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Effects of time use intervention on occupational balance, mental health and quality of life in isolated COVID-19 patients : A Randomized Controlled study.

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

    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
    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
  • 2. Institutional Review Board / Ethics Committee

    Institutional Review Board Information
    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
    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 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 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

    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 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

    Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
    1. Source of Monetary/Material Support
    Organization Name Yonsei University
    Organization Type University
    Project ID 1041849-202010-BM-15
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Yonsei University
    Organization Type University
  • 7. Study Summary

    Study Summary Information
    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.
  • 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
     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

    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
  • 9. Subject Eligibility

    Subject Eligibility Information
    Condition(s)/Problem(s) * (U00-U99)Codes for special purposes 
       (U07.1)Coronavirus disease 2019, virus identified [COVID-19, virus identified] 

    COVID19
    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
    Exclusion Criteria
    1. Not medically stable
    2. Have difficulty of using Korean or communication problems
    Healthy Volunteers Yes
  • 10. Outcome Measure(s)

    Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
    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
  • 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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