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A study on the empirical model of chronic obstructive pulmonary disease for the next-generation life and health industrial ecosystem creation project

Status Approved

  • First Submitted Date

    2020/11/09

  • Registered Date

    2021/01/14

  • Last Updated Date

    2021/01/04

CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

  • 1. Background

    Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
    CRIS
    Registration Number
    KCT0005784
    Unique Protocol ID CR319136
    Public/Brief Title A study on the empirical model applying IoT devices and systems for health management of patients with chronic obstructive pulmonary disease
    Scientific Title A study on the empirical model of chronic obstructive pulmonary disease for the next-generation life and health industrial ecosystem creation project
    Acronym COPD IoT Trials
    MFDS Regulated Study No
    IND/IDE Protocol No
    Registered at Other Registry No
    Healthcare Benefit Approval Status Not applicable
  • 2. Institutional Review Board / Ethics Committee

    Institutional Review Board Information
    Board Approval Status Submitted approval
    Board Approval Number CR319136
    Approval Date 2020-02-19
    Institutional Review Board Name Yonsei University Wonju Severance Christian Hospital Human Derivatives Bank Bioethics Review Committee
    Institutional Review Board Address 20, Ilsan-ro, Wonju-si, Gangwon-do
    Institutional Review Board Telephone 033-741-1555
    Data Monitoring Committee No
  • 3. Contact Details

    Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
    Contact Person for Principal Investigator / Scientific Queries
    Name KangHyun Lee
    Title Professor
    Telephone +82-33-741-5400
    Affiliation Yonsei University, Wonju Severance Christian Hospital
    Address 20 Ilsan-ro, Wonju-si, Gangwon-do,
    Contact Person for Public Queries
    Name Hyun Youk
    Title Professor
    Telephone +82-33-741-5401
    Affiliation Yonsei University, Wonju Severance Christian Hospital
    Address 20 Ilsan-ro, Wonju-si, Gangwon-do,
    Contact Person for Updating Information
    Name Hyun Youk
    Title Professor
    Telephone +82-33-741-5401
    Affiliation Yonsei University, Wonju Severance Christian Hospital
    Address 20 Ilsan-ro, Wonju-si, Gangwon-do,
  • 4. Status

    Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
    Study Site Single
    Overall Recruitment Status Not yet recruiting
    Date of First Enrollment 2021-01-11 Anticipated
    Target Number of Participant 100
    Primary Completion Date 2021-11-30 , Anticipated
    Study Completion Date 2021-12-31 , Anticipated
    Recruitment Status by Participating Study Site 1
    Name of Study Yonsei University, Wonju Severance Christian Hospital
    Recruitment Status Not yet recruiting
    Date of First Enrollment 2021-01-11 ,
  • 5. Source of Monetary / Material Support

    Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
    1. Source of Monetary/Material Support
    Organization Name Ministry of Trade, Industry & Energy
    Organization Type Government
    Project ID R6000229
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Yonsei University, Wonju Severance Christian Hospital
    Organization Type Medical Institute
  • 7. Study Summary

