UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026240
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email hkroba@koto.kpu-m.ac.jp

Sponsor
Institute Kyoto Prefectural University of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030138

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.