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
CRIS Registration Number |
KCT0004346 |
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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
Board Approval Status | Submitted approval |
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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 Person for Principal Investigator / Scientific Queries | |
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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
Study Site | Single | |
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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
1. Source of Monetary/Material Support | |
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Organization Name | Kangwon National University Hospital |
Organization Type | Medical Institute |
Project ID |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | Kangwon National University Hospital |
Organization Type | Medical Institute |
7. Study Summary
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. |
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8. Study Design
Study Type | Interventional Study |
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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
Condition(s)/Problem(s) |
* (J00-J99)Diseases of the respiratory system (J98.9)Respiratory disorder, unspecified Pneumonia, COPD, Asthma |
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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)
Type of Primary Outcome | Efficacy | |
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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
Result Registered | No |
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12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | No |
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