
  description: Post-bronchodilator FEV1 is measured by trained staff. The change in post-bronchodilator FEV1 is defined as the difference in FEV1 between week 24 follow-up and enrollment.
  measure: Changes in post-bronchodilator FEV1%
  time frame: 6 months
  description: Post-bronchodilator FEV1% is measured by trained staff. The change in post-bronchodilator FEV1% is defined as the difference in FEV1 between week 24 follow-up and enrollment.
  measure: Changes in post-bronchodilator FVC
  time frame: 6 months
  description: Post-bronchodilator FVC is measured by trained staff. The change in post-bronchodilator FVC is defined as the difference in FEV1 between week 24 follow-up and enrollment.
  measure: Changes in post-bronchodilator FVC%
  time frame: 6 months
  description: Post-bronchodilator FVC% is measured by trained staff. The change in post-bronchodilator FVC% is defined as the difference in FEV1 between week 24 follow-up and enrollment.
  measure: Changes in post-bronchodilator FEV1/FVC
  time frame: 6 months
  description: Post-bronchodilator FEV1/FVC is measured by trained staff. The change in post-bronchodilator FEV1/FVC is defined as the difference in FEV1 between week 24 follow-up and enrollment.
  measure: Herat rate parameters
  time frame: 6 months
  description: A wearable device worn by the subject continuously monitors heart rate parameters, from which parameters such as heart rate can be obtained.
  measure: Blood oxygen saturation
  time frame: 6 months
  description: A wearable device worn by the subject continuously monitors blood oxygen saturation.
  measure: Physical parameters from wearable device
  time frame: 6 months
  description: A wearable device worn by the subject continuously monitors physical parameters, from which parameters such as steps can be obtained.
  measure: Sleep parameters from wearable device
  time frame: 6 months
  description: A wearable device worn by the subject continuously monitors sleep parameters, from which parameters such as sleep duration can be obtained.
  measure: Wearing compliance
  time frame: 6 months
  description: Compliance is defined as the ratio of the time of wearing a device to the total study time.
  measure: Data loss rate
  time frame: 6 months
  description: Data loss rate
  arm group label: Wearing device
  description: The subjects are required to fill in the COPD symptom diary every day, and conducted online or offline follow-up at the 4th, 8th, 12th, 16th, 20th, and 24th weeks after enrollment. The physiological parameters of wearable devices, including pulse rate, blood oxygen saturation, physical activity, electrocardiogram, and sleep, will be continuously collected during the study.
  intervention type: Device
  intervention name: Consumer wearable device
  description: The subjects are required to wear the consumer wearable devices continuously during the whole study period. The device can provided several physiological parameters, including pulse rate, blood oxygen saturation, physical activity, electrocardiogram, and sleep.
  arm group label: Wearing device
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 35 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: Guangfa Wang, MD.
  role: Study Chair
  affiliation: Peking University First Hospital
  last name: Jiping Liao, MD.
  phone: 13521714181
  email: colorfulwing01@163.com
  last name: Chunbo Zhang
  phone: 13086645758
  email: 2399637945@qq.com
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  facility: 
  status: Not yet recruiting
  contact: 
  facility: 
  status: Not yet recruiting
  contact: 
  facility: 
  status: Not yet recruiting
  contact: 
  facility: 
  status: Not yet recruiting
  contact: 
  facility: 
  status: Not yet recruiting
  contact: 
  facility: 
  status: Not yet recruiting
  contact: 
  country: China
  responsible party type: Sponsor
  sharing ipd: No