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  • Status : Approved
    • First Submitted Date : 2020/04/08
    • Registered Date : 2020/06/16
    • Last Updated Date : 2020/06/12
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1. Background

Background Information
CRIS
Registration Number
KCT0005135 
Unique Protocol ID HL19C0023 
Public/Brief Title Development of service model and program for alcohol addiction treatment 
Scientific Title Development of hospital, community integrated service model and program for alcohol addiction treatment  
Acronym ALCOHOL ADDICTION TREATMENT SERVICE PROGRAM 
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 CHUNCHEON 2019-02-010-004 
Approval Date 2020-03-27 
Institutional Review Board  
Name Chuncheon Sacred Heart Hospital Institusional Review Board/Ethics Committee 
Address 77, Sakju-ro, Chuncheon-si, Gangwon-do 
Telephone 033-240-5128 
Data Monitoring Committee No  

3. Contact Details

Contact Details Information
Contact Person for Principal Investigator / Scientific Queries  
Name Sang-Kyu Lee 
Title Professor 
Telephone +82-33-240-5174 
Affiliation Hallym University 
Address 77, Sakju-ro, Chuncheon-si, Gangwon-do 
Contact Person for Public Queries
Name Sang-Wook Park 
Title Researcher 
Telephone +82-33-255-3482 
Affiliation Hallym University 
Address Chuncheon Community Addiction Management Center, 3rd, 84, Sakju-ro, Chuncheon-si, Gangwon-do 
Contact Person for Updating Information
Name Sang-Kyu Lee 
Title Professor 
Telephone +82-33-240-5174 
Affiliation Hallym University 
Address 77, Sakju-ro, Chuncheon-si, Gangwon-do 

4. Status

Status Information
Study Site Multi-center (Number of center : 3)
Overall Recruitment Status Not yet recruiting  
Date of First Enrollment 2020-07-06 , Anticipated
Target Number of Participant 1,000
Primary Completion Date 2021-11-30 , Anticipated
Study Completion Date 2021-12-31 , Anticipated
Recruitment Status by Participating Study Site 1
Name of Study Site Hallym University Medical Center- Chuncheon 
Recruitment Status Not yet recruiting  
Date of First Enrollment 2020-07-06 , Anticipated
Recruitment Status by Participating Study Site 2
Name of Study Site Hanyang University Seoul Hospital 
Recruitment Status Not yet recruiting  
Date of First Enrollment 2020-07-06 , Anticipated
Recruitment Status by Participating Study Site 3
Name of Study Site Konyang University Hospital 
Recruitment Status Not yet recruiting  
Date of First Enrollment 2020-07-06 , Anticipated

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information
Source of Monetary/Material Support 1   
Organization Name Ministry of Health & Welfare 
Organization Type Government  
Project ID HL19C0023 

6. Sponsor Organization

Sponsor Organization Information
Sponsor Organization 1   
Organization Name Hallym University 
Organization Type University  

7. Study Summary

Study Summary Information
Lay Summary [Purpose]
The purpose of this study is to promote national health by strengthening the effect of alcohol treatment trhough integrated treatment services and effective programs

[Background]
To recover from alocoholism, an optimal clinical treatment process including continuum is required, and systematic and effective treatment programs accordig to appropriate treatment arragnements and integrated tretmnet services linked to medical institutions nand communities should be provided

[Hypothesis]
Patients who reveive integrated treatment serivces will have a higher rate of treatment compliance than patients who do not.

[Study Plan]
Depending on the patient's overall condition, they are placed at the appropriate treatment level. After 1, 3, and 6 months, follow-up evaluation was conducted to investigate how the patient's overall condition changed and treatment compliance.  

8. Study Design

Study Design Information
Study Type Interventional Study 
Study Purpose Treatment    
Phase Not applicable 
Intervention Model Single Group  
Blinding/Masking Open 
Allocation Non-RCT 
Intervention Type Behavioral  
Intervention Description (1) level 0.5 (Community center intervention)
- One or more of the following programs 1) Participate more than once in 2 weeks 2) More than 50% of the total session of the program or more than 4 hours/month
○ SIBIRT
• Program for patients placed in level 0.5 by K-PPC algorithm
○ abstinence program
• Program to improve the cognitive, emotional, and interpersonal relationships of patient
○ Community center case management
• Regular / irregular home visits, telephone consultations, center visits, sue management, rehabilitation programs, etc.

(2) Level 1 (Basic outpatient)
- Drug treatment and 1 or more of the following programs 1) Participated more than once every 2 weeks 2) More than 50% of the total session of the program or more than 4 hours / month

(3) Level 2 (Intense outpatient)
- Drug treatment and 2 or more of the following programs 1) Participated more than once every 2 weeks 2) More than 50% of the total session of the program or more than 4 hours / month

(4) Level 3 (Basic inpatient)
- 1) Frequency of treatment: 3 or more times a week, 2) Criteria for participation in treatment: Participation in 2 or more programs excluding drug treatment among the following programs (or own program), 3) Criteria for completing the program: 50% or more of the total session of each program or the total program participation time is 8 hours / month or more

