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The effect evaluation of the transitional care intervention for respiratory disease patients

Status Approved

  • First Submitted Date

    2019/10/04

  • Registered Date

    2019/10/17

  • Last Updated Date

    2019/10/04

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
    KCT0004346
    Unique Protocol ID KNUH-2019-07-008-001
    Public/Brief Title The effect evaluation of the transitional care intervention for respiratory disease patients
    Scientific Title The effect evaluation of the transitional care intervention for respiratory disease patients
    Acronym
    MFDS Regulated Study No
    IND/IDE Protocol
    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 KNUH-2019-07-008-001
    Approval Date 2019-08-14
    Institutional Review Board Name Kangwon National University Hospital Institutional Review Board
    Institutional Review Board Address 156, Baengnyeong-ro, Chuncheon-si, Gangwon-do
    Institutional Review Board Telephone 033-258-9199
    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 Heuisug Jo
    Title Professor
    Telephone +82-33-258-9266
    Affiliation Kangwon National University Hospital
    Address Baengnyeong-ro 156
    Contact Person for Public Queries
    Name Seungmin Jeong
    Title Associate Professor
    Telephone +82-33-258-9266
    Affiliation Kangwon National University Hospital
    Address Baengnyeong-ro 156
    Contact Person for Updating Information
    Name Seungmin Jeong
    Title Associate Professor
    Telephone +82-33-258-9266
    Affiliation Kangwon National University Hospital
    Address Baengnyeong-ro 156
  • 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 Recruiting
    Date of First Enrollment 2019-09-01 Actual
    Target Number of Participant 2373
    Primary Completion Date 2021-08-31 , Anticipated
    Study Completion Date 2021-12-31 , Anticipated
    Recruitment Status by Participating Study Site 1
    Name of Study Kangwon National University Hospital
    Recruitment Status Recruiting
    Date of First Enrollment 2019-09-01 ,
  • 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 Kangwon National University Hospital
    Organization Type Medical Institute
    Project ID
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Kangwon National University Hospital
    Organization Type Medical Institute
  • 7. Study Summary

    Study Summary Information
    Lay Summary
    Purpose: To see if there is a change in survival of patients with respiratory diseases (pneumonia, COPD, asthma)  when, the medical providers plan for post-discharge continuous medical and care services in the community after discharge. 
    
    METHODS: 1) Allocation of test and control groups: Allocate test and control groups according to the room where the patient is admitted.
    
    2) Basic data collection: All patients who are hospitalized should conduct a basic patient interview using a structured questionnaire.
    
    3) In-patient education: The nurse and the social worker prepare a medical problem list and a social welfare problem list for the patient in the test group and prepare goals and plans accordingly. The social worker explains the overall business to the patient and the caregiver, and the nurse provides individualized education on the disease and management, which takes about 30 minutes to the patient and the caregiver within 3 days of admission.
    
    4) Management of patients during hospitalization: The nurse in charge checks the patient's important events through daily electronic medical records and interviews every three days.
    
    5) Discharge Education and Discharge: The nurse in charge provides discharge training materials and provides personalized training for 60 minutes. Your caseworker introduces, links, and registers community care programs available to patients after discharge.
    For the control group, the nurse in charge presents the discharge education materials pamphlet for the inpatient diagnosis of the patient.
    
    6) Fill out and provide the discharge patient form: The nurse and the social worker fill out the discharge patient form for the patient in the test group.The discharge patient form is registered in the public medical cooperation network established by the National Medical Center. The primary medical institutions, public health centers, and welfare service providers who use the hospitals to identify the medical condition and care status of the patients and provide appropriate services. Make this form available to medical institutions and services that are not registered at
    
    7) Post-discharge patient management: The nurse / social worker in charge 1 and 2 weeks after the discharge of the patient confirms and encourages the management status after discharge by phone.
    
    8) Confirmation of results: Confirmation of the outcome variables by telephone 30, 90 and 6 months after the patient was discharged.
  • 8. Study Design

    Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
    Study Type Interventional Study
    Study Purpose
     Health Services Research
    Phase Not applicable
    Intervention Model Parallel  
    Blinding/Masking Open
    Allocation RCT
    Intervention Type Others (Health service provide)
    Intervention Description
    For the trial group, provide patient education prior to discharge, provide community services after discharge, and provide phone management after discharge.
    Only discharge training materials brochure is provided for the control group
    Number of Arms 2
    Arm 1

    Arm Label

    Experimental group

    Target Number of Participant

    1249

    Arm Type

    Experimental

    Arm Description

    1) In-patient education: The nurse and the social worker prepare a medical problem list and a social welfare problem list for the patient in the test group and prepare goals and plans accordingly. The social worker explains the overall business to the patient and the caregiver, and the nurse provides individualized education on the disease and management, which takes about 30 minutes to the patient and the caregiver within 3 days of admission.
    
    2) Management of patients during hospitalization: The nurse in charge checks the patient's important events through daily electronic medical records and interviews every three days.
    
    3) Discharge Education and Discharge: The nurse in charge provides discharge training materials and provides personalized training for 60 minutes. Your caseworker introduces, links, and registers community care programs available to patients after discharge.
    
    4) Fill out and provide the discharge patient form: The nurse and the social worker fill out the discharge patient form for the patient in the test group.The discharge patient form is registered in the public medical cooperation network established by the National Medical Center. The primary medical institutions, public health centers, and welfare service providers who use the hospitals to identify the medical condition and care status of the patients and provide appropriate services. Make this form available to medical institutions and services that are not registered at
    
    5) Post-discharge patient management: The nurse / social worker in charge 1 and 2 weeks after the discharge of the patient confirms and encourages the management status after discharge by phone.
    Arm 2

    Arm Label

    Control group

    Target Number of Participant

    1124

    Arm Type

    No intervention

    Arm Description

    The nurse in charge presents the discharge education materials pamphlet for the inpatient diagnosis of the patient.
  • 9. Subject Eligibility

    Subject Eligibility Information
    Condition(s)/Problem(s) * (J00-J99)Diseases of the respiratory system 
       (J98.9)Respiratory disorder, unspecified 

    Pneumonia, COPD, Asthma
    Rare Disease No
    Inclusion Criteria

    Gender

    Both

    Age

    18Year~No Limit

    Description

    Adults 18 years of age and older who were hospitalized under the following diagnoses in Ward 82, Room 01~10, Respiratory Center, Kangwon National University Hospital during the study period
    Chronic obstructive pulmonary disease (COPD)
    - asthma
    - Pneumonia
    Exclusion Criteria
    -Patients who refuse to participate in this study
    -Patients who are being treated separately from general patients due to infection
    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
    re-admission
    Timepoint
    1 month, 3 months, 6 months after discharge
    Secondary Outcome(s) 1
    Outcome
    Emergency department visit
    Timepoint
    1 month, 3 months, 6 months after discharge
    Secondary Outcome(s) 2
    Outcome
    Patients' satisfaction
    Timepoint
    1 month, 3 months, 6 months after discharge
    Secondary Outcome(s) 3
    Outcome
    Survival
    Timepoint
    1 month, 3 months, 6 months after discharge
    Secondary Outcome(s) 4
    Outcome
    OPD compliance
    Timepoint
    1 month, 3 months, 6 months after discharge
  • 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 No
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