    Study Summary Information
    Lay Summary
    For patients with chronic obstructive pulmonary disease, a health management service model using IoT medical devices and IoT wellness devices IoT medical devices and IoT wellness devices, as well as test groups applying IoT medical devices and IoT wellness devices to develop It is divided into a control group that does not apply the group, and measures the lung capacity between the two groups, IoT medical devices and IoT wellness devices. It aims to collect lifelog data through. In addition, we would like to investigate whether monitoring using IoT medical devices and IoT wellness devices and active intervention* based on individual figures are effective in preventing acute exacerbation in patients with metabolic syndrome. 
    * Intervention method: alarm message transmission according to the clinical trial compliance level of the test group, regular text service information, bulletin board
    Health information using Chronic Obstructive Pulmonary Disease (COPD) is characterized by irreversible airflow restrictions.
    It is a lung disease caused by damage to the airways and lungs due to chronic inflammation. 
    It is known for external factors such as smoking, air pollution, respiratory infections, genes, age, sex, and respiratory sensitization.
    All. COPD, such as high blood pressure, diabetes, and asthma, can reduce symptoms and hospitalization if properly managed in primary care.
    It is a representative outpatient sensitive condition (CSC) that may be the cause of death in 2030.
    It is the leading cause of death, predicted to be the fourth largest cause of death (Mathers and Loncar, 2006). In Korea, in the last 20 years
    It is not consistently included in the top 10 causes of death, and chronic lower respiratory tract diseases ranked 7th among the causes of death in 2013.
    W Not only shows a sharp increase, but in 2013, the prevalence of chronic obstructive pulmonary disease in adults over 40
    It was 13.5%, and the prevalence also tended to increase with increasing age, and especially in men, the increase was high after their 60s.
    While the prevalence rate increases by 2-3% every year, the phosphorus of people diagnosed with chronic obstructive pulmonary disease.
    The fate rate was 2.9%, and only 3 out of 100 patients with disease recognized the disease. This low recognition rate is appropriate
    Management such as improvement of quality of life, acute deterioration and mortality, as well as relief of symptoms through one prevention and treatment
    Even though it is a possible and necessary disease, it may cause the death rate to increase over time.
     In addition, COPD causes a lot of socioeconomic burden. In the case of Korea, according to the Health Insurance Review and Assessment Service in February 2019, about 115.3 billion won (228,000 patients) was spent as direct medical expenses for COPD treatment, and the total number of outpatient specifications If 717,000 cases and medical expenses are about 20.8 billion won, the medical expenses per person is about 140,000 won, an increase of about 8,000 won compared to last year. Among them, acute deterioration is the most significant among COPD-related medical expenses.
    It is the largest weight.
    However, chronic obstructive pulmonary disease is an Ambulatory Care Sensitive Condition (ACSC) that can prevent exacerbation of the disease and hospitalization if it is effectively treated in an outpatient clinic.
    According to the Health Insurance Review and Assessment Service in 2019, patients with chronic obstructive pulmonary disease were found to experience a decrease in the hospitalization experience rate according to constant management (prescription of inhalation bronchodilators, continuous visits, and pulmonary function tests). Appeared to be.
    The actual prevalence of COPD was determined by the results of studies conducted using the COPD GOLD criteria (FEV1/FVC<0.7).
    While it is generally 10%, in Korea, 13.6% over 40 years old and 30.5% over 65 years old, which is a high level and c
  • 8. Study Design

    Study Design Information - Study Type, Observational Study Model, Time Perspective, Target Number of Participant, Cohort/Group Number, Cohort/Group, Cohort/Group Label, Cohort/Group Description, Biospecimen Collection & Archiving, Biospecimen Description
    Study Type Observational Study
    Observational Study Model Case-control
    Time Perspective Prospective  
    Target Number of Participant 100
    Cohort/Group Number 2
    Cohort/
    Group 1

    Cohort/Group Label

    Among patients with chronic obstructive pulmonary disease, a test group that applied IoT medical devices and IoT wellness devices

    Cohort/Group Description

    Tests that applied IoT medical devices and IoT wellness devices among 200 subjects eligible for chronic obstructive pulmonary disease 100 people in the military measure lung capacity before and after the clinical trial and collect it, and collect lifelog data of the subject through an APP that can link IoT medical devices and IoT wellness devices.
    Cohort/
    Group 2

    Cohort/Group Label

    Control group who did not apply IoT medical device and IoT wellness device among patients with chronic obstructive pulmonary disease

    Cohort/Group Description

    Among 200 subjects eligible for chronic obstructive pulmonary disease, 100 control subjects applied IoT medical devices and IoT wellness devices, For comparison, only health information through smart watches and apps is provided.
    Biospecimen
    Collection & Archiving
    Not collect nor Archive
    Biospecimen Description
  • 9. Subject Eligibility

    Subject Eligibility Information
    Study Population Description
    Among the residents of Wonju, those with chronic obstructive diseases who visited the Department of Respiratory Medicine in a superior general hospital are adults aged 20 to 80 years old.
    Sampling Method
    This clinical trial is a prospective study, and it is a parallel study in the test group and the control group. Wonju Severance Christian Hospital
    Among the patients with chronic obstructive pulmonary disease visiting the outpatient department of inspiratory medicine, Nagun and Da according to the COPD guidelines of the Korean Respiratory Society
    Only subjects in the group are recruited, and a test group and a control group are selected after randomization with a 50% probability.
    Condition(s)/Problem(s) * (J00-J99)Diseases of the respiratory system 
       (J44.99)Chronic obstructive pulmonary disease, unspecified, unspecified 

