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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000031831
Receipt No. R000036353
Scientific Title The verification of educational programs for nurses and care workers to improve care quality in Japanese long-term care hospitals.
Date of disclosure of the study information 2018/04/01
Last modified on 2019/03/27

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Basic information
Public title The verification of educational programs for nurses and care workers to improve care quality in Japanese long-term care hospitals.
Acronym The effects of intervention using case conferences on staff well-being in long-term care hospitals.
Scientific Title The verification of educational programs for nurses and care workers to improve care quality in Japanese long-term care hospitals.
Scientific Title:Acronym The effects of intervention using case conferences on staff well-being in long-term care hospitals.
Region
Japan

Condition
Condition Mental health
Classification by specialty
Nursing Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To conduct the intervention using case conferences and evaluate its effects on the mental health among nurses and care workers working in long-term care hospitals.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Burnout will be measured by the 17- item Japanese Burnout scale. Work engagement will be measured by the Japanese short version of the Utrecht work engagement scale.

We will conduct self-administered, anonymous questionnaire surveys four times: before the intervention (Baseline: Time 0), 3 months after the intervention (Time 1), 6 months after the intervention (Time 2) and 12 months after the baseline (Time 3).
Key secondary outcomes The perception of support from nursing managers and colleagues, care quality in their ward and job demands.Furthermore, physical restraint, urinary tract infection, incidence of pressure ulcer, number of patients who fell down and so on.

In addition to questionnaire surveys, We will conduct chart review: before the intervention (Baseline: Time 0), 6 months after the intervention (Time 2) and 12 months after the baseline (Time 3).

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking YES
Concealment

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 This intervention will consist of monthly,60-minute sessions, for a total of 6 months.

Course A
Receive intervention using case conferences first(Intervention group).
Interventions/Control_2 Course B
Receive intervention in the later phase (Control group).
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 Nurses and care workers working in the long-term care hospitals.
Key exclusion criteria Nurses and care workers who decline in the participation of this study.
Target sample size 160

Research contact person
Name of lead principal investigator
1st name Noriko
Middle name
Last name Yamamoto-Mitani
Organization The University of Tokyo
Graduate School of Medicine
School of Health Sciences and Nursing
Division name Department of Gerontological Home-Care & Long-term Care Nursing
Zip code 113-0033
Address 7-3-1 Hongo, Bunyo-ku, Tokyo 113-0033 Japan
TEL 03-5841-3508
Email noriko-tky@umin.ac.jp

Public contact
Name of contact person
1st name Yumiko
Middle name
Last name Saito
Organization The University of Tokyo Graduate School of Medicine School of Health Sciences and Nursing
Division name Department of Gerontological Home-Care & Long-term Care Nursing
Zip code 113-0033
Address 7-3-1 Hongo, Bunyo-ku, Tokyo 113-0033 Japan
TEL 03-5841-3508
Homepage URL
Email syumiko-tky@umin.ac.jp

Sponsor
Institute Department of Gerontological Home-Care & Long-term Care Nursing
School of Health Sciences and Nursing
Graduate School of Medicine
The University of Tokyo
Institute
Department

Funding Source
Organization Nippon Life Insurance Foundation and
the Univers 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 Office for Human Research Studies Graduate School of Medicine and Faculty of Medicine, The University of Tokyo
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo 113-0033 Japan
Tel 03-5841-0818
Email ethics@m.u-tokyo.ac.jp

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
2018 Year 04 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 Enrolling by invitation
Date of protocol fixation
2018 Year 02 Month 09 Day
Date of IRB
2017 Year 09 Month 04 Day
Anticipated trial start date
2018 Year 03 Month 01 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
2019 Year 03 Month 31 Day
Date trial data considered complete
2019 Year 03 Month 31 Day
Date analysis concluded
2022 Year 06 Month 30 Day

Other
Other related information

Management information
Registered date
2018 Year 03 Month 21 Day
Last modified on
2019 Year 03 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036353

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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