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criskorea@korea.kr
  • Status : Approved
    • First Submitted Date : 2020/12/13
    • Registered Date : 2020/12/29
    • Last Updated Date : 2020/12/21
Background Information
1.Background  
CRIS Registration Number KCT0005711 
Unique Protocol ID 1041849-202010-BM-152-02 
Public/Brief Title Effects of time use intervention on occupational balance, mental health and quality of life in COVID-19 patients 
Scientific Title Effects of time use intervention on occupational balance, mental health and quality of life in isolated COVID-19 patients : A Randomized Controlled study.  
Acronym  
MFDS Regulated Study No
IND/IDE Protocol No
Registered at Other Registry No
Healthcare Benefit
Approval Status
Not applicable
Institutional Review Board Information
2. Institutional Review Board/Ethics Committee  
Board Approval Status Submitted approval 
Board Approval Number 1041849-202010-BM-152-02 
Approval Date 2020-12-07 
Institutional Review Board  
- Name Yonsei University Wonju Institutional Review Board  
- Address 1, Yeonsedae-gil, Heungeop-myeon, Wonju-si, Gangwon-do 
- Telephone 033-760-5238 
Data Monitoring Committee    
Contact Details
3.Contact Details  
Contact Person for Principal Investigator / Scientific Queries
- Name JIHYUK PARK 
- Title Professor 
- Telephone +82-33-760-2450 
- Affiliation Yonsei University 
- Address 1, Yeonsedae-gil, Heungeop-myeon, Wonju-si, Gangwon-do, Republic of Korea 
Contact Person for Public Queries
- Name JAEHYU JUNG 
- Title graduate student 
- Telephone +82-31-8046-5380 
- Affiliation Yonsei University 
- Address 1, Yeonsedae-gil, Heungeop-myeon, Wonju-si, Gangwon-do, Republic of Korea 
Contact Person for Updating Information
- Name JAEHYU JUNG 
- Title graduate student 
- Telephone +82-31-8046-5380 
- Affiliation Yonsei University 
- Address 1, Yeonsedae-gil, Heungeop-myeon, Wonju-si, Gangwon-do, Republic of Korea 
Status
4. Status Status  
Study Site Single
Overall Recruitment Status Not yet recruiting  
Date of First Enrollment 2020-12-28 , Anticipated
Target Number of Participant 50
Primary Completion Date 2021-08-06 , Anticipated
Study Completion Date 2021-08-06 , Anticipated
Recruitment Status by Participating Study Site 1 
- Name of Study Site Gyeonggi Provincial Medical Center Ansung Hospital 
- Recruitment Status Not yet recruiting  
- Date of First Enrollment 2020-12-28 , Anticipated
Source of Monetary / Material Support 정보
5. Source of Monetary/Material Support  
Source of Monetary/Material Support1 
- Organization Name Yonsei University 
- Organization Type University  
- Project ID 1041849-202010-BM-15 
Sponsor Organization
6. Sponsor Organization  
Sponsor Organization 1 
- Organization Name Yonsei University 
- Organization Type University  
Study Summary
7. Study Summary  
Lay Summary World Health Organization(WHO) has declared COVID-19 an Public Health Emergency of International Concern(PHEIC)(WHO, 2020). The number of confirmed cases in Korea is also rapidly increasing. Patient confirmed or suspected as COVID-19 are isolated in hospital or residential treatment center(Central Disaster and Safety Countermeasures Headquarters, 2020). Isolation have advantage of preventing the spread of the virus, but there are several negative aspects(Jiménez et al., 2020). Isolation could lead to changes in lifestyle which a complex health measure that includes many factors such as personal values, life habit, and culture, and it could destroy the balance of meaningful work(Mandel, 1999; Kim, Sumi, 2016). In addition, isolated people could undergo stress, boredom, fear, anxiety, loneliness, excessive worry, and depression. Theses negative emotion could be a risk factor that deteriorating physical health and developing psychological diseases (Abad et al., 2010; Jiménez et al., 2020 ; Soheili, et al., 2020). It has been reported that lifestyle changes, occupational imbalances, and mental health problems in confirmed cases of COVID-19 due to environmental and psychological factors. However, there are few studies that applied intervention to them. Therefore, this study aims to investigate the effects of time use interventions on occupational balance, mental health, and quality of life in confirmed cases of COVID-19. Time use intervention is the scheduling of routines to promote time to engage in meaningful activities. Before and after the intervention, an evaluation tool is conducted that measures occupational balance, mental health and quality of life using the Google online survey form. The results of this study will serve as the basis for interventions that are conducive to occupational balance, mental health, and quality of life of confirmed cases. Also, it will be used as clinical evidence for coping with patients' isolation experiences.  
Study Design 정보
8. Study Design  
Study Type Interventional Study 
Study Purpose Supportive Care
Phase Not applicable 
Intervention Model Factorial  
Blinding/Masking Single 
Blinded Subject Subject 
Allocation RCT 
Intervention Type Behavioral  
Intervention Description 1. Time use intervention
- for experimental group
- A total of 10 sessions for 2 weeks, 5 times a weekday
- 1 day : step 1~3(about 40minitues)
- 2 day~10day : step 4(about 15minitues)
- Intervention is conducted over the phone. Tools which necessary for intervention are provided by the way that the therapist puts them in front of the patient`s room and then the patient takes them(Currently, the therapist is entering the ward every day due to quarantine work, so there is no additional problem for this).
- Step 1 (time use analysis)
1) Check occupational imbalance through K-LBI results
2) Analyzing time use through Occupational Questionnaire
- Step 2 (select occupation)
1) Thinking about a fixed time after hospitalization: time for meals, time for measuring vital signs, etc.
2) Listing the basic activities need to do : sleep, personal hygiene, etc., time to listen to remote classes if you are a student, or work time if you are an office worker if it is possible to work from home
3) Providing a list of activities available in the isolated room and selecting desired activity through an interview with the therapist
:  Stretching, physical activity with thera-band and dumbbells, stress management through relaxation activities, handicraft activities (knitting, coloring book, scratch book, foil art, jewelry embroidery, dream catcher making, etc.)
- Step 3 (placement of activities)
1) On the basis of the OQ (Operation Questionnaire), a meaningful tasks selected in step 2 are arranged at a pointless time period.
2) Set time for fixed, basic activities: time to wake up, time to sleep, time to personal hygiene, etc.
3) Set time for activities you want to do: physical activity time, leisure time, etc.
- Step 4 (Practice and involvement of therapist)
1) Implement as planned
2) Call the therapist every morning to discuss about previous day's time use and modifying activity if needed.

2. Provision of educational materials for self-education and exercise
- for control group
- Explained 1 sessions when hospitalized(30 minutes)
- Education materials are provided along with admission documents, and education is conducted over the phone.
- The educational materials were produced for corona patients, and we confirmed that there is no problem with the use of educational materials when the source is indicated by inquiring with the relevant institution.
- Educational material includes stress management and stabilization techniques.

3. Medical and conservative treatment
- for experimental group and control group
- Isolation and conservative treatment according to COVID-19 response guidelines
- Implemented according to the patient's condition by medical staff  
Number of Arms
Arm 1 Arm Label Time use intervention group 
Target Number of Participant 25 
Arm Type Experimental 
Arm Description 1. Time use intervention(Scheduling) - A total of 10 sessions for 2 weeks, 5 times a weekday - 1 day : step 1~3(about 40minitues) - 2 day~10day : step 4(about 15minitues) 2. Medical and conservative treatment - Isolation and conservative treatment according to COVID-19 response guidelines - Implemented according to the patient's condition by medical staff 
Arm 2 Arm Label Conventional treatment group 
Target Number of Participant 25 
Arm Type No intervention 
Arm Description 1. Provision of educational materials for self-education and exercise - Explained 1 sessions when hospitalized(30 minutes) 2. Medical and conservative treatment - Isolation and conservative treatment according to COVID-19 response guidelines - Implemented according to the patient's condition by medical staff 
Subject Eligibility Information
9. Subject  
Condition(s)/Problem(s) * Diseases of th respiratory system
COVID19  
Rare Disease No
Inclusion
Criteria
Gender Both 
Age 18 Year ~ 65 Year
Description 1. Diagnosed with COVID-19 and isolated in facility
2. Classified as mild by psychiatrist
- Without underlying respiratory disease
- Oxygen saturation is more than 95% and hemodynamically stable
- No have prominent pneumonia on the chest radiography image
3.18~65 years of aged patients
4. Able and willing to participate in study and to sign a consent form  
Exclusion Criteria 1. Not medically stable
2. Have difficulty of using Korean or communication problems  
Healthy Volunteers Yes
Outcome Measure(s) Information
10. Outcome Measure(s)  
Type of Primary Outcome Not applicable 
Primary Outcome(s) 1 
- Outcome K-LBI(Korean Version of Life Balance Inventory) 
- Timepoint The day before the start of the intervention, the day after the end of the intervention, and two weeks after discharge 
Primary Outcome(s) 2 
- Outcome PHQ-9 : (Patient Health Questionnaire-9) 
- Timepoint The day before the start of the intervention, the day after the end of the intervention, and two weeks after discharge 
Primary Outcome(s) 3 
- Outcome SAS(self rating anxiety scale) 
- Timepoint The day before the start of the intervention, the day after the end of the intervention, and two weeks after discharge 
Primary Outcome(s) 4 
- Outcome Korean version of Insomnia severity index(ISI-K) 
- Timepoint The day before the start of the intervention, the day after the end of the intervention, and two weeks after discharge 
Primary Outcome(s) 5 
- Outcome Korean version of WHOQOL-BREF(World Health Organization Quality of Life Assessment Instrument-BRIEF) 
- Timepoint The day before the start of the intervention, the day after the end of the intervention, and two weeks after discharge 
Secondary Outcome(s) 1 
- Outcome FCV-19S(Fear of COVID-19 scale) 
- Timepoint The day before the start of the intervention, the day after the end of the intervention, and two weeks after discharge 
Secondary Outcome(s) 2 
- Outcome Multidimensional State Boredom Scale-8(MSBS-8) 
- Timepoint The day before the start of the intervention, the day after the end of the intervention, and two weeks after discharge 
Study Results and Publication Information
11. Study Results and Publication
Result Registerd No
Sharing of Study Data Information
12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement Yes 
Time of Sharing 2020-09
Way of Sharing Available on Request