    This clinical trial is a prospective study, and it is a parallel study in the test group and the control group. Among the patients with chronic obstructive pulmonary disease who visit the Outpatient Department of Respiratory Medicine at Wonju Severance Christian Hospital, only those who fall under the COPD guidelines of the Korean Respiratory Society are recruited, and are randomly assigned with a 50% probability and then the test group and control group are selected . Out of 200 subjects eligible for chronic obstructive pulmonary disease, lung capacity measurements were conducted before and after clinical trials from 100 test groups to which IoT medical devices and IoT wellness devices were applied, and 100 control subjects that did not apply, and IoT medical devices and IoT wellness devices were collected. The lifelog data of the subject is collected through an interlockable APP. After the clinical trial is over, health information collected from the test group and the control group, lung capacity measurement values, life log data, and survey data are analyzed together to develop a health management service algorithm using IoT medical devices and IoT wellness devices. In addition, based on the collected IoT monitoring life log data, we will try to find out whether active intervention using the manpower of the smart healthcare support center installed at Wonju Severance Christian Hospital is effective in preventing acute exacerbation of chronic obstructive pulmonary disease patients. *Intervention method: Sending alarm messages according to the test group's compliance with clinical trials, regular text service information, and health information delivery using bulletin boards, etc.
    Rare Disease No
    Inclusion Criteria

    Gender

    Both

    Age

    20Year~80Year

    Description

    Selection criteria for test subjects
    The diagnosis was confirmed through post-bronchodilator spirometry after administration of bronchodilators in our hospital.
    Among the patients, Forced vital capacity (FVC), Forced expiratory volume for 1 second (Forced vital capacity)
    Expiratory volume in 1 second; FEV1) and the ratio of the forced expiratory volume to the hard lung capacity for 1 second
    Patients who meet the (FEV1/FVC, GOLDb) criteria (less than 0.7) and include the following selection criteria.
    -17-
    1) Adults 20 to 80 years old
     2) Among the subjects with chronic obstructive pulmonary disease, group Na and group multi according to the COPD guidelines of the Korean Respiratory Society
     3) Outpatient patients in the Department of Respiratory Medicine, Wonju Severance Christian Hospital
     4) Those who consented in writing to this clinical trial
     5) Those who can understand and carry out education and instructions, and can participate in the entire clinical trial period
    Exclusion Criteria
    Exclusion criteria for test subjects
     1) Persons with physical disabilities who cannot wear IoT medical devices and IoT wellness devices
     2) Patients with high reversibility of airflow restrictions
     3) Patients with chronic airway restrictions due to causes other than chronic obstructive pulmonary disease
     (Asthma, patients with predominant asthma, cystic fibrosis, bronchiectasis, closed bronchiolitis, fibrosis due to tuberculosis, etc.
     Patient)
     4) Persons suffering from skin diseases or dysfunctions in the contact area of ​​IoT medical devices
     5) Those who have negative opinions or reluctance to wear IoT medical devices
     6) Subjects who have implanted medical devices in their bodies
     7) pregnant women
     8) Participating in another clinical trial at the same time or taking part in a previous clinical trial
     Those who have not passed (within 3 months)
     9) Subjects judged as inappropriate by the doctor in charge of other examinations
    Healthy Volunteers No
  • 10. Outcome Measure(s)

    Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
    Type of Primary Outcome Efficacy
    Primary Outcome(s) 1
    Outcome
    Pulmonary Function Test result
    Timepoint
    Comparison before and after clinical trials
    Secondary Outcome(s) 1
    Outcome
    Number of exacerbations and emergency room visits during the clinical trial participant
    Timepoint
    Evaluate events within the duration of the clinical trial within one month after the trial
  • 11. Study Results and Publication

    Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
    Result Registered No
  • 12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

    Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
    Sharing Statement Yes
    Time of Sharing 2021. 12
    Way of Sharing Available on Request
    (yhmentor@gmail.com)
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