(5) Level 4 (Intense outpatient)
- 1) Frequency of treatment: 3 or more times a week, 2) Criteria for participation in treatment: Participation in 3 or more programs excluding drug treatment among the following programs (case management (hospital/community center program required)), 3) Criteria for completing the program: 50% or more of the total session of each program or the total program participation time is 12 hours / month or more
○ Drug treatment
• Taking medication prescribed by a doctor
○ MET (motivational enhancement therapy)
• Enhance the motivation for change to abstinence by recognizing the problem and accepting the need for change
○ CBT (cognitive behavioral therapy)
• Providing programs to realize and change the relationship between cognition, behavior, and emotions related to alcohol
○ 12 step principle
• Providing 12-step program to promote AA meeting attendance
○ Relapse prevention program
• Improve risk coping ability by checking risk factors of re-drinking in a crisis situation that can lead to relapse after discharge
○ Disease education
• Introducing definitions, symptoms, and treatment methods for alcohol use disorders
○ Family therapy
• Promoting changes in family members through the process of finding out what effects alcohol dependence has on their families
○ Hospital case management
• The patient's condition and needs are kept assessing after discharge, and filling the gap in treatment through appropriate intervention and community linkage.
○ Community center case management
• Regular / irregular home visits, telephone consultations, center visits, sue management, rehabilitation programs, etc.
○ Therapeutic community or Alcoholics Anonymous
• Sharing own stories to help other alcoholics.  
Number of Arms
Arm 1 Arm Label Intervention group based on K-PPC (Korean version of patient placement criteria) 
Target Number of Participant 1000 
Arm Type Experimental 
Arm Description (1) level 0.5 (Community center intervention) - One or more of the following programs 1) Participate more than once in 2 weeks 2) More than 50% of the total session of the program or more than 4 hours/month ○ SIBIRT • Program for patients placed in level 0.5 by K-PPC algorithm ○ abstinence program • Program to improve the cognitive, emotional, and interpersonal relationships of patient ○ Community center case management • Regular / irregular home visits, telephone consultations, center visits, sue management, rehabilitation programs, etc. (2) Level 1 (Basic outpatient) - Drug treatment and 1 or more of the following programs 1) Participated more than once every 2 weeks 2) More than 50% of the total session of the program or more than 4 hours / month (3) Level 2 (Intense outpatient) - Drug treatment and 2 or more of the following programs 1) Participated more than once every 2 weeks 2) More than 50% of the total session of the program or more than 4 hours / month (4) Level 3 (Basic inpatient) - 1) Frequency of treatment: 3 or more times a week, 2) Criteria for participation in treatment: Participation in 2 or more programs excluding drug treatment among the following programs (or own program), 3) Criteria for completing the program: 50% or more of the total session of each program or the total program participation time is 8 hours / month or more (5) Level 4 (Intense outpatient) - 1) Frequency of treatment: 3 or more times a week, 2) Criteria for participation in treatment: Participation in 3 or more programs excluding drug treatment among the following programs (case management (hospital/community center program required)), 3) Criteria for completing the program: 50% or more of the total session of each program or the total program participation time is 12 hours / month or more ○ Drug treatment • Taking medication prescribed by a doctor ○ MET (motivational enhancement therapy) • Enhance the motivation for change to abstinence by recognizing the problem and accepting the need for change ○ CBT (cognitive behavioral therapy) • Providing programs to realize and change the relationship between cognition, behavior, and emotions related to alcohol ○ 12 step principle • Providing 12-step program to promote AA meeting attendance ○ Relapse prevention program • Improve risk coping ability by checking risk factors of re-drinking in a crisis situation that can lead to relapse after discharge ○ Disease education • Introducing definitions, symptoms, and treatment methods for alcohol use disorders ○ Family therapy • Promoting changes in family members through the process of finding out what effects alcohol dependence has on their families ○ Hospital case management • The patient's condition and needs are kept assessing after discharge, and filling the gap in treatment through appropriate intervention and community linkage. ○ Community center case management • Regular / irregular home visits, telephone consultations, center visits, sue management, rehabilitation programs, etc. ○ Therapeutic community or Alcoholics Anonymous • Sharing own stories to help other alcoholics. 

9. Subject Eligibility

Subject Eligibility Information
Condition(s) / Problem(s) * Factors influencing health status and contact with health servisces
 Alcohol Drinking    
Rare Disease No
Inclusion
Criteria
Gender Both 
Age 18 Year ~ No Limit
Description ① Those with Korean nationality <br />② Men with scores of 10 or higher and women with scores of 6 or higher on the AUDIT-K screening test <br />③ Those who have thoroughly read the introductory leaflet for this study, understood the content, and given their consent to participation in the study    
Exclusion Criteria ① A person with history of brain damage and organic mental disroder in confirmed <br />② Those with suspected intellectual disabilities  
Healthy Volunteers No

10. Outcome Measure(s)

Outcome Measure(s) Information
Type of Primary Outcome Efficacy 
Primary Outcome(s) 1 
Outcome Attending 50% or more of recommended treatment 
Timepoint Time point: f/u 3 months, 6 months 
Secondary Outcome(s) 1 
Outcome Hospital-community center linkage rate 
Timepoint Time point: f/u 3 months, 6 months 
Secondary Outcome(s) 2 
Outcome Symptoms related to acloholism (Alcohol consumption, readiness to change, insight, depression) 
Timepoint Time point: f/u 3 months, 6 months 

11. Study Results and Publication

Study Results and Publication Information
Result Registered No

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information
Sharing Statement No 
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