UMIN-CTR Clinical Trial

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	Delay expected
Results Delay Reason	From April 2018 to March 2019, we conducted an intervention using case conferences for nurses and care workers in nine long-term care hospitals (five intervention groups and four control groups). After the implementation of the intervention, we conducted questionnaires and medical record surveys to verify the effectiveness of the intervention. We completely collected data through questionnaires and medical record surveys without any problems, and the data is currently being analyzed.
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events	Not applicable
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
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	2022 Year 04 Month 01 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000036353