Status Approved
First Submitted Date
2020/12/13
Registered Date
2020/12/29
Last Updated Date
2023/03/03
CRIS Required
WHO ICTRP (International Clinical Trial Registry Platform) Required
1. Background
CRIS Registration Number |
KCT0005711 |
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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 |
2. Institutional Review Board / Ethics Committee
Board Approval Status | Submitted approval |
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Board Approval Number | 1041849-202010-BM-152-02 |
Approval Date | 2020-12-07 |
Institutional Review Board Name | Yonsei University Wonju Institutional Review Board |
Institutional Review Board Address | 1, Yeonsedae-gil, Heungeop-myeon, Wonju-si, Gangwon-do |
Institutional Review Board Telephone | 033-760-5238 |
Data Monitoring Committee |
3. Contact Details
Contact Person for Principal Investigator / Scientific Queries | |
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Name | JIHYUK PARK |
Title | Professor |
Telephone | +82-33-760-2450 |
Affiliation | Yonsei University |
Address | 50-1, Yonsei-ro, Seodaemun-gu, Seoul, 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 |
4. Status
Study Site | Single | |
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Overall Recruitment Status | Completed | |
Date of First Enrollment | 2021-02-01 Actual | |
Target Number of Participant | 50 | |
Primary Completion Date | 2021-03-19 , Actual | |
Study Completion Date | 2021-05-31 , Actual | |
Recruitment Status by Participating Study Site 1 | ||
Name of Study | Gyeonggi Provincial Medical Center Ansung Hospital | |
Recruitment Status | Completed | |
Date of First Enrollment | 2021-02-01 , |
5. Source of Monetary / Material Support
1. Source of Monetary/Material Support | |
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Organization Name | Yonsei University |
Organization Type | University |
Project ID | 1041849-202010-BM-15 |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | Yonsei University |
Organization Type | University |
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. |
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8. Study Design
Study Type | Interventional Study |
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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 | 2 |
Arm 1 |
Arm Label Time use intervention group |
Target Number of Participant 25 |
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Arm Type Experimental |
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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 |
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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 |
9. Subject Eligibility
Condition(s)/Problem(s) |
* (U00-U99)Codes for special purposes (U07.1)Coronavirus disease 2019, virus identified [COVID-19, virus identified] COVID19 |
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Rare Disease | No |
Inclusion Criteria |
Gender Both |
Age 18Year~No Limit |
|
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. Adults 18 years of age or older 4. Able and willing to participate in study and to sign a consent form |
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Exclusion Criteria |
1. Not medically stable 2. Have difficulty of using Korean or communication problems |
Healthy Volunteers | Yes |
10. Outcome Measure(s)
Type of Primary Outcome | Not applicable | |
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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) |
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Timepoint | The day before the start of the intervention, the day after the end of the intervention, and two weeks after discharge |
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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 |
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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