UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026240 |
|---|---|
| Receipt number | R000030138 |
| Scientific Title | Effects of stress management program for care worker |
| Date of disclosure of the study information | 2017/07/01 |
| Last modified on | 2018/08/31 11:27:22 |
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Basic information
Public title
Effects of stress management program for care worker
Acronym
Effects of stress management program for care worker
Scientific Title
Effects of stress management program for care worker
Scientific Title:Acronym
Effects of stress management program for care worker
Region
| Japan |
Condition
Condition
Care workers
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the effect of stress management program to care worker on mental health
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
General Health Questionnaire -12 (GHQ-12)
Key secondary outcomes
1. The dysfunctional beliefs and attitudes about sleep questionnaire (DBAS)
2. Stressor scale for care staff
3. Coping skills with Behavioral and Psychological Symptoms of Dementia
4. Time Management Scale
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Period: 1 day (6 hours; 90 minutes * 4 times)
Methods: Seminar training
Contents: To conduct the seminar focused on sleep, time management, communication skills, and Coping skills with BPSD
Evaluation: Three times (Before 1 month of the seminar, after the seminar, and after 1 month of the seminar)
Interventions/Control_2
They do not participate the seminar, but answer the questionnaire at each period.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Care workers who work in day and evening shift.
Key exclusion criteria
1.The staff whose main work is not personal care.
2.The staff who only work in day shift.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hikaru Oba |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Psychiatry, Graduate School of Medical Science
Zip code
Address
465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan
TEL
075-251-5612
hkroba@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hikaru Oba |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Psychiatry, Graduate School of Medical Science
Zip code
Address
465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan
TEL
075-251-5612
Homepage URL
hkroba@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
Pfizer Health Research Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 07 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 06 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 11 | Month | 15 | Day |
Date trial data considered complete
| 2017 | Year | 11 | Month | 30 | Day |
Date analysis concluded
| 2018 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 02 | Month | 21 | Day |
Last modified on
| 2018 | Year | 08 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